This document is also available in PDF format.
Extension of Comment Period -- Juice HACCP November 23, 1999
Federal Register: April 24, 1998 (Volume 63, Number 79)
Proposed Rules
Page 20449-20486
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr24ap98-27
Page 20449
_______________________________________________________________________
Part II
Department of Health and Human Services
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 120 and 101
Hazard Analysis and Critical Control Point (HACCP); Procedures for the
Safe and Sanitary Processing and Importing of Juice; Food Labeling:
Warning Notice Statements; Labeling of Juice Products; Proposed Rules
Page 20450
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.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt
regulations to ensure the safe and sanitary processing of fruit and
vegetable juices and juice products. The proposed regulation, if
adopted, will mandate the application of Hazard Analysis and Critical
Control Point (HACCP) principles to the processing of these foods.
HACCP is a preventive system of hazard control. FDA is proposing these
regulations because there have been a number of outbreaks of illness,
including some directly affecting children, associated with juice
products and because a system of preventive control measures is the
most effective and efficient way to ensure that these products will be
safe. Elsewhere in this issue of the Federal Register, FDA is
publishing a warning label proposal for packaged juice.
DATES: Submit written comments by July 8, 1998. For information on the
proposed compliance dates for small businesses and very small
businesses see the Supplementary Information section of this document.
Submit written comments on the information collection requirements
by May 26, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Submit written comments regarding information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget, New Executive Office Bldg., 725 17th St. NW.,
rm. 10235, Washington, DC 20503, Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4681.
SUPPLEMENTARY INFORMATION:
The agency proposes to make any final rule based upon this proposal
effective 1 year after its date of publication in the Federal Register.
However, by its terms, the final rule will not be binding on small
businesses as defined in proposed Sec. 120.1(b)(1) until 2 years after
the date of publication of a final rule in the Federal Register; and
for very small businesses as defined in proposed Sec. 120.1(b)(2), the
final rule will not be binding until 3 years after the date of its
publication in the Federal Register.
I. Concerns With Juice
A. Microbial Outbreaks
The Seattle-King County Department of Public Health and the
Washington State Department of Health reported on October 30, 1996, an
outbreak of Escherichia coli O157:H7 infections epidemiologically
associated with drinking a particular brand of unpasteurized apple
juice, or juice mixtures containing unpasteurized apple juice,
purchased from a coffee shop chain, grocery stores, and other locations
(Ref. 1). A case was defined as hemolytic uremic syndrome (HUS) or a
stool culture yielding E. coli O157:H7 in a person who became ill after
September 30, 1996, after drinking the particular brand of juice within
10 days before illness onset. There were at least 66 cases of illness,
with 14 cases of HUS and the death of one child, associated with this
outbreak (Ref. 2). Cases occurred in British Columbia, California,
Colorado, and Washington. E. coli O157:H7 isolates cultured from a
previously unopened container of the particular brand of apple juice
had a deoxyribonucleic acid (DNA) ``fingerprint'' pattern (restriction
fragment length polymorphism) indistinguishable from case-related
isolates (Ref. 1).
Various juices have been documented as vehicles for causing
outbreaks from microorganisms. A 1967 outbreak from contaminated water
added to orange juice concentrate affected approximately 5,200 persons
and was caused by an unidentified virus and possibly other contaminants
(Refs. 3 and 4). About 300 people became ill from Salmonella
typhimurium in cider made from apples, including some that had been
picked up from the ground in an orchard fertilized with manure, in a
1974 outbreak in New Jersey (Ref. 5). A 1991 outbreak of Vibrio
cholerae was associated with coconut milk contaminated during
manufacturing in Thailand (Ref. 6). There have been two Cryptosporidium
outbreaks related to drinking apple cider, the first in Maine in 1993
and the other in New York State in 1996. In the first case, the apples
used for cider came from trees near a cow pasture (Ref. 7), and in the
second case, water used for rinsing came from a well that tested
positive for coliforms (Ref. 8). In 1995 there was an outbreak in
Florida that was caused by Salmonella hartford in unpasteurized orange
juice (Ref. 9).
E. coli O157:H7 has been recognized relatively recently as a human
pathogen and has been a source of a number of outbreaks related to
juice. Thirteen and possibly 14 children had bloody diarrhea and
developed HUS in Toronto, Canada, between September 15 and 25, 1980.
The children's illnesses were associated with drinking fresh apple
juice. The children's stools were examined for enteropathogenic E.
coli, Campylobacter, Salmonella, Shigella, and Yersinia. None of these
organisms were found. E. coli O157:H7 is the suspected causative
organism. Conclusive testing for that organism was not done because E.
coli O157:H7 was not recognized as a human pathogen before 1982 (Ref.
10).
A 1991 E. coli O157:H7 outbreak in southeast Massachusetts
conclusively showed that fresh-pressed unpasteurized apple juice can
transmit E. coli O157:H7 bacteria. In this outbreak, 23 individuals had
diarrhea, 16 had bloody diarrhea, and 4 developed HUS (Ref. 11).
In Connecticut, a 1996 outbreak of E. coli O157:H7 illness was
associated with drinking a particular brand of apple cider. There were
14 cases of illness (including 7 hospitalized), with 3 cases of HUS
associated with the outbreak (Ref. 8).
There was a small outbreak of E. coli O157:H7 illness in Washington
State in 1996 that was related to apple cider made at a church event.
This outbreak occurred during the same time as the unpasteurized apple
juice outbreak described in previous paragraphs. The apples were washed
in a chlorine solution, but it was not reported how much chlorine was
used. Six people became ill, but no estimate was given on how many
people may have drunk the apple cider (Ref. 12).
FDA's recall data also provide evidence of microbial hazards in
juice. There were 85 cases of illness in 1994 resulting in a recall of
orange juice that had fermented and contained Bacillus cereus and yeast
(Ref. 13).
State investigations provide additional evidence of microbial
hazards in juice. A 1989 outbreak in New York was caused by the
presence in orange juice of Salmonella typhi that originated from an
infected worker and
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resulted in 69 illnesses with 21 individuals hospitalized (Ref. 14).
The State of Washington reported that in 1993 one individual was
hospitalized from home-made carrot juice found to contain Clostridium
botulinum (Ref. 15). A 1993 Ohio outbreak caused by yeast or some other
unknown toxicant in orange juice resulted in 23 illnesses (Ref. 16). A
home-made watermelon drink contaminated with Salmonella spp. caused
illness in 18 individuals in a 1993 Florida outbreak (Ref. 17). The
State of Colorado reported two outbreaks of gastrointestinal illness
from fresh squeezed orange juice at a mountain resort (Ref. 18). There
were food handlers that were ill in both Colorado instances, and a
virus was suspected as the causative agent.
The evidence shows that certain juices have been the vehicle for
outbreaks of foodborne illnesses. Although fruit juice is acidic, and
thus would generally be considered to inhibit the growth of most
microorganisms, most juice-related outbreaks have been associated with
fruit juices.
B. Illnesses From Nonheat-treatable Hazards
Illnesses that have been caused by hazards that can not be reduced
to acceptable levels by heat treatments have also been associated with
juice. Tin in canned tomato juice caused illness in 113 individuals in
1969 (Ref. 19). Soil nitrate had resulted in a high nitrate content in
the tomatoes, and this high nitrate content accelerated detinning in
the cans. In 1984, 11 persons became ill from consuming elderberry
juice prepared by staff of a religious/philosophic group that contained
poisonous parts of the plant (Ref. 20). A 1990 guanabana juice outbreak
was caused by the presence of toxic guanabana seed material and caused
illness in nine individuals (Ref. 21). A 1997 outbreak was caused by
tin in pineapple juice (Ref. 22).
In 1992 an 18-month-old child with a blood lead level of 36
micrograms per deciliter (<greek-m>g/dL) was found in a routine county
health department blood lead monitoring program. Investigation of this
incident by the county health department revealed that the only
significant source of lead exposure for this child was lead in imported
fruit juice packed in 12-ounce, lead-soldered cans (Ref. 23). Analysis
by the State health department of multiple flavors of the fruit juices
in lead-soldered cans available to the child found lead levels ranging
from 160 to 810 parts per billion (ppb). An exposure assessment
performed by the county health department estimated that the child
consumed about three cans of these fruit juices per day and estimated
that the child's daily lead intake from these fruit juices was
approximately 600 <greek-m>g/day (Ref. 23). As a result of this
incident, FDA announced an emergency action level of 80 ppb for lead in
fruit beverages (such as juices, nectars, and drinks) packed in lead-
soldered cans (58 FR 17233, April 1, 1993). The agency subsequently
banned the use of lead-soldered cans (60 FR 33106, June 27, 1995).
Recalls also provide evidence of nonheat-treatable hazards in
juice. In 1988 a fruit punch drink was recalled because of the presence
of tin caused by the acidity of the drink reacting with the tin coating
of the cans (Ref. 24). The product had been packaged in the wrong
container.
There were 10 recalls between 1990 and 1995 for fruit juice or
beverages containing fruit juice because of the presence of food
ingredients that were inadvertently added to the product, not declared
on the label, or not suitable for the food. Food ingredients involved
with these recalls were natamycin (Ref. 25), sulfites (Ref. 26), FD&C
yellow No. 5 (Refs. 27 through 33), and salt (Ref. 34).
Five recalls between 1991 and 1997 were caused by improper
sanitation procedures or faulty equipment. In 1991 sodium hydroxide
from a clean-in-place system contaminated the caps of a citrus punch
drink (Ref. 35). In 1992 three persons became ill, with 1 hospitalized,
from a sodium hydroxide sanitizing agent that got into fruit drink
product containers during cleaning (Ref. 36). In 1993 cracks in a heat
exchanger allowed an orange flavored soft drink containing pear juice
to come in contact with copper pipe fittings and, thus, to become
contaminated with copper (Ref. 37). In 1994 milk was found in orange
juice from filler lines that were not cleaned between milk and juice
production (Ref. 38). In 1997 the presence of an alkaline cleaning
solution in a berry juice caused gastrointestinal distress in several
persons (Ref. 39).
Companies have recalled fruit drinks because pieces of glass or
plastic were found in their products. The presence of glass in products
is typically caused by the use of glass bottles, which can chip or
shatter during the production process (Refs. 40 through 42). The
plastic was present from the company's practice of draping plastic bags
over the side of the bottle loading bin (Ref. 43).
One company recalled apple-prune juice and prune juice in 1996
because of unacceptable levels of lead (Refs. 46 and 47). The cause was
contaminated imported prune juice.
In response to the establishment of maximum levels for patulin in
apple juice by several foreign governments, FDA initiated a sampling
survey to determine the levels commonly found in domestic and imported
apple juice. Patulin may be present in juice made from moldy apples. In
March 1997 the agency found inordinately high levels of patulin in
apple juice from a processor in Washington State (Ref. 48). The level
of patulin found in the product was sufficient to pose a health hazard,
especially considering the fact that apple juice is commonly used by
infants and young children (Ref. 49). All affected products that had
left the plant had been used in the manufacture of fermented apple
cider. Patulin could not be detected in fermented product, and it was
assumed that the patulin was destroyed through the fermentation
process.
Therefore, as the foregoing discussion reveals, the evidence
demonstrates that juice and juice beverages are susceptible to chemical
and physical hazards as well as microbiological hazards.
C. Underreporting
There is wide agreement that the laboratory-confirmed cases from
outbreaks and recalls understate the actual number of juice-related
cases, but no consensus exists on the size of the understatement.
Individuals may not manifest all symptoms or have severe enough
symptoms to necessitate medical attention. Medical personnel may simply
treat an individual's symptoms without determining the underlying
cause. The laboratory-confirmed cases only represent those cases where
individuals sought medical attention, and where medical personnel
performed the necessary testing and reported the case to a government
agency.
While the actual number of juice-related illnesses is unknown, FDA
has derived an estimate of the total number by multiplying the average
number of laboratory-confirmed cases by factors that account for under-
reporting. The factors are based on the relationships between annual
outbreak cases and published estimates of the number of foodborne
illnesses. For example, using these adjustment factors, it is estimated
that the average 16 annual laboratory-confirmed cases of Salmonella
represents 4,900 to 7,600 actual cases (Ref. 50). For E. coli O157:H7,
an average 22 laboratory-confirmed cases per year may actually
represent 2,200 to 4,300 total juice-related cases (Ref. 50).
Therefore, the agency assumes that the
Page 20452
actual number of illnesses from the outbreaks described in sections I.A
and I.B of this document is much greater than the confirmed number of
illnesses. (For a more complete discussion of these estimates, see the
agency's preliminary regulatory impact analysis and Ref. 50)
D. Pesticides
Pesticides are usually applied to plants to combat insects, plant
diseases, and weed growth to assist in the growth of the fruit or
vegetable. A food is considered adulterated under section 402(a)(2)(B)
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
342(a)(2)(B) if pesticide residues are present above the Environmental
Protection Agency (EPA) established tolerances, or if EPA has not
established a tolerance for use of the pesticide on the particular
plant. FDA annually monitors a wide variety of foods for pesticide
residues.
In 1994 FDA sampled 1,411 domestic fruits and fruit products,
including apple juice and other fruit juices, for pesticide residues
and found that less than 1 percent were violative for being over
tolerance and less than 1 percent were violative for having no
tolerance (Ref. 51). None of the 122 samples of apple juice or 44
samples of other fruit juices were violative. Out of 1,795 samples of
domestic vegetables and vegetable products tested, FDA found that less
than 1 percent of samples were over tolerance, and that 2 percent were
violative for having no tolerance.
FDA also tested 1,940 imported fruits and fruit products in its
1994 pesticide residue monitoring program. Less than 1 percent of the
items tested were over tolerance and 3 percent were violative for
having no tolerance. None of the 110 fruit juices sampled were
violative. The agency sampled 2,460 imported vegetables and vegetable
products and found that less than 1 percent were violative for being
over tolerance and 4 percent for having no tolerance.
In its 1995 pesticide monitoring program FDA found less than 1
percent of 1,437 samples of domestic fruits and fruit products to be
violative for being over tolerance and 1 percent to be violative for
having no tolerance (Ref. 52). Of the 110 apple juices and 22 other
fruit juices sampled, only a single apple juice sample was found to be
violative, because of the presence of a pesticide with no established
tolerance. Analysis of 1,585 samples of domestic vegetable and
vegetable product produced results similar to the results found in
1994, i.e., less than 1 percent of samples were over tolerance, and
approximately 2 percent were violative because there were no tolerances
for the pesticide residues that FDA found.
The agency sampled 1,757 imported fruits and fruit products for
pesticides in 1995 and found that less than 1 percent were violative
for being over tolerance, and that 3 percent were violative for having
no tolerance. Of the 19 apple juices and 52 other fruit juices tested,
2 apple juice samples were violative because they contained pesticides
for which there were no established tolerances. The agency sampled
2,535 imported vegetables and vegetable products and found that 1
percent were violative for being over tolerance, and that 3 percent
were violative for having pesticide residues for which there was no
tolerance. Some of these samples contained both residues over tolerance
and residues with no tolerance.
Although there are no documented outbreaks caused by unlawful
pesticide residues, chronic exposure to pesticide residues that do not
conform to EPA tolerances increase risks to the public health.
Therefore, juice processors must determine whether the possible
presence of unlawful pesticide residues is a hazard that is reasonably
likely to occur.
E. FDA's Public Meeting
As a result of the October 1996 apple juice outbreak from E. coli
O157:H7, FDA held a public meeting on December 16 and 17, 1996
(hereafter referred to as the juice meeting) (see notice of meeting (61
FR 60290, November 27, 1996)), to review the current science, including
technological and safety factors, relating to fresh juices and to
consider measures necessary to provide safe fruit juices to the public.
Interested persons were given until January 3, 1997, to submit written
comments on the notice. On January 2, 1997 (62 FR 102), FDA extended
the comment period to February 3, 1997, in response to several requests
for an extension.
The purpose of the juice meeting was to provide a forum for an
information exchange on current industry practices for the production
of juice products and on developments in the science underlying the
production of safe juices. Experts from industry, academia, and the
regulatory and consumer sectors presented information on illnesses and
the epidemiology of outbreaks arising from contaminated juices;
concerns about emerging pathogens; the E. coli O157:H7 outbreak in
October 1996 caused by contaminated apple juice; procedures for
processing juices; and new and existing technology to remove or
decrease the number of pathogens or other contaminating microorganisms.
Time was available for questions and comments from all attendees.
The meeting provided an opportunity to: (1) Consider how FDA's
regulatory program for fresh juice and juice products should be
revised,(2) discuss and exchange information on relevant safety issues,
(3) to identify research needs where appropriate, (4) consider whether
additional consumer education is necessary, and (5) consider whether
other measures are needed to reduce the risk of future outbreaks of
illness from juice.
FDA received over 180 comments from industry (with a number of
these describing themselves as small businesses), consumers, consumer
organizations, trade organizations, scientific/technical companies,
academic institutions or organizations, State agencies, a local
government agency, and members of Congress. Although most of the
comments concerned apple juice specifically, many comments pertained to
juices in general, and some referred only to citrus juices. Most
comments were concerned with changes in processing to improve the
safety of juices. Among the changes suggested were requiring
pasteurization of juices, requiring HACCP, or establishing current good
manufacturing practices (CGMP's) in juice processing. The agency has
attempted to address the comments made at the meeting or submitted in
response to the Federal Register notice in this proposal. If there are
any significant concerns that the agency has not addressed, these
concerns should be brought to the agency's attention in comments on
this proposal.
The Fresh Produce Subcommittee (FPS) of the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) attended the
public meeting. The FPS met after the public meeting and made
recommendations to the NACMCF. The NACMCF subsequently met to discuss
the issues that were raised at the meeting. Based on information that
was presented at the meeting and on the FPS's expertise, the full
NACMCF made several recommendations (Ref. 53). The NACMCF stated that
there are many aspects that affect pathogen control, such as
agricultural practices; product handling; equipment used; growing
location, including produce obtained from below ground (carrots), on
ground (e.g., tree drops), or picked from trees; pH; acidulants; method
of processing; degree of animal contact; refrigeration; packaging; and
the distribution system. It stated that, in determining the best
control mechanisms, it is important to remember that the conditions for
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microbial survival differ from those for growth. The NACMCF recognized
that, while the risks associated with specific juices vary, there are
safety concerns associated with juices, especially unpasteurized
juices.
The NACMCF concluded that: (1) The history of public health
problems associated with fresh juices indicates a need for active
safety interventions, and (2) for some fruit (e.g., oranges), the need
for intervention may be limited to surface treatment, but for others,
additional interventions may be required (e.g., pasteurization of the
juice).
The NACMCF recommended to FDA the use of safety performance
criteria instead of mandating the use of a specific intervention
technology. In the absence of known specific pathogen-product
associations, the NACMCF recommended the use of E. coli O157:H7 or
Listeria monocytogenes as the target organism, as appropriate. This
recommendation was based on the premise that these organisms are two of
the most difficult to control (i.e., by juice acidity or heat
lethality), and that, by controlling them, other pathogenic organisms
will likely be controlled. The NACMCF suggested that a tolerable level
of risk may be achieved by requiring interventions that have been
validated to achieve a cumulative 5 log reduction in the target
pathogen or a reduction in yearly risk of illness to less than
10<SUP>-5</SUP>, assuming consumption of 100 milliliters (mL) of juice
daily.
In addition, the NACMCF stated that HACCP and safety performance
criteria should form the general conceptual framework to ensure the
safety of juices, and that control measures should be based on a
thorough hazard analysis. The NACMCF also stated that validation of the
process must be an integral part of this framework. The NACMCF
recommended mandatory HACCP for all juice products, and that processors
should implement and strictly adhere to industry CGMP's. The NACMCF
also recommended industry education programs addressing basic food
microbiology, the principles of cleaning and sanitizing equipment,
CGMP's, and HACCP.
The NACMCF recommended further study in several areas:
(1) The efficacy of new technologies and intervention strategies
for safety;
(2) The contamination, survival, and growth of pathogens on produce
with or without breaks in skin, with or without areas of rot, and
within the core;
(3) How produce becomes contaminated with human pathogens,
including the relevant microbial ecology during production and
processing of juice. In particular, the NACMCF stated that there is an
urgent need for these types of studies on E. coli O157:H7 in apple
juice;
(4) The baseline incidence of human pathogens on fruits and
vegetables, particularly on those used in juice processing; and
(5) Labeling information needed for consumer understanding and
choice of safer juices and juice products.
On the basis of all the testimony presented at the December 16 and
17, 1996, meeting, the NACMCF agreed that there is a need to understand
the differences among all juice and juice products (e.g., citrus versus
other). A significant problem identified by the NACMCF is that
consumers presently do not have a means to clearly differentiate
between unpasteurized and pasteurized products, and that terms used to
refer to juice products do not always have universal meanings. For
example, the term ``cider'' is perceived to be an unpasteurized product
whereas the term ``juice'' is often perceived to be pasteurized.
The NACMCF also stated that traditional heat treatments given to
juices and juice products have been designed to achieve shelf
stability, to remove water (i.e., concentration), or to affect other
quality-related factors, and that these treatments, commonly referred
to as ``pasteurization,'' are greatly in excess of a process needed to
inactivate foodborne pathogens.
Because of the lack of sufficient data to evaluate the
effectiveness of labeling statements as safety interventions or to
inform consumer choice, the NACMCF stated that it could not strongly
endorse labeling as an interim safety measure.
Although the NACMCF did not endorse labeling as an interim safety
measure, elsewhere in this issue of the Federal Register FDA is
proposing interim labeling measures for packaged juice. The agency sets
forth its reasons for proposing to adopt these measures in that
proposal.
II. Consideration of How to Address Problems
A. Current Regulation of Juice
FDA has established labeling regulations and standards of identity
for a number of juices. 21 CFR 101.30 pertains to percentage juice
declaration for beverages that contain fruit or vegetable juice. Common
or usual name regulations for nonstandardized beverages that contain
fruit or vegetable juice are found in 21 CFR 102.33. Standards of
identity are found in part 146 (21 CFR part 146) for a number of fruit
juices and beverages and in part 156 (21 CFR part 156) for tomato
juice. The standard of identity for pasteurized orange juice
(Sec. 146.140) states that ``The orange juice is so treated by heat as
to reduce substantially the enzymatic activity and the number of viable
microorganisms.'' Pasteurized orange juice must be labeled as such.
In the 1997 Food Code, FDA articulated its policy regarding
unpasteurized apple juice (Ref. 54). The code states that food
establishments (e.g., nursing homes) that serve apple juice, apple
cider, or other beverages that contain apple juice to segments of the
population that are highly susceptible to disease (e.g., the elderly)
should serve juice that has been pasteurized or that is in a
commercially sterile, shelf-stable form, in a hermetically sealed
container.
B. The Current Inspection System
Juice processors, like other food processors, are subject to
periodic unannounced, mandatory inspection by FDA. This inspection
system provides the agency with a picture of conditions at a facility
at the time of the inspection. However, assumptions must be made about
conditions at the facility before and after that inspection, as well as
about important factors beyond the facility that have a bearing on the
safety of the finished product. The reliability of these assumptions
over the intervals between inspections can create questions about the
adequacy of the system.
FDA's inspections are based, in part, upon its regulations on CGMP
in the manufacturing, packing, or holding human food in part 110 (21
CFR part 110). For the most part, these regulations set out broad
statements of general applicability to all food processing on matters
such as sanitation, facilities, equipment and utensils, processes, and
controls. HACCP-type controls are listed as one of several options
available to prevent food contamination (Sec. 110.80(b)(13)(i)), but
they are not integral to the controls outlined in the regulations.
The inspection and surveillance strategies that FDA uses ascertain
a manufacturer's knowledge of hazards and preventive control measures
largely by inference (i.e., based on whether a company's products are
in fact adulterated, or whether conditions in a plant are consistent
with CGMP). It is the manufacturer's responsibility to ensure that its
products are in compliance with the act. However, in the face of new
pathogens, such as E. coli O157:H7, and the risk of illness associated
with these pathogens, especially for children, the elderly, and
Page 20454
the immunocompromised, FDA tentatively concludes that, at least for
juices, new measures to control microbial, chemical, and physical
hazards are necessary to ensure that finished products comply with the
act's standards.
C. Alternatives
Comments from the juice meeting suggested several alternatives to
ensure that juice products are safe. These alternatives are discussed
in sections II.C.1 through II.C.6 of this document along with their
impact on the current situation with juice.
1. Increased Inspection
Continuous visual inspection of juice production is not a viable
alternative because few hazards associated with juice are detectable
through visual inspection.
Another possibility is to direct significant additional resources
toward increasing the frequency of FDA's inspection of juice
manufacturers, as well as increasing the agency's sampling, laboratory
analysis, and related regulatory activities with respect to these
products. While many samples of domestic and imported juice products
are collected each year for analysis in FDA laboratories, and this
sampling is designed to represent a broad range of products and to
target known problems, the product sampled represents only a small
fraction of the total poundage of the juice products consumed in this
country. Substantially more expenditures would be needed to increase
laboratory analyses to statistically significant levels.
Even if the funds for increased FDA inspection and increased
sampling and analysis were available, this approach alone would not
likely be the best way for the agency to spend its limited resources to
protect the public health. Reliance on end-product testing involves a
certain amount of inefficiency and enormous sample sizes and testing on
a lot-by-lot basis are necessary to overcome that inefficiency.
Therefore, this option has significant limitations.
Some comments from the juice meeting stated that juice safety would
be improved through more local/State inspection rather than Federal
inspection.
FDA agrees that more local/State inspection would help to ensure
the safety of juices, particularly where because FDA lacks
jurisdiction, there is no connection between the juice products and
interstate commerce. However, FDA is not in a position to mandate that
State and local regulatory agencies conduct additional inspections with
their limited resources. Further, FDA cannot mandate that a State
ensure that a firm is complying with FDA's regulations. Therefore,
increased local/State inspection for juice is not an option upon which
FDA can rely.
2. CGMP's
Many comments from the juice meeting urged the implementation of
industry CGMP's or sanitation standards to increase the safety of
juices. Some comments provided State rules, model CGMP's, or sanitation
guidelines for FDA's consideration. Other comments stated that there is
a need for more industry education on sanitation and hygiene.
CGMP regulations have a twofold purpose: (1) To provide guidance on
how to reduce insanitary manufacturing practices and on how to protect
against food becoming contaminated, and (2) to set out objective
requirements that enable industry to know what FDA expects an
investigator to find when he or she visits a food plant (51 FR 22458 at
22459, June 19, 1986). CGMP's consist generally of broad statements on
sanitation, facilities, equipment and utensils, processes, and controls
that are of general applicability to food processing. Therefore, FDA
issuance of CGMP's for juice would be an approach that could assist
manufacturers in the production of safe juices.
FDA encourages the juice industry to use CGMP's to help ensure the
safety of their juices. As stated previously, the NACMCF recommended
that processors implement and strictly adhere to industry CGMP's.
However, the use of CGMP's alone may not be adequate to ensure that
juices are safe because of the broad based nature of CGMP's. CGMP's are
directed at plantwide operating procedures and do not concentrate on
the identification and prevention of food hazards. Therefore, the
agency tentatively concludes that CGMP's, although useful, will not be
adequate, without additional measures, to ensure the safety of juices.
3. Mandatory Pasteurization
The majority of the comments from the juice public meeting
pertained to pasteurization of juice. A number of comments urged FDA to
mandate pasteurization or other equivalent treatment of fruit juice to
ensure its safety. One person who commented reported that customers of
his apple cider had not complained about a difference in flavor when he
implemented pasteurization. One comment requested a 2-year grace period
for small businesses before implementation if pasteurization were to be
required. Another suggested that pasteurization be required for apple
cider only if CGMP's and HACCP fail. One comment suggested that
pasteurization be required only for apple juice, because of the
difficulty in cleaning apples as compared to other fruits.
However, most comments opposed mandatory pasteurization of juices
because of: (1) The expense of pasteurization equipment, (2) preference
by some consumers for the flavor of unpasteurized over pasteurized
juice, (3) the safety record of juices, and (4) degradation of
nutritional value from heat treatment. Many comments from small
businesses claimed that they would be forced to close their operations
if pasteurization were required. Some comments also stated an economic
need for the use of dropped apples (``drops''), with one recommending
the use of only hand-picked (rather than machine-picked) drops. Other
comments stated that the use of drops should be prohibited, at least in
unpasteurized juices.
FDA is aware of the significant safety advantages of pasteurizing
juice as well as of the reasons that some processors choose not to
pasteurize their products. Pasteurization is a heat treatment used to
kill the vegetative forms of specific bacteria in liquid or semi-liquid
food products. Pasteurization is an effective and proven technology to
ensure that juice does not contain pathogens. However, there may be
other methods that are equally effective. Thus, the NACMCF recommended
the establishment of safety performance criteria for appropriate target
organisms rather than the establishment of a specific intervention
technology. The NACMCF stated that safety performance criteria would be
most effective.
For example, whole oranges with an intact skin may be processed so
that pathogens on the surface of the fruit are destroyed. Because
pathogens are not reasonably likely to be present in the interior of an
orange, surface treatment could be adequate to ensure the safety of the
juice. This example illustrates that if FDA were to mandate
pasteurization, such action could have the effect of limiting the
development of new technologies that are as effective as pasteurization
in particular circumstances but less intrusive and less expensive.
Therefore, the agency tentatively concludes that relying on safety
performance criteria, as recommended by the NACMCF, is an approach
preferable to pasteurization. However, if the use of safety performance
criteria
Page 20455
does not significantly decrease the number of microbial outbreaks
caused by juice, the agency may consider adopting a regulation that
mandates pasteurization.
The agency disagrees with the comments that stated that it should
require that apple juice be pasteurized because apples can be difficult
to clean. FDA recognizes that pastuerization is a process that has been
validated to meet NACMCF's recommendations. Manufacturers may be able
to use other technologies and practices provided that their process is
validated to achieve a 5-log reduction in the target pathogen.
Therefore, reliance on safety performance criteria is a better long-
term approach because it provides for the development of new
technologies.
A number of comments at the juice meeting urged FDA to consider
alternatives to pasteurization to increase the safety of juices.
Alternatives suggested by the comments included extreme isostatic
pressure, high pressure sterilization, ultra short time-heat exchanger
processing, ohmic heating, aseptic packaging, modified atmosphere
packaging, ultrafiltration, high temperature and high pH adjustment of
wash-water, ultrahigh hydrostatic pressure, electric pulses,
electromagnetic field, pulsed light, ultraviolet (UV) water treatment,
UV treatment with photoreactivation, electron beam sterilization,
irradiation, ozonated water treatment, microbiocidal additives
(benzoate, sorbate), and pH adjustment. The comments recommended that
sanitizers or ingredients for washes include use of chlorine, chlorous
acid, chlorine with emulsifiers, trisodium phosphate, peroxyacetic
acid, peracetic acid, or dimethyl dicarbonate.
The agency agrees that there may be a number of agents that can
reduce the number of microorganisms present in juice. As the NACMCF
recommended, a tolerable level of risk may be achieved by interventions
that have been validated to achieve a cumulative 5 log reduction in the
target pathogens or a reduction in yearly risk of illness to less than
10<SUP>-5</SUP>, assuming consumption of 100 mL of juice daily.
However, the NACMCF did not specify the manner in which this risk
reduction should be accomplished, only the target that must be reached.
In section IV.M of this document the agency will discuss its proposed
approach as to how this performance standard will apply to juice.
4. Labeling
A number of comments suggested that labeling to distinguish
pasteurized from unpasteurized juice would enable consumers to make an
informed choice. One of the comments requested warnings to those ``at-
risk,'' one urged the publication of warnings in the newspaper, and
another wanted labeling with no warning. Rather than labeling, one
comment suggested point of sale information. One comment urged FDA not
to require labeling to distinguish pasteurized from unpasteurized
juices.
The NACMCF recommended research on labeling information needed for
consumer understanding and choice of safer juice products. The NACMCF
concluded that, while the risks associated with specific juices vary,
there are safety concerns associated with juices generally, especially
unpasteurized juices.
Labeling whether a product is pasteurized or unpasteurized is
useful information that the agency encourages processors to place on
labels. However, such labeling would not inform purchasers of
unpasteurized product that children, the elderly, and the
immunocompromised are ``at-risk'' from consuming the product. Without
effective consumer education, the label statements ``pasteurized'' and
``unpasteurized'' are likely to have relatively little meaning to
consumers and could even cause confusion because some consumers might
select unpasteurized juice, considering it more ``healthy'' because it
is less processed. Finally, a labeling requirement that focuses only on
whether a product is pasteurized or unpasteurized does not take into
account technologies other than pasteurization that are adequate to
control pathogens, and, thus, such a requirement could be viewed as
restricting the development of new technologies.
The agency outlined interim measures in a notice published August
28, 1997 (62 FR 45593), and elsewhere in this issue of the Federal
Register, FDA is issuing a proposal on labeling for packaged juice.
These labeling measures attempt to provide information on the risks
that juice that has not been processed to control for pathogens poses
to children, the elderly, and the immunocompromised. The agency is
proposing that the labeling measures be superseded when these juice
products are processed under adequate HACCP programs or are otherwise
processed to destroy pathogens (e.g., pasteurization).
It is possible for firms that manufacture juice to control for
pathogens. Labeling a product to alert consumers to possible harmful
effects from its consumption must not substitute for a manufacturer
adequately addressing those concerns during processing. FDA is
reluctant to rely on labeling as a safety measure and does so only when
its analysis of the countervailing factors reveals that, on balance,
labeling provides the most reasonable approach to protecting the public
health. Juice is a product that is typically consumed by children, as
well as adults. Therefore, FDA tentatively concludes that, for juice,
manufacturers need to implement controls for pathogens to ensure that
their products are safe and not rely solely on labeling, except as an
interim measure. FDA requests comment on this tentative conclusion.
5. Education
Other comments from the juice meeting suggested that education
would increase the awareness associated with the safety of juices and
of all foods. Some comments suggested that more industry education or
training was needed. Other comments wanted more consumer education,
especially for those at highest risk from foodborne disease.
The NACMCF recommended that the industry be educated on basic food
microbiology, the principles of cleaning and sanitizing equipment,
CGMP's, and HACCP. FDA agrees that industry education can serve a
valuable role in controlling potential food hazards and encourages the
industry to take an active part in educating its employees and
utilizing up-to-date technologies. The agency will assist the industry
in its education effort.
Concerning consumer education, the agency has launched several
initiatives to inform consumers about the potential hazards presented
by juice to at-risk individuals (see 62 FR 45593, August 28, 1997).
However, no matter how extensive a consumer education initiative the
agency undertakes, it is doubtful that consumer education will reach
all at-risk consumers. Therefore, consumer education alone will not be
adequate to inform the at-risk population of the potential hazards of
consumption of juice that has not been processed to control pathogens.
Given that effective processing methods are available, primary reliance
needs to be placed on them to ensure the safety of juice.
6. The HACCP Option
Many of the attendees at the juice meeting urged FDA to mandate
HACCP for juice processors, whereas others were opposed. A number of
the attendees urged use of CGMP's together with HACCP. Some attendees
at the juice meeting recommended that microbiological criteria or
performance
Page 20456
standards be used in addition to HACCP, with two suggesting a 5 log
reduction for E. coli O157:H7.
The NACMCF concluded that HACCP and safety performance criteria can
provide the general conceptual framework needed to ensure the safety of
juices, and that validation of the HACCP plan for the juice process
(i.e., ensuring that the process is adequate to control hazards) must
be an integral part of this framework. The NACMCF stated that
processors should establish HACCP control measures based on a thorough
hazard analysis.
HACCP is a preventive system of hazard control that places the
responsibility for identifying safety problems with the manufacturer.
Use of the HACCP system means that a firm is engaged in continuous
problem prevention and problem solving, rather than relying on facility
inspections by regulatory agencies or consumer complaints to detect a
loss of control. HACCP provides for real time monitoring to assess the
effectiveness of control. A HACCP system put in place by a manufacturer
for a particular facility is unique and must reflect the type of juice,
its method of processing, its packaging, the facility in which it is
prepared, and the intended consumers.
As discussed previously, there is sufficient evidence to
demonstrate that there are significant problems with the presence of
pathogens in some juice products. Pathogens in juice can be controlled
by heat treatment. However, there may be other treatments that meet the
same performance standard that are equally effective (e.g., multiple
barriers, surface treatment of intact fruit). The use of a HACCP system
provides flexibility to a processor to use alternative pathogen control
methods and, thus, encourages the development of new technologies but
does not dictate either their development or use. Moreover, not only is
HACCP effective in controlling microbiological hazards, it also is
effective in preventing chemical and physical hazards. Thus, HACCP is
particularly well-suited for the juice industry given, as discussed
previously, the range of hazards that must be addressed in processing
juice.
The agency agrees with the comments that urged use of CGMP's
together with HACCP. CGMP's form the foundation upon which a HACCP
system is built. Therefore, CGMP's are integral to the HACCP approach.
Because there are significant concerns with the microbial safety of
juices, HACCP systems must control pathogens. As will be discussed in
section IV.M of this document, FDA is proposing a 5 log reduction in
target pathogens, as the NACMCF recommended, as a necessary step in a
HACCP plan for juice. Validation of a HACCP system must ensure that the
process that is employed is adequate to control the relevant pathogens,
in addition to chemical and physical hazards. Validation of performance
standards consists of determining the ability of the pathogens in
question to resist acid and other chemical or heat treatment and the
ability of the process applied to overcome that resistance. The agency
requests comment on this approach to safety performance criteria. FDA
also requests comment on the benefits of requiring a general HACCP
approach as opposed to those of specifically requiring pasteurization.
7. Alternative Approach
An alternative approach to mandating HACCP would be to draw a
distinction between untreated apple cider and all other juices.
Manufacturers of apple cider would be provided a permanent option
choosing between labeling or implementing a HACCP program with a 5-log
pathogen reduction. All juices other than untreated apple cider would
be provided a permanent option of choosing between labeling,
implementing a HACCP system, or achieving a 5-log pathogen reduction as
discussed in section M of this document, entitled ``Pathogen
Reduction.'' The agency requests comments on this alternative approach
to a mandatory HACCP program.
D. Decision to Propose HACCP
The evidence discussed in section I.A of this document shows that
juices have been a vehicle for pathogens that have caused a number of
foodborne illnesses. Pathogens can be controlled through heat
treatment. Information set forth in sections I.B and I.D of this
document, however, demonstrates that there are many hazards that can
occur with juice and juice beverages that cannot be controlled through
heat treatment. Although not all of the problems discussed in section I
of this document are caused by hazards that could be considered
reasonably likely to occur in many juice operations, through the use of
HACCP programs, a firm can evaluate its process to determine if the
problem could have been controlled.
As discussed in section I.E of this document, the NACMCF stated
that HACCP and safety performance criteria can form the general
conceptual framework needed to ensure the safety of juices. FDA has
evaluated each of the seven alternatives that have been suggested for
dealing with the problems with juice. While the agency finds that these
alternatives are by no means mutually exclusive, FDA has tentatively
concluded that a preventive system, such as HACCP, appears to offer the
most effective way to control the significant microbial hazards, along
with other hazards, that have become a problem with juice.
Increased inspection, while having some beneficial impact on the
safety of juices, is resource intensive to the agency. Even if funds
were available to the agency for this purpose, increased inspection
would likely not be the best way for the agency to utilize its
resources to protect the public health. It is ultimately the
responsibility of manufacturers to ensure that their products are safe.
A preventive approach, such as HACCP, on the other hand, enhances a
processor's ability to make safe products because HACCP concentrates on
examining all aspects of production, identifying hazards that are
reasonably likely to occur in that production process, and establishing
measures that will control or minimize those hazards. HACCP also
enhances FDA's inspections because it allows the agency to inspect the
production facility more efficiently and then to verify that the firm
is operating in accordance with the firm's HACCP plan, and it provides
some assurance that any problems that have occurred have been
identified and appropriately addressed.
CGMP's, the second alternative to HACCP, are plantwide operating
procedures. Although FDA supports the use of CGMP's, it tentatively
concludes that use of CGMP's alone would not be sufficient to control
the problems with juices because CGMP's do not concentrate on the
identification and prevention of food hazards. Nonetheless, CGMP's are
necessary to provide the foundation on which a HACCP system is built.
Therefore, the agency tentatively concludes that, while CGMP's are
important to a HACCP system, they are not an adequate alternative to
HACCP.
Mandating pasteurization, the third suggested alternative to HACCP,
would reduce many microbial hazards in juices but would eliminate the
incentive to develop alternative methods (e.g., use of multiple
barriers, surface treatment of fruit) that can accomplish the same
purpose. FDA does not want to limit innovative approaches to achieving
food safety. HACCP, on the other hand, allows and encourages firms to
explore more technologically efficient and more cost-efficient ways of
managing all of the hazards that they face. Moreover, pasteurization
only controls microbial hazards. HACCP systems can control all
Page 20457
food hazards that are reasonably likely to occur.
Labeling was also suggested as an alternative. FDA acknowledges
that, from a public health protection standpoint, there are certain
advantages to labeling. Elsewhere in this issue of the Federal
Register, FDA is proposing to require certain labeling, in the form of
a warning statement, for packaged juice products that have not been
processed to control, reduce, or eliminate pathogenic microorganisms
that may be present in such juices. Such labeling will serve to reduce
the risk of foodborne illness. However, such reduction will occur only
to the extent that consumers read and understand the labeling.
Accordingly, the agency has tentatively concluded that mandating HACCP
for most juice products will provide more comprehensive public health
protection by greatly reducing the number of juice products that
contain dangerous pathogens.
Importantly, manufacturers do have the ability to process juice to
control pathogens. Labeling a product to alert consumers to possible
harmful effects from its consumption is not a substitute for a
manufacturer adequately addressing those concerns during processing.
Juice is a product consumed by children, as well as by adults. FDA is
reluctant to rely on labeling as a safety measure and does so only when
its analysis of the countervailing factors reveals that, on balance,
labeling provides the most reasonable approach to protect the public
health. Here, a situation in which HACCP offers a real long-term
solution to controlling, if not eliminating, hazards in juice, the
agency tentatively believes that labeling is not a reasonable long-term
approach. The agency is soliciting comment on the appropriateness of
this tentative conclusion.
The fifth alternative to HACCP that was suggested is education.
Industry education can play a valuable role in the production of safe
juices. Consumer education can play an important part in consumer
purchasing choices. However, education is only effective if people
understand and use the information conveyed. Moreover, even an
extensive education program may not reach all consumers. Conversely,
mandatory HACCP would ensure that industry produces safe juice, and
that the product that reaches consumers is safe.
For the foregoing reasons, FDA has tentatively concluded that HACCP
represents the appropriate system of controls that is necessary for
producing safe juice products. Therefore, FDA is proposing to add part
120 to its regulations to establish procedures for implementing HACCP
systems for fruit and vegetable juices. As the agency did with seafood,
it is proposing to issue these HACCP regulations under various sections
of the the act, including, most significantly, sections 402(a)(1) and
(a)(4) and 701(a) of the act (21 U.S.C. 371(a)).
Section 402(a)(1) of the act states that a food is adulterated if
it bears or contains any poisonous or deleterious substance that may
render the food injurious to health. Section 402(a)(4) of the act
states that a food is adulterated if it has been prepared, packed, or
held under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to health.
It is important to recognize that section 402(a)(4) of the act
addresses conditions that may render a food injurious to health, rather
than conditions that have actually caused the food to be injurious (see
United States v. 1,200 Cans, Pasteurized Whole Eggs, etc., 339 F. Supp.
131, 141 (N.D. Ga. 1972)). The question is whether the conditions under
which the food is processed and held are insanitary and may render the
food injurious to health. The agency tentatively finds that, if a
processor of juice products does not incorporate certain basic controls
into its procedures for preparing, packing, and holding food, it is
operating under insanitary conditions that may render the juice that is
produced injurious to health and, therefore, adulterated under the act.
Section 701(a) of the act authorizes the agency to adopt regulations
for the efficient enforcement of the act.
The legal basis for mandating HACCP systems for juice processors is
the same as that for seafood. Additional discussion of the legal basis
is set out in the proposed rule (59 FR 4142 at 4150, January 28, 1994)
and final rule (60 FR 65096 at 65098) for fish and fishery products.
E. Notice of Intent
FDA published a notice of intent on August 28, 1997 (62 FR 45593),
that announced a comprehensive program to address the incidence of
foodborne illness related to consumption of fresh juice and to address
ultimately the safety aspects of all juice products. The agency invited
comment on the appropriateness of its strategy to: (1) Initiate
rulemaking on a mandatory HACCP program for some or all juice products,
(2) propose that the labels and labeling of some or all juice products
not specifically processed to prevent or eliminate the presence of
harmful bacteria bear a warning statement informing consumers of the
risk of illness associated with consumption of the product, and (3)
initiate several educational programs to minimize the hazards
associated with fresh juice. The agency stated that it would consider
comments received within 15 days of publication of the notice prior to
publication of any proposed rule.
Some comments on the notice suggested that FDA mandate HACCP only
for fresh juice processors. One comment stated that HACCP should be
mandated only for firms that process large quantities of fresh juice.
Other comments supported mandatory pasteurization or equivalent
treatment of juice, especially apple cider. One comment added that
pasteurization and use of CGMP would preclude the need for the
mandatory use of HACCP.
In section II.D of this document the agency has already discussed
its reasons for proposing HACCP. The illnesses discussed in sections
I.A and I.B of this document did not pinpoint problems related solely
to fresh juice processors or to the amount of fresh juice that a firm
produced. The comments have not provided any new information to alter
the agency's tentative conclusion that HACCP is necessary to ensure the
safe production of juice. However, FDA requests information on whether
there are categories of juice that should be excluded from the proposed
regulation.
FDA has reviewed all of the comments received within 15 days of
publication of the notice and has determined that the comments provided
no information that would cause the agency to conclude that this
proposal is inappropriate. The agency has attempted to address these
comments to the extent that they are relevant to this proposal. All
comments received in response to the notice that address the issues in
this proposal will be considered either in this proposal or in any
final rule published in response to this proposal.
F. Fresh Produce Guidance
FDA, working with the U.S. Department of Agriculture (USDA) and the
agricultural community, has developed voluntary good agricultural
practice (GAP) and GMP guidance for fruits and vegetables that has been
issued in draft for comment. The guidance, which is a science-based
evaluation of risks, will address potential food safety problems
throughout the food production and distribution system such as
sanitation, worker health, and water quality. This voluntary guidance
can be used by both domestic and foreign fresh fruit and vegetable
producers to help ensure the safety of their produce.
Page 20458
III. The HACCP System
The HACCP concept is a systematic approach to the identification
and assessment of the risk (likelihood of occurrence and severity) of
biological, chemical, and physical hazards from a particular food
production process or practice and the control of those hazards. HACCP
is a preventive strategy for food safety. Under it, the food producer
develops a plan that anticipates and identifies the points in the
production process where a failure would likely result in a food hazard
being created or allowed to persist. These points are referred to as
critical control points (CCP's). Under HACCP, identified CCP's are
systematically monitored to ensure that critical limits (CL's) are not
exceeded, and records are kept of that monitoring. Corrective actions
are taken when control of a CCP is lost, including proper disposition
of the food produced during that period, and these actions are
documented. The effectiveness of HACCP is also systematically verified
by the processor.
HACCP has been endorsed by the NACMCF as an effective and rational
means of ensuring food safety. HACCP also is recognized in the
international food safety community as the state-of-the-art means to
ensure the safety and integrity of food. In particular, the Committee
on Food Hygiene of the United Nations' Codex Alimentarius Commission
(Codex) has endorsed the HACCP concept as a worldwide guideline. The
European Union (EU) and other countries around the world have begun to
require that foods produced within their borders be processed in a
HACCP system. HACCP also is required for shipment of some foods (e.g.,
seafood) into EU countries.
A. Five Preliminary Steps of HACCP
The NACMCF recommends a process for developing a HACCP system that
includes: (1) Assembling a HACCP team, (2) describing the food and its
distribution, (3) identifying the intended use and consumers of the
food, (4) developing a flow diagram, and (5) verifying the flow diagram
(Ref. 55). These steps have been identified by the NACMCF as the ``five
preliminary steps'' of HACCP. Although the agency is not proposing to
mandate that processors use these preliminary steps, processors will
greatly benefit from using these preliminary steps in developing their
HACCP systems. The NACMCF advises that the preliminary tasks should be
accomplished before the application of HACCP principles to a specific
process (Ref. 55).
B. The Seven Principles of HACCP
The NACMCF has developed the following seven principles that
describe the HACCP concept:
1. Conduct a Hazard Analysis
The first step in the establishment of a HACCP system for a food
production process or practice is the identification of the hazards
associated with the product. The NACMCF defines a hazard as a
biological, chemical, or physical factor that may cause a food to be
unsafe for consumption. The hazard analysis step should include not
only a written identification of the hazard but a written assessment of
the likelihood that the hazard will occur and its severity if it does
occur. This analysis should also involve the identification of CCP's
along with control measures for each identified hazard.
2. Determine the CCP's
A CCP is a point, step, or procedure at which control can be
applied, so that a potential food hazard can be prevented, eliminated,
or reduced to acceptable levels. Points in the manufacturing process
that may be CCP's include heat treatment, chilling, specific sanitation
procedures, product formulation control, prevention of cross
contamination, and certain aspects of employee and environmental
hygiene.
3. Establish Critical Limits
This step involves establishing parameters that must not be
exceeded for each control measure associated with a CCP. Critical
limits (CL's) can be thought of as boundaries of safety for each CCP
and may be set for control measures such as temperature, time, physical
dimensions, moisture level, water activity, pH, and available chlorine.
A CL is used to distinguish between safe and unsafe operating
conditions at a CCP. For example, the minimum temperature and time
combination that will kill pathogens in a heat treatment step is the CL
for that CCP.
4. Establish Monitoring Procedures
Monitoring is a planned sequence of observations or measurements to
assess whether a CCP is under control (i.e., operating within its CL)
and to produce an accurate record of the monitoring for use in future
verification procedures. An unsafe food may result if a process is not
properly controlled and a deviation occurs. Because of the potentially
serious consequences of a CL deviation, monitoring procedures must be
effective. Continuous monitoring is possible with many types of
physical and chemical methods. When it is not possible to monitor a CL
on a continuous basis, monitoring intervals must be established that
are frequent enough to permit the manufacturer to determine whether the
step/process/procedure designed to control the hazard is working.
5. Establish Corrective Actions
While the HACCP system is intended to prevent deviations in a
planned process from occurring, total prevention can rarely, if ever,
be achieved. Therefore, there needs to be a corrective action plan in
place to fix or correct the cause of the deviation to ensure that the
CCP is brought under control, to ensure that there is appropriate
disposition of any food produced during a deviation, and to ensure that
records are made of the corrective actions taken. Out of control
situations should be used to identify opportunities for improvement of
the process to prevent future occurrences.
6. Establish Verification Procedures
This process involves the application of methods, procedures,
tests, and evaluations, other than monitoring, to determine the
adequacy of, and compliance with, the HACCP system. The major infusion
of science in a HACCP system centers on proper identification of the
hazards, CCP's, and CL's and the institution of proper verification
procedures.
7. Establish Recordkeeping and Documentation Procedures
This principle requires the preparation and maintenance of written
HACCP records that list the hazards, CCP's, and CL's identified by the
firm, as well as the monitoring, recordkeeping, and other procedures
that the firm intends to use to implement the system. This principle
also requires the maintenance of records generated during the operation
of the HACCP system.
C. History of the Use of HACCP
1. HACCP for Fish and Fishery Products
On December 18, 1995, FDA published a final rule in the Federal
Register (60 FR 65096) on procedures for the safe and sanitary
processing and importing of fish and fishery products (part 123 (21 CFR
part 123)) (seafood final rule). The regulations require that seafood
processors develop, implement, and document sanitation control
procedures and mandate the application of HACCP principles to the
processing of seafood. The effective date for the seafood final rule
was December 18, 1997.
Page 20459
The regulations proposed herein are based on the seafood final rule
with some modification to reflect the differences between seafood and
juice products and to reflect recent developments in the application of
HACCP. An extensive administrative record was compiled in the seafood
proceeding. FDA is incorporating that record as support for the current
proposal. Although the regulations proposed herein differ in some
aspects from part 123, they are not intended to supersede or otherwise
alter the seafood final rule.
2. Advance Notice of Proposed Rulemaking for the Development of HACCP
for the Food Industry
In the Federal Register of August 4, 1994 (59 FR 39888), FDA
published an advance notice of proposed rulemaking (ANPRM) requesting
public comment about whether and how the agency should develop
regulations that would establish requirements for a new comprehensive
food safety assurance program, based on HACCP, for both domestically
produced and imported foods. The agency stated its tentative view that,
if such regulations were issued, they would enhance FDA's ability to
ensure the safety of the U.S. food supply. FDA requested comments on a
number of specific issues, as well as on all aspects of such a food
safety program.
3. HACCP Pilot Programs
In addition to the ANPRM, FDA also published in the Federal
Register on August 4, 1994 (59 FR 39771), a notice announcing that it
intended to conduct a pilot program in which volunteers from the food
manufacturing industry would use a HACCP system that FDA would audit.
The pilot program was intended to provide information that FDA could
use in deciding whether to propose to adopt regulations and in
developing and implementing a regulatory system in which food
manufacturers are required to perform the food safety aspects of their
operations based on HACCP principles. In the notice, FDA invited
individual firms that wished to participate in the program to submit
letters of interest. Approximately 50 firms expressed initial interest
in participating in the pilot program, and 11 firms were selected to
participate. In 1997 FDA completed the pilot program at six firms and
published a second interim report.
4. HACCP for Meat and Poultry
On July 25, 1996, USDA published a final rule (61 FR 38806) that,
among other things, required that each meat and poultry establishment
develop and implement written sanitation standard operating procedures
(Sanitation SOP's) and a system of HACCP controls designed to improve
the safety of their products. The effective date for the Sanitation
SOP's was January 27, 1997, and for the HACCP regulations was January
26, 1998. FDA has reviewed the meat and poultry HACCP regulations and
has incorporated portions of them as appropriate in the proposed HACCP
regulations for juice.
D. Issues from the ANPRM
FDA received approximately 150 comments in response to the August
4, 1994, ANPRM. The comments represented the views of consumers,
consumer organizations, health professionals, academicians, food
industry officials, trade associations, and foreign, State, and local
government agencies. The agency has attempted to address these comments
to the extent that they are relevant to this proposal.
1. The agency asked in the ANPRM how the responsibility for food
safety should be shared between the food industry and government.
Comments generally agreed that the food industry is responsible for
producing safe food products. All respondents on this issue recognized
that the Government's role is to verify industry compliance with any
applicable safety regulations.
FDA agrees that it is the manufacturer's responsibility to ensure
that the food that it produces is safe, and that it is the Government's
role to verify that manufacturers are fulfilling their responsibility.
Through use of a HACCP system, both the firm and FDA are able to better
fulfill their roles. The proposed regulation in part 120 underscores
the division of roles. Under the proposed regulation, industry is
charged with examining all aspects of production, identifying hazards
that are reasonably likely to occur, and establishing measures that
will control or minimize those hazards. HACCP records enable the agency
to inspect the production facility more efficiently and to verify that
the firm is operating in accordance with its HACCP plan. They also give
the agency insight into whether any problems that have occurred have
been identified and appropriately addressed.
It is important that the juice industry focus on its responsibility
to produce safe food. Recent outbreaks evidence that some members of
the industry have not kept up with the need to evaluate the hazards
presented by juice and to design processes to address those hazards.
Firms need to be aware of the emerging problems presented by their raw
materials and to decide whether, and if so what, steps are necessary to
address these problems. Firms may decide that it is necessary to
incorporate a step designed to kill bacteria into their process (e.g.,
pasteurization), that there are alternative steps that they can take to
ensure the safety of their products, or that, given the nature of the
raw materials, no steps are necessary. Firms also need to monitor the
process that they decide to employ to ensure that it is functioning
adequately and appropriately. FDA notes that some firms have already
addressed food safety concerns and have implemented HACCP systems.
Moreover, given the heightened concerns about these products,
Government needs to be in a position to fulfill its role of verifying
that industry is doing its job. Given the sporadic and variable way in
which the problems that have been associated with juice arise, sampling
and end-product testing of juice products will not enable it to do so.
Other steps that will give Government insights into the production
itself appear to be in order.
2. FDA requested comment in the ANPRM about the likelihood of
occurrence of a hazard that would warrant HACCP-type control.
Generally, the comments consistently identified two features that would
characterize a properly formulated definition of likelihood: Processing
conditions and nature of hazard. The majority of comments offered by
the food industry stipulated that the necessary condition for
likelihood of occurrence of the hazard appropriate to trigger HACCP
control must not be speculative, as in worst-case scenarios, but be
real, practical, and intrinsic to the processing or hazards
demonstrably present for specific commodities. Several responses
recommended that the question be referred to broadly based expert
panels to establish the likelihood of risk.
According to the NACMCF, each potential hazard is evaluated based
on the severity of the potential hazard and its likely occurrence (Ref.
55). Severity is the seriousness of the consequences of exposure to the
hazard. Considerations of severity (e.g., impact of sequelae and
magnitude and duration of illness or injury) can be helpful in
understanding the public health impact of the hazard. Likelihood of
occurrence of a hazard is generally judged based on processing
experience, epidemiological data, and information in the technical
literature.
The agency agrees with the comments that stated that the processing
conditions and the nature of the hazard are key elements in assessing
the
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likelihood of a hazard occurring. It would be futile for processors to
attempt to control for every theoretical hazard because doing so would
entail assessing hazards that the processor could not reasonably
anticipate would actually occur. The assessment of the likelihood of
risk of illness or injury to consumers should be practical for the
specific commodity and not be speculative. For example, use of
pesticides on fruits and vegetables is a common practice while these
foods grow. The presence of pesticides on fruits or vegetables used to
make juice is considered a hazard if: (1) The pesticide is not approved
for use on the fruit or vegetable, or (2) it is found in amounts above
its EPA established tolerance. If a pesticide is applied to fruits or
vegetables in conformance with EPA regulations, and the appropriate
period of time has elapsed between application and harvest, the
presence of the pesticide is not considered to present a hazard that is
reasonably likely to occur.
The agency disagrees that it should rely on broadly based expert
panels to establish likelihood of occurrence of a hazard. Although such
committees could provide insight into the issue, on balance, the
insights that they would be likely to provide would not justify the
expenditure of resources that convening such committees would require.
However, interested persons are welcome to consider voluntarily the
question and to submit the results of their consideration to the
agency.
3. Comments on the ANPRM stated that because epidemiological
studies consistently show that microbial pathogens are the most
significant source of food hazards, issues such as pesticides, heavy
metals, filth, physical contaminants, and others pale by comparison
with the immediate health consequences of foodborne microbial
pathogens. They stated that HACCP is best suited for preventing
microbial hazards rather than physical or chemical hazards because CCP
monitoring can be readily established in a timely fashion for pathogens
and, particularly, for the unsanitary conditions that promote their
growth.
The comments added that effects that result from events that occur
after the food has left the processor's HACCP system are not
controllable by the processor. The comments said that this fact is
significant because food service establishments and the lack of
consumer education have contributed to the majority of incidences of
foodborne illness reported in current epidemiological data. They stated
that HACCP systems are essentially localized management tools that will
not permit any measurable improvement in national or international food
safety effectiveness and have been implemented voluntarily solely as a
corporate practice to provide strategic business advantages in
increasingly competitive markets.
The comments stated that regulation may be premature because of the
adequacy and feasibility of presently available analytical tests to
control all hazards. They stated that, consequently, HACCP is an
excellent tool but only in the very specific case of high-risk food
processing that is focused on controlling microbiological risks. The
comments stated that, instead of misdirecting its efforts, FDA needs to
look to itself to reinforce food preparation safety awareness at food
service establishments and to pursue vigorously an enhanced consumer
education policy on unsafe food practices as the best preventative food
risk control program.
FDA agrees that microbial hazards are a significant source of food
hazards. FDA also agrees that HACCP is an ideal mechanism to deal with
microbial hazards because it is a system of prevention. Prevention
makes up for the inadequacies of end-product testing. For example, for
maximum quality, nonshelf stable juice must be distributed quickly, and
end-product testing usually takes at least several days to obtain
results. If pathogens are discovered in the juice after distribution,
the product must be recalled, and consumers may have already ingested
product. Finally, the particular samples taken in end product testing
may not contain pathogens because the pathogens may not be ubiquitous
in the lot (i.e., there may be low level or sporadic contamination) and
thus produce false negatives.
A system of preventive controls, like HACCP, on the other hand, is
designed to identify and manage conditions where pathogens could be
present in juice while it is still being processed. HACCP is designed
to ensure that there is early discovery, and timely correction, of any
problems that may develop. Although HACCP is well suited for preventing
microbial hazards, this does not mean, as some of the comments
asserted, that it is not useful for other types of hazards. As the
NACMCF has recognized, it is well suited for preventing chemical and
physical hazards. For example, processors can establish CCP's to
prevent pieces of glass from contaminating a product when glass bottles
are used.
The NACMCF endorses HACCP as an effective and rational means of
assuring food safety (Ref. 55). According to the NACMCF, its use will
likely result in measurable improvement in food safety. Under HACCP,
processors view the processing plant from a prevention perspective and
thus are in a position to react appropriately to new hazards if they
arise. In preparing this proposal, FDA has reviewed the history of
juice related outbreaks. All of these outbreaks might have been
prevented if a HACCP system of the type that FDA is proposing herein
had been in use.
The agency agrees that there are hazards that can occur after food
has left the processing plant that the processor cannot control. The
agency has established the Food Code to assist State agencies and food
workers in retail food establishments and has addressed handling of
high risk foods in the Food Code. FDA also provides consumer
information on food safety through a consumer hotline, public affairs
specialists in FDA's district offices, and various brochures and other
publications. These efforts are intended to educate consumers on safe
handling of foods at home. In addition, as described in the interim
notice, the agency has initiated a consumer education program
concerning juice that is not treated to prevent or eliminate the
presence of harmful bacteria.
4. The agency requested information in the ANPRM on its possible
role in assisting the food industry in the development of HACCP plans.
Comments stated that FDA preparation of general background materials on
HACCP would be beneficial in establishing a common approach to plan
development, in assisting hazard identification analysis, and in using
consistent language. They stated that FDA could provide informational
resources such as examples of HACCP plans adaptable to the individual
circumstances of a business' operations or consultative documents that
could serve to guide plan development.
However, some comments urged that FDA avoid over-regulation. They
stated that an excessively ambitious regulatory approach will limit the
effectiveness of any HACCP program.
The agency agrees that it should avoid over-regulation because such
an approach can inhibit future developments and new technology in HACCP
systems and in safe food processing. FDA is proposing a HACCP
regulation that, if adopted, will be mandatory for juice processors (as
defined at proposed Sec. 120.3(i)) but that can be used as a model for
other foods in that it outlines the minimum essential components of a
HACCP system. To the extent possible, the proposed regulation is in
harmony with
Page 20461
the existing HACCP regulations for seafood and meat and poultry.
FDA has developed the ``Fish & Fisheries Products Hazards &
Controls Guide'' to assist manufacturers in the implementation of HACCP
for seafood. The Federal Safety and Inspection Service (FSIS) has
developed, in conjunction with the International Meat and Poultry HACCP
Alliance, 13 HACCP models for meat and poultry products, a ``Guidebook
for the Preparation of HACCP Plans,'' and the ``Meat and Poultry
Products Hazards and Control Guide.'' However, it is not clear whether
FDA will be able to provide such detailed information for juice.
Therefore, in this rulemaking, the agency will attempt to provide
guidance, to the extent possible, concerning the application of the
regulation to juice.
5. Some comments on the ANPRM stated that, if EPA tolerances for
pesticides in agricultural commodities become HACCP-focused safety
issues in food processing and service industries, then explicit
coordination by FDA with EPA is needed to define truly significant
hazards. They stated that this effort would greatly assist HACCP
development in such circumstances, so that duplication of effort would
be avoided, consistency among regulatory requirements would be
achieved, and impediments to international commerce would be removed.
FDA has attempted to harmonize its regulations with those of other
Federal agencies and with Codex. EPA establishes regulations for
pesticide use and tolerances for pesticide residues, and FDA and USDA
enforce those tolerances on foods.
Under section 402(a)(2)(B) of the act, a food is deemed to be
adulterated if it bears or contains a pesticide chemical residue unless
a tolerance or an exemption for such pesticide has been established,
and the quantity of such pesticide on the commodity is within the
tolerance limits. Pesticide chemical residues for which there is no
tolerance or exemption are deemed to be unsafe as a matter of law.
HACCP is intended to protect against unsafe products. Thus, there is no
reason why pesticide residues and similar types of food safety measures
should be outside the scope of HACCP.
6. In the ANPRM, the agency asked if there was a need for
microbiological criteria in HACCP regulations. Some comments favored
inclusion of microbiological criteria for known high risk foods because
such criteria are practical, efficient, and cost effective. However,
most comments maintained that microbiological criteria, set as national
standards, are not warranted because: (1) Criteria are discordant with
HACCP purposes because they depend on end product testing, (2) criteria
possess inadequate scientific basis, and (3) criteria are preemptive of
localized development of HACCP systems.
The agency tentatively agrees with those comments that stated that
microbiological criteria in HACCP regulations are warranted for some
foods. Contrary to what many of the comments asserted, effective
microbial controls depend not on end product testing but on processing
controls and the establishment of CL's. For example, juice made from
apples that have fallen on the ground must be processed in some manner
to destroy pathogens because pathogens are likely to be present and, as
discussed previously, end product testing may produce false negatives.
If a regulation is flexible, it should not ``preempt'' the processor's
development of HACCP, but it can provide the CL's needed for the safe
processing of food under a HACCP system. However, the agency agrees
that the decision on which processing controls are to be used must have
a valid scientific basis.
Microbial pathogens have emerged as a significant problem in
unpasteurized juice in recent years. The NACMCF recommended that safety
performance criteria, rather than a specific intervention technology,
be mandated for juice (Ref. 53). The safety performance criteria
recommended by the NACMCF is whether the measures that a juice
processor employs have been validated to achieve a cumulative 5 log
reduction in the target organisms or a reduction in yearly risk of
illness to less than 10<SUP>-5</SUP>, assuming consumption of 100 mL of
juice daily. As will be discussed in section IV.M of this document, FDA
is proposing to require that firms include in their HACCP plans
measures that will produce, at a minimum, a 5 log reduction in target
pathogens.
7. Comments on the ANPRM stated that FDA should require end product
testing records to provide information as to the effectiveness of a
HACCP program. These comments stated that end product testing was
practical because mandated testing was a necessary, continuing, and
recordable validation of the completeness of a HACCP system, thereby
ensuring that 100 percent control is manifested.
Comments from the juice meeting also supported the use of end
product testing. One of the these comments proposed using testing to
decide whether to pasteurize each lot. Several comments pointed to new
rapid testing technologies and testing kits for pathogens.
However, other comments maintained that information generated from
end product tests would not be useful. One comment stated that end
product testing activities were counterproductive to a well-planned
HACCP system. Furthermore, these comments added, any requirements that
FDA puts forward must be practical, and no process can be regulated
into 100 percent certainty.
The agency is not proposing to require end product testing. End
product testing is most useful where there are high levels of the
substance being tested, and there is uniformity throughout the lot
being sampled. Product sampled for testing for microbial hazards, where
a pathogen (e.g., E. coli O157:H7) is hazardous even at very low
levels, or for physical hazards (e.g., glass), where the hazard is the
presence of a discrete unit, may not contain the hazard even under the
best sampling procedure. In these cases end product testing is likely
to produce false negatives and, thus, to provide scant protection. It
is prohibitive to use end product testing adequately in these
situations because of the amount of testing that is necessary for a
statistically valid test, and because it would be necessary to channel
a significant portion of the product for that testing. Therefore, the
agency has tentatively concluded that use of control measures under a
HACCP system to prevent hazards from occurring, with subsequent
monitoring, verification, validation, and recordkeeping, is more
effective than end product testing in ensuring that food is safe. Thus,
FDA has not included a requirement for end product testing in this
proposed rule on juice products.
8. The agency asked in the ANPRM whether it should mandate HACCP
for all segments of the food industry. Many comments stated that
mandatory HACCP regulations for low-risk foods would be inappropriate
because trying to manage low risk hazards through HACCP would dilute
agency resources and therefore the effectiveness of HACCP. The comments
stated that FDA could utilize its resources most efficiently by
focusing on those high-risk food processing operations identified in
its 1993 model Food Code as ``Potentially Hazardous.'' They stated that
the U.S. food supply is already demonstrably the world's safest, so
that there is no valid reason for requiring HACCP plans of the entire
industry. The comments stated that enforcement mechanisms in the act
are, and will continue to be, sufficient without adding to the
regulatory burden on
Page 20462
industry. They added that incorporation of HACCP into food industry
operations should be permitted to proceed on a voluntary basis, unless
a well-defined need requires implementation through specific authority
provisions of the act into specific high-risk segments of the food
industry.
However, some comments stated that unless all segments of the food
chain are mandatorily included, adoption of HACCP is unlikely to result
in measurable enhancement of the safety of the food supply. They stated
that less than universal coverage would create confusion about what
should be excluded. The comments stated that any attempt to limit HACCP
to identified ``high-risk'' processors would hinder efforts to address
significant public health problems that may arise in the future. They
concluded that it is not unduly burdensome to mandate HACCP for all.
The comments maintained that HACCP regulations should be as
comprehensive as practicable and applied throughout the food chain to
the fullest extent possible and reasonable, and that HACCP principles
must be applied from farm to fork.
FDA disagrees with the comments that stated that HACCP is
inappropriate for low-risk foods. Both food processors and government
regulatory agencies would benefit from the use of HACCP systems. The
U.S.'s excellent record for having a safe food supply does not mean
that this country should not consider ways of improving on that record.
In the face of emerging pathogens and other new food hazards, HACCP
provides a flexible system in which processors reassess their
procedures on an on-going basis. HACCP also enables processors to meet
future demands.
The use of HACCP allows food processors to concentrate their
efforts on the aspects of the processes that they use where risks are
highest and provides regulatory agencies with assurance that processors
are observing prudent processing practices. HACCP also provides
assurance that problems in the process are likely to be discovered, and
that unsafe product is unlikely to leave the firm. The complexity of
HACCP is a function of the number of hazards that must be controlled
and the nature of the controls for each hazard. Foods that involve few
hazards will tend to have fewer CCP's, and, conversely, those that have
multiple hazards will tend to have more complex HACCP plans and
monitoring requirements.
FDA is proposing a regulation that will mandate HACCP for juices.
The agency has tentatively concluded that there is a safety basis to
require that processors use HACCP systems in the processing of juice.
As the agency gains experience and additional information from the
pilot program and from seafood HACCP implementation, it will examine
the appropriateness of expanding the scope of proposed part 120 (if the
agency adopts it) to include other foods. Clearly, the agency will
consider HACCP's use with foods that it has identified as presenting
likely hazards, as it is doing in this proposal.
In developing the proposed regulations for juice, FDA came to
recognize that the elements of a HACCP regulation for juice are really
no different than those for seafood. This insight suggests that part
120 can act as a model for HACCP for other parts of the food industry
should the agency become aware of facts that would justify extending
the coverage of the regulation. Firms that are interested in
voluntarily instituting HACCP can use the regulations in part 120 as a
guide for doing so.
9. The ANPRM requested information on the criteria that FDA should
use in deciding whether to cover some or all segments of the food
industry with a mandatory HACCP rule. Some of the comments stated that
exclusions cannot be justified on the basis of business size because
about 75 percent of the food industry would be considered to be small
businesses. The comments asserted that exclusions can only be judged
with respect to properly defined risks for the food hazards involved in
producing the end-product.
FDA agrees that exemptions from HACCP regulations cannot be
justified on the basis that a business is small because food hazards
that are reasonably likely to occur in the production of most foods
occur regardless of the size of the firm. The agency also agrees that
any exceptions to mandatory HACCP systems must be based on instances in
which risks are not reasonably likely to occur. However, FDA is
required by law to consider ways to assist small businesses when it
implements regulations. While FDA does not propose to exempt any small
businesses from the food safety requirements in this proposed rule, FDA
is considering ways to provide regulatory options that will serve to
reduce the burden of compliance on such small businesses.
IV. FDA's Proposal
A. Applicability
1. Scope
The agency tentatively concludes that HACCP is necessary for the
safe and sanitary production of fruit and vegetable juices to address
the special concerns discussed previously. Therefore, FDA is proposing
new Sec. 120.1(a), which states that part 120 applies to juice and
defines what juice means for purposes of this regulation.
Fruit and vegetable juices may be used as ingredients in other
beverages (e.g., flavored bottled waters; juice beverages and
cocktails). These products often resemble juices, are processed in a
manner that is similar to juices, and handled by consumers similarly to
juices. Thus, they can present the same food hazards as juices.
Therefore, FDA is proposing to require that any juice sold as such or
used as an ingredient in beverages be processed in accordance with the
requirements of part 120.
As stated in section II of this document, FDA has established
standards of identity for a number of fruit juices in part 146 and for
tomato juice in Sec. 156.145. These standardized juices are generally
described as the liquid extracted or expressed from a fruit or
vegetable. However, prune juice (Sec. 146.187) is prepared from a water
extract of dried prunes.
A typical dictionary definition of the term ``juice'' is a fluid
naturally contained in plant or animal tissue (Ref. 56). As described
above, the present situation has demonstrated a need to control food
hazards associated with fruit and vegetable juices. The present
situation does not include oil extracts of fruits and vegetables (e.g.,
olive oil) because these are not traditionally considered juice. Some
juices (e.g., banana juice) and fruit nectars, when purees of the fruit
used, need to be included in any definition FDA proposes because such
purees are often blended with other juices. If there are food hazards
associated with extractives of a fruit or vegetable, those food hazards
will be present in purees of that fruit or vegetable. Concentrates of
juice and purees also need to be included in the definition because, if
a hazard is present in the juice or puree, it could also likely be
present in the juice concentrate. Therefore, the agency is tentatively
defining ``juice'' as the aqueous liquid expressed or extracted from a
fruit or vegetable, purees of the edible portions of a fruit or
vegetable, or any concentrates of such liquid or puree.
The agency requests comments on the definition of ``juice.'' FDA
also requests comments on the scope of the regulation and on whether it
should mandate HACCP for all types of juices, or whether it would be
sufficient to mandate HACCP for certain types of juices.
Page 20463
2. Effective Date
The seafood final rule provided processors 2 years to implement
HACCP. This was done to: (1) Allow time for training of industry
personnel and regulatory personnel; (2) provide the States with the
time to have a full opportunity to understand and respond to the
effects of these regulations; (3) increase the likelihood that more
agreements with other countries will exist; (4) increase the
opportunity for processors to engage in ``voluntary'' HACCP inspections
in advance of the effective date to obtain preliminary, informal
feedback from the agency on their progress; and (5) allow incorporation
of modifications made in the final rule and publication of FDA
assistance materials for the seafood industry (60 FR 65096 at 65169).
The period of time between publication of the final rule and the
effective dates of the HACCP regulations for meat and poultry issued by
FSIS are: (1) Eighteen months for large establishments with 500 or more
employees, (2) Thirty months for smaller establishments with 10 or more
employees but fewer than 500, and (3) Forty-two months for very small
establishments with fewer than 10 employees or annual sales of less
than $2.5 million (61 FR 38806).
A comment from a fresh juice trade association submitted to the
agency in response to the NACMCF recommendations to FDA on the safety
of juices, requested that FDA mandate HACCP for all juice products and
phase this requirement in over a 3-year period from the publication of
the final rule in a manner similar to the FSIS HACCP regulation. The
comment requested that FDA consider annual inspections of fresh juice
firms until the regulation is effective. It stated that the delay in
implementing HACCP requirements would allow FDA and juice processors
the ability to review conclusions of specific research and establish
performance standards based on this research.
Comments on FDA's notice of intent (62 FR 45593) generally
supported a phased-in approach for small firms taking 3 to 4 years.
However, one comment expected that a phase-in approach would take no
more than 2 years.
The agency is considering the significant issues surrounding
orderly implementation of HACCP. FDA must balance the need for
immediate implementation of HACCP, because of its associated food
safety benefits, against the costs of implementation and consider
options to minimize the burden to small businesses. The proposed
timeframe for implementation of these regulations attempts to balance
these competing concerns. The implementation of HACCP may be more
burdensome for small firms than for large firms. Large firms tend to
have quality control personnel already in place. In addition, many
regulatory requirements are less burdensome for a large firm in
proportion to output than they are for a small firm.
FDA recognizes that HACCP systems cannot be developed and
implemented overnight. The HACCP system of controls can involve new
ways of thinking and performing on a routine basis.
The agency issued a notice on August 28, 1997 (62 FR 45593), that
provided interim measures, and elsewhere in this issue of the Federal
Register, FDA is proposing to require labeling for juice to address the
agency's immediate public health concerns. If finalized, these measures
will require labeling on juice to provide information that juice
unprocessed to control pathogens poses risks to children, the elderly,
and the immunocompromised. The agency is proposing that the labeling
measures be superseded once packaged juice products are processed under
adequate HACCP programs, or are otherwise processed in a manner to
destroy pathogens (e.g., pasteurization). Therefore, as proposed,
before the applicable effective date, juice will be processed to
control for pathogens or, if not, will bear labeling to alert consumers
that such processing has not occurred. After any applicable effective
date, processors will use HACCP systems in the production of juice.
The agency has considered the precedents established by other HACCP
regulations and the comments submitted on juice. There are two
significant differences between the HACCP regulation that FDA is
proposing for juice and the HACCP regulations for seafood and for meat
and poultry. First, FDA has issued interim guidance suggesting that
juice that has not been processed to control pathogens be labeled
accordingly. Elsewhere in this issue of the Federal Register, the
agency is proposing to require such labeling. Second, at the present
time, FDA's available resources would make it very difficult, if not
impossible, to implement a comprehensive inspection program for the
entire juice industry. A phased in approach for compliance will thus
ease the burden not only on small businesses but also on the agency
itself. Accordingly, FDA is proposing that the regulations proposed
herein generally be effective 1 year after the date of publication of
the final rule, with special provisions that will extend the phase-in
to up to 3 years after publication of the final rule. This proposed
phase-in approach will permit the regulated industry time to accomplish
the training of personnel and adjust its activities to include
necessary HACCP activities and takes into account the needs of smaller
businesses.
The agency proposes to establish a timetable for phasing in HACCP
based on business size. FDA proposes in Sec. 120.1(b) that the
effective date be 1 year following publication of the final rule. The
agency is proposing that, by its terms, the regulation will not be
binding until 2 years following the date of publication of the final
rule for small businesses employing fewer than 500 persons
(Sec. 120.1(b)(1)). This is based on the definition of a small business
used by the Small Business Administration. In addition, the agency is
proposing that, by its terms, the regulation will not be binding until
3 years following the date of publication of the final rule for very
small businesses that have either total annual sales of less than
$500,000, or that have total annual sales that are greater than
$500,000 but total annual food sales of less than $50,000, or that
employ fewer than an average of 100 full-time equivalent employees and
that sold fewer than 100,000 units of the product in the United States
(Sec. 120.1(b)(2)). These criteria are consistent with those that the
agency has used in its regulation on small firms and compliance with
the nutrition labeling rules that implement the Nutrition Labeling and
Education Act (the 1990 amendments) (61 FR 40963) (see Sec. 101.9(j)(1)
and (j)(18)) (21 CFR 101.9(j)(1) and (j)(18)). In the 1990 amendments
context, these criteria represent the outcome of three hearings in
different parts of the country, an act of Congress, and informal
rulemaking by FDA. Thus, FDA tentatively concludes that food
manufacturers agree with and understand the definition of very small
businesses. As discussed in the next section of this document, for
purposes of this proposed rule, the agency has tentatively decided that
a retail establishment as set out in proposed Sec. 120.3(h)(2)(iii)
includes a very small processor that makes juice on its premises and
directly sells this juice both to consumers and other retailers
provided that total juice sales do not exceed 40,000 gallons per year.
In implementing proposed Sec. 120.1(b)(2), FDA intends to use the
definitions for the terms ``unit,'' ``food product,'' ``person,'' and
``full-time equivalent employee'' in
Page 20464
Sec. 101.9(j)(18)(vi). These definitions are as follows: (1) ``Unit''
means the packaging or, if there is no packaging, the form in which a
food product is offered for sale to consumers; (2) ``food product``
means food in any size package that is manufactured by a single
manufacturer or that bears the same brand name, that bears the same
statement of identity, and that has similar preparation methods; (3)
``person'' means all domestic and foreign affiliates, as defined in 13
CFR 121.401, of the corporation, in the case of a corporation, and all
affiliates, as defined in 13 CFR 121.401, of a firm or other entity,
when referring to a firm or other entity that is not a corporation; and
(4) ``full-time equivalent employee'' means all individuals employed by
the person claiming the exemption. The number of full-time equivalent
employees is determined by dividing the total number of hours of salary
or wages paid directly to employees of the person and of all of its
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,
40 hours x 52 weeks).
FDA is committed to its mission of ensuring that food is safe and
not misbranded. This commitment is the basis for proposing interim
labeling measures. The agency tentatively finds that a phase-in HACCP
implementation is necessary because of the logistical effort required
to manage a fundamental change in work processes, roles, and
responsibilities for smaller processors. The proposed implementation
schedule reflects the abilities of processors of varying sizes to
implement HACCP, and the time needed by industry to develop HACCP plans
and train employees.
Upon the proposed implementation date, processors must be ready to
operate their HACCP system, and FDA will conduct inspection activities
according to HACCP principles to ensure that the HACCP system is
operating acceptably. FDA requests comment on its proposed phased-in
implementation of HACCP.
B. Definitions
FDA is proposing in the introductory paragraph of Sec. 120.3 that
the definitions and interpretations of terms in section 201 of the act
(21 U.S.C. 321), in Sec. 101.9(j)(18)(vi), and in part 110 be
applicable to such terms when used in part 120, except where they are
redefined in Sec. 120.3.
The agency is proposing to include in Sec. 120.3 all definitions
applicable to juice that are in the seafood HACCP regulation. The
following terms have proposed definitions that are the same as their
definitions in Sec. 123.3: ``critical limit'' (Sec. 120.3(d)), ``food
hazard'' (Sec. 120.3(e)), ``importer'' (Sec. 120.3(f)), ``shall''
(Sec. 120.3(j)), and ``should'' Sec. 120.3(k)).
However, FDA is proposing to modify the term ``preventive measure''
to ``control measure'' (Sec. 120.3(b)) and to modify its definition
from that used in the seafood HACCP regulation (Sec. 123.3(i)) to
conform with recent NACMCF changes in terminology (Ref. 55). The term
``control measure'' is used because not all hazards can be prevented,
but virtually all can be controlled to some degree. The new NACMCF
definition describes the control measures as actions or activities
rather than as chemical, physical, or other factors. Further, the term
``control'' is clarified to mean prevention, elimination, or reduction
of hazards. The agency tentatively concludes that the recent NACMCF
definition better describes the measures that processors must take.
Therefore, FDA is proposing that ``control measure'' means any action
or activity that can be used to prevent, eliminate, or reduce a hazard.
The NACMCF also recently modified its definition for ``critical
control point'' (Ref. 55). The modified definition incorporates the new
definition of ``control measure'' and emphasizes the essential or
critical nature of the step. Thus, FDA tentatively concludes that the
recent NACMCF definition better characterizes the term. Therefore, the
agency is proposing in Sec. 120.3(c) that ``critical control point''
means a point, step, or procedure in a food process at which a control
measure can be applied and at which control is essential to reduce an
identified food hazard to an acceptable level.
The seafood HACCP regulation defines ``processing'' in
Sec. 123.3(k) with specific product application. To apply these
definitions to juice and to avoid listing specific processes, the
agency is proposing in Sec. 120.3(h)(1) to define ``processing'' as
activities that are conducted by a processor that are directly related
to the production of juice products.
As with the seafood HACCP regulation, there are certain handlers of
juice products that are not covered by the proposed definition. FDA has
tentatively concluded that harvesting, picking, or transporting raw
agricultural ingredients of juice products, without otherwise engaging
in processing, should not be included in the term ``processing''
(Sec. 120.3(h)(2)(i)). FDA has developed voluntary GAP guidance that
has been issued in draft for comment and will apply to these
activities. The agency believes that growers will find GAP's useful and
that the regulations that it is proposing in this rulemaking will, if
adopted, reinforce use of both FDA and specific industry GAP's, thus
affecting harvesting, picking, or transporting indirectly through
processor and importer controls over raw materials and imported
shipments (e.g., preventive controls such as the purchasing of raw
materials only from farms that engage in proper handling of produce).
The agency notes that, with FSIS, it published an ANPRM (61 FR
59372, November 22, 1996) concerning transportation and storage
requirements for potentially hazardous foods. In that ANPRM, FDA and
FSIS requested information and comments on approaches that the two
agencies should take to foster food safety improvements in the
transportation and storage of potentially hazardous foods. While juice
has not historically been considered a potentially hazardous food,
recent illnesses associated with juice necessitate reconsideration of
whether this food should not be included in that category. FSIS and FDA
are reviewing the comments received in response to the joint
transportation notice and will decide whether rulemaking is warranted.
FDA invites comment on whether its approach to transportation is
adequate.
The agency has also tentatively decided to exclude the operation of
a retail establishment from the definition of ``processing''
(Sec. 120.3(g)(2)(ii)). For purposes of this rule, the agency has
tentatively decided that a retail establishment as set out in proposed
Sec. 120.3(h)(2)(iii) includes a very small processor that makes juice
on its premises and directly sells juice to consumers and other
retailers provided that total juice sales do not exceed 40,000 gallons
per year.
FDA has traditionally refrained from directly regulating retail
establishments, although it has authority to do so. FDA provides
training and other forms of technical assistance to States and local
governments who inspect retail food establishments through the agency's
retail Federal/State cooperative program. A major part of that
cooperative program involves the development of model codes, some of
which have been widely adopted by States and local governments. FDA has
consolidated those model codes into a single, updated food code for the
retail sector. Appropriate controls are included in the food code that
can be applied to address juice hazards at retail. FDA will continue to
operate through the Federal/State cooperative mechanism and,
consequently, has not proposed to regulate juice retailers in
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this proposal. However, elsewhere in this issue of the Federal
Register, the agency is proposing to require labeling statements for
packaged juice products including those sold by retailers that have not
been pasteurized or otherwise processed to reduce, eliminate, or
control pathogens. The proposed labeling requirement would apply to
packaged untreated juice products produced in retail establishments for
immediate consumption (such as grocery stores and very small
processors) and would serve to inform consumers of the risk of
untreated juices. (Retail processors selling unpackaged juice on-site
for immediate consumption, such as restaurants and juice bars, would be
exempt from both HACCP and labeling.) FDA notes that 2 of the outbreaks
associated with apple cider (an outbreak of E. Coli. 0157:H7 infection
and an outbreak of cryptosporidosis involving very small apple cider
mills, refs. 8, 8A, and 11) would have fallen under the retail
exclusion. Under the proposed labeling rule, the cider mills would have
been required to label their apple cider. FDA seeks comment on whether
the provisions of the food code in combination with the labeling
statements will provide adequate public health protection. In addition,
in formulating its proposal to include in the definition of retailer a
processor that sells less than 40,000 gallons per year, the agency
considered two other alternatives on which it requests comments. The
first alternative would be to subject these establishments to the HACCP
requirements and to provide a 3-year effective date. The second
alternative would be to subject these establishments to the HACCP
requirements and to provide a 5-year effective date. The agency is also
soliciting comment on the appropriateness of including these
establishments in the retail exemption as well as the appropriateness
of the other two options considered.
The agency is proposing to define the term ``control,'' even though
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(a),
that ``control'' means to prevent, eliminate, or reduce. This
definition is consistent with the use of the term ``control'' in the
definition for ``control measure'' (Sec. 120.3(b)) and describes more
specifically what is to be accomplished in the control of food hazards.
FDA is also proposing to define the term ``monitor,'' even though
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(g) to
define ``monitor'' as conducting a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and producing an accurate record of those observations or
measurements for use in verification. This definition is identical with
that of the NACMCF (Ref. 55). The agency tentatively concludes that
defining this term will assist juice processors to be aware of what
activities constitute monitoring of the various components of the HACCP
system and prerequisite programs; and comply with the monitoring and
recordkeeping requirements necessary for acceptable verification of
HACCP.
C. CGMP's
Section 120.5 of the proposed regulations references the umbrella
CGMP regulations in part 110 as providing general guidance to such
matters as facility design, materials, personnel practices, and
cleaning and sanitation procedures. Because part 110 provides guidance
of general applicability to all foods, including juice, the agency
intends that this guidance will continue to apply to juice processors
even if FDA adopts the proposed regulations in part 120.
D. Prerequisite Program Standard Operating Procedures
The available evidence, including FDA's experience with the HACCP
pilot programs, points to the effectiveness of two programs that do not
fall within the parameters of traditional HACCP. FDA will refer to
these programs in this document as ``prerequisite programs.'' The first
of these programs is that the firm have in place SOP's designed to
ensure plant sanitation.
The seafood final rule requires in Sec. 123.11 that the processor
monitor certain sanitation measures and document both the monitoring
activities and any corrective actions taken when such monitoring finds
an insanitary condition that may contribute to the likelihood of
product becoming hazardous. While seafood processors are not required
under Sec. 123.11(a) to develop and implement written sanitation or
prerequisite program SOP's, processors must maintain sanitation control
records that, at a minimum, document that certain monitoring
requirements have been met, and that corrective actions are taken when
necessary (Sec. 123.11(c)). Section 123.11(b) sets forth requirements
for sanitation monitoring.
FSIS's regulations for meat and poultry require that official
establishments develop, implement, and maintain written SOP's for
sanitation (9 CFR 416.11). Each official establishment must take
appropriate corrective action when it or FSIS determines that the SOP's
have failed to prevent direct contamination or adulteration of product
(9 CFR 416.15). Each establishment must maintain daily records that are
initialed and dated to document the implementation and monitoring of
the SOP's and any corrective actions taken (9 CFR 416.16). Finally,
FSIS verifies the adequacy and effectiveness of the SOP's (9 CFR
416.17).
Insanitary facilities or equipment, poor food handling, improper
personal hygiene, and similar insanitary conditions create an
environment in which products may become contaminated with
microorganisms, including pathogens. However, sanitation controls may
be difficult to fit into HACCP plans. Sanitation covers the whole
processing environment, not just CCP's. A prerequisite program is an
appropriate mechanism for a situation, such as sanitation, that does
not lend itself well to HACCP controls. Therefore, sanitation SOP's are
a type of prerequisite program that is essential to provide a solid
foundation for HACCP systems. The agency tentatively concludes that
sanitation SOP's are an essential foundation for HACCP systems for
juice.
The second prerequisite program is one that provides control over
materials that are entering the plant. The SOP requirements of both the
seafood and FSIS regulations are limited to sanitation. However, the
pilot program experience has suggested the utility of controls on
incoming material. A processor could use incoming material prerequisite
program SOP's, in a manner similar to the sanitation SOP's, i.e., to
cover a range of processing factors, not just CCP's. Although use of
incoming material SOP's may not obviate the need for some CCP's in a
HACCP plan, FDA anticipates that their use could help to ensure the
safety of the food produced.
Incoming material controls for raw produce could be invaluable in
establishing the conditions under which produce needs to be grown
(including pesticide application) and harvested to provide assurance to
the processor that the raw produce will not present hazards that the
processor will otherwise need to control. For example, the processor's
incoming material SOP's could specify that the processor will only
purchase carrots that have not been fertilized with manure during
growth. Another example is that the incoming material control could
specify that the processor will only accept apples that have been
picked from the tree, and that dropped apples are unacceptable. A
simple solution to control the possible
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presence of unlawful pesticide residues on fruits and vegetables is to
establish SOP's for incoming material control that ensure that any
pesticides that have been used on the produce are approved for that
use, are used at the appropriate level, and that appropriate time has
elapsed between application and harvest.
As discussed previously, FDA is developing GAP and GMP guidance
that has been issued in draft for comment. The guidance will address
potential food safety problems throughout the food production and
distribution system such as sanitation, worker health, and water
quality.
A manufacturer also could use controls on the packaging materials
that it receives. Proper packaging is essential if a processor is to
minimize the possibility of the occurrence of hazards after juice has
been processed. Juice that is not packed in hermetically sealed
containers may be subject to contamination from a number of sources.
The processor also needs to ensure that the container coating that it
uses will not deteriorate through reasonable storage. Evidence in
section I.B of this document showed examples where the acid content of
some juices corroded the tin lining of the container, and the tin was
present in sufficient concentration to be toxic. Incoming material
controls will mean that the processor will act to ensure that packaging
materials are safe and suitable before accepting them.
Incoming material controls for ingredients that a processor may add
to juice can also be helpful. For example, if a processor is purchasing
juice or juice concentrate from a supplier for use in a multi-juice
beverage, it is essential that that juice have been processed under an
adequate HACCP system and have not been contaminated during
transportation. Thus, incoming material SOP's will lead the processor
to establish controls on ingredients as criteria for acceptance in the
plant.
However, the agency is not proposing to provide for the use of
incoming materials SOP's in part 120 at this time and requests comment
on this issue. FDA is seeking comment on whether incoming material
SOP's can be utilized in a similar relationship to the HACCP system as
the sanitation SOP's. Do interested persons see value in FDA requiring
that these SOP's be written, monitored, and verified? How do these
SOP's relate to FDA's draft guidance on fresh produce? What are
reasonable procedures for acceptance of incoming materials that could
be incorporated into SOP's?
1. Sanitation SOP's
FDA is proposing in Sec. 120.6(a)(1) to require that processors
have and implement SOP's that address sanitary conditions and practices
before, during, and after processing. Good sanitation practices are
critical to the prevention of microbiologically related foodborne
illnesses. FDA's CGMP regulations for food in part 110 set out general
principles of sanitation that should be followed in plants that
manufacture, package, label, or hold human food. They address such
matters as personal hygiene and cleanliness among workers who handle
food, the suitability of the plant design to sanitary operations, and
the cleaning of food-contact surfaces. The proposed sanitation SOP's
relate to the entire facility, not just to a limited number of CCP's.
FDA tentatively concludes that this step is necessary to fully
implement section 402(a)(4) of the act and yet at the same time not
overload the HACCP system. FDA invites comments on this approach.
FDA did not elect to make the development of a written sanitation
SOP mandatory for seafood because it recognized that some processors
may be able to achieve satisfactory sanitary conditions and practices
without having to commit their sanitary control procedures to writing
(60 FR 65096 at 65149). In the seafood final rule, FDA concluded that
as long as there were records demonstrating that the plant was being
kept in sanitary condition, it was not necessary to require written
sanitation SOP's, even though the agency strongly recommended that a
processor have them. The agency requests comment on whether it should
require for juice HACCP that sanitation SOP's be written.
In the evidence discussed in section I.A of this document, there
were several instances where contaminated water was the cause of the
outbreak. The water that the processor used was contaminated and when
produce was washed with it before juicemaking, the water contaminated
the produce, resulting in contaminated juice. Therefore, the safety of
the water that comes into contact with food or food contact surfaces is
an important factor that a processor must consider to maintain proper
sanitation and prevent contamination of the product and plant. The
seafood HACCP regulation in Sec. 123.11(b) lists eight sanitary
conditions and practices that processors must monitor, and monitoring
the safety of the water that comes into the plant is one of them
(Sec. 123.11(b)(1)). Based on the foregoing, FDA is proposing a similar
requirement in Sec. 120.6(a)(1).
In section I.B of this document, FDA recounted the evidence
demonstrating, that several outbreaks were caused by cleaning solution
directly contaminating the juice. Sanitation SOP's for seafood in
Sec. 123.11(b)(5) require that processors protect food from
adulteration with cleaning compounds. Given that cleaning compounds,
sanitizing agents, pesticides, and other materials can pose a similar
threat if not properly used in a juice processing facility, FDA is
proposing a parallel requirement in Sec. 120.6(a)(5).
The other provisions of Sec. 123.11(b) are based on CGMP and
encompass basic sanitation principles. Based on its consideration of
the factors that it cited in arriving at Sec. 123.11(b), the agency
tentatively concludes that it is appropriate to require in
Sec. 120.6(a) that juice processors address the same sanitary
conditions and practices in their SOP that must be monitored by seafood
processors. FDA requests comment on the proposed matters that must be
addressed in the sanitation SOP, and whether others are necessary for
juice.
2. Other Requirements for Prerequisite Program SOP's
FDA is proposing in Sec. 120.6(b) that processors monitor
sanitation conditions and practices during processing with sufficient
frequency to ensure, at a minimum, conformance with those conditions
and practices specified in part 110 that are appropriate both to the
plant and to the food being processed. The seafood HACCP regulation
requires sanitation monitoring (Sec. 123.11(b)). Because prerequisite
programs potentially include facility-wide control points and provide a
foundation for HACCP systems, processors need to monitor the
performance of the SOP's to ensure that they are functioning as
designed, and that they are corrected if there is a problem.
The agency is proposing in Sec. 120.6(c) that processors maintain
records that document the monitoring that they do under the
prerequisite program SOP's and any corrections to those SOP's that they
make. Monitoring and recording of conditions and practices under the
prerequisite program SOP's are as much keys to the success in improving
those conditions as is the development by a processor of the SOP's. As
in the case of HACCP records, FDA is proposing to require that
processors engage in systematic monitoring of their own sanitation
practices and conditions. This proposed requirement is similar to what
is required for sanitation SOP's for seafood (Sec. 123.11(c)).
Monitoring to
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ensure that sanitation is under control is the responsibility of all
processors. Monitoring records help processors to see trends, and also
allow the regulator to assess a processor's compliance over a period of
time, not just at the time of an inspection.
FDA believes that the records bearing on the monitoring of relevant
sanitation conditions and practices and the agency's access to such
records are essential if proposed Sec. 120.6 is to be an effective
regulatory strategy. Therefore, as with HACCP records, the agency
tentatively concludes that these records be subject to the
recordkeeping requirements in proposed Sec. 120.12.
Proposed Sec. 120.6(d) provides the option to juice processors to
include prerequisite program SOP controls in the HACCP plan. However,
if these controls are implemented as part of the prerequisite program
SOP's, there is no need to include them in the HACCP plan. The control
must be in the HACCP plan or in the prerequisite program SOP but need
not be in both places. This proposed provision is similar to
Sec. 123.1