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Citation: 45 Fed. Reg. 73948 1980
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7/23/2019 FR Vol No
2/14
Federal
Register
/ Vol. 45, No. 218 Friday,
November
7, 1980 Proposed Rules
accreditation for either
chemical residue
arialysis or
PMFS analysis,
or both.
It
would
also specify the
on-going
standards
which must be continually
met by
an
accredited laboratory-o
maintain
accreditation for
either or
both
of these
two
categories
of analysis.
In
addition,
the
proposal would
establish
conditions
under which
accreditation
may be refused
or
withdrawn and
would
contain
provisions
offering
the
opportunity for
an
oral hearing
to
appeal
such a decision
by the
Administrator
of
FSQS.
Laboratories
designated
as certified or
recognized
on the
effective
date of these
regulations would
automatically become
accredited
laboratories
for their current
type
of analysis since
they
have I
demonstrated their
ability to
meet the
criteria
for
obtaining
accreditation.
However,
such
laboratories would
be
required to meet
the standards
for
maintaining
accreditation,
as set forth
in
the
proposal.
All
other
laboratories
which
wished to be
accredited would
have
to
apply
for
accreditation
in
accordance
with
these regulations.
Most
of
the
particular standards in
the
proposal
have been used
for several
years by the
Department in
making
determinations
in specific
cases for
certifying or recognizing
laboratory
programs. No method
of
analysis can
ascertain in all
instances the
exact
amount
of a chemidal
present in an y
particular
product. However,
numerous
studies have
been
conducted
over
the
years
under
the
auspices of the
Association
of Official Analytical
Chemists,
various'
governmental
agencies, private
and industry
groups,
and academic
institutions
to ascertain
the degree
of accuracy
in
analysis
for
specific
chemicals
that
can
be
achieved
under the methods
of analysis.
The
particular
numerical
variations
proposed
by the Department,
both as
to
percentage
and amount, are
based upon
these
studies.I In
addition, the
USDA
has an ongoing
program to
sponsor or
participate in further
studies
to
refine
or
assure
the efficacy of these
numerical
variations in light
of present
scientific
and
technological expertise.
The standards also
contain
requirements
as
to supervisory
experience
anZ education,
recordkeeping,
reporting, FSQS'access,
and
check
samples
which
the
Department
believes
are
necessary
to
assure that accredited
laboratories have
sufficient expertise
to perform
the types
IA list
of. or
copies
of, the scientific
studies relied
upon by USDA in
determining these variations
r
particular chemicals are
available
from
the
Chemistry
Division.
Science
Program,
Food
Safety
and Quality
Service.
U.S. Department
of
Agiculture, Washington, D.C.
20250.
of analysis
for which
they are
accredited and to assure that the
samples
in
accredited laboratories
are
being
properly
analyzed.
Finally, it is
rerfuired
that
a
laboratory
seeking
accreditation for PMFS analysis provide
the name
and addreis
of an
official
meat
or poultry establishment
which
has
agreed
to
employ
its
services. Since
many
laboratories can
perform this type
of analysis, the
Department
wishes to
avoid overburdening
its
resources
by
evaluating
applicants who
have
no
foreseeable need
for such
accreditation.
In sum,
the
Department has had very
good experience
with these standards
and programs. It
iS
believed,
therefore,
that these
programs and standards
should
be
accorded
a
more permanent
basis of
general
applicability.
Thus,
these amendments
to the
regulations are
being
proposed.
Options Considered
The
Department
has reviewed
both
the
certified
and
the
recognized
laboratory
programs
and
considered
two
options for suggested
revisions in
the
programs. Under
Option
I, the
Department itould
provide all
laboratory services
for participating
meat and poultry
processing
establishments. Non-USDA
laboratories
would no
longer
be
used.
Under Option
II,
the
Department
would
combine the
certified
and
the
recognized
laboratory
programs into one Accredited
Laboratory
Program and propose
laboratory
accreditation
standards
and
procedures in
order to
permit
public
review and comment.
A comparison
of
the
two
options
-indicates
that
there would be
a
substantial cost savings
to the
Department
in the selection
of Option II
over Option
I. The
annual cost
to the
Department
of maintaining
USDA
laboratories to
analyze
36,000 official
samples (Option
I
would-be
over
750,000
more than
the cost
of
effectively monitoring
non-USDA
laboratories
to perform
the same
work
under
an Accredited
Laboratory
Program
(Option
II . In
addition,
the
accreditation
of non-USDA
laboratories
under
Option It may
increase the
number
and locations of
laboratories
available
to
the
industry.
This,
in
turn,
would
decrease turnaround
time
for'the
analysis
of meat
and
poultry
samples,
and would
thus save
the industry
money, as
well as provide a more
flexible,
responsive
system
to meet
industry needs. Such a
responsive
system
may ultimately benefit
the
public
through
a
more
healthy and
safe food
supply.
Thus, for the
reasons
stated
herein, Option II
was chosen.
This document incorporates by
reference the Official Methods of
Analysis
of the
Association
of Official
Analytical Chemists . See
318.19(a)(13)
and 381.153(13).)
PART
318 ENTRY INTO OFFICIAL
ESTABLISHMENTS;
REINSPECTION
AND
PREPARATION OF PRODUCTS
Accordingly,
Part
318
of the
Federal
ment inspection
regulations (9
CFR
318]
would
be
amended
by
adding
a
now
318.19, and the Table of Contents
would be
amendedsccordingly,
to read
as follows:
318.19 Accreditation
of
chemistry
laboratories
a)Definitions:
1)
Accredited
Laboratory-Anon-
USDA
chemistry
laboratory
that
has
met the
requirements specified in
this
section
for accreditation.
Payment for
analysis
of
official
samples is to
be
made
by the laboratory
client.
2)
Split
Samples-A duplicate
of an
official sample
which
is
analyzed by an
FSQS
Multidisciplinary Laboratory
and
is used for
comparison
to
determine
the
continued
analytical
capability
of
the
accredited
laboratory.
3) FSQS
Form
62 2 The
laboratory
biweekly'report used by
FSQS
and
those
laboratories accredited
for moisture,
protein, fat, and
salt
analysis
in meat and
poultry products.
The results of the
analysis for
protein,
moisture,
salt, and fat content are
reporied
on
this form
to
the
Chemistry
Division,
Science
Program,
Food
Safety
and Quality Service,
U.S. Department
of
Agriculture,
Washington, DC 20250.
4) MPForm
115-The
laboratory
biweekly
ieport used
by FSQS and
those
laboratories
accredited
for
chemical residue analysis-in
meat
an d
poultry
food
products.
The
results of the
analysis
for chemical
residues are
reported
on
this
form
to
the
Chemistry
Division,
Science
Program,
Food Safely
and Quality
Service, U.S. Department
of
Agriculture,
Washington,
DC 20250.
(5) Minordeviation-
i)Laboratories
accreditedor
analysisofprotein moisture
at
and
saltcontent:
A difference between the accredited
laboratory sample result
and
the
FSQS
Multidisciplinary Laboratory split
sample or
check sample
result
that
exceeds the following values:
protein=
0.5%, moisture and
fat=1.0 ,
and salt=--0.3%;
but does
not exceed the
following values:
protein=1.0 ,
moisture
and
fat=:2.0%,
and sylt= 0.6 .
(ii) Laboratoriesaccredited
or
analysis
of
chemical
residues:
7 9 8
7/23/2019 FR Vol No
3/14
Federal Register / Vol.
45. No. 218 / Friday,
November
7. 1980 1 Proposed Rules
A difference
between
the accredited
laboratory
sample
result and
the FSQS
Multidisciplinary
Laboratory
split
sample
or check sample
result that
exceeds 2
times
but not
4
times
the
coefficient
of variation times the mean
of
the
two results.
[6) Majordeviation-
(i)
Laboratories
accreditedor
analysisqfprotein.
moisture,
at
and
salt
content
A
difference
between
the
accredited
laboratory
sample
result
and the
FSQS
Multidisciplinary
Laboratory
split
sample
or
check
sample
result that
exceeds the following values:
protein =
1.0%,
moisture and
fat
=
2.0%.
and
salt
0.6%.
(ii)
Laboratories
accredited
or
analysis
of chemical residues
A difference between
the accredited
laboratory
sample
result and
the FSQS
Multidisciplinary
Laboratory split
sample
or check sample
result that
exceeds
4 times
the coefficient of
variation
times the
mean of the
two
results.
(7)
Official
sample.-A
sample
selected
by a Federal
inspector
at
an
establishment.
For
samples for chemical
residue analysis,
this
term
also
includes
any sample
selected and
submitted
under
USDA
supervision
by
a
grower of
livestock
or by an establishment.
(8)
Accredited
Laboratory
Coordinator-The
FSQS
official
responsible
for coordinating
all
activities of laboratory
accreditation
and automatic
data
processing
(ADP)
analysis.
(9)
Minimum ProficiencyLevel-The
minimum level
of incurred residue
expected
to
be
identified
and quantified
by an accredited
laboratory.
(10)
COV
[Coefficient
of
Variation)-
The
standard deviation
of
a
set
of
analytical
results multiplied
by 100.
divided
by the average value
of
those
analytical results.
(11)
Accreditation
Check Samples-A
set
of samples prepared
by an FSQS
laboratory
and
used
to
ascertain a non-
USDA
laboratory's analytical
capability
for
obtaining
accreditation.
(12)
Official
Check
Samples-
Samples
prepared
by
an
FSQS
laboratory
and
used
to
determine
an
accredited laboratory s continued
analytical
capability.
(13)
AOACprocedures-Procedures
f
chemical analysis
accepted
by
the
Association
of Official Analytical
Chemists
(AOAC) and published
in
the
Official Methods
of Analysis
of the
Association
of Official
Analytical
Chemists .'
(14)
Standards
of
performance or
initial
and
continued
aborator
accreditationfor chemical
residue
analysis-Table
1
stablishes
the
standards of performance
which must
be set by non-USDA laboratories
for
residues
analyses using
analytical
procedures
designated and
approved
by
FSQS:
Tab4. 1
Res4Lde
BenM hex&&Acqvde
DOT
DOE
TOE
Endwm
Heptiwo
~
H,~ eptor
re
Toxaphefe
PolycNomrle bphwo
Nexachloobelt
M 'ex
Nonaeh
PcboWled bptyls
S&ja drugs
DES
NWoris
0tOpp-
10 pp'
3
pm
010 ppnm
15ppn
0 10 PP-i
1 ppin
0S p
10 ppm
0
1t ppm
15 KM
2
Fxn
0 5 ;Prm
2
~b
2
ppm
0
-Proper 4debf~cilton
Of M-1~o-,ije prewl~
s
r&:FN,1
(b)
Laboratories
accredited
or
analysis
of
protein,
moisture,
fat
und
saltcontent in meat
food
products.
(1)
Applying for Accreditation.s
Application
for accreditation
shall
be
made
by letter by the owner
or operator
of the
non-USDA laboratory to
the
Accredited
Laboratory Coordinator,
Chemistry
Division, Science
Program,
Food
Safety
and
Quality
Service,
U.S.
Department of
Agriculture,
Washington,
DC
20250. Laboratories
whose
accreditation
has been
refused
or
withdrawn
under
the circumstances
described
in paragraph
Id) or
teJ
of this
section may reapply for accreditation
no
sooner
than
1 year
after the effective
date
of
that
action.
(2)
Criteria
or
obtaining
accreditation.
Non-USDA chemistry
laboratories
may
be accredited for
the
Accredited
Laboratory
Program
for the
analysis
of
moisture, protein,
fat, and
salt content. This
accreditation
authorizes
official FSQS
acceptance
of
such
analytical test
results
from such
laboratories
on
official
samples.
To
obtain FSQS
accreditation for
moisture,
I
Copies
of
this pubhcatIn
a re
fn
file ,
h
t
Director. Office uf
the Federal
Reester.
antJ are
aialable from
ihv Assoualtun offOffio,'i
Andlytcdl
Chernibts,
1111 n 191h
Strerl, Sj
e 210
Arlington.
Virginia 22-N
80-1
o
811-103
6.2- 03
5, -it*)
812-10
EQ-fD3
80-It')
52-1
CQ
WrA
E2-9
,'0-x110
protein,
fat,
and
salt
analyses, a
non-
USDA
chemistry
laboratory
must:
(i)
Provide to
FSQS
the name
and
address
of at least
one
official
meal
establishment
which has
agreed
to
employ
its
services,
(ii)Be
supervised
by a person
holding.
at a
minimum,
a
bachelor s degree
in
chemistry,
and
1
year's experience
in
meat chemistry,
or the
equivalent
as
determined by the
Administrator. FSQS,
(iii) Successfully demonstrate
analytical
capability using
AOAC
procedures
I by
taking
part in a 30 check
sample
accreditation study carried
out
between
the applying laboratory and a
Multidisciplinary
Laboratory, Field
Service Laboratories
Division,
Science
Program, FSQS. USDA.
The applying
laboratory
will bear the
costs
of
its
analysis. If
analysis of the first
set of
accreditation
check
samples does not
meet FSQS
standards for obtaining
accreditation,
a
second set of
samples
will
be
provided
to
the
non-USDA
laboratory. If the
analysis of the second
set
of
samples does
not
meet
FSQS
2L.aboratrtesdetgnated
by
FSQS as
'cet1ed
on
the effecti.e
dite
of this regul3tion will
autiWmaically
bze. e a:-redited
laboratcies for
thcircurrent t pe
o aniI,,sis
without
c'-pTyin
, tth
paragraphs (bltI] and Ib](2)
of
ths
stiz.
Howe er, all other reqzrements of
thi
seatim
shall
be applis
e
to su2J laboratoies.
1-eq rec-Nwy
ortmral
arterea
,=1 15
c.CG 5
-,Ol
IS'.
,40 d'
5%
4co 5
,Xo3 151.
7/23/2019 FR Vol No
4/14
Federal
Register / Vol. 45, No.
218 Friday, November
7, 1980 Proposed
Rules
standards
for obtaining
accreditation.
no additional set of accreditation
check
samples
will
be'provided for a 1-year
time period
commencing from the date
on which
the analysis results of
the
second setwas reported to
FSQS. The
applying
laboratory
must meet
the
following
standards
on
results
from
analyzing
the
30 accreditation
check
samples:
a)
Not more
than
25
percent
of
samples
tested
shall
have
minor
deviations.
b) Not
more than 5
percent
of
samples
tested shall have major
deviations.
c)
Data mustconform to normal'
statistical
distribution.
(iv) Allow access to and
inspection
of
the
laboratory by
FSQS officials
prior
to
a determination as to the granting of
accredited status.
3)Standards
or
maintaining
accreditation. o maintain accreditation
for
the
Accredited Laboratory
Program
for moisture, protein,
fat,
and
salt
analyses,
a
non-USDA
chemistry
laboratory must:
(i)Report analytical results of the
moisture,
protein, fat, and salt bontent of
official
samples biweekly
on
FSQS Form
6200-2
to the
Chemistry
Division,
Science Program,
FSQS, USDA.
(ii)
Maintain
laboratory
quality
control records for a
period of
3
years.
(iii)
Maintain complete records of
the
receipt, analysis, and
dispositon
of,
official samples in a
permanently bound
book for a period of
3
years after the lasi
entry.
(iv) Maintain a, standards book
which
is
a permanently
bound
book
with sequentially numbered pages,
containing all readings and calculations
for standardization of solutions,
determination of recoveries, and
calibration of instruments. All entries
are
to
be
dated and
signed
by
the
analyst and his/her supervisor within 1
working
day, and
the
book is to
be
maintained
for
a
period of 3 years after
the
last entry.
(v) Analyze
official
check samples,
whenever
requested by
USDA,
at no
cost to USDA within 1 week of sample
receipt.
(vi) Inform the Chemistry
Division,
Science Program, FSQS, by certified or
registered
mail,
when
a
change
in
laboratory supervisory
personnel
occurs.
(vii) Permit FSQS
officials
to perform
both announced
and unannounced
on-
site laboratory
reviews.
(viii)
Use official
AOAC procedures'
on official
samples.
(ix) Maintain
acceptable analytical
agreement
of
the
laboratory s official
sample
results
with split sample
results
from
a
Multidisciplinary Laboratory,
Field
Service Laboratories Division,
Science
Program,
FSQS. Acceptable
agreement is:
a)Not more than 25 percent of the
samples
tested having
minor deviations.
b) Not
more than
5
percent of the
samples
tested
having
major deviations.
(c)
Data conforming
to normal
statistical distribution.
(x)
Report analytical results
of
official
samples in
accordance with
the
instructions of the Accredited
Laboratory
Coordinator
before making
the
results available to any other party.
The
Federal inspector
at
any
establishment
may assign the
analysis
of official samples t 6 an
FSQS-Science
Multidisciplinary
Laboratory
if, in
his/
her
view,
there are an excessive number
of delays
in
receiving test results on
official samples from
an
accredited
laboratory.
c)
Laboratories
accredited or
chemical
residue
analysis n meat ood
products.- 1) Applying for
accreditation.
Application
for
accreditation
shall be made
by
letter by
the
owner
or operator of
the
non-USDA
laboratory. to the
Accredited Laboratory
Coordinator, Chemistry
Division,
Science Program Food Safety and
Quality Service, U.S. Department
of
Agriculture, Washington, D.C. 20250.
Laboratories
whose accreditation has
been refused
or
withdrawn under the
circumstances
described
in
paragraphs
d)
or (e) of
this
section may reapply for
accreditation
no
sooner than 1 year after
the effective
date of that
action.
2)
Criteria
or
obtaining
~accreditation.Non-USDA chemistry
laboratories may
be
accredited
for
the
Accredited Laboratory Program
for the
analysis for
residue content of particular
chemicals or
classes of chemicals. This
accreditation authorizes official
FSQS
acceptance
of such analyticAl
test
results from such laboratories on official
samples.
To obtain F SQS accreditation
for chemical
residue analysis, a non-
USDA
chemistry
laboratory
must:
(i)Be supervised by
a
person holding,
at
a minimum, a
bachelor's degree in
chemistry from an American Chemical
Society ACS) approved
college
or
university and
having
a minimum of
3
years
experiehce
in the preceding
6
years
in the
residue analysis of
those
particular chemicals or classes
of
chemicals
for which accreditation
is
sought or the equivalent as determined
3
Laboratories designated
by
FSQS as
recognized
on
the effective
date of
this regulation
will
automatically
become accredited laboratories
for
their
current type
of
analysis
without
complying
with
paragraphs (c)i)
and [c)[2) of
this section.
However,
all other
requirements of
this'section shall
be applicable to such laboratories.
by
the Administrator, FSQS; or
8 years'
experience in the preceding 10
years
in
the
residue
analysis of those particular
chemicals
or
classes
of chemicals
for
which
accreditation
is sought, and
a
bachelor's
degree
in chemistry from
any
college or
university.
(ii)Successfully
demonstrate
analytical capability for
the
particular
chemical
or
class of
chemicals applied
for
using
procedures designated and
approved
by FSQS by
taking
part In a
check
sample accreditation study
carried out
between the applying
laboratory
and a Multidisciplinary
Laboratory, Field Service Laboratorles
Diision, Science
Program, FSQS,
USDA. The applying laboratory
will
bear
the costs of its
Analysis. If
analysis
of the first
set
of
accreditation
check
samples for
the
particular
chemicals
or
class
of chemicals does
not meet
FSQS
standards for obtaining
accreditation,
a
second set of samples
will be
provided
to the
non-USDA
laboratory. If the
analysis of the second
set
of samples
does
not
meet
FSQS
standards
for
obtaining
accreditation,
no
additional
set of accreditation
check
samples
for
the particular chemical or
class
of
chemicals will be
provided
for wa-year
time period commencing
from the
date
on which
the
analysis
results
of
the
second
set was reported to FSQS. With
regard
to the
accreditation check
samples,
the
applying laboratory
must
meet the
standards of performance for
initial laboratory accreditation for
chemical residue analysis
of
the
particular chemical
or class
of
chemidals
(Table
1
and
a)Not
more than 25 percent
of
the
samples
tested
shall
have
minor
deviations.
b)
Not
more than 5
percent
of'the
samples tested shall
have
major
deviations.
c)
Data
must conform
to normal
statistical
distribution.
(iii) Allow access to and
inspection
of
the laboratory by FSQS officials prior to
a
determination
as
to
the granting
of
accredited status.
3)Standards ormaintain
accreditation.To maintaining
accreditation for
the
Accredited
Laboratory Program
for
chemical
residue
analysis, a non-USDA
chemistry
laboratory must:
(i) Report
analytical chemical residue
results
of official samples biweekly on
MP Form 115 to the Chemistry Division,
Sciende Program,
FSQS, USDA.
(it) Maintain
laboratory quality
control
records
for a period
of
3
years.
(iii)
Maintain
complete
records
of
the
receipt,
analysis, and
disposition of
official
samples
in a
permanently bound
7 95
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/
Friday. November 7. 1980 Proposed
Rules
book
for a period
of
3 years after the last
entry.
(iv) Maintain
a standards
book*
which is a permanently
bound
book
with
sequentially numbered
pages
containing
all readings and calculations
for standardization of solutions,
determination
of recoveries, an d
calibration
of instruments.
All entries
are to be
dated and signed by
the
analyst and
his/her supervisor within 1
working
day
and
the
book is
to
be
maintained
for a period
of
3
years
after
the
last entry.
(v)
Analyze
official
check samples
whenever
requested by
USDA, at no
cost to USDA within
1
week
of the
sample receipt.
(vi) Inform Chemistry
Division,
Science
Program,
FSQS, by
certified or
registered mail,
when a change
in
laboratory supervisory personnel
occurs.
(vii)
Permit
FSQS officials
access to
perform both
announced and
unannounced on-site
laboratory
reviews.
(viii) Use
analytical procedures
designated
and approved by
FSQS
officials
on official
samples.
(ix)
Maintain
acceptable
analytical
agreement
of
the laboratory's
official
sample
results with split
sample
results
from
a Multidisciplinary Laboratory,
Field Service
Laboratories Division,
Science Program,
FSQS.
Acceptable
agreement
is
meeting
the
standards of
performance for
continued
laboratory
accreditation for chemical residue
analysis
for
the
particular chemical
or
class of chemicals
(Table
I)
and
a] Not more
than 25
percent of the
samples
tested
minor
deviations.
b)
Not more
than
5
percent
of the
samples tested
major deviations.
c)ata conforming
to normal
statistical distribution.
(x) Report
analytical
results of official
samples
in
accordance
with the
instructions of
the Accredited
Laboratory Coordinator
before making
the results available
to any
other party.
(d) Refusal
of accreditation.
Upon a
determination by
the Administrator
a
laboratory may
be
refused accreditation
for the
Following
reasons:
1)
Laboratory
may be
refused
accreditation for
protein,
moisture,
fat
and
salt
analysis for failure to meet
the
requirements
of
paragraph
(b)(2)
of
this
section.
(2) A
laboratory may
be
refused
accreditation for chemical
residue
analysis for failure
to meet the
requirements
of
paragraph (c)(2) of
this
section.
The
refusal may
be
limited
to
the
analysis of particular chemicals
or
classes
of
chemicals
if the deficiencies
relate
only
to those chemicals
or classes
of chemicals
and to the requirements
in
paragraph (c](2)(i) or (ii)
of this se ction.
e) Withdrawalof accreditation.Upon
a determination
by
the
Administrator
an
accredited
laboratory
may
have
its
accreditation withdrawn for
the
following
reasons:
1)An accredited
laboratory may
have
its accreditation
withdrawn for
protein, mositure,
fat and salt analysis
for
failure
to meet
the requirements
of
paragraph
(b)(3)
of
this
section.
(2)
An
accredited laboratory ma y
have
its
accreditation withdrawn for
chemical
residue
analysis for
failure to
meet the requirements
of
paragraph
c)H3) of
this section.
(3) An
accredited
laboratory may
have
its
accreditation withdrawn for
either
protein, mositure, fat and salt
analysis
or for
chemical
residue analysis
if the laboratory owner
or operator, or
any
agent
or
employee in the
scope of
his agency
or
employment,
has:
(i)
Altered
any official sample or
analytical
findings,
or.
(ii)
Substituted any analysis from
a
non-accredited
laboratory.
Accredited
laboratories
may not send official
samples
to non-accredited
laboratories
for
analysis.
(4)
Withdrawals of
accreditation for
chemical
residue analysis
may be
limited to
the
analysis of
particular
chemicals
or
classes
of
chemicals if the
deficiencies
relate only the those
chemcials
or classes
of chemicals and
to
the requirements
in
paragraph
(c)(3)(ix)
of this section.
I)Appeal procedures.Accreditation
of any
laboratory may be refused
or
withdrawn
under the conditions
previously described
herein. The
owner
or
operator
of
the
laboratory
will
be sent
written
notice
of the
refusal or
withdrawal of
accreditation by
the
Administrator. In such
cases,
the
laboratory owner
or operator will be
provided the opportunity
to present,
within 30 days
of
the
date
of the
notification of the action,
a statement
challenging
the merits
or
validity
of such
action
and to
request
an oral
hearing
with
respect to the denial
or withdrawal
decision.
An oral hearing shall
be
granted if there is an y
dispute of
material
fact joined in such responsive
statement. The proceeding shall
thereafter
be conducted
in accordance
with
the
applicable rules of practice
which
shall
be
adopted for the
proceeding. Any such
refusal shall
be
effective
upon the
notification,
and shall
continue
in effect unitl
final
determination of the
matter.Any such
withdrawal
shall
be
effective upon
notification,
but shall
be
held
in
abeyance
until final
determination
of the
matter except
in cases where the
Administrator
determines the
public
health, interest, or
safety
requires the
withdrawal to continue in effect until
the
final determination of the matter.
(Sec.
21.34 Stat.
1260,
as
amended.
21
U.S.C.
621; 42 FR
35625,
35626)
PART
381-POULTRY
PRODUCTS
INSPECTION
REGULATIONS
Furthermore, Part 381, Subpart 0, of
the
poultry
products
inspection
regulations (9
CFR 381) would
be
amended
y adding a new
381.153,
and the
Table of Contents
would
be
amended accordingly,
to
read
as
follows:
381.153
Accreditation of
chemistry
laboratories.
(a)
Definitions:
1)Accredited
Laboratory-Anon-
USDA chemistry
laboratory
that has
met the requirements
specified
in
this
section for accreditation. Payment
for
analysis of
official samples
is
to be
made by the
laboratory
client.
2) Spilt
Samples-Aduplicate
of
an
official
sample, which is
analyzed
by an
FSQS Multidisciplinary
Laboratory and
is used
for comparison to determine
the
continued
analytical
capability
of
the
accredited
laboratory.
3) FSQS orm 6200-2-The
laboratory
biweekly
report
used by
FSQS
and
those laboratories
accredited
for moisture,
protein, fat and salt
analysis in
meat and poultry
products.
The results of the analysis for protein,
mositure,
salt, and fat
content
are
reported on
this
form
to
the Chemistry
Division,
Science Program,
Food Safety
and Quality
Service, U.S.
Department of
Agriculture, Washington,
DC
20250.
(4) AIPForm
115 The laboratory
biweekly
report
used by
FSQS and
those laboratories
accredited for
chemical residue
analysis
in
meat
and
poultry food
products. The
results of the
analysis
for chemical
residues
are
reported on this
form to
the Chemistry
Division, Science Program,
Food
Safety
and Quality Service, U.S.
Department
of
Agriculture,
Washington,
DC
20250.
5 ) Minordeviation-
(i)
Laboratoriesaccreditedor
analysis
ofprotein moisture
at
and
salt
content:
A
difference
between the accredited
laboratory sample result
and the
FSQS
Multidisciplinary
Laboratory split
sample or check sample
result
that
exceeds
the
following values:
protein
t 0.5 ,
moisture and fat
-L
1.0 , and
salt - 0.37; but does
not
exeed
the
following values: protein
1.07,
moisture
and
fat
t
2.07a, nd
salt
=
0.67.
ii) Laboratoriesaccredited
or
analyvsis
of chemicalresidues:
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Proposed
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A difference
between
the
accredited
laboratory
sample
result
and the
FSQS
Multidisciplinary
Laboratory
split
sample
or check
sample
result
that
exceeds
2 times
but not 4
times the
coefficient
of
variation
times the mean
of the two
results.
(6) Major
deviation-
(i)
Laboratories
accredited
or
analysis
of
protein,moisture,
at
and
saltcontent:
A difference
between
the
accredited
laboratory
sample
result
and the
FSQS
Multidisciplinary
Laboratory
split
sample
or check
sample
result
that
exceeds the
following
values:
protein
=
_k
.0o,
moisture
and
fat
=
L
2.0%,
and
salt = ;
0.6 .
(ii)
Laboratories
accredited
or
analysis
of chemical
residues:
A difference
between the
accredited
laboratory
sample
result
and the FSQS
Multidisciplinary
Laboratory
split
sample
or check
sample
result that
exceeds 4 times the
coefficient
of
variation times
the
mean of the
tw o
results.
(7)
Official
sample-A
sample
selected
by a Federal
inspector at an
establishment.
For samples
for chemical
residue
analysis,
this,
term also inclildes
any
sample selected
and submitted
under USDA supervision
by
a
grower
of
poultry
or
by an
establishment.
(8)
AccreditedLaboratory
Coordinator-The
FSQS official
responsible for
coordinating
all activites
of
laboratory
accreditation
and
automatic
data processing
(ADP)
analysis.
(9) Minimum
Proficiency
Level-The
minimum
level
of incurred residue
expected
to be
identified
and quantified
by
an
accredited laboratory.
(10) COV Coefficient
o
Variation)-
The standard
deviation of
a set
of
analytical
results
multiplied by
100,
divided
by
the
average
value
of those
analytical
results.
(11)
Accreditation
Check Samples-A
set of samples
prepared by an
FSQS
laboratory and
used to
ascertain
anon-
USDA laboratory's
analytical
capability
for
obtaining
accreditation.
(12)
Official
Check Samples-
Samples
prepared
by an FSQS
laboratory
and used
to determine
an
accredited
laboratory s continued
analytical
capability.
(13)
AOACproceduresr--Procedures
f
chemical
analysis
accepted by the
Association
of Official
Analytical
Chemists
(AOAC) and
published
in the
Official
Methods
of Analysis of
the
Association
of Official
Analytical
Chemists.'
I opies of
this publication are
on
file with the
Director.
Office
of
the Federal
Register,
and
are
(14) Standards ofperformancefoi
initialandcontinued aboratory
accreditation
orchemical
residue
analyses-Table1 establishes the
standards
of performance which
must
be
met
by non-USDA
laboratories
for
residue analyses
using
analytical
procedures
designated
and
approved
by
FSQS:
Table 1
Minimum Percent Initial Continued
Residue
Proficiency expected
acceptance
acceplano
level
recovery cdteia
Criteria
Alddn .....
0.10
ppm
80-100
7/23/2019 FR Vol No
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Friday. November
7. 1980 / Proposed Rules
standards
for
obtaining
accreditation,
no additional set of accreditation check
samples
will
be provided
for a
1-year
time period commencing
from
the date
on
which
the
analysis results
of
the
second set was
reported
to FSQS. The
applying laboratory must meet the
following standards on results from
analyzing
the
30 accreditation
check
samples:
a)Not more
than
25 percent of
samples
tested
shall have
minor
deviations.
b) Not more than
5
percent
of
samples
tested shall have major
deviations.
c)Data must conform to normal
statistical distribution.
(iv) Allow access to
and inspection of
the laboratory by FSQS
officials prior
to
a determination
as
to the
granting
of
accredited status.
3)Standardsor maintaining
accreditation.
To maintain accreditation
for the Accredited Laboratory Program
for m oisture,
protein,
fat, and salt
analyses,
a
non-USDA chemistry
laboratory
must:
fi Report
analytical
results of the
moisture, protein, fat and salt content of
official samples biweekly
on
FSQS Form
6200-2
to the
Chemistry Division,
Science Program, FSQS, UDSA.
(ii) Maintain laboratory quality
control
records for a
period
of
3
years.
(iii) Maintain complete records of the
receipt, analysis, and
disposition
of
official samples
in
a
permanently
bound
book for a
period of 3 years after the last
entry.
(iv)
Maintain
a
standards book
which is a premanently
bound
book
with sequentially numbered
pages
containing
all
readings and calculations
for standardization
of solutions,
determination
of recoveries, and
calibration
of instruments.
All
entries
are to be
dated and-signed by the
analyst and
his/her supervisor within
1
working day, and
the book is
to
be
maintained for a
period of 3 years after
the
last
entry.
(v)
Analyze official
check
samples
whenever requested
by
USDA,
at
no
cost
to USDA
within
week
of sample
receipt.
(vi) Inform the Chemistry Division,
Science Program,
FSQS,
by certified or
registered mail, when a change in
laboratory
supervisory personnel
occurs.
(vii) Permit FSQS
officials
to perform
both
announced and
unannounced
on-
site laboratory reviews.
(viii) Use
official AOAC procedures
I
on
official samples.
(ix]
Maintain
acceptable analytical
agreement of
the
laboratory's
official
sample results
with split sample results
from
a
Multidisciplinary Laboratory,
Field
Service Laboratories
Division,
Science Program,
FSQS.
ALceptable
agreement
is:
a)
Not
more
than 25
percent
of the
samples tested having minor
deviations.
b)
Not
more than 5
percent of the
samples tested having
major deviations.
c)Data
conforming to normal
statistical
distribution.
(x) Report
analytical results
of official
samples
in
accordance
with
the
instructions of the Accredited
Laboratory
Coordinator
before making
the
results available to
any other party.
The Federal inspector
at an y
establishment
may
assign
the
analysis
of official samples
to an
FSQS-Science
Multidisciplinary Laboratory if, in his/
her
view, there are an
excessive
number
of delays in receiving test results
on
official samples from an accredited
laboratory.
c)Laboratoriesaccredited
or
chemical
residue
analysis n poultry
products.-- 1)
Applying for
accreditation.
Application for
accreditation
shall be made
by
letter
by
the
owner or operator of
the
non-USDA
laboratory
to the Accredited Laboratory
Coordinator.
Chemistry
Division,
Science Program, Food Safety and
Quality Service.
U.S.
Department of
Agriculture,
Washington, DC 20250.
Laboratories
whose
accreditation
has
been refused or withdrawn under
the
circumstances described in paragraphs
(d)
or
(e)
of this
section may reapply for
accreditation
no sooner
than 1
year after
the effective
date of that
action.
2)
Criteria
or
obtaining
accreditation.Non-USDA
chemistry
laboratories may be
accredited
for
the
Accredited Laboratory
Program
for
the
analysis for the
residue
content of
particular chemicals or classes of
chemicals. This accreditation authorizes
official
FSQS acceptance of
such
analytical test results
from
such
laboratories
on official samples. To
obtain FSQS
accreditation for
chemical
residue analysis,
a non-USDA chemistry
laboratory
must:
(i)Be supervised
by a person
holding,
at
a minimum, a bachelor's degree in
chemistry from an American
Chemical
Society (ACS)
approved college or
university and having a minimum
of
3
years' experience
in
the preceding 6
years
in
the residue analysis of
those
particular chemicals or classes of
chemicals
for
which accreditation is
3Laboratones
designated
by FSQS
as
recognized
on
the
effectie
date
of
this
regulation
will
automatically
become
accredited laboratones
for their current
type
of
analysis without omplying
with
paragraphs cX) and cX2)
of
this
section,
However. all
other requirements
of this
section
shall
be applicable to such laboratories.
sought or the equivalent as determined
by the Administrator, FSQS; or a years'
e\perience in the preceding
10
years in
the
residue analysis of
those
particular
chemicals or classes
of chemicals for
which accreditation
is sought, and
a
bachelor's degree in chemistry from any
college or university.
(ii)
Successfully
demonstrate
analytical capability
for the particular
chemical
or classes of chemicals applied
for
using
procedures
designated
and
approved
by
FSQS
by taking part in
a
check
sample
accreditation
study
carried out between the applying
laboratory and a Multidisciplinary
Laboratory.
Field
Service Laboratories
Division. Science
Program,
FSQS.
USDA, The applying
laboratory will
bear
the
costs of its analysis.
If
analysis
of
the
first set of accreditation check.,,
samples for the
particular chemical
or
classes of chemicals does not
meet
FSQS
standards for obtaining
accreditation, a second set of samples
will be
provided to
the
non-USDA
laboratory. If
the
analysis of
the second
set
of
samples does
not meet
FSQS
standards
for obtaining
accreditation,
no
additional
set
of accreditation
check
samples
for the particular chemical
or
class of chemicals will be provided
for
a
1-year
time period commencing
from the
date
on
which the analysis results of
the
second set was reported
to
FSQS.
With
regard
to the
accreditation
check
samples,
the applying laboratory
must
meet
the
standards of performance
for
initial
laboratory accreditation
for
chemical residue analysis of
the
particular chemical or class
of
chemicals
(Table 1 and
a)Not more
than
25
percent of
the
samples tested
shall
have
minor
deviations.
b)
Not
more than
5
percent of the
samples tested shall have
major
deviations.
c) Data must
conform to normal
statistical
distribution.
(iii]
Allow
access
to
and
inspection
of
the laboratory by
FSQS
officials
prior
to
a determination as
to
the granting
of
accredited
status.
3)Standards
or
maintaining
accreditation. o maintain
accreditation
for the
Accredited
Laboratory Program
for chemical
residue
analysis, a
non-
USDA
chemistry
laboratory
must:
(i)Report analytical
chemical
residue
results of
official
samples
biweekly
on
MP
Form
115
to
the Chemistry
Division.
Science
Program,
FSQS, USDA.
(ii)
Maintain laboratory quality
control
records for a period of 3
years.
(iii) Maintain complete records
of
the
receipt, analysis, and
disposition of
official samples
in a
permanently boun d
73953
7/23/2019 FR Vol No
8/14
Federal
Register-
Vol.
45,
No.
218 Friday,
November
7,
1980 Proposed Rules
book
for
a
period
of 3
years after the
last
entry.
(iv) Maintain
a
standards
book
which
is a
permanently
bound book
with
sequentially
numbered
pages
containing all readings
and calculations
for
standardization of
solutions,
determination
of
recoveries,
and
calibration of
instruments. Alr
entries
are to be
dated and
signed
by the
analyst
and
his/her
supervisor
within 1
working
day and
the
book.is
to be
maintained
for
a
period
of
3 years after
the
last
entry.
(v) Analyze official check
samples
whenever
requested by
USDA, at no
cost
to
USDA within
1week of sample
receipt.
(vi)
Inform
Chemistry Division,
Science
Program, FSQS,
by certified
or
registered mail,
when
a
change in
laboratory supervisory
personnel
occurs.
(vii) Permit
FSQS officials
access
to
perform both
announced and
unannounced
on-site
laboratory
reviews.
(viii) Use
analytical
procedures
designated
and approved
by FSQS
officials
on official
samples.
(ix)
Maintain
acceptable analytical
agreement
of the
laboratory s official
sample
results with
split sample
results
from a
Multidisciplinary
Laboratory,
Field Service
Laboratories
Division,
Science Program,
FSQS.
Acceptable
agreement
is
meeting the standards
of
performance
for continued
laboratory
accreditation
for chemical
residue
analysis for
the particular
chemical
or
class of
chemicals (Table
I),and
a)
Not more
than 25
percent
of
the
samples
tested having
minor deviations.
b]
Not more
than
5
percent
of
the
samples
tested having
major deviations.
c)
Data conforming
to normal
statistical
distribution.
(x)
Report analytical
results
of official
samples in
accordance
with
the
instructions
of
the Accredited
Laboratory Coordinator
before
making
the
results
available to any
other party.
d)Refusal
of accreditation.
Upon
a
determination.
by
the
Administrator
a
laboratory
may
be
refused
accreditation
for
the
following
reasons:
(1)
A
laboratory
may be refused
accreditation
for protein,
moisture, fat
and salt
analysis for failure
to meet the
requirements
of
paragraph
(b)(2)
of this
section.
(2) A laboratory
may
be refused
accreditation
for chemical residue
analysis for
failure
to
meet
the
requirements
of
paragraph
(c)(2) of this
section.
The refusal
may
be
limited
to
the
analysis
of
particular chemicals
or
classes
of
chemicals
if the deficiencies
relate only
to those
chemicals or
classes
of chemicals
and to the
requirements
in
paragraph
(c)(2)(i) or
(ii) of
this section.
(e) Withdrawal
of
accreditation.Upon
a determination by
the
Administrator
an
accredited laboratory
may
have its
accreditation
withdrawn for the
following
reasons:
(1)
An
accredited laboratory
may
have
its
accreditation
withdrawn
for
protein, moisture,
fat and
salt analysis
for failure to meet
the
requirements of
paragraph
(b)(3)
of this section.
(2)
An
accredited
laboratory
ma y
have its
accreditation withdrawn for
chemical
residue
analysis for failure
to
meet the requirements
of
paragraph
(c)(3) of
this section.,
3)An accredited
laboratory ma y
have
its accreditation
withdrawn
for
either
protein,
moisture,
fat and
salt
analysis
or for chemical
residue
analysis
if
the laboratory
owner
or operator, or
any agent
or
employee
in the
scope
of
his agency
or employment,
has:
(i) Altered
any official sample or
analytical
finding,
or
(ii)
Substituted any
analysis from
a
non-accredited laboratory.
Accredited
laboratories
may not send
official
samples
to non-accredited
laboratories
for analysis.
(4) Withdrawals
of
accreditation
for
chemical residues
analysis may be
limited
to
the
analysis of
particular
chemicals or
classes of chemicals
if
the
deficiencies
relate only
to those
chemicals or
classes of
chemicals
and to
the
requirements in
paragraph
(c)(3)(ix)
of this section.
f) Appeal
procedures.
Accreditation
of any
laboratory may be
refused or
withdrawn
dnder the conditions
previously
described
herein. The
owner
or
operator
of the
laboratory
will be sent
written
notice
of the
refusal or
withdrawal
of
accreditation
by the
Administrator. In
such cases,
the
laboratory
owner
or
operator will
be
provided
the opportunity
to
present,
within
30 days of the
date of the
notification
of
the
proposed action,
a
statement challenging the merits
or
validity
of such action and to
request an
oral hearing with
respect
to
the denial
or
withdrawal
decision. An oral
hearing
shall be
granted if there is
any dispute
of
material
fact joined in
such
responsive
statement. The proceeding
shall
thereafter be
conducted in
accordance
with the
applicable rules
of
practice which shall
be adopted
for
the
proceeding.
Any
such refusal shall
be
effective
upon the
notificationand
shall
continue in effect
until final
determination
of the
matter. Any such
withdrawal shall
be effective
upon
notification,
but
shall
be
held in
abeyance
until
final
determination
of the
matter
except in
cases where
the
Administrator determines the
public
health, interest, or
safety
requires
the
withdrawal
to
continue
in effect until
the final
determination
of the
matter.
(Sec.
14, 71
Stat.
441, as
amended, 21 U.SC.
463; 42 FR 35625, 35026
Done at
Washington,
D.C.,
on November
3,
1980.
Carol
Tucker Foreman,
AssistantSecretary orFood
and Consumer
Services
[FR
Doc. 80-34787
Filed
11-0-80:
8:45 aml
BILLING
CODE
3410-DM-M
SECURITIES
AND
EXCHANGE
COMMISSION
17
CFR Parts 240
and
249
[Release
No.
34-17259
File No. S7-5901
Filings
by
Self-Regulatory
Organizations of Proposed
Rule
Changes
and Other
Materials With
the
Commission
AGENCY:
Securities and
Exchange
Commission.
ACTION:
Withdrawal of proposed
rule
and
withdrawal
of
proposed
amendments
to
a
rule
and a
related
form.
SUMMARY:
In
light
of amendments
it
has
adopted to requirements
applicable
to
the
filings
by
Self-regulatory
organizations
of
proposed
rule
changes
and
certain
other materials, the
Commission is
announcing (i)
withdrawal
of
a
proposed
rule that
would
have defined the
term rule
of a
self-regulatory
organization
and if)
withdrawal
of proposed amendments
to
a
rule and related.form
that
would
have
provided summary
effectiveness
for
certain
proposed rule changes
of
a self-
regulatory
organization
circulated,
for
pre-filing review,
to the Commission
and
to persons
who would be
subject
to the
rules.
EFFECTIVE
DATE:
November 7
1980.
FOR
FURTHER
INFORMATION
CONTACT:
Susan
Davis, Esq., 202) 272-2846 or
Jeffrey
Jordan,
Esq., 202) 272-2847
-
Division of Market Regulation,
Securities
and Exchange Commission,
Washington,
D.C. 20549.
SUPPLEMENTARY
INFORMATION:
In
companion
release issued today,
I
he
Securities
and Exchange
Commission
Is
announcing
certain
actions designed
to
facilitate
review
of proposed
rule
changes of
self-regulatory
organizations
under
Section 19(b)
2
of the
Securities
'Securities
Exchange
Act
Release
No, 17250
(October
30. 1980).
2 5 U.S.C.
7?stb].
73954
7/23/2019 FR Vol No
9/14
Federal
Register Vol. 45, No.
218
Friday,
November 7 1960 Proposed
Rules
Exchange Act of
1934
(the
Act ).
3
As
part
of those actions, the
Commission
is
withdrawing certain proposals
made
earlier
4
relating to these
matters.
Specifically,
for the
reasons
explained in
the
companion
release,
the Commission
is
announcing the
following
actions:
(1) Withdrawal
of proposed Rule 3b-7
which would have defined
the term
rule
of
a
self-regulatory organization
for purposes of Sections
3(a)(27)
and
3(a)(28)
of the Act.
2)
Withdrawal
of proposed
amendments
to
Rule
19b-4
and related
Form
19b-4A that would
have provided
summary effectiveness
for certain
proposed rule
changes of
a
self-
regulatory
organization circulated, for
pre-filing
review,
to the Commission
and
to persons
who would
be
subject to the
rules.
Further explanation of
the above
actions, and
of
other
actions being taken
concerning filings
of proposed rule
changes and other materials, is provided.
in
the companion release issued today.
By
the Commission.
George A.
Fit simmons,
Secret y
October 30,1980.
[FR DUG. 0-34738 PI-
01-8-aa
SM a1
9U.LII4
CODE
3010-01-U
ENVIRONMENTAL
PROTECTION
GEN Y
21
CFR
Part
193
[FRL
1596-1; F P
9H5196/P19]
Glyphosate; Proposed
Food Additive
Tolerances
orrection
In FR Doc.
80-26939,
appearing
at
page 5494 in
the issue for Wednesday,
September 3, 1980,
make
the
following
corrections:
1) n
the
Summary paragraph,
in
the seventh line,
isopropylsponic
should have
read
isopropylamine .
(2)
In
the first
paragraph under
Supplementary
Information , in
the
twelfth
line, the
word
the should
have
read from .
BILLNG CODE 1505-01-M
3 5
U.S.C.
78a
et
seq.
Securities Exchange
Act Release No.
15838
(May
18. 1979), 44
FR 30924 (May
29.1979).
DEPARTMENT OF HEALTH
AND
HUMAN SERVICES
Food and
Drug Administration
2 CFR
Part
310
[Docket
No. 5ON 0357]
Hair
Grower and
Hair
Loss
Prevention
Drug Products for Over the Counter
Human
Use
AGENCY:.
Food
and
Drug Administration.
ACTION: Proposed rule.
SUMMARY
This document proposes that
hair
grower and hair loss prevention
drug products be classified in
Category
II
as being not
generally
recognized
as
effective and as
being
misbranded
for
over-the-counter (OTC) use. The
document, based on the
recommendations
of the Advisory
Review
Panel
on
OTC
Miscellaneous
External
Drug
Products, is
part
of
the
ongoing
review of OTC drug
products
conducted by the
Food
and Drug
Administration
(FDA).
oATES: Comments
by February 5 1981.
Reply
comments by
March
9 1981.
ADDRESS:
Written
comments to
the
Hearing Clerk (HFA-30),
Food
and
Drug
Administration, Rm. 4-2 5800
Fishers Lane, Rockville,
MD
20857.
FOR FURTH R
INFORMATION CO4TACT.
William F. Gilbertson, Bureau of Drugs
(HFA-510),
Food
and
Drug
Administration, 500 Fishers Lane,
Rockville,
MD 20857 301-443-490.
SUPPLEMENTARY
INPORMATION: In
accordance with Part 330 (21
CFR
Part
330), FDA received on
December 10,
1979
a report
on
hair grower and hair
loss prevention drug
products from the
Advisory Review
Panel
on
OTC
Miscellaneous
External Drug
Products.
Under
330.10(a](6)
(21
CF R
330.10(a)(6)), the
agency
issues (1) a
proposed
regulation containing
the
monograph
recommended
by
the Panel,
which establishes
conditions under
which
OTC hair
grower and hair
loss
prevention drugs are
generally
recognized as safe
and
effective
and
not
misbranded. (2] a statement of
the
conditions excluded
from
the
monograph
because the Panel
determined
that
they would result
in
the
drugs' not being generally recognized
as
safe
and
effective or would result in
misbranding;
(3) a statement of
the
conditions excluded from the
monograph because the Panel
determined that
the available
data
are
insufficient
to
classify these
conditions
under
either
(1)
or
(2)
above:
and
(4)
the
conclusions and
recommendations
of
the
Panel.
Because
the
Panel's recommendations
on
hair grower and
hair loss
prevention
drug
products
for
OTC
use
contain no
Category
I or Category
HI conditions,
FDA is therefore
issuing the Panel's
recommendations
as
a notice
proposing
Category
IIclassification
of
hair
grower
and
hair
loss
prevention
drug
products
for
OTC
use.
The unaltered
conclusions and
recommendations of the
Panel are
issued
to
stimulate discussion,
evaluation,
and comment on the full
sweep of the Panel's
deliberations. The
report has been prepared independently
of FDA, and
the
agency has not yet fully
evaluated the report. This document
represents the
best
scientific
judgment
of
the
Panel
members, but does not
necessarily
reflect
the
agency's position
on
any particular
matter contained
in
it.
The
Panel s
findings
appear in this
document
as
a formal
notice
to
propose
classification of hair grower
and hair
loss prevention drug
products as
Category
II and
to obtain public
comment before
the
agency
reaches
any
decision on the
Panel's
recommendations. Should
the
agency
accept the Paners recommendation
that
the
ingredients
in hair grower
and
hair
loss
prevention
drug
products be
classified
as Category IL
a regulation
declaring the products to
be new
drugs
within
the
meaning of
section 201(p)
of
the
Federal
Food, Drug.
and
Cosmetic
Act (21 U.S.C 321(p)) will
be proposed
for inclusion in Part
310, Subpart E (21
CFR Part 310,
Subpart
E).
The agency
is
including
the proposed
regulation
in this
notice to
obtain full public
comment at
this time.
After FDA
has
carefully
reviewed
the
comments
and
reply
comments, submitted in response to this
notice,
the
agency will issue a tentative
final order on
hair grower
and
hair
loss
prevention drug products
for OTC use.
Should
FDA accept the
conclusions
and
recommendations
of the Panel, the
agency would propose
that hair grower
and
hair
loss prevention drug products
be eliminated from
the OTC market.
effective
6
months
after the
date of
publication
of a final order in the
Federal Register, regardless
of whether
further
testing
is undertaken to
justify
their
future
use.
In accordance with 330.10(a}(2), the
Panel
and
FDA
have held as
confidential
all information concerning
OTC
hair grower
and hair loss
prevention drug
products submitted for
consideration by
the
Advisory Review
Panel.
All
the submitted information
will
be put on public display at the Hearing
Clerk's Office, Food and Drug
Administration.
after December
8,1980,
except to
the extent
that
the person
73955
7/23/2019 FR Vol No
10/14
73956
submitting
it
demonstrates
that
it still
falls
within
the
confidentiality
provisions
of
18 U.S.C.
1905
or
section
301 j)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(21
U.S.C.
331j .
RequestE
for
confidentialityshould
be
submitted
to
William
E.
Gilbertson,
Bureau
of
Drugs
HFD-510)
(address
above).
A
proposed
review
of
the
safety,
effectiveness,
and
labeling
of
all
OT C
drugs
by
independent
advisory
review
panels
was
announced
in the
Federal
Register
of January
5,,1972 37 FR
85).
The
final
regulations
providing
for
this
OTC
drug
review
inder
330.10
were
published
and
made
effective
in
the
Federal
Register
of
May
11,
1972
37
FR
9464).
In
accordance
with
these
regulations,
requests
for
data
and
information
on
all
active
ingredients
used
in
OTC
miscellaneous
external
drug
products
were
issued
in
the
Federal
Register
of
November
16,1973
38
FR
31697)
and
August
27,
1975
(40
FR
38179).
The
Commissioner
of Food
and
Drugs
appointed
the
following
Panel
to
review
the
information
submitted
and
to
prepare
a
report
under
330.10(a)
1)
and 5)
on the
safety, effectiveness, and
labeling
of
those
products:
William
E.
Lotterhos,
M.D.,
Chairman.
Rose
Dagirmanjian,
Ph.
D.
Vincent
J.
Derbes,
M.D.
(resigned
July
1976).
George
C.
Cypress,
M.D.
(resigned
November
1978).
Yelva
L. Lynfield,
M.D
(appointed
October
1977).
Harry
E.
Morton,
Sc.
D.
Marianne
N.
O Donoghue,
M.D.
Chester
L.
Rossi,
D.P.M.
J.
Robert
Hewson,
M.D.
(appointed
September
1978).
Representatives
of
consumer
and,
industry
interests
served
as
nonvoting
members of
the Panel. Marvin
M.
Lipman,
M.D.,
of
Consumers
Union,
served
as
the
consumer
liaison.
Gavin
Hildick-Smith,
M.D.,
served
as
industry
liaison
from
January
until
August
1975,
followed
by
Bruce
Semple,
M.D.,
until
February
1978.
Both
were
nominated
by
the
Proprietary
Association.
Saul
A.
Bell,
Pharm.
D.,
nominated
by
the
Cosmetic,
Toiletry,
and
Fragrance
Association,
also
served
as
an industry
liaison
since
June
1975.
Two
nonvoting
consultants,
Albert
A.
Ph. D.,
and
Jon
J.
Tanja,
R.Ph.,
have
provided
assistance
to
the
since
February
1977.
The following
FDA
employees
the
Panel:
John
M.
Davitt
as
Executive
Secretary
until
19Y7,
followed
by
Arthur
Auer
September
1978,
followed
by John
McElroy,
J.D.
Thomas
D.
DeCillis,
served
as
Panel
Administrator
April
196,
followed
by
Michael
D.
until
January
1978,
followed
by
John
T. McElroy,
J.D.
Joseph
Hussion,
R.Ph.,
served
as
Drug
Information
Analyst
until
April
1976,
followed
by
Victor
H.
Lindmark,
Pharm.
D.,
until
March
1978,
followed
by
Thomas
J.
McGinnis, R.Ph.
The
Advisory
Review
Panel
on
OT C
Miscellaneous
External
Drug
Products
was
charged
with
the
review
of
many
categories
of drugs.
Due
to
the
large
number
of
ingredients
and
varied
labeling
claims,
the Panel decided
to
review
and
publish
its
findings
separately
for
several
drug
categories
and
individual
drug
products.
The
Panel
presents
its
conclusions
and
recommendations
for
hair
grower
and
hair
loss
prevention
drug
products
in
this document.
The review
of other
categories
of miscellaneous
external
drug
products
will
be
continued
by
the
Panel,
and
its
findings
will
be
published
periodically
in
future
issues
of
the
Federal
Register.
The
Panel
was
first
convened
on
January
13,
1975
in an
organizational
meeting.
Working
meetings
which
dealt
with the
topic in this
document were
held
on:
October
29
and
30,
1978;
January
14 and
15,
March
11
and
12,
May
18
and
19,
August
3 and
4,
September
28 and
29,
October
28
and
29 ,
and
December
9 and
10,
1979.
The
minutes
of
the
Panel
meetings
are
on
public
display
in
the
Hearing.Clerk s
Office
IFA-305),
Food
and
Drug
Administration
(address
above).
At
the
Panel s
request,
Norman
Orentreich,
M.D.,
appeared
before
the
Panel
to
express
his
views
on
hair
grower
and
hair
loss
prevention
drug
products.
No
person
who so
requested was
denied
an
opportunity
to appear
before
the
Panel.
The.
Panel
has
thoroughly
reviewed
the
literature
and
data
submissions,
has
listened
to
additional
testimony
from
an
interested
person,
and
has
considered
all
pertinent
information
submitted
through
December
10,
1979
in arriving
at
its
conclusions
and
recommendations.
In
accordance
with
the
OTC
drug
review
regulations
in
330.10,
the
Panel
reviewed
OTC
hair
grower
and
hair
loss
prevention
drug
products
with
respect
to
the
following
three
categories:
Category
I.
Conditions
under
which
OTC
hair grower and hair
loss
prevention
drug
products
are
generally
recognized
as
safe
and
effective
and
are
not
misbranded.
Category
II.
Conditions
under
which
OTC
hair
grower
and
hair
loss
prevention
drug
products
are not
generally
recognized
as
safe
and
effective
or
are
misbranded.
Category
III. Conditions
for
which
the
ayailable
data
are
insufficient
to permit
final
classification
at this
time.
The
Panel
concludes
that
all hair
grower
and
hair
loss
prevention
active
ingredients
reviewed
are
safe,
but
nona
is
effective
for
OTC
use
(Category
II),
I.
Submission
of Data
and
Information
In
an
attempt
to make
this
review
as
extensive
as possible
and
to aid
manufacturers
and
other interested
persons,
the
agency
compiled
a
list of
ingredients
recognized,
either
through
historical
use
or use
in marketed
products,
as hair
growers
and
sebum
hair
loss
hair
loss
prevention)
active
ingredients.
Thirteen
hair
grower
ingredients
were
identified
as follows:
Amino
acids,
ascorbic
acid,
benzoic
acid,
essential
oils,
fatty
acids,
hormone
constituents,
lanolin,
oil
of
eucalyptus,
olive
oil,
proteins,
tar
oil,
vegetable
oil,
and
vitamins.
Thirteen
sebum
hair
loss
prevention
ingredients
were
identified
as follows:
Allantoin
5-
ureidohydantoin),
ammonium
lauryl
sulfate, dichlorophene,
di-isobutyl-
phenoxy-ethoxy-ethyl-dimethylbenzyl-
ammonium
chloride,
estradiol,
isopropyl
alcohol,
lauric
diethanolamide,
methyl
ethyl
ketone,
polyethylene
glycol,
propytlene
glycol,
sulfonated
vegetable
and
mineral
oils,
and
tetracaine
hydrochloride.
Notices
were
published
in
the
Federal
Register
of
November
10,
1973
38
FR 31679)
and
August
27,
1975
(40 FR
38179)
requesting
the
submission
of data
and
information
on
these
ingredients
or
any
other
ingredients
used
in
OTC
hair
growers
and
sebum
hair
loss
drug
products.
A
Submissions
Pursuant
to the
above
notices,
the following
submiss
