38 rri m S A F~ cAP) I t~A CL OS U lrg ON A150cc HDPEROUND BOTTLE
for SenibIltResecuringEffectiveness
forariBlarcorri C losu r es I nc
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Dear MrScud~ri - -
bullbull He rein is ~ urJeport titled Evaluatjmiddotonof t1 1 ~038n1i11 SAF-CAP III ~A CLOSuREONA 150cc HD PE ROUND B OT f CE forSeni or-ResecLlring Eftectivenes s forV anBlarcom Closures I nc
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T Ie teslunit was evaluated by usingthe ConsumerProduct SafetyCommission Protocciand Standards In thestudy the testunitfulfi llstherequirements for senior-resecuringeffectiveness as
perthe Cod e ofFederalReguations (CFf) Tit le 16 Part 1700 with final rule changes cited in bull the federal Register VoL60 No 140 Friday July21 199 ~ pp middot 377 10 to 377~4
1 After you middothave had an opportunity to read the report I will -be pleased to review It Iith you ~
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~ middotSi8cerel y PERlUT t LADORATOrUES I ~ C
o - ~ti~~~ - Richa rd A Watd~
~Direc t o r ofC~nsu nf er Product Testing
Pace 2 of26 0
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41 SUM11ARY
II INTRODUCT ION 5
6
IlL c PROCEDURE
pHbtOG ~ApH ()F UNIT 16
IV RESULTS A ND DISC USSI ON 17
v COl lCLUSTON 18
TABLES 19
INTER YIEVE R A N D METHOD CODES 25
A bpENDUt1
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middot R eport to V~n ~ B l ill ~~m Ci6smiddotti rmiddotes r~c i
middot S amp f~s ot lt middot middot 3smrrimiddot S AF~CAP middotnfA Ci6SUREON middot~ middot ~ middot lt -
A I 50~c HDPE middotRO0ND J3middotOTTLE- middotmiddot lt gt Co ntract N o lt 1 2 7 1 ~0 1 i c
SamplesmiddotReceivec Se ptember 8 1997 ~ -
S ubrnitted by gt V inceScuderi
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~ The protoco l fort fie cvaluation of packaging fo r poison preventio n CCFRmiddot T i l ~ ( 6Pa rt t700 wi th fi nal rule changescited int heFederalReg isterV6L 60 No 140FridaYiJuly 21 1995 pp
~ ~ r 37710 to 37744) was strictlyadhered to for t hisltstlldy
Panelists
middot~ middotIrl t he course o f thisstudy lOuscniors (50to 7qye~ ~-6Id s 70 fen1~l e) ~middot~~e ~ri1ploAd middot An middotmiddot lt
add itional 100 c hUdren we re employed totestthe packag esthattheseniorsreclosed r
Thisstudy does not include (j 50 child sequential test panel for chilcl-resistarH efl~ct j ven es s as -
stipulated in the reg ulation
Resultsof t l~e studyi ndicate that the 38mmS AF~CAP III A CLOS URE ONA ImiddotSOccHDPE RO UNDBOTTLE flilfills theslandardsfor se nlo r-resecu ring effecrivenessa ccordingto CF R
T it(e 16Part l 700 vitil fi nal rule changes middotcit ~ d-i r1 t h ~ Fed eral Register ~ol middot 60 No I40 Friday Juty middot2I) 995 PPJ77 10 to 3 77~4 middot middot
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bullmiddotmiddotbull V~n B larcentOm C I9 sur~S I~ ~ishdi( d~t~I~ i~ i(lh~3~l1~ShGJIII-ict6~3ti6N gtmiddot 150cc HDP E R QUND BOTTLE fulfills the Consumer P ro ductSafetj Con1n1isstonsCPS C) sta ndards and protoeols fors enior-resecuring effectiveness set forth inthe Codeof Federal ltgt RegulationsTitle16 j Part l7 00 twit~Jiri ~1 rule cC1 ~nges ~ itedd ri t heFed epi l Reg i st e r VoL6QNo 140 Friday ] ulY 2 1 19 9 pp 3 77 1atq) 77 44 ~gerri ttLabOJa to ri es Inc aNANfASaccredited labor~a to ryt fortesting child-resistan( paGkaginga-ccor dirg t6 t h~ CPSCpro ioco Va~ requested bull bull
to evaluate the packaging usirrgtheabove protocoL
Perritt Labo r~torie~ln~ j ~n i nd e~~~de n [ t esting l~b~r at o ry ~il asb~~nev~I~ a t ng middotch i-10 ~ r~~ i~ta ~t p a~kag i f1g for both indusryandgovernment fo r -ove r twenty years Th~ c6mpa ~y is recog nized
as t he leader i nt hefi eld by virtue ofhavingemp loyed hund reds Ofthousandsofpanelistsand middot evalLlate d thousands ~f pack ag i ngco n c ep t s for chil d -res i s t ance ~ Pe rri ttL -bo ra t o ~ i es I nc u til izes s tandard operating p roceclUr~ ( SOP ~ ) middot alo ng vith~q Li al i ty as surance prograns inacco rdance wi th good I a b o ra to ry pr~d i c cs(GLP) fo r no n-clinical la bora to ries - bull
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gt l rl tlcc6urse bftliscvaluation the packagirig vas tested w i tl p~n el s cQ r1 s i s ting cilOb ~~n i 6 rs5 0 lo70 )ear- o lds 70 femal e) andI 00 children (42 t0 5 1 mo nthsof age evenlyd istributed) bull
bull obtainedfro rh nursery schoo i s middotd ayCare ce~ t e rs and civicg roups The data derived frointhe middot study were assembledin a meani ngful fashiori ahdrevi ewed t o d e t e rm i nfhet he r t h c p ~ckagi ng metthe cited standardforpoison p rev e n tiOnP ack aging i t h re~ecwing effectiv eness presented
Perritt Labo r~t o r i c s InC received its updated tJ AMAS ac~ re~l i t at i o il ( 14 5 7 Sll l)fort es t i ng
~packaging for child-resistance according to CPSCs
fi nalru li ng published in theFederal R~g~
i s t e r
Vo l 60 No 140 pp 377 10 to 3774 4 in August of 1995
NAt1AS is the Natiomd Measurement Accreditation Service of the jnited Kingdo nl Organizations a ccredtted by NM 1AS meet thereq uirements of EN4SOOI ISO Guide is andthe releantrequirenleiltso ft he ISO 9000E N29000113 5 57 50 ser iesof standards including t h ~se of
the l1lodeldescribed in ISO 9002(EN 2900-218 55750 Pa~t middot 2 wh en acting as supplie rs p roducing tesLr Cslllts ~
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-bull Cod ~ ofFede r~i RegulaionsTi tl ~ 1 6 ~ Part 1 7()O lt with fi~al TUt~ changes cited inthe Federal
1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
middot middot1 middot
170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
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requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
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NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
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perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
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whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
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1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
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sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
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N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
I
- -
~ ~
bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
~
v
~
- -gt
bullbull I bullbull
- ~
shy
- ~
~ bull ~
Pag e middot150f2(5 ~
~ I
lt ~ v bull
vVan l3 iCOrll C1 o s ~ l r c s Ir ~ c ~
12 71 ~O J7 shyNbembcr pound7 997 I
shy
~
~ gt
~ -
~ - ~ -
~ - J
v--
i - ~ ~
)
~
lt shy
t
~~
bull t -
~ ~ ~ --
~
~
t
~I l i i~ SAhCA P II lA-(I OSU l i o~ L~(rc I top r rt ()ut) t)irnlLl
Fi~u hl
~
-
t o
~
~
middott ~~~ ~ ~~ ~ ~ -
shybull ~ bullbull I
middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
~
)
~ ~ ~
I bull bull ~ bull t bull bull ~ bull
- bull bullbull lt bull bull bull 1 ~
~ - ~ -~ - -
middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
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Dear MrScud~ri - -
bullbull He rein is ~ urJeport titled Evaluatjmiddotonof t1 1 ~038n1i11 SAF-CAP III ~A CLOSuREONA 150cc HD PE ROUND B OT f CE forSeni or-ResecLlring Eftectivenes s forV anBlarcom Closures I nc
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T Ie teslunit was evaluated by usingthe ConsumerProduct SafetyCommission Protocciand Standards In thestudy the testunitfulfi llstherequirements for senior-resecuringeffectiveness as
perthe Cod e ofFederalReguations (CFf) Tit le 16 Part 1700 with final rule changes cited in bull the federal Register VoL60 No 140 Friday July21 199 ~ pp middot 377 10 to 377~4
1 After you middothave had an opportunity to read the report I will -be pleased to review It Iith you ~
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~ middotSi8cerel y PERlUT t LADORATOrUES I ~ C
o - ~ti~~~ - Richa rd A Watd~
~Direc t o r ofC~nsu nf er Product Testing
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41 SUM11ARY
II INTRODUCT ION 5
6
IlL c PROCEDURE
pHbtOG ~ApH ()F UNIT 16
IV RESULTS A ND DISC USSI ON 17
v COl lCLUSTON 18
TABLES 19
INTER YIEVE R A N D METHOD CODES 25
A bpENDUt1
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middot R eport to V~n ~ B l ill ~~m Ci6smiddotti rmiddotes r~c i
middot S amp f~s ot lt middot middot 3smrrimiddot S AF~CAP middotnfA Ci6SUREON middot~ middot ~ middot lt -
A I 50~c HDPE middotRO0ND J3middotOTTLE- middotmiddot lt gt Co ntract N o lt 1 2 7 1 ~0 1 i c
SamplesmiddotReceivec Se ptember 8 1997 ~ -
S ubrnitted by gt V inceScuderi
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~ The protoco l fort fie cvaluation of packaging fo r poison preventio n CCFRmiddot T i l ~ ( 6Pa rt t700 wi th fi nal rule changescited int heFederalReg isterV6L 60 No 140FridaYiJuly 21 1995 pp
~ ~ r 37710 to 37744) was strictlyadhered to for t hisltstlldy
Panelists
middot~ middotIrl t he course o f thisstudy lOuscniors (50to 7qye~ ~-6Id s 70 fen1~l e) ~middot~~e ~ri1ploAd middot An middotmiddot lt
add itional 100 c hUdren we re employed totestthe packag esthattheseniorsreclosed r
Thisstudy does not include (j 50 child sequential test panel for chilcl-resistarH efl~ct j ven es s as -
stipulated in the reg ulation
Resultsof t l~e studyi ndicate that the 38mmS AF~CAP III A CLOS URE ONA ImiddotSOccHDPE RO UNDBOTTLE flilfills theslandardsfor se nlo r-resecu ring effecrivenessa ccordingto CF R
T it(e 16Part l 700 vitil fi nal rule changes middotcit ~ d-i r1 t h ~ Fed eral Register ~ol middot 60 No I40 Friday Juty middot2I) 995 PPJ77 10 to 3 77~4 middot middot
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bullmiddotmiddotbull V~n B larcentOm C I9 sur~S I~ ~ishdi( d~t~I~ i~ i(lh~3~l1~ShGJIII-ict6~3ti6N gtmiddot 150cc HDP E R QUND BOTTLE fulfills the Consumer P ro ductSafetj Con1n1isstonsCPS C) sta ndards and protoeols fors enior-resecuring effectiveness set forth inthe Codeof Federal ltgt RegulationsTitle16 j Part l7 00 twit~Jiri ~1 rule cC1 ~nges ~ itedd ri t heFed epi l Reg i st e r VoL6QNo 140 Friday ] ulY 2 1 19 9 pp 3 77 1atq) 77 44 ~gerri ttLabOJa to ri es Inc aNANfASaccredited labor~a to ryt fortesting child-resistan( paGkaginga-ccor dirg t6 t h~ CPSCpro ioco Va~ requested bull bull
to evaluate the packaging usirrgtheabove protocoL
Perritt Labo r~torie~ln~ j ~n i nd e~~~de n [ t esting l~b~r at o ry ~il asb~~nev~I~ a t ng middotch i-10 ~ r~~ i~ta ~t p a~kag i f1g for both indusryandgovernment fo r -ove r twenty years Th~ c6mpa ~y is recog nized
as t he leader i nt hefi eld by virtue ofhavingemp loyed hund reds Ofthousandsofpanelistsand middot evalLlate d thousands ~f pack ag i ngco n c ep t s for chil d -res i s t ance ~ Pe rri ttL -bo ra t o ~ i es I nc u til izes s tandard operating p roceclUr~ ( SOP ~ ) middot alo ng vith~q Li al i ty as surance prograns inacco rdance wi th good I a b o ra to ry pr~d i c cs(GLP) fo r no n-clinical la bora to ries - bull
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gt l rl tlcc6urse bftliscvaluation the packagirig vas tested w i tl p~n el s cQ r1 s i s ting cilOb ~~n i 6 rs5 0 lo70 )ear- o lds 70 femal e) andI 00 children (42 t0 5 1 mo nthsof age evenlyd istributed) bull
bull obtainedfro rh nursery schoo i s middotd ayCare ce~ t e rs and civicg roups The data derived frointhe middot study were assembledin a meani ngful fashiori ahdrevi ewed t o d e t e rm i nfhet he r t h c p ~ckagi ng metthe cited standardforpoison p rev e n tiOnP ack aging i t h re~ecwing effectiv eness presented
Perritt Labo r~t o r i c s InC received its updated tJ AMAS ac~ re~l i t at i o il ( 14 5 7 Sll l)fort es t i ng
~packaging for child-resistance according to CPSCs
fi nalru li ng published in theFederal R~g~
i s t e r
Vo l 60 No 140 pp 377 10 to 3774 4 in August of 1995
NAt1AS is the Natiomd Measurement Accreditation Service of the jnited Kingdo nl Organizations a ccredtted by NM 1AS meet thereq uirements of EN4SOOI ISO Guide is andthe releantrequirenleiltso ft he ISO 9000E N29000113 5 57 50 ser iesof standards including t h ~se of
the l1lodeldescribed in ISO 9002(EN 2900-218 55750 Pa~t middot 2 wh en acting as supplie rs p roducing tesLr Cslllts ~
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1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
middot middot1 middot
170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
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requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
Page 6 d f2 G
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NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
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perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
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whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
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9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
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r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
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th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
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bull bull1
-
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gt ~
~
~ ~ fmiddot
- ~gt r ~
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middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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Pag e middot150f2(5 ~
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~
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middott ~~~ ~ ~~ ~ ~ -
shybull ~ bullbull I
middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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- bull bullbull lt bull bull bull 1 ~
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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EYalu atib~ 6f he 3 8 n~m S AF~tAP i tl~AcLosuRE o A 15bb6HDPE ROUNb
BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
c -
igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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6 l middot1 1 0 6 9 7 C888middot middotJ7 4 1 0 9 4 43 Mmiddotmiddot60l lt O lt
62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
middot S amp f~s ot lt middot middot 3smrrimiddot S AF~CAP middotnfA Ci6SUREON middot~ middot ~ middot lt -
A I 50~c HDPE middotRO0ND J3middotOTTLE- middotmiddot lt gt Co ntract N o lt 1 2 7 1 ~0 1 i c
SamplesmiddotReceivec Se ptember 8 1997 ~ -
S ubrnitted by gt V inceScuderi
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~ The protoco l fort fie cvaluation of packaging fo r poison preventio n CCFRmiddot T i l ~ ( 6Pa rt t700 wi th fi nal rule changescited int heFederalReg isterV6L 60 No 140FridaYiJuly 21 1995 pp
~ ~ r 37710 to 37744) was strictlyadhered to for t hisltstlldy
Panelists
middot~ middotIrl t he course o f thisstudy lOuscniors (50to 7qye~ ~-6Id s 70 fen1~l e) ~middot~~e ~ri1ploAd middot An middotmiddot lt
add itional 100 c hUdren we re employed totestthe packag esthattheseniorsreclosed r
Thisstudy does not include (j 50 child sequential test panel for chilcl-resistarH efl~ct j ven es s as -
stipulated in the reg ulation
Resultsof t l~e studyi ndicate that the 38mmS AF~CAP III A CLOS URE ONA ImiddotSOccHDPE RO UNDBOTTLE flilfills theslandardsfor se nlo r-resecu ring effecrivenessa ccordingto CF R
T it(e 16Part l 700 vitil fi nal rule changes middotcit ~ d-i r1 t h ~ Fed eral Register ~ol middot 60 No I40 Friday Juty middot2I) 995 PPJ77 10 to 3 77~4 middot middot
-
Pane 4 bf2 6 middotmiddotmiddot v
- - bull gt -
Van BlarcomClosures Ir1C ~ ~
gt~ 1 2 7 1~ 0 17 gt ~
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rr~ INTRODuctroN
bullmiddotmiddotbull V~n B larcentOm C I9 sur~S I~ ~ishdi( d~t~I~ i~ i(lh~3~l1~ShGJIII-ict6~3ti6N gtmiddot 150cc HDP E R QUND BOTTLE fulfills the Consumer P ro ductSafetj Con1n1isstonsCPS C) sta ndards and protoeols fors enior-resecuring effectiveness set forth inthe Codeof Federal ltgt RegulationsTitle16 j Part l7 00 twit~Jiri ~1 rule cC1 ~nges ~ itedd ri t heFed epi l Reg i st e r VoL6QNo 140 Friday ] ulY 2 1 19 9 pp 3 77 1atq) 77 44 ~gerri ttLabOJa to ri es Inc aNANfASaccredited labor~a to ryt fortesting child-resistan( paGkaginga-ccor dirg t6 t h~ CPSCpro ioco Va~ requested bull bull
to evaluate the packaging usirrgtheabove protocoL
Perritt Labo r~torie~ln~ j ~n i nd e~~~de n [ t esting l~b~r at o ry ~il asb~~nev~I~ a t ng middotch i-10 ~ r~~ i~ta ~t p a~kag i f1g for both indusryandgovernment fo r -ove r twenty years Th~ c6mpa ~y is recog nized
as t he leader i nt hefi eld by virtue ofhavingemp loyed hund reds Ofthousandsofpanelistsand middot evalLlate d thousands ~f pack ag i ngco n c ep t s for chil d -res i s t ance ~ Pe rri ttL -bo ra t o ~ i es I nc u til izes s tandard operating p roceclUr~ ( SOP ~ ) middot alo ng vith~q Li al i ty as surance prograns inacco rdance wi th good I a b o ra to ry pr~d i c cs(GLP) fo r no n-clinical la bora to ries - bull
I
gt l rl tlcc6urse bftliscvaluation the packagirig vas tested w i tl p~n el s cQ r1 s i s ting cilOb ~~n i 6 rs5 0 lo70 )ear- o lds 70 femal e) andI 00 children (42 t0 5 1 mo nthsof age evenlyd istributed) bull
bull obtainedfro rh nursery schoo i s middotd ayCare ce~ t e rs and civicg roups The data derived frointhe middot study were assembledin a meani ngful fashiori ahdrevi ewed t o d e t e rm i nfhet he r t h c p ~ckagi ng metthe cited standardforpoison p rev e n tiOnP ack aging i t h re~ecwing effectiv eness presented
Perritt Labo r~t o r i c s InC received its updated tJ AMAS ac~ re~l i t at i o il ( 14 5 7 Sll l)fort es t i ng
~packaging for child-resistance according to CPSCs
fi nalru li ng published in theFederal R~g~
i s t e r
Vo l 60 No 140 pp 377 10 to 3774 4 in August of 1995
NAt1AS is the Natiomd Measurement Accreditation Service of the jnited Kingdo nl Organizations a ccredtted by NM 1AS meet thereq uirements of EN4SOOI ISO Guide is andthe releantrequirenleiltso ft he ISO 9000E N29000113 5 57 50 ser iesof standards including t h ~se of
the l1lodeldescribed in ISO 9002(EN 2900-218 55750 Pa~t middot 2 wh en acting as supplie rs p roducing tesLr Cslllts ~
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middotYanB l a tcomC losl1r~s gt In~ middot lt
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- - izi l -017 middotmiddot -
-No c mber 171 997 bull
-
middotTIfmiddotmiddotPROmiddotCED URE 0 ~
~ ~
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-bull Cod ~ ofFede r~i RegulaionsTi tl ~ 1 6 ~ Part 1 7()O lt with fi~al TUt~ changes cited inthe Federal
1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
middot middot1 middot
170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
~
requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
Page 6 d f2 G
~ ~
V~n BIarcom t l ~ sur~s I nc lt 0
~ 127 1-0 17 - gt
NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
~
perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
~
whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
-----
r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
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- -
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bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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bullbull I bullbull
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Pag e middot150f2(5 ~
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~
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middott ~~~ ~ ~~ ~ ~ -
shybull ~ bullbull I
middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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- bull bullbull lt bull bull bull 1 ~
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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EYalu atib~ 6f he 3 8 n~m S AF~tAP i tl~AcLosuRE o A 15bb6HDPE ROUNb
BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
c -
igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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6 l middot1 1 0 6 9 7 C888middot middotJ7 4 1 0 9 4 43 Mmiddotmiddot60l lt O lt
62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
middot S amp f~s ot lt middot middot 3smrrimiddot S AF~CAP middotnfA Ci6SUREON middot~ middot ~ middot lt -
A I 50~c HDPE middotRO0ND J3middotOTTLE- middotmiddot lt gt Co ntract N o lt 1 2 7 1 ~0 1 i c
SamplesmiddotReceivec Se ptember 8 1997 ~ -
S ubrnitted by gt V inceScuderi
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~ The protoco l fort fie cvaluation of packaging fo r poison preventio n CCFRmiddot T i l ~ ( 6Pa rt t700 wi th fi nal rule changescited int heFederalReg isterV6L 60 No 140FridaYiJuly 21 1995 pp
~ ~ r 37710 to 37744) was strictlyadhered to for t hisltstlldy
Panelists
middot~ middotIrl t he course o f thisstudy lOuscniors (50to 7qye~ ~-6Id s 70 fen1~l e) ~middot~~e ~ri1ploAd middot An middotmiddot lt
add itional 100 c hUdren we re employed totestthe packag esthattheseniorsreclosed r
Thisstudy does not include (j 50 child sequential test panel for chilcl-resistarH efl~ct j ven es s as -
stipulated in the reg ulation
Resultsof t l~e studyi ndicate that the 38mmS AF~CAP III A CLOS URE ONA ImiddotSOccHDPE RO UNDBOTTLE flilfills theslandardsfor se nlo r-resecu ring effecrivenessa ccordingto CF R
T it(e 16Part l 700 vitil fi nal rule changes middotcit ~ d-i r1 t h ~ Fed eral Register ~ol middot 60 No I40 Friday Juty middot2I) 995 PPJ77 10 to 3 77~4 middot middot
-
Pane 4 bf2 6 middotmiddotmiddot v
- - bull gt -
Van BlarcomClosures Ir1C ~ ~
gt~ 1 2 7 1~ 0 17 gt ~
~ November 17 1 997
~
rr~ INTRODuctroN
bullmiddotmiddotbull V~n B larcentOm C I9 sur~S I~ ~ishdi( d~t~I~ i~ i(lh~3~l1~ShGJIII-ict6~3ti6N gtmiddot 150cc HDP E R QUND BOTTLE fulfills the Consumer P ro ductSafetj Con1n1isstonsCPS C) sta ndards and protoeols fors enior-resecuring effectiveness set forth inthe Codeof Federal ltgt RegulationsTitle16 j Part l7 00 twit~Jiri ~1 rule cC1 ~nges ~ itedd ri t heFed epi l Reg i st e r VoL6QNo 140 Friday ] ulY 2 1 19 9 pp 3 77 1atq) 77 44 ~gerri ttLabOJa to ri es Inc aNANfASaccredited labor~a to ryt fortesting child-resistan( paGkaginga-ccor dirg t6 t h~ CPSCpro ioco Va~ requested bull bull
to evaluate the packaging usirrgtheabove protocoL
Perritt Labo r~torie~ln~ j ~n i nd e~~~de n [ t esting l~b~r at o ry ~il asb~~nev~I~ a t ng middotch i-10 ~ r~~ i~ta ~t p a~kag i f1g for both indusryandgovernment fo r -ove r twenty years Th~ c6mpa ~y is recog nized
as t he leader i nt hefi eld by virtue ofhavingemp loyed hund reds Ofthousandsofpanelistsand middot evalLlate d thousands ~f pack ag i ngco n c ep t s for chil d -res i s t ance ~ Pe rri ttL -bo ra t o ~ i es I nc u til izes s tandard operating p roceclUr~ ( SOP ~ ) middot alo ng vith~q Li al i ty as surance prograns inacco rdance wi th good I a b o ra to ry pr~d i c cs(GLP) fo r no n-clinical la bora to ries - bull
I
gt l rl tlcc6urse bftliscvaluation the packagirig vas tested w i tl p~n el s cQ r1 s i s ting cilOb ~~n i 6 rs5 0 lo70 )ear- o lds 70 femal e) andI 00 children (42 t0 5 1 mo nthsof age evenlyd istributed) bull
bull obtainedfro rh nursery schoo i s middotd ayCare ce~ t e rs and civicg roups The data derived frointhe middot study were assembledin a meani ngful fashiori ahdrevi ewed t o d e t e rm i nfhet he r t h c p ~ckagi ng metthe cited standardforpoison p rev e n tiOnP ack aging i t h re~ecwing effectiv eness presented
Perritt Labo r~t o r i c s InC received its updated tJ AMAS ac~ re~l i t at i o il ( 14 5 7 Sll l)fort es t i ng
~packaging for child-resistance according to CPSCs
fi nalru li ng published in theFederal R~g~
i s t e r
Vo l 60 No 140 pp 377 10 to 3774 4 in August of 1995
NAt1AS is the Natiomd Measurement Accreditation Service of the jnited Kingdo nl Organizations a ccredtted by NM 1AS meet thereq uirements of EN4SOOI ISO Guide is andthe releantrequirenleiltso ft he ISO 9000E N29000113 5 57 50 ser iesof standards including t h ~se of
the l1lodeldescribed in ISO 9002(EN 2900-218 55750 Pa~t middot 2 wh en acting as supplie rs p roducing tesLr Cslllts ~
- gt ~
gtPage50f26 ~
~
~
gt ~ I middot
middotYanB l a tcomC losl1r~s gt In~ middot lt
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- - izi l -017 middotmiddot -
-No c mber 171 997 bull
-
middotTIfmiddotmiddotPROmiddotCED URE 0 ~
~ ~
~
-bull Cod ~ ofFede r~i RegulaionsTi tl ~ 1 6 ~ Part 1 7()O lt with fi~al TUt~ changes cited inthe Federal
1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
middot middot1 middot
170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
~
requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
Page 6 d f2 G
~ ~
V~n BIarcom t l ~ sur~s I nc lt 0
~ 127 1-0 17 - gt
NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
~
perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
~
whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
-----
r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
I
- -
~ ~
bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
~
v
~
- -gt
bullbull I bullbull
- ~
shy
- ~
~ bull ~
Pag e middot150f2(5 ~
~ I
lt ~ v bull
vVan l3 iCOrll C1 o s ~ l r c s Ir ~ c ~
12 71 ~O J7 shyNbembcr pound7 997 I
shy
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
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6 slei led i Y ~ 7 D amagedpackage
8 middot ~ Tchiched i n d i ca t 6 r middotmiddot 9middotmiddotmiddotmiddotmiddotmiddot Used t e e th ~i1d fingers-
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rr~ INTRODuctroN
bullmiddotmiddotbull V~n B larcentOm C I9 sur~S I~ ~ishdi( d~t~I~ i~ i(lh~3~l1~ShGJIII-ict6~3ti6N gtmiddot 150cc HDP E R QUND BOTTLE fulfills the Consumer P ro ductSafetj Con1n1isstonsCPS C) sta ndards and protoeols fors enior-resecuring effectiveness set forth inthe Codeof Federal ltgt RegulationsTitle16 j Part l7 00 twit~Jiri ~1 rule cC1 ~nges ~ itedd ri t heFed epi l Reg i st e r VoL6QNo 140 Friday ] ulY 2 1 19 9 pp 3 77 1atq) 77 44 ~gerri ttLabOJa to ri es Inc aNANfASaccredited labor~a to ryt fortesting child-resistan( paGkaginga-ccor dirg t6 t h~ CPSCpro ioco Va~ requested bull bull
to evaluate the packaging usirrgtheabove protocoL
Perritt Labo r~torie~ln~ j ~n i nd e~~~de n [ t esting l~b~r at o ry ~il asb~~nev~I~ a t ng middotch i-10 ~ r~~ i~ta ~t p a~kag i f1g for both indusryandgovernment fo r -ove r twenty years Th~ c6mpa ~y is recog nized
as t he leader i nt hefi eld by virtue ofhavingemp loyed hund reds Ofthousandsofpanelistsand middot evalLlate d thousands ~f pack ag i ngco n c ep t s for chil d -res i s t ance ~ Pe rri ttL -bo ra t o ~ i es I nc u til izes s tandard operating p roceclUr~ ( SOP ~ ) middot alo ng vith~q Li al i ty as surance prograns inacco rdance wi th good I a b o ra to ry pr~d i c cs(GLP) fo r no n-clinical la bora to ries - bull
I
gt l rl tlcc6urse bftliscvaluation the packagirig vas tested w i tl p~n el s cQ r1 s i s ting cilOb ~~n i 6 rs5 0 lo70 )ear- o lds 70 femal e) andI 00 children (42 t0 5 1 mo nthsof age evenlyd istributed) bull
bull obtainedfro rh nursery schoo i s middotd ayCare ce~ t e rs and civicg roups The data derived frointhe middot study were assembledin a meani ngful fashiori ahdrevi ewed t o d e t e rm i nfhet he r t h c p ~ckagi ng metthe cited standardforpoison p rev e n tiOnP ack aging i t h re~ecwing effectiv eness presented
Perritt Labo r~t o r i c s InC received its updated tJ AMAS ac~ re~l i t at i o il ( 14 5 7 Sll l)fort es t i ng
~packaging for child-resistance according to CPSCs
fi nalru li ng published in theFederal R~g~
i s t e r
Vo l 60 No 140 pp 377 10 to 3774 4 in August of 1995
NAt1AS is the Natiomd Measurement Accreditation Service of the jnited Kingdo nl Organizations a ccredtted by NM 1AS meet thereq uirements of EN4SOOI ISO Guide is andthe releantrequirenleiltso ft he ISO 9000E N29000113 5 57 50 ser iesof standards including t h ~se of
the l1lodeldescribed in ISO 9002(EN 2900-218 55750 Pa~t middot 2 wh en acting as supplie rs p roducing tesLr Cslllts ~
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middotYanB l a tcomC losl1r~s gt In~ middot lt
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-bull Cod ~ ofFede r~i RegulaionsTi tl ~ 1 6 ~ Part 1 7()O lt with fi~al TUt~ changes cited inthe Federal
1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
middot middot1 middot
170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
~
requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
Page 6 d f2 G
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~ 127 1-0 17 - gt
NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
~
perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
~
whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
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r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
I
- -
~ ~
bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
~
v
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
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DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
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1 R egister Vo L6Q No )4qF r i d ay J~ )) 2 1 ltl995pp71 Oip 37741gt ~ bullbull ~
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170020 Testirigprocedure fof testingspecial p ackag i ~g ~ bull - lt
(a) T~s i protocbsj I) Gener-al reql i reme nts ~ ( i ReCl uii~m~n t s fo~ p~a ckag i n~ As specifi ed it1sectl70015(b) specia l packaging isrequiredto meet the child test -
~
requ irements andtheapplicable adult test requirementsofthis sectJ 700Wmiddot middot (ii) -Condition ofpackag~s to betested(A) Ta mper-resistant feature Any~
t ampe r ~ r es i s t a fit featu re of thepackage tobe rested shall be removed prioriotestirig i
unless it is part of the packages child resistantdesign middotWhere a- package is supplied t o th e co nsu rnerinanouter package that is notpart ofthe packag eschild-resistantd esig n one
o f the following situat io ns applies ( 1) middotmiddotmiddot middotIn the ch1ldJcst th6 pac kage is rcruovedfromtheouter packagcltl [1d the o uter package is nOt give n to the child
(2) I ~bP l lnh e id u i t tcs ts if theouter pack~gebea rs i ris tru ct i 6 ns- fcir how to bull open o rp roperlyresecurethepackage the packageshallbegiven tothetes t subj ectintheouter package The t ime requ ired to rcrnov ethepackage from the bullouter packages is not cou nted in the tj ill csall6 ~dforattem pt i ng toopenandsif
a ppropriate recluse thepackage
(3) In both the adult tests i f the outer p ack~ge does not bear anyinst ructions relevant ro the test the p acb ge vill be rCI11QVed fnimmiddottheoutermiddotpacb geand the out er package isrio t given to thetes t $tbjeclaquo
CBY bullRcclosablepackage svadult tests In b6 tli tiicad Lilt tests reclosable pac kag es Tfas sembled middotby t he testi ngagency shallbe p roperly securedat le ~st 72 hours
prior to beginningthe te st toallow thematerials (e g jt heclosu re linerjto ~ t akc a set I f
assembled by -the testiiig agencY torqu e-depende ntclosures shall besecureda tthe sam~ on-tofqueas applied2n the packaging line App l icat i o rI torq ues rnu s ~ be recorded iii th ~ bull test report All p cwkag~s shallb e handled so that rio d arhage orj arring wirLoccur duri ng
= s torage oi- transportat ion Thepackages shall not be ~x posed t o extreme conditionsof middot heltor coldgt The packages shall be tested at rOom temperature bull
(2 Clli ld test - (i )Tes t s~ l bjeCts (A) SelectiOn c rite r i ~ middot Use from r to 4 g roupsmiddotbull bullof 50 children a~ re CJ L l irc(r L1 n~ert he seqllentialtesling criteria irt Table L N o more than ~
20 percent o f the children iriea ch g roup shall be tcst e~ at or obtained fronl anygivensite bull Eacll g r9u p o f ch i l d ie n sh al ~be ra~doml)i screCt eda~(to age subject to thelimitationsset
Page 6 d f2 G
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NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
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perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
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whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
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9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
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child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
-----
r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
I
- -
~ ~
bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
~
v
~
- -gt
bullbull I bullbull
- ~
shy
- ~
~ bull ~
Pag e middot150f2(5 ~
~ I
lt ~ v bull
vVan l3 iCOrll C1 o s ~ l r c s Ir ~ c ~
12 71 ~O J7 shyNbembcr pound7 997 I
shy
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lt shy
t
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bull t -
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~
~
t
~I l i i~ SAhCA P II lA-(I OSU l i o~ L~(rc I top r rt ()ut) t)irnlLl
Fi~u hl
~
-
t o
~
~
middott ~~~ ~ ~~ ~ ~ -
shybull ~ bullbull I
middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
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middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
2 middot - tjs ~d fi r1ge rn~ i Lmiddot middotmiddot bull - bull
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6 slei led i Y ~ 7 D amagedpackage
8 middot ~ Tchiched i n d i ca t 6 r middotmiddot 9middotmiddotmiddotmiddotmiddotmiddot Used t e e th ~i1d fingers-
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NOernber 17 19sn bullbull lt fo~h be l ow h i rt~ perc~ ~middott o f the ~hii4 reni ~ ~ ~~h ~r6~b sh~ I Lbe orag~ middotmiddot42~ 4~ middot rn~n th~middot ~ O
middotpercento f the childrer in-eacbgroupsha] be of age4 5 -~ 8 m6n t~s a n d3middot9 percent of the shymiddotchild ren in each groupshitll) e of- age ~9 5 months The childrens ages shall be - bullbull
calculated as-follows lt -~ ~ gtlt lt ~ lt lt i ~ltgtmiddotj lt ~ ( 1)middot Arni ~g et h~bi-rth~datemiddota qd testdmiddotae b~he nuri)eri ca ldes~g nai ioh s fd r in ~middotn th middot r daY aiidymiddotear ~ gt ~ 0 lt~ lt bull bull ~ -~ ~ bull
(2CSubtnlctmiddotthemiddotin6ntb dayearrunlbers f6t thebirthdatefrbnl t l l~ re spective bull numbers forthetes date This may result innegaii ve nurnbersfo r the mo~th s ordays - (3rMultiplythe difference i r1 middotye amiddotrs middot bY 1 2 tci ob ta i njhemiddot nLlrilb e ~ 8f rl1onthSint he
diff erence inyearsbulla~d middot~dd this valueto the nu mber ofmonths that i a s~ obtained when the birth d~t c ya s su b (~ac le ci from th~ test da te iT his fi gu te e i t he r middot IU rcent (11 a i ~ t l1 es~ ni e or
oea djllstcdupo d6wii by I month deperidingon thenu mbe r ofda~sobt a iticd in the su~ t rac t i o n o ft h e b i rtli date from th ~n~~rd ~ te ~ ~
bull (4) -Ift he nu mbeLo fdays 6b i ai n ed b y s Ll b t rad i ng t he d ~ys i n t h ~ birth date from gt
thedays in the rest- date 15+16o rnlore 1 monthsmiddotadqedtot henJmber of I110 nths gt obtained above If the number o fd ays i S ~ 6 or less sub tract l mont h lf t IH~ri u rnher of days isbet ween -ISmiddota rid+i s inclus ivcinochangeismade i n t h~ rlumb~ r o f11 1lt)1 ths
- CD) Gender distribut iorivTh e diffe rence between thenurnberc f boysan d the
number ofg rls ineachage range shall notexccedIO percent 6tthe number of children in
that rangc T hechlldrei1selected sYloulclhave no ob i~ ll S orove rt middotphysiCalmiddot or r n~ n tal ~ a~ cii ca ri ~EaClich i l ds parent-or gu~ rdi ~middotn middot~lia l L r~aCi ands ign middotaG~ nscnLJ~r rl1- I )middot r i 9r tothe ~
childs pa rtic i pat i o0 middotTh e Commissi o middotri s ~ari vi ll not disregard t I H~ res ~illsmiddotoJt c s t sgtlt middot-
~
perfori1iedby ~therp ill middotpesmiddot si n~piybccau sc i i forI11~d coqse i~t for chi)d reri 1S 11 ot -obtained) J (ii) Test fa ilures A test failure shall be any childwhoopensthc spccialpackaging o ~ gains act ess to i t sc ci n t ~ nt s l n J h~ casc of lll1i tpacka-ginghOeverate~ fa i l l i ~e shall
middot middotmiddotmiddotbe an ~h ilei ltd ici QmiddotP ~(1 sorgainsaccess to tlie ri Ll mljEir df indiviq alltnil5 hi chcmiddotomiddotnstiiote the alllQlIntthaf tila) proqucGSeri()lis perSOJ1ainj llt) Of seriomiddotiis illhess6i a cllikLvhomiddot opens or ga i n smiddota cce ~s t o rilOr e thanS individual unitsvhichcvmiddoternuinberis ovcrd Jring
the fun OniinLlles oftcstihg T he min1bcr of lthits a child ol)eilsor gairis access to is~~ gt ~ interpretcc as t li e i n d i ~id ll~ I u n i ts from which the product h asbeen or cal1bc r cfl1 ()vedln
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whole or III pa rt T he clcterri1inat9n 0f th e ~ rll qun~ of sub s~ance tl l at m~gt prodllce serious persort Cll inj llry () r s ~ riO Li s illness shall be based on a2~~ po u middotnd childmiddot l1alufactutcrs or
packagers i n t e rmiddot1d ing fo ~ se unit p ~cka~iJlg ~o r a sll bst a nce requiring sped iLl pacb (gingmiddotmiddotare middot
~ lrcquestccl tOsllb mitsudl tqxicologlCal dina to the Cominissionf s Of1iceof COIllpliance
( iii Seq u e nti ~ i i es t The sequentiaLtest is i n i t i aHycon d l l ct~cl Lls j ng 50 c hi r~ren ariddepcncl ing o ll the resultsmiddot thmiddotcmiddotmiddotc rrteria i ~middot Tab lc middot de t en liln e whethef thcpackage ls
ei ther ehild-resistant or not ch(ld-res istant or ~h e t h c r ftirthe r t estihg IS req ~ l i [c cl middot f llrtlier testirlg is i eqllircd if the rcslIl ts are inconclusivcancl i1Vb lves ti)emiddotil se oforie middot0C tliore
middot middotadditomiddotnal grblimiddotpsmiddotof 50 ch ildren eamiddotchli P toa ll1 ax i r l i l i ~ 1 1 of 200 t hildien No inclimiddotidual bull ~ shall (lcI ~ ni nl stc he lCSt ~ Il~o r~ than 3Opcrce1t of rhe child ~e n tested ~ncac h grO l P
Tablc 1 gives t h~ a cc ci) t a nce (pass) tOnt) lllICtestlng gtandrejebticgtn(fai lclitcli to be - -
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
-----
r bullbull bullbullbull
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~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
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bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
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v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
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~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
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th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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lt 12 7 1-01 7 gt ~ bull 1
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Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
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Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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~
tmiddot middotmiddotmiddotmiddot lt
6 l middot1 1 0 6 9 7 C888middot middotJ7 4 1 0 9 4 43 Mmiddotmiddot60l lt O lt
62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
used for the ft sf s mimli es and the fuII IOininuttmiddotsoft hemiddotchildrens test If ihe testmiddotmiddot middotmiddot - con t i n u ~ rpas t ti i ejrihi aI S O~chHd p hne l t he- p~ckage O pehjng s sho Vn inTablcmiddotl middot a ic
cumulative
raquo (i v) middotT est procedures The childi-eri shaiIbe d ivided into groups of toT he testingsha] be done ina location that is famiiia tothe children for exanlp l e ~ t be i r
custorna rynurseryschool o rregular kindergarten No child shall tesmiddottloe thantwo ~ middotmiddot special packages rWhenmo rcthano ne special package isbei ng tested each package shall
middot ltbeofa different AST0 type and middottllCy middots hmiddot~lI middot bc p te s ~n t ed io t he p a ired childrcnl rl f andorn middot
e
0 rderThisorder shall-be recorded The c hildrenshall be t estcd by the-procedure ~
incorporated in the following tc stinstructions
~ bull
~
1 Red osable packages if-assembledby t he testi rig agency ~h~ l i beptopcrIYmiddotmiddot _secured at Ieasti i hours prior to theo peningdescribed in i ~s t ru c li a ri rliJrl1oer3 to allow
th ~ rnaterialsv egtheclosure liner) totake a set Application torquesmu s be
middot recorded in the t est rcport ~
bull bull 2 Allpackagesshallbehandledso t 1 at l10 darnageorj erringvif occur during bull ~~~ - storage or transportation ltThepackages sha ll not be exposed toextrernecondijions o f
heat or co ld The packages sha llbe tes t ed~at room t erri pera t u re ~ -
3 Reclosable packages shall be opined and properlyresecured one time (or more bull ifa ppropriR te) byt he t esting agency or o the r middotadult prio r tO lesting Tbc opening and
~ resccuring shall not be dOll e in the presenceof the chiiqrei1(fn the adult-resecu(irlg te st the te s lcr must n~t opcl and re secure t IH~ packagepri9r to the tcst) ff multiple
oj)cningslresecu riogs nrc tohe l ls ~d each or four (4) testers s hall open cnd propcry resccLire oneforth of t he packages on~e and the tl~h all op e n and properlyreseClI[-e each p a ~kage as econd thirdfurthmiddot th roLlgh tenth () r o ther specifi ed nU ll1bemiddotrf tinle in the
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
-----
r bullbull bullbullbull
lt bull ~ ~
~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
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~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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- bull bullbull lt bull bull bull 1 ~
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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Pa~e 18of26
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BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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6 l middot1 1 0 6 9 7 C888middot middotJ7 4 1 0 9 4 43 Mmiddotmiddot60l lt O lt
62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
sam~ seq~en~e ~ ~ th~ fi fst () p~ni l1g ~~dr~~e~ ti~i ~g Thep a6kag~s ~hal l no t bi~pened 2nd res ecured agaihpri9ito t ~S tl riggt middotThe na me ofcentachtester and the pmiddotacentk agemiddot n L l ti ~~middot~middot(S middot that
middotmiddotmiddot middot heshc opensmiddotandreSeCliresshafI bcrecorded arld reported It imiddotsmiddotnotnecessaGltfort he ~ t es ter t op r ot ocoLte~ t the pa ckages tha tmiddot~ heY bp~nedand middot res ecured ~ - - - raquo
middotmiddotmiddotmiddotmiddot4 The centflild shal1 ha ve no overtph ysj caLo r m~n ta l h~nd icaps No ch i ld vrth ~ ~ middot middot bull permanent or t~n1p6riryi (lnessgt i nJ~ lry-bull~o r hand icmiddotapth~l -_V6u l d jiiterfemiddotre middot t i t h hj si e ~
lt5 ~the tesiingsha l l takeplacein aveIl-lighted J()c atio~ tGat i Sfan l i liar tqtle childre nand that isisora tedfro m alldisract ions ~ ~
6 Thet estero ( another admiddotLltshmiddot~Hesco rt a pair ot ~hi l middotdre ii tothemiddottes t areaThe bull
t ~ s t e r s hall seat th6tlo chil drensothatt here isho middotvi~ualbarrier be t Ve c n the children and t ~ tl1e tester
middot 7 middotTlre testershall talk to th echildrcntornakethern feel at -ease
bull 8 T hechildrenshannot begilen t ire impressicnthattheyare in arace 6r c ontest theYare f1ottobe loldth at the~testisagarnc or that ) ( is fun Th~y a re n ot tobe offere d
- a reivard
~
9 Tlie tes ter shall record all datap rior to or Ml crthc test so that fltl l attert i ~ n middot middot middot c a i ~ beo n the chiklrenrluringthctest )crioc bull
lO fheUstcr shallusca sto p ~ a t ~h ( s)or other tinjing device to timethe number o f seconds it takes thechild middottci openthe packag eandtct iructheSvminute test periods
middot11 ~ middotT6_ ocgin thete st thetcsrershallhand -thechildren identica l packages and say l jLi~iS E TI~ Y TO OIgtEN middot([Sron MI I -
1 2 lfachild refusestoparticipat e after t hc ust has started the tester shaH middot bull bull reassu ret he c hildandgent ly encouragetbe child to t [ylt Jf l b e ~h i l d continues to refu se
the teste rshallaskhe Cilild tohold the pack age i n h i s he d~ p until theo ther chiLd is bullfi ni ~he cl middot middot middotTh is pairo C ch iJd rcn sMall no tbccliminatedFron) the results unless the refusing
~ ~
child disru pts theparticipation of the other-child 1 3 Eachch ildshall be givenupt o Sun inu tcs toope n hisher package Tlletester
-
sha llwatch the c hildre n at alltirnesduringtheiest T he H~s t e r s h a l l rQi nin1ize c middot middot
corw ersationsvith the chil dren aslong RSthey co ntitl ue to attempt to open middottheir packages ~ bull I - The tester shall not cliscou rage tile children verbatry or withTciCi al expressions It a chi ld
~ gets fru s t rat e cl q i- bor~d a nd stomiddotps trying tp open hisher package theiester s l1all reassure
bull the ~hi ld a l ~d gently encourage tl1e child to keep trying (cg please tr) t0 9Pen the package)
14 1J le childrenshallb e allowed freed on1 of mo gtcment l o ~ o r k on their packag es bull astong as d lct estercan ~I H ch loth ~ h i dren (~ g t h cycan s t ~ nd~ipgel downon the ~oor or bang or p rythe p ack~gc )
middot15 ) [achild is endangering 1 lmself oro thers at a nyt inl e ~ tlletes shall be stopped and the pair- of children eliminated from tlie final results
l O T hemiddotc~l ~ ( d re [ i s ha l l b~ a lIo ~ved to Ota l k to each other ab o~t o pe n ing the packages and shaHbeaIrowed to watch cac h o t I H~ r t ry to openthe packages
-
Pag ~ 9 of26
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r bullbull bullbullbull
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~ V a ~ BlardQn1C IOSllr~sIncgt - middotmiddot L27 1Q17
N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
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bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
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J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
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th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
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lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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12 71 ~O J7 shyNbembcr pound7 997 I
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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I bull bull ~ bull t bull bull ~ bull
- bull bullbull lt bull bull bull 1 ~
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
c -
igtSuccessfu I Pa nelisiS -- gt ~ s(cood6~) e ning and
raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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6 l middot1 1 0 6 9 7 C888middot middotJ7 4 1 0 9 4 43 Mmiddotmiddot60l lt O lt
62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
2 middot - tjs ~d fi r1ge rn~ i Lmiddot middotmiddot bull - bull
-] - Us ~d fi ngers
Usedteeth raquo 4
S Used f et ( middot bull
6 slei led i Y ~ 7 D amagedpackage
8 middot ~ Tchiched i n d i ca t 6 r middotmiddot 9middotmiddotmiddotmiddotmiddotmiddot Used t e e th ~i1d fingers-
bull bull bull f 10 Banged or tlqor bull
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N overilber l1 1997 -
r raquo bullbullbull bullbull bull bullbull bull bull bullbull bull ~ ~ bull gt 17 A childshallnot b e a lldw~d to trytoopen t he 6thed~hild s pmiddotack age middot middot bullbull
middot - middotmiddot18Iri chird o p cn s hj ~lh e( p ack~ge t he t e s t e rmiddot sha [ say I 1) lA~ YOUi take the bull middot packag ef ronl thech ild a0d put it out of the ch1 cl s reach The chlld shall not be asked to
open the package asecond time s ~ bull lt
~ middot19 middotAtthi end middoto ft h~$ -nli nuiemiddot pe i-i 6d t he estersha[i ~de o ns t rae middot hOv toOpen middot the package-if either cnild has not opened his or her packagei A ~e parat e demo package -
)
shall beusedfor thedentonsttatiorurgt bull 20 middotP(io rmiddot t6 beginfl ingmiddott hemiddot d e hl on~tr~tio ~ thmiddote test ~ r shaJr askt he Sh ildrent o set
iheir p ad(ages as i d e~The child reif shallnotbeallowed tocentorlt inuet6 try to o Jen t heir packages during the de no ri s tr~ ti6n-middotper iod o i gt middot lt ~
2 1 The tester shallsay II WATC I1middotMEOrahvtYmiddotPACKAG2 II
220f1 ce thetesterge tsthechild-ensful l-attent ionthe testershallhold t hedemo pack ageapproximately two- feetfromt hechildren and openthe packige atano rrha speed
middot ~ ~~~~ ~ee~i~ter werC g~ingto use theco ntents The r~ middotS h middota ~ 1 beno ~~ agge rat~d ope ning ~
~ 23 The tes tershallnot discusso r describe hov fb open the p ackage 24 Tob egin the -second 5-rninute p e~i o d ~ thc tes ter shall sayJt-- CJ li Y() UTRYTO
O J L t~ ~6u l ~ Ct)~( i1 S
bull middotmiddot middot2 5 rf one middot ci~ b()t hchi ld re n haveno t ll s ed t he i r t e e t ht ~ try to openthe ir packag es during thefirst 5 middot r1 1 i nu re s t he tes t e rs h a l ls ayj ri llll ed i ate I Y befOr~ beginningthesecond 5 ~
middotmiddotmiddot minu teperiod i OUCAN USE yOuimiddotEGnmiddot[ [ FYoU WiN~[TO JI This isiheorilys tatern ent thatthe tester shillma ke abou t-usfhgreeth ~ ~
middotmiddot 26 The tcst shali continue foran additional 5 11 1 i n h~sO ~ U ri t i l bothchlldrenhave ope ned their packag~s which~ver conlesJi rs L
2 7 At thee ndo f the te stperiod themiddottester shall saYiTiINU( YOJFO[ ([ EU~rNG ji If childrenwere told tha t they could use t hmiddotc ir middot t eetli the te t c~ shallsay l ~ NO i 110 pound0 bullbullYOUTl r~TYoUco tiLlJ l jSE Y OUR i E IT I- I TbD~ Y13UT v o osuouic u orrur l ( lNCi S Ll KE
1 1115 iN yo lJIU -10un [ AGA IN Inad ditio n the tester shallsay NEVER OiEN(CK AGES
U KETl lls ITIENYOVJE 8 Y YOLJH SELF~ T Ilrs KfND OF PACKJOE MIGIIT l l E SOMETHfNG middotfN middot rr imiddot I middot I I~r voumiddotLtimiddot ~1AKE YOU SiCKII - -lt ~ -
28 Th~ ch i clr ~ n s h~ Hbe es~ 6 rtedbackto tile i r cl a s s ro o m ~ ~ ot h ~ r sll p e rv i ~ed ~-areamiddot middot by tlictester or anothcraduIL ~ 29 If the t hil cl ren a re to part icipnte in a secohd tes t theJester shall have them
stard c pad stlctch for Cshort t ime before begi nr1ng thesccohcrtesmiddott The tester shall ta ~ e care that tile children do fl ol disrup[ other test s i ~ pf6gr~ s s bull
(3 ) S9nio~~adull panel - middot(i)middot Test subjectmiddots Use agroupof I00 seni oraduIts Npt l11ore tllan 24 pe rc ~ n l of themiddotsenioradulls testedshalibe obtained from6r tested at any
one middotsite Eacli gro~l p o f sCnim adlilts sh ~~ltbe randomly sc cc t ~d ~s to agesltuject to the middot IIIlitatioris Set fcirth bclov l eIlty-f lve percent o ~the p~ rticip an ts shaHbeSO-54 yea r~of middotmiddot age-2 5 of prlli iclpanis shallb eS 5-59 years or age and 5 0~of t lH~ part ici paiits sha1 be ~
Page 10 of26
- ~
~ -
~ lt
gt r c ~ bull bullbull bull bull bull
bull Va~middot Bl arcO~l Closu res middotInc bullbullbull bull -
-lt 12 7 1-0 1T gt gt gt
~ Nc vcrnber 17 1997 ~ lt
60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
~
plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
middot ~
~
2
-
~ -
~
~
v a h~ B l ar c 6rn Clb suresInc
J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
r
~ ~
~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
~ -
f
(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
~ J ~ Adll1t-ReS~~lliiigPo cc dt1rc
t An
--
e~
th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
1
J lt
v - ~ bull I ~f~~ v ~h 8 I iHCO ri1 middotClosuresbullI~c ~ ~
gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
-
~ ~ ~ bull raquo
I bull bull bull bull
~ ~ ~
c
~ ~ I
I middot middot
middot f
~ ~~ ~
-~
~
-
bull-
I
- -
~ ~
bull bull1
-
~
gt ~
~
~ ~ fmiddot
- ~gt r ~
~ f -
middot middot v~ middot~ Bl ~rcomCI ~ su resf~~
lt 12 7 1-01 7 gt ~ bull 1
Nove mb er 17 19QT ltC i
Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
~
v
~
- -gt
bullbull I bullbull
- ~
shy
- ~
~ bull ~
Pag e middot150f2(5 ~
~ I
lt ~ v bull
vVan l3 iCOrll C1 o s ~ l r c s Ir ~ c ~
12 71 ~O J7 shyNbembcr pound7 997 I
shy
~
~ gt
~ -
~ - ~ -
~ - J
v--
i - ~ ~
)
~
lt shy
t
~~
bull t -
~ ~ ~ --
~
~
t
~I l i i~ SAhCA P II lA-(I OSU l i o~ L~(rc I top r rt ()ut) t)irnlLl
Fi~u hl
~
-
t o
~
~
middott ~~~ ~ ~~ ~ ~ -
shybull ~ bullbull I
middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
~ ~ gt
- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
~
)
~ ~ ~
I bull bull ~ bull t bull bull ~ bull
- bull bullbull lt bull bull bull 1 ~
~ - ~ -~ - -
middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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60-70 years middotOld ~~ve~ntyp~rce nt~rtl ~ ~ah ti~ant ~ ~f ~ges 5b~55r arj ~~ ~~middot60~70 sh ali middotbe female(1 7 ocmiddot18middotJemales shall beapportioned t o th e 50~54 Year ageg rqu middot ~N ~)i ndivi d ual -
tmiddotes t ers haUmiddot ad tn l n i ~ terthe te st 6 mo re thari3 5of thesenlot adlilts tesd ithe adults selected shouldhave no ob~ i6us oi ov~ rt physicalbr mentaf disability ~ (
( i ijltSc reeri i ng p roced~tes ltPa~tici p~ ritsvho a r e u nab l e to opmiddotcent n t hpac~~ag i ~g-- bei nktes t ed~ int heflrst 5-rninutetime middot p ~ ri ()d a re g i vena screening test J he scree-nirig
t ests fo rthis pu rp6 s es haU u ~e t~vo pack age~ i th co n le ilti onal (notc hild-resisant CCR)middot middotmiddotmiddotor sp eci al) closures 0 ric clos ure shall beaplas ticsnap-closu re and th~ o t het a CT
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plastic dosti re middot ~middotach c l osu re sh tl l havead iarneterof z amrn i 1 8 ~G ndmiddot the CT ciosu~es ~
shall have bee ri n~s~c L i c ed 72 hou rsbeforetest inga lO i n ch ~ p ou n d s o ( [o ~qu e The middot coitain e rs [or botJ1 1hesnap ~ andCt -typcclosuresshal] beroundplastic ccntainersJ n
sizes of 2 0uncefYi ounce for the CT- f~p c c 1 6su re and 8 d ra Illsplusmn A drams fa r the snapshytype closur eiPersonswho cannot open and middotcJose b~ th of the s~ reen in5 p a c k~ges in 1- minu te screening testsshall notbe coun te d as participan ts inthese nior-adult panel bull -
(iii) middotS AUE T he seitior acl lil t middotLt se d Yecdveness ( SAtJE) is tile ptl C e~tag e of adu lts vho bo tlr opened middotthepatkagc in llleOfirst (5-mi nute) testper iod and opcred arid (i f
bull iqiptoprl ate) properly resecu red tile packag ei n-thet-rninute tesrperiod bull (iv) T esrproccd uresiThe senio radul tsshallbe tested individialiy ratlie rt hani n groups of two or morc Th e senior ad ults shal lreceiveo nly suchprin ~ e d instructio ns on
howio openand properlysecure t he s p ccia l p a c kag i rig middota $ middot vi l l ap p ~ a r o n oraccompany
th c ~pack~ge as it isdeli vered totheconsumer ~T hc se nior-adult pailAjsrested-according
tol 1e procedure iocorpdrltitccl int he folJovilg senio r-adul t-panelte st inst ru ctionsr ~
T~s t l i ls inJ ~t i (j l s Ior S elliorTcs t
Thefollo wing tcslins trlIct ions arcused for all sc 1i~( t ests lfnoi-reclosable pacb gc are heing te s te th ~ commandsto close the package a r c e1 i i n ~ d middot
middot ~ 1 No adult with aperrnancnt or temporary illn e ss injui-)t or dsS r1 ity hich gt middot wottld interfere itfi his hereffect ive p a rt ic ipa tio n shall be includcd int hetest middotmiddot middotmiddot
middot f
2 Each adult shal] read and sign consent form prior to p a rt j middot i p ~ng Any approp riatel anguage from the consent fo rm may be used to recruit pCl e ~ i n l participants
Theform shall include the basicelementsofi nformed consentasd e fi ced ii 6 CFR bullmiddotmiddot middot middot10281l 6gt Before beginningthetest the t es t e r sh1IIsay ~ PLEAS E [(EJi lt D S I (N ~nmiddotHS bull bull
~
bullbull CON~2N I FORMH lf an a dult ca nno t readthe c o nsent fo rmfor any re2sor (forgot glasses ill iterate etc) hesheshallnot participate in the test
J Each adul t shall participate individu allyand nc ti n theprese nce ofotlier participants-oronlookers bull
4middot The tests shalf becondLlcted in we (-lighted and d is ( rac t i o - middot f~t reas middot 5 middotRecords shall be fi lled in before o r a ftci the tes( so that tietesc rs full ~
attent ion ison tiicpnrticipiult dllring th ~ test period Reco rd [ng t h~ t ~ s ~ t ~ le st obp en a nd resccu re t hcpackages arc the o nlyexceptici ris
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J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
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bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
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(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
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- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
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gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
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~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
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6 slei led i Y ~ 7 D amagedpackage
8 middot ~ Tchiched i n d i ca t 6 r middotmiddot 9middotmiddotmiddotmiddotmiddotmiddot Used t e e th ~i1d fingers-
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J 27 1--0 17 Novernber 17)9 97 lt d gt _
bull 6 Toh~gip t n~ f(r5tS ~ rnin~te tee t pi~c1 thet~e te iy~ (AmiddotO(JINGTCl ASkYd0bull - TO OPENANDPHOPERiYCL6st ~llmiddotllisE TWo rDENT rCN PAcKAGES ACc6u)[N(jTdl HE
- rNmiddotsT~IJCTIO~S FbU~D ()NTHECJT (Sp eci fy middotci th e ~ i n st ru ~t i onlocat i o ~sf app rbptiat~) - gt - 7 ~ T~e fi rs t package) s h indedt9 -t h~ ~ pa rti9i p ah t bythe t es ter ~l io sais n p~E ~S~ _
- OPEN rni s r ACKAQE ACCORDrNG T~[EDIRpoundtTIONSQF THE ~AP~ (S pecifyo her ins trirct iori locationsifappropriate) ff thepackage~o nta i risp r6duc t ~ the t es ter shall s a~~PLEAS( EMPTYJ -rm(PILisTA8LEfS CON-i13NTs t i c ) rNToTH-I S CONTA rNER I middot middot middotAfl~ thcparti Ci p ani middot
- o penst he p ~c~age t he t est e r says LEASECLOSE THEPACKAGE PR6~ERL Y ACC()RDINq i middot
ro TlIE rNSTRUCTlONS OF ll-E CAI ~ c(Specify- Other instructiqnlocations if appro pria te) ~ - 8 -Participantsa teallowed-ip to 5 minutes t o read _the instructions and opena nd-
close t hepackage TIle tester-uses a stopvatch(s or cith e r~ i m i ng deviceto tin~e the ~ ope ning ~nd resecuringtimes The elapsed times in seco ndsjcopenthepeckageand to
closethe packagearerecordedonthedara sheetastwc separate i i m~s ~~ 9 Afte rS minut es or when t he participant hasopened andclosed th e packflge
~
middot vhiciJcvercoines firsl thelester shall h keall test materials fromthe participaiit T he p articipan t my -remove and replace the C l osL l ~ e rnore than once if the participahtlni tiates
middot these ac tions I f the participant does no topenthepac kage andstops trying to open i t
before the end or tile S minukpcriod the tester shal l-say II iRti i()l rIfsl liJ ) vrr1THAi- bullbull 1 bull
middotmiddot I)ACKt GE OR WOUU) YCJULH~I ~ ro TR y ACit iN It l f thepa rticipant indicates tl1at hesheis finishe~ or cadnot 6p e n i il e package and do cs noLvisll to contlnuelryingskipto
Ins tru c tio n 13 ~- bull l (LT() beg i n tl~ s eco n d t est period thet ~ste r shangive t heparticipailt ~~o t he~
middot but idcnticalpackageand sa) T liS I~ i~ IiJ [ NTIC tL PACKAGEPIJ2ASE OI EN [T ~
r- jCCQID IN G TO THE INSTIW CTle) 0iSON n [E CII (Specify other instruction Iocations if
approp riate ) If the p~ c kage c o lt a i ns pro duct the tcste( shall sa5 P LrJ~ ~I (~illi U IE -
(1IIL STA IJL trs CON JEN r s ~dc ) l gtiTU TI II$COI [IINE I Ahcr the participant opens t he bull - package the tester saysIrEAS I CLe)SET H1S PAC Kt Ci E P~()i)riRLY ACC9W I~G6 THE -
lNsTIW ClIONSO N T( U~ Ct P (Specify ot her instruc tion locationsifappropriate) middot bull 11 T llc participants are al lowedup to 1 linute (GO fu ll s ~c ond s) to ope riand
close the package The elap sed times in se conds to op en and to cl ose tliepackagea re middot recorded on the-data ~hee t ast wo separate t i nl e~ T he time that elapses between the middot
gti bullbull ~ ~I~i~go ~ I ~ el ~~~~~~tt ~td f theins tructi o n toclose tllOP Ckage isn~ counted
1 2 After the l- rri inutetest ior when the pa rtic ipantliasopenedand closed the packagewhichcercornes fi rs tthe test ershallt akeall thetest mat~ ri a l s rrom th e
participa0t T he participant shall not bea llowed tohandle the packageagain If the participant docs noto p en t h e p ~ckag~ andst ops tryingtoopenit beforethe end of the 1-
minute period the tester shall say A l~ i YOU F (N ISH ~ () wI 1i I~HAT f A( ~ (lOI~ WOULD middot
bull vo u ll KE TO TIZY IQA IN7 10 I f the participant inclicatcsthat heshe is finished or canno t
OPC) t he i ~c k ag~ ( Ild doe not ish to co nlinuc t rying this ~hall b~ COlln tccf -as af aillre of
the l-ill il1ltt c tesL ~
- Page 12 of16
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~ ~ ~ middotVa~ B l a rcO~l C I6~ 1Imiddotrcs gt middotIhc
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
~ -
middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
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(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
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th e ad u i t pa rt i c l pai1t i n either tl~ e ~en i br-~d Ll I t test or I~ CFi~
- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
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gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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Th e ~a ~kage middot dmiddot lt~gt middotu ~ ~ middot i ~ - ~ ~
T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
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Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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middotf - p~g~ 1 7 o f 26 middot middotmiddot i bull - bull bull
~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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BOTTLEfd s enl ~ r~ us ~ e ftect i ve~ ~sst6V~n B l atco~ CI6su res l l n G ~~ c 3 ltgt ~ F - - bull
ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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62 1 1 0 6 97 middotC8 8 8middot middotmiddot 17 4-01 9 4 4 3 M 601 ~ o
bullbull bull 13 middotParti cipan ts~hQ do ii9 t openmiddott h ~ pa~kagc in theftrst 5 ~mi n J t6 testpamprfomiddotaar e middot askedtoopen amiddotndcl o se t 10middotn()nch ild ~ res i st aq middotsc reen i ng p a~kages Thepart i ci p a n t s are - bullbullbullbullg iven aI -rninute test period fqreachpackage) The tes ter shall give themiddotpirtiCipant a middot
middotpackage and say1 ~I pLEASE 6PENmiddotANDmiddotPROPtRLY C LdsE THrSPAC~OE~ I r he middott ~s ~c-r r~co rds the timif() ropen l ng a nd d6s i rigi or6 Lseco n d~ whicheveris esso0) he da ta sheet T h~middot middotmiddot gt teste r then gives the-participant thesecondpackage and says i I PLEA~ E OrENANjj ~ gt
middotbullbullmiddotmiddot PR6PERLYCLQsE ~nlS P AcKAGE i imiddot Th e tirn estoopenaod resecu re or 61seeo ~dsmiddot middot middot
~vh i~h e Ye ~ i s le~s~middots il ~middotf ber ecmiddotOrd ~d o nt h e da t amiddots h cent~ fmiddotmiddotmiddot - ~ gt- ~
14( Pa rt i ~ i pmiddotan ts ~v l lo ca li[l Q tope ri anclredeeure bot h middotof the n6 ri~ c hild~fesi5 t a ~ t - scree ning packagesar e not cou nteda s part oft b e lOO~~e~ior panel Additlonal
p arti c i pil ri t are seI eG ~9~ a n d t es t ed middot i ~
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middotl S middotN ()ad ultpay participatemiddotinmorethaniwo testspe r sitting rt a person partlcipa tes ifl t o tests the pas kages testedshall riotbetlicsameAs Itvi typeof
shygt middot (middot p ~c~ age middot gt i - r middot gt bull r bullbullbull bull bull bull bull
J6 I f nroreadulrs iri a sexor ageg roupare tes tedthanare necessary todetermine SAU E t he last personts) tested shallbcelirnina tcdfrorn tliatgrou p
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(4) i0 i r 1g~radu i [ p cinmiddote i ( i) 6~e t1U ndred adul t s ag e L 8 to 4 5 i nclusi ve ~ i th no overt p hysical or mental hariclicapsand 70pert erit of whom are fe r1i a le ~ s li allco rnprisethe
middot test pane for young~r aci Ll l t s No t middotm6reth arij 5 ofadulrsshallbc obtainedortested at middot anyo nesit e Noindividua testershall admini st eri het cst tornorer ha t35middot oftheadults
~es t c cl The adults shall lJe testedindividuall rather than ingroups oft wo orme ~e T he adul tsshallrecci 0only such printcd instruc tio rrs Oi1 how to openandproperly rcsecure
~ the special packaging as wlll appear on tt1~package as it is del iver~d fo th c c o n Sll mer ~
middot middot Five tni~u~~$ s lialLb c middot a Uo ~v c 9toc9 il1 pI 6t~~t Ilc o pe nng and Irapp r6pri l~ t h ~ resccliring process gt ~
( Ii Y Reco i~d s ~s hall be kept of tIle nLl niber cgtfa dllits uhable to openancL 6(t he middot ~ - nltn1ber qf tlicother ttclLi ltst~sU~d ~~ hO fail to J[opc rlyr esecutethe sp~c r l [a ~bging The
~ ~ nUll1be~ ad ~ l t sv h9 sLiccessfully open tlie spec ial packaging ~nd then properlY Tesecu re the
spccial pC ckC g ing ci ~resec u ring i s appropriate) isthepercent of adui i ~u se ef1cc t i ve n es s ~f
themiddotspeciaf packaging In the case of Llnt p ack ag in g t hepe rc e n tofadu l t ~lI sc effectiveness middot shall be thenUr11b er 6f adults who succc s s fulr y o p~ri a s jnglc(u nit) packag~
(i i i)Ad llr t -~s e effectiveleSS Of noJ cssthan 9 0 per2er1( ~~ ~~
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- bull 1 70 0 ~20( a) (J) 6 r th)ouriger-adult test o f 10 CfR 17CiO20(a)(4) has r CSCCLlred tIle package or at theend oft hetes t pedod (vhicllever comes fir st) the tester shrr take th e
package and phc~it out of reach T hq ndLl It particlpant shallfot be alloIcdto 11i1ndle the packagc aiain
bull - ~
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gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
middot a gt Adu l t usemiddot effec ti l e riess )middot ~gt gtmiddotmiddot r gtThenLrriber dr-adultopenirig anc(rei~~uri ng failurespt8sth~ n~ri1~ er of
gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
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~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
~ middot ~ ltmiddot ien i o t~umiddot se ~ ffect i ~er1e ss ~ lt gt gt lt
~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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- - ~ ~ lt Meeting CFR Tldei 6 Part 1700witil fi n~l rul e changesc i t ~di ri the F~cfe r~ rR~g j ~ fer Voi GO
No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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~ The~data prese tlteamp in t b e repod demiddotm6i sl ratcentqhaUh~ J 8 nim SAF CAPJn~ACLOSURE ON Ac
e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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ab t emiddotmiddot l - pac~~-~emiddot oi ~middot~ i ngt ~ sr~y a l ~ ~te ~ by ad01t55 0 t O 70 ~earOf middot age fo(seni o r u see~ec li v en es middotlaquo
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raquo raquo - 1 fTi~~nt t~ ~ST ~middot ~gtiS ECONi~lt ~ $ middot ECor i 0 ~~~ middot ~~CIltAGE middot +E S Tgt S I TElt- I NT ER - middot middot OP E NI NG i CLDS I NGmiddot OP E NINCF C L OS I ti C
~Hti~ i middot bull laquo ie L ~~~~t~~f~~~~i1i~~~~jf ~~jf ~~fiEY C L rENT NAH E Va h middotBlarcorn Closlfre s I n c raquo - ~~
DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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gt 2 Thepackages thathave b~e l)openedanq appeartoberesecuredbyadults shalL b~ j es edby children accordingthe cl1 i ~ldteSt middotp~qcedu res t middotode t em1i ri e if thepamiddotckagesh~ve
bullbullbeenprop erly resecumiddot r~d~~The packages a r emiddot g iy~nt o middoti he Gh i I 9 re il Yi l houtb e i ng middotomiddotp ene d hr middot
~ middot res ec~[e d middot again for a ny pLi rpos~ middotmiddot middot~ ~ ~ middot gt middot middot~t laquo ~ ~- ~ gt gt -
3 Usingtheresultsof the ad0 1de~ts ahd middot~h~ tests gtOrap pare n t fY~resec ured middot lt - p ac kage by~hildren~ th~middotadJl t us~ effe~ t i veness iscalculated as fQll O~s ~- _
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gtpackages th arWei-~ middotop en emiddotdmiddotbY the childrenduringthe fu lrlo~ri1i ri Litei es tthat eiceeds2 0 o f t he apparent ly-resecured p ac~age~ eq d a ls the tbtal mi~b er omiddotffai l~re s middot middot
2The fotanQtnbe( of packagestestedbyadults (w hlcenth is100) rimiddot nu~ l I1e tt al nu rnberoffaiI~ resequaIi I h perce ~ i d~ll-use e ~e~ l iveness bull bullbullbull _ bullbull
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T~ e tes t paCka~e vas t h~ 3 8~m SAF~CAPiIr~A~~b~~ QNt 15bcc HDPEROUND BOT TLE For pur posesof this test ail ofthe units te sted were emptyand received assembled D ire c tions to open the package read P USHDOWN ampmiddotTURNTO OPEN~~CLOSE)middotIGHTLY ~
A p ic tu reoft he package middotappe~ rs i n F igure l o fthisJepoft ~ ~ - -
~ ~ ~
r lt i
bull
Tes t s~erv i ~or ( ~ i - ~
~ Te st supervisor(s) we re instructed to cOlduct t h ~ eval u ation o f t he p ~~ k~ging in s t r i ~~ a ccord ~[lce with- t he CFR T itle 16 Part 1700 with fi nal ru le ch anges cited in the Fede ralRegiste r v cieo
_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
~ packageeva l u ~ t i on -
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middotimiddot ~~ middot ~ ~ - - ~lt lt Va ri Biarc6mmiddotClosGresmiddot Inc
~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
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middot middot middot middot efrec l i v e il c~ s middot -
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No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
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- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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_ Ncl140 Frid25i JtIly 2 1 1 ~95 pp 377 1oto 37j~4 T ocnsure Jhese prb cedures wefeildGeted lt gt i ~ ou r completequality sysierr wasfollowed inc ludin g periodicobserva tions throughout the
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
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~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
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No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
~ the Fed eral Register voVmiddot 60Nb l4 0 - ~
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~~~ gt1~7 1~Q 17 middot gt middot middot i gt lt gt middotltmiddotr ~ Novernbe r 17 1997 - -
~ bull I V~E~ tJLTSAND DisCUSSION ~ laquo -
Restilts ~t his jdYafgtfgt~ari~~~ailei ~eJ~nbf ~i~r~iampX~his1~I~ fe~bs~ni bull middotmiddot bull ibull gti comp il a ti on 6f~1I9 at a ob t ~ined du d-rlg th e s t uYgtFo r ~ l ari tx i~p res ~ntati o n a n d i ~cus~ 5gt n 6f thi~ 7 ( middot inforrnationmiddotthefollowingfeatures willbeus ed ~~~ themiddot ~ri1ajoqjo ipound1 ts ~ Ql dis~uss i o n middoti bull bull ~ ~ ~ ~ ~ - r ~- ~
S ~nior~umiddot~~~f(ectr~ ~rie~~ middotmiddot middotmiddot rmiddot )
- Senior-resecuring use-effectiveness gt lt
Meeting C FR~ T it l ~ middot16 PRCt) 700 vilh fi nal nile changes c i ~ ed fnthe Fede ral ~ middot3-egistecmiddotY9 1 60 N6 middot 1 40 middotmiddotF ~ i p amiddoty)uly 2 1middot1~9X middotpp middot3 ~71 Oto 744 middot middot
~ bull ~ bull bull bull bull ~ bull bull bull bullbull bull bull ~ bull i - bull I
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~ The sehiorpanel co nsisted o f Ote rna i cs ~ n d 30 middotmafes Re su i tS---() ffhesen i odes t appear in Table ~middot Mt lmiddot 6ft h i s r~po rt A t o t a i 6f 25 0he25schiors i nthe S O t o 5~(ye~ t oI4 age g ro~p ~e~middote successfu l ~ - inopening the firstpackageand opening and p roperty c losing thesecond package 25of thc 2 ~J senio rs [nthe $5 to 59jcar old age g roup were su cc essful middotamiddotnpmiddot 50c f theSoseniorswere
middot middotsllccessflit inthe 60 t0 70 yearo ld age groupT bescn ior-useeffecrivenesswas calculatedat 100 v bull
~~ ~l i ri l1 s 0 fo ra fina lse nior-use effectiveness inc luding the resecu ring test middotq r rOOforlhel OO ~ lt senio rs aHdlOOchildren whotested thepackag es apparent lyresecured byiheseniors T heexac tv
op e n i n g a n cl cLSing -t i nH~S aieE i ~~ ri ~ I e ~enio~Gs t ~ aC~ ~gi7fi D at~ t middot middotmiddot middot middot middotmiddot middot middot ~ bull
S e ~ or- r ~~ e c tl ~ i n g iJ s ee~ccmiddott i middot e ~ emiddots middot d gtmiddotmiddotmiddot middotmiddot lt - ) ~ - Agrou p of 1OO ~ chi ldren e lfen)p l ~yecl t o t ~ ~middottmiddot d y middotp ~ cbges th~middotlaquo I~te a ppa i-~ n t l r~s ~ Cured by cgt t he senior-adults Results of thsenior-resecuring test wit h ~hi lc(re na p pea rin r igtblb2 of this - i-cpo rt A rota of lchild a sticmiddotc e~sful middot tn opemiddotningthe ap rn re iIy resecured p ~c k ag e sltThe amount over 2CYo ( 1OOmiddotx2 = 20) is o andis su bt racted from the calculated senior-use bull
middot middot middot middot efrec l i v e il c~ s middot -
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No 1 40 Fri d a Yl~ul y - l 199 p 377 1Oqtomiddot3774 4 middotlt middot middotq u middotmiddot raquo lt
middot1middothemiddotmiddot38tllr1 iSA= -CAP nLAC~~S lir O~ Alsocd HDPEROD-B 6T~~E fu l firi~ tmiddotI~ ~ middot middot middot middot middot middots tamiddotndards fo r se n io r~ resec li ring~efrec t i ven~ss acco tding tomiddotC FRTi t l e 6 ~ Part 1700Vith fi nal
- gt Tu le c h a nge~ c i ted i n the Fedmiddoterar Reg i s t erVo l middot6middot6 ~o iAG F r i daY j~iy 2 1 middot199 5 bullpp ~ 7J-I Omiddotto middotmiddot ~ 3 77 44 bull bull
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e require mmiddotent sfo(ieniOrr~secu ring efr~c t ive ne~s gt- lt laquo ~ 1 5 0cc i-rDPE ROuND BQTTLE fulfiikth
l ~middotrul e ch~nges ci t ed j~t~ accord ing to(he Code ofFedera l Regul ati ons middot fi tl e 1 6~ Part J 70o withfina
Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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DES CRIPT I ON l~ ~ S en l o r - re s ecu red ~~ ~ - - ~ ~ ~ ~ ~ ~
middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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Fd daY~J u l )t 21 ~ 1 995 ppf 37710 to37744 0
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middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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middot0 ~~~~~~7E~~~ I~TER3 ~~kTr~~ ~~E~)ff~O(~~~~~~~~~1middot~ f gt N Ul-rB E R middot D~rE CODE07VIE WER -DAT Emiddot -lt NoN S EX middoti ~() O1 NO T ~ME~HOD
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