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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

RIN 0910–AA43

[Docket No. 97N–0511]

Hazard Analysis and Critical Control

Point (HACCP); Procedures for the

Safe and Sanitary Processing and

Importing of Juice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

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 § 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 § 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 (μg/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 μg/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 leadsoldered 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 laboratoryconfirmed 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 juicerelated 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 laboratoryconfirmed 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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20453

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 pathogenproduct 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 (§ 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 (§ 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
20454 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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 handpicked (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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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 longterm 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
20456 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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.
20458 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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-ofthe-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.
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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
20460 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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 § 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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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 highrisk 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
20462 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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

§ 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 § 156.145. These standardized

juices are generally described as the

liquid extracted or expressed from a

fruit or vegetable. However, prune juice

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

§ 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 (§ 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

(§ 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 § 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

§ 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

§ 120.1(b)(2), FDA intends to use the

definitions for the terms ‘‘unit,’’ ‘‘food

product,’’ ‘‘person,’’ and ‘‘full-time

equivalent employee’’ in
20464 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

§ 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 § 120.3 that the definitions

and interpretations of terms in section

201 of the act (21 U.S.C. 321), in

§ 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 § 120.3.

The agency is proposing to include in

§ 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 § 123.3: ‘‘critical

limit’’ (§ 120.3(d)), ‘‘food hazard’’

(§ 120.3(e)), ‘‘importer’’ (§ 120.3(f)),

‘‘shall’’ (§ 120.3(j)), and ‘‘should’’

§ 120.3(k)).

However, FDA is proposing to modify

the term ‘‘preventive measure’’ to

‘‘control measure’’ (§ 120.3(b)) and to

modify its definition from that used in

the seafood HACCP regulation

(§ 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 § 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 § 123.3(k) with

specific product application. To apply

these definitions to juice and to avoid

listing specific processes, the agency is

proposing in § 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’’ (§ 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’’ (§ 120.3(g)(2)(ii)). For

purposes of this rule, the agency has

tentatively decided that a retail

establishment as set out in proposed

§ 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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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 § 123.3. FDA is proposing in

§ 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’’ (§ 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 § 123.3. FDA is proposing in

§ 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

§ 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 § 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 (§ 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
20466 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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 § 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

§ 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 (§ 123.11(b)(1)). Based on

the foregoing, FDA is proposing a

similar requirement in § 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 § 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

§ 120.6(a)(5).

The other provisions of § 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 § 123.11(b), the agency

tentatively concludes that it is

appropriate to require in § 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 § 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 (§ 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 § 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 (§ 123.11(c)). Monitoring to
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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 § 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 § 120.12.

Proposed § 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

§ 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

§ 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 § 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 § 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:
20468 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

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 § 120.7 that the hazard

analysis be written and maintained as a

record in accordance with proposed

recordkeeping requirements (§ 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

§ 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

§ 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 § 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 § 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 § 120.7(b).

F. HACCP Plan

1. The HACCP Plan

The seafood HACCP regulation

requires in § 123.6(b) that processors

have and implement a written HACCP
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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

§ 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 § 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

§ 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

§ 120.8(a) is similar to provisions in

both § 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 § 120.8(a)

that the HACCP plan be developed by

an individual or individuals who have

been trained in accordance with

proposed § 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 § 120.8

that the HACCP plan be maintained in

accordance with the recordkeeping

requirements of § 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 § 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

§ 120.8(b)(1) to require that the plan list

the food hazards that are reasonably

likely to occur as identified in

accordance with § 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 § 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 § 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 § 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

§ 120.8(b)(5) that processors include in

their HACCP plan any corrective action

plans that have been developed in

accordance with proposed § 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
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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

§ 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

§ 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 § 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 lowacid canned foods and acidified foods

be processed in a manner to become

commercially sterile. Commercial

sterility of thermally processed food is

defined in § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 120.9

that failure of a juice processor to have

and to implement a HACCP system that

complies with § 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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 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, § 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 § 123.7(c). The steps in

§ 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 generictype plan that is intended to be

applicable to any situation, some of the

steps, such as segregating and holding

the affected product (§ 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 proposing essentially the same

requirements in § 120.10 that it requires

in § 123.7 of the seafood HACCP

regulation because the agency is not

aware that a juice processor has any

options other than those that are

available to the seafood processor. The

processor can either follow its own

established corrective action plan, as

appropriate for the particular deviation,

or follow the generic provisions of the

regulation that are applicable to any

food. Thus, FDA tentatively concludes

that the seafood HACCP requirements

for corrective actions are applicable to

juice processing.

Proposed § 120.10 sets forth the

corrective action procedures that a

processor must take whenever a

deviation from a CL occurs. A processor

may take corrective action either by

following: (1) A corrective action plan

as identified in the HACCP plan (see

proposed § 120.8(b)(5)), or (2) the

procedures outlined in proposed

§ 120.10(b). Predetermined plans

provide processors with benefits, such

as faster action when a deviation occurs,

less need to justify to management the

appropriateness of the corrective action

after it has been taken, and a more

timely response to the deviation than is

possible when trained or otherwise

qualified individuals are not readily

available to make determinations, and a

plan is not available.

The agency is proposing to provide in

§ 120.10(a) that processors may develop

written corrective action plans, which

become part of their HACCP plans in

accordance with § 120.8(b)(5), by which

they predetermine the corrective actions

that they will take whenever there is a

deviation from a CL. According to the

NACMCF, specific corrective actions

should be developed in advance for

each CCP and included in the HACCP

plan (Ref. 55). The agency is also

proposing in § 120.10(a) that a

corrective action plan that is

appropriate for a particular deviation is

one that describes the steps to be taken

and assigns responsibility for taking

those steps, to ensure that: (1) No

product enters commerce that is either

injurious to health or is otherwise

adulterated as a result of the deviation,

and (2) the cause of the deviation is

corrected. These two considerations are

essential because they represent the

reasons for taking corrective actions

(i.e., protecting the public health and

correcting the problem at hand).

In § 120.10(b), FDA is proposing the

steps that processors must take when a

deviation from a CL occurs, and they do

not have a corrective action plan that is

appropriate for that deviation. First,

under proposed § 120.10(b)(1), any CL

deviation will require the segregation

and holding of the affected product

until the significance of the deviation

can be determined. FDA tentatively

finds that this step is necessary to

ensure that products that may be

injurious to health do not enter

commerce until the deviation’s impact

on safety has been determined.

Proposed § 120.10(b)(2) requires that

processors perform or obtain a review to

determine the acceptability of the

affected product for distribution. This is

fundamental to determining the final

outcome of the affected product. In

some instances product may simply

need to be reprocessed, while at other

times, the product may not be

considered adulterated. For example, if

the pasteurization process did not reach

the minimum temperature specified by

the CL, the juice can be diverted and

rerouted through the pasteurizer for
20472 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

reprocessing at acceptable temperatures.

However, if the juice contains a

pesticide above an established tolerance

level, the juice is deemed to be

adulterated.

FDA is also proposing to require in

§ 120.10(b)(2) that the safety

determination be made by an individual

who has adequate training or experience

to perform such a review. Adequate

training may or may not include

training in accordance with proposed

§ 120.13, but the individual’s training

must be sufficient to qualify him or her

to make the public health

determinations of this nature. For

example, an individual must have some

training to understand that pasteurized

juice must have been processed to reach

a minimum time and temperature

combination and know methods of

reprocessing to remedy problem

situations. Adequate training in this

context requires only knowledge of how

to perform the particular operation

responsibility rather than training in the

concepts of HACCP.

Under proposed § 120.10(b)(3),

processors must take corrective action,

when necessary, with respect to the

affected product to ensure that no

product enters commerce that is either

injurious to health or is otherwise

adulterated as a result of the deviation.

Under proposed § 120.10(b)(4)

processors must take corrective action,

when necessary, to correct the cause of

the deviation. As discussed for

proposed § 120.10(a), the actions called

for under these two provisions are

essential to any corrective action plan

because they address one of the two

reasons for taking corrective actions,

that is, correcting the problem at hand.

FDA is proposing in § 120.10(b)(5) to

require that a trained person validate

the HACCP plan that was in use at the

time of the deviation to determine

whether it needs to be modified to

reduce the risk of recurrence of the

deviation and to modify the HACCP

plan as necessary. It is critically

important that processors learn as much

as possible from the occurrence of a

deviation, and that they take the steps

necessary to ensure that such deviation

will not be repeated. Proposed

§ 120.10(b)(5) reflects these principles.

Finally, proposed § 120.10(c) requires

that processors maintain records of all

corrective actions that they take

following either the corrective action

procedures in the HACCP plan or those

specified in § 120.10(b). The agency is

proposing that these records be subject

to the verification requirements in

proposed § 120.11(a) and the

recordkeeping requirements of § 120.12.

The records need to reflect all actions

taken in response to a deviation (i.e.,

provide the specifics about the actions

taken and not simply refer to a written

procedure). Such information helps the

processor to determine if there are

recurring problems that it needs to

address. The information also will

enable both the processor and the

regulator to identify factors that may

help prevent problems in the future.

The agency requests comments on its

proposed approach to corrective actions.

I. Verification and Validation

The seafood HACCP regulation

requires that every processor verify that

the HACCP plan is adequate to control

food safety hazards that are reasonably

likely to occur, and that the plan is

being effectively implemented

(§ 123.8(a)). Section 123.8 includes

requirements for reassessment of the

HACCP plan and for various other

verification activities, including

reviewing monitoring records,

reviewing records of corrective actions,

and reviewing calibration records.

Section 123.8 also requires, in certain

circumstances, that processors who had

concluded that no HACCP plan was

necessary reassess that judgment and

reevaluate their HACCP analysis.

The meat and poultry HACCP

regulation requires that every

establishment validate the HACCP

plan’s adequacy in controlling the food

safety hazards identified during the

hazard analysis and verify that the plan

is being effectively implemented (9 CFR

417.4(a)). Section 417.4 includes

requirements for initial validation,

ongoing verification activities,

reassessment of the HACCP plan, and

reassessment of the hazard analysis for

processors that do not need a HACCP

plan.

According to the NACMCF (Ref. 55),

there are four aspects to verification.

One is verifying whether the facility’s

HACCP system is functioning according

to the HACCP plan. Another aspect is

the initial validation of the HACCP plan

to determine whether the significant

hazards have been identified, and

whether, if the HACCP plan is properly

implemented, these hazards will be

effectively controlled. The third aspect

consists of documented validations that

are done after the initial development

and implementation of the HACCP plan.

The fourth aspect of verification deals

with a periodic verification of the

HACCP system by an unbiased,

independent authority.

1. Verification

The agency is proposing in § 120.11(a)

to require that every processor verify

that the HACCP system is being

implemented according to design.

According to the NACMCF, a

functioning HACCP system requires

little end-product sampling because

appropriate monitored safeguards are

inherent to the process. Therefore,

rather than relying on end-product

sampling, firms need to conduct

frequent reviews of their HACCP plan to

verify that it is being correctly followed,

to review CCP records, and to ensure

that appropriate risk management

decisions and product dispositions are

made when process deviations occur.

Proposed § 120.11(a) sets forth the

minimum requirements for verification

activities. Proposed § 120.11(a)(1) deals

with ongoing verification activities.

These ongoing activities are in keeping

with the NACMCF’s view that

verification needs to take the form of

‘‘frequent reviews.’’ Frequent reviews

relate primarily to whether the HACCP

plan is functioning effectively on a dayto-day basis.

The agency is proposing to require in

§ 120.11(a)(1)(i) that a processor review

any consumer complaint that it receives

to determine whether the complaint

relates to the performance of the HACCP

plan or reveal the existence of

unidentified CCP’s. Although the

absence of consumer complaints does

not, by itself, verify the adequacy of a

HACCP system, those consumer

complaints alleging a safety problem

that a processor does receive can be of

value as a verification tool and should

be used for that purpose.

Proposed § 120.11(a)(1)(ii) provides

for the calibration of process-monitoring

instruments as a verification activity.

Calibration provides assurance that an

instrument is measuring correctly.

Calibration is an important activity and

involves readily defined procedures,

usually provided by the instrument

manufacturer, that can easily be

included in the plan.

Proposed § 120.11(a)(1)(iii) provides

that the processor may perform periodic

end-product or in-process testing. FDA

acknowledges the shortcomings of

product testing, especially

microbiological testing, as a process

control. However, the agency recognizes

that many processors will find that

product testing may be included in their

verification activities, and the agency

encourages incorporation of testing into

HACCP systems, where appropriate. For

example, in cases where a processor is

obtaining fruits and vegetables from

unknown sources, and there is no

assurance that pesticides have been

correctly applied, product testing for

pesticide residues is an appropriate step

in a HACCP plan.
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20473

Proposed § 120.11(a)(1)(iv) provides

for a review by a trained individual of

all records that document monitoring of

CCP’s, the taking of corrective actions,

the calibration of any process control

instruments, and the performance of any

end-product or in-process testing. As

proposed, the review must include

signing and dating of the records. The

primary purpose of the record review is

the periodic verification that the HACCP

plan is appropriate and is being

properly implemented. This review of

these records must occur with sufficient

frequency so as to ensure that any

problems in the design and

implementation of the HACCP plan will

be promptly uncovered, and that

modifications to the plan or process will

be promptly made.

FDA tentatively concludes that a

weekly review of HACCP monitoring

and corrective action records

(§ 120.11(a)(1)(iv)(A) would provide the

industry with the necessary flexibility to

handle a highly perishable commodity

like fresh juice without interruption,

while still facilitating timely feedback of

information. FDA’s experience with

low-acid canned foods and acidified

foods has demonstrated that timely

review of these kinds of records is a

critical verification tool.

However, this principle need not

apply to the review of records of such

verification activities as process control

instrument calibration and product

testing. The frequency of these activities

will be variable and dependent upon the

HACCP plan. For example, pesticide

testing of fruits and vegetables may only

need to be done when the source of the

produce is new or unfamiliar to the

firm. Consequently, the agency

tentatively concludes that setting a

specific review frequency for these

records is not warranted and thus is

only proposing that the review be

conducted within a reasonable time

after the records are made (see proposed

§ 120.11(a)(iv)(C)).

Proposed § 120.11(a)(1)(v) requires

that processors take appropriate

corrective action whenever any

verification procedure, including the

review of a consumer complaint, reveals

the need to do so. This proposed

provision is essentially a reminder to

processors that information obtained

through verification may require a

corrective action.

FDA is proposing in § 120.11(a)(2)

that processors document, in records

that are subject to the recordkeeping

requirements of § 120.12, the calibration

of process-monitoring instruments and

the performance of any periodic endproduct and in-process testing, in

accordance with paragraphs (a)(1)(iv)(B)

and (a)(1)(iv)(C). For a processor’s

HACCP controls to work, the

instruments and equipment that it relies

upon in monitoring CCP’s, such as

thermometers, temperature-recording

devices, and computer software, must

be accurate and reliable. FDA has

tentatively concluded that the best way

to ensure such accuracy and reliability

for juice is to require that the

processor’s monitoring procedures

include steps necessary to verify the

reliability of these instruments and

devices. The proposed requirement that

records of end-product testing be kept is

consistent with the general

recordkeeping principles of HACCP.

The agency requests comment on its

proposed verification procedures for

juice.

2. Validation of the HACCP Plan

The agency is proposing, in

§ 120.11(b) to require that juice

processors validate that their HACCP

plan is adequate to control the food

hazards that are reasonably likely to

occur in their products; this validation

is required at least once during the year

after implementation and at least

annually thereafter or whenever any

changes occur that could affect the

hazard analysis or alter the HACCP plan

and prerequisite program SOP’s in any

significant way. The proposed

requirement that HACCP plan

validation be conducted at least once

during the year after implementation is

based on a recommendation from the

NACMCF (Ref. 55). This process

consists of reviewing the CL’s to verify

that the limits at CCP’s are adequate to

control the hazards that are likely to

occur.

The proposed requirement that the

HACCP plan be validated at least

annually, or whenever any relevant

changes occur, is based on the NACMCF

view that validation must occur on a

regular basis (Ref. 55), although the

NACMCF does not specify timeframes.

Validation should be conducted on a

regular basis, even in the absence of a

recognized change, to ensure that the

plan continues to address all of the

reasonably likely food hazards with

appropriate control limits and

monitoring procedures. Processors

should conduct the review at intervals

that are appropriate for their processes,

although FDA is proposing to require

that this interval not exceed 1 year.

Proposed § 120.11(b) provides

examples of changes that could trigger

a validation. These include changes in

raw materials or source of raw materials;

product formulation; processing

methods or systems, including

computers and their software;

packaging; finished product distribution

systems; or the intended use or

consumers of the finished product.

These examples are derived from the

NACMCF materials on the ‘‘five

preliminary steps’’ that form the basis

for the HACCP plan (Ref. 55). A change

in any of these areas could necessitate

a change in the plan to respond to any

new hazards that may have been

introduced or to maintain preventive

control over existing ones. It is

important to recognize that this list is

not all inclusive.

Proposed § 120.11(b) requires that the

plan validation be performed by an

individual or individuals who have

been trained in accordance with

§ 120.13. The validation is fundamental

in determining whether the HACCP

plan is adequate to control food hazards

that are reasonably likely to occur.

HACCP plan validation may result in a

need to alter other aspects of the HACCP

system and the prerequisite program

SOP’s. The activities involved in plan

validation are not routine activities but

require an understanding of the

principles of HACCP and of plan

development. This understanding is

obtained through training.

Initial validation of the HACCP plan

is necessary to ensure that all significant

hazards have been identified, and that,

if the HACCP plan is properly

implemented, these hazards will be

effectively controlled. Subsequent

validation of the HACCP plan ensures

that the plan continues to be effective.

Validation is especially important

whenever any changes occur that could

affect the hazard analysis or alter the

HACCP plan and prerequisite program

SOP’s in any way. Without these

assessments and subsequent changes,

the HACCP plan may not control the

hazards that it should, and unsafe juice

may be distributed. Therefore, the

agency tentatively concludes that

validation of the HACCP plan is

necessary to ensure that juice processed

in accordance with the plan will not

have been processed under conditions

whereby it may have been rendered

injurious to health.

The NACMCF states that the HACCP

plan should be updated and revised as

needed (Ref. 55). Changes in sources of

incoming materials, formulations,

processing, distribution, and consumer

use usually occur over time. New

technologies may be developed. New

concerns that previously were not

considered hazards reasonably likely to

occur may become apparent. For

example, E. coli O157:H7 was not

recognized as a human pathogen before

1982 (Ref. 10), and the impact of its acid

tolerance was not well understood.
20474 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

Therefore, the agency tentatively

concludes that processors must

maintain records demonstrating that

they have been diligent in keeping their

HACCP plans current. Thus, FDA is

proposing to require in § 120.11(b) that

records of the plan validation be subject

to the requirements of § 120.12.

Proposed § 120.11(b) also requires

that, where validation shows that the

HACCP plan is inadequate, the

processor modify immediately the plan.

Failure of a processor to modify

immediately its HACCP plan after the

processor has determined that the plan

is inadequate would result in the

processor operating under insanitary

conditions that may render the food

prepared under the inadequate plan

injurious to health and thus would

render the food adulterated.

FDA requests comments on its

proposed approach to validation of

HACCP plans for juice.

3. Validation of the Hazard Analysis

Proposed § 120.11(c) requires that,

whenever a juice processor has no

HACCP plan because a hazard analysis

has revealed no food hazards that are

reasonably likely to occur, the processor

reassess the adequacy of that hazard

analysis whenever there are any changes

that could reasonably affect whether a

food hazard exists. FDA has proposed to

include examples of such changes in

§ 120.11(c). The list is identical to that

proposed in § 120.11(b), on when a plan

must be validated. Any change in these

factors could warrant a validation to be

certain that a plan is still not needed

because, as stated in the discussion of

proposed § 120.11(b), such changes

could introduce new hazards.

FDA has tentatively concluded that,

under a mandatory HACCP system for

juice, the principle of validation applies

equally to a decision that a HACCP plan

is not necessary as it does to a decision

that the plan is adequate. Circumstances

change, and processors must be alert to

whether factors that effectively exempt

them from the requirement to have a

plan continue to apply.

The agency is proposing in § 120.11(c)

that the validation be performed by an

individual or individuals who have

been trained in accordance with

proposed § 120.13. The validation is

fundamental in determining whether

the hazard analysis considers all food

hazards that are reasonably likely to

occur. The hazard analysis validation

may result in a need to alter other

aspects of the HACCP system and the

prerequisite program SOP’s. These

kinds of activities are not routine but

require an understanding of the

principles of HACCP that is obtained

through appropriate training.

The agency requests comment on its

proposed approach to validation

requirements of a hazard analysis in the

absence of a HACCP plan.

J. Records

Implementing a HACCP program

involves engaging in adequate

monitoring of CCP’s and documenting

the results of that monitoring through

records. It also involves the taking of

appropriate corrective actions in

response to any deviations and, again,

documenting the results. HACCP

records also include the hazard analysis,

the HACCP plan itself, and

documentation of verification and

validation activities. Records of

prerequisite program SOP’s, although

not a part of the HACCP system, are

significant records in a HACCP program

in that the SOP’s may be used in place

of HACCP controls. Record systems

used by the pilot firms in FDA’s pilot

program included hand written logs,

filing systems for continuous recording

charts and inspection sheets, and

computer files of data of monitoring

results and followup corrective actions.

In § 123.9 of the seafood regulation,

FDA established requirements for

HACCP records. Under this provision,

all required records must include: (1)

The name and location of the processor

or importer; (2) the date and time of the

activity that the record reflects; (3) the

signature or initials of the person

performing the operation; and (4) where

appropriate, the identity of the product

and the production code, if any.

Processing and other information must

be entered on records at the time that it

is observed (§ 123.9(a)(4)). Records must

be retained for at least 1 year for

refrigerated foods and for at least 2 years

for all other foods, similarly, records

relating to the general adequacy of

equipment or processes being used by a

processor must be retained for 2 years

(§ 123.9(b)). Off site provisions for

storage of records from processing

facilities that seasonally pack are

allowed, provided that the records are

reasonably accessible (§ 123.9(b)(3)). All

records must be available for official

review (§ 123.9(c)). Section 123.9 also

provides information concerning public

disclosure of records and maintenance

of records on computers.

According to the NACMCF,

maintenance of appropriate records is

fundamental to the success of a HACCP

system (Ref. 55). In recognition of this

fact, FDA is proposing to require in

§ 120.12 that specific records be kept;

that HACCP records contain certain

necessary information; that records be

maintained for specific periods of time;

and that records be available for FDA

review.

The agency is proposing in § 120.12(a)

to list the records that the processor is

required to maintain to document its

HACCP system. FDA has discussed the

basis for requiring that these records be

kept in the sections addressing each

particular provision. The proposed

sections also state that records shall be

maintained. The list of records that juice

processors are required to maintain is

included in § 120.12(a), although this

list is included simply for simplicity, in

that the list reflects the record

requirements that are set out in other

sections of the proposed regulation.

Proposed § 120.12(b) describes the

general requirements for records. The

purpose of the proposed requirements

in this provision is to ensure that

records maintained under part 120 can

be readily linked to a product and to the

timeframe in which the product was

manufactured. Linking a record to a

specific product will be especially

important when there has been a

deviation at a CCP and will enable

processors to isolate product that has

not been processed properly, thereby

preventing the product from reaching

consumers. These records will also

benefit processors in that only those lots

that were processed inadequately will

need to be recalled or isolated. The

agency has tentatively concluded that

including the name and location of the

processor or importer; the date and time

of the activity that the record reflects;

the signature or initials of the person

performing the operation or creating the

record; and, where appropriate, the

identity of the product and the

production code, if any, are the

minimum information necessary to

enable the processor to determine what

product may have been affected by a

deviation and to take any appropriate

actions with respect to that product.

Proposed § 120.12(b)(3) requires that

the record include the signature or

initials of the person performing the

operation or creating the record.

Requiring that the record be signed by

the individual who made the

observation will ensure responsibility

and accountability. Also, if there is a

question about the record, a signature

ensures that the source of the record

will be known.

Proposed § 120.12(b)(4) requires that

processing and other information be

entered on records at the time that it is

observed and that the records contain

the actual values and observations

obtained during monitoring. It is

important that information relating to

observations be recorded immediately
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20475

and that the records contain the actual

values and observations to enhance

accuracy.

Both the HACCP regulations for

seafood and for meat and poultry

require that the HACCP plan be signed

and dated. In the seafood final rule (60

FR 65096 at 65124), FDA emphasized

the importance of signing and dating the

HACCP plan. The agency stated that:

Such a signature would provide direct

evidence of management’s acceptance of the

plan for implementation. FDA cannot stress

enough that for HACCP to succeed, there

must be a clear commitment to it from the

top of the firm on down. Management must

set a strong example in this regard. A

signature requirement will remind

management of this important responsibility

and will signal to all employees that the firm

regards the HACCP plan as a document to be

taken seriously. Additionally, the

representative’s signature, along with the

date of signing, would serve to minimize

potential confusion over the authenticity of

any differing versions or editions of the

document that might exist.

The agency tentatively concludes that

this same reasoning applies to HACCP

plans for juice processing, and that there

are significant benefits of requiring

similar steps for the HACCP plan for

juice.

The agency is also proposing to

require that the hazard analysis for juice

be written (see proposed § 120.7). FDA

tentatively concludes that the hazard

analysis shall be signed and dated in a

manner similar to what is required for

the HACCP plan because of its

relationship to and importance in the

development of an adequate HACCP

plan.

Therefore, the agency is proposing to

require in § 120.12(c)(1) that the hazard

analysis and the HACCP plan be signed

and dated by the most responsible

individual on-site at the processing

facility or by a higher level official of

the processor. Proposed § 120.12(c)(1)

provides that the signatures signify that

these records have been accepted for

incorporation into the HACCP system

by the firm.

In § 120.12(c)(2)(i) through (c)(2)(iii),

FDA is proposing to require that the

hazard analysis and the HACCP plan be

dated and signed upon initial

acceptance, upon any modification, and

upon verification and validation of the

plan in accordance with proposed

§ 120.11(d)(1). As was discussed fully in

the ‘‘Verification and Validation’’

section of this preamble, FDA is

proposing in § 120.11 that the adequacy

of the HACCP plan, or, in the absence

of a HACCP plan, the hazard analysis,

be validated at least once during the

year after implementation and at least

annually thereafter or whenever any

changes occur that could affect the

hazard analysis or that could alter the

HACCP plan and prerequisite program

SOP’s in any way. These verifications,

validations, and modifications are

necessary to ensure that the HACCP

program remains current, and that it is

responsive to emerging problems. The

signature of the firm representative will

document that these validations and

modifications are performed as

required. The requirements for

documentation are the same as those

required for the HACCP plan in the

seafood regulation (§ 123.6(d)).

The agency is proposing in

§ 120.12(d) requirements for record

retention. Proposed § 120.12(d)(1) states

that, in the case of perishable or

refrigerated products, all required

records shall be retained at the

processing facility or importer’s place of

business in the United States for at least

1 year after the date that they were

prepared and in the case of frozen,

preserved, or shelf-stable products, 2

years after the date that they were

prepared. These timeframes are based

on the length of time that these products

can be expected to be in commercial

distribution plus a reasonable time

thereafter to ensure that the records are

available for the processor’s and FDA’s

verification activities.

FDA is proposing in § 120.12(d)(2)

that records that relate to the general

adequacy of equipment or processes

being used by a processor, including the

results of scientific studies and

evaluations, be retained at the

processing facility or the importer’s

place of business in the United States

for at least 2 years after the date that the

processor last used that equipment or

process. Under § 120.12(a)(5) processors

are required to maintain records

documenting validation of the HACCP

plan. If the firm is relying on equipment

or processes to control hazards that are

reasonably likely to occur then the firm

must have some assurance that the

equipment or process is adequate for

that purpose. Should FDA adopt

proposed § 120.12(d)(2), a written

certification from the equipment

manufacturer will likely generally be

sufficient to establish equipment

adequacy. However, the processor may

need to obtain a written scientific

evaluation of a process, especially in

cases where two or more treatments are

used to accomplish a 5 log reduction in

the target pathogen, to ensure that the

process is adequate to destroy

microorganisms of public health

significance or to prevent their growth.

Such an evaluation may also be

necessary to ensure the adequacy of the

pasteurization or refrigerating

equipment that the processor is using.

As with processing records, these

records are required to be retained for a

period of time that reflects the period

that the products to which they relate

can be expected to be in commercial

distribution.

The agency realizes that under the

proposed requirements for

recordkeeping, some juice processors

may be required to store a significant

quantity of records, and that there may

not be adequate storage space in the

processing facility for all of these

records. However, if HACCP is to work,

these records must be available for the

processor’s verification activities and for

FDA inspections. Therefore, the agency

is proposing to provide some relief to

processors in § 120.12(d)(3), which

allows for off-site storage of the

prerequisite program SOP records and

records documenting the ongoing

application of the HACCP plan (i.e.,

monitoring of CCP’s and their CL’s and

corrective actions) 6 months after the

date that the monitoring occurred, if

such records can be retrieved and

provided on-site within 24 hours of

request for official review. The records

for which FDA is proposing to allow offsite storage are the more routine

processing operation records and thus

are of the type that are likely to be

generated in the greatest numbers. FDA

tentatively concludes that the proposed

relief will benefit processors but will

not interfere with the purpose for record

retention because the records will be

readily available.

The use of computers in the food

processing industry is increasing.

Computerized systems within large

corporations can be networked,

allowing for the sending and receiving

of information in a secure fashion to all

of the different food processing facilities

of that corporation worldwide. This

type of system can easily be used to

maintain all of the processing records

from each of the processing facilities at

corporate headquarters. Therefore, for

clarity, FDA is proposing in

§ 120.12(d)(3) that electronic records are

considered to be on-site if they are

accessible from an on-site location and

comply with proposed § 120.12(g).

FDA recognizes that some juice

processing plants may be closed on a

seasonal basis. Given the nature of the

HACCP system, however, FDA may

choose to inspect at least the records of

a plant even if the plant is not in

operation. Therefore, FDA is providing

in proposed § 120.12(d)(4) that, if the

processing facility is closed for a

prolonged period between seasonal

packs, the records may be transferred to

some other reasonably accessible
20476 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

location at the end of the seasonal pack

but shall be immediately returned for

official review upon request. This

proposed provision will give the juice

processor some relief, yet will serve to

ensure that the records in question will

be readily available.

Proposed § 120.12(e) requires that all

records required under part 120 be

available for official review and copying

at reasonable times. The agency’s access

to HACCP records is essential to ensure

that the HACCP system is working, and

that the safety of juice is being ensured

by design. FDA’s authority to require

maintenance of these records, and to

provide for agency access to them, was

fully discussed in the rulemaking on

seafood HACCP (60 FR 65096 at 65139).

The importance of the records in

ensuring that juice will not be rendered

injurious to health has been fully

discussed. FDA access to these records

will expedite the agency’s efforts to

ensure that the juice products in

interstate commerce are not adulterated

and to identify any such products that

are. The agency points out that the

proposed language in § 120.12(e) is

intended to be flexible enough to cover

State officials if their agency adopts any

final regulation by reference.

Proposed § 120.12(f) sets forth

information concerning public

disclosure of processing records. The

agency concluded in the seafood final

rule (60 FR 65096 at 65139):

that records and plans should be protected

to the extent possible in order to promote the

implementation of HACCP across the seafood

industry. FDA has concluded that the public

will benefit from the protection of records

because it will actually strengthen the

HACCP system. So long as the legitimate

public need to be able to evaluate the system

can be met through other means, the

confidentiality of HACCP records and plans

generally will foster the industry’s

acceptance of HACCP. Even though HACCP

may be mandatory under these regulations,

in order for it to succeed, processors must be

committed to it because they see value in it

for themselves. Fear of public disclosure of

matters that have long been regarded as

confidential business matters could

significantly undermine that commitment.

FDA concludes, therefore, that it is in the

public interest to foster tailored HACCP

plans that demonstrate understanding and

thought, rather than promote the use of rote

plans and minimally acceptable standards

due to fear of public disclosure.

FDA understands that it cannot make

promises of confidentiality that exceed the

permissible boundaries established under the

Freedom of Information Act, nor does the

agency wish to do so in this case. The agency

still does not expect that it will be in

possession of a large volume of plans and

records at any given moment. However, given

the significant interest in this subject as

conveyed by the comments, FDA has

concluded that the final regulations should

reflect the fact that the HACCP plans and

records that do come into FDA’s possession

will generally meet the definition of either

trade secret or commercial confidential

materials.

The agency is not aware of any

circumstances that would warrant

different conditions for public

disclosure for records for juice HACCP

than those required for seafood HACCP.

Therefore, FDA is proposing the same

provisions for § 120.12(f) as are found in

§ 123.9(d).

In the Federal Register of March 20,

1997 (62 FR 13430), FDA issued

regulations at part 11 (21 CFR part 11)

that provide criteria for acceptance by

FDA, under certain circumstances, of

electronic records, electronic signatures,

and handwritten signatures executed to

electronic records as equivalent to paper

records and handwritten signatures

executed on paper. Proposed § 120.12(g)

allows for the maintenance of records

on computers in accordance with part

11. This provision simply makes clear

the fact that records can be maintained

on computers.

The agency requests comments on its

proposed approach to recordkeeping for

juice processors.

K. Training

In § 123.10 of the seafood HACCP

regulation, FDA required that certain

functions relating to the operation of a

HACCP system be conducted by an

individual who has successfully

completed training in the application of

HACCP principles to fish and fishery

product processing that is at least

equivalent to that received under a

standardized curriculum recognized as

adequate by FDA. Job experience that

has provided equivalent knowledge is

also acceptable. The trained individual

need not be an employee of the

company.

Training is essential to the effective

implementation of a HACCP system for

juice. Only a trained individual is

capable of effectively executing certain

activities, such as identifying

appropriate CCP’s, how to establish

CL’s, control measures, corrective

actions, and recordkeeping procedures.

The often seasonal nature, remote

location, and small size of many juice

processors also support the need for

formalized training.

However, these conditions also create

difficulty recruiting highly qualified

management and supervisory staff.

Given these factors, particularly in light

of what FDA learned in its pilot

program, the agency is concerned that a

significant portion of the juice industry

will be unprepared to meet the

requirements of a mandatory HACCP

program without some training (Ref. 59).

Therefore, FDA is proposing in

§ 120.13(a) that only an individual who

has met specified training requirements

can be responsible for certain functions.

Those functions are listed in proposed

§ 120.13(a)(1) through (a)(4). FDA has

discussed the basis for requiring that a

trained individual perform these

functions in the sections addressing

each particular proposed provision. The

agency is listing the functions that shall

be performed by a trained individual in

§ 120.13(a) for simplicity and is not

imposing any additional requirement

through this list.

Proposed § 120.13(b) requires that the

individual performing the functions

listed in proposed § 120.13(a) have

successfully completed training in the

application of HACCP principles to food

processing. The agency anticipates that

2- or 3-day training sessions, modeled

after the Better Process Control Schools

currently in place for low acid canned

food and acidified food manufacturers,

will be provided by various private

organizations and through academia.

FDA does not intend to run HACCPtraining courses for the industry.

FDA has been extensively involved

with a consortium called the ‘‘Seafood

HACCP Alliance’’ (the Alliance)

consisting of representatives from

Federal and State agencies, industry,

and academia, who have worked to

create a uniform, core training program

that will meet the requirements of the

seafood HACCP regulations and that

will cost very little. The training

program that has been developed by the

Alliance is based on the

recommendations of the NACMCF. The

core curriculum for the course consists

of basic HACCP principles that are

applicable to any food and, thus, are

also applicable to juice. It is the

agency’s intent to utilize the Alliance

materials, as applicable, as the standard

against which other course materials

may be judged. Therefore, the agency is

proposing in § 120.13(b) that the

training be at least equivalent to that

received under standardized curriculum

recognized as adequate by FDA.

FDA is also proposing in § 120.13(b)

that job experience may qualify an

individual to perform these functions if

such experience has provided

knowledge at least equivalent to that

provided through the standardized

curriculum. FDA acknowledges that a

short course in HACCP has its

limitations. For example, a 3-day course

might not have anything important to

offer to an individual who has had

significant job experience working with

or for an individual who is well-versed
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20477

in HACCP. Where a job experience has

imparted a level of knowledge at least

equivalent to that that could be

provided by short course training, that

individual would qualify as a trained

individual. FDA requests comments on

how processors will be able to

determine whether job experience has

provided the individual with the

specific knowledge and expertise to

develop and implement a HACCP

program.

FDA is proposing to provide in

§ 120.13(b) that the trained individual

need not be an employee of the

processor. Processors may utilize

consultants or other trained individuals

to perform these functions if they so

choose.

L. Application of Requirements to

Imported Products

The seafood HACCP regulation sets

forth requirements for importers of fish

and fishery products in § 123.12.

According to § 123.12(a), the importer

must either: (1) Obtain fish or fishery

products from a country that has an

active memorandum of understanding

or similar agreement with FDA that

documents the equivalency or

compliance of the inspection system of

the foreign country with the U.S. system

relative to the products being imported,

or (2) have and implement written

verification procedures, as described in

the regulation, for ensuring that the

products being imported were processed

in accordance with the requirements of

part 123. If the importer must engage in

affirmative verification steps, records of

the taking of these steps must be made

in English and be on file with the

importer, and available for inspection

by FDA (§ 123.12(c)). In the absence of

assurances that the imported fish or

fishery product has been processed

under conditions that are equivalent to

those required of domestic processors,

the product will appear to be

adulterated under section 402(a)(4) of

the act, and FDA will deny the product

entry (§ 123.12(d)) under section 801(a)

of the act (21 U.S.C. 381(a)).

Many types of juice are imported into

the United States. FDA’s inspection

system for imports consists largely of

reviewing the customs entries for

products being offered for entry into the

United States, engaging in wharf

examinations and sample collections for

laboratory analysis, and automatically

detaining products with a history of

problems (e.g., tamarind and tamarind

products, including juice and juice

concentrate). The same problems that

are present in domestically produced

juice can be present in imported juice

and may not be apparent from the

import review currently conducted by

FDA. Consequently, the agency

tentatively concludes that HACCP

controls for juice should apply to

imported products as well as to

domestic products.

FDA also tentatively concludes that

the importer should share responsibility

with the foreign processor for safety.

More often than not, it is the U.S.

importer, rather than the foreign

processor, who actually offers imported

juice for entry into the United States.

While many importers are conscientious

about the safety of the products that

they import, others have little

understanding of the potential hazards

associated with their products.

In the rulemaking process for seafood

HACCP, the agency considered many

options for compliance with HACCP

requirements and carefully crafted the

final regulation to incorporate a number

of them. These options provide great

flexibility for importers to achieve

compliance and thus, would appear to

be suitable for a wide variety of foods.

FDA tentatively concludes that importer

requirements for fish and fishery

products in § 123.12 are appropriate for

and applicable to juice, and is proposing

the same requirements in § 120.14

because the agency is not aware of any

circumstances that would necessitate

any differences in treatment between

juice imports and seafood imports.

Thus, while the agency has made some

minor editorial revisions for clarity,

proposed § 120.14 essentially tracks

§ 123.12. FDA requests comments on the

proposed import requirements for juice.

M. Pathogen Reduction

As discussed previously, one of the

NACMCF’s recommendations to FDA

was the use of safety performance

criteria instead of mandating the use of

a specific intervention technology (Ref.

53). Performance standards set forth

requirements in terms of what is to be

achieved by a given regulatory

requirement, and represent a shift in

focus from ‘‘command-and-control’’

regulations because they specify the

ends to be achieved (producing safe

juice products), not the means to

achieve those ends.

The NACMCF suggested that a

tolerable level of risk would 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 ml of juice daily. In addition, the

NACMCF stated that HACCP and safety

performance criteria should form the

general conceptual framework needed to

ensure the safety of juices, and that

control measures should be based on a

thorough hazard analysis. The NACMCF

stated that validation of the process

must be an integral part of this

framework.

Based on the evidence of microbial

outbreaks discussed in section I.A of

this document, FDA tentatively

concludes that processors must

establish controls for pathogen

reduction in juice. The requirements of

parts 113 and 114 mandate a process

that exceeds the proposed provision,

and, therefore, it is not necessary to

require that juices subject to part 113 or

114 meet the 5 log reduction

requirement in proposed § 120.24.

FDA is proposing to require in part

120, subpart B, that juice processors,

except those subject to the requirements

of part 113 or 114, include in their

HACCP plans control measures that are

known, or can be shown, to produce, at

a minimum, a 5 log (i.e., 105) reduction

in the most resistant microorganism of

public health significance that is likely

to occur in the juice for at least as long

as the shelf life of the product under

normal and moderate abuse conditions.

The agency requests comment on the

appropriateness of the 5 log reduction

performance standard and if other

approaches, such as establishing a

minimal acceptable risk standard for

juices, could be used that would ensure

the safety of the juice. The agency

requests comments on what such a

minimal acceptable risk standard

should be and how it would be

implemented. The agency also invites

interested persons to submit scientific

data concerning the acceptability of a 5

log reduction requirement or whether a

more or less stringent performance

standard (e.g., 3 or 7 log reduction) for

specific juices would be more

appropriate or whether different

approaches consistent with a minimal

acceptable risk standard for juices might

be appropriate for specific juices based

on their unique characteristics.

In the absence of known specific

pathogen-product associations, the

NACMCF recommended the use of E.

coli O157:H7 or L. monocytogenes as the

target organism, as appropriate. This

recommendation is based on the

number of known outbreaks of E.coli in

juice as described in section I.A of this

document and the ubiquitous nature of

L. monocytogenes. E. coli is known to be

unusually acid resistant (Refs. 60 and

61), and L. monocytogenes is relatively

heat resistant (Refs. 62 and 63).

Therefore, depending on the type of

juice, one of the two NACMCF

recommended target organisms will

likely be the most resistant

microorganism of public health
20478 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

significance. In controlling the target

microorganism, other pathogenic

organisms will likely also be controlled.

However, because FDA is proposing a

performance standard for pathogen

reduction in lieu of a time/temperature

requirement and is providing for a

cumulative pathogen reduction process,

the agency recognizes that other

microorganisms may be more

appropriate targets for juice processing.

For example, control measures other

than pasteurization may be more

effective for reducing E. coli O157:H7

and less effective for another pathogen,

and, thus, the most resistant pathogen

under the circumstances must be the

target pathogen.

Pasteurization is one process that will

achieve the 5 log reduction performance

standard. However, other interventions

(e.g., surface treatments) may be

adequate for some types of produce

(e.g., citrus fruits). As discussed

previously in section I.E of this

document, 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). Pathogens are not reasonably

likely to be present in the interior of

sound whole oranges or other citrus

fruits. In addition, the acidic nature of

citrus fruits may further inactivate any

pathogens that may be present.

Therefore, any contamination being

introduced into the juice will come from

the surface of the fruit or the food

contact surfaces of the equipment.

There are two possible means by

which contamination on the surface of

the fruit can be introduced into the

juice. First, the skin of the fruit can be

damaged allowing any pathogens

present to migrate inside the orange. An

appropriate HACCP program can control

this means of contamination through

grading and culling. This step may be

the first CCP in a HACCP plan for fresh

orange juice production with a critical

limit of zero defectives.

Secondly, contamination on the

surface of the skin can be introduced

from cutting into the orange to extract

the juice. This source may be controlled

by washing, brushing, and sanitizing the

fruit prior to cutting. This step may be

a CCP in the processing of fresh orange

juice with processors establishing

critical limits for the associated

parameters (e.g., temperature of water,

type and strength of sanitizers,

effectiveness of equipment).

Proper implementation of these two

CCP’s (i.e., zero defects and washing,

brushing, and sanitizing the fruit) could

potentially achieve a three log reduction

in microorganisms (Ref. 64). However,

as proposed, processors must validate

that such a reduction in the target

pathogen is occurring.

In addition to the two CCP’s,

processors must implement CGMP’s

(proposed § 120.5) and sanitation SOP’s

(proposed § 120.6) to ensure that the

working area and equipment are clean.

The most important step is sanitation of

the extraction equipment which may

harbor yeasts, molds, and acid tolerant

bacteria (Ref. 65). The 1995 outbreak of

Salmonella hartford associated with

fresh orange juice was most likely

related to poor CGMP’s (Ref. 9).

However, CGMP’s and sanitation SOP’s

alone are not sufficient to ensure a 5 log

reduction.

Extraction of orange juice and other

citrus juices is generally done by either

a machine which scores and cores the

fruit before squeezing or by cutting the

fruit in half and reaming out each side.

In the first instance, the only part of the

peel which is exposed to the fruit is the

cut core. In the second instance, the

edge of the knife will make contact with

the peel and could potentially

contaminate the fruit through the first

half of the cut (in the second half of the

cut, the knife leaves the fruit after

making contact with the peel). If most

of the surface of the skin of the orange

does not contact the interior (juice)

during extraction and the peel is

discarded, such an extraction technique

may be considered a CCP contributing

towards the reduction of the potential

pathogenic load.

For purposes of illustration, FDA has

simplified some of the extraction

methods in order to calculate the

possible log reduction in pathogens that

might occur from different methods of

extraction. In the ‘‘coring’’ extraction

method, using an example of an orange

that is 4 inches in diameter with a 1⁄2

inch core cut, there could potentially be

a 2 log reduction by only allowing

contact with the surface area contained

by a 1⁄2-inch circle of the outside of the

peel. That is, a 4-inch orange has about

50 square inches of peel and a 1⁄2-inch

circle contains an area of 0.78 inches so

that only 1.6 percent (.78/50) of the

outside would be potentially in contact

with the inner part of the orange.

However, FDA points out that under

proposed part 120, processors must be

able to validate that the reduction in the

target pathogen is occurring.

In the cutting method of extraction,

there would also be a considerable

reduction in the amount of potentially

contaminated produce discarded. If, for

example the knives used were 0.01 inch

thick, the area of the exterior part of the

orange that would make contact with

the interior would be the top half of the

circumference of the orange multiplied

by the width of the knife, or about 0.06

square inches with a 4-inch (diameter)

orange. Thus, the reduction of

pathogens could be approximately 3 log

(0.06/50) just by discarding the orange

peel. Again, under proposed part 120,

processors must be able to validate that

this reduction is occurring in the target

pathogen.

Thus, it may be feasible that a

processor use a combination of CGMP’s,

sanitation SOP’s, and at least the three

CCP’s discussed previously ((1) Culling

and grading; (2) washing, brushing, and

sanitizing; and (3) appropriate methods

of extraction) and achieve a 5 log

reduction in a target pathogen for orange

juice. If so, it is unlikely that processors

of fresh orange juice, and perhaps other

fresh citrus fruit juices, will have to

implement pasteurization in order to

achieve a 5 log reduction in pathogenic

bacteria. In addition, FDA anticipates

that manufacturers of other juices, such

as apple juice, may be able to use other

technologies and practices in lieu of

pasteurization (such as a combination of

eliminating use of drops, brushing,

washing, and using sanitizers) provided

that the process is validated to achieve

the 5 log reduction in the target

pathogen. However, the agency points

out that under the proposed rule,

processors must establish CL’s for each

CCP, monitor CL’s to ensure

compliance, conduct verification and

validation procedures, and maintain

records of these actions. In addition, the

5 log reduction must be of a target

organism.

Each type of control measure used in

a cumulative process introduces a

unique variable in attaining the overall

target of pathogen reduction. The

physical parameters of the juice and

how the product will be handled after

it leaves the processing plant, and

before it is consumed, must be

considered in the selection of the target

organism. Processors must take into

consideration time, temperature, pH,

and Brix parameters and other matters

for juice products in order to provide

adequate pathogen control. Time,

temperature, juice pH, and Brix directly

affect the rate of growth and the types

of microorganisms.

The proposed 5 log reduction

standard of proposed § 120.24 requires

that this reduction be achieved and

persist for at least the shelf life of the

product when the product is stored

under normal and moderate abuse
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20479

conditions. Normal handling of juice

includes the movement of the juice from

the plant to retail (e.g., transportation,

warehouse storage) and consumer

handling after purchase (e.g., transport

home, setting out on a counter or table).

Moderate abuse may occur when

unusual circumstances arise during

regular handling. For example,

unloading a truck on a hot day where

the product may sit on a loading dock

for a short period of time could

constitute moderate abuse. In addition,

moderate abuse could occur if

consumers purchase a product on a

warm day, place it in their car, and run

errands before refrigerating the product.

In FDA’s view, moderate abuse does not

include exposure to high temperatures

for extended periods of time.

The proposed requirement mandates

that processors validate that the control

measures are both appropriate to their

operation and scientifically sound. In

many cases, processors may rely on a

written certification from the equipment

manufacturer or may obtain a written

scientific evaluation of a process,

especially in cases where two or more

control measures are used to accomplish

the 5 log reduction in the target

pathogen, to ensure that the process is

adequate to destroy microorganisms of

public health significance or to prevent

their growth. Such an evaluation may

also be necessary to ensure the

adequacy of the pasteurization or

refrigerating equipment used by the

processor.

Comments on the notice of intent (62

FR 45593, August 28, 1997) addressed

the issue of pathogen reduction. One

comment stated that a 2 1/2 log

reduction in fruit surface microflora

from washing was adequate. Some

comments asked from what point the 5

log reduction would be measured (e.g.,

washing of produce).

FDA tentatively concludes that the

cumulative 5 log reduction could be

measured from the point of the

processors’ initial treatment of the intact

fruit or vegetable. If pathogens are

meaningfully reduced on the raw

produce through washing or other

treatment, and the product is processed

under an adequate HACCP program, the

hazard from the presence of pathogens

may be controlled. However, this

control measure may not be adequate or

appropriate for all types of produce

because of differences in surfaces, areas

that are difficult to clean, inclusion of

peel or outer layer in the juice, and

tissue fragility.

The agency requests comments on its

approach to pathogen reduction. In

particular, the agency requests

comments on whether all juices should

be subject to proposed § 120.24, or

whether such a requirement may not be

necessary for certain juices or types of

juices. FDA also requests comments on

whether a 5 log reduction is appropriate

for all juices, or whether a higher or

lower requirement would be adequate

for some types of juice.

V. The Paperwork Reduction Act of

1995

This proposed rule contains

information collection requirements that

are subject to public comment and

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The title, description, and

respondent description of the

information collections are shown

below with an estimate of the annual

recordkeeping burden. Included in the

estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

FDA invites comments on: (1)

Whether the proposed collection of

information is necessary for the proper

performance of FDA’s functions,

including whether the information will

have practical utility; (2) the accuracy of

the agency’s estimate of the burden of

the proposed collection of information

including the validity of methodology

and assumptions used; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques

when appropriate or other forms of

information technology.

Title: Hazard Analysis and Critical

Control Point (HACCP) Systems—

Reporting and recordkeeping

requirements for processors of fruit and

vegetable juices under the provisions of

21 CFR part 120.

Description: Section 402(a)(1) (21

U.S.C. 342(a)(1)) of the Federal Food,

Drug, and Cosmetic Act (the act) states

that a food shall be deemed to be

adulterated if it bears or contains any

poisonous or deleterious substance

which may render it injurious to health.

Section 402(a)(4) (21 U.S.C. 342(a)(4)) of

the act states that a food shall be

deemed to be adulterated if it has been

prepared, packed, or held under

insanitary conditions whereby it may

have become contaminated with filth, or

whereby it may have been rendered

injurious to health. The proposed

regulation set forth in this proposed rule

would require processors to use Hazard

Analysis and Critical Control Point

(HACCP) methodology to ensure that

fruit and vegetable juices are safe under

the act. HACCP is a preventive system

of hazard control.

Description of Respondents:

Businesses or other for profit

organizations.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Sections No. of

Recordkeepers

Annual

Frequency

Hours per

Recordkeeper Total Hours

120.6(c) 600 12 4 4,8002

120.12(a)(1) and (a)(2), 120.6(c)-(d), and 120.12(a)(5) 600 1 2 1,200

120.7 and 120.12(a)(2) and (c)(1) 600 12 8 4,8002

120.8(a) and 120.12(a)(3) and (c) 600 12 8 4,8002

120.8(b)(7) and 120.12(a)(4)(i) 600 14,600 0.01 87,600

120.11(b) and 120.12(a)(5) 600 1 4 2,400

120.11(a)(1)(iv) 600 52 0.1 3,120

120.10(c) and 120.12(a)(4)(ii) 600 12 0.1 720

120.14(a)(2) 308 1 4 1,232

120.12(e) 1823 1 4 728

Totals:

First year 111,400

Subsequent years 97,000
20480 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

There are no operating and maintenance cost or capital costs associated with this collection of information.

2First year only.

3Assuming that producers and importers are subject to official review on a 5-year cycle.

The burden for these activities will

vary considerably among processors and

importers of juice and juice products,

depending on the type and number of

products involved, and the nature of the

equipment or instruments required to

monitor critical control points. The

burdens have been estimated based on

the estimated average annual

information collection burden for

seafood HACCP (60 FR 65096 at 65178;

December 18, 1995). As noted in the

preliminary regulatory impact analysis

for this proposal, FDA estimates that

there are at least 600 firms producing

juice products of the type affected by

this proposed rulemaking.

In compliance with section 3507(d) of

the Paperwork Reduction Act of 1995

(44 U.S.C. 3507(d)), the agency has

submitted the information collection

provisions of this proposed rule to OMB

for review. Interested persons are

requested to submit comments regarding

information collection by May 26, 1998,

to the OMB (address above), Attention:

Desk Officer for FDA.

VI. Environmental Impact

The agency has determined under 21

CFR 25.30(j) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VII. Analysis of Impacts

A. Preliminary Regulatory Impact

Analysis

In accordance with Executive Order

12886, FDA has developed a single

preliminary regulatory impact analysis

(PRIA) that estimates benefits and costs

associated with both this HACCP

proposal and the warning label proposal

for juice. The agency will promptly

publish the PRIA in the Federal

Register.

B. Small Entity Analysis

In accordance with the Regulatory

Flexibility Act (5 U.S.C. 601–612), FDA

has developed a single small entity

analysis that estimates benefits and

costs associated with both this HACCP

proposal and the warning label proposal

for juice. The agency will promptly

publish the small entity analysis in the

Federal Register.

VIII. Request for Comments

Interested persons may, on or before

July 8, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

IX. References

The following information has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m. Monday

through Friday.

1. Centers for Disease Control and

Prevention, ‘‘Outbreak of Escherichia coli

O157:H7 Infections Associated With

Drinking Unpasteurized Commercial Apple

Juice—British Columbia, California,

Colorado, and Washington,’’ October 1996,

MMWR, 45(44):875, November 8, 1996.

2. Griffin, P. M., ‘‘Report of O157:H7

Outbreaks Caused by Juices,’’ Current

Science and Technology on Fresh Juices,

Transcript of Public Meeting, vol. 1:15–27,

December 16 and 17, 1996.

3. Tabershaw, I. R., L. L. Schmelzer, and

H. B. Bruyn, ‘‘Gastroenteritis From an Orange

Juice Preparation I, Clinical and

Epidemiological Aspects,’’ Archives of

Environmental Health 15:72–77, 1967.

4. Schmelzer, L. L., J. M. Gates, M. S.

Redfearn, and I. R. Tabershaw,

‘‘Gastroenteritis From an Orange Juice

Preparation II, Field and Laboratory

Investigation,’’ Archives of Environmental

Health, 15:78–82, 1967.

5. Centers for Disease Control, ‘‘Salmonella

typhimurium Outbreak Traced to a

Commercial Apple Cider— New Jersey,’’

MMWR 24:87–88, 1975

6. Centers for Disease Control and

Prevention, ‘‘Cholera Associated With

Imported Frozen Coconut Milk—Maryland,’’

MMWR 40(49):844–843, 1991.

7. Millard, P. S., K. R. Gensheimer, D. G.

Addiss, D. M. Sosin, G. A. Beckett, A. HouckJankoski, and A. Hudson, ‘‘An Outbreak of

Cryptosporidiosis From Fresh-pressed Apple

Cider,’’ JAMA 272(20):1592–1596, 1994.

8. Centers for Disease Control and

Prevention, 1997, ‘‘Outbreaks of Escherichia

coli O157:H7 Infection and Cryptosporidiosis

Associated With Drinking Unpasteurized

Apple Cider—Connecticut and New York,’’

MMWR 46(1):4–8, October 1996.

8A. Memorandum of telephone

conversation between Mike Cambridge, New

York State Health Department, and Clark

Nardinelli, FDA, April 20, 1998.

9. Cook, K. A., 1996, EPI–AID 95–62 Trip

Report: ‘‘Outbreak of Salmonella Hartford

Infections Among Travelers to Orlando,

Florida,’’ Centers for Disease Control and

Prevention Memorandum, October 1, 1995.

10. Steele, B. T., N. Murphy, G. S. Arbus,

and C. P. Rance, ‘‘An Outbreak of Hemolytic

Uremic Syndrome Associated With

Ingestions of Fresh Apple Juice,’’ Journal of

Pediatrics 101(6):963–965, 1982.

11. Besser, R. E., S. M. Lett, J. T. Weber,

M. P. Doyle, T. J. Barrett, J. G. Wells, and P.

M. Griffin, ‘‘An Outbreak of Diarrhea and

Hemolytic Uremic Syndrome From

Escherichia coli O157:H7 in Fresh-pressed

Apple Cider, JAMA 269(17):2217–2220, 1993.

12. Whatcom County (Washington) Health

Department, Summary of a Suspected

Outbreak of E. coli O157:H7 Associated With

Consumption of Unpasteurized Apple Cider,

2 pages, 1996.

13. Webb, R. W., ‘‘Gastroenteritis in

Elementary School Students after Drinking

Orange Juice, Mobile County,’’ Note to

Epidemiology File, May 10, 1994.

14. Memorandum of telephone

conversation between Mike Cambridge, New

York State Health Department, and Debra

Street, FDA, January 22, 1997.

15.Memorandum of telephone

conversation between Patty Walker,

Washington State Health Department, and

Debra Street, FDA, January 15, 1997.

16.Memorandum of telephone

conversation between Susan Karam, Ohio

State Health Department, and Debra Street,

FDA, January 21, 1997.

17. Memorandum of telephone

conversation between Roberta Hammond,

Florida State Health Department, and Debra

Street, FDA, January 21, 1997.

18. Memorandum of telephone

conversation between Pam Shillam, Colorado

State Health Department, and Debra Street,

FDA, January 17, 1997.

19. Barker, W. H., and V. Runte, 1972,

‘‘Tomato Juice-associated Gastroenteritis,

Washington and Oregon,’’ American Journal

of Epidemiology 96(2):219–226, 1969.

20. Centers for Disease Control, ‘‘Poisoning

From Elderberry Juice —California,’’ MMWR

33(13):173–174, 1984.

21. Memorandum of telephone

conversation between Dr. K. Hendricks,

Texas State Health Department, and Debra

Street, FDA, January 16, 1997.

22. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–680–7, August 12

and 27, 1997.

23. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–411/420–2, July

14 and 30, 1992, and August 12, 1992.

24. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–346–8, July 14, 20,

and 27, 1988.

25. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20481

for firm-initiated recall #F–400/421–1, May

23, 1991, and June 6 and 19, 1991.

26. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–189/190–5,

January 6 and 25, 1995.

27. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–338/339–8, July 6, 7, and 27,

1988.

28. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–68–9, November

16, 1988, and December 6 and 14, 1988.

29. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–092/093–0, October 19, 1989,

and November 1, 1989.

30. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–523–0, June 27, 1990, and July

10 and 18, 1990.

31. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–107–1, November 14, 1990;

December 31, 1990; January 9, 1991; and

February 6, 1991.

32. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–421–2, July 8, 10, and 22, 1992.

33. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–285–3, April 1 and 21, 1993.

34. FDA, Health hazard evaluation,

classification and FDA Enforcement Report

for recall #F–665–5, May 16, 18, and 31,

1995.

35. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–529–1, September 4, 5, and 18,

1991.

36. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–364–2, June 23, 1992, and July

2, 1992.

37. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm initiated recall #F–319–3, May 4 and

19, 1993.

38. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–250–4, January 13 and 27, 1994,

and February 9, 1994.

39. FDA, Health hazard evaluations,

classification, and FDA Enforcement Report

for recall #F–492–7, June 27, 1997, and July

2 and 16, 1997.

40. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–427–1, June 3, 11,

and 19, 1991.

41. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–781–4, August 9,

10, and 24, 1994.

42. FDA, Health hazard evaluation,

classification, and Enforcement Report for

recall #F–406–7, May 1 and 7, 1997

43. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for firm-initiated recall #F–584/596–6, June

6, 7, and 26, 1996.

44. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–023–7, October 24 and 30, 1996.

45. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–036–7, October 23 and 30, 1996,

and November 13, 1996.

46. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–072–7, November 14 and 20,

1996.

47. FDA, Health hazard evaluation,

classification, and FDA Enforcement Report

for recall #F–073–7, November 14 and 20,

1996.

48. Trucksess, M. W., memorandum to

Martin J. Stutsman on Patulin—97–688–239,

Apple Juice Concentrate, March 31, 1997.

49. Wagstaff, J., memorandum to M. J.

Stutsman, and T. C. Troxell on the hazard of

patulin in apple juice concentrate sample 97–

688–239, April 2, 1997, and July 18, 1997.

50. Williams, R. T. Wilcox, B. Timbo, D.

Street, C. Nardinelli, P. McCarthy, G. Jackson,

M. T. Hendricks, and E. Elliot, ‘‘Preliminary

Investigation Into the Morbidity and

Mortality Effects Associated With the

Consumption of Fruit and Vegetable Juices,’’

October 31, 1997.

51. FDA, ‘‘Pesticide Program Residue

Monitoring 1994,’’ J. AOAC International,

vol. 78, September/October 1995.

52. FDA, 1996, ‘‘Pesticide Program Residue

Monitoring 1995.’’

53. National Advisory Committee on

Microbiological Criteria for Foods,

‘‘NACMCF Recommendations on Fresh

Juice,’’ April 9, 1997.

54. U.S. Public Health Service, ‘‘Food

Code, 1997 Recommendations of the United

States Public Health Service, Food and Drug

Administration,’’ National Technical

Information Service Publication PB95–

265492, p. 73.

55. National Advisory Committee on

Microbiological Criteria for Foods, ‘‘Hazard

Analysis and Critical Control Point

Principles and Application Guidelines,’’

August 14, 1997.

56. Webster’s II New Riverside University

Dictionary, The Riverside Publishing Co., p.

657, 1994.

57. FDA, ‘‘Hazard Analysis and Critical

Control Point (HACCP) Pilot Program for

Selected Food Manufacturers: Second

Interim Report of Observations and

Comments,’’ October 31, 1997.

58. Davis, S. A., memorandum to file: ‘‘

Hazard Analysis and Critical Control Point

(HACCP) Systems for Juice; Consideration of

Hazards that are Reasonably Likely to

Occur,’’ October 21, 1997.

59. FDA, Hazard Analysis Critical Control

Point (HACCP) Pilot Program for Selected

Food Manufacturers: Interim Report of

Observations and Comments, June 19, 1996.

60. Zhao, T., M. P. Doyle, and R. E. Besser,

‘‘Fate of Enterohemorrhagic Escherichia coli

O157:H7 in Apple Cider With and Without

Preservatives,’’ Applied and Environmental

Microbiology, 59(8):2526–2530.

61. Miller, L. G., and C. W. Kaspar,

‘‘Escherichia coli O157:H7 Acid Tolerance

and Survival in Apple Cider,’’ Journal of

Food Protection, 57(6):460–464, 1994.

62. Bradshaw, J. G., J. T. Peeler, J. J.

Corwin, J. M. Hunt, J. T. Tierney, E. P.

Larkin, and R. M. Twedt, ‘‘Thermal

Resistance of Listeria monocytogenes in

Milk,’’ Journal of Food Protection, 48:743–

745, 1985.

63. Doyle, M. P., K. A. Glass, J. T. Beery,

G. A. Garcia, D. J. Pollard, and R. D. Schultz,

‘‘Survival of Listeria monocytogenes in Milk

During High-Temperature, Short-Time

Pasteurization,’’ Applied and Environmental

Microbiology, 53(7):1433–1438, 1987.

64. Memorandum of telephone

conversation between Mickey Parish,

University of Florida, and Richard Williams,

FDA, December 31, 1997.

65. Winniczuk, P. P., and M. E. Parish,

‘‘Minimum Inhibitory Concentrations of

Antimicrobials Against Microorganisms

Related to Juice,’’ Food Microbiol., 14(4):373–

381, 1997.

List of Subjects in 21 CFR Part 120

Fruit and vegetable juice, Food,

Imports, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, under the

Public Health Service Act, and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

title 21 CFR chapter I be amended as

follows:

1. Part 120 is added to read as follows:

PART 120—HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP)

SYSTEMS

Subpart A—General Provisions

Sec.

120.1 Applicability.

120.3 Definitions.

120.5 Current good manufacturing practice.

120.6 Prerequisite program standard

operating procedures.

120.7 Hazard analysis.

120.8 Hazard Analysis Critical Control Point

(HACCP) plan.

120.9 Legal basis.

120.10 Corrective actions.

120.11 Verification and validation.

120.12 Records.

120.13 Training.

120.14 Application of requirements to

imported products.

Subpart B—Pathogen Reduction

120.20 General.

120.24 Process controls.

Authority: 21 U.S.C. 321, 342, 343, 346,

348, 371, 374, 379e, 381, 393; 42 U.S.C. 241,

242l, 264.

Subpart A—General Provisions

§ 120.1 Applicability.

(a) Any juice sold as such or used as

an ingredient in beverages shall be

processed in accordance with the

requirements of this part. Juice means

the aqueous liquid expressed or

extracted from one or more fruits or

vegetables, purees of the edible portions

of one or more fruits or vegetables, or

any concentrates of such liquid or

puree.
20482 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

(b) The regulations in this part shall

be effective 1 year after the date of

publication of the final rule in the

Federal Register. However, by its terms,

this part is not binding on small and

very small businesses until the dates

listed in paragraphs (b)(1) and (b)(2) of

this section.

(1) For small businesses employing

fewer than 500 persons the regulations

in this part are binding 2 years after the

date of publication of the final rule in

the Federal Register.

(2) For very small businesses that

have either total annual sales of less

than $500,000, or if their total annual

sales are greater than $500,000 but their

total food sales are less than $50,000; or

the person claiming this exemption

employed fewer than an average of 100

full-time equivalent employees and

fewer than 100,000 units of juice were

sold in the United States, the

regulations are binding 3 years after the

date of publication of the final rule in

the Federal Register.

§ 120.3 Definitions.

The definitions and interpretations of

terms in section 201 of the Federal

Food, Drug, and Cosmetic Act,

§ 101.9(j)(18)(vi), and part 110 of this

chapter are applicable to such terms

when used in this part, except where

redefined in this part. The following

definitions shall also apply:

(a) Control means to prevent,

eliminate, or reduce.

(b) Control measure means any action

or activity that can be used to prevent,

eliminate, or reduce a hazard.

(c) 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.

(d) Critical limit means the maximum

or minimum value to which a physical,

biological, or chemical parameter must

be controlled at a critical control point

to prevent, eliminate, or reduce to an

acceptable level the occurrence of the

identified food hazard.

(e) Food hazard means any biological,

chemical, or physical property that may

cause a food to be unsafe for human

consumption.

(f) Importer means either the U.S.

owner or consignee at the time of entry

of a food product into the United States,

or the U.S. agent or representative of the

foreign owner or consignee at the time

of entry into the United States. The

importer is responsible for ensuring that

goods being offered for entry into the

United States are in compliance with all

applicable laws. For the purposes of this

definition, the importer is ordinarily not

the custom house broker, the freight

forwarder, the carrier, or the steamship

representative.

(g) Monitor means to conduct a

planned sequence of observations or

measurements to assess whether a

process, point, or procedure is under

control and to produce an accurate

record for use in verification.

(h)(1) Processing means activities that

are directly related to the production of

juice products.

(2) For purposes of this part,

processing does not include:

(i) Harvesting, picking, or transporting

raw agricultural ingredients of juice

products, without otherwise engaging in

processing.

(ii) The operation of a retail

establishment; and

(iii) The operation of a retail

establishment that is a very small

business and that makes juice on its

premises, provided that the

establishment’s total sales of juice and

juice products do not exceed 40,000

gallons per year, and that sells such

juice:

(A) Directly to consumers or

(B) directly to consumers and other

retail establishments.

(i) Processor means any person

engaged in commercial, custom, or

institutional processing of juice

products, either in the United States or

in a foreign country. A processor

includes any person engaged in the

processing of juice products that are

intended for use in market or consumer

tests.

(j) Shall is used to state mandatory

requirements.

(k) Should is used to state

recommended or advisory procedures or

to identify recommended equipment.

§ 120.5 Current good manufacturing

practice.

Part 110 of this chapter applies in

determining whether the facilities,

methods, practices, and controls used to

process food are safe, and whether the

food has been processed under sanitary

conditions.

§ 120.6 Prerequisite program standard

operating procedures.

(a) Sanitation controls. Each processor

shall have and implement a sanitation

standard operating procedure (SOP) that

addresses sanitation conditions and

practices before, during, and after

processing and relates to the following:

(1) Safety of the water that comes into

contact with food or food contact

surfaces or that is used in the

manufacture of ice;

(2) Condition and cleanliness of food

contact surfaces, including utensils,

gloves, and outer garments;

(3) Prevention of cross-contamination

from insanitary objects to food, food

packaging material, and other food

contact surfaces, including utensils,

gloves, and outer garments, and from

raw product to processed product;

(4) Maintenance of hand washing,

hand sanitizing, and toilet facilities;

(5) Protection of food, food packaging

material, and food contact surfaces from

adulteration with lubricants, fuel,

pesticides, cleaning compounds,

sanitizing agents, condensate, and other

chemical, physical, and biological

contaminants;

(6) Proper labeling, storage, and use of

toxic compounds;

(7) Control of employee health

conditions that could result in the

microbiological contamination of food,

food packaging materials, and food

contact surfaces; and

(8) Exclusion of pests from the food

plant.

(b) Monitoring. The processor shall

monitor the conditions and practices

during processing with sufficient

frequency to ensure, at a minimum,

conformance with those conditions and

practices specified in part 110 of this

chapter that are appropriate both to the

plant and to the food being processed.

Each processor shall correct, in a timely

manner, those conditions and practices

that are not met.

(c) Records. Each processor shall

maintain prerequisite program SOP

records that, at a minimum, document

the monitoring and corrections

prescribed by paragraph (b) of this

section. These records are subject to the

recordkeeping requirements of § 120.12.

(d) Relationship to Hazard Analysis

and Critical Control Point (HACCP)

plan. Prerequisite program SOP controls

may be included in the HACCP plan

required under § 120.8(b). However, to

the extent that they are implemented in

accordance with this section, they need

not be included in the HACCP plan.

§ 120.7 Hazard analysis.

Each processor shall develop, or have

developed for it, a written hazard

analysis to determine whether there are

food hazards that are reasonably likely

to occur for each type of juice processed

by that processor and to identify the

control measures that the processor can

apply to control those hazards. The

hazard analysis shall include food

hazards that can be introduced both

within and outside the processing plant

environment, including food hazards

that can occur before, during, and after

harvest. A food hazard that is

reasonably likely to occur is one for

which a prudent processor would

establish controls because experience,
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20483

illness data, scientific reports, or other

information provide a basis to conclude

that there is a reasonable possibility

that, in the absence of those controls,

the food hazard will occur in the

particular type of product being

processed. The hazard analysis shall be

developed by an individual or

individuals who have been trained in

accordance with § 120.13 and shall be

subject to the recordkeeping

requirements of § 120.12.

(a) In evaluating what 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 pesticides residues;

(5) Decomposition in food where a

food hazard has been associated with

decomposition;

(6) Natural toxins;

(7) Unapproved use of food or color

additives;

(8) Presence of undeclared ingredients

that may be allergens; and

(9) Physical hazards.

(b) 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.

§ 120.8 Hazard Analysis Critical Control

Point (HACCP) plan.

(a) HACCP plan. Every processor shall

have and implement a written HACCP

plan whenever a hazard analysis reveals

one or more food hazards that are

reasonably likely to occur during

processing, as described in § 120.7. The

HACCP plan shall be developed by an

individual or individuals who have

been trained in accordance with

§ 120.13 and shall be subject to the

recordkeeping requirements of § 120.12.

A HACCP plan shall be specific to:

(1) Each location where juice is

processed by that processor; and

(2) Each type of juice processed by the

processor. The plan may group types of

juice products together, or group types

of production methods together, if the

food hazards, critical control points,

critical limits, and procedures required

to be identified and performed by

paragraph (b) of this section are

essentially identical, 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.

(b) The contents of the HACCP plan.

The HACCP plan shall, at a minimum:

(1) List all food hazards that are

reasonably likely to occur as identified

in accordance with § 120.7, and that

thus must be controlled for each type of

product.

(2) List the critical control points for

each of the identified food hazards,

including as appropriate:

(i) Critical control points designed to

control food hazards that could occur or

could be introduced inside the

processing plant environment; and

(ii) Critical control points designed to

control food hazards introduced outside

the processing plant environment,

including food hazards that occur

before, during, and after harvest;

(3) List the critical limits that shall be

met at each of the critical control points;

(4) List the procedures, and the

frequency with which they are to be

performed, that will be used to monitor

each of the critical control points to

ensure compliance with the critical

limits;

(5) Include any corrective action plans

that have been developed in accordance

with § 120.10(a), and that are to be

followed in response to deviations from

critical limits at critical control points;

(6) List the validation and verification

procedures, and the frequency with

which they are to be performed, that the

processor will use in accordance with

§ 120.11; and

(7) Provide for a recordkeeping system

that documents the monitoring of the

critical control points in accordance

with § 120.12. The records shall contain

the actual values and observations

obtained during monitoring.

(c) Products subject to other

regulations. HACCP plans for juice need

not address the food hazards associated

with microorganisms and microbial

toxins that are controlled by the

requirements of part 113 or 114 of this

chapter. A HACCP plan for such juice

shall address any other food hazards

that are reasonably likely to occur.

(d) Sanitation. Sanitation controls

may be included in the HACCP plan.

However, to the extent that they are

monitored in accordance with § 120.6,

they are not required to be included in

the HACCP plan.

§ 120.9 Legal basis.

Failure of a processor to have and to

implement a Hazard Analysis and

Critical Control Point (HACCP) system

that complies with §§ 120.6, 120.7, and

120.8, or otherwise to operate in

accordance with the requirements of

this part, shall render the juice products

of that processor adulterated under

section 402(a)(4) of the Federal Food,

Drug, and Cosmetic Act. Whether a

processor’s actions are consistent with

ensuring the safety of juice will be

determined through an evaluation of the

processor’s overall implementation of

its HACCP system.

§ 120.10 Corrective actions.

Whenever a deviation from a critical

limit occurs, a processor shall take

corrective action by following the

procedures set forth in paragraph (a) or

paragraph (b) of this section.

(a) Processors may develop written

corrective action plans, which become

part of their Hazard Analysis and

Critical Control Point (HACCP) plans in

accordance with § 120.8(b)(5), by which

processors predetermine the corrective

actions that they will take whenever

there is a deviation from a critical limit.

A corrective action plan that is

appropriate for a particular deviation is

one that describes the steps to be taken

and assigns responsibility for taking

those steps, to ensure that:

(1) No product enters commerce that

is either injurious to health or is

otherwise adulterated as a result of the

deviation; and

(2) The cause of the deviation is

corrected.

(b) When a deviation from a critical

limit occurs, and the processor does not

have a corrective action plan that is

appropriate for that deviation, the

processor shall:

(1) Segregate and hold the affected

product, at least until the requirements

of paragraphs (b)(2) and (b)(3) of this

section are met;

(2) Perform or obtain a review to

determine the acceptability of the

affected product for distribution. The

review shall be performed by an

individual or individuals who have

adequate training or experience to

perform such review. Adequate training

may or may not include training in

accordance with § 120.13;

(3) Take corrective action, when

necessary, with respect to the affected

product 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, when

necessary, to correct the cause of the

deviation; and

(5) Perform or obtain timely

validation in accordance with § 120.11,

by an individual or individuals who

have been trained in accordance with

§ 120.13, to determine whether

modification of the HACCP plan is

required to reduce the risk of recurrence

of the deviation, and to modify the

HACCP plan as necessary.

(c) All corrective actions taken in

accordance with this section shall be

fully documented in records that are
20484 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

subject to verification in accordance

with § 120.11(a)(1)(iv)(B) and the

recordkeeping requirements of § 120.12.

§ 120.11 Verification and validation.

(a) Verification. Every processor shall

verify that the Hazard Analysis and

Critical Control Point (HACCP) system

is being implemented according to

design.

(1) Verification activities shall

include:

(i) A review of any consumer

complaints that have been received by

the processor to determine whether

such complaints relate to the

performance of the HACCP plan or

reveal previously unidentified critical

control points;

(ii) The calibration of processmonitoring instruments;

(iii) At the option of the processor, the

performance of periodic end-product or

in-process testing;

(iv) A review, including signing and

dating, by an individual who has been

trained in accordance with § 120.13, of

the records that document:

(A) The monitoring of critical control

points. The purpose of this review shall

be, at a minimum, to ensure that the

records are complete and to verify that

the records document values that are

within the critical limits. This review

shall occur within 1 week (7 days) of the

day that the records are made;

(B) The taking of corrective actions.

The purpose of this review shall be, at

a minimum, to ensure that the records

are complete and to verify that

appropriate corrective actions were

taken in accordance with § 120.10. This

review shall occur within 1 week (7

days) of the day that the records are

made; and

(C) The calibrating of any process

monitoring instruments used at critical

control points and the performance of

any periodic end-product or in-process

testing that is part of the processor’s

verification activities. The purpose of

these reviews shall be, at a minimum, to

ensure that the records are complete and

that these activities occurred in

accordance with the processor’s written

procedures. These reviews shall occur

within a reasonable time after the

records are made; and

(v) The following of procedures in

§ 120.10 whenever any verification

procedure, including the review of

consumer complaints, establishes the

need to take a corrective action.

(2) The calibration of processmonitoring instruments, and the

performance of any periodic endproduct and in-process testing, in

accordance with paragraphs (a)(1)(iv)(B)

through (a)(1)(iv)(C) of this section, shall

be documented in records that are

subject to the recordkeeping

requirements of § 120.12.

(b) Validation of the HACCP plan.

Every processor shall validate that the

HACCP plan is adequate to control food

hazards that are reasonably likely to

occur; this validation shall occur at least

once within 12 months after

implementation and at least annually

thereafter or whenever any changes in

the process occur that could affect the

hazard analysis or alter the HACCP plan

and prerequisite program of the

standard operating procedures (SOP’s)

in any way. Such changes may include

changes in the following: Raw materials

or source of raw materials; product

formulation; processing methods or

systems, including computers and their

software; packaging; finished product

distribution systems; or the intended

use or consumers of the finished

product. The validation shall be

performed by an individual or

individuals who have been trained in

accordance with § 120.13 and shall be

subject to the recordkeeping

requirements of § 120.12. The HACCP

plan shall be modified immediately

whenever a validation reveals that the

plan is no longer adequate to fully meet

the requirements of this part.

(c) Validation of the hazard analysis.

Whenever a juice processor has no

HACCP plan because a hazard analysis

has revealed no food hazards that are

reasonably likely to occur, the processor

shall reassess the adequacy of that

hazard analysis whenever there are any

changes in the process that could

reasonably affect whether a food hazard

exists. Such changes may include

changes in the following: Raw materials

or source of raw materials; product

formulation; processing methods or

systems, including computers and their

software; packaging; finished product

distribution systems; or the intended

use or intended consumers of the

finished product. The validation shall

be performed by an individual or

individuals who have been trained in

accordance with § 120.13 and shall be

subject to the recordkeeping

requirements of § 120.12.

§ 120.12 Records.

(a) Required records. Processors shall

maintain the following records

documenting the processor’s Hazard

Analysis and Critical Control Point

(HACCP) system:

(1) Records documenting the

implementation of the prerequisite

program of the standard operating

procedures (SOP’s) (see § 120.6);

(2) The written hazard analysis

required by § 120.7;

(3) The written HACCP plan required

by § 120.8;

(4) Records documenting the ongoing

application of the HACCP plan that

include:

(i) Monitoring of critical control

points and their critical limits,

including the recording of actual times,

temperatures, or other measurements, as

prescribed in the establishment’s

HACCP plan; and

(ii) Corrective actions, including all

actions taken in response to a deviation;

and

(5) Records documenting verification

of the HACCP system and validation of

the HACCP plan or hazard analysis.

(b) General requirements. All records

required by this part shall include:

(1) The name and location of the

processor or importer;

(2) The date and time of the activity

that the record reflects;

(3) The signature or initials of the

person performing the operation or

creating the record; and

(4) Where appropriate, the identity of

the product and the production code, if

any. Processing and other information

shall be entered on records at the time

that it is observed. The records shall

contain the actual values and

observations obtained during

monitoring.

(c) Documentation. (1) The records in

paragraphs (a)(2) and (a)(3) of this

section shall be signed and dated by the

most responsible individual onsite at

the processing facility or by a higher

level official of the processor. These

signatures shall signify that these

records have been accepted by the firm.

(2) The records in paragraphs (a)(2)

and (a)(3) of this section shall be signed

and dated:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) Upon verification and validation

in accordance with § 120.11.

(d) Record retention. (1) All records

required by this part shall be retained at

the processing facility or at the

importer’s place of business in the

United States for, in the case of

perishable or refrigerated juices, at least

1 year after the date that such products

were prepared, and for, in the case of

frozen, preserved, or shelf-stable

products, 2 years or the shelf life of the

product, whichever is greater, after the

date that the products were prepared.

(2) Records that relate to the general

adequacy of equipment or processes

used by a processor, including the

results of scientific studies and

evaluations, shall be retained at the

processing facility or at the importer’s

place of business in the United States

for at least 2 years after the date that the
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20485

processor last used such equipment or

process.

(3) Off-site storage of processing

records required by paragraphs (a)(1)

and (a)(3) of this section is permitted

after 6 months following the date that

the monitoring occurred, if such records

can be retrieved and provided on-site

within 24 hours of request for official

review. Electronic records are

considered to be on-site if they are

accessible from an on-site location and

comply with § 120.12(g).

(4) If the processing facility is closed

for a prolonged period between seasonal

packs, the records may be transferred to

some other reasonably accessible

location at the end of the seasonal pack

but shall be immediately returned to the

processing facility for official review

upon request.

(e) Official review. All records

required by this part shall be available

for official review and copying at

reasonable times.

(f) Public disclosure. (1) Subject to

the limitations in paragraph (d)(2) of

this section, all records required by this

part are not available for public

disclosure unless they have been

previously disclosed to the public, as

defined in § 20.81 of this chapter, or

unless they relate to a product or

ingredient that has been abandoned and

thus, no longer represent a trade secret

or confidential commercial or financial

information as defined in § 20.61 of this

chapter.

(2) Records required to be maintained

by this part are subject to disclosure to

the extent that they are otherwise

publicly available, or that disclosure

could not reasonably be expected to

cause a competitive hardship, such as

generic-type HACCP plans that reflect

standard industry practices.

(g) Records maintained on computers.

The maintenance of records on

computers, in accordance with part 11

of this chapter, is acceptable.

§ 120.13 Training.

(a) Only an individual who has met

the requirements of paragraph (b) of this

section shall be responsible for the

following functions:

(1) Developing the hazard analysis,

including delineating control measures,

as required by § 120.7;

(2) Developing a Hazard Analysis and

Critical Control Point (HACCP) plan that

is appropriate for a specific processor,

in order to meet the requirements of

§ 120.8;

(3) Validating and modifying the

HACCP plan in accordance with the

corrective action procedures specified

in § 120.10(c)(5) and the validation

activities specified in § 120.11(b) and

(c); and

(4) Performing the record review

required by § 120.11(a)(1)(iv).

(b) The individual performing the

functions listed in paragraph (a) of this

section shall have successfully

completed training in the application of

HACCP principles to juice processing at

least equivalent to that received under

standardized curriculum recognized as

adequate by the Food and Drug

Administration or shall be otherwise

qualified through job experience to

perform these functions. Job experience

may qualify an individual to perform

these functions if such experience has

provided knowledge at least equivalent

to that provided through the

standardized curriculum. The trained

individual need not be an employee of

the processor.

§ 120.14 Application of requirements to

imported products.

This section sets forth specific

requirements for imported food.

(a) Importer requirements. Every

importer of food shall either:

(1) Obtain the food from a country

that has an active memorandum of

understanding (MOU) or similar

agreement with the Food and Drug

Administration, that covers the food and

documents the equivalency or

compliance of the inspection system of

the foreign country with the U.S.

system, accurately reflects the

relationship between the signing parties,

and is functioning and enforceable in its

entirety; or

(2) Have and implement written

procedures for ensuring that the food

that such importer receives for import

into the United States was processed in

accordance with the requirements of

this part. The procedures shall provide,

at a minimum:

(i) Product specifications that are

designed to ensure that the product is

not adulterated under section 402 of the

Federal Food, Drug, and Cosmetic Act

because it may be injurious to health or

because it may have been processed

under insanitary conditions; and

(ii) Affirmative steps to ensure that

the products being offered for entry

were processed under controls that meet

the requirements of this part. These

steps may include any of the following:

(A) Obtaining from the foreign

processor the Hazard Analysis and

Critical Control Point (HACCP) plan and

prerequisite program of the standard

operating procedure (SOP) records

required by this part that relate to the

specific lot of food being offered for

import;

(B) Obtaining either a continuing or

lot specific certificate from an

appropriate foreign government

inspection authority or competent third

party certifying that the imported food

has been processed in accordance with

the requirements of this part;

(C) Regularly inspecting the foreign

processor’s facilities to ensure that the

imported food is being processed in

accordance with the requirements of

this part;

(D) Maintaining on file a copy, in

English, of the foreign processor’s

hazard analysis and HACCP plan, and a

written guarantee from the foreign

processor that the imported food is

processed in accordance with the

requirements of this part;

(E) Periodically testing the imported

food, and maintaining on file a copy, in

English, of a written guarantee from the

foreign processor that the imported food

is processed in accordance with the

requirements of this part; or

(F) Other such verification measures

as appropriate that provide an

equivalent level of assurance of

compliance with the requirements of

this part.

(b) Competent third party. An

importer may hire a competent third

party to assist with or perform any or all

of the verification activities specified in

paragraph (a)(2) of this section,

including writing the importer’s

verification procedures on the

importer’s behalf.

(c) Records. The importer shall

maintain records, in English, that

document the performance and results

of the affirmative steps specified in

paragraph (a)(2)(ii) of this section. These

records shall be subject to the applicable

provisions of § 120.12.

(d) Determination of compliance. The

importer shall provide evidence that all

food offered for entry into the United

States has been processed under

conditions that comply with this part. If

assurances do not exist that an imported

food has been processed under

conditions that are equivalent to those

required of domestic processors under

this part, the product will appear to be

adulterated and will be denied entry.

Subpart B—Pathogen Reduction

§ 120.20 General.

This subpart augments subpart A of

this part by setting forth specific

requirements for process controls.

§ 120.24 Process controls.

In order to meet the requirements of

subpart A of this part, processors of

juice products, except those subject to

the requirements of part 113 or 114 of
20486 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

1 In this proposal, the terms ‘‘juice’’ and ‘‘juice

products’’ are used interchangeably. Thus, ‘‘juice’’

refers both to beverages that are composed

exclusively of an aqueous liquid or liquids

extracted from one or more fruits or vegetables and

those beverages that contain other ingredients in

addition to juice. Similarly, ‘‘juice product’’ refers

both to beverages that contain only juice and

beverages that are composed of juice and other

ingredients.

this chapter, shall include in their

Hazard Analysis and Critical Control

Point (HACCP) plans control measures

that will produce, at a minimum, a 5 log

(i.e., 105) reduction, for a period at least

as long as the shelf life of the product

when stored under normal and

moderate abuse conditions, in the

pertinent microorganism. For the

purposes of this regulation, the

‘‘pertinent microorganism’’ is the most

resistant microorganism of public health

significance that is likely to occur in the

juice.

Dated: April 17, 1998.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–11025 Filed 4–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N–0524]

RIN 0910–AA43

Food Labeling: Warning and Notice

Statements; Labeling of Juice

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

require warning statements on packaged

fruit and vegetable juice products that

have not been processed to destroy

pathogenic microorganisms that may be

present. FDA is taking this action

because of the recent outbreaks of

foodborne illness and deaths caused by

consumption of juice products that were

not pasteurized or otherwise processed

to control pathogenic microorganisms.

This requirement for warning labels will

serve to reduce the risk of foodborne

illness. Elsewhere in this issue of the

Federal Register, FDA is proposing to

require that juice be processed under a

Hazard Analysis and Critical Control

Point program (HACCP).

DATES: Submit written comments by

May 26, 1998. See section V of the

SUPPLEMENTARY INFORMATION section of

this document for the proposed effective

date of a final rule based on this

document.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Geraldine A. June, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5099.

SUPPLEMENTARY INFORMATION:

I. Background

There recently have been outbreaks of

foodborne illness associated with the

consumption of juice and beverages

containing juice, i.e., juice products,

that have not been pasteurized or

otherwise treated to destroy pathogenic

microorganisms.1 On October 30, 1996,

the Seattle-King County Department of

Public Health and the Washington State

Department of Health reported an

outbreak of Escherichia coli O157:H7

infections epidemiologically associated

with consumption of unpasteurized

apple juice. The outbreak resulted in at

least 66 cases of illness in 3 western

States and British Columbia, and the

death of 1 child (Refs. 1 and 2).

Pathogens other than E. coli O157:H7

may be present in apple and other types

of juice products and have been

documented as the cause of foodborne

illness. In particular, outbreaks caused

by Salmonella typhimurium and

Cryptosporidium in apple cider (Refs. 3,

4, and 5) and Vibrio cholerae in coconut

milk (Ref. 6) have been reported. In

addition, outbreaks caused by

consumption of unpasteurized orange

juice contaminated with S. hartford

(Ref. 7), orange juice drink

contaminated with S. agona (Ref. 8),

orange juice contaminated with Bacillus

cereus (Ref. 9), and home-made carrot

juice contaminated with Clostridium

botulinum (Ref. 10) have been reported.

Because of the agency’s concern that

its regulatory program for fresh juices

may not be adequate to ensure the

production of safe juice and juice

products, and because of the severity of

the recent outbreak of E. coli O157:H7

associated with apple juice, the agency

held a public meeting on December 16

and 17, 1996, to discuss safety issues

presented by juice products. At that

meeting, FDA met with interested

parties to review the current science,

including technological and safety

factors, relating to fresh juice

production and to consider the

measures that would be necessary to

provide safe fruit and vegetable juices.

Experts from industry, academia, and

the regulatory and consumer sectors

presented information on illnesses and

the epidemiology of outbreaks arising

from microbially contaminated juices;

concerns with emerging pathogens;

procedures for processing juices; and

new and existing technology to control

pathogens in juice products.

In light of the information developed

at the public meeting and in comments

received by the agency, as well as other

information available to the agency,

FDA has developed a strategy that it

believes will address both the

immediate goal of reducing the risk of

foodborne illness associated with juice

products and the long-term goal of

ensuring that juice products are safe. In

the Federal Register of August 28, 1997

(62 FR 45593), the agency published a

notice of intent (‘‘the notice of intent’’)

that announced a comprehensive

program to address the incidence of

foodborne illness related to

consumption of fresh juice and

ultimately to address 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 or labeling of juice products not

specifically processed to prevent,

reduce, 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. FDA stated that it would

consider comments received within 15

days of publication of the notice of

intent as part of any rule proposed by

the agency.

This document addresses the warning

statements for labels of packaged juice

products that have not been specifically

processed to prevent, reduce, or

eliminate the presence of harmful

pathogens. FDA has reviewed all the

comments received within 15 days of

publication of the notice of intent and

has determined that the comments

provide no information that would

cause the agency to conclude that this

proposal is inappropriate. In this

document, the agency addresses these

comments to the extent that they are

relevant to this proposal. Comments in

response to the notice of intent received

more than 15 days after publication of

that notice that address issues in this