Hazard Analysis and Critical Control on Juice

20450 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 120RIN 0910AA43

[Docket No. 97N0511]Hazard Analysis and Critical ControlPoint (HACCP); Procedures for theSafe and Sanitary Processing andImporting of Juice

AGENCY: Food and Drug Administration,HHS.ACTION: Proposed rule.

SUMMARY: The Food and DrugAdministration (FDA) is proposing toadopt regulations to ensure the safe andsanitary processing of fruit andvegetable juices and juice products. Theproposed regulation, if adopted, willmandate the application of HazardAnalysis and Critical Control Point(HACCP) principles to the processing ofthese foods. HACCP is a preventivesystem of hazard control. FDA isproposing these regulations becausethere have been a number of outbreaksof illness, including some directlyaffecting children, associated with juiceproducts and because a system ofpreventive control measures is the mosteffective and efficient way to ensure thatthese products will be safe. Elsewherein this issue of the Federal Register,FDA is publishing a warning labelproposal for packaged juice.DATES: Submit written comments byJuly 8, 1998. For information on theproposed compliance dates for smallbusinesses and very small businessessee the SUPPLEMENTARY INFORMATIONsection of this document.

Submit written comments on theinformation collection requirements byMay 26, 1998.ADDRESSES: Submit written commentsto the Dockets Management Branch(HFA305), Food and DrugAdministration, 12420 Parklawn Dr.,rm. 123, Rockville, MD 20857. Submitwritten comments regarding informationcollection to the Office of Informationand Regulatory Affairs, Office ofManagement and Budget, NewExecutive Office Bldg., 725 17th St.NW., rm. 10235, Washington, DC 20503,Attention: Desk Officer for FDA.FOR FURTHER INFORMATION CONTACT:Shellee A. Davis, Center for Food Safetyand Applied Nutrition (HFS306), Foodand Drug Administration, 200 C St. SW.,Washington, DC 20204, 2022054681.SUPPLEMENTARY INFORMATION:

The agency proposes to make anyfinal rule based upon this proposaleffective 1 year after its date ofpublication in the Federal Register.However, by its terms, the final rule willnot be binding on small businesses asdefined in proposed 120.1(b)(1) until 2years after the date of publication of afinal rule in the Federal Register; andfor very small businesses as defined inproposed 120.1(b)(2), the final rulewill not be binding until 3 years afterthe date of its publication in the FederalRegister.

I. Concerns With Juice

A. Microbial OutbreaksThe Seattle-King County Department

of Public Health and the WashingtonState Department of Health reported onOctober 30, 1996, an outbreak ofEscherichia coli O157:H7 infectionsepidemiologically associated withdrinking a particular brand ofunpasteurized apple juice, or juicemixtures containing unpasteurizedapple juice, purchased from a coffeeshop chain, grocery stores, and otherlocations (Ref. 1). A case was defined ashemolytic uremic syndrome (HUS) or astool culture yielding E. coli O157:H7 ina person who became ill after September30, 1996, after drinking the particularbrand of juice within 10 days beforeillness onset. There were at least 66cases of illness, with 14 cases of HUSand the death of one child, associatedwith this outbreak (Ref. 2). Casesoccurred in British Columbia,California, Colorado, and Washington.E. coli O157:H7 isolates cultured from apreviously unopened container of theparticular brand of apple juice had adeoxyribonucleic acid (DNA)``fingerprint'' pattern (restrictionfragment length polymorphism)indistinguishable from case-relatedisolates (Ref. 1).

Various juices have been documentedas vehicles for causing outbreaks frommicroorganisms. A 1967 outbreak fromcontaminated water added to orangejuice concentrate affected approximately5,200 persons and was caused by anunidentified virus and possibly othercontaminants (Refs. 3 and 4). About 300people became ill from Salmonellatyphimurium in cider made fromapples, including some that had beenpicked up from the ground in anorchard fertilized with manure, in a1974 outbreak in New Jersey (Ref. 5). A1991 outbreak of Vibrio cholerae wasassociated with coconut milkcontaminated during manufacturing inThailand (Ref. 6). There have been twoCryptosporidium outbreaks related todrinking apple cider, the first in Maine

in 1993 and the other in New York Statein 1996. In the first case, the applesused for cider came from trees near acow pasture (Ref. 7), and in the secondcase, water used for rinsing came froma well that tested positive for coliforms(Ref. 8). In 1995 there was an outbreakin Florida that was caused bySalmonella hartford in unpasteurizedorange juice (Ref. 9).

E. coli O157:H7 has been recognizedrelatively recently as a human pathogenand has been a source of a number ofoutbreaks related to juice. Thirteen andpossibly 14 children had bloodydiarrhea and developed HUS inToronto, Canada, between September 15and 25, 1980. The children's illnesseswere associated with drinking freshapple juice. The children's stools wereexamined for enteropathogenic E. coli,Campylobacter, Salmonella, Shigella,and Yersinia. None of these organismswere found. E. coli O157:H7 is thesuspected causative organism.Conclusive testing for that organism wasnot done because E. coli O157:H7 wasnot recognized as a human pathogenbefore 1982 (Ref. 10).

A 1991 E. coli O157:H7 outbreak insoutheast Massachusetts conclusivelyshowed that fresh-pressedunpasteurized apple juice can transmitE. coli O157:H7 bacteria. In thisoutbreak, 23 individuals had diarrhea,16 had bloody diarrhea, and 4developed HUS (Ref. 11).

In Connecticut, a 1996 outbreak of E.coli O157:H7 illness was associatedwith drinking a particular brand ofapple cider. There were 14 cases ofillness (including 7 hospitalized), with3 cases of HUS associated with theoutbreak (Ref. 8).

There was a small outbreak of E. coliO157:H7 illness in Washington State in1996 that was related to apple cidermade at a church event. This outbreakoccurred during the same time as theunpasteurized apple juice outbreakdescribed in previous paragraphs. Theapples were washed in a chlorinesolution, but it was not reported howmuch chlorine was used. Six peoplebecame ill, but no estimate was given onhow many people may have drunk theapple cider (Ref. 12).

FDA's recall data also provideevidence of microbial hazards in juice.There were 85 cases of illness in 1994resulting in a recall of orange juice thathad fermented and contained Bacilluscereus and yeast (Ref. 13).

State investigations provideadditional evidence of microbialhazards in juice. A 1989 outbreak inNew York was caused by the presencein orange juice of Salmonella typhi thatoriginated from an infected worker and

20451Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

resulted in 69 illnesses with 21individuals hospitalized (Ref. 14). TheState of Washington reported that in1993 one individual was hospitalizedfrom home-made carrot juice found tocontain Clostridium botulinum (Ref. 15).A 1993 Ohio outbreak caused by yeastor some other unknown toxicant inorange juice resulted in 23 illnesses(Ref. 16). A home-made watermelondrink contaminated with Salmonellaspp. caused illness in 18 individuals ina 1993 Florida outbreak (Ref. 17). TheState of Colorado reported twooutbreaks of gastrointestinal illness fromfresh squeezed orange juice at amountain resort (Ref. 18). There werefood handlers that were ill in bothColorado instances, and a virus wassuspected as the causative agent.

The evidence shows that certainjuices have been the vehicle foroutbreaks of foodborne illnesses.Although fruit juice is acidic, and thuswould generally be considered to inhibitthe growth of most microorganisms,most juice-related outbreaks have beenassociated with fruit juices.

B. Illnesses From Nonheat-treatableHazards

Illnesses that have been caused byhazards that can not be reduced toacceptable levels by heat treatmentshave also been associated with juice.Tin in canned tomato juice causedillness in 113 individuals in 1969 (Ref.19). Soil nitrate had resulted in a highnitrate content in the tomatoes, and thishigh nitrate content accelerateddetinning in the cans. In 1984, 11persons became ill from consumingelderberry juice prepared by staff of areligious/philosophic group thatcontained poisonous parts of the plant(Ref. 20). A 1990 guanabana juiceoutbreak was caused by the presence oftoxic guanabana seed material andcaused illness in nine individuals (Ref.21). A 1997 outbreak was caused by tinin pineapple juice (Ref. 22).

In 1992 an 18-month-old child with ablood lead level of 36 micrograms perdeciliter (g/dL) was found in a routinecounty health department blood leadmonitoring program. Investigation ofthis incident by the county healthdepartment revealed that the onlysignificant source of lead exposure forthis child was lead in imported fruitjuice packed in 12-ounce, lead-solderedcans (Ref. 23). Analysis by the Statehealth department of multiple flavors ofthe fruit juices in lead-soldered cansavailable to the child found lead levelsranging from 160 to 810 parts per billion(ppb). An exposure assessmentperformed by the county healthdepartment estimated that the child

consumed about three cans of these fruitjuices per day and estimated that thechild's daily lead intake from these fruitjuices was approximately 600 g/day(Ref. 23). As a result of this incident,FDA announced an emergency actionlevel of 80 ppb for lead in fruitbeverages (such as juices, nectars, anddrinks) packed in lead-soldered cans (58FR 17233, April 1, 1993). The agencysubsequently banned the use of lead-soldered cans (60 FR 33106, June 27,1995).

Recalls also provide evidence ofnonheat-treatable hazards in juice. In1988 a fruit punch drink was recalledbecause of the presence of tin caused bythe acidity of the drink reacting with thetin coating of the cans (Ref. 24). Theproduct had been packaged in thewrong container.

There were 10 recalls between 1990and 1995 for fruit juice or beveragescontaining fruit juice because of thepresence of food ingredients that wereinadvertently added to the product, notdeclared on the label, or not suitable forthe food. Food ingredients involvedwith these recalls were natamycin (Ref.25), sulfites (Ref. 26), FD&C yellow No.5 (Refs. 27 through 33), and salt (Ref.34).

Five recalls between 1991 and 1997were caused by improper sanitationprocedures or faulty equipment. In 1991sodium hydroxide from a clean-in-placesystem contaminated the caps of a citruspunch drink (Ref. 35). In 1992 threepersons became ill, with 1 hospitalized,from a sodium hydroxide sanitizingagent that got into fruit drink productcontainers during cleaning (Ref. 36). In1993 cracks in a heat exchanger allowedan orange flavored soft drink containingpear juice to come in contact withcopper pipe fittings and, thus, tobecome contaminated with copper (Ref.37). In 1994 milk was found in orangejuice from filler lines that were notcleaned between milk and juiceproduction (Ref. 38). In 1997 thepresence of an alkaline cleaningsolution in a berry juice causedgastrointestinal distress in severalpersons (Ref. 39).

Companies have recalled fruit drinksbecause pieces of glass or plastic werefound in their products. The presence ofglass in products is typically caused bythe use of glass bottles, which can chipor shatter during the production process(Refs. 40 through 42). The plastic waspresent from the company's practice ofdraping plastic bags over the side of thebottle loading bin (Ref. 43).

One company recalled apple-prunejuice and prune juice in 1996 because ofunacceptable levels of lead (Refs. 46 and

47). The cause was contaminatedimported prune juice.

In response to the establishment ofmaximum levels for patulin in applejuice by several foreign governments,FDA initiated a sampling survey todetermine the levels commonly foundin domestic and imported apple juice.Patulin may be present in juice madefrom moldy apples. In March 1997 theagency found inordinately high levels ofpatulin in apple juice from a processorin Washington State (Ref. 48). The levelof patulin found in the product wassufficient to pose a health hazard,especially considering the fact thatapple juice is commonly used by infantsand young children (Ref. 49). Allaffected products that had left the planthad been used in the manufacture offermented apple cider. Patulin could notbe detected in fermented product, and itwas assumed that the patulin wasdestroyed through the fermentationprocess.

Therefore, as the foregoing discussionreveals, the evidence demonstrates thatjuice and juice beverages are susceptibleto chemical and physical hazards aswell as microbiological hazards.

C. UnderreportingThere is wide agreement that the

laboratory-confirmed cases fromoutbreaks and recalls understate theactual number of juice-related cases, butno consensus exists on the size of theunderstatement. Individuals may notmanifest all symptoms or have severeenough symptoms to necessitatemedical attention. Medical personnelmay simply treat an individual'ssymptoms without determining theunderlying cause. The laboratory-confirmed cases only represent thosecases where individuals sought medicalattention, and where medical personnelperformed the necessary testing andreported the case to a governmentagency.

While the actual number of juice-related illnesses is unknown, FDA hasderived an estimate of the total numberby multiplying the average number oflaboratory-confirmed cases by factorsthat account for under-reporting. Thefactors are based on the relationshipsbetween annual outbreak cases andpublished estimates of the number offoodborne illnesses. For example, usingthese adjustment factors, it is estimatedthat the average 16 annual laboratory-confirmed cases of Salmonellarepresents 4,900 to 7,600 actual cases(Ref. 50). For E. coli O157:H7, anaverage 22 laboratory-confirmed casesper year may actually represent 2,200 to4,300 total juice-related cases (Ref. 50).Therefore, the agency assumes that the


actual number of illnesses from theoutbreaks described in sections I.A andI.B of this document is much greaterthan the confirmed number of illnesses.(For a more complete discussion ofthese estimates, see the agency'spreliminary regulatory impact analysisand Ref. 50)

D. PesticidesPesticides are usually applied to

plants to combat insects, plant diseases,and weed growth to assist in the growthof the fruit or vegetable. A food isconsidered adulterated under section402(a)(2)(B) of the Federal Food, Drug,and Cosmetic Act (the act) (21 U.S.C.342(a)(2)(B) if pesticide residues arepresent above the EnvironmentalProtection Agency (EPA) establishedtolerances, or if EPA has not establisheda tolerance for use of the pesticide onthe particular plant. FDA annuallymonitors a wide variety of foods forpesticide residues.

In 1994 FDA sampled 1,411 domesticfruits and fruit products, includingapple juice and other fruit juices, forpesticide residues and found that lessthan 1 percent were violative for beingover tolerance and less than 1 percentwere violative for having no tolerance(Ref. 51). None of the 122 samples ofapple juice or 44 samples of other fruitjuices were violative. Out of 1,795samples of domestic vegetables andvegetable products tested, FDA foundthat less than 1 percent of samples wereover tolerance, and that 2 percent wereviolative for having no tolerance.

FDA also tested 1,940 imported fruitsand fruit products in its 1994 pesticideresidue monitoring program. Less than 1percent of the items tested were overtolerance and 3 percent were violativefor having no tolerance. None of the 110fruit juices sampled were violative. Theagency sampled 2,460 importedvegetables and vegetable products andfound that less than 1 percent wereviolative for being over tolerance and 4percent for having no tolerance.

In its 1995 pesticide monitoringprogram FDA found less than 1 percentof 1,437 samples of domestic fruits andfruit products to be violative for beingover tolerance and 1 percent to beviolative for having no tolerance (Ref.52). Of the 110 apple juices and 22 otherfruit juices sampled, only a single applejuice sample was found to be violative,because of the presence of a pesticidewith no established tolerance. Analysisof 1,585 samples of domestic vegetableand vegetable product produced resultssimilar to the results found in 1994, i.e.,less than 1 percent of samples were overtolerance, and approximately 2 percentwere violative because there were no

tolerances for the pesticide residues thatFDA found.

The agency sampled 1,757 importedfruits and fruit products for pesticidesin 1995 and found that less than 1percent were violative for being overtolerance, and that 3 percent wereviolative for having no tolerance. Of the19 apple juices and 52 other fruit juicestested, 2 apple juice samples wereviolative because they containedpesticides for which there were noestablished tolerances. The agencysampled 2,535 imported vegetables andvegetable products and found that 1percent were violative for being overtolerance, and that 3 percent wereviolative for having pesticide residuesfor which there was no tolerance. Someof these samples contained bothresidues over tolerance and residueswith no tolerance.

Although there are no documentedoutbreaks caused by unlawful pesticideresidues, chronic exposure to pesticideresidues that do not conform to EPAtolerances increase risks to the publichealth. Therefore, juice processors mustdetermine whether the possiblepresence of unlawful pesticide residuesis a hazard that is reasonably likely tooccur.

E. FDA's Public MeetingAs a result of the October 1996 apple

juice outbreak from E. coli O157:H7,FDA held a public meeting on December16 and 17, 1996 (hereafter referred to asthe juice meeting) (see notice of meeting(61 FR 60290, November 27, 1996)), toreview the current science, includingtechnological and safety factors, relatingto fresh juices and to consider measuresnecessary to provide safe fruit juices tothe public. Interested persons weregiven until January 3, 1997, to submitwritten comments on the notice. OnJanuary 2, 1997 (62 FR 102), FDAextended the comment period toFebruary 3, 1997, in response to severalrequests for an extension.

The purpose of the juice meeting wasto provide a forum for an informationexchange on current industry practicesfor the production of juice products andon developments in the scienceunderlying the production of safe juices.Experts from industry, academia, andthe regulatory and consumer sectorspresented information on illnesses andthe epidemiology of outbreaks arisingfrom contaminated juices; concernsabout emerging pathogens; the E. coliO157:H7 outbreak in October 1996caused by contaminated apple juice;procedures for processing juices; andnew and existing technology to removeor decrease the number of pathogens orother contaminating microorganisms.

Time was available for questions andcomments from all attendees.

The meeting provided an opportunityto: (1) Consider how FDA's regulatoryprogram for fresh juice and juiceproducts should be revised,(2) discussand exchange information on relevantsafety issues, (3) to identify researchneeds where appropriate, (4) considerwhether additional consumer educationis necessary, and (5) consider whetherother measures are needed to reduce therisk of future outbreaks of illness fromjuice.

FDA received over 180 commentsfrom industry (with a number of thesedescribing themselves as smallbusinesses), consumers, consumerorganizations, trade organizations,scientific/technical companies,academic institutions or organizations,State agencies, a local governmentagency, and members of Congress.Although most of the commentsconcerned apple juice specifically,many comments pertained to juices ingeneral, and some referred only to citrusjuices. Most comments were concernedwith changes in processing to improvethe safety of juices. Among the changessuggested were requiring pasteurizationof juices, requiring HACCP, orestablishing current good manufacturingpractices (CGMP's) in juice processing.The agency has attempted to address thecomments made at the meeting orsubmitted in response to the FederalRegister notice in this proposal. If thereare any significant concerns that theagency has not addressed, theseconcerns should be brought to theagency's attention in comments on thisproposal.

The Fresh Produce Subcommittee(FPS) of the National AdvisoryCommittee on Microbiological Criteriafor Foods (NACMCF) attended thepublic meeting. The FPS met after thepublic meeting and maderecommendations to the NACMCF. TheNACMCF subsequently met to discussthe issues that were raised at themeeting. Based on information that waspresented at the meeting and on theFPS's expertise, the full NACMCF madeseveral recommendations (Ref. 53). TheNACMCF stated that there are manyaspects that affect pathogen control,such as agricultural practices; producthandling; equipment used; growinglocation, including produce obtainedfrom below ground (carrots), on ground(e.g., tree drops), or picked from trees;pH; acidulants; method of processing;degree of animal contact; refrigeration;packaging; and the distribution system.It stated that, in determining the bestcontrol mechanisms, it is important toremember that the conditions for


microbial survival differ from those forgrowth. The NACMCF recognized that,while the risks associated with specificjuices vary, there are safety concernsassociated with juices, especiallyunpasteurized juices.

The NACMCF concluded that: (1) Thehistory of public health problemsassociated with fresh juices indicates aneed for active safety interventions, and(2) for some fruit (e.g., oranges), theneed for intervention may be limited tosurface treatment, but for others,additional interventions may berequired (e.g., pasteurization of thejuice).

The NACMCF recommended to FDAthe use of safety performance criteriainstead of mandating the use of aspecific intervention technology. In theabsence of known specific pathogen-product associations, the NACMCFrecommended the use of E. coliO157:H7 or Listeria monocytogenes asthe target organism, as appropriate. Thisrecommendation was based on thepremise that these organisms are two ofthe most difficult to control (i.e., byjuice acidity or heat lethality), and that,by controlling them, other pathogenicorganisms will likely be controlled. TheNACMCF suggested that a tolerablelevel of risk may be achieved byrequiring interventions that have beenvalidated to achieve a cumulative 5 logreduction in the target pathogen or areduction in yearly risk of illness to lessthan 10-5, assuming consumption of 100milliliters (mL) of juice daily.

In addition, the NACMCF stated thatHACCP and safety performance criteriashould form the general conceptualframework to ensure the safety of juices,and that control measures should bebased on a thorough hazard analysis.The NACMCF also stated that validationof the process must be an integral partof this framework. The NACMCFrecommended mandatory HACCP for alljuice products, and that processorsshould implement and strictly adhere toindustry CGMP's. The NACMCF alsorecommended industry educationprograms addressing basic foodmicrobiology, the principles of cleaningand sanitizing equipment, CGMP's, andHACCP.

The NACMCF recommended furtherstudy in several areas:

(1) The efficacy of new technologiesand intervention strategies for safety;

(2) The contamination, survival, andgrowth of pathogens on produce with orwithout breaks in skin, with or withoutareas of rot, and within the core;

(3) How produce becomescontaminated with human pathogens,including the relevant microbial ecologyduring production and processing of

juice. In particular, the NACMCF statedthat there is an urgent need for thesetypes of studies on E. coli O157:H7 inapple juice;

(4) The baseline incidence of humanpathogens on fruits and vegetables,particularly on those used in juiceprocessing; and

(5) Labeling information needed forconsumer understanding and choice ofsafer juices and juice products.

On the basis of all the testimonypresented at the December 16 and 17,1996, meeting, the NACMCF agreed thatthere is a need to understand thedifferences among all juice and juiceproducts (e.g., citrus versus other). Asignificant problem identified by theNACMCF is that consumers presentlydo not have a means to clearlydifferentiate between unpasteurized andpasteurized products, and that termsused to refer to juice products do notalways have universal meanings. Forexample, the term ``cider'' is perceivedto be an unpasteurized product whereasthe term ``juice'' is often perceived to bepasteurized.

The NACMCF also stated thattraditional heat treatments given tojuices and juice products have beendesigned to achieve shelf stability, toremove water (i.e., concentration), or toaffect other quality-related factors, andthat these treatments, commonlyreferred to as ``pasteurization,'' aregreatly in excess of a process needed toinactivate foodborne pathogens.

Because of the lack of sufficient datato evaluate the effectiveness of labelingstatements as safety interventions or toinform consumer choice, the NACMCFstated that it could not strongly endorselabeling as an interim safety measure.

Although the NACMCF did notendorse labeling as an interim safetymeasure, elsewhere in this issue of theFederal Register FDA is proposinginterim labeling measures for packagedjuice. The agency sets forth its reasonsfor proposing to adopt these measures inthat proposal.

II. Consideration of How to AddressProblems

A. Current Regulation of Juice

FDA has established labelingregulations and standards of identity fora number of juices. 21 CFR 101.30pertains to percentage juice declarationfor beverages that contain fruit orvegetable juice. Common or usual nameregulations for nonstandardizedbeverages that contain fruit or vegetablejuice are found in 21 CFR 102.33.Standards of identity are found in part146 (21 CFR part 146) for a number offruit juices and beverages and in part

156 (21 CFR part 156) for tomato juice.The standard of identity for pasteurizedorange juice ( 146.140) states that ``Theorange juice is so treated by heat as toreduce substantially the enzymaticactivity and the number of viablemicroorganisms.'' Pasteurized orangejuice must be labeled as such.

In the 1997 Food Code, FDAarticulated its policy regardingunpasteurized apple juice (Ref. 54). Thecode states that food establishments(e.g., nursing homes) that serve applejuice, apple cider, or other beveragesthat contain apple juice to segments ofthe population that are highlysusceptible to disease (e.g., the elderly)should serve juice that has beenpasteurized or that is in a commerciallysterile, shelf-stable form, in ahermetically sealed container.

B. The Current Inspection SystemJuice processors, like other food

processors, are subject to periodicunannounced, mandatory inspection byFDA. This inspection system providesthe agency with a picture of conditionsat a facility at the time of the inspection.However, assumptions must be madeabout conditions at the facility beforeand after that inspection, as well asabout important factors beyond thefacility that have a bearing on the safetyof the finished product. The reliabilityof these assumptions over the intervalsbetween inspections can createquestions about the adequacy of thesystem.

FDA's inspections are based, in part,upon its regulations on CGMP in themanufacturing, packing, or holdinghuman food in part 110 (21 CFR part110). For the most part, theseregulations set out broad statements ofgeneral applicability to all foodprocessing on matters such assanitation, facilities, equipment andutensils, processes, and controls.HACCP-type controls are listed as one ofseveral options available to prevent foodcontamination ( 110.80(b)(13)(i)), butthey are not integral to the controlsoutlined in the regulations.

The inspection and surveillancestrategies that FDA uses ascertain amanufacturer's knowledge of hazardsand preventive control measures largelyby inference (i.e., based on whether acompany's products are in factadulterated, or whether conditions in aplant are consistent with CGMP). It isthe manufacturer's responsibility toensure that its products are incompliance with the act. However, inthe face of new pathogens, such as E.coli O157:H7, and the risk of illnessassociated with these pathogens,especially for children, the elderly, and


the immunocompromised, FDAtentatively concludes that, at least forjuices, new measures to controlmicrobial, chemical, and physicalhazards are necessary to ensure thatfinished products comply with the act'sstandards.

C. AlternativesComments from the juice meeting

suggested several alternatives to ensurethat juice products are safe. Thesealternatives are discussed in sectionsII.C.1 through II.C.6 of this documentalong with their impact on the currentsituation with juice.

1. Increased InspectionContinuous visual inspection of juice

production is not a viable alternativebecause few hazards associated withjuice are detectable through visualinspection.

Another possibility is to directsignificant additional resources towardincreasing the frequency of FDA'sinspection of juice manufacturers, aswell as increasing the agency'ssampling, laboratory analysis, andrelated regulatory activities with respectto these products. While many samplesof domestic and imported juice productsare collected each year for analysis inFDA laboratories, and this sampling isdesigned to represent a broad range ofproducts and to target known problems,the product sampled represents only asmall fraction of the total poundage ofthe juice products consumed in thiscountry. Substantially moreexpenditures would be needed toincrease laboratory analyses tostatistically significant levels.

Even if the funds for increased FDAinspection and increased sampling andanalysis were available, this approachalone would not likely be the best wayfor the agency to spend its limitedresources to protect the public health.Reliance on end-product testinginvolves a certain amount ofinefficiency and enormous sample sizesand testing on a lot-by-lot basis arenecessary to overcome that inefficiency.Therefore, this option has significantlimitations.

Some comments from the juicemeeting stated that juice safety wouldbe improved through more local/Stateinspection rather than Federalinspection.

FDA agrees that more local/Stateinspection would help to ensure thesafety of juices, particularly wherebecause FDA lacks jurisdiction, there isno connection between the juiceproducts and interstate commerce.However, FDA is not in a position tomandate that State and local regulatory

agencies conduct additional inspectionswith their limited resources. Further,FDA cannot mandate that a State ensurethat a firm is complying with FDA'sregulations. Therefore, increased local/State inspection for juice is not anoption upon which FDA can rely.

2. CGMP'sMany comments from the juice

meeting urged the implementation ofindustry CGMP's or sanitation standardsto increase the safety of juices. Somecomments provided State rules, modelCGMP's, or sanitation guidelines forFDA's consideration. Other commentsstated that there is a need for moreindustry education on sanitation andhygiene.

CGMP regulations have a twofoldpurpose: (1) To provide guidance onhow to reduce insanitary manufacturingpractices and on how to protect againstfood becoming contaminated, and (2) toset out objective requirements thatenable industry to know what FDAexpects an investigator to find when heor she visits a food plant (51 FR 22458at 22459, June 19, 1986). CGMP'sconsist generally of broad statements onsanitation, facilities, equipment andutensils, processes, and controls that areof general applicability to foodprocessing. Therefore, FDA issuance ofCGMP's for juice would be an approachthat could assist manufacturers in theproduction of safe juices.

FDA encourages the juice industry touse CGMP's to help ensure the safety oftheir juices. As stated previously, theNACMCF recommended that processorsimplement and strictly adhere toindustry CGMP's. However, the use ofCGMP's alone may not be adequate toensure that juices are safe because of thebroad based nature of CGMP's. CGMP'sare directed at plantwide operatingprocedures and do not concentrate onthe identification and prevention offood hazards. Therefore, the agencytentatively concludes that CGMP's,although useful, will not be adequate,without additional measures, to ensurethe safety of juices.

3. Mandatory PasteurizationThe majority of the comments from

the juice public meeting pertained topasteurization of juice. A number ofcomments urged FDA to mandatepasteurization or other equivalenttreatment of fruit juice to ensure itssafety. One person who commentedreported that customers of his applecider had not complained about adifference in flavor when heimplemented pasteurization. Onecomment requested a 2-year graceperiod for small businesses before

implementation if pasteurization wereto be required. Another suggested thatpasteurization be required for applecider only if CGMP's and HACCP fail.One comment suggested thatpasteurization be required only forapple juice, because of the difficulty incleaning apples as compared to otherfruits.

However, most comments opposedmandatory pasteurization of juicesbecause of: (1) The expense ofpasteurization equipment, (2) preferenceby some consumers for the flavor ofunpasteurized over pasteurized juice,(3) the safety record of juices, and (4)degradation of nutritional value fromheat treatment. Many comments fromsmall businesses claimed that theywould be forced to close theiroperations if pasteurization wererequired. Some comments also stated aneconomic need for the use of droppedapples (``drops''), with onerecommending the use of only hand-picked (rather than machine-picked)drops. Other comments stated that theuse of drops should be prohibited, atleast in unpasteurized juices.

FDA is aware of the significant safetyadvantages of pasteurizing juice as wellas of the reasons that some processorschoose not to pasteurize their products.Pasteurization is a heat treatment usedto kill the vegetative forms of specificbacteria in liquid or semi-liquid foodproducts. Pasteurization is an effectiveand proven technology to ensure thatjuice does not contain pathogens.However, there may be other methodsthat are equally effective. Thus, theNACMCF recommended theestablishment of safety performancecriteria for appropriate target organismsrather than the establishment of aspecific intervention technology. TheNACMCF stated that safety performancecriteria would be most effective.

For example, whole oranges with anintact skin may be processed so thatpathogens on the surface of the fruit aredestroyed. Because pathogens are notreasonably likely to be present in theinterior of an orange, surface treatmentcould be adequate to ensure the safetyof the juice. This example illustratesthat if FDA were to mandatepasteurization, such action could havethe effect of limiting the development ofnew technologies that are as effective aspasteurization in particularcircumstances but less intrusive andless expensive.

Therefore, the agency tentativelyconcludes that relying on safetyperformance criteria, as recommendedby the NACMCF, is an approachpreferable to pasteurization. However, ifthe use of safety performance criteria


does not significantly decrease thenumber of microbial outbreaks causedby juice, the agency may consideradopting a regulation that mandatespasteurization.

The agency disagrees with thecomments that stated that it shouldrequire that apple juice be pasteurizedbecause apples can be difficult to clean.FDA recognizes that pastuerization is aprocess that has been validated to meetNACMCF's recommendations.Manufacturers may be able to use othertechnologies and practices provided thattheir process is validated to achieve a 5-log reduction in the target pathogen.Therefore, reliance on safetyperformance criteria is a better long-term approach because it provides forthe development of new technologies.

A number of comments at the juicemeeting urged FDA to consideralternatives to pasteurization to increasethe safety of juices. Alternativessuggested by the comments includedextreme isostatic pressure, high pressuresterilization, ultra short time-heatexchanger processing, ohmic heating,aseptic packaging, modified atmospherepackaging, ultrafiltration, hightemperature and high pH adjustment ofwash-water, ultrahigh hydrostaticpressure, electric pulses,electromagnetic field, pulsed light,ultraviolet (UV) water treatment, UVtreatment with photoreactivation,electron beam sterilization, irradiation,ozonated water treatment, microbiocidaladditives (benzoate, sorbate), and pHadjustment. The commentsrecommended that sanitizers oringredients for washes include use ofchlorine, chlorous acid, chlorine withemulsifiers, trisodium phosphate,peroxyacetic acid, peracetic acid, ordimethyl dicarbonate.

The agency agrees that there may bea number of agents that can reduce thenumber of microorganisms present injuice. As the NACMCF recommended, atolerable level of risk may be achievedby interventions that have beenvalidated to achieve a cumulative 5 logreduction in the target pathogens or areduction in yearly risk of illness to lessthan 10-5, assuming consumption of 100mL of juice daily. However, theNACMCF did not specify the manner inwhich this risk reduction should beaccomplished, only the target that mustbe reached. In section IV.M of thisdocument the agency will discuss itsproposed approach as to how thisperformance standard will apply tojuice.

4. LabelingA number of comments suggested that

labeling to distinguish pasteurized from

unpasteurized juice would enableconsumers to make an informed choice.One of the comments requestedwarnings to those `àt-risk,'' one urgedthe publication of warnings in thenewspaper, and another wanted labelingwith no warning. Rather than labeling,one comment suggested point of saleinformation. One comment urged FDAnot to require labeling to distinguishpasteurized from unpasteurized juices.

The NACMCF recommended researchon labeling information needed forconsumer understanding and choice ofsafer juice products. The NACMCFconcluded that, while the risksassociated with specific juices vary,there are safety concerns associatedwith juices generally, especiallyunpasteurized juices.

Labeling whether a product ispasteurized or unpasteurized is usefulinformation that the agency encouragesprocessors to place on labels. However,such labeling would not informpurchasers of unpasteurized productthat children, the elderly, and theimmunocompromised are `àt-risk'' fromconsuming the product. Withouteffective consumer education, the labelstatements ``pasteurized'' and`ùnpasteurized'' are likely to haverelatively little meaning to consumersand could even cause confusion becausesome consumers might selectunpasteurized juice, considering it more``healthy'' because it is less processed.Finally, a labeling requirement thatfocuses only on whether a product ispasteurized or unpasteurized does nottake into account technologies otherthan pasteurization that are adequate tocontrol pathogens, and, thus, such arequirement could be viewed asrestricting the development of newtechnologies.

The agency outlined interim measuresin a notice published August 28, 1997(62 FR 45593), and elsewhere in thisissue of the Federal Register, FDA isissuing a proposal on labeling forpackaged juice. These labeling measuresattempt to provide information on therisks that juice that has not beenprocessed to control for pathogens posesto children, the elderly, and theimmunocompromised. The agency isproposing that the labeling measures besuperseded when these juice productsare processed under adequate HACCPprograms or are otherwise processed todestroy pathogens (e.g., pasteurization).

It is possible for firms thatmanufacture juice to control forpathogens. Labeling a product to alertconsumers to possible harmful effectsfrom its consumption must notsubstitute for a manufacturer adequatelyaddressing those concerns during

processing. FDA is reluctant to rely onlabeling as a safety measure and does soonly when its analysis of thecountervailing factors reveals that, onbalance, labeling provides the mostreasonable approach to protecting thepublic health. Juice is a product that istypically consumed by children, as wellas adults. Therefore, FDA tentativelyconcludes that, for juice, manufacturersneed to implement controls forpathogens to ensure that their productsare safe and not rely solely on labeling,except as an interim measure. FDArequests comment on this tentativeconclusion.

5. EducationOther comments from the juice

meeting suggested that education wouldincrease the awareness associated withthe safety of juices and of all foods.Some comments suggested that moreindustry education or training wasneeded. Other comments wanted moreconsumer education, especially forthose at highest risk from foodbornedisease.

The NACMCF recommended that theindustry be educated on basic foodmicrobiology, the principles of cleaningand sanitizing equipment, CGMP's, andHACCP. FDA agrees that industryeducation can serve a valuable role incontrolling potential food hazards andencourages the industry to take anactive part in educating its employeesand utilizing up-to-date technologies.The agency will assist the industry in itseducation effort.

Concerning consumer education, theagency has launched several initiativesto inform consumers about the potentialhazards presented by juice to at-riskindividuals (see 62 FR 45593, August28, 1997). However, no matter howextensive a consumer educationinitiative the agency undertakes, it isdoubtful that consumer education willreach all at-risk consumers. Therefore,consumer education alone will not beadequate to inform the at-riskpopulation of the potential hazards ofconsumption of juice that has not beenprocessed to control pathogens. Giventhat effective processing methods areavailable, primary reliance needs to beplaced on them to ensure the safety ofjuice.

6. The HACCP OptionMany of the attendees at the juice

meeting urged FDA to mandate HACCPfor juice processors, whereas otherswere opposed. A number of theattendees urged use of CGMP's togetherwith HACCP. Some attendees at thejuice meeting recommended thatmicrobiological criteria or performance


standards be used in addition toHACCP, with two suggesting a 5 logreduction for E. coli O157:H7.

The NACMCF concluded that HACCPand safety performance criteria canprovide the general conceptualframework needed to ensure the safetyof juices, and that validation of theHACCP plan for the juice process (i.e.,ensuring that the process is adequate tocontrol hazards) must be an integral partof this framework. The NACMCF statedthat processors should establish HACCPcontrol measures based on a thoroughhazard analysis.

HACCP is a preventive system ofhazard control that places theresponsibility for identifying safetyproblems with the manufacturer. Use ofthe HACCP system means that a firm isengaged in continuous problemprevention and problem solving, ratherthan relying on facility inspections byregulatory agencies or consumercomplaints to detect a loss of control.HACCP provides for real timemonitoring to assess the effectiveness ofcontrol. A HACCP system put in placeby a manufacturer for a particularfacility is unique and must reflect thetype of juice, its method of processing,its packaging, the facility in which it isprepared, and the intended consumers.

As discussed previously, there issufficient evidence to demonstrate thatthere are significant problems with thepresence of pathogens in some juiceproducts. Pathogens in juice can becontrolled by heat treatment. However,there may be other treatments that meetthe same performance standard that areequally effective (e.g., multiple barriers,surface treatment of intact fruit). Theuse of a HACCP system providesflexibility to a processor to usealternative pathogen control methodsand, thus, encourages the developmentof new technologies but does not dictateeither their development or use.Moreover, not only is HACCP effectivein controlling microbiological hazards,it also is effective in preventingchemical and physical hazards. Thus,HACCP is particularly well-suited forthe juice industry given, as discussedpreviously, the range of hazards thatmust be addressed in processing juice.

The agency agrees with the commentsthat urged use of CGMP's together withHACCP. CGMP's form the foundationupon which a HACCP system is built.Therefore, CGMP's are integral to theHACCP approach.

Because there are significant concernswith the microbial safety of juices,HACCP systems must controlpathogens. As will be discussed insection IV.M of this document, FDA isproposing a 5 log reduction in target

pathogens, as the NACMCFrecommended, as a necessary step in aHACCP plan for juice. Validation of aHACCP system must ensure that theprocess that is employed is adequate tocontrol the relevant pathogens, inaddition to chemical and physicalhazards. Validation of performancestandards consists of determining theability of the pathogens in question toresist acid and other chemical or heattreatment and the ability of the processapplied to overcome that resistance. Theagency requests comment on thisapproach to safety performance criteria.FDA also requests comment on thebenefits of requiring a general HACCPapproach as opposed to those ofspecifically requiring pasteurization.

7. Alternative ApproachAn alternative approach to mandating

HACCP would be to draw a distinctionbetween untreated apple cider and allother juices. Manufacturers of applecider would be provided a permanentoption choosing between labeling orimplementing a HACCP program with a5-log pathogen reduction. All juicesother than untreated apple cider wouldbe provided a permanent option ofchoosing between labeling,implementing a HACCP system, orachieving a 5-log pathogen reduction asdiscussed in section M of thisdocument, entitled ``PathogenReduction.'' The agency requestscomments on this alternative approachto a mandatory HACCP program.

D. Decision to Propose HACCPThe evidence discussed in section I.A

of this document shows that juices havebeen a vehicle for pathogens that havecaused a number of foodborne illnesses.Pathogens can be controlled throughheat treatment. Information set forth insections I.B and I.D of this document,however, demonstrates that there aremany hazards that can occur with juiceand juice beverages that cannot becontrolled through heat treatment.Although not all of the problemsdiscussed in section I of this documentare caused by hazards that could beconsidered reasonably likely to occur inmany juice operations, through the useof HACCP programs, a firm can evaluateits process to determine if the problemcould have been controlled.

As discussed in section I.E of thisdocument, the NACMCF stated thatHACCP and safety performance criteriacan form the general conceptualframework needed to ensure the safetyof juices. FDA has evaluated each of theseven alternatives that have beensuggested for dealing with the problemswith juice. While the agency finds that

these alternatives are by no meansmutually exclusive, FDA has tentativelyconcluded that a preventive system,such as HACCP, appears to offer themost effective way to control thesignificant microbial hazards, alongwith other hazards, that have become aproblem with juice.

Increased inspection, while havingsome beneficial impact on the safety ofjuices, is resource intensive to theagency. Even if funds were available tothe agency for this purpose, increasedinspection would likely not be the bestway for the agency to utilize itsresources to protect the public health. Itis ultimately the responsibility ofmanufacturers to ensure that theirproducts are safe. A preventiveapproach, such as HACCP, on the otherhand, enhances a processor's ability tomake safe products because HACCPconcentrates on examining all aspects ofproduction, identifying hazards that arereasonably likely to occur in thatproduction process, and establishingmeasures that will control or minimizethose hazards. HACCP also enhancesFDA's inspections because it allows theagency to inspect the production facilitymore efficiently and then to verify thatthe firm is operating in accordance withthe firm's HACCP plan, and it providessome assurance that any problems thathave occurred have been identified andappropriately addressed.

CGMP's, the second alternative toHACCP, are plantwide operatingprocedures. Although FDA supports theuse of CGMP's, it tentatively concludesthat use of CGMP's alone would not besufficient to control the problems withjuices because CGMP's do notconcentrate on the identification andprevention of food hazards.Nonetheless, CGMP's are necessary toprovide the foundation on which aHACCP system is built. Therefore, theagency tentatively concludes that, whileCGMP's are important to a HACCPsystem, they are not an adequatealternative to HACCP.

Mandating pasteurization, the thirdsuggested alternative to HACCP, wouldreduce many microbial hazards in juicesbut would eliminate the incentive todevelop alternative methods (e.g., use ofmultiple barriers, surface treatment offruit) that can accomplish the samepurpose. FDA does not want to limitinnovative approaches to achieving foodsafety. HACCP, on the other hand,allows and encourages firms to exploremore technologically efficient and morecost-efficient ways of managing all ofthe hazards that they face. Moreover,pasteurization only controls microbialhazards. HACCP systems can control all


food hazards that are reasonably likelyto occur.

Labeling was also suggested as analternative. FDA acknowledges that,from a public health protectionstandpoint, there are certain advantagesto labeling. Elsewhere in this issue ofthe Federal Register, FDA is proposingto require certain labeling, in the formof a warning statement, for packagedjuice products that have not beenprocessed to control, reduce, oreliminate pathogenic microorganismsthat may be present in such juices. Suchlabeling will serve to reduce the risk offoodborne illness. However, suchreduction will occur only to the extentthat consumers read and understand thelabeling. Accordingly, the agency hastentatively concluded that mandatingHACCP for most juice products willprovide more comprehensive publichealth protection by greatly reducingthe number of juice products thatcontain dangerous pathogens.

Importantly, manufacturers do havethe ability to process juice to controlpathogens. Labeling a product to alertconsumers to possible harmful effectsfrom its consumption is not a substitutefor a manufacturer adequatelyaddressing those concerns duringprocessing. Juice is a product consumedby children, as well as by adults. FDAis reluctant to rely on labeling as asafety measure and does so only whenits analysis of the countervailing factorsreveals that, on balance, labelingprovides the most reasonable approachto protect the public health. Here, asituation in which HACCP offers a reallong-term solution to controlling, if noteliminating, hazards in juice, the agencytentatively believes that labeling is nota reasonable long-term approach. Theagency is soliciting comment on theappropriateness of this tentativeconclusion.

The fifth alternative to HACCP thatwas suggested is education. Industryeducation can play a valuable role in theproduction of safe juices. Consumereducation can play an important part inconsumer purchasing choices. However,education is only effective if peopleunderstand and use the informationconveyed. Moreover, even an extensiveeducation program may not reach allconsumers. Conversely, mandatoryHACCP would ensure that industryproduces safe juice, and that theproduct that reaches consumers is safe.

For the foregoing reasons, FDA hastentatively concluded that HACCPrepresents the appropriate system ofcontrols that is necessary for producingsafe juice products. Therefore, FDA isproposing to add part 120 to itsregulations to establish procedures for

implementing HACCP systems for fruitand vegetable juices. As the agency didwith seafood, it is proposing to issuethese HACCP regulations under varioussections of the the act, including, mostsignificantly, sections 402(a)(1) and(a)(4) and 701(a) of the act (21 U.S.C.371(a)).

Section 402(a)(1) of the act states thata food is adulterated if it bears orcontains any poisonous or deleterioussubstance that may render the foodinjurious to health. Section 402(a)(4) ofthe act states that a food is adulteratedif it has been prepared, packed, or heldunder insanitary conditions whereby itmay have been contaminated with filth,or whereby it may have been renderedinjurious to health. It is important torecognize that section 402(a)(4) of theact addresses conditions that mayrender a food injurious to health, ratherthan conditions that have actuallycaused the food to be injurious (seeUnited States v. 1,200 Cans, PasteurizedWhole Eggs, etc., 339 F. Supp. 131, 141(N.D. Ga. 1972)). The question iswhether the conditions under which thefood is processed and held areinsanitary and may render the foodinjurious to health. The agencytentatively finds that, if a processor ofjuice products does not incorporatecertain basic controls into its proceduresfor preparing, packing, and holdingfood, it is operating under insanitaryconditions that may render the juicethat is produced injurious to health and,therefore, adulterated under the act.Section 701(a) of the act authorizes theagency to adopt regulations for theefficient enforcement of the act.

The legal basis for mandating HACCPsystems for juice processors is the sameas that for seafood. Additionaldiscussion of the legal basis is set out inthe proposed rule (59 FR 4142 at 4150,January 28, 1994) and final rule (60 FR65096 at 65098) for fish and fisheryproducts.

E. Notice of IntentFDA published a notice of intent on

August 28, 1997 (62 FR 45593), thatannounced a comprehensive program toaddress the incidence of foodborneillness related to consumption of freshjuice and to address ultimately thesafety aspects of all juice products. Theagency invited comment on theappropriateness of its strategy to: (1)Initiate rulemaking on a mandatoryHACCP program for some or all juiceproducts, (2) propose that the labels andlabeling of some or all juice productsnot specifically processed to prevent oreliminate the presence of harmfulbacteria bear a warning statementinforming consumers of the risk of

illness associated with consumption ofthe product, and (3) initiate severaleducational programs to minimize thehazards associated with fresh juice. Theagency stated that it would considercomments received within 15 days ofpublication of the notice prior topublication of any proposed rule.

Some comments on the noticesuggested that FDA mandate HACCPonly for fresh juice processors. Onecomment stated that HACCP should bemandated only for firms that processlarge quantities of fresh juice. Othercomments supported mandatorypasteurization or equivalent treatmentof juice, especially apple cider. Onecomment added that pasteurization anduse of CGMP would preclude the needfor the mandatory use of HACCP.

In section II.D of this document theagency has already discussed its reasonsfor proposing HACCP. The illnessesdiscussed in sections I.A and I.B of thisdocument did not pinpoint problemsrelated solely to fresh juice processorsor to the amount of fresh juice that afirm produced. The comments have notprovided any new information to alterthe agency's tentative conclusion thatHACCP is necessary to ensure the safeproduction of juice. However, FDArequests information on whether thereare categories of juice that should beexcluded from the proposed regulation.

FDA has reviewed all of thecomments received within 15 days ofpublication of the notice and hasdetermined that the comments providedno information that would cause theagency to conclude that this proposal isinappropriate. The agency hasattempted to address these comments tothe extent that they are relevant to thisproposal. All comments received inresponse to the notice that address theissues in this proposal will beconsidered either in this proposal or inany final rule published in response tothis proposal.

F. Fresh Produce GuidanceFDA, working with the U.S.

Department of Agriculture (USDA) andthe agricultural community, hasdeveloped voluntary good agriculturalpractice (GAP) and GMP guidance forfruits and vegetables that has beenissued in draft for comment. Theguidance, which is a science-basedevaluation of risks, will addresspotential food safety problemsthroughout the food production anddistribution system such as sanitation,worker health, and water quality. Thisvoluntary guidance can be used by bothdomestic and foreign fresh fruit andvegetable producers to help ensure thesafety of their produce.


III. The HACCP System

The HACCP concept is a systematicapproach to the identification andassessment of the risk (likelihood ofoccurrence and severity) of biological,chemical, and physical hazards from aparticular food production process orpractice and the control of thosehazards. HACCP is a preventive strategyfor food safety. Under it, the foodproducer develops a plan thatanticipates and identifies the points inthe production process where a failurewould likely result in a food hazardbeing created or allowed to persist.These points are referred to as criticalcontrol points (CCP's). Under HACCP,identified CCP's are systematicallymonitored to ensure that critical limits(CL's) are not exceeded, and records arekept of that monitoring. Correctiveactions are taken when control of a CCPis lost, including proper disposition ofthe food produced during that period,and these actions are documented. Theeffectiveness of HACCP is alsosystematically verified by the processor.

HACCP has been endorsed by theNACMCF as an effective and rationalmeans of ensuring food safety. HACCPalso is recognized in the internationalfood safety community as the state-of-the-art means to ensure the safety andintegrity of food. In particular, theCommittee on Food Hygiene of theUnited Nations' Codex AlimentariusCommission (Codex) has endorsed theHACCP concept as a worldwideguideline. The European Union (EU)and other countries around the worldhave begun to require that foodsproduced within their borders beprocessed in a HACCP system. HACCPalso is required for shipment of somefoods (e.g., seafood) into EU countries.

A. Five Preliminary Steps of HACCP

The NACMCF recommends a processfor developing a HACCP system thatincludes: (1) Assembling a HACCPteam, (2) describing the food and itsdistribution, (3) identifying the intendeduse and consumers of the food, (4)developing a flow diagram, and (5)verifying the flow diagram (Ref. 55).These steps have been identified by theNACMCF as the ``five preliminarysteps'' of HACCP. Although the agencyis not proposing to mandate thatprocessors use these preliminary steps,processors will greatly benefit fromusing these preliminary steps indeveloping their HACCP systems. TheNACMCF advises that the preliminarytasks should be accomplished before theapplication of HACCP principles to aspecific process (Ref. 55).

B. The Seven Principles of HACCPThe NACMCF has developed the

following seven principles that describethe HACCP concept:

1. Conduct a Hazard AnalysisThe first step in the establishment of

a HACCP system for a food productionprocess or practice is the identificationof the hazards associated with theproduct. The NACMCF defines a hazardas a biological, chemical, or physicalfactor that may cause a food to be unsafefor consumption. The hazard analysisstep should include not only a writtenidentification of the hazard but a writtenassessment of the likelihood that thehazard will occur and its severity if itdoes occur. This analysis should alsoinvolve the identification of CCP's alongwith control measures for eachidentified hazard.

2. Determine the CCP'sA CCP is a point, step, or procedure

at which control can be applied, so thata potential food hazard can beprevented, eliminated, or reduced toacceptable levels. Points in themanufacturing process that may beCCP's include heat treatment, chilling,specific sanitation procedures, productformulation control, prevention of crosscontamination, and certain aspects ofemployee and environmental hygiene.

3. Establish Critical LimitsThis step involves establishing

parameters that must not be exceededfor each control measure associatedwith a CCP. Critical limits (CL's) can bethought of as boundaries of safety foreach CCP and may be set for controlmeasures such as temperature, time,physical dimensions, moisture level,water activity, pH, and availablechlorine. A CL is used to distinguishbetween safe and unsafe operatingconditions at a CCP. For example, theminimum temperature and timecombination that will kill pathogens ina heat treatment step is the CL for thatCCP.

4. Establish Monitoring ProceduresMonitoring is a planned sequence of

observations or measurements to assesswhether a CCP is under control (i.e.,operating within its CL) and to producean accurate record of the monitoring foruse in future verification procedures.An unsafe food may result if a processis not properly controlled and adeviation occurs. Because of thepotentially serious consequences of a CLdeviation, monitoring procedures mustbe effective. Continuous monitoring ispossible with many types of physicaland chemical methods. When it is not

possible to monitor a CL on acontinuous basis, monitoring intervalsmust be established that are frequentenough to permit the manufacturer todetermine whether the step/process/procedure designed to control thehazard is working.

5. Establish Corrective Actions

While the HACCP system is intendedto prevent deviations in a plannedprocess from occurring, total preventioncan rarely, if ever, be achieved.Therefore, there needs to be a correctiveaction plan in place to fix or correct thecause of the deviation to ensure that theCCP is brought under control, to ensurethat there is appropriate disposition ofany food produced during a deviation,and to ensure that records are made ofthe corrective actions taken. Out ofcontrol situations should be used toidentify opportunities for improvementof the process to prevent futureoccurrences.

6. Establish Verification Procedures

This process involves the applicationof methods, procedures, tests, andevaluations, other than monitoring, todetermine the adequacy of, andcompliance with, the HACCP system.The major infusion of science in aHACCP system centers on properidentification of the hazards, CCP's, andCL's and the institution of properverification procedures.

7. Establish Recordkeeping andDocumentation Procedures

This principle requires thepreparation and maintenance of writtenHACCP records that list the hazards,CCP's, and CL's identified by the firm,as well as the monitoring,recordkeeping, and other proceduresthat the firm intends to use toimplement the system. This principlealso requires the maintenance of recordsgenerated during the operation of theHACCP system.

C. History of the Use of HACCP

1. HACCP for Fish and Fishery Products

On December 18, 1995, FDApublished a final rule in the FederalRegister (60 FR 65096) on proceduresfor the safe and sanitary processing andimporting of fish and fishery products(part 123 (21 CFR part 123)) (seafoodfinal rule). The regulations require thatseafood processors develop, implement,and document sanitation controlprocedures and mandate the applicationof HACCP principles to the processingof seafood. The effective date for theseafood final rule was December 18,1997.


The regulations proposed herein arebased on the seafood final rule withsome modification to reflect thedifferences between seafood and juiceproducts and to reflect recentdevelopments in the application ofHACCP. An extensive administrativerecord was compiled in the seafoodproceeding. FDA is incorporating thatrecord as support for the currentproposal. Although the regulationsproposed herein differ in some aspectsfrom part 123, they are not intended tosupersede or otherwise alter the seafoodfinal rule.

2. Advance Notice of ProposedRulemaking for the Development ofHACCP for the Food Industry

In the Federal Register of August 4,1994 (59 FR 39888), FDA published anadvance notice of proposed rulemaking(ANPRM) requesting public commentabout whether and how the agencyshould develop regulations that wouldestablish requirements for a newcomprehensive food safety assuranceprogram, based on HACCP, for bothdomestically produced and importedfoods. The agency stated its tentativeview that, if such regulations wereissued, they would enhance FDA'sability to ensure the safety of the U.S.food supply. FDA requested commentson a number of specific issues, as wellas on all aspects of such a food safetyprogram.

3. HACCP Pilot ProgramsIn addition to the ANPRM, FDA also

published in the Federal Register onAugust 4, 1994 (59 FR 39771), a noticeannouncing that it intended to conducta pilot program in which volunteersfrom the food manufacturing industrywould use a HACCP system that FDAwould audit. The pilot program wasintended to provide information thatFDA could use in deciding whether topropose to adopt regulations and indeveloping and implementing aregulatory system in which foodmanufacturers are required to performthe food safety aspects of theiroperations based on HACCP principles.In the notice, FDA invited individualfirms that wished to participate in theprogram to submit letters of interest.Approximately 50 firms expressedinitial interest in participating in thepilot program, and 11 firms wereselected to participate. In 1997 FDAcompleted the pilot program at six firmsand published a second interim report.

4. HACCP for Meat and PoultryOn July 25, 1996, USDA published a

final rule (61 FR 38806) that, amongother things, required that each meat

and poultry establishment develop andimplement written sanitation standardoperating procedures (Sanitation SOP's)and a system of HACCP controlsdesigned to improve the safety of theirproducts. The effective date for theSanitation SOP's was January 27, 1997,and for the HACCP regulations wasJanuary 26, 1998. FDA has reviewed themeat and poultry HACCP regulationsand has incorporated portions of themas appropriate in the proposed HACCPregulations for juice.

D. Issues from the ANPRMFDA received approximately 150

comments in response to the August 4,1994, ANPRM. The commentsrepresented the views of consumers,consumer organizations, healthprofessionals, academicians, foodindustry officials, trade associations,and foreign, State, and local governmentagencies. The agency has attempted toaddress these comments to the extentthat they are relevant to this proposal.

1. The agency asked in the ANPRMhow the responsibility for food safetyshould be shared between the foodindustry and government. Commentsgenerally agreed that the food industryis responsible for producing safe foodproducts. All respondents on this issuerecognized that the Government's role isto verify industry compliance with anyapplicable safety regulations.

FDA agrees that it is themanufacturer's responsibility to ensurethat the food that it produces is safe,and that it is the Government's role toverify that manufacturers are fulfillingtheir responsibility. Through use of aHACCP system, both the firm and FDAare able to better fulfill their roles. Theproposed regulation in part 120underscores the division of roles. Underthe proposed regulation, industry ischarged with examining all aspects ofproduction, identifying hazards that arereasonably likely to occur, andestablishing measures that will controlor minimize those hazards. HACCPrecords enable the agency to inspect theproduction facility more efficiently andto verify that the firm is operating inaccordance with its HACCP plan. Theyalso give the agency insight intowhether any problems that haveoccurred have been identified andappropriately addressed.

It is important that the juice industryfocus on its responsibility to producesafe food. Recent outbreaks evidencethat some members of the industry havenot kept up with the need to evaluatethe hazards presented by juice and todesign processes to address thosehazards. Firms need to be aware of theemerging problems presented by their

raw materials and to decide whether,and if so what, steps are necessary toaddress these problems. Firms maydecide that it is necessary to incorporatea step designed to kill bacteria into theirprocess (e.g., pasteurization), that thereare alternative steps that they can taketo ensure the safety of their products, orthat, given the nature of the rawmaterials, no steps are necessary. Firmsalso need to monitor the process thatthey decide to employ to ensure that itis functioning adequately andappropriately. FDA notes that somefirms have already addressed food safetyconcerns and have implementedHACCP systems.

Moreover, given the heightenedconcerns about these products,Government needs to be in a position tofulfill its role of verifying that industryis doing its job. Given the sporadic andvariable way in which the problems thathave been associated with juice arise,sampling and end-product testing ofjuice products will not enable it to doso. Other steps that will giveGovernment insights into theproduction itself appear to be in order.

2. FDA requested comment in theANPRM about the likelihood ofoccurrence of a hazard that wouldwarrant HACCP-type control. Generally,the comments consistently identifiedtwo features that would characterize aproperly formulated definition oflikelihood: Processing conditions andnature of hazard. The majority ofcomments offered by the food industrystipulated that the necessary conditionfor likelihood of occurrence of thehazard appropriate to trigger HACCPcontrol must not be speculative, as inworst-case scenarios, but be real,practical, and intrinsic to the processingor hazards demonstrably present forspecific commodities. Several responsesrecommended that the question bereferred to broadly based expert panelsto establish the likelihood of risk.

According to the NACMCF, eachpotential hazard is evaluated based onthe severity of the potential hazard andits likely occurrence (Ref. 55). Severityis the seriousness of the consequencesof exposure to the hazard.Considerations of severity (e.g., impactof sequelae and magnitude and durationof illness or injury) can be helpful inunderstanding the public health impactof the hazard. Likelihood of occurrenceof a hazard is generally judged based onprocessing experience, epidemiologicaldata, and information in the technicalliterature.

The agency agrees with the commentsthat stated that the processingconditions and the nature of the hazardare key elements in assessing the


likelihood of a hazard occurring. Itwould be futile for processors to attemptto control for every theoretical hazardbecause doing so would entail assessinghazards that the processor could notreasonably anticipate would actuallyoccur. The assessment of the likelihoodof risk of illness or injury to consumersshould be practical for the specificcommodity and not be speculative. Forexample, use of pesticides on fruits andvegetables is a common practice whilethese foods grow. The presence ofpesticides on fruits or vegetables used tomake juice is considered a hazard if: (1)The pesticide is not approved for use onthe fruit or vegetable, or (2) it is foundin amounts above its EPA establishedtolerance. If a pesticide is applied tofruits or vegetables in conformance withEPA regulations, and the appropriateperiod of time has elapsed betweenapplication and harvest, the presence ofthe pesticide is not considered topresent a hazard that is reasonablylikely to occur.

The agency disagrees that it shouldrely on broadly based expert panels toestablish likelihood of occurrence of ahazard. Although such committeescould provide insight into the issue, onbalance, the insights that they would belikely to provide would not justify theexpenditure of resources that conveningsuch committees would require.However, interested persons arewelcome to consider voluntarily thequestion and to submit the results oftheir consideration to the agency.

3. Comments on the ANPRM statedthat because epidemiological studiesconsistently show that microbialpathogens are the most significantsource of food hazards, issues such aspesticides, heavy metals, filth, physicalcontaminants, and others pale bycomparison with the immediate healthconsequences of foodborne microbialpathogens. They stated that HACCP isbest suited for preventing microbialhazards rather than physical orchemical hazards because CCPmonitoring can be readily established ina timely fashion for pathogens and,particularly, for the unsanitaryconditions that promote their growth.

The comments added that effects thatresult from events that occur after thefood has left the processor's HACCPsystem are not controllable by theprocessor. The comments said that thisfact is significant because food serviceestablishments and the lack of consumereducation have contributed to themajority of incidences of foodborneillness reported in currentepidemiological data. They stated thatHACCP systems are essentially localizedmanagement tools that will not permit

any measurable improvement innational or international food safetyeffectiveness and have beenimplemented voluntarily solely as acorporate practice to provide strategicbusiness advantages in increasinglycompetitive markets.

The comments stated that regulationmay be premature because of theadequacy and feasibility of presentlyavailable analytical tests to control allhazards. They stated that, consequently,HACCP is an excellent tool but only inthe very specific case of high-risk foodprocessing that is focused on controllingmicrobiological risks. The commentsstated that, instead of misdirecting itsefforts, FDA needs to look to itself toreinforce food preparation safetyawareness at food serviceestablishments and to pursue vigorouslyan enhanced consumer education policyon unsafe food practices as the bestpreventative food risk control program.

FDA agrees that microbial hazards area significant source of food hazards.FDA also agrees that HACCP is an idealmechanism to deal with microbialhazards because it is a system ofprevention. Prevention makes up for theinadequacies of end-product testing. Forexample, for maximum quality,nonshelf stable juice must be distributedquickly, and end-product testing usuallytakes at least several days to obtainresults. If pathogens are discovered inthe juice after distribution, the productmust be recalled, and consumers mayhave already ingested product. Finally,the particular samples taken in endproduct testing may not containpathogens because the pathogens maynot be ubiquitous in the lot (i.e., theremay be low level or sporadiccontamination) and thus produce falsenegatives.

A system of preventive controls, likeHACCP, on the other hand, is designedto identify and manage conditionswhere pathogens could be present injuice while it is still being processed.HACCP is designed to ensure that thereis early discovery, and timelycorrection, of any problems that maydevelop. Although HACCP is wellsuited for preventing microbial hazards,this does not mean, as some of thecomments asserted, that it is not usefulfor other types of hazards. As theNACMCF has recognized, it is wellsuited for preventing chemical andphysical hazards. For example,processors can establish CCP's toprevent pieces of glass fromcontaminating a product when glassbottles are used.

The NACMCF endorses HACCP as aneffective and rational means of assuringfood safety (Ref. 55). According to the

NACMCF, its use will likely result inmeasurable improvement in food safety.Under HACCP, processors view theprocessing plant from a preventionperspective and thus are in a position toreact appropriately to new hazards ifthey arise. In preparing this proposal,FDA has reviewed the history of juicerelated outbreaks. All of these outbreaksmight have been prevented if a HACCPsystem of the type that FDA isproposing herein had been in use.

The agency agrees that there arehazards that can occur after food has leftthe processing plant that the processorcannot control. The agency hasestablished the Food Code to assist Stateagencies and food workers in retail foodestablishments and has addressedhandling of high risk foods in the FoodCode. FDA also provides consumerinformation on food safety through aconsumer hotline, public affairsspecialists in FDA's district offices, andvarious brochures and otherpublications. These efforts are intendedto educate consumers on safe handlingof foods at home. In addition, asdescribed in the interim notice, theagency has initiated a consumereducation program concerning juice thatis not treated to prevent or eliminate thepresence of harmful bacteria.

4. The agency requested informationin the ANPRM on its possible role inassisting the food industry in thedevelopment of HACCP plans.Comments stated that FDA preparationof general background materials onHACCP would be beneficial inestablishing a common approach to plandevelopment, in assisting hazardidentification analysis, and in usingconsistent language. They stated thatFDA could provide informationalresources such as examples of HACCPplans adaptable to the individualcircumstances of a business' operationsor consultative documents that couldserve to guide plan development.

However, some comments urged thatFDA avoid over-regulation. They statedthat an excessively ambitious regulatoryapproach will limit the effectiveness ofany HACCP program.

The agency agrees that it should avoidover-regulation because such anapproach can inhibit futuredevelopments and new technology inHACCP systems and in safe foodprocessing. FDA is proposing a HACCPregulation that, if adopted, will bemandatory for juice processors (asdefined at proposed 120.3(i)) but thatcan be used as a model for other foodsin that it outlines the minimumessential components of a HACCPsystem. To the extent possible, theproposed regulation is in harmony with


the existing HACCP regulations forseafood and meat and poultry.

FDA has developed the ``Fish &Fisheries Products Hazards & ControlsGuide'' to assist manufacturers in theimplementation of HACCP for seafood.The Federal Safety and InspectionService (FSIS) has developed, inconjunction with the International Meatand Poultry HACCP Alliance, 13HACCP models for meat and poultryproducts, a ``Guidebook for thePreparation of HACCP Plans,'' and the``Meat and Poultry Products Hazardsand Control Guide.'' However, it is notclear whether FDA will be able toprovide such detailed information forjuice. Therefore, in this rulemaking, theagency will attempt to provideguidance, to the extent possible,concerning the application of theregulation to juice.

5. Some comments on the ANPRMstated that, if EPA tolerances forpesticides in agricultural commoditiesbecome HACCP-focused safety issues infood processing and service industries,then explicit coordination by FDA withEPA is needed to define truly significanthazards. They stated that this effortwould greatly assist HACCPdevelopment in such circumstances, sothat duplication of effort would beavoided, consistency among regulatoryrequirements would be achieved, andimpediments to international commercewould be removed.

FDA has attempted to harmonize itsregulations with those of other Federalagencies and with Codex. EPAestablishes regulations for pesticide useand tolerances for pesticide residues,and FDA and USDA enforce thosetolerances on foods.

Under section 402(a)(2)(B) of the act,a food is deemed to be adulterated if itbears or contains a pesticide chemicalresidue unless a tolerance or anexemption for such pesticide has beenestablished, and the quantity of suchpesticide on the commodity is withinthe tolerance limits. Pesticide chemicalresidues for which there is no toleranceor exemption are deemed to be unsafeas a matter of law. HACCP is intendedto protect against unsafe products. Thus,there is no reason why pesticideresidues and similar types of food safetymeasures should be outside the scope ofHACCP.

6. In the ANPRM, the agency asked ifthere was a need for microbiologicalcriteria in HACCP regulations. Somecomments favored inclusion ofmicrobiological criteria for known highrisk foods because such criteria arepractical, efficient, and cost effective.However, most comments maintainedthat microbiological criteria, set as

national standards, are not warrantedbecause: (1) Criteria are discordant withHACCP purposes because they dependon end product testing, (2) criteriapossess inadequate scientific basis, and(3) criteria are preemptive of localizeddevelopment of HACCP systems.

The agency tentatively agrees withthose comments that stated thatmicrobiological criteria in HACCPregulations are warranted for somefoods. Contrary to what many of thecomments asserted, effective microbialcontrols depend not on end producttesting but on processing controls andthe establishment of CL's. For example,juice made from apples that have fallenon the ground must be processed insome manner to destroy pathogensbecause pathogens are likely to bepresent and, as discussed previously,end product testing may produce falsenegatives. If a regulation is flexible, itshould not ``preempt'' the processor'sdevelopment of HACCP, but it canprovide the CL's needed for the safeprocessing of food under a HACCPsystem. However, the agency agrees thatthe decision on which processingcontrols are to be used must have avalid scientific basis.

Microbial pathogens have emerged asa significant problem in unpasteurizedjuice in recent years. The NACMCFrecommended that safety performancecriteria, rather than a specificintervention technology, be mandatedfor juice (Ref. 53). The safetyperformance criteria recommended bythe NACMCF is whether the measuresthat a juice processor employs havebeen validated to achieve a cumulative5 log reduction in the target organismsor a reduction in yearly risk of illnessto less than 10-5, assuming consumptionof 100 mL of juice daily. As will bediscussed in section IV.M of thisdocument, FDA is proposing to requirethat firms include in their HACCP plansmeasures that will produce, at aminimum, a 5 log reduction in targetpathogens.

7. Comments on the ANPRM statedthat FDA should require end producttesting records to provide information asto the effectiveness of a HACCPprogram. These comments stated thatend product testing was practicalbecause mandated testing was anecessary, continuing, and recordablevalidation of the completeness of aHACCP system, thereby ensuring that100 percent control is manifested.

Comments from the juice meeting alsosupported the use of end producttesting. One of the these commentsproposed using testing to decidewhether to pasteurize each lot. Severalcomments pointed to new rapid testing

technologies and testing kits forpathogens.

However, other comments maintainedthat information generated from endproduct tests would not be useful. Onecomment stated that end product testingactivities were counterproductive to awell-planned HACCP system.Furthermore, these comments added,any requirements that FDA puts forwardmust be practical, and no process can beregulated into 100 percent certainty.

The agency is not proposing to requireend product testing. End product testingis most useful where there are highlevels of the substance being tested, andthere is uniformity throughout the lotbeing sampled. Product sampled fortesting for microbial hazards, where apathogen (e.g., E. coli O157:H7) ishazardous even at very low levels, or forphysical hazards (e.g., glass), where thehazard is the presence of a discrete unit,may not contain the hazard even underthe best sampling procedure. In thesecases end product testing is likely toproduce false negatives and, thus, toprovide scant protection. It isprohibitive to use end product testingadequately in these situations becauseof the amount of testing that isnecessary for a statistically valid test,and because it would be necessary tochannel a significant portion of theproduct for that testing. Therefore, theagency has tentatively concluded thatuse of control measures under a HACCPsystem to prevent hazards fromoccurring, with subsequent monitoring,verification, validation, andrecordkeeping, is more effective thanend product testing in ensuring thatfood is safe. Thus, FDA has notincluded a requirement for end producttesting in this proposed rule on juiceproducts.

8. The agency asked in the ANPRMwhether it should mandate HACCP forall segments of the food industry. Manycomments stated that mandatoryHACCP regulations for low-risk foodswould be inappropriate because tryingto manage low risk hazards throughHACCP would dilute agency resourcesand therefore the effectiveness ofHACCP. The comments stated that FDAcould utilize its resources mostefficiently by focusing on those high-risk food processing operationsidentified in its 1993 model Food Codeas ``Potentially Hazardous.'' They statedthat the U.S. food supply is alreadydemonstrably the world's safest, so thatthere is no valid reason for requiringHACCP plans of the entire industry. Thecomments stated that enforcementmechanisms in the act are, and willcontinue to be, sufficient withoutadding to the regulatory burden on


industry. They added that incorporationof HACCP into food industry operationsshould be permitted to proceed on avoluntary basis, unless a well-definedneed requires implementation throughspecific authority provisions of the actinto specific high-risk segments of thefood industry.

However, some comments stated thatunless all segments of the food chain aremandatorily included, adoption ofHACCP is unlikely to result inmeasurable enhancement of the safety ofthe food supply. They stated that lessthan universal coverage would createconfusion about what should beexcluded. The comments stated that anyattempt to limit HACCP to identified``high-risk'' processors would hinderefforts to address significant publichealth problems that may arise in thefuture. They concluded that it is notunduly burdensome to mandate HACCPfor all. The comments maintained thatHACCP regulations should be ascomprehensive as practicable andapplied throughout the food chain to thefullest extent possible and reasonable,and that HACCP principles must beapplied from farm to fork.

FDA disagrees with the commentsthat stated that HACCP is inappropriatefor low-risk foods. Both food processorsand government regulatory agencieswould benefit from the use of HACCPsystems. The U.S.'s excellent record forhaving a safe food supply does not meanthat this country should not considerways of improving on that record. In theface of emerging pathogens and othernew food hazards, HACCP provides aflexible system in which processorsreassess their procedures on an on-goingbasis. HACCP also enables processors tomeet future demands.

The use of HACCP allows foodprocessors to concentrate their efforts onthe aspects of the processes that theyuse where risks are highest and providesregulatory agencies with assurance thatprocessors are observing prudentprocessing practices. HACCP alsoprovides assurance that problems in theprocess are likely to be discovered, andthat unsafe product is unlikely to leavethe firm. The complexity of HACCP isa function of the number of hazards thatmust be controlled and the nature of thecontrol

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Hazard Analysis and Critical Control on Juice

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