Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice

SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt

regulations to ensure the safe and sanitary processing of fruit and

vegetable juices and juice products. The proposed regulation, if

adopted, will mandate the application of Hazard Analysis and Critical

Control Point (HACCP) principles to the processing of these foods.

HACCP is a preventive system of hazard control. FDA is proposing these

regulations because there have been a number of outbreaks of illness,

including some directly affecting children, associated with juice

products and because a system of preventive control measures is the

most effective and efficient way to ensure that these products will be

safe. Elsewhere in this issue of the Federal Register, FDA is

publishing a warning label proposal for packaged juice.

DATES: Submit written comments by July 8, 1998. For information on the

proposed compliance dates for small businesses and very small

businesses see the Supplementary Information section of this document.

Submit written comments on the information collection requirements

by May 26, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857. Submit written comments regarding information

collection to the Office of Information and Regulatory Affairs, Office

of Management and Budget, New Executive 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

Safety and Applied Nutrition (HFS-306), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

The agency proposes to make any final rule based upon this proposal

effective 1 year after its date of publication in the Federal Register.

However, by its terms, the final rule will not be binding on small

businesses as defined in proposed Sec. 120.1(b)(1) until 2 years after

the date of publication of a final rule in the Federal Register; and

for very small businesses as defined in proposed Sec. 120.1(b)(2), the

final rule will not be binding until 3 years after the date of its

publication in the Federal Register.

I. Concerns With Juice

A. Microbial Outbreaks

The Seattle-King County Department of Public Health and the

Washington State Department of Health reported on October 30, 1996, an

outbreak of Escherichia coli O157:H7 infections epidemiologically

associated with drinking a particular brand of unpasteurized apple

juice, or juice mixtures containing unpasteurized apple juice,

purchased from a coffee shop chain, grocery stores, and other locations

(Ref. 1). A case was defined as hemolytic uremic syndrome (HUS) or a

stool culture yielding E. coli O157:H7 in a person who became ill after

September 30, 1996, after drinking the particular brand of juice within

10 days before illness onset. There were at least 66 cases of illness,

with 14 cases of HUS and the death of one child, associated with this

outbreak (Ref. 2). Cases occurred in British Columbia, California,

Colorado, and Washington. E. coli O157:H7 isolates cultured from a

previously unopened container of the particular brand of apple juice

had a deoxyribonucleic acid (DNA) ``fingerprint'' pattern (restriction

fragment length polymorphism) indistinguishable from case-related

isolates (Ref. 1).

Various juices have been documented as vehicles for causing

outbreaks from microorganisms. A 1967 outbreak from contaminated water

added to orange juice concentrate affected approximately 5,200 persons

and was caused by an unidentified virus and possibly other contaminants

(Refs. 3 and 4). About 300 people became ill from Salmonella

typhimurium in cider made from apples, including some that had been

picked up from the ground in an orchard fertilized with manure, in a

1974 outbreak in New Jersey (Ref. 5). A 1991 outbreak of Vibrio

cholerae was associated with coconut milk contaminated during

manufacturing in Thailand (Ref. 6). There have been two Cryptosporidium

outbreaks related to drinking apple cider, the first in Maine in 1993

and the other in New York State in 1996. In the first case, the apples

used for cider came from trees near a cow pasture (Ref. 7), and in the

second case, water used for rinsing came from a well that tested

positive for coliforms (Ref. 8). In 1995 there was an outbreak in

Florida that was caused by Salmonella hartford in unpasteurized orange

juice (Ref. 9).

E. coli O157:H7 has been recognized relatively recently as a human

pathogen and has been a source of a number of outbreaks related to

juice. Thirteen and possibly 14 children had bloody diarrhea and

developed HUS in Toronto, Canada, between September 15 and 25, 1980.

The children's illnesses were associated with drinking fresh apple

juice. The children's stools were examined for enteropathogenic E.

coli, Campylobacter, Salmonella, Shigella, and Yersinia. None of these

organisms were found. E. coli O157:H7 is the suspected causative

organism. Conclusive testing for that organism was not done because E.

coli O157:H7 was not recognized as a human pathogen before 1982 (Ref.

10).

A 1991 E. coli O157:H7 outbreak in southeast Massachusetts

conclusively showed that fresh-pressed unpasteurized apple juice can

transmit E. coli O157:H7 bacteria. In this outbreak, 23 individuals had

diarrhea, 16 had bloody diarrhea, and 4 developed HUS (Ref. 11).

In Connecticut, a 1996 outbreak of E. coli O157:H7 illness was

associated with drinking a particular brand of apple cider. There were

14 cases of illness (including 7 hospitalized), with 3 cases of HUS

associated with the outbreak (Ref. 8).

There was a small outbreak of E. coli O157:H7 illness in Washington

State in 1996 that was related to apple cider made at a church event.

This outbreak occurred during the same time as the unpasteurized apple

juice outbreak described in previous paragraphs. The apples were washed

in a chlorine solution, but it was not reported how much chlorine was

used. Six people became ill, but no estimate was given on how many

people may have drunk the apple cider (Ref. 12).

FDA's recall data also provide evidence of microbial hazards in

juice. There were 85 cases of illness in 1994 resulting in a recall of

orange juice that had fermented and contained Bacillus cereus and yeast

(Ref. 13).

State investigations provide additional evidence of microbial

hazards in juice. A 1989 outbreak in New York was caused by the

presence in orange juice of Salmonella typhi that originated from an

infected worker and

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resulted in 69 illnesses with 21 individuals hospitalized (Ref. 14).

The State of Washington reported that in 1993 one individual was

hospitalized from home-made carrot juice found to contain Clostridium

botulinum (Ref. 15). A 1993 Ohio outbreak caused by yeast or some other

unknown toxicant in orange juice resulted in 23 illnesses (Ref. 16). A

home-made watermelon drink contaminated with Salmonella spp. caused

illness in 18 individuals in a 1993 Florida outbreak (Ref. 17). The

State of Colorado reported two outbreaks of gastrointestinal illness

from fresh squeezed orange juice at a mountain resort (Ref. 18). There

were food handlers that were ill in both Colorado instances, and a

virus was suspected as the causative agent.

The evidence shows that certain juices have been the vehicle for

outbreaks of foodborne illnesses. Although fruit juice is acidic, and

thus would generally be considered to inhibit the growth of most

microorganisms, most juice-related outbreaks have been associated with

fruit juices.

B. Illnesses From Nonheat-treatable Hazards

Illnesses that have been caused by hazards that can not be reduced

to acceptable levels by heat treatments have also been associated with

juice. Tin in canned tomato juice caused illness in 113 individuals in

1969 (Ref. 19). Soil nitrate had resulted in a high nitrate content in

the tomatoes, and this high nitrate content accelerated detinning in

the cans. In 1984, 11 persons became ill from consuming elderberry

juice prepared by staff of a religious/philosophic group that contained

poisonous parts of the plant (Ref. 20). A 1990 guanabana juice outbreak

was caused by the presence of toxic guanabana seed material and caused

illness in nine individuals (Ref. 21). A 1997 outbreak was caused by

tin in pineapple juice (Ref. 22).

In 1992 an 18-month-old child with a blood lead level of 36

micrograms per deciliter (g/dL) was found in a routine county

health department blood lead monitoring program. Investigation of this

incident by the county health department revealed that the only

significant source of lead exposure for this child was lead in imported

fruit juice packed in 12-ounce, lead-soldered cans (Ref. 23). Analysis

by the State health department of multiple flavors of the fruit juices

in lead-soldered cans available to the child found lead levels ranging

from 160 to 810 parts per billion (ppb). An exposure assessment

performed by the county health department estimated that the child

consumed about three cans of these fruit juices per day and estimated

that the child's daily lead intake from these fruit juices was

approximately 600 g/day (Ref. 23). As a result of this

incident, FDA announced an emergency action level of 80 ppb for lead in

fruit beverages (such as juices, nectars, and drinks) packed in lead-

soldered cans (58 FR 17233, April 1, 1993). The agency subsequently

banned the use of lead-soldered cans (60 FR 33106, June 27, 1995).

Recalls also provide evidence of nonheat-treatable hazards in

juice. In 1988 a fruit punch drink was recalled because of the presence

of tin caused by the acidity of the drink reacting with the tin coating

of the cans (Ref. 24). The product had been packaged in the wrong

container.

There were 10 recalls between 1990 and 1995 for fruit juice or

beverages containing fruit juice because of the presence of food

ingredients that were inadvertently added to the product, not declared

on the label, or not suitable for the food. Food ingredients involved

with 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 1997 were caused by improper

sanitation procedures or faulty equipment. In 1991 sodium hydroxide

from a clean-in-place system contaminated the caps of a citrus punch

drink (Ref. 35). In 1992 three persons became ill, with 1 hospitalized,

from a sodium hydroxide sanitizing agent that got into fruit drink

product containers during cleaning (Ref. 36). In 1993 cracks in a heat

exchanger allowed an orange flavored soft drink containing pear juice

to come in contact with copper pipe fittings and, thus, to become

contaminated with copper (Ref. 37). In 1994 milk was found in orange

juice from filler lines that were not cleaned between milk and juice

production (Ref. 38). In 1997 the presence of an alkaline cleaning

solution in a berry juice caused gastrointestinal distress in several

persons (Ref. 39).

Companies have recalled fruit drinks because pieces of glass or

plastic were found in their products. The presence of glass in products

is typically caused by the use of glass bottles, which can chip or

shatter during the production process (Refs. 40 through 42). The

plastic was present from the company's practice of draping plastic bags

over the side of the bottle loading bin (Ref. 43).

One company recalled apple-prune juice and prune juice in 1996

because of unacceptable levels of lead (Refs. 46 and 47). The cause was

contaminated imported prune juice.

In response to the establishment of maximum levels for patulin in

apple juice by several foreign governments, FDA initiated a sampling

survey to determine the levels commonly found in domestic and imported

apple juice. Patulin may be present in juice made from moldy apples. In

March 1997 the agency found inordinately high levels of patulin in

apple juice from a processor in Washington State (Ref. 48). The level

of patulin found in the product was sufficient to pose a health hazard,

especially considering the fact that apple juice is commonly used by

infants and young children (Ref. 49). All affected products that had

left the plant had been used in the manufacture of fermented apple

cider. Patulin could not be detected in fermented product, and it was

assumed that the patulin was destroyed through the fermentation

process.

Therefore, as the foregoing discussion reveals, the evidence

demonstrates that juice and juice beverages are susceptible to chemical

and physical hazards as well as microbiological hazards.

C. Underreporting

There is wide agreement that the laboratory-confirmed cases from

outbreaks and recalls understate the actual number of juice-related

cases, but no consensus exists on the size of the understatement.

Individuals may not manifest all symptoms or have severe enough

symptoms to necessitate medical attention. Medical personnel may simply

treat an individual's symptoms without determining the underlying

cause. The laboratory-confirmed cases only represent those cases where

individuals sought medical attention, and where medical personnel

performed the necessary testing and reported the case to a government

agency.

While the actual number of juice-related illnesses is unknown, FDA

has derived an estimate of the total number by multiplying the average

number of laboratory-confirmed cases by factors that account for under-

reporting. The factors are based on the relationships between annual

outbreak cases and published estimates of the number of foodborne

illnesses. For example, using these adjustment factors, it is estimated

that the average 16 annual laboratory-confirmed cases of Salmonella

represents 4,900 to 7,600 actual cases (Ref. 50). For E. coli O157:H7,

an average 22 laboratory-confirmed cases per year may actually

represent 2,200 to 4,300 total juice-related cases (Ref. 50).

Therefore, the agency assumes that the

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actual number of illnesses from the outbreaks described in sections I.A

and I.B of this document is much greater than the confirmed number of

illnesses. (For a more complete discussion of these estimates, see the

agency's preliminary regulatory impact analysis and Ref. 50)

D. Pesticides

Pesticides are usually applied to plants to combat insects, plant

diseases, and weed growth to assist in the growth of the fruit or

vegetable. A food is considered adulterated under section 402(a)(2)(B)

of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.

342(a)(2)(B) if pesticide residues are present above the Environmental

Protection Agency (EPA) established tolerances, or if EPA has not

established a tolerance for use of the pesticide on the particular

plant. FDA annually monitors a wide variety of foods for pesticide

residues.

In 1994 FDA sampled 1,411 domestic fruits and fruit products,

including apple juice and other fruit juices, for pesticide residues

and found that less than 1 percent were violative for being over

tolerance and less than 1 percent were violative for having no

tolerance (Ref. 51). None of the 122 samples of apple juice or 44

samples of other fruit juices were violative. Out of 1,795 samples of

domestic vegetables and vegetable products tested, FDA found that less

than 1 percent of samples were over tolerance, and that 2 percent were

violative for having no tolerance.

FDA also tested 1,940 imported fruits and fruit products in its

1994 pesticide residue monitoring program. Less than 1 percent of the

items tested were over tolerance and 3 percent were violative for

having no tolerance. None of the 110 fruit juices sampled were

violative. The agency sampled 2,460 imported vegetables and vegetable

products and found that less than 1 percent were violative for being

over tolerance and 4 percent for having no tolerance.

In its 1995 pesticide monitoring program FDA found less than 1

percent of 1,437 samples of domestic fruits and fruit products to be

violative for being over tolerance and 1 percent to be violative for

having no tolerance (Ref. 52). Of the 110 apple juices and 22 other

fruit juices sampled, only a single apple juice sample was found to be

violative, because of the presence of a pesticide with no established

tolerance. Analysis of 1,585 samples of domestic vegetable and

vegetable product produced results similar to the results found in

1994, i.e., less than 1 percent of samples were over tolerance, and

approximately 2 percent were violative because there were no tolerances

for the pesticide residues that FDA found.

The agency sampled 1,757 imported fruits and fruit products for

pesticides in 1995 and found that less than 1 percent were violative

for being over tolerance, and that 3 percent were violative for having

no tolerance. Of the 19 apple juices and 52 other fruit juices tested,

2 apple juice samples were violative because they contained pesticides

for which there were no established tolerances. The agency sampled

2,535 imported vegetables and vegetable products and found that 1

percent were violative for being over tolerance, and that 3 percent

were violative for having pesticide residues for which there was no

tolerance. Some of these samples contained both residues over tolerance

and residues with no tolerance.

Although there are no documented outbreaks caused by unlawful

pesticide residues, chronic exposure to pesticide residues that do not

conform to EPA tolerances increase risks to the public health.

Therefore, juice processors must determine whether the possible

presence of unlawful pesticide residues is a hazard that is reasonably

likely to occur.

E. FDA's Public Meeting

As a result of the October 1996 apple juice outbreak from E. coli

O157:H7, FDA held a public meeting on December 16 and 17, 1996

(hereafter referred to as the juice meeting) (see notice of meeting (61

FR 60290, November 27, 1996)), to review the current science, including

technological and safety factors, relating to fresh juices and to

consider measures necessary to provide safe fruit juices to the public.

Interested persons were given until January 3, 1997, to submit written

comments on the notice. On January 2, 1997 (62 FR 102), FDA extended

the comment period to February 3, 1997, in response to several requests

for an extension.

The purpose of the juice meeting was to provide a forum for an

information exchange on current industry practices for the production

of juice products and on developments in the science underlying the

production of safe juices. Experts from industry, academia, and the

regulatory and consumer sectors presented information on illnesses and

the epidemiology of outbreaks arising from contaminated juices;

concerns about emerging pathogens; the E. coli O157:H7 outbreak in

October 1996 caused by contaminated apple juice; procedures for

processing juices; and new and existing technology to remove or

decrease the number of pathogens or other contaminating microorganisms.

Time was available for questions and comments from all attendees.

The meeting provided an opportunity to: (1) Consider how FDA's

regulatory program for fresh juice and juice products should be

revised,(2) discuss and exchange information on relevant safety issues,

(3) to identify research needs where appropriate, (4) consider whether

additional consumer education is necessary, and (5) consider whether

other measures are needed to reduce the risk of future outbreaks of

illness from juice.

FDA received over 180 comments from industry (with a number of

these describing themselves as small businesses), consumers, consumer

organizations, trade organizations, scientific/technical companies,

academic institutions or organizations, State agencies, a local

government agency, and members of Congress. Although most of the

comments concerned apple juice specifically, many comments pertained to

juices in general, and some referred only to citrus juices. Most

comments were concerned with changes in processing to improve the

safety of juices. Among the changes suggested were requiring

pasteurization of juices, requiring HACCP, or establishing current good

manufacturing practices (CGMP's) in juice processing. The agency has

attempted to address the comments made at the meeting or submitted in

response to the Federal Register notice in this proposal. If there are

any significant concerns that the agency has not addressed, these

concerns should be brought to the agency's attention in comments on

this proposal.

The Fresh Produce Subcommittee (FPS) of the National Advisory

Committee on Microbiological Criteria for Foods (NACMCF) attended the

public meeting. The FPS met after the public meeting and made

recommendations to the NACMCF. The NACMCF subsequently met to discuss

the issues that were raised at the meeting. Based on information that

was presented at the meeting and on the FPS's expertise, the full

NACMCF made several recommendations (Ref. 53). The NACMCF stated that

there are many aspects that affect pathogen control, such as

agricultural practices; product handling; equipment used; growing

location, including produce obtained from 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 best

control mechanisms, it is important to remember that the conditions for

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microbial survival differ from those for growth. The NACMCF recognized

that, while the risks associated with specific juices vary, there are

safety concerns associated with juices, especially unpasteurized

juices.

The NACMCF concluded that: (1) The history of public health

problems associated with fresh juices indicates a need for active

safety interventions, and (2) for some fruit (e.g., oranges), the need

for intervention may be limited to surface treatment, but for others,

additional interventions may be required (e.g., pasteurization of the

juice).

The NACMCF recommended to FDA the use of safety performance

criteria instead of mandating the use of a specific intervention

technology. In the absence of known specific pathogen-product

associations, the NACMCF recommended the use of E. coli O157:H7 or

Listeria monocytogenes as the target organism, as appropriate. This

recommendation was based on the premise that these organisms are two of

the most difficult to control (i.e., by juice acidity or heat

lethality), and that, by controlling them, other pathogenic organisms

will likely be controlled. The NACMCF suggested that a tolerable level

of risk may be achieved by requiring interventions that have been

validated to achieve a cumulative 5 log reduction in the target

pathogen or a reduction in yearly risk of illness to less than

10-5, assuming consumption of 100 milliliters (mL) of juice

daily.

In addition, the NACMCF stated that HACCP and safety performance

criteria should form the general conceptual framework to ensure the

safety of juices, and that control measures should be based on a

thorough hazard analysis. The NACMCF also stated that validation of the

process must be an integral part of this framework. The NACMCF

recommended mandatory HACCP for all juice products, and that processors

should implement and strictly adhere to industry CGMP's. The NACMCF

also recommended industry education programs addressing basic food

microbiology, the principles of cleaning and sanitizing equipment,

CGMP's, and HACCP.

The NACMCF recommended further study in several areas:

(1) The efficacy of new technologies and intervention strategies

for safety;

(2) The contamination, survival, and growth of pathogens on produce

with or without breaks in skin, with or without areas of rot, and

within the core;

(3) How produce becomes contaminated with human pathogens,

including the relevant microbial ecology during production and

processing of juice. In particular, the NACMCF stated that there is an

urgent need for these types of studies on E. coli O157:H7 in apple

juice;

(4) The baseline incidence of human pathogens on fruits and

vegetables, particularly on those used in juice processing; and

(5) Labeling information needed for consumer understanding and

choice of safer juices and juice products.

On the basis of all the testimony presented at the December 16 and

17, 1996, meeting, the NACMCF agreed that there is a need to understand

the differences among all juice and juice products (e.g., citrus versus

other). A significant problem identified by the NACMCF is that

consumers presently do not have a means to clearly differentiate

between unpasteurized and pasteurized products, and that terms used to

refer to juice products do not always have universal meanings. For

example, the term ``cider'' is perceived to be an unpasteurized product

whereas the term ``juice'' is often perceived to be pasteurized.

The NACMCF also stated that traditional heat treatments given to

juices and juice products have been designed to achieve shelf

stability, to remove water (i.e., concentration), or to affect other

quality-related factors, and that these treatments, commonly referred

to as ``pasteurization,'' are greatly in excess of a process needed to

inactivate foodborne pathogens.

Because of the lack of sufficient data to evaluate the

effectiveness of labeling statements as safety interventions or to

inform consumer choice, the NACMCF stated that it could not strongly

endorse labeling as an interim safety measure.

Although the NACMCF did not endorse labeling as an interim safety

measure, elsewhere in this issue of the Federal Register FDA is

proposing interim labeling measures for packaged juice. The agency sets

forth its reasons for proposing to adopt these measures in that

proposal.

II. Consideration of How to Address Problems

A. Current Regulation of Juice

FDA has established labeling regulations and standards of identity

for a number of juices. 21 CFR 101.30 pertains to percentage juice

declaration for beverages that contain fruit or vegetable juice. Common

or usual name regulations for nonstandardized beverages that contain

fruit or vegetable juice are found in 21 CFR 102.33. Standards of

identity are found in part 146 (21 CFR part 146) for a number of fruit

juices and beverages and in part 156 (21 CFR part 156) for tomato

juice. The standard of identity for pasteurized orange juice

(Sec. 146.140) states that ``The orange juice is so treated by heat as

to reduce substantially the enzymatic activity and the number of viable

microorganisms.'' Pasteurized orange juice must be labeled as such.

In the 1997 Food Code, FDA articulated its policy regarding

unpasteurized apple juice (Ref. 54). The code states that food

establishments (e.g., nursing homes) that serve apple juice, apple

cider, or other beverages that contain apple juice to segments of the

population that are highly susceptible to disease (e.g., the elderly)

should serve juice that has been pasteurized or that is in a

commercially sterile, shelf-stable form, in a hermetically sealed

container.

B. The Current Inspection System

Juice processors, like other food processors, are subject to

periodic unannounced, mandatory inspection by FDA. This inspection

system provides the agency with a picture of conditions at a facility

at the time of the inspection. However, assumptions must be made about

conditions at the facility before and after that inspection, as well as

about important factors beyond the facility that have a bearing on the

safety of the finished product. The reliability of these assumptions

over the intervals between inspections can create questions about the

adequacy of the system.

FDA's inspections are based, in part, upon its regulations on CGMP

in the manufacturing, packing, or holding human food in part 110 (21

CFR part 110). For the most part, these regulations set out broad

statements of general applicability to all food processing on matters

such as sanitation, facilities, equipment and utensils, processes, and

controls. HACCP-type controls are listed as one of several options

available to prevent food contamination (Sec. 110.80(b)(13)(i)), but

they are not integral to the controls outlined in the regulations.

The inspection and surveillance strategies that FDA uses ascertain

a manufacturer's knowledge of hazards and preventive control measures

largely by inference (i.e., based on whether a company's products are

in fact adulterated, or whether conditions in a plant are consistent

with CGMP). It is the manufacturer's responsibility to ensure that its

products are in compliance with the act. However, in the face of new

pathogens, such as E. coli O157:H7, and the risk of illness associated

with these pathogens, especially for children, the elderly, and

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the immunocompromised, FDA tentatively concludes that, at least for

juices, new measures to control microbial, chemical, and physical

hazards are necessary to ensure that finished products comply with the

act's standards.

C. Alternatives

Comments from the juice meeting suggested several alternatives to

ensure that juice products are safe. These alternatives are discussed

in sections II.C.1 through II.C.6 of this document along with their

impact on the current situation with juice.

1. Increased Inspection

Continuous visual inspection of juice production is not a viable

alternative because few hazards associated with juice are detectable

through visual inspection.

Another possibility is to direct significant additional resources

toward increasing the frequency of FDA's inspection of juice

manufacturers, as well as increasing the agency's sampling, laboratory

analysis, and related regulatory activities with respect to these

products. While many samples of domestic and imported juice products

are collected each year for analysis in FDA laboratories, and this

sampling is designed to represent a broad range of products and to

target known problems, the product sampled represents only a small

fraction of the total poundage of the juice products consumed in this

country. Substantially more expenditures would be needed to increase

laboratory analyses to statistically significant levels.

Even if the funds for increased FDA inspection and increased

sampling and analysis were available, this approach alone would not

likely be the best way for the agency to spend its limited resources to

protect the public health. Reliance on end-product testing involves a

certain amount of inefficiency and enormous sample sizes and testing on

a lot-by-lot basis are necessary to overcome that inefficiency.

Therefore, this option has significant limitations.

Some comments from the juice meeting stated that juice safety would

be improved through more local/State inspection rather than Federal

inspection.

FDA agrees that more local/State inspection would help to ensure

the safety of juices, particularly where because FDA lacks

jurisdiction, there is no connection between the juice products and

interstate commerce. However, FDA is not in a position to mandate that

State and local regulatory agencies conduct additional inspections with

their limited resources. Further, FDA cannot mandate that a State

ensure that a firm is complying with FDA's regulations. Therefore,

increased local/State inspection for juice is not an option upon which

FDA can rely.

2. CGMP's

Many comments from the juice meeting urged the implementation of

industry CGMP's or sanitation standards to increase the safety of

juices. Some comments provided State rules, model CGMP's, or sanitation

guidelines for FDA's consideration. Other comments stated that there is

a need for more industry education on sanitation and hygiene.

CGMP regulations have a twofold purpose: (1) To provide guidance on

how to reduce insanitary manufacturing practices and on how to protect

against food becoming contaminated, and (2) to set out objective

requirements that enable industry to know what FDA expects an

investigator to find when he or she visits a food plant (51 FR 22458 at

22459, June 19, 1986). CGMP's consist generally of broad statements on

sanitation, facilities, equipment and utensils, processes, and controls

that are of general applicability to food processing. Therefore, FDA

issuance of CGMP's for juice would be an approach that could assist

manufacturers in the production of safe juices.

FDA encourages the juice industry to use CGMP's to help ensure the

safety of their juices. As stated previously, the NACMCF recommended

that processors implement and strictly adhere to industry CGMP's.

However, the use of CGMP's alone may not be adequate to ensure that

juices are safe because of the broad based nature of CGMP's. CGMP's are

directed at plantwide operating procedures and do not concentrate on

the identification and prevention of food hazards. Therefore, the

agency tentatively concludes that CGMP's, although useful, will not be

adequate, without additional measures, to ensure the safety of juices.

3. Mandatory Pasteurization

The majority of the comments from the juice public meeting

pertained to pasteurization of juice. A number of comments urged FDA to

mandate pasteurization or other equivalent treatment of fruit juice to

ensure its safety. One person who commented reported that customers of

his apple cider had not complained about a difference in flavor when he

implemented pasteurization. One comment requested a 2-year grace period

for small businesses before implementation if pasteurization were to be

required. Another suggested that pasteurization be required for apple

cider only if CGMP's and HACCP fail. One comment suggested that

pasteurization be required only for apple juice, because of the

difficulty in cleaning apples as compared to other fruits.

However, most comments opposed mandatory pasteurization of juices

because of: (1) The expense of pasteurization equipment, (2) preference

by some consumers for the flavor of unpasteurized over pasteurized

juice, (3) the safety record of juices, and (4) degradation of

nutritional value from heat treatment. Many comments from small

businesses claimed that they would be forced to close their operations

if pasteurization were required. Some comments also stated an economic

need for the use of dropped apples (``drops''), with one recommending

the use of only hand-picked (rather than machine-picked) drops. Other

comments stated that the use of drops should be prohibited, at least in

unpasteurized juices.

FDA is aware of the significant safety advantages of pasteurizing

juice as well as of the reasons that some processors choose not to

pasteurize their products. Pasteurization is a heat treatment used to

kill the vegetative forms of specific bacteria in liquid or semi-liquid

food products. Pasteurization is an effective and proven technology to

ensure that juice does not contain pathogens. However, there may be

other methods that are equally effective. Thus, the NACMCF recommended

the establishment of safety performance criteria for appropriate target

organisms rather than the establishment of a specific intervention

technology. The NACMCF stated that safety performance criteria would be

most effective.

For example, whole oranges with an intact skin may be processed so

that pathogens on the surface of the fruit are destroyed. Because

pathogens are not reasonably likely to be present in the interior of an

orange, surface treatment could be adequate to ensure the safety of the

juice. This example illustrates that if FDA were to mandate

pasteurization, such action could have the effect of limiting the

development of new technologies that are as effective as pasteurization

in particular circumstances but less intrusive and less expensive.

Therefore, the agency tentatively concludes that relying on safety

performance criteria, as recommended by the NACMCF, is an approach

preferable to pasteurization. However, if the use of safety performance

criteria

[[Page 20455]]

does not significantly decrease the number of microbial outbreaks

caused by juice, the agency may consider adopting a regulation that

mandates pasteurization.

The agency disagrees with the comments that stated that it should

require that apple juice be pasteurized because apples can be difficult

to clean. FDA recognizes that pastuerization is a process that has been

validated to meet NACMCF's recommendations. Manufacturers may be able

to use other technologies and practices provided that their process is

validated to achieve a 5-log reduction in the target pathogen.

Therefore, reliance on safety performance criteria is a better long-

term approach because it provides for the development of new

technologies.

A number of comments at the juice meeting urged FDA to consider

alternatives to pasteurization to increase the safety of juices.

Alternatives suggested by the comments included extreme isostatic

pressure, high pressure sterilization, ultra short time-heat exchanger

processing, ohmic heating, aseptic packaging, modified atmosphere

packaging, ultrafiltration, high temperature and high pH adjustment of

wash-water, ultrahigh hydrostatic pressure, electric pulses,

electromagnetic field, pulsed light, ultraviolet (UV) water treatment,

UV treatment with photoreactivation, electron beam sterilization,

irradiation, ozonated water treatment, microbiocidal additives

(benzoate, sorbate), and pH adjustment. The comments recommended that

sanitizers or ingredients for washes include use of chlorine, chlorous

acid, chlorine with emulsifiers, trisodium phosphate, peroxyacetic

acid, peracetic acid, or dimethyl dicarbonate.

The agency agrees that there may be a number of agents that can

reduce the number of microorganisms present in juice. As the NACMCF

recommended, a tolerable level of risk may be achieved by interventions

that have been validated to achieve a cumulative 5 log reduction in the

target pathogens or a reduction in yearly risk of illness to less than

10-5, assuming consumption of 100 mL of juice daily.

However, the NACMCF did not specify the manner in which this risk

reduction should be accomplished, only the target that must be reached.

In section IV.M of this document the agency will discuss its proposed

approach as to how this performance standard will apply to juice.

4. Labeling

A number of comments suggested that labeling to distinguish

pasteurized from unpasteurized juice would enable consumers to make an

informed choice. One of the comments requested warnings to those ``at-

risk,'' one urged the publication of warnings in the newspaper, and

another wanted labeling with no warning. Rather than labeling, one

comment suggested point of sale information. One comment urged FDA not

to require labeling to distinguish pasteurized from unpasteurized

juices.

The NACMCF recommended research on labeling information needed for

consumer understanding and choice of safer juice products. The NACMCF

concluded that, while the risks associated with specific juices vary,

there are safety concerns associated with juices generally, especially

unpasteurized juices.

Labeling whether a product is pasteurized or unpasteurized is

useful information that the agency encourages processors to place on

labels. However, such labeling would not inform purchasers of

unpasteurized product that children, the elderly, and the

immunocompromised are ``at-risk'' from consuming the product. Without

effective consumer education, the label statements ``pasteurized'' and

``unpasteurized'' are likely to have relatively little meaning to

consumers and could even cause confusion because some consumers might

select unpasteurized juice, considering it more ``healthy'' because it

is less processed. Finally, a labeling requirement that focuses only on

whether a product is pasteurized or unpasteurized does not take into

account technologies other than pasteurization that are adequate to

control pathogens, and, thus, such a requirement could be viewed as

restricting the development of new technologies.

The agency outlined interim measures in a notice published August

28, 1997 (62 FR 45593), and elsewhere in this issue of the Federal

Register, FDA is issuing a proposal on labeling for packaged juice.

These labeling measures attempt to provide information on the risks

that juice that has not been processed to control for pathogens poses

to children, the elderly, and the immunocompromised. The agency is

proposing that the labeling measures be superseded when these juice

products are processed under adequate HACCP programs or are otherwise

processed to destroy pathogens (e.g., pasteurization).

It is possible for firms that manufacture juice to control for

pathogens. Labeling a product to alert consumers to possible harmful

effects from its consumption must not substitute for a manufacturer

adequately addressing those concerns during processing. FDA is

reluctant to rely on labeling as a safety measure and does so only when

its analysis of the countervailing factors reveals that, on balance,

labeling provides the most reasonable approach to protecting the public

health. Juice is a product that is typically consumed by children, as

well as adults. Therefore, FDA tentatively concludes that, for juice,

manufacturers need to implement controls for pathogens to ensure that

their products are safe and not rely solely on labeling, except as an

interim measure. FDA requests comment on this tentative conclusion.

5. Education

Other comments from the juice meeting suggested that education

would increase the awareness associated with the safety of juices and

of all foods. Some comments suggested that more industry education or

training was needed. Other comments wanted more consumer education,

especially for those at highest risk from foodborne disease.

The NACMCF recommended that the industry be educated on basic food

microbiology, the principles of cleaning and sanitizing equipment,

CGMP's, and HACCP. FDA agrees that industry education can serve a

valuable role in controlling potential food hazards and encourages the

industry to take an active part in educating its employees and

utilizing up-to-date technologies. The agency will assist the industry

in its education effort.

Concerning consumer education, the agency has launched several

initiatives to inform consumers about the potential hazards presented

by juice to at-risk individuals (see 62 FR 45593, August 28, 1997).

However, no matter how extensive a consumer education initiative the

agency undertakes, it is doubtful that consumer education will reach

all at-risk consumers. Therefore, consumer education alone will not be

adequate to inform the at-risk population of the potential hazards of

consumption of juice that has not been processed to control pathogens.

Given that effective processing methods are available, primary reliance

needs to be placed on them to ensure the safety of juice.

6. The HACCP Option

Many of the attendees at the juice meeting urged FDA to mandate

HACCP for juice processors, whereas others were opposed. A number of

the attendees urged use of CGMP's together with HACCP. Some attendees

at the juice meeting recommended that microbiological criteria or

performance

[[Page 20456]]

standards be used in addition to HACCP, with two suggesting a 5 log

reduction for E. coli O157:H7.

The NACMCF concluded that HACCP and safety performance criteria can

provide the general conceptual framework needed to ensure the safety of

juices, and that validation of the HACCP plan for the juice process

(i.e., ensuring that the process is adequate to control hazards) must

be an integral part of this framework. The NACMCF stated that

processors should establish HACCP control measures based on a thorough

hazard analysis.

HACCP is a preventive system of hazard control that places the

responsibility for identifying safety problems with the manufacturer.

Use of the HACCP system means that a firm is engaged in continuous

problem prevention and problem solving, rather than relying on facility

inspections by regulatory agencies or consumer complaints to detect a

loss of control. HACCP provides for real time monitoring to assess the

effectiveness of control. A HACCP system put in place by a manufacturer

for a particular facility is unique and must reflect the type of juice,

its method of processing, its packaging, the facility in which it is

prepared, and the intended consumers.

As discussed previously, there is sufficient evidence to

demonstrate that there are significant problems with the presence of

pathogens in some juice products. Pathogens in juice can be controlled

by heat treatment. However, there may be other treatments that meet the

same performance standard that are equally effective (e.g., multiple

barriers, surface treatment of intact fruit). The use of a HACCP system

provides flexibility to a processor to use alternative pathogen control

methods and, thus, encourages the development of new technologies but

does not dictate either their development or use. Moreover, not only is

HACCP effective in controlling microbiological hazards, it also is

effective in preventing chemical and physical hazards. Thus, HACCP is

particularly well-suited for the juice industry given, as discussed

previously, the range of hazards that must be addressed in processing

juice.

The agency agrees with the comments that urged use of CGMP's

together with HACCP. CGMP's form the foundation upon which a HACCP

system is built. Therefore, CGMP's are integral to the HACCP approach.

Because there are significant concerns with the microbial safety of

juices, HACCP systems must control pathogens. As will be discussed in

section IV.M of this document, FDA is proposing a 5 log reduction in

target pathogens, as the NACMCF recommended, as a necessary step in a

HACCP plan for juice. Validation of a HACCP system must ensure that the

process that is employed is adequate to control the relevant pathogens,

in addition to chemical and physical hazards. Validation of performance

standards consists of determining the ability of the pathogens in

question to resist acid and other chemical or heat treatment and the

ability of the process applied to overcome that resistance. The agency

requests comment on this approach to safety performance criteria. FDA

also requests comment on the benefits of requiring a general HACCP

approach as opposed to those of specifically requiring pasteurization.

7. Alternative Approach

An alternative approach to mandating HACCP would be to draw a

distinction between untreated apple cider and all other juices.

Manufacturers of apple cider would be provided a permanent option

choosing between labeling or implementing a HACCP program with a 5-log

pathogen reduction. All juices other than untreated apple cider would

be provided a permanent option of choosing between labeling,

implementing a HACCP system, or achieving a 5-log pathogen reduction as

discussed in section M of this document, entitled ``Pathogen

Reduction.'' The agency requests comments on this alternative approach

to a mandatory HACCP program.

D. Decision to Propose HACCP

The evidence discussed in section I.A of this document shows that

juices have been a vehicle for pathogens that have caused a number of

foodborne illnesses. Pathogens can be controlled through heat

treatment. Information set forth in sections I.B and I.D of this

document, however, demonstrates that there are many hazards that can

occur with juice and juice beverages that cannot be controlled through

heat treatment. Although not all of the problems discussed in section I

of this document are caused by hazards that could be considered

reasonably likely to occur in many juice operations, through the use of

HACCP programs, a firm can evaluate its process to determine if the

problem could have been controlled.

As discussed in section I.E of this document, the NACMCF stated

that HACCP and safety performance criteria can form the general

conceptual framework needed to ensure the safety of juices. FDA has

evaluated each of the seven alternatives that have been suggested for

dealing with the problems with juice. While the agency finds that these

alternatives are by no means mutually exclusive, FDA has tentatively

concluded that a preventive system, such as HACCP, appears to offer the

most effective way to control the significant microbial hazards, along

with other hazards, that have become a problem with juice.

Increased inspection, while having some beneficial impact on the

safety of juices, is resource intensive to the agency. Even if funds

were available to the agency for this purpose, increased inspection

would likely not be the best way for the agency to utilize its

resources to protect the public health. It is ultimately the

responsibility of manufacturers to ensure that their products are safe.

A preventive approach, such as HACCP, on the other hand, enhances a

processor's ability to make safe products because HACCP concentrates on

examining all aspects of production, identifying hazards that are

reasonably likely to occur in that production process, and establishing

measures that will control or minimize those hazards. HACCP also

enhances FDA's inspections because it allows the agency to inspect the

production facility more efficiently and then to verify that the firm

is operating in accordance with the firm's HACCP plan, and it provides

some assurance that any problems that have occurred have been

identified and appropriately addressed.

CGMP's, the second alternative to HACCP, are plantwide operating

procedures. Although FDA supports the use of CGMP's, it tentatively

concludes that use of CGMP's alone would not be sufficient to control

the problems with juices because CGMP's do not concentrate on the

identification and prevention of food hazards. Nonetheless, CGMP's are

necessary to provide the foundation on which a HACCP system is built.

Therefore, the agency tentatively concludes that, while CGMP's are

important to a HACCP system, they are not an adequate alternative to

HACCP.

Mandating pasteurization, the third suggested alternative to HACCP,

would reduce many microbial hazards in juices but would eliminate the

incentive to develop alternative methods (e.g., use of multiple

barriers, surface treatment of fruit) that can accomplish the same

purpose. FDA does not want to limit innovative approaches to achieving

food safety. HACCP, on the other hand, allows and encourages firms to

explore more technologically efficient and more cost-efficient ways of

managing all of the hazards that they face. Moreover, pasteurization

only controls microbial hazards. HACCP systems can control all

[[Page 20457]]

food hazards that are reasonably likely to occur.

Labeling was also suggested as an alternative. FDA acknowledges

that, from a public health protection standpoint, there are certain

advantages to labeling. Elsewhere in this issue of the Federal

Register, FDA is proposing to require certain labeling, in the form of

a warning statement, for packaged juice products that have not been

processed to control, reduce, or eliminate pathogenic microorganisms

that may be present in such juices. Such labeling will serve to reduce

the risk of foodborne illness. However, such reduction will occur only

to the extent that consumers read and understand the labeling.

Accordingly, the agency has tentatively concluded that mandating HACCP

for most juice products will provide more comprehensive public health

protection by greatly reducing the number of juice products that

contain dangerous pathogens.

Importantly, manufacturers do have the ability to process juice to

control pathogens. Labeling a product to alert consumers to possible

harmful effects from its consumption is not a substitute for a

manufacturer adequately addressing those concerns during processing.

Juice is a product consumed by children, as well as by adults. FDA is

reluctant to rely on labeling as a safety measure and does so only when

its analysis of the countervailing factors reveals that, on balance,

labeling provides the most reasonable approach to protect the public

health. Here, a situation in which HACCP offers a real long-term

solution to controlling, if not eliminating, hazards in juice, the

agency tentatively believes that labeling is not a reasonable long-term

approach. The agency is soliciting comment on the appropriateness of

this tentative conclusion.

The fifth alternative to HACCP that was suggested is education.

Industry education can play a valuable role in the production of safe

juices. Consumer education can play an important part in consumer

purchasing choices. However, education is only effective if people

understand and use the information conveyed. Moreover, even an

extensive education program may not reach all consumers. Conversely,

mandatory HACCP would ensure that industry produces safe juice, and

that the product that reaches consumers is safe.

For the foregoing reasons, FDA has tentatively concluded that HACCP

represents the appropriate system of controls that is necessary for

producing safe juice products. Therefore, FDA is proposing to add part

120 to its regulations to establish procedures for implementing HACCP

systems for fruit and vegetable juices. As the agency did with seafood,

it is proposing to issue these HACCP regulations under various sections

of the the act, including, most significantly, 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 that a food is adulterated if

it bears or contains any poisonous or deleterious substance that may

render the food injurious to health. Section 402(a)(4) of the act

states that a food is adulterated if it has been prepared, packed, or

held under insanitary conditions whereby it may have been contaminated

with filth, or whereby it may have been rendered injurious to health.

It is important to recognize that section 402(a)(4) of the act

addresses conditions that may render a food injurious to health, rather

than conditions that have actually caused the food to be injurious (see

United States v. 1,200 Cans, Pasteurized Whole Eggs, etc., 339 F. Supp.

131, 141 (N.D. Ga. 1972)). The question is whether the conditions under

which the food is processed and held are insanitary and may render the

food injurious to health. The agency tentatively finds that, if a

processor of juice products does not incorporate certain basic controls

into its procedures for preparing, packing, and holding food, it is

operating under insanitary conditions that may render the juice that is

produced injurious to health and, therefore, adulterated under the act.

Section 701(a) of the act authorizes the agency to adopt regulations

for the efficient enforcement of the act.

The legal basis for mandating HACCP systems for juice processors is

the same as that for seafood. Additional discussion of the legal basis

is set out in the proposed rule (59 FR 4142 at 4150, January 28, 1994)

and final rule (60 FR 65096 at 65098) for fish and fishery products.

E. Notice of Intent

FDA published a notice of intent on August 28, 1997 (62 FR 45593),

that announced a comprehensive program to address the incidence of

foodborne illness related to consumption of fresh juice and to address

ultimately the safety aspects of all juice products. The agency invited

comment on the appropriateness of its strategy to: (1) Initiate

rulemaking on a mandatory HACCP program for some or all juice products,

(2) propose that the labels and labeling of some or all juice products

not specifically processed to prevent or eliminate the presence of

harmful bacteria bear a warning statement informing consumers of the

risk of illness associated with consumption of the product, and (3)

initiate several educational programs to minimize the hazards

associated with fresh juice. The agency stated that it would consider

comments received within 15 days of publication of the notice prior to

publication of any proposed rule.

Some comments on the notice suggested that FDA mandate HACCP only

for fresh juice processors. One comment stated that HACCP should be

mandated only for firms that process large quantities of fresh juice.

Other comments supported mandatory pasteurization or equivalent

treatment of juice, especially apple cider. One comment added that

pasteurization and use of CGMP would preclude the need for the

mandatory use of HACCP.

In section II.D of this document the agency has already discussed

its reasons for proposing HACCP. The illnesses discussed in sections

I.A and I.B of this document did not pinpoint problems related solely

to fresh juice processors or to the amount of fresh juice that a firm

produced. The comments have not provided any new information to alter

the agency's tentative conclusion that HACCP is necessary to ensure the

safe production of juice. However, FDA requests information on whether

there are categories of juice that should be excluded from the proposed

regulation.

FDA has reviewed all of the comments received within 15 days of

publication of the notice and has determined that the comments provided

no information that would cause the agency to conclude that this

proposal is inappropriate. The agency has attempted to address these

comments to the extent that they are relevant to this proposal. All

comments received in response to the notice that address the issues in

this proposal will be considered either in this proposal or in any

final rule published in response to this proposal.

F. Fresh Produce Guidance

FDA, working with the U.S. Department of Agriculture (USDA) and the

agricultural community, has developed voluntary good agricultural

practice (GAP) and GMP guidance for fruits and vegetables that has been

issued in draft for comment. The guidance, which is a science-based

evaluation of risks, will address potential food safety problems

throughout the food production and distribution system such as

sanitation, worker health, and water quality. This voluntary guidance

can be used by both domestic and foreign fresh fruit and vegetable

producers to help ensure the safety of their produce.

[[Page 20458]]

III. The HACCP System

The HACCP concept is a systematic approach to the identification

and assessment of the risk (likelihood of occurrence and severity) of

biological, chemical, and physical hazards from a particular food

production process or practice and the control of those hazards. HACCP

is a preventive strategy for food safety. Under it, the food producer

develops a plan that anticipates and identifies the points in the

production process where a failure would likely result in a food hazard

being created or allowed to persist. These points are referred to as

critical control points (CCP's). Under HACCP, identified CCP's are

systematically monitored to ensure that critical limits (CL's) are not

exceeded, and records are kept of that monitoring. Corrective actions

are taken when control of a CCP is lost, including proper disposition

of the food produced during that period, and these actions are

documented. The effectiveness of HACCP is also systematically verified

by the processor.

HACCP has been endorsed by the NACMCF as an effective and rational

means of ensuring food safety. HACCP also is recognized in the

international food safety community as the state-of-the-art means to

ensure the safety and integrity of food. In particular, the Committee

on Food Hygiene of the United Nations' Codex Alimentarius Commission

(Codex) has endorsed the HACCP concept as a worldwide guideline. The

European Union (EU) and other countries around the world have begun to

require that foods produced within their borders be processed in a

HACCP system. HACCP also is required for shipment of some foods (e.g.,

seafood) into EU countries.

A. Five Preliminary Steps of HACCP

The NACMCF recommends a process for developing a HACCP system that

includes: (1) Assembling a HACCP team, (2) describing the food and its

distribution, (3) identifying the intended use and consumers of the

food, (4) developing a flow diagram, and (5) verifying the flow diagram

(Ref. 55). These steps have been identified by the NACMCF as the ``five

preliminary steps'' of HACCP. Although the agency is not proposing to

mandate that processors use these preliminary steps, processors will

greatly benefit from using these preliminary steps in developing their

HACCP systems. The NACMCF advises that the preliminary tasks should be

accomplished before the application of HACCP principles to a specific

process (Ref. 55).

B. The Seven Principles of HACCP

The NACMCF has developed the following seven principles that

describe the HACCP concept:

1. Conduct a Hazard Analysis

The first step in the establishment of a HACCP system for a food

production process or practice is the identification of the hazards

associated with the product. The NACMCF defines a hazard as a

biological, chemical, or physical factor that may cause a food to be

unsafe for consumption. The hazard analysis step should include not

only a written identification of the hazard but a written assessment of

the likelihood that the hazard will occur and its severity if it does

occur. This analysis should also involve the identification of CCP's

along with control measures for each identified hazard.

2. Determine the CCP's

A CCP is a point, step, or procedure at which control can be

applied, so that a potential food hazard can be prevented, eliminated,

or reduced to acceptable levels. Points in the manufacturing process

that may be CCP's include heat treatment, chilling, specific sanitation

procedures, product formulation control, prevention of cross

contamination, and certain aspects of employee and environmental

hygiene.

3. Establish Critical Limits

This step involves establishing parameters that must not be

exceeded for each control measure associated with a CCP. Critical

limits (CL's) can be thought of as boundaries of safety for each CCP

and may be set for control measures such as temperature, time, physical

dimensions, moisture level, water activity, pH, and available chlorine.

A CL is used to distinguish between safe and unsafe operating

conditions at a CCP. For example, the minimum temperature and time

combination that will kill pathogens in a heat treatment step is the CL

for that CCP.

4. Establish Monitoring Procedures

Monitoring is a planned sequence of observations or measurements to

assess whether a CCP is under control (i.e., operating within its CL)

and to produce an accurate record of the monitoring for use in future

verification procedures. An unsafe food may result if a process is not

properly controlled and a deviation occurs. Because of the potentially

serious consequences of a CL deviation, monitoring procedures must be

effective. Continuous monitoring is possible with many types of

physical and chemical methods. When it is not possible to monitor a CL

on a continuous basis, monitoring intervals must be established that

are frequent enough to permit the manufacturer to determine whether the

step/process/procedure designed to control the hazard is working.

5. Establish Corrective Actions

While the HACCP system is intended to prevent deviations in a

planned process from occurring, total prevention can rarely, if ever,

be achieved. Therefore, there needs to be a corrective action plan in

place to fix or correct the cause of the deviation to ensure that the

CCP is brought under control, to ensure that there is appropriate

disposition of any food produced during a deviation, and to ensure that

records are made of the corrective actions taken. Out of control

situations should be used to identify opportunities for improvement of

the process to prevent future occurrences.

6. Establish Verification Procedures

This process involves the application of methods, procedures,

tests, and evaluations, other than monitoring, to determine the

adequacy of, and compliance with, the HACCP system. The major infusion

of science in a HACCP system centers on proper identification of the

hazards, CCP's, and CL's and the institution of proper verification

procedures.

7. Establish Recordkeeping and Documentation Procedures

This principle requires the preparation and maintenance of written

HACCP records that list the hazards, CCP's, and CL's identified by the

firm, as well as the monitoring, recordkeeping, and other procedures

that the firm intends to use to implement the system. This principle

also requires the maintenance of records generated during the operation

of the HACCP system.

C. History of the Use of HACCP

1. HACCP for Fish and Fishery Products

On December 18, 1995, FDA published a final rule in the Federal

Register (60 FR 65096) on procedures for the safe and sanitary

processing and importing of fish and fishery products (part 123 (21 CFR

part 123)) (seafood final rule). The regulations require that seafood

processors develop, implement, and document sanitation control

procedures and mandate the application of HACCP principles to the

processing of seafood. The effective date for the seafood final rule

was December 18, 1997.

[[Page 20459]]

The regulations proposed herein are based on the seafood final rule

with some modification to reflect the differences between seafood and

juice products and to reflect recent developments in the application of

HACCP. An extensive administrative record was compiled in the seafood

proceeding. FDA is incorporating that record as support for the current

proposal. Although the regulations proposed herein differ in some

aspects from part 123, they are not intended to supersede or otherwise

alter the seafood final rule.

2. Advance Notice of Proposed Rulemaking for the Development of HACCP

for the Food Industry

In the Federal Register of August 4, 1994 (59 FR 39888), FDA

published an advance notice of proposed rulemaking (ANPRM) requesting

public comment about whether and how the agency should develop

regulations that would establish requirements for a new comprehensive

food safety assurance program, based on HACCP, for both domestically

produced and imported foods. The agency stated its tentative view that,

if such regulations were issued, they would enhance FDA's ability to

ensure the safety of the U.S. food supply. FDA requested comments on a

number of specific issues, as well as on all aspects of such a food

safety program.

3. HACCP Pilot Programs

In addition to the ANPRM, FDA also published in the Federal

Register on August 4, 1994 (59 FR 39771), a notice announcing that it

intended to conduct a pilot program in which volunteers from the food

manufacturing industry would use a HACCP system that FDA would audit.

The pilot program was intended to provide information that FDA could

use in deciding whether to propose to adopt regulations and in

developing and implementing a regulatory system in which food

manufacturers are required to perform the food safety aspects of their

operations based on HACCP principles. In the notice, FDA invited

individual firms that wished to participate in the program to submit

letters of interest. Approximately 50 firms expressed initial interest

in participating in the pilot program, and 11 firms were selected to

participate. In 1997 FDA completed the pilot program at six firms and

published a second interim report.

4. HACCP for Meat and Poultry

On July 25, 1996, USDA published a final rule (61 FR 38806) that,

among other things, required that each meat and poultry establishment

develop and implement written sanitation standard operating procedures

(Sanitation SOP's) and a system of HACCP controls designed to improve

the safety of their products. The effective date for the Sanitation

SOP's was January 27, 1997, and for the HACCP regulations was January

26, 1998. FDA has reviewed the meat and poultry HACCP regulations and

has incorporated portions of them as appropriate in the proposed HACCP

regulations for juice.

D. Issues from the ANPRM

FDA received approximately 150 comments in response to the August

4, 1994, ANPRM. The comments represented the views of consumers,

consumer organizations, health professionals, academicians, food

industry officials, trade associations, and foreign, State, and local

government agencies. The agency has attempted to address these comments

to the extent that they are relevant to this proposal.

1. The agency asked in the ANPRM how the responsibility for food

safety should be shared between the food industry and government.

Comments generally agreed that the food industry is responsible for

producing safe food products. All respondents on this issue recognized

that the Government's role is to verify industry compliance with any

applicable safety regulations.

FDA agrees that it is the manufacturer's responsibility to ensure

that the food that it produces is safe, and that it is the Government's

role to verify that manufacturers are fulfilling their responsibility.

Through use of a HACCP system, both the firm and FDA are able to better

fulfill their roles. The proposed regulation in part 120 underscores

the division of roles. Under the proposed regulation, industry is

charged with examining all aspects of production, identifying hazards

that are reasonably likely to occur, and establishing measures that

will control or minimize those hazards. HACCP records enable the agency

to inspect the production facility more efficiently and to verify that

the firm is operating in accordance with its HACCP plan. They also give

the agency insight into whether any problems that have occurred have

been identified and appropriately addressed.

It is important that the juice industry focus on its responsibility

to produce safe food. Recent outbreaks evidence that some members of

the industry have not kept up with the need to evaluate the hazards

presented by juice and to design processes to address those hazards.

Firms need to be aware of the emerging problems presented by their raw

materials and to decide whether, and if so what, steps are necessary to

address these problems. Firms may decide that it is necessary to

incorporate a step designed to kill bacteria into their process (e.g.,

pasteurization), that there are alternative steps that they can take to

ensure the safety of their products, or that, given the nature of the

raw materials, no steps are necessary. Firms also need to monitor the

process that they decide to employ to ensure that it is functioning

adequately and appropriately. FDA notes that some firms have already

addressed food safety concerns and have implemented HACCP systems.

Moreover, given the heightened concerns about these products,

Government needs to be in a position to fulfill its role of verifying

that industry is doing its job. Given the sporadic and variable way in

which the problems that have been associated with juice arise, sampling

and end-product testing of juice products will not enable it to do so.

Other steps that will give Government insights into the production

itself appear to be in order.

2. FDA requested comment in the ANPRM about the likelihood of

occurrence of a hazard that would warrant HACCP-type control.

Generally, the comments consistently identified two features that would

characterize a properly formulated definition of likelihood: Processing

conditions and nature of hazard. The majority of comments offered by

the food industry stipulated that the necessary condition for

likelihood of occurrence of the hazard appropriate to trigger HACCP

control must not be speculative, as in worst-case scenarios, but be

real, practical, and intrinsic to the processing or hazards

demonstrably present for specific commodities. Several responses

recommended that the question be referred to broadly based expert

panels to establish the likelihood of risk.

According to the NACMCF, each potential hazard is evaluated based

on the severity of the potential hazard and its likely occurrence (Ref.

55). Severity is the seriousness of the consequences of exposure to the

hazard. Considerations of severity (e.g., impact of sequelae and

magnitude and duration of illness or injury) can be helpful in

understanding the public health impact of the hazard. Likelihood of

occurrence of a hazard is generally judged based on processing

experience, epidemiological data, and information in the technical

literature.

The agency agrees with the comments that stated that the processing

conditions and the nature of the hazard are key elements in assessing

the

[[Page 20460]]

likelihood of a hazard occurring. It would be futile for processors to

attempt to control for every theoretical hazard because doing so would

entail assessing hazards that the processor could not reasonably

anticipate would actually occur. The assessment of the likelihood of

risk of illness or injury to consumers should be practical for the

specific commodity and not be speculative. For example, use of

pesticides on fruits and vegetables is a common practice while these

foods grow. The presence of pesticides on fruits or vegetables used to

make juice is considered a hazard if: (1) The pesticide is not approved

for use on the fruit or vegetable, or (2) it is found in amounts above

its EPA established tolerance. If a pesticide is applied to fruits or

vegetables in conformance with EPA regulations, and the appropriate

period of time has elapsed between application and harvest, the

presence of the pesticide is not considered to present a hazard that is

reasonably likely to occur.

The agency disagrees that it should rely on broadly based expert

panels to establish likelihood of occurrence of a hazard. Although such

committees could provide insight into the issue, on balance, the

insights that they would be likely to provide would not justify the

expenditure of resources that convening such committees would require.

However, interested persons are welcome to consider voluntarily the

question and to submit the results of their consideration to the

agency.

3. Comments on the ANPRM stated that because epidemiological

studies consistently show that microbial pathogens are the most

significant source of food hazards, issues such as pesticides, heavy

metals, filth, physical contaminants, and others pale by comparison

with the immediate health consequences of foodborne microbial

pathogens. They stated that HACCP is best suited for preventing

microbial hazards rather than physical or chemical hazards because CCP

monitoring can be readily established in a timely fashion for pathogens

and, particularly, for the unsanitary conditions that promote their

growth.

The comments added that effects that result from events that occur

after the food has left the processor's HACCP system are not

controllable by the processor. The comments said that this fact is

significant because food service establishments and the lack of

consumer education have contributed to the majority of incidences of

foodborne illness reported in current epidemiological data. They stated

that HACCP systems are essentially localized management tools that will

not permit any measurable improvement in national or international food

safety effectiveness and have been implemented voluntarily solely as a

corporate practice to provide strategic business advantages in

increasingly competitive markets.

The comments stated that regulation may be premature because of the

adequacy and feasibility of presently available analytical tests to

control all hazards. They stated that, consequently, HACCP is an

excellent tool but only in the very specific case of high-risk food

processing that is focused on controlling microbiological risks. The

comments stated that, instead of misdirecting its efforts, FDA needs to

look to itself to reinforce food preparation safety awareness at food

service establishments and to pursue vigorously an enhanced consumer

education policy on unsafe food practices as the best preventative food

risk control program.

FDA agrees that microbial hazards are a significant source of food

hazards. FDA also agrees that HACCP is an ideal mechanism to deal with

microbial hazards because it is a system of prevention. Prevention

makes up for the inadequacies of end-product testing. For example, for

maximum quality, nonshelf stable juice must be distributed quickly, and

end-product testing usually takes at least several days to obtain

results. If pathogens are discovered in the juice after distribution,

the product must be recalled, and consumers may have already ingested

product. Finally, the particular samples taken in end product testing

may not contain pathogens because the pathogens may not be ubiquitous

in the lot (i.e., there may be low level or sporadic contamination) and

thus produce false negatives.

A system of preventive controls, like HACCP, on the other hand, is

designed to identify and manage conditions where pathogens could be

present in juice while it is still being processed. HACCP is designed

to ensure that there is early discovery, and timely correction, of any

problems that may develop. Although HACCP is well suited for preventing

microbial hazards, this does not mean, as some of the comments

asserted, that it is not useful for other types of hazards. As the

NACMCF has recognized, it is well suited for preventing chemical and

physical hazards. For example, processors can establish CCP's to

prevent pieces of glass from contaminating a product when glass bottles

are used.

The NACMCF endorses HACCP as an effective and rational means of

assuring food safety (Ref. 55). According to the NACMCF, its use will

likely result in measurable improvement in food safety. Under HACCP,

processors view the processing plant from a prevention perspective and

thus are in a position to react appropriately to new hazards if they

arise. In preparing this proposal, FDA has reviewed the history of

juice related outbreaks. All of these outbreaks might have been

prevented if a HACCP system of the type that FDA is proposing herein

had been in use.

The agency agrees that there are hazards that can occur after food

has left the processing plant that the processor cannot control. The

agency has established the Food Code to assist State agencies and food

workers in retail food establishments and has addressed handling of

high risk foods in the Food Code. FDA also provides consumer

information on food safety through a consumer hotline, public affairs

specialists in FDA's district offices, and various brochures and other

publications. These efforts are intended to educate consumers on safe

handling of foods at home. In addition, as described in the interim

notice, the agency has initiated a consumer education program

concerning juice that is not treated to prevent or eliminate the

presence of harmful bacteria.

4. The agency requested information in the ANPRM on its possible

role in assisting the food industry in the development of HACCP plans.

Comments stated that FDA preparation of general background materials on

HACCP would be beneficial in establishing a common approach to plan

development, in assisting hazard identification analysis, and in using

consistent language. They stated that FDA could provide informational

resources such as examples of HACCP plans adaptable to the individual

circumstances of a business' operations or consultative documents that

could serve to guide plan development.

However, some comments urged that FDA avoid over-regulation. They

stated that an excessively ambitious regulatory approach will limit the

effectiveness of any HACCP program.

The agency agrees that it should avoid over-regulation because such

an approach can inhibit future developments and new technology in HACCP

systems and in safe food processing. FDA is proposing a HACCP

regulation that, if adopted, will be mandatory for juice processors (as

defined at proposed Sec. 120.3(i)) but that can be used as a model for

other foods in that it outlines the minimum essential components of a

HACCP system. To the extent possible, the proposed regulation is in

harmony with

[[Page 20461]]

the existing HACCP regulations for seafood and meat and poultry.

FDA has developed the ``Fish & Fisheries Products Hazards &

Controls Guide'' to assist manufacturers in the implementation of HACCP

for seafood. The Federal Safety and Inspection Service (FSIS) has

developed, in conjunction with the International Meat and Poultry HACCP

Alliance, 13 HACCP models for meat and poultry products, a ``Guidebook

for the Preparation of HACCP Plans,'' and the ``Meat and Poultry

Products Hazards and Control Guide.'' However, it is not clear whether

FDA will be able to provide such detailed information for juice.

Therefore, in this rulemaking, the agency will attempt to provide

guidance, to the extent possible, concerning the application of the

regulation to juice.

5. Some comments on the ANPRM stated that, if EPA tolerances for

pesticides in agricultural commodities become HACCP-focused safety

issues in food processing and service industries, then explicit

coordination by FDA with EPA is needed to define truly significant

hazards. They stated that this effort would greatly assist HACCP

development in such circumstances, so that duplication of effort would

be avoided, consistency among regulatory requirements would be

achieved, and impediments to international commerce would be removed.

FDA has attempted to harmonize its regulations with those of other

Federal agencies and with Codex. EPA establishes regulations for

pesticide use and tolerances for pesticide residues, and FDA and USDA

enforce those tolerances on foods.

Under section 402(a)(2)(B) of the act, a food is deemed to be

adulterated if it bears or contains a pesticide chemical residue unless

a tolerance or an exemption for such pesticide has been established,

and the quantity of such pesticide on the commodity is within the

tolerance limits. Pesticide chemical residues for which there is no

tolerance or exemption are deemed to be unsafe as a matter of law.

HACCP is intended to protect against unsafe products. Thus, there is no

reason why pesticide residues and similar types of food safety measures

should be outside the scope of HACCP.

6. In the ANPRM, the agency asked if there was a need for

microbiological criteria in HACCP regulations. Some comments favored

inclusion of microbiological criteria for known high risk foods because

such criteria are practical, efficient, and cost effective. However,

most comments maintained that microbiological criteria, set as national

standards, are not warranted because: (1) Criteria are discordant with

HACCP purposes because they depend on end product testing, (2) criteria

possess inadequate scientific basis, and (3) criteria are preemptive of

localized development of HACCP systems.

The agency tentatively agrees with those comments that stated that

microbiological criteria in HACCP regulations are warranted for some

foods. Contrary to what many of the comments asserted, effective

microbial controls depend not on end product testing but on processing

controls and the establishment of CL's. For example, juice made from

apples that have fallen on the ground must be processed in some manner

to destroy pathogens because pathogens are likely to be present and, as

discussed previously, end product testing may produce false negatives.

If a regulation is flexible, it should not ``preempt'' the processor's

development of HACCP, but it can provide the CL's needed for the safe

processing of food under a HACCP system. However, the agency agrees

that the decision on which processing controls are to be used must have

a valid scientific basis.

Microbial pathogens have emerged as a significant problem in

unpasteurized juice in recent years. The NACMCF recommended that safety

performance criteria, rather than a specific intervention technology,

be mandated for juice (Ref. 53). The safety performance criteria

recommended by the NACMCF is whether the measures that a juice

processor employs have been validated to achieve a cumulative 5 log

reduction in the target organisms or a reduction in yearly risk of

illness to less than 10-5, assuming consumption of 100 mL of

juice daily. As will be discussed in section IV.M of this document, FDA

is proposing to require that firms include in their HACCP plans

measures that will produce, at a minimum, a 5 log reduction in target

pathogens.

7. Comments on the ANPRM stated that FDA should require end product

testing records to provide information as to the effectiveness of a

HACCP program. These comments stated that end product testing was

practical because mandated testing was a necessary, continuing, and

recordable validation of the completeness of a HACCP system, thereby

ensuring that 100 percent control is manifested.

Comments from the juice meeting also supported the use of end

product testing. One of the these comments proposed using testing to

decide whether to pasteurize each lot. Several comments pointed to new

rapid testing technologies and testing kits for pathogens.

However, other comments maintained that information generated from

end product tests would not be useful. One comment stated that end

product testing activities were counterproductive to a well-planned

HACCP system. Furthermore, these comments added, any requirements that

FDA puts forward must be practical, and no process can be regulated

into 100 percent certainty.

The agency is not proposing to require end product testing. End

product testing is most useful where there are high levels of the

substance being tested, and there is uniformity throughout the lot

being sampled. Product sampled for testing for microbial hazards, where

a pathogen (e.g., E. coli O157:H7) is hazardous even at very low

levels, or for physical hazards (e.g., glass), where the hazard is the

presence of a discrete unit, may not contain the hazard even under the

best sampling procedure. In these cases end product testing is likely

to produce false negatives and, thus, to provide scant protection. It

is prohibitive to use end product testing adequately in these

situations because of the amount of testing that is necessary for a

statistically valid test, and because it would be necessary to channel

a significant portion of the product for that testing. Therefore, the

agency has tentatively concluded that use of control measures under a

HACCP system to prevent hazards from occurring, with subsequent

monitoring, verification, validation, and recordkeeping, is more

effective than end product testing in ensuring that food is safe. Thus,

FDA has not included a requirement for end product testing in this

proposed rule on juice products.

8. The agency asked in the ANPRM whether it should mandate HACCP

for all segments of the food industry. Many comments stated that

mandatory HACCP regulations for low-risk foods would be inappropriate

because trying to manage low risk hazards through HACCP would dilute

agency resources and therefore the effectiveness of HACCP. The comments

stated that FDA could utilize its resources most efficiently by

focusing on those high-risk food processing operations identified in

its 1993 model Food Code as ``Potentially Hazardous.'' They stated that

the U.S. food supply is already demonstrably the world's safest, so

that there is no valid reason for requiring HACCP plans of the entire

industry. The comments stated that enforcement mechanisms in the act

are, and will continue to be, sufficient without adding to the

regulatory burden on

[[Page 20462]]

industry. They added that incorporation of HACCP into food industry

operations should be permitted to proceed on a voluntary basis, unless

a well-defined need requires implementation through specific authority

provisions of the act into specific high-risk segments of the food

industry.

However, some comments stated that unless all segments of the food

chain are mandatorily included, adoption of HACCP is unlikely to result

in measurable enhancement of the safety of the food supply. They stated

that less than universal coverage would create confusion about what

should be excluded. The comments stated that any attempt to limit HACCP

to identified ``high-risk'' processors would hinder efforts to address

significant public health problems that may arise in the future. They

concluded that it is not unduly burdensome to mandate HACCP for all.

The comments maintained that HACCP regulations should be as

comprehensive as practicable and applied throughout the food chain to

the fullest extent possible and reasonable, and that HACCP principles

must be applied from farm to fork.

FDA disagrees with the comments that stated that HACCP is

inappropriate for low-risk foods. Both food processors and government

regulatory agencies would benefit from the use of HACCP systems. The

U.S.'s excellent record for having a safe food supply does not mean

that this country should not consider ways of improving on that record.

In the face of emerging pathogens and other new food hazards, HACCP

provides a flexible system in which processors reassess their

procedures on an on-going basis. HACCP also enables processors to meet

future demands.

The use of HACCP allows food processors to concentrate their

efforts on the aspects of the processes that they use where risks are

highest and provides regulatory agencies with assurance that processors

are observing prudent processing practices. HACCP also provides

assurance that problems in the process are likely to be discovered, and

that unsafe product is unlikely to leave the firm. The complexity of

HACCP is a function of the number of hazards that must be controlled

and the nature of the controls for each hazard. Foods that involve few

hazards will tend to have fewer CCP's, and, conversely, those that have

multiple hazards will tend to have more complex HACCP plans and

monitoring requirements.

FDA is proposing a regulation that will mandate HACCP for juices.

The agency has tentatively concluded that there is a safety basis to

require that processors use HACCP systems in the processing of juice.

As the agency gains experience and additional information from the

pilot program and from seafood HACCP implementation, it will examine

the appropriateness of expanding the scope of proposed part 120 (if the

agency adopts it) to include other foods. Clearly, the agency will

consider HACCP's use with foods that it has identified as presenting

likely hazards, as it is doing in this proposal.

In developing the proposed regulations for juice, FDA came to

recognize that the elements of a HACCP regulation for juice are really

no different than those for seafood. This insight suggests that part

120 can act as a model for HACCP for other parts of the food industry

should the agency become aware of facts that would justify extending

the coverage of the regulation. Firms that are interested in

voluntarily instituting HACCP can use the regulations in part 120 as a

guide for doing so.

9. The ANPRM requested information on the criteria that FDA should

use in deciding whether to cover some or all segments of the food

industry with a mandatory HACCP rule. Some of the comments stated that

exclusions cannot be justified on the basis of business size because

about 75 percent of the food industry would be considered to be small

businesses. The comments asserted that exclusions can only be judged

with respect to properly defined risks for the food hazards involved in

producing the end-product.

FDA agrees that exemptions from HACCP regulations cannot be

justified on the basis that a business is small because food hazards

that are reasonably likely to occur in the production of most foods

occur regardless of the size of the firm. The agency also agrees that

any exceptions to mandatory HACCP systems must be based on instances in

which risks are not reasonably likely to occur. However, FDA is

required by law to consider ways to assist small businesses when it

implements regulations. While FDA does not propose to exempt any small

businesses from the food safety requirements in this proposed rule, FDA

is considering ways to provide regulatory options that will serve to

reduce the burden of compliance on such small businesses.

IV. FDA's Proposal

A. Applicability

1. Scope

The agency tentatively concludes that HACCP is necessary for the

safe and sanitary production of fruit and vegetable juices to address

the special concerns discussed previously. Therefore, FDA is proposing

new Sec. 120.1(a), which states that part 120 applies to juice and

defines what juice means for purposes of this regulation.

Fruit and vegetable juices may be used as ingredients in other

beverages (e.g., flavored bottled waters; juice beverages and

cocktails). These products often resemble juices, are processed in a

manner that is similar to juices, and handled by consumers similarly to

juices. Thus, they can present the same food hazards as juices.

Therefore, FDA is proposing to require that any juice sold as such or

used as an ingredient in beverages be processed in accordance with the

requirements of part 120.

As stated in section II of this document, FDA has established

standards of identity for a number of fruit juices in part 146 and for

tomato juice in Sec. 156.145. These standardized juices are generally

described as the liquid extracted or expressed from a fruit or

vegetable. However, prune juice (Sec. 146.187) is prepared from a water

extract of dried prunes.

A typical dictionary definition of the term ``juice'' is a fluid

naturally contained in plant or animal tissue (Ref. 56). As described

above, the present situation has demonstrated a need to control food

hazards associated with fruit and vegetable juices. The present

situation does not include oil extracts of fruits and vegetables (e.g.,

olive oil) because these are not traditionally considered juice. Some

juices (e.g., banana juice) and fruit nectars, when purees of the fruit

used, need to be included in any definition FDA proposes because such

purees are often blended with other juices. If there are food hazards

associated with extractives of a fruit or vegetable, those food hazards

will be present in purees of that fruit or vegetable. Concentrates of

juice and purees also need to be included in the definition because, if

a hazard is present in the juice or puree, it could also likely be

present in the juice concentrate. Therefore, the agency is tentatively

defining ``juice'' as the aqueous liquid expressed or extracted from a

fruit or vegetable, purees of the edible portions of a fruit or

vegetable, or any concentrates of such liquid or puree.

The agency requests comments on the definition of ``juice.'' FDA

also requests comments on the scope of the regulation and on whether it

should mandate HACCP for all types of juices, or whether it would be

sufficient to mandate HACCP for certain types of juices.

[[Page 20463]]

2. Effective Date

The seafood final rule provided processors 2 years to implement

HACCP. This was done to: (1) Allow time for training of industry

personnel and regulatory personnel; (2) provide the States with the

time to have a full opportunity to understand and respond to the

effects of these regulations; (3) increase the likelihood that more

agreements with other countries will exist; (4) increase the

opportunity for processors to engage in ``voluntary'' HACCP inspections

in advance of the effective date to obtain preliminary, informal

feedback from the agency on their progress; and (5) allow incorporation

of modifications made in the final rule and publication of FDA

assistance materials for the seafood industry (60 FR 65096 at 65169).

The period of time between publication of the final rule and the

effective dates of the HACCP regulations for meat and poultry issued by

FSIS are: (1) Eighteen months for large establishments with 500 or more

employees, (2) Thirty months for smaller establishments with 10 or more

employees but fewer than 500, and (3) Forty-two months for very small

establishments with fewer than 10 employees or annual sales of less

than $2.5 million (61 FR 38806).

A comment from a fresh juice trade association submitted to the

agency in response to the NACMCF recommendations to FDA on the safety

of juices, requested that FDA mandate HACCP for all juice products and

phase this requirement in over a 3-year period from the publication of

the final rule in a manner similar to the FSIS HACCP regulation. The

comment requested that FDA consider annual inspections of fresh juice

firms until the regulation is effective. It stated that the delay in

implementing HACCP requirements would allow FDA and juice processors

the ability to review conclusions of specific research and establish

performance standards based on this research.

Comments on FDA's notice of intent (62 FR 45593) generally

supported a phased-in approach for small firms taking 3 to 4 years.

However, one comment expected that a phase-in approach would take no

more than 2 years.

The agency is considering the significant issues surrounding

orderly implementation of HACCP. FDA must balance the need for

immediate implementation of HACCP, because of its associated food

safety benefits, against the costs of implementation and consider

options to minimize the burden to small businesses. The proposed

timeframe for implementation of these regulations attempts to balance

these competing concerns. The implementation of HACCP may be more

burdensome for small firms than for large firms. Large firms tend to

have quality control personnel already in place. In addition, many

regulatory requirements are less burdensome for a large firm in

proportion to output than they are for a small firm.

FDA recognizes that HACCP systems cannot be developed and

implemented overnight. The HACCP system of controls can involve new

ways of thinking and performing on a routine basis.

The agency issued a notice on August 28, 1997 (62 FR 45593), that

provided interim measures, and elsewhere in this issue of the Federal

Register, FDA is proposing to require labeling for juice to address the

agency's immediate public health concerns. If finalized, these measures

will require labeling on juice to provide information that juice

unprocessed to control pathogens poses risks to children, the elderly,

and the immunocompromised. The agency is proposing that the labeling

measures be superseded once packaged juice products are processed under

adequate HACCP programs, or are otherwise processed in a manner to

destroy pathogens (e.g., pasteurization). Therefore, as proposed,

before the applicable effective date, juice will be processed to

control for pathogens or, if not, will bear labeling to alert consumers

that such processing has not occurred. After any applicable effective

date, processors will use HACCP systems in the production of juice.

The agency has considered the precedents established by other HACCP

regulations and the comments submitted on juice. There are two

significant differences between the HACCP regulation that FDA is

proposing for juice and the HACCP regulations for seafood and for meat

and poultry. First, FDA has issued interim guidance suggesting that

juice that has not been processed to control pathogens be labeled

accordingly. Elsewhere in this issue of the Federal Register, the

agency is proposing to require such labeling. Second, at the present

time, FDA's available resources would make it very difficult, if not

impossible, to implement a comprehensive inspection program for the

entire juice industry. A phased in approach for compliance will thus

ease the burden not only on small businesses but also on the agency

itself. Accordingly, FDA is proposing that the regulations proposed

herein generally be effective 1 year after the date of publication of

the final rule, with special provisions that will extend the phase-in

to up to 3 years after publication of the final rule. This proposed

phase-in approach will permit the regulated industry time to accomplish

the training of personnel and adjust its activities to include

necessary HACCP activities and takes into account the needs of smaller

businesses.

The agency proposes to establish a timetable for phasing in HACCP

based on business size. FDA proposes in Sec. 120.1(b) that the

effective date be 1 year following publication of the final rule. The

agency is proposing that, by its terms, the regulation will not be

binding until 2 years following the date of publication of the final

rule for small businesses employing fewer than 500 persons

(Sec. 120.1(b)(1)). This is based on the definition of a small business

used by the Small Business Administration. In addition, the agency is

proposing that, by its terms, the regulation will not be binding until

3 years following the date of publication of the final rule for very

small businesses that have either total annual sales of less than

$500,000, or that have total annual sales that are greater than

$500,000 but total annual food sales of less than $50,000, or that

employ fewer than an average of 100 full-time equivalent employees and

that sold fewer than 100,000 units of the product in the United States

(Sec. 120.1(b)(2)). These criteria are consistent with those that the

agency has used in its regulation on small firms and compliance with

the nutrition labeling rules that implement the Nutrition Labeling and

Education Act (the 1990 amendments) (61 FR 40963) (see Sec. 101.9(j)(1)

and (j)(18)) (21 CFR 101.9(j)(1) and (j)(18)). In the 1990 amendments

context, these criteria represent the outcome of three hearings in

different parts of the country, an act of Congress, and informal

rulemaking by FDA. Thus, FDA tentatively concludes that food

manufacturers agree with and understand the definition of very small

businesses. As discussed in the next section of this document, for

purposes of this proposed rule, the agency has tentatively decided that

a retail establishment as set out in proposed Sec. 120.3(h)(2)(iii)

includes a very small processor that makes juice on its premises and

directly sells this juice both to consumers and other retailers

provided that total juice sales do not exceed 40,000 gallons per year.

In implementing proposed Sec. 120.1(b)(2), FDA intends to use the

definitions for the terms ``unit,'' ``food product,'' ``person,'' and

``full-time equivalent employee'' in

[[Page 20464]]

Sec. 101.9(j)(18)(vi). These definitions are as follows: (1) ``Unit''

means the packaging or, if there is no packaging, the form in which a

food product is offered for sale to consumers; (2) ``food product``

means food in any size package that is manufactured by a single

manufacturer or that bears the same brand name, that bears the same

statement of identity, and that has similar preparation methods; (3)

``person'' means all domestic and foreign affiliates, as defined in 13

CFR 121.401, of the corporation, in the case of a corporation, and all

affiliates, as defined in 13 CFR 121.401, of a firm or other entity,

when referring to a firm or other entity that is not a corporation; and

(4) ``full-time equivalent employee'' means all individuals employed by

the person claiming the exemption. The number of full-time equivalent

employees is determined by dividing the total number of hours of salary

or wages paid directly to employees of the person and of all of its

affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,

40 hours x 52 weeks).

FDA is committed to its mission of ensuring that food is safe and

not misbranded. This commitment is the basis for proposing interim

labeling measures. The agency tentatively finds that a phase-in HACCP

implementation is necessary because of the logistical effort required

to manage a fundamental change in work processes, roles, and

responsibilities for smaller processors. The proposed implementation

schedule reflects the abilities of processors of varying sizes to

implement HACCP, and the time needed by industry to develop HACCP plans

and train employees.

Upon the proposed implementation date, processors must be ready to

operate their HACCP system, and FDA will conduct inspection activities

according to HACCP principles to ensure that the HACCP system is

operating acceptably. FDA requests comment on its proposed phased-in

implementation of HACCP.

B. Definitions

FDA is proposing in the introductory paragraph of Sec. 120.3 that

the definitions and interpretations of terms in section 201 of the act

(21 U.S.C. 321), in Sec. 101.9(j)(18)(vi), and in part 110 be

applicable to such terms when used in part 120, except where they are

redefined in Sec. 120.3.

The agency is proposing to include in Sec. 120.3 all definitions

applicable to juice that are in the seafood HACCP regulation. The

following terms have proposed definitions that are the same as their

definitions in Sec. 123.3: ``critical limit'' (Sec. 120.3(d)), ``food

hazard'' (Sec. 120.3(e)), ``importer'' (Sec. 120.3(f)), ``shall''

(Sec. 120.3(j)), and ``should'' Sec. 120.3(k)).

However, FDA is proposing to modify the term ``preventive measure''

to ``control measure'' (Sec. 120.3(b)) and to modify its definition

from that used in the seafood HACCP regulation (Sec. 123.3(i)) to

conform with recent NACMCF changes in terminology (Ref. 55). The term

``control measure'' is used because not all hazards can be prevented,

but virtually all can be controlled to some degree. The new NACMCF

definition describes the control measures as actions or activities

rather than as chemical, physical, or other factors. Further, the term

``control'' is clarified to mean prevention, elimination, or reduction

of hazards. The agency tentatively concludes that the recent NACMCF

definition better describes the measures that processors must take.

Therefore, FDA is proposing that ``control measure'' means any action

or activity that can be used to prevent, eliminate, or reduce a hazard.

The NACMCF also recently modified its definition for ``critical

control point'' (Ref. 55). The modified definition incorporates the new

definition of ``control measure'' and emphasizes the essential or

critical nature of the step. Thus, FDA tentatively concludes that the

recent NACMCF definition better characterizes the term. Therefore, the

agency is proposing in Sec. 120.3(c) that ``critical control point''

means a point, step, or procedure in a food process at which a control

measure can be applied and at which control is essential to reduce an

identified food hazard to an acceptable level.

The seafood HACCP regulation defines ``processing'' in

Sec. 123.3(k) with specific product application. To apply these

definitions to juice and to avoid listing specific processes, the

agency is proposing in Sec. 120.3(h)(1) to define ``processing'' as

activities that are conducted by a processor that are directly related

to the production of juice products.

As with the seafood HACCP regulation, there are certain handlers of

juice products that are not covered by the proposed definition. FDA has

tentatively concluded that harvesting, picking, or transporting raw

agricultural ingredients of juice products, without otherwise engaging

in processing, should not be included in the term ``processing''

(Sec. 120.3(h)(2)(i)). FDA has developed voluntary GAP guidance that

has been issued in draft for comment and will apply to these

activities. The agency believes that growers will find GAP's useful and

that the regulations that it is proposing in this rulemaking will, if

adopted, reinforce use of both FDA and specific industry GAP's, thus

affecting harvesting, picking, or transporting indirectly through

processor and importer controls over raw materials and imported

shipments (e.g., preventive controls such as the purchasing of raw

materials only from farms that engage in proper handling of produce).

The agency notes that, with FSIS, it published an ANPRM (61 FR

59372, November 22, 1996) concerning transportation and storage

requirements for potentially hazardous foods. In that ANPRM, FDA and

FSIS requested information and comments on approaches that the two

agencies should take to foster food safety improvements in the

transportation and storage of potentially hazardous foods. While juice

has not historically been considered a potentially hazardous food,

recent illnesses associated with juice necessitate reconsideration of

whether this food should not be included in that category. FSIS and FDA

are reviewing the comments received in response to the joint

transportation notice and will decide whether rulemaking is warranted.

FDA invites comment on whether its approach to transportation is

adequate.

The agency has also tentatively decided to exclude the operation of

a retail establishment from the definition of ``processing''

(Sec. 120.3(g)(2)(ii)). For purposes of this rule, the agency has

tentatively decided that a retail establishment as set out in proposed

Sec. 120.3(h)(2)(iii) includes a very small processor that makes juice

on its premises and directly sells juice to consumers and other

retailers provided that total juice sales do not exceed 40,000 gallons

per year.

FDA has traditionally refrained from directly regulating retail

establishments, although it has authority to do so. FDA provides

training and other forms of technical assistance to States and local

governments who inspect retail food establishments through the agency's

retail Federal/State cooperative program. A major part of that

cooperative program involves the development of model codes, some of

which have been widely adopted by States and local governments. FDA has

consolidated those model codes into a single, updated food code for the

retail sector. Appropriate controls are included in the food code that

can be applied to address juice hazards at retail. FDA will continue to

operate through the Federal/State cooperative mechanism and,

consequently, has not proposed to regulate juice retailers in

[[Page 20465]]

this proposal. However, elsewhere in this issue of the Federal

Register, the agency is proposing to require labeling statements for

packaged juice products including those sold by retailers that have not

been pasteurized or otherwise processed to reduce, eliminate, or

control pathogens. The proposed labeling requirement would apply to

packaged untreated juice products produced in retail establishments for

immediate consumption (such as grocery stores and very small

processors) and would serve to inform consumers of the risk of

untreated juices. (Retail processors selling unpackaged juice on-site

for immediate consumption, such as restaurants and juice bars, would be

exempt from both HACCP and labeling.) FDA notes that 2 of the outbreaks

associated with apple cider (an outbreak of E. Coli. 0157:H7 infection

and an outbreak of cryptosporidosis involving very small apple cider

mills, refs. 8, 8A, and 11) would have fallen under the retail

exclusion. Under the proposed labeling rule, the cider mills would have

been required to label their apple cider. FDA seeks comment on whether

the provisions of the food code in combination with the labeling

statements will provide adequate public health protection. In addition,

in formulating its proposal to include in the definition of retailer a

processor that sells less than 40,000 gallons per year, the agency

considered two other alternatives on which it requests comments. The

first alternative would be to subject these establishments to the HACCP

requirements and to provide a 3-year effective date. The second

alternative would be to subject these establishments to the HACCP

requirements and to provide a 5-year effective date. The agency is also

soliciting comment on the appropriateness of including these

establishments in the retail exemption as well as the appropriateness

of the other two options considered.

The agency is proposing to define the term ``control,'' even though

it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(a),

that ``control'' means to prevent, eliminate, or reduce. This

definition is consistent with the use of the term ``control'' in the

definition for ``control measure'' (Sec. 120.3(b)) and describes more

specifically what is to be accomplished in the control of food hazards.

FDA is also proposing to define the term ``monitor,'' even though

it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(g) to

define ``monitor'' as conducting a planned sequence of observations or

measurements to assess whether a process, point, or procedure is under

control and producing an accurate record of those observations or

measurements for use in verification. This definition is identical with

that of the NACMCF (Ref. 55). The agency tentatively concludes that

defining this term will assist juice processors to be aware of what

activities constitute monitoring of the various components of the HACCP

system and prerequisite programs; and comply with the monitoring and

recordkeeping requirements necessary for acceptable verification of

HACCP.

C. CGMP's

Section 120.5 of the proposed regulations references the umbrella

CGMP regulations in part 110 as providing general guidance to such

matters as facility design, materials, personnel practices, and

cleaning and sanitation procedures. Because part 110 provides guidance

of general applicability to all foods, including juice, the agency

intends that this guidance will continue to apply to juice processors

even if FDA adopts the proposed regulations in part 120.

D. Prerequisite Program Standard Operating Procedures

The available evidence, including FDA's experience with the HACCP

pilot programs, points to the effectiveness of two programs that do not

fall within the parameters of traditional HACCP. FDA will refer to

these programs in this document as ``prerequisite programs.'' The first

of these programs is that the firm have in place SOP's designed to

ensure plant sanitation.

The seafood final rule requires in Sec. 123.11 that the processor

monitor certain sanitation measures and document both the monitoring

activities and any corrective actions taken when such monitoring finds

an insanitary condition that may contribute to the likelihood of

product becoming hazardous. While seafood processors are not required

under Sec. 123.11(a) to develop and implement written sanitation or

prerequisite program SOP's, processors must maintain sanitation control

records that, at a minimum, document that certain monitoring

requirements have been met, and that corrective actions are taken when

necessary (Sec. 123.11(c)). Section 123.11(b) sets forth requirements

for sanitation monitoring.

FSIS's regulations for meat and poultry require that official

establishments develop, implement, and maintain written SOP's for

sanitation (9 CFR 416.11). Each official establishment must take

appropriate corrective action when it or FSIS determines that the SOP's

have failed to prevent direct contamination or adulteration of product

(9 CFR 416.15). Each establishment must maintain daily records that are

initialed and dated to document the implementation and monitoring of

the SOP's and any corrective actions taken (9 CFR 416.16). Finally,

FSIS verifies the adequacy and effectiveness of the SOP's (9 CFR

416.17).

Insanitary facilities or equipment, poor food handling, improper

personal hygiene, and similar insanitary conditions create an

environment in which products may become contaminated with

microorganisms, including pathogens. However, sanitation controls may

be difficult to fit into HACCP plans. Sanitation covers the whole

processing environment, not just CCP's. A prerequisite program is an

appropriate mechanism for a situation, such as sanitation, that does

not lend itself well to HACCP controls. Therefore, sanitation SOP's are

a type of prerequisite program that is essential to provide a solid

foundation for HACCP systems. The agency tentatively concludes that

sanitation SOP's are an essential foundation for HACCP systems for

juice.

The second prerequisite program is one that provides control over

materials that are entering the plant. The SOP requirements of both the

seafood and FSIS regulations are limited to sanitation. However, the

pilot program experience has suggested the utility of controls on

incoming material. A processor could use incoming material prerequisite

program SOP's, in a manner similar to the sanitation SOP's, i.e., to

cover a range of processing factors, not just CCP's. Although use of

incoming material SOP's may not obviate the need for some CCP's in a

HACCP plan, FDA anticipates that their use could help to ensure the

safety of the food produced.

Incoming material controls for raw produce could be invaluable in

establishing the conditions under which produce needs to be grown

(including pesticide application) and harvested to provide assurance to

the processor that the raw produce will not present hazards that the

processor will otherwise need to control. For example, the processor's

incoming material SOP's could specify that the processor will only

purchase carrots that have not been fertilized with manure during

growth. Another example is that the incoming material control could

specify that the processor will only accept apples that have been

picked from the tree, and that dropped apples are unacceptable. A

simple solution to control the possible

[[Page 20466]]

presence of unlawful pesticide residues on fruits and vegetables is to

establish SOP's for incoming material control that ensure that any

pesticides that have been used on the produce are approved for that

use, are used at the appropriate level, and that appropriate time has

elapsed between application and harvest.

As discussed previously, FDA is developing GAP and GMP guidance

that has been issued in draft for comment. The guidance will address

potential food safety problems throughout the food production and

distribution system such as sanitation, worker health, and water

quality.

A manufacturer also could use controls on the packaging materials

that it receives. Proper packaging is essential if a processor is to

minimize the possibility of the occurrence of hazards after juice has

been processed. Juice that is not packed in hermetically sealed

containers may be subject to contamination from a number of sources.

The processor also needs to ensure that the container coating that it

uses will not deteriorate through reasonable storage. Evidence in

section I.B of this document showed examples where the acid content of

some juices corroded the tin lining of the container, and the tin was

present in sufficient concentration to be toxic. Incoming material

controls will mean that the processor will act to ensure that packaging

materials are safe and suitable before accepting them.

Incoming material controls for ingredients that a processor may add

to juice can also be helpful. For example, if a processor is purchasing

juice or juice concentrate from a supplier for use in a multi-juice

beverage, it is essential that that juice have been processed under an

adequate HACCP system and have not been contaminated during

transportation. Thus, incoming material SOP's will lead the processor

to establish controls on ingredients as criteria for acceptance in the

plant.

However, the agency is not proposing to provide for the use of

incoming materials SOP's in part 120 at this time and requests comment

on this issue. FDA is seeking comment on whether incoming material

SOP's can be utilized in a similar relationship to the HACCP system as

the sanitation SOP's. Do interested persons see value in FDA requiring

that these SOP's be written, monitored, and verified? How do these

SOP's relate to FDA's draft guidance on fresh produce? What are

reasonable procedures for acceptance of incoming materials that could

be incorporated into SOP's?

1. Sanitation SOP's

FDA is proposing in Sec. 120.6(a)(1) to require that processors

have and implement SOP's that address sanitary conditions and practices

before, during, and after processing. Good sanitation practices are

critical to the prevention of microbiologically related foodborne

illnesses. FDA's CGMP regulations for food in part 110 set out general

principles of sanitation that should be followed in plants that

manufacture, package, label, or hold human food. They address such

matters as personal hygiene and cleanliness among workers who handle

food, the suitability of the plant design to sanitary operations, and

the cleaning of food-contact surfaces. The proposed sanitation SOP's

relate to the entire facility, not just to a limited number of CCP's.

FDA tentatively concludes that this step is necessary to fully

implement section 402(a)(4) of the act and yet at the same time not

overload the HACCP system. FDA invites comments on this approach.

FDA did not elect to make the development of a written sanitation

SOP mandatory for seafood because it recognized that some processors

may be able to achieve satisfactory sanitary conditions and practices

without having to commit their sanitary control procedures to writing

(60 FR 65096 at 65149). In the seafood final rule, FDA concluded that

as long as there were records demonstrating that the plant was being

kept in sanitary condition, it was not necessary to require written

sanitation SOP's, even though the agency strongly recommended that a

processor have them. The agency requests comment on whether it should

require for juice HACCP that sanitation SOP's be written.

In the evidence discussed in section I.A of this document, there

were several instances where contaminated water was the cause of the

outbreak. The water that the processor used was contaminated and when

produce was washed with it before juicemaking, the water contaminated

the produce, resulting in contaminated juice. Therefore, the safety of

the water that comes into contact with food or food contact surfaces is

an important factor that a processor must consider to maintain proper

sanitation and prevent contamination of the product and plant. The

seafood HACCP regulation in Sec. 123.11(b) lists eight sanitary

conditions and practices that processors must monitor, and monitoring

the safety of the water that comes into the plant is one of them

(Sec. 123.11(b)(1)). Based on the foregoing, FDA is proposing a similar

requirement in Sec. 120.6(a)(1).

In section I.B of this document, FDA recounted the evidence

demonstrating, that several outbreaks were caused by cleaning solution

directly contaminating the juice. Sanitation SOP's for seafood in

Sec. 123.11(b)(5) require that processors protect food from

adulteration with cleaning compounds. Given that cleaning compounds,

sanitizing agents, pesticides, and other materials can pose a similar

threat if not properly used in a juice processing facility, FDA is

proposing a parallel requirement in Sec. 120.6(a)(5).

The other provisions of Sec. 123.11(b) are based on CGMP and

encompass basic sanitation principles. Based on its consideration of

the factors that it cited in arriving at Sec. 123.11(b), the agency

tentatively concludes that it is appropriate to require in

Sec. 120.6(a) that juice processors address the same sanitary

conditions and practices in their SOP that must be monitored by seafood

processors. FDA requests comment on the proposed matters that must be

addressed in the sanitation SOP, and whether others are necessary for

juice.

2. Other Requirements for Prerequisite Program SOP's

FDA is proposing in Sec. 120.6(b) that processors monitor

sanitation conditions and practices during processing with sufficient

frequency to ensure, at a minimum, conformance with those conditions

and practices specified in part 110 that are appropriate both to the

plant and to the food being processed. The seafood HACCP regulation

requires sanitation monitoring (Sec. 123.11(b)). Because prerequisite

programs potentially include facility-wide control points and provide a

foundation for HACCP systems, processors need to monitor the

performance of the SOP's to ensure that they are functioning as

designed, and that they are corrected if there is a problem.

The agency is proposing in Sec. 120.6(c) that processors maintain

records that document the monitoring that they do under the

prerequisite program SOP's and any corrections to those SOP's that they

make. Monitoring and recording of conditions and practices under the

prerequisite program SOP's are as much keys to the success in improving

those conditions as is the development by a processor of the SOP's. As

in the case of HACCP records, FDA is proposing to require that

processors engage in systematic monitoring of their own sanitation

practices and conditions. This proposed requirement is similar to what

is required for sanitation SOP's for seafood (Sec. 123.11(c)).

Monitoring to

[[Page 20467]]

ensure that sanitation is under control is the responsibility of all

processors. Monitoring records help processors to see trends, and also

allow the regulator to assess a processor's compliance over a period of

time, not just at the time of an inspection.

FDA believes that the records bearing on the monitoring of relevant

sanitation conditions and practices and the agency's access to such

records are essential if proposed Sec. 120.6 is to be an effective

regulatory strategy. Therefore, as with HACCP records, the agency

tentatively concludes that these records be subject to the

recordkeeping requirements in proposed Sec. 120.12.

Proposed Sec. 120.6(d) provides the option to juice processors to

include prerequisite program SOP controls in the HACCP plan. However,

if these controls are implemented as part of the prerequisite program

SOP's, there is no need to include them in the HACCP plan. The control

must be in the HACCP plan or in the prerequisite program SOP but need

not be in both places. This proposed provision is similar to

Sec. 123.11(d) for seafood. It is intended to provide manufacturers

with flexibility in how they address the issues involved in the

prerequisite controls.

The agency requests comment on its proposed approach to

prerequisite program SOP's.

E. Hazard Analysis

1. The Hazard Analysis

The seafood HACCP regulation in Sec. 123.6(a) requires that every

processor conduct, or have conducted for it, a hazard analysis to

determine whether there are food hazards that are reasonably likely to

occur for each kind of fish and fishery product processed by that

processor and to identify the preventive (i.e., control) measures that

the processor can apply to control those hazards. Section 123.6(a)

reflects the fact that food hazards can be introduced both within and

outside the processing plant environment, including before, during, and

after harvest. A food hazard that is reasonably likely to occur is one

that, based on the evidence and insights provided by experience,

illness data, scientific reports, and other information, has a

reasonable possibility of occurring in the particular food if

appropriate controls to protect against the hazard are not put in

place. Thus, ensuring that a food will be safe involves identifying

these hazards and preparing for them. The FSIS HACCP regulation for

meat and poultry, in 9 CFR 417.2(a)(1), also requires that a hazard

analysis be done.

According to the NACMCF, a thorough hazard analysis is the key to

preparing an effective HACCP plan (Ref. 55). If the hazard analysis is

not done correctly, and the hazards warranting control within the HACCP

system are not identified, the plan will not be effective regardless of

how well it is followed.

The hazard analysis involves hazard identification and evaluation.

According to the NACMCF, each potential hazard is evaluated based on

the severity of the potential hazard and the likelihood of its

occurrence (Ref. 55). The NACMCF defined severity as the seriousness of

the consequences of exposure to the hazard. They stated that

consideration of the likelihood of its occurrence is usually based upon

a combination of experience, epidemiological data, and information in

the technical literature, and that when conducting the hazard

evaluation, it is helpful to consider the likelihood of exposure and

the severity of the potential consequences if the hazard is not

properly controlled. The NACMCF also stated that consideration should

be given to the effects of short term, as well as long term, exposure

to the potential hazard.

The seafood HACCP regulation does not differentiate between hazards

that cause acute harm and hazards that cause harm through chronic

exposure. FDA stated in the seafood final rule that:

HACCP should be the norm, rather than the exception, for

controlling safety related hazards in the seafood industry. Existing

standards for such contaminants as drug residues, pesticides, and

industrial contaminants, are established to ensure that their

presence in foods does not render the food unsafe. Processors of

fish and fishery products are obliged to produce foods that meet

these standards.

Processors are obliged to exercise control over all food safety

hazards that are reasonably likely to occur.

An important principle is that the processor has the burden of

determining the reasonable likelihood of a hazard's occurrence,

regardless of whether it is a chronic or an acute exposure hazard. In

determining whether a chronic hazard is reasonably likely to occur, a

processor should consider whether it is reasonably likely that, without

some form of control, the food will contain a contaminant in sufficient

quantity to cause it to be adulterated under the act (e.g., it exceeds

a Federal tolerance for a pesticide residue).

The agency tentatively concludes that the requirement for a

processor to conduct a hazard analysis is appropriate for juice

processors. The evidence presented in section I of this proposal

demonstrates that hazards are reasonably likely to occur in the

processing of juice. Therefore, FDA is proposing to require in

Sec. 120.7 that processors develop a hazard analysis to determine

whether there are food hazards that are reasonably likely to occur for

each type of juice processed and to identify the control measures that

the processor can employ to control those hazards. The agency requests

comments on how processors should consider the severity of the hazard,

as the NACMCF discussed, along with its likelihood of occurrence, in a

hazard analysis.

FDA is also proposing in Sec. 120.7 to require that juice

processors use the same considerations in their hazard analysis as

required of seafood and meat and poultry processors (i.e., that they

determine where hazards are introduced, and which hazards need to be

controlled) because these considerations raise the fundamental issues

that must be considered in identifying the hazards present in any

processing operation.

Finally, under the proposed regulation, the hazard analysis must be

developed by an individual trained in HACCP. Training is critical to

the successful implementation of HACCP systems. A trained individual

will be able to understand and apply HACCP principles to the hazard

analysis.

The hazard analysis serves several purposes. It can identify any

modifications to a process or product that are necessary to ensure or

improve the product's safety. It can also provide the basis for

determining CCP's. A specific analysis of a process is necessary

because aspects of the process that represent significant hazards in

one operation may not present significant hazards in another operation

even though the two operations produce the same or a similar product.

Differences in equipment and incoming materials are generally the basis

for these variations. For example, processors will use different

equipment and incoming materials if producing juice from concentrate

than if they are producing the same juice from raw materials.

A summary of the deliberations and the rationale developed during

the hazard analysis should be kept for future reference. This

information will be useful during reviews and updates of the hazard

analysis and the HACCP plan.

Although under both seafood HACCP and meat and poultry HACCP a

hazard analysis is required, a written hazard analysis is only required

under the meat and poultry regulation. In the seafood HACCP final rule,

the agency presented its reasons for not requiring a written hazard

analysis (60 FR 65096 at 65118). It stated:

[[Page 20468]]

The agency recognizes that the best way for it to verify a

processor's hazard analysis is indirectly, through its own

evaluations of whether a processor ought to have a HACCP plan, and

whether a HACCP plan appropriately identifies the food safety

hazards and CCP's that are reasonably likely to occur. In other

words, it is the end product of the hazard analysis, the HACCP plan

and its implementation, that should be judged by the regulator. For

this reason, the agency is not requiring that hazard analyses be

performed according to a standardized regimen, or that they be

documented in writing for FDA review.

Even though FDA is not requiring that the hazard analysis be

available to the agency, there may be cases in which it would be to

the processor's advantage to have a carefully documented written

hazard analysis to show to FDA. Such documentation may prove useful

in resolving differences between the processor and the agency about

whether a HACCP plan is needed and about the selection of hazards,

CCP's, and CL's. Written hazard analyses may also be useful to

processors in that they may help provide the rationale for the

establishment of CL's and other plan components. Having the basis

for these decisions available may be helpful when processors

experience changes in personnel, especially those associated with

the HACCP process, and in responding to unanticipated CL deviations.

FDA believes that the position taken in the seafood HACCP

regulation continues to be appropriate for seafood. The agency notes

that the ``Fish & Fisheries Products Hazards & Controls Guide'' assists

processors in the development of their HACCP plans, including the

hazard analysis. It lists numerous potential hazards and guides seafood

processors through the hazard analysis. However, as discussed

previously, it is not clear whether, given the limitations on its

resources, FDA will be able to provide such detailed information for

juice. Therefore, the agency tentatively concludes that a requirement

for a written hazard analysis is appropriate for juice.

Moreover, most firms in the FDA pilot program reported that

preparing a written hazard analysis, including a list of preventive

measures, helped them conduct a more scientific analysis rather than

just a qualitative one; they also reported that the written hazard

analysis provided a means of communicating to employees the public

health significance of the hazards that were being controlled (Ref.

57). Thus, FDA believes that processors likely will conduct a more

appropriate hazard analysis if they have to document it. If the hazard

analysis has not been conducted properly, the HACCP plan will likely be

inadequate. Therefore, FDA tentatively concludes that HACCP plans alone

may not be adequate without a documented hazard analysis.

Accordingly, FDA is proposing to include in Sec. 120.7 that the

hazard analysis be written and maintained as a record in accordance

with proposed recordkeeping requirements (Sec. 120.12). The agency

requests comments on its approach of requiring a written hazard

analysis.

2. Evaluation of Hazards

Section 123.6(c) requires that processors consider in the hazard

analysis whether any food safety hazards are reasonably likely to occur

as a result of natural toxins, microbiological contamination, chemical

contamination, pesticides, drug residues, decomposition, parasites,

unapproved use of direct or indirect food or color additives, and

physical hazards. In 9 CFR 417.2(a)(3), FSIS lists these same

considerations where food safety hazards might be expected to arise and

adds zoonotic diseases to the list.

FDA has reviewed the food hazards that are reasonably likely to

occur in juice. For the most part, the hazards that processors should

consider in doing a hazard analysis for this type of food are the same

as those that FDA and USDA have listed in the regulations for seafood,

meat, and poultry (Ref. 58). However, unlike seafood, meat, and

poultry, pesticides may be intentionally applied to fruits, vegetables,

and other plant products during their growth. All pesticides applied to

produce must be approved for use on that plant, and the residue levels

of the pesticides at the time of harvest must be within tolerances.

Therefore, processors must ensure that any pesticide residues on plant

foods are lawful for that food and are within tolerances.

The presence of possible allergens in foods is a second possible

hazard that was not considered in HACCP regulations for seafood or meat

and poultry. Food ingredients must be declared on the label in

accordance with Sec. 101.4, and individuals sensitive to particular

ingredients may avoid consuming them by checking the ingredient list.

However, there is a possibility that traces of undeclared food

materials could be present in food products from foods run previously

on the same equipment as used for the juice or on nearby equipment. The

presence of even traces of certain food ingredients can cause life

threatening reactions in sensitive individuals. For example, dairies

may process juice using the same equipment that they use to process

milk. Therefore, dairies processing juice in this manner must consider

whether traces of milk are present in the juice. The same principle

holds for processors producing several types of juices on the same

equipment. A hazard analysis should determine whether a food hazard is

created as a result. FDA tentatively concludes that a hazard analysis

should consider the potential presence of undeclared food ingredients

that could be possible allergens.

Therefore, FDA is proposing in Sec. 120.7(a) that in evaluating

which food hazards are reasonably likely to occur, consideration should

be given, at a minimum, to the following: (1) Microbiological

contamination, (2) parasites, (3) chemical contamination, (4) unlawful

pesticide residues, (5) decomposition in food where a food hazard has

been associated with decomposition, (6) natural toxins, (7) unapproved

use of direct or indirect food or color additives, (8) presence of

undeclared allergens, and (9) physical hazards. The agency requests

comment on these hazards and any others that should be included in the

regulation.

3. Other Considerations

The agency is proposing in Sec. 120.7(b) that processors should

evaluate product ingredients, processing procedures, packaging,

storage, and intended use; facility and equipment function and design;

and plant sanitation, including employee hygiene, to determine the

potential effect of each on the safety of the finished food for the

intended consumer. These are factors that a prudent processor should

consider in conducting a hazard analysis. The seafood HACCP regulations

at Sec. 123.6(a) did not list specific items or factors that processors

should consider when conducting a hazard analysis. The preamble to the

final rule for those regulations stated that, as of December 1995, the

methodology for conducting a hazard analysis was not sufficiently

standardized to justify mandating what the hazard analysis must

include. The preamble encouraged processors to study the NACMCF

guidance on the subject. The agency tentatively concludes, however,

that including in the codified text the minimum elements that the

processor should consider in developing a hazard analysis will assist

processors. This material is included to be helpful and does not

constitute a substantive change from the seafood HACCP regulation. FDA

requests comment on proposed Sec. 120.7(b).

F. HACCP Plan

1. The HACCP Plan

The seafood HACCP regulation requires in Sec. 123.6(b) that

processors have and implement a written HACCP

[[Page 20469]]

plan whenever a hazard analysis reveals one or more food safety hazards

that are reasonably likely to occur. FSIS has established a similar

requirement for meat and poultry (9 CFR 417.2(b)).

FDA is proposing to require in Sec. 120.8(a) that every juice

processor have and implement a written HACCP plan whenever a hazard

analysis reveals that one or more food hazards are reasonably likely to

occur during processing, as described in Sec. 120.7. This could include

adapting a model or generic-type plan to a processor's specific

situation. This proposed requirement is in keeping with Principle 7 of

the NACMCF guidelines that firms prepare and maintain written HACCP

records (Ref. 55).

The agency is also proposing in Sec. 120.8(a)(1) and (a)(2) that a

HACCP plan be specific to each location where juice is, and to each

type of juice that is, processed by that processor. The plan may group

types of juice products together, or group types of production methods

together, if the food hazards, CCP's, CL's, and procedures required to

be identified and performed are essentially the same for the products

or methods being grouped, provided that any required features of the

plan that are unique to a specific product or method are clearly

delineated in the plan and are observed in practice. Proposed

Sec. 120.8(a) is similar to provisions in both Sec. 123.6(b) of the

seafood HACCP regulation and 9 CFR 417.2(b) of the HACCP regulation for

meat and poultry.

A plan is specific to each location because the likely hazards,

CCP's, CL's, and monitoring procedures can vary from one facility to

another depending on such factors as type of equipment, conditions and

procedures, personnel, and location. A plan also should be specific to

each type of juice for the same kinds of reasons. Hazards can vary

depending on the type of fruit or vegetable used to make the juice, pH,

and other factors. The agency has tentatively concluded, however, that

some types of juices can be grouped together in a HACCP plan if the

hazard analysis reveals that the juices present similar hazards, their

processing includes the same CCP's, or there are other appropriate

commonalities in their production. Grouping would reduce the paperwork

burden on some processors without altering the benefits attainable

through HACCP. The agency requests comment on this approach.

A valid HACCP plan delineates the procedures to be followed in

processing the juice. Thus, FDA tentatively concludes that the HACCP

plan needs to be developed by individuals who not only are

knowledgeable in juice processing but who have been trained in HACCP.

This activity requires specialized training in the principles of HACCP,

various aspects of food science, and the knowledge of criteria of

existing regulations and guidelines. Therefore, the agency is proposing

in Sec. 120.8(a) that the HACCP plan be developed by an individual or

individuals who have been trained in accordance with proposed

Sec. 120.13.

Seafood and meat and poultry processors are required to have a

written HACCP plan that is subject to certain recordkeeping

requirements. An adequate recordkeeping system is the key to HACCP. In

addition, adequate records allow the processor to be able to reference

the HACCP plan as necessary. Thus, FDA tentatively concludes that,

because of the plan's importance in a HACCP system, the HACCP plan for

juice must also be subject to certain recordkeeping requirements.

Therefore, the agency is also proposing in Sec. 120.8 that the HACCP

plan be maintained in accordance with the recordkeeping requirements of

Sec. 120.12.

2. The Contents of the HACCP Plan

As discussed previously, the NACMCF has developed seven principles

that describe the HACCP concept and what constitutes a HACCP plan. Both

Sec. 123.6(c) and 9 CFR 417.2(c) include minimum requirements for the

contents of HACCP plans for seafood and meat and poultry, respectively,

that are based on these seven principles. FDA is proposing to require

similar minimum criteria for HACCP plans for juice products.

The agency is proposing in Sec. 120.8(b)(1) to require that the

plan list the food hazards that are reasonably likely to occur as

identified in accordance with Sec. 120.7 and that thus must be

controlled for each type of product. This list identifies the hazards

that will be controlled by adhering to the HACCP plan in the processing

of that type of juice.

Consistent with the HACCP principles identified by the NACMCF, FDA

is proposing in Sec. 120.8(b)(2) that processors list the CCP's for

each of the identified food hazards, including, as appropriate, CCP's

designed to control hazards that could occur or be introduced inside

the processing plant environment, and CCP's designed to control food

hazards introduced outside the processing plant environment, including

hazards that occur before, during, or after harvest. Complete and

accurate identification of CCP's is fundamental to controlling food

hazards (Ref. 55). Hazards may be caused by improper processing or by

events outside the processor's direct control. These hazards are

controlled by the CL's, monitoring, control procedures, and

recordkeeping that are done as part of HACCP.

In Sec. 120.8(b)(3), FDA is proposing, consistent with the NACMCF

principles, that processors list the CL's that must be met at each of

the CCP's. CL's must be met to ensure that the relevant hazard is

controlled or avoided. According to the NACMCF, each CCP will have one

or more control measures to ensure that the identified hazards are

prevented, eliminated, or reduced to acceptable levels (Ref. 55). Each

control measure has one or more associated CL's. Thus, some CL's can be

set to reflect regulatory levels established by FDA or EPA in the form

of action levels, regulatory limits, or tolerances for contaminants

such as pesticide residues, natural toxins, and other contaminants.

According to the NACMCF, monitoring serves three main purposes

(Ref. 55). First, monitoring is essential to food safety management in

that it facilitates tracking of the operation. If monitoring indicates

that there is a trend towards loss of control, then action can be taken

to bring the process back into control before a deviation from a

critical limit occurs. Second, monitoring is used to determine when

there is loss of control and thus a deviation at a CCP (i.e., exceeding

or not meeting a CL). When a deviation occurs, an appropriate

corrective action must be taken. Third, it provides written

documentation for use in verification.

Proposed Sec. 120.8(b)(4) requires that processors list the

procedures, and the frequency with which they are to be performed, that

will be used to monitor each of the CCP's to ensure compliance with the

CL's. Monitoring steps are necessary to ensure that the CCP is in fact

under control and to produce an accurate record of what has occurred at

the CCP. The frequency of monitoring affects the level of confidence

that a firm has in the safety of its product, with continuous

monitoring providing the highest level of confidence.

The agency is proposing in Sec. 120.8(b)(5) that processors include

in their HACCP plan any corrective action plans that have been

developed in accordance with proposed Sec. 120.10(a), and that are to

be followed in response to deviations from CL's at CCP's. As explained

in more detail in the ``Corrective Actions'' section of this preamble,

FDA has tentatively concluded that these regulations should provide the

processor with the option of predetermining corrective actions.

Predetermined corrective action

[[Page 20470]]

procedures have the potential to facilitate faster action when a

deviation occurs than would be possible in the absence of such

procedures and to enable a processor to make a more timely response to

the deviation when trained or otherwise qualified individuals are not

readily available.

Consistent with the NACMCF principles, the agency is proposing in

Sec. 120.8(b)(6) that processors list the verification and validation

procedures, and the frequency with which they are to be performed, that

the processor will use in accordance with proposed Sec. 120.11. As

explained in more detail in the ``Verification and Validation'' section

of this preamble, FDA has tentatively concluded that a processor must

specify in its HACCP plan the verification and validation procedures

that it will use and the frequency with which it will use those

procedures. FDA tentatively finds that inclusion of this information in

the plan is necessary to underscore that a processor has an ongoing

obligation to ensure that the verification and validation steps it has

determined are necessary are readily ascertainable by its employees as

well as by regulatory officials.

Finally, in Sec. 120.8(b)(7), FDA is proposing that processors

provide for a recordkeeping system that documents the monitoring of the

CCP's, and that the records contain the actual values and observations

obtained during monitoring. Implementing a HACCP system depends on

adequate records to document the controls at each CCP and the

corrective actions taken in response to any deviations. FDA has

tentatively concluded that it is neither possible for processors to

derive the full benefits of a HACCP system, nor to verify or validate

the operation of the system, without actual measurement values.

Notations that heat treatment temperatures are ``satisfactory'' or

``unsatisfactory,'' without recording the actual times and

temperatures, are vague and subject to varying interpretations and

thus, will not ensure that controls are working properly. Also, it is

not possible to discern trends without actual measurement values.

The agency requests comments on developing a HACCP plan based on

the NACMCF principles.

3. Products Subject to Other Regulations

FDA has already established HACCP type regulations for acidified

and low acid canned foods. FDA examined this issue in the seafood final

rule (60 FR 65096 at 65124) and acknowledged that there is no need for

a processor to restate in its HACCP plan the requirements of part 113

or 114 (21 CFR part 113 or 114).

Parts 113 and 114 dictate that low-acid canned foods and acidified

foods be processed in a manner to become commercially sterile.

Commercial sterility of thermally processed food is defined in

Sec. 113.3(e)(1) as a process that renders the food free of: (1)

Microorganisms capable of reproducing in the food under normal

nonrefrigerated conditions of storage and distribution, and (2) viable

microorganisms (including spores) of public health significance.

Consequently, juice processors who must comply with the requirements of

part 113 or 114 need not address these particular hazards at all in

their HACCP plans.

However, it is important to note that other hazards may be

reasonably likely to occur in an acidified or low-acid canned juice.

FDA is proposing to require that these hazards be addressed in the

HACCP plan, as appropriate. For example, FDA anticipates that the

possible presence of glass in carrot juice packed in glass containers

is a hazard that is reasonably likely to occur and thus the agency

expects this hazard to be addressed in the HACCP plan. Accordingly, to

clarify what is required of processors of acidified and low-acid canned

juice products, FDA is proposing to adopt Sec. 120.8(c) for juice

products subject to other regulations.

4. Relationship to Prerequisite Programs

All hazards identified during the hazard analysis as being

reasonably likely to occur need to be addressed by control measures

that a processor can apply. Determining how the control measures, in

turn, are to be addressed is a primary consideration in developing the

HACCP plan. Control measures involve identifying the relevant CCP's and

CL's as part of the HACCP plan, or, in those limited circumstances

specified in proposed Sec. 120.6, making appropriate provision in a

prerequisite program SOP. The safety of the product can be compromised

if control measures are not properly monitored and addressed.

As it required for seafood HACCP, FDA is proposing to require that

processors address plant sanitation by monitoring certain key sanitary

conditions and practices apart from CCP monitoring activities, either

by including sanitation controls as part of the HACCP plan, or as part

of an SOP in accordance with Sec. 120.6, or by adopting some

combination of these two approaches, at the option of the processor.

To reflect this approach, the agency is proposing in Sec. 120.8(d)

to state that sanitation controls may be included in the HACCP plan,

but that, to the extent that they are monitored in accordance with

Sec. 120.6, they need not be included in the HACCP plan.

FDA recognizes that many processing operation sanitation controls,

such as hand and equipment washing and sanitizing, are critical to the

safety of the food because they serve to minimize the risk of pathogen

introduction into finished products that may not be further heat

treated before consumption. For this reason, some processors may elect

to include in their HACCP plan the control of sanitation through

standardized practices in addition to, or in place of, monitoring of

sanitation conditions and control practices apart from the HACCP plan.

However, FDA also recognizes that sanitation controls may be difficult

to fit into HACCP plans, with appropriate CL's and corrective actions

sometimes being elusive. For this reason, some processors may elect to

rely exclusively on sanitation controls that are not part of the HACCP

plan. Either approach is likely to be acceptable, so long as whatever

approach is chosen is fully implemented and followed. FDA requests

comment on this view.

G. Legal Basis

The seafood HACCP regulation states that the failure of a processor

to have and to implement a HACCP plan that complies with Sec. 123.6(g),

whenever a HACCP plan is necessary, or otherwise to operate in

accordance with the requirements of part 123, will render the fish or

fishery products of that processor adulterated under section 402(a)(4)

of the act, and potentially section 402(a)(1). Whether a processor's

actions are consistent with ensuring the safety of food will be

determined through an evaluation of the processor's overall

implementation of its HACCP plan, if one is required. The legal basis

for FDA's proposed mandatory HACCP systems for juice processors is the

same as that for seafood processors. Additional discussion of the legal

basis may be found in the proposed rule (59 FR 4142 at 4150) and final

rule (60 FR 65096 at 65098) for fish and fishery products.

The agency is proposing in Sec. 120.9 that failure of a juice

processor to have and to implement a HACCP system that complies with

Sec. 120.8 or otherwise to operate in accordance with the requirements

of this part, will have similar consequences as a failure to comply

with the seafood HACCP regulations. FDA has tentatively determined that

the hazards, especially microbial hazards, inherent in juice

[[Page 20471]]

processing are such that, unless there is adherence to HACCP

principles, there cannot be assurance that the product is safe. Thus,

failure to operate a juice processing operation in accordance with

HACCP is itself an insanitary condition that may render the juice

product injurious to health.

H. Corrective Actions

The fifth HACCP principle, as articulated by the NACMCF, is that

processors establish the corrective actions that they will take should

monitoring show a CL deviation. The NACMCF's expectation is that these

corrective actions should be predetermined and written into the

processor's HACCP plan. Where there is a deviation from established

CL's, corrective actions are necessary (Ref. 55).

Section 123.7 of the seafood regulation permits, but does not

require, processors to include in their HACCP plans any written

corrective action plans that they develop. When a deviation from a CL

occurs, Sec. 123.7(a) requires that the processor either: (1) Follow a

corrective action plan that is appropriate for the particular

deviation, or (2) follow the series of actions provided in

Sec. 123.7(c). The steps in Sec. 123.7(c) constitute a minimum generic

model for corrective actions.

Section 123.7(b) of the seafood HACCP regulation defines an

appropriate action plan as one that addresses both the safety of the

product that was being processed when the CL failure occurred and the

cause of the deviation. In this respect, the contents of the corrective

action plan are consistent with the views of the NACMCF (Ref. 55).

Action necessary to correct the potential hazard may involve one or

more of the following steps: Immediately reprocessing the product;

diverting the product to another use for which it is safe; segregating,

holding, and having the product evaluated by a competent expert; or

destroying the product (60 FR 65096 at 65127). To ensure that

subsequent product is not subjected to the same deviation, the

corrective action must be sufficient to bring the process back under

control. FDA advised in the preamble to the seafood final rule (60 FR

65096 at 65127) that such action may involve, where appropriate,

adjustments to those process parameters that have an effect on the

relevant CL (e.g., flow rate, temperature, source of raw materials);

temporarily diverting product around a point in the process at which

problems are being encountered; or temporarily stopping production

until the problem can be corrected.

Section 123.7(c) of the seafood HACCP regulation describes the

steps that a processor must take whenever there is a deviation from a

CL, but the processor has not prepared a corrective action plan for

that situation. If the processor does not have a corrective action plan

for a particular deviation, then the processor must: (1) Segregate and

hold the affected product for as long as necessary, (2) perform or

obtain a review by a trained individual to determine the affected

product's acceptability for distribution, (3) take corrective action to

ensure that no product enters commerce that is either injurious to

health or is otherwise adulterated as a result of the deviation, (4)

take corrective action to correct the cause of the deviation, and (5)

have a trained individual perform a timely reassessment to determine

whether the HACCP plan needs to be modified to reduce the risk of

recurrence of the deviation and modify the HACCP plan as necessary.

As stated in a previous paragraph , these steps constitute a

minimum generic-type corrective action plan. The objectives of these

steps are the same as those of a preconceived plan: To ensure that

adulterated product does not enter commerce and to correct the cause of

the deviation. Because it is a generic-type plan that is intended to be

applicable to any situation, some of the steps, such as segregating and

holding the affected product (Sec. 123.7(c)(1)), might not be necessary

if the corrective action had been predetermined. This aspect of the

generic-type plan may provide processors with an incentive to

predetermine corrective actions whenever practical.

FDA is propo

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