[Federal Register Volume 63, Number 79 (Friday, April 24, 1998)]
[Proposed Rules]
[Pages 20450-20486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11025]
[[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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 /
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
[[Page 20451]]
resulted in 69 illnesses with 21 individuals hospitalized (Ref. 14).
The State of Washington reported that in 1993 one individual was
hospitalized from home-made carrot juice found to contain Clostridium
botulinum (Ref. 15). A 1993 Ohio outbreak caused by yeast or some other
unknown toxicant in orange juice resulted in 23 illnesses (Ref. 16). A
home-made watermelon drink contaminated with Salmonella spp. caused
illness in 18 individuals in a 1993 Florida outbreak (Ref. 17). The
State of Colorado reported two outbreaks of gastrointestinal illness
from fresh squeezed orange juice at a mountain resort (Ref. 18). There
were food handlers that were ill in both Colorado instances, and a
virus was suspected as the causative agent.
The evidence shows that certain juices have been the vehicle for
outbreaks of foodborne illnesses. Although fruit juice is acidic, and
thus would generally be considered to inhibit the growth of most
microorganisms, most juice-related outbreaks have been associated with
fruit juices.
B. Illnesses From Nonheat-treatable Hazards
Illnesses that have been caused by hazards that can not be reduced
to acceptable levels by heat treatments have also been associated with
juice. Tin in canned tomato juice caused illness in 113 individuals in
1969 (Ref. 19). Soil nitrate had resulted in a high nitrate content in
the tomatoes, and this high nitrate content accelerated detinning in
the cans. In 1984, 11 persons became ill from consuming elderberry
juice prepared by staff of a religious/philosophic group that contained
poisonous parts of the plant (Ref. 20). A 1990 guanabana juice outbreak
was caused by the presence of toxic guanabana seed material and caused
illness in nine individuals (Ref. 21). A 1997 outbreak was caused by
tin in pineapple juice (Ref. 22).
In 1992 an 18-month-old child with a blood lead level of 36
micrograms per deciliter (g/dL) was found in a routine county
health department blood lead monitoring program. Investigation of this
incident by the county health department revealed that the only
significant source of lead exposure for this child was lead in imported
fruit juice packed in 12-ounce, lead-soldered cans (Ref. 23). Analysis
by the State health department of multiple flavors of the fruit juices
in lead-soldered cans available to the child found lead levels ranging
from 160 to 810 parts per billion (ppb). An exposure assessment
performed by the county health department estimated that the child
consumed about three cans of these fruit juices per day and estimated
that the child's daily lead intake from these fruit juices was
approximately 600 g/day (Ref. 23). As a result of this
incident, FDA announced an emergency action level of 80 ppb for lead in
fruit beverages (such as juices, nectars, and drinks) packed in lead-
soldered cans (58 FR 17233, April 1, 1993). The agency subsequently
banned the use of lead-soldered cans (60 FR 33106, June 27, 1995).
Recalls also provide evidence of nonheat-treatable hazards in
juice. In 1988 a fruit punch drink was recalled because of the presence
of tin caused by the acidity of the drink reacting with the tin coating
of the cans (Ref. 24). The product had been packaged in the wrong
container.
There were 10 recalls between 1990 and 1995 for fruit juice or
beverages containing fruit juice because of the presence of food
ingredients that were inadvertently added to the product, not declared
on the label, or not suitable for the food. Food ingredients involved
with these recalls were natamycin (Ref. 25), sulfites (Ref. 26), FD&C
yellow No. 5 (Refs. 27 through 33), and salt (Ref. 34).
Five recalls between 1991 and 1997 were caused by improper
sanitation procedures or faulty equipment. In 1991 sodium hydroxide
from a clean-in-place system contaminated the caps of a citrus punch
drink (Ref. 35). In 1992 three persons became ill, with 1 hospitalized,
from a sodium hydroxide sanitizing agent that got into fruit drink
product containers during cleaning (Ref. 36). In 1993 cracks in a heat
exchanger allowed an orange flavored soft drink containing pear juice
to come in contact with copper pipe fittings and, thus, to become
contaminated with copper (Ref. 37). In 1994 milk was found in orange
juice from filler lines that were not cleaned between milk and juice
production (Ref. 38). In 1997 the presence of an alkaline cleaning
solution in a berry juice caused gastrointestinal distress in several
persons (Ref. 39).
Companies have recalled fruit drinks because pieces of glass or
plastic were found in their products. The presence of glass in products
is typically caused by the use of glass bottles, which can chip or
shatter during the production process (Refs. 40 through 42). The
plastic was present from the company's practice of draping plastic bags
over the side of the bottle loading bin (Ref. 43).
One company recalled apple-prune juice and prune juice in 1996
because of unacceptable levels of lead (Refs. 46 and 47). The cause was
contaminated imported prune juice.
In response to the establishment of maximum levels for patulin in
apple juice by several foreign governments, FDA initiated a sampling
survey to determine the levels commonly found in domestic and imported
apple juice. Patulin may be present in juice made from moldy apples. In
March 1997 the agency found inordinately high levels of patulin in
apple juice from a processor in Washington State (Ref. 48). The level
of patulin found in the product was sufficient to pose a health hazard,
especially considering the fact that apple juice is commonly used by
infants and young children (Ref. 49). All affected products that had
left the plant had been used in the manufacture of fermented apple
cider. Patulin could not be detected in fermented product, and it was
assumed that the patulin was destroyed through the fermentation
process.
Therefore, as the foregoing discussion reveals, the evidence
demonstrates that juice and juice beverages are susceptible to chemical
and physical hazards as well as microbiological hazards.
C. Underreporting
There is wide agreement that the laboratory-confirmed cases from
outbreaks and recalls understate the actual number of juice-related
cases, but no consensus exists on the size of the understatement.
Individuals may not manifest all symptoms or have severe enough
symptoms to necessitate medical attention. Medical personnel may simply
treat an individual's symptoms without determining the underlying
cause. The laboratory-confirmed cases only represent those cases where
individuals sought medical attention, and where medical personnel
performed the necessary testing and reported the case to a government
agency.
While the actual number of juice-related illnesses is unknown, FDA
has derived an estimate of the total number by multiplying the average
number of laboratory-confirmed cases by factors that account for under-
reporting. The factors are based on the relationships between annual
outbreak cases and published estimates of the number of foodborne
illnesses. For example, using these adjustment factors, it is estimated
that the average 16 annual laboratory-confirmed cases of Salmonella
represents 4,900 to 7,600 actual cases (Ref. 50). For E. coli O157:H7,
an average 22 laboratory-confirmed cases per year may actually
represent 2,200 to 4,300 total juice-related cases (Ref. 50).
Therefore, the agency assumes that the
[[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
10-5, assuming consumption of 100 milliliters (mL) of juice
daily.
In addition, the NACMCF stated that HACCP and safety performance
criteria should form the general conceptual framework to ensure the
safety of juices, and that control measures should be based on a
thorough hazard analysis. The NACMCF also stated that validation of the
process must be an integral part of this framework. The NACMCF
recommended mandatory HACCP for all juice products, and that processors
should implement and strictly adhere to industry CGMP's. The NACMCF
also recommended industry education programs addressing basic food
microbiology, the principles of cleaning and sanitizing equipment,
CGMP's, and HACCP.
The NACMCF recommended further study in several areas:
(1) The efficacy of new technologies and intervention strategies
for safety;
(2) The contamination, survival, and growth of pathogens on produce
with or without breaks in skin, with or without areas of rot, and
within the core;
(3) How produce becomes contaminated with human pathogens,
including the relevant microbial ecology during production and
processing of juice. In particular, the NACMCF stated that there is an
urgent need for these types of studies on E. coli O157:H7 in apple
juice;
(4) The baseline incidence of human pathogens on fruits and
vegetables, particularly on those used in juice processing; and
(5) Labeling information needed for consumer understanding and
choice of safer juices and juice products.
On the basis of all the testimony presented at the December 16 and
17, 1996, meeting, the NACMCF agreed that there is a need to understand
the differences among all juice and juice products (e.g., citrus versus
other). A significant problem identified by the NACMCF is that
consumers presently do not have a means to clearly differentiate
between unpasteurized and pasteurized products, and that terms used to
refer to juice products do not always have universal meanings. For
example, the term ``cider'' is perceived to be an unpasteurized product
whereas the term ``juice'' is often perceived to be pasteurized.
The NACMCF also stated that traditional heat treatments given to
juices and juice products have been designed to achieve shelf
stability, to remove water (i.e., concentration), or to affect other
quality-related factors, and that these treatments, commonly referred
to as ``pasteurization,'' are greatly in excess of a process needed to
inactivate foodborne pathogens.
Because of the lack of sufficient data to evaluate the
effectiveness of labeling statements as safety interventions or to
inform consumer choice, the NACMCF stated that it could not strongly
endorse labeling as an interim safety measure.
Although the NACMCF did not endorse labeling as an interim safety
measure, elsewhere in this issue of the Federal Register FDA is
proposing interim labeling measures for packaged juice. The agency sets
forth its reasons for proposing to adopt these measures in that
proposal.
II. Consideration of How to Address Problems
A. Current Regulation of Juice
FDA has established labeling regulations and standards of identity
for a number of juices. 21 CFR 101.30 pertains to percentage juice
declaration for beverages that contain fruit or vegetable juice. Common
or usual name regulations for nonstandardized beverages that contain
fruit or vegetable juice are found in 21 CFR 102.33. Standards of
identity are found in part 146 (21 CFR part 146) for a number of fruit
juices and beverages and in part 156 (21 CFR part 156) for tomato
juice. The standard of identity for pasteurized orange juice
(Sec. 146.140) states that ``The orange juice is so treated by heat as
to reduce substantially the enzymatic activity and the number of viable
microorganisms.'' Pasteurized orange juice must be labeled as such.
In the 1997 Food Code, FDA articulated its policy regarding
unpasteurized apple juice (Ref. 54). The code states that food
establishments (e.g., nursing homes) that serve apple juice, apple
cider, or other beverages that contain apple juice to segments of the
population that are highly susceptible to disease (e.g., the elderly)
should serve juice that has been pasteurized or that is in a
commercially sterile, shelf-stable form, in a hermetically sealed
container.
B. The Current Inspection System
Juice processors, like other food processors, are subject to
periodic unannounced, mandatory inspection by FDA. This inspection
system provides the agency with a picture of conditions at a facility
at the time of the inspection. However, assumptions must be made about
conditions at the facility before and after that inspection, as well as
about important factors beyond the facility that have a bearing on the
safety of the finished product. The reliability of these assumptions
over the intervals between inspections can create questions about the
adequacy of the system.
FDA's inspections are based, in part, upon its regulations on CGMP
in the manufacturing, packing, or holding human food in part 110 (21
CFR part 110). For the most part, these regulations set out broad
statements of general applicability to all food processing on matters
such as sanitation, facilities, equipment and utensils, processes, and
controls. HACCP-type controls are listed as one of several options
available to prevent food contamination (Sec. 110.80(b)(13)(i)), but
they are not integral to the controls outlined in the regulations.
The inspection and surveillance strategies that FDA uses ascertain
a manufacturer's knowledge of hazards and preventive control measures
largely by inference (i.e., based on whether a company's products are
in fact adulterated, or whether conditions in a plant are consistent
with CGMP). It is the manufacturer's responsibility to ensure that its
products are in compliance with the act. However, in the face of new
pathogens, such as E. coli O157:H7, and the risk of illness associated
with these pathogens, especially for children, the elderly, and
[[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
10-5, assuming consumption of 100 mL of juice daily.
However, the NACMCF did not specify the manner in which this risk
reduction should be accomplished, only the target that must be reached.
In section IV.M of this document the agency will discuss its proposed
approach as to how this performance standard will apply to juice.
4. Labeling
A number of comments suggested that labeling to distinguish
pasteurized from unpasteurized juice would enable consumers to make an
informed choice. One of the comments requested warnings to those ``at-
risk,'' one urged the publication of warnings in the newspaper, and
another wanted labeling with no warning. Rather than labeling, one
comment suggested point of sale information. One comment urged FDA not
to require labeling to distinguish pasteurized from unpasteurized
juices.
The NACMCF recommended research on labeling information needed for
consumer understanding and choice of safer juice products. The NACMCF
concluded that, while the risks associated with specific juices vary,
there are safety concerns associated with juices generally, especially
unpasteurized juices.
Labeling whether a product is pasteurized or unpasteurized is
useful information that the agency encourages processors to place on
labels. However, such labeling would not inform purchasers of
unpasteurized product that children, the elderly, and the
immunocompromised are ``at-risk'' from consuming the product. Without
effective consumer education, the label statements ``pasteurized'' and
``unpasteurized'' are likely to have relatively little meaning to
consumers and could even cause confusion because some consumers might
select unpasteurized juice, considering it more ``healthy'' because it
is less processed. Finally, a labeling requirement that focuses only on
whether a product is pasteurized or unpasteurized does not take into
account technologies other than pasteurization that are adequate to
control pathogens, and, thus, such a requirement could be viewed as
restricting the development of new technologies.
The agency outlined interim measures in a notice published August
28, 1997 (62 FR 45593), and elsewhere in this issue of the Federal
Register, FDA is issuing a proposal on labeling for packaged juice.
These labeling measures attempt to provide information on the risks
that juice that has not been processed to control for pathogens poses
to children, the elderly, and the immunocompromised. The agency is
proposing that the labeling measures be superseded when these juice
products are processed under adequate HACCP programs or are otherwise
processed to destroy pathogens (e.g., pasteurization).
It is possible for firms that manufacture juice to control for
pathogens. Labeling a product to alert consumers to possible harmful
effects from its consumption must not substitute for a manufacturer
adequately addressing those concerns during processing. FDA is
reluctant to rely on labeling as a safety measure and does so only when
its analysis of the countervailing factors reveals that, on balance,
labeling provides the most reasonable approach to protecting the public
health. Juice is a product that is typically consumed by children, as
well as adults. Therefore, FDA tentatively concludes that, for juice,
manufacturers need to implement controls for pathogens to ensure that
their products are safe and not rely solely on labeling, except as an
interim measure. FDA requests comment on this tentative conclusion.
5. Education
Other comments from the juice meeting suggested that education
would increase the awareness associated with the safety of juices and
of all foods. Some comments suggested that more industry education or
training was needed. Other comments wanted more consumer education,
especially for those at highest risk from foodborne disease.
The NACMCF recommended that the industry be educated on basic food
microbiology, the principles of cleaning and sanitizing equipment,
CGMP's, and HACCP. FDA agrees that industry education can serve a
valuable role in controlling potential food hazards and encourages the
industry to take an active part in educating its employees and
utilizing up-to-date technologies. The agency will assist the industry
in its education effort.
Concerning consumer education, the agency has launched several
initiatives to inform consumers about the potential hazards presented
by juice to at-risk individuals (see 62 FR 45593, August 28, 1997).
However, no matter how extensive a consumer education initiative the
agency undertakes, it is doubtful that consumer education will reach
all at-risk consumers. Therefore, consumer education alone will not be
adequate to inform the at-risk population of the potential hazards of
consumption of juice that has not been processed to control pathogens.
Given that effective processing methods are available, primary reliance
needs to be placed on them to ensure the safety of juice.
6. The HACCP Option
Many of the attendees at the juice meeting urged FDA to mandate
HACCP for juice processors, whereas others were opposed. A number of
the attendees urged use of CGMP's together with HACCP. Some attendees
at the juice meeting recommended that microbiological criteria or
performance
[[Page 20456]]
standards be used in addition to HACCP, with two suggesting a 5 log
reduction for E. coli O157:H7.
The NACMCF concluded that HACCP and safety performance criteria can
provide the general conceptual framework needed to ensure the safety of
juices, and that validation of the HACCP plan for the juice process
(i.e., ensuring that the process is adequate to control hazards) must
be an integral part of this framework. The NACMCF stated that
processors should establish HACCP control measures based on a thorough
hazard analysis.
HACCP is a preventive system of hazard control that places the
responsibility for identifying safety problems with the manufacturer.
Use of the HACCP system means that a firm is engaged in continuous
problem prevention and problem solving, rather than relying on facility
inspections by regulatory agencies or consumer complaints to detect a
loss of control. HACCP provides for real time monitoring to assess the
effectiveness of control. A HACCP system put in place by a manufacturer
for a particular facility is unique and must reflect the type of juice,
its method of processing, its packaging, the facility in which it is
prepared, and the intended consumers.
As discussed previously, there is sufficient evidence to
demonstrate that there are significant problems with the presence of
pathogens in some juice products. Pathogens in juice can be controlled
by heat treatment. However, there may be other treatments that meet the
same performance standard that are equally effective (e.g., multiple
barriers, surface treatment of intact fruit). The use of a HACCP system
provides flexibility to a processor to use alternative pathogen control
methods and, thus, encourages the development of new technologies but
does not dictate either their development or use. Moreover, not only is
HACCP effective in controlling microbiological hazards, it also is
effective in preventing chemical and physical hazards. Thus, HACCP is
particularly well-suited for the juice industry given, as discussed
previously, the range of hazards that must be addressed in processing
juice.
The agency agrees with the comments that urged use of CGMP's
together with HACCP. CGMP's form the foundation upon which a HACCP
system is built. Therefore, CGMP's are integral to the HACCP approach.
Because there are significant concerns with the microbial safety of
juices, HACCP systems must control pathogens. As will be discussed in
section IV.M of this document, FDA is proposing a 5 log reduction in
target pathogens, as the NACMCF recommended, as a necessary step in a
HACCP plan for juice. Validation of a HACCP system must ensure that the
process that is employed is adequate to control the relevant pathogens,
in addition to chemical and physical hazards. Validation of performance
standards consists of determining the ability of the pathogens in
question to resist acid and other chemical or heat treatment and the
ability of the process applied to overcome that resistance. The agency
requests comment on this approach to safety performance criteria. FDA
also requests comment on the benefits of requiring a general HACCP
approach as opposed to those of specifically requiring pasteurization.
7. Alternative Approach
An alternative approach to mandating HACCP would be to draw a
distinction between untreated apple cider and all other juices.
Manufacturers of apple cider would be provided a permanent option
choosing between labeling or implementing a HACCP program with a 5-log
pathogen reduction. All juices other than untreated apple cider would
be provided a permanent option of choosing between labeling,
implementing a HACCP system, or achieving a 5-log pathogen reduction as
discussed in section M of this document, entitled ``Pathogen
Reduction.'' The agency requests comments on this alternative approach
to a mandatory HACCP program.
D. Decision to Propose HACCP
The evidence discussed in section I.A of this document shows that
juices have been a vehicle for pathogens that have caused a number of
foodborne illnesses. Pathogens can be controlled through heat
treatment. Information set forth in sections I.B and I.D of this
document, however, demonstrates that there are many hazards that can
occur with juice and juice beverages that cannot be controlled through
heat treatment. Although not all of the problems discussed in section I
of this document are caused by hazards that could be considered
reasonably likely to occur in many juice operations, through the use of
HACCP programs, a firm can evaluate its process to determine if the
problem could have been controlled.
As discussed in section I.E of this document, the NACMCF stated
that HACCP and safety performance criteria can form the general
conceptual framework needed to ensure the safety of juices. FDA has
evaluated each of the seven alternatives that have been suggested for
dealing with the problems with juice. While the agency finds that these
alternatives are by no means mutually exclusive, FDA has tentatively
concluded that a preventive system, such as HACCP, appears to offer the
most effective way to control the significant microbial hazards, along
with other hazards, that have become a problem with juice.
Increased inspection, while having some beneficial impact on the
safety of juices, is resource intensive to the agency. Even if funds
were available to the agency for this purpose, increased inspection
would likely not be the best way for the agency to utilize its
resources to protect the public health. It is ultimately the
responsibility of manufacturers to ensure that their products are safe.
A preventive approach, such as HACCP, on the other hand, enhances a
processor's ability to make safe products because HACCP concentrates on
examining all aspects of production, identifying hazards that are
reasonably likely to occur in that production process, and establishing
measures that will control or minimize those hazards. HACCP also
enhances FDA's inspections because it allows the agency to inspect the
production facility more efficiently and then to verify that the firm
is operating in accordance with the firm's HACCP plan, and it provides
some assurance that any problems that have occurred have been
identified and appropriately addressed.
CGMP's, the second alternative to HACCP, are plantwide operating
procedures. Although FDA supports the use of CGMP's, it tentatively
concludes that use of CGMP's alone would not be sufficient to control
the problems with juices because CGMP's do not concentrate on the
identification and prevention of food hazards. Nonetheless, CGMP's are
necessary to provide the foundation on which a HACCP system is built.
Therefore, the agency tentatively concludes that, while CGMP's are
important to a HACCP system, they are not an adequate alternative to
HACCP.
Mandating pasteurization, the third suggested alternative to HACCP,
would reduce many microbial hazards in juices but would eliminate the
incentive to develop alternative methods (e.g., use of multiple
barriers, surface treatment of fruit) that can accomplish the same
purpose. FDA does not want to limit innovative approaches to achieving
food safety. HACCP, on the other hand, allows and encourages firms to
explore more technologically efficient and more cost-efficient ways of
managing all of the hazards that they face. Moreover, pasteurization
only controls microbial hazards. HACCP systems can control all
[[Page 20457]]
food hazards that are reasonably likely to occur.
Labeling was also suggested as an alternative. FDA acknowledges
that, from a public health protection standpoint, there are certain
advantages to labeling. Elsewhere in this issue of the Federal
Register, FDA is proposing to require certain labeling, in the form of
a warning statement, for packaged juice products that have not been
processed to control, reduce, or eliminate pathogenic microorganisms
that may be present in such juices. Such labeling will serve to reduce
the risk of foodborne illness. However, such reduction will occur only
to the extent that consumers read and understand the labeling.
Accordingly, the agency has tentatively concluded that mandating HACCP
for most juice products will provide more comprehensive public health
protection by greatly reducing the number of juice products that
contain dangerous pathogens.
Importantly, manufacturers do have the ability to process juice to
control pathogens. Labeling a product to alert consumers to possible
harmful effects from its consumption is not a substitute for a
manufacturer adequately addressing those concerns during processing.
Juice is a product consumed by children, as well as by adults. FDA is
reluctant to rely on labeling as a safety measure and does so only when
its analysis of the countervailing factors reveals that, on balance,
labeling provides the most reasonable approach to protect the public
health. Here, a situation in which HACCP offers a real long-term
solution to controlling, if not eliminating, hazards in juice, the
agency tentatively believes that labeling is not a reasonable long-term
approach. The agency is soliciting comment on the appropriateness of
this tentative conclusion.
The fifth alternative to HACCP that was suggested is education.
Industry education can play a valuable role in the production of safe
juices. Consumer education can play an important part in consumer
purchasing choices. However, education is only effective if people
understand and use the information conveyed. Moreover, even an
extensive education program may not reach all consumers. Conversely,
mandatory HACCP would ensure that industry produces safe juice, and
that the product that reaches consumers is safe.
For the foregoing reasons, FDA has tentatively concluded that HACCP
represents the appropriate system of controls that is necessary for
producing safe juice products. Therefore, FDA is proposing to add part
120 to its regulations to establish procedures for implementing HACCP
systems for fruit and vegetable juices. As the agency did with seafood,
it is proposing to issue these HACCP regulations under various sections
of the the act, including, most significantly, sections 402(a)(1) and
(a)(4) and 701(a) of the act (21 U.S.C. 371(a)).
Section 402(a)(1) of the act states that a food is adulterated if
it bears or contains any poisonous or deleterious substance that may
render the food injurious to health. Section 402(a)(4) of the act
states that a food is adulterated if it has been prepared, packed, or
held under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to health.
It is important to recognize that section 402(a)(4) of the act
addresses conditions that may render a food injurious to health, rather
than conditions that have actually caused the food to be injurious (see
United States v. 1,200 Cans, Pasteurized Whole Eggs, etc., 339 F. Supp.
131, 141 (N.D. Ga. 1972)). The question is whether the conditions under
which the food is processed and held are insanitary and may render the
food injurious to health. The agency tentatively finds that, if a
processor of juice products does not incorporate certain basic controls
into its procedures for preparing, packing, and holding food, it is
operating under insanitary conditions that may render the juice that is
produced injurious to health and, therefore, adulterated under the act.
Section 701(a) of the act authorizes the agency to adopt regulations
for the efficient enforcement of the act.
The legal basis for mandating HACCP systems for juice processors is
the same as that for seafood. Additional discussion of the legal basis
is set out in the proposed rule (59 FR 4142 at 4150, January 28, 1994)
and final rule (60 FR 65096 at 65098) for fish and fishery products.
E. Notice of Intent
FDA published a notice of intent on August 28, 1997 (62 FR 45593),
that announced a comprehensive program to address the incidence of
foodborne illness related to consumption of fresh juice and to address
ultimately the safety aspects of all juice products. The agency invited
comment on the appropriateness of its strategy to: (1) Initiate
rulemaking on a mandatory HACCP program for some or all juice products,
(2) propose that the labels and labeling of some or all juice products
not specifically processed to prevent or eliminate the presence of
harmful bacteria bear a warning statement informing consumers of the
risk of illness associated with consumption of the product, and (3)
initiate several educational programs to minimize the hazards
associated with fresh juice. The agency stated that it would consider
comments received within 15 days of publication of the notice prior to
publication of any proposed rule.
Some comments on the notice suggested that FDA mandate HACCP only
for fresh juice processors. One comment stated that HACCP should be
mandated only for firms that process large quantities of fresh juice.
Other comments supported mandatory pasteurization or equivalent
treatment of juice, especially apple cider. One comment added that
pasteurization and use of CGMP would preclude the need for the
mandatory use of HACCP.
In section II.D of this document the agency has already discussed
its reasons for proposing HACCP. The illnesses discussed in sections
I.A and I.B of this document did not pinpoint problems related solely
to fresh juice processors or to the amount of fresh juice that a firm
produced. The comments have not provided any new information to alter
the agency's tentative conclusion that HACCP is necessary to ensure the
safe production of juice. However, FDA requests information on whether
there are categories of juice that should be excluded from the proposed
regulation.
FDA has reviewed all of the comments received within 15 days of
publication of the notice and has determined that the comments provided
no information that would cause the agency to conclude that this
proposal is inappropriate. The agency has attempted to address these
comments to the extent that they are relevant to this proposal. All
comments received in response to the notice that address the issues in
this proposal will be considered either in this proposal or in any
final rule published in response to this proposal.
F. Fresh Produce Guidance
FDA, working with the U.S. Department of Agriculture (USDA) and the
agricultural community, has developed voluntary good agricultural
practice (GAP) and GMP guidance for fruits and vegetables that has been
issued in draft for comment. The guidance, which is a science-based
evaluation of risks, will address potential food safety problems
throughout the food production and distribution system such as
sanitation, worker health, and water quality. This voluntary guidance
can be used by both domestic and foreign fresh fruit and vegetable
producers to help ensure the safety of their produce.
[[Page 20458]]
III. The HACCP System
The HACCP concept is a systematic approach to the identification
and assessment of the risk (likelihood of occurrence and severity) of
biological, chemical, and physical hazards from a particular food
production process or practice and the control of those hazards. HACCP
is a preventive strategy for food safety. Under it, the food producer
develops a plan that anticipates and identifies the points in the
production process where a failure would likely result in a food hazard
being created or allowed to persist. These points are referred to as
critical control points (CCP's). Under HACCP, identified CCP's are
systematically monitored to ensure that critical limits (CL's) are not
exceeded, and records are kept of that monitoring. Corrective actions
are taken when control of a CCP is lost, including proper disposition
of the food produced during that period, and these actions are
documented. The effectiveness of HACCP is also systematically verified
by the processor.
HACCP has been endorsed by the NACMCF as an effective and rational
means of ensuring food safety. HACCP also is recognized in the
international food safety community as the state-of-the-art means to
ensure the safety and integrity of food. In particular, the Committee
on Food Hygiene of the United Nations' Codex Alimentarius Commission
(Codex) has endorsed the HACCP concept as a worldwide guideline. The
European Union (EU) and other countries around the world have begun to
require that foods produced within their borders be processed in a
HACCP system. HACCP also is required for shipment of some foods (e.g.,
seafood) into EU countries.
A. Five Preliminary Steps of HACCP
The NACMCF recommends a process for developing a HACCP system that
includes: (1) Assembling a HACCP team, (2) describing the food and its
distribution, (3) identifying the intended use and consumers of the
food, (4) developing a flow diagram, and (5) verifying the flow diagram
(Ref. 55). These steps have been identified by the NACMCF as the ``five
preliminary steps'' of HACCP. Although the agency is not proposing to
mandate that processors use these preliminary steps, processors will
greatly benefit from using these preliminary steps in developing their
HACCP systems. The NACMCF advises that the preliminary tasks should be
accomplished before the application of HACCP principles to a specific
process (Ref. 55).
B. The Seven Principles of HACCP
The NACMCF has developed the following seven principles that
describe the HACCP concept:
1. Conduct a Hazard Analysis
The first step in the establishment of a HACCP system for a food
production process or practice is the identification of the hazards
associated with the product. The NACMCF defines a hazard as a
biological, chemical, or physical factor that may cause a food to be
unsafe for consumption. The hazard analysis step should include not
only a written identification of the hazard but a written assessment of
the likelihood that the hazard will occur and its severity if it does
occur. This analysis should also involve the identification of CCP's
along with control measures for each identified hazard.
2. Determine the CCP's
A CCP is a point, step, or procedure at which control can be
applied, so that a potential food hazard can be prevented, eliminated,
or reduced to acceptable levels. Points in the manufacturing process
that may be CCP's include heat treatment, chilling, specific sanitation
procedures, product formulation control, prevention of cross
contamination, and certain aspects of employee and environmental
hygiene.
3. Establish Critical Limits
This step involves establishing parameters that must not be
exceeded for each control measure associated with a CCP. Critical
limits (CL's) can be thought of as boundaries of safety for each CCP
and may be set for control measures such as temperature, time, physical
dimensions, moisture level, water activity, pH, and available chlorine.
A CL is used to distinguish between safe and unsafe operating
conditions at a CCP. For example, the minimum temperature and time
combination that will kill pathogens in a heat treatment step is the CL
for that CCP.
4. Establish Monitoring Procedures
Monitoring is a planned sequence of observations or measurements to
assess whether a CCP is under control (i.e., operating within its CL)
and to produce an accurate record of the monitoring for use in future
verification procedures. An unsafe food may result if a process is not
properly controlled and a deviation occurs. Because of the potentially
serious consequences of a CL deviation, monitoring procedures must be
effective. Continuous monitoring is possible with many types of
physical and chemical methods. When it is not possible to monitor a CL
on a continuous basis, monitoring intervals must be established that
are frequent enough to permit the manufacturer to determine whether the
step/process/procedure designed to control the hazard is working.
5. Establish Corrective Actions
While the HACCP system is intended to prevent deviations in a
planned process from occurring, total prevention can rarely, if ever,
be achieved. Therefore, there needs to be a corrective action plan in
place to fix or correct the cause of the deviation to ensure that the
CCP is brought under control, to ensure that there is appropriate
disposition of any food produced during a deviation, and to ensure that
records are made of the corrective actions taken. Out of control
situations should be used to identify opportunities for improvement of
the process to prevent future occurrences.
6. Establish Verification Procedures
This process involves the application of methods, procedures,
tests, and evaluations, other than monitoring, to determine the
adequacy of, and compliance with, the HACCP system. The major infusion
of science in a HACCP system centers on proper identification of the
hazards, CCP's, and CL's and the institution of proper verification
procedures.
7. Establish Recordkeeping and Documentation Procedures
This principle requires the preparation and maintenance of written
HACCP records that list the hazards, CCP's, and CL's identified by the
firm, as well as the monitoring, recordkeeping, and other procedures
that the firm intends to use to implement the system. This principle
also requires the maintenance of records generated during the operation
of the HACCP system.
C. History of the Use of HACCP
1. HACCP for Fish and Fishery Products
On December 18, 1995, FDA published a final rule in the Federal
Register (60 FR 65096) on procedures for the safe and sanitary
processing and importing of fish and fishery products (part 123 (21 CFR
part 123)) (seafood final rule). The regulations require that seafood
processors develop, implement, and document sanitation control
procedures and mandate the application of HACCP principles to the
processing of seafood. The effective date for the seafood final rule
was December 18, 1997.
[[Page 20459]]
The regulations proposed herein are based on the seafood final rule
with some modification to reflect the differences between seafood and
juice products and to reflect recent developments in the application of
HACCP. An extensive administrative record was compiled in the seafood
proceeding. FDA is incorporating that record as support for the current
proposal. Although the regulations proposed herein differ in some
aspects from part 123, they are not intended to supersede or otherwise
alter the seafood final rule.
2. Advance Notice of Proposed Rulemaking for the Development of HACCP
for the Food Industry
In the Federal Register of August 4, 1994 (59 FR 39888), FDA
published an advance notice of proposed rulemaking (ANPRM) requesting
public comment about whether and how the agency should develop
regulations that would establish requirements for a new comprehensive
food safety assurance program, based on HACCP, for both domestically
produced and imported foods. The agency stated its tentative view that,
if such regulations were issued, they would enhance FDA's ability to
ensure the safety of the U.S. food supply. FDA requested comments on a
number of specific issues, as well as on all aspects of such a food
safety program.
3. HACCP Pilot Programs
In addition to the ANPRM, FDA also published in the Federal
Register on August 4, 1994 (59 FR 39771), a notice announcing that it
intended to conduct a pilot program in which volunteers from the food
manufacturing industry would use a HACCP system that FDA would audit.
The pilot program was intended to provide information that FDA could
use in deciding whether to propose to adopt regulations and in
developing and implementing a regulatory system in which food
manufacturers are required to perform the food safety aspects of their
operations based on HACCP principles. In the notice, FDA invited
individual firms that wished to participate in the program to submit
letters of interest. Approximately 50 firms expressed initial interest
in participating in the pilot program, and 11 firms were selected to
participate. In 1997 FDA completed the pilot program at six firms and
published a second interim report.
4. HACCP for Meat and Poultry
On July 25, 1996, USDA published a final rule (61 FR 38806) that,
among other things, required that each meat and poultry establishment
develop and implement written sanitation standard operating procedures
(Sanitation SOP's) and a system of HACCP controls designed to improve
the safety of their products. The effective date for the Sanitation
SOP's was January 27, 1997, and for the HACCP regulations was January
26, 1998. FDA has reviewed the meat and poultry HACCP regulations and
has incorporated portions of them as appropriate in the proposed HACCP
regulations for juice.
D. Issues from the ANPRM
FDA received approximately 150 comments in response to the August
4, 1994, ANPRM. The comments represented the views of consumers,
consumer organizations, health professionals, academicians, food
industry officials, trade associations, and foreign, State, and local
government agencies. The agency has attempted to address these comments
to the extent that they are relevant to this proposal.
1. The agency asked in the ANPRM how the responsibility for food
safety should be shared between the food industry and government.
Comments generally agreed that the food industry is responsible for
producing safe food products. All respondents on this issue recognized
that the Government's role is to verify industry compliance with any
applicable safety regulations.
FDA agrees that it is the manufacturer's responsibility to ensure
that the food that it produces is safe, and that it is the Government's
role to verify that manufacturers are fulfilling their responsibility.
Through use of a HACCP system, both the firm and FDA are able to better
fulfill their roles. The proposed regulation in part 120 underscores
the division of roles. Under the proposed regulation, industry is
charged with examining all aspects of production, identifying hazards
that are reasonably likely to occur, and establishing measures that
will control or minimize those hazards. HACCP records enable the agency
to inspect the production facility more efficiently and to verify that
the firm is operating in accordance with its HACCP plan. They also give
the agency insight into whether any problems that have occurred have
been identified and appropriately addressed.
It is important that the juice industry focus on its responsibility
to produce safe food. Recent outbreaks evidence that some members of
the industry have not kept up with the need to evaluate the hazards
presented by juice and to design processes to address those hazards.
Firms need to be aware of the emerging problems presented by their raw
materials and to decide whether, and if so what, steps are necessary to
address these problems. Firms may decide that it is necessary to
incorporate a step designed to kill bacteria into their process (e.g.,
pasteurization), that there are alternative steps that they can take to
ensure the safety of their products, or that, given the nature of the
raw materials, no steps are necessary. Firms also need to monitor the
process that they decide to employ to ensure that it is functioning
adequately and appropriately. FDA notes that some firms have already
addressed food safety concerns and have implemented HACCP systems.
Moreover, given the heightened concerns about these products,
Government needs to be in a position to fulfill its role of verifying
that industry is doing its job. Given the sporadic and variable way in
which the problems that have been associated with juice arise, sampling
and end-product testing of juice products will not enable it to do so.
Other steps that will give Government insights into the production
itself appear to be in order.
2. FDA requested comment in the ANPRM about the likelihood of
occurrence of a hazard that would warrant HACCP-type control.
Generally, the comments consistently identified two features that would
characterize a properly formulated definition of likelihood: Processing
conditions and nature of hazard. The majority of comments offered by
the food industry stipulated that the necessary condition for
likelihood of occurrence of the hazard appropriate to trigger HACCP
control must not be speculative, as in worst-case scenarios, but be
real, practical, and intrinsic to the processing or hazards
demonstrably present for specific commodities. Several responses
recommended that the question be referred to broadly based expert
panels to establish the likelihood of risk.
According to the NACMCF, each potential hazard is evaluated based
on the severity of the potential hazard and its likely occurrence (Ref.
55). Severity is the seriousness of the consequences of exposure to the
hazard. Considerations of severity (e.g., impact of sequelae and
magnitude and duration of illness or injury) can be helpful in
understanding the public health impact of the hazard. Likelihood of
occurrence of a hazard is generally judged based on processing
experience, epidemiological data, and information in the technical
literature.
The agency agrees with the comments that stated that the processing
conditions and the nature of the hazard are key elements in assessing
the
[[Page 20460]]
likelihood of a hazard occurring. It would be futile for processors to
attempt to control for every theoretical hazard because doing so would
entail assessing hazards that the processor could not reasonably
anticipate would actually occur. The assessment of the likelihood of
risk of illness or injury to consumers should be practical for the
specific commodity and not be speculative. For example, use of
pesticides on fruits and vegetables is a common practice while these
foods grow. The presence of pesticides on fruits or vegetables used to
make juice is considered a hazard if: (1) The pesticide is not approved
for use on the fruit or vegetable, or (2) it is found in amounts above
its EPA established tolerance. If a pesticide is applied to fruits or
vegetables in conformance with EPA regulations, and the appropriate
period of time has elapsed between application and harvest, the
presence of the pesticide is not considered to present a hazard that is
reasonably likely to occur.
The agency disagrees that it should rely on broadly based expert
panels to establish likelihood of occurrence of a hazard. Although such
committees could provide insight into the issue, on balance, the
insights that they would be likely to provide would not justify the
expenditure of resources that convening such committees would require.
However, interested persons are welcome to consider voluntarily the
question and to submit the results of their consideration to the
agency.
3. Comments on the ANPRM stated that because epidemiological
studies consistently show that microbial pathogens are the most
significant source of food hazards, issues such as pesticides, heavy
metals, filth, physical contaminants, and others pale by comparison
with the immediate health consequences of foodborne microbial
pathogens. They stated that HACCP is best suited for preventing
microbial hazards rather than physical or chemical hazards because CCP
monitoring can be readily established in a timely fashion for pathogens
and, particularly, for the unsanitary conditions that promote their
growth.
The comments added that effects that result from events that occur
after the food has left the processor's HACCP system are not
controllable by the processor. The comments said that this fact is
significant because food service establishments and the lack of
consumer education have contributed to the majority of incidences of
foodborne illness reported in current epidemiological data. They stated
that HACCP systems are essentially localized management tools that will
not permit any measurable improvement in national or international food
safety effectiveness and have been implemented voluntarily solely as a
corporate practice to provide strategic business advantages in
increasingly competitive markets.
The comments stated that regulation may be premature because of the
adequacy and feasibility of presently available analytical tests to
control all hazards. They stated that, consequently, HACCP is an
excellent tool but only in the very specific case of high-risk food
processing that is focused on controlling microbiological risks. The
comments stated that, instead of misdirecting its efforts, FDA needs to
look to itself to reinforce food preparation safety awareness at food
service establishments and to pursue vigorously an enhanced consumer
education policy on unsafe food practices as the best preventative food
risk control program.
FDA agrees that microbial hazards are a significant source of food
hazards. FDA also agrees that HACCP is an ideal mechanism to deal with
microbial hazards because it is a system of prevention. Prevention
makes up for the inadequacies of end-product testing. For example, for
maximum quality, nonshelf stable juice must be distributed quickly, and
end-product testing usually takes at least several days to obtain
results. If pathogens are discovered in the juice after distribution,
the product must be recalled, and consumers may have already ingested
product. Finally, the particular samples taken in end product testing
may not contain pathogens because the pathogens may not be ubiquitous
in the lot (i.e., there may be low level or sporadic contamination) and
thus produce false negatives.
A system of preventive controls, like HACCP, on the other hand, is
designed to identify and manage conditions where pathogens could be
present in juice while it is still being processed. HACCP is designed
to ensure that there is early discovery, and timely correction, of any
problems that may develop. Although HACCP is well suited for preventing
microbial hazards, this does not mean, as some of the comments
asserted, that it is not useful for other types of hazards. As the
NACMCF has recognized, it is well suited for preventing chemical and
physical hazards. For example, processors can establish CCP's to
prevent pieces of glass from contaminating a product when glass bottles
are used.
The NACMCF endorses HACCP as an effective and rational means of
assuring food safety (Ref. 55). According to the NACMCF, its use will
likely result in measurable improvement in food safety. Under HACCP,
processors view the processing plant from a prevention perspective and
thus are in a position to react appropriately to new hazards if they
arise. In preparing this proposal, FDA has reviewed the history of
juice related outbreaks. All of these outbreaks might have been
prevented if a HACCP system of the type that FDA is proposing herein
had been in use.
The agency agrees that there are hazards that can occur after food
has left the processing plant that the processor cannot control. The
agency has established the Food Code to assist State agencies and food
workers in retail food establishments and has addressed handling of
high risk foods in the Food Code. FDA also provides consumer
information on food safety through a consumer hotline, public affairs
specialists in FDA's district offices, and various brochures and other
publications. These efforts are intended to educate consumers on safe
handling of foods at home. In addition, as described in the interim
notice, the agency has initiated a consumer education program
concerning juice that is not treated to prevent or eliminate the
presence of harmful bacteria.
4. The agency requested information in the ANPRM on its possible
role in assisting the food industry in the development of HACCP plans.
Comments stated that FDA preparation of general background materials on
HACCP would be beneficial in establishing a common approach to plan
development, in assisting hazard identification analysis, and in using
consistent language. They stated that FDA could provide informational
resources such as examples of HACCP plans adaptable to the individual
circumstances of a business' operations or consultative documents that
could serve to guide plan development.
However, some comments urged that FDA avoid over-regulation. They
stated that an excessively ambitious regulatory approach will limit the
effectiveness of any HACCP program.
The agency agrees that it should avoid over-regulation because such
an approach can inhibit future developments and new technology in HACCP
systems and in safe food processing. FDA is proposing a HACCP
regulation that, if adopted, will be mandatory for juice processors (as
defined at proposed Sec. 120.3(i)) but that can be used as a model for
other foods in that it outlines the minimum essential components of a
HACCP system. To the extent possible, the proposed regulation is in
harmony with
[[Page 20461]]
the existing HACCP regulations for seafood and meat and poultry.
FDA has developed the ``Fish & Fisheries Products Hazards &
Controls Guide'' to assist manufacturers in the implementation of HACCP
for seafood. The Federal Safety and Inspection Service (FSIS) has
developed, in conjunction with the International Meat and Poultry HACCP
Alliance, 13 HACCP models for meat and poultry products, a ``Guidebook
for the Preparation of HACCP Plans,'' and the ``Meat and Poultry
Products Hazards and Control Guide.'' However, it is not clear whether
FDA will be able to provide such detailed information for juice.
Therefore, in this rulemaking, the agency will attempt to provide
guidance, to the extent possible, concerning the application of the
regulation to juice.
5. Some comments on the ANPRM stated that, if EPA tolerances for
pesticides in agricultural commodities become HACCP-focused safety
issues in food processing and service industries, then explicit
coordination by FDA with EPA is needed to define truly significant
hazards. They stated that this effort would greatly assist HACCP
development in such circumstances, so that duplication of effort would
be avoided, consistency among regulatory requirements would be
achieved, and impediments to international commerce would be removed.
FDA has attempted to harmonize its regulations with those of other
Federal agencies and with Codex. EPA establishes regulations for
pesticide use and tolerances for pesticide residues, and FDA and USDA
enforce those tolerances on foods.
Under section 402(a)(2)(B) of the act, a food is deemed to be
adulterated if it bears or contains a pesticide chemical residue unless
a tolerance or an exemption for such pesticide has been established,
and the quantity of such pesticide on the commodity is within the
tolerance limits. Pesticide chemical residues for which there is no
tolerance or exemption are deemed to be unsafe as a matter of law.
HACCP is intended to protect against unsafe products. Thus, there is no
reason why pesticide residues and similar types of food safety measures
should be outside the scope of HACCP.
6. In the ANPRM, the agency asked if there was a need for
microbiological criteria in HACCP regulations. Some comments favored
inclusion of microbiological criteria for known high risk foods because
such criteria are practical, efficient, and cost effective. However,
most comments maintained that microbiological criteria, set as national
standards, are not warranted because: (1) Criteria are discordant with
HACCP purposes because they depend on end product testing, (2) criteria
possess inadequate scientific basis, and (3) criteria are preemptive of
localized development of HACCP systems.
The agency tentatively agrees with those comments that stated that
microbiological criteria in HACCP regulations are warranted for some
foods. Contrary to what many of the comments asserted, effective
microbial controls depend not on end product testing but on processing
controls and the establishment of CL's. For example, juice made from
apples that have fallen on the ground must be processed in some manner
to destroy pathogens because pathogens are likely to be present and, as
discussed previously, end product testing may produce false negatives.
If a regulation is flexible, it should not ``preempt'' the processor's
development of HACCP, but it can provide the CL's needed for the safe
processing of food under a HACCP system. However, the agency agrees
that the decision on which processing controls are to be used must have
a valid scientific basis.
Microbial pathogens have emerged as a significant problem in
unpasteurized juice in recent years. The NACMCF recommended that safety
performance criteria, rather than a specific intervention technology,
be mandated for juice (Ref. 53). The safety performance criteria
recommended by the NACMCF is whether the measures that a juice
processor employs have been validated to achieve a cumulative 5 log
reduction in the target organisms or a reduction in yearly risk of
illness to less than 10-5, assuming consumption of 100 mL of
juice daily. As will be discussed in section IV.M of this document, FDA
is proposing to require that firms include in their HACCP plans
measures that will produce, at a minimum, a 5 log reduction in target
pathogens.
7. Comments on the ANPRM stated that FDA should require end product
testing records to provide information as to the effectiveness of a
HACCP program. These comments stated that end product testing was
practical because mandated testing was a necessary, continuing, and
recordable validation of the completeness of a HACCP system, thereby
ensuring that 100 percent control is manifested.
Comments from the juice meeting also supported the use of end
product testing. One of the these comments proposed using testing to
decide whether to pasteurize each lot. Several comments pointed to new
rapid testing technologies and testing kits for pathogens.
However, other comments maintained that information generated from
end product tests would not be useful. One comment stated that end
product testing activities were counterproductive to a well-planned
HACCP system. Furthermore, these comments added, any requirements that
FDA puts forward must be practical, and no process can be regulated
into 100 percent certainty.
The agency is not proposing to require end product testing. End
product testing is most useful where there are high levels of the
substance being tested, and there is uniformity throughout the lot
being sampled. Product sampled for testing for microbial hazards, where
a pathogen (e.g., E. coli O157:H7) is hazardous even at very low
levels, or for physical hazards (e.g., glass), where the hazard is the
presence of a discrete unit, may not contain the hazard even under the
best sampling procedure. In these cases end product testing is likely
to produce false negatives and, thus, to provide scant protection. It
is prohibitive to use end product testing adequately in these
situations because of the amount of testing that is necessary for a
statistically valid test, and because it would be necessary to channel
a significant portion of the product for that testing. Therefore, the
agency has tentatively concluded that use of control measures under a
HACCP system to prevent hazards from occurring, with subsequent
monitoring, verification, validation, and recordkeeping, is more
effective than end product testing in ensuring that food is safe. Thus,
FDA has not included a requirement for end product testing in this
proposed rule on juice products.
8. The agency asked in the ANPRM whether it should mandate HACCP
for all segments of the food industry. Many comments stated that
mandatory HACCP regulations for low-risk foods would be inappropriate
because trying to manage low risk hazards through HACCP would dilute
agency resources and therefore the effectiveness of HACCP. The comments
stated that FDA could utilize its resources most efficiently by
focusing on those high-risk food processing operations identified in
its 1993 model Food Code as ``Potentially Hazardous.'' They stated that
the U.S. food supply is already demonstrably the world's safest, so
that there is no valid reason for requiring HACCP plans of the entire
industry. The comments stated that enforcement mechanisms in the act
are, and will continue to be, sufficient without adding to the
regulatory burden on
[[Page 20462]]
industry. They added that incorporation of HACCP into food industry
operations should be permitted to proceed on a voluntary basis, unless
a well-defined need requires implementation through specific authority
provisions of the act into specific high-risk segments of the food
industry.
However, some comments stated that unless all segments of the food
chain are mandatorily included, adoption of HACCP is unlikely to result
in measurable enhancement of the safety of the food supply. They stated
that less than universal coverage would create confusion about what
should be excluded. The comments stated that any attempt to limit HACCP
to identified ``high-risk'' processors would hinder efforts to address
significant public health problems that may arise in the future. They
concluded that it is not unduly burdensome to mandate HACCP for all.
The comments maintained that HACCP regulations should be as
comprehensive as practicable and applied throughout the food chain to
the fullest extent possible and reasonable, and that HACCP principles
must be applied from farm to fork.
FDA disagrees with the comments that stated that HACCP is
inappropriate for low-risk foods. Both food processors and government
regulatory agencies would benefit from the use of HACCP systems. The
U.S.'s excellent record for having a safe food supply does not mean
that this country should not consider ways of improving on that record.
In the face of emerging pathogens and other new food hazards, HACCP
provides a flexible system in which processors reassess their
procedures on an on-going basis. HACCP also enables processors to meet
future demands.
The use of HACCP allows food processors to concentrate their
efforts on the aspects of the processes that they use where risks are
highest and provides regulatory agencies with assurance that processors
are observing prudent processing practices. HACCP also provides
assurance that problems in the process are likely to be discovered, and
that unsafe product is unlikely to leave the firm. The complexity of
HACCP is a function of the number of hazards that must be controlled
and the nature of the controls for each hazard. Foods that involve few
hazards will tend to have fewer CCP's, and, conversely, those that have
multiple hazards will tend to have more complex HACCP plans and
monitoring requirements.
FDA is proposing a regulation that will mandate HACCP for juices.
The agency has tentatively concluded that there is a safety basis to
require that processors use HACCP systems in the processing of juice.
As the agency gains experience and additional information from the
pilot program and from seafood HACCP implementation, it will examine
the appropriateness of expanding the scope of proposed part 120 (if the
agency adopts it) to include other foods. Clearly, the agency will
consider HACCP's use with foods that it has identified as presenting
likely hazards, as it is doing in this proposal.
In developing the proposed regulations for juice, FDA came to
recognize that the elements of a HACCP regulation for juice are really
no different than those for seafood. This insight suggests that part
120 can act as a model for HACCP for other parts of the food industry
should the agency become aware of facts that would justify extending
the coverage of the regulation. Firms that are interested in
voluntarily instituting HACCP can use the regulations in part 120 as a
guide for doing so.
9. The ANPRM requested information on the criteria that FDA should
use in deciding whether to cover some or all segments of the food
industry with a mandatory HACCP rule. Some of the comments stated that
exclusions cannot be justified on the basis of business size because
about 75 percent of the food industry would be considered to be small
businesses. The comments asserted that exclusions can only be judged
with respect to properly defined risks for the food hazards involved in
producing the end-product.
FDA agrees that exemptions from HACCP regulations cannot be
justified on the basis that a business is small because food hazards
that are reasonably likely to occur in the production of most foods
occur regardless of the size of the firm. The agency also agrees that
any exceptions to mandatory HACCP systems must be based on instances in
which risks are not reasonably likely to occur. However, FDA is
required by law to consider ways to assist small businesses when it
implements regulations. While FDA does not propose to exempt any small
businesses from the food safety requirements in this proposed rule, FDA
is considering ways to provide regulatory options that will serve to
reduce the burden of compliance on such small businesses.
IV. FDA's Proposal
A. Applicability
1. Scope
The agency tentatively concludes that HACCP is necessary for the
safe and sanitary production of fruit and vegetable juices to address
the special concerns discussed previously. Therefore, FDA is proposing
new Sec. 120.1(a), which states that part 120 applies to juice and
defines what juice means for purposes of this regulation.
Fruit and vegetable juices may be used as ingredients in other
beverages (e.g., flavored bottled waters; juice beverages and
cocktails). These products often resemble juices, are processed in a
manner that is similar to juices, and handled by consumers similarly to
juices. Thus, they can present the same food hazards as juices.
Therefore, FDA is proposing to require that any juice sold as such or
used as an ingredient in beverages be processed in accordance with the
requirements of part 120.
As stated in section II of this document, FDA has established
standards of identity for a number of fruit juices in part 146 and for
tomato juice in Sec. 156.145. These standardized juices are generally
described as the liquid extracted or expressed from a fruit or
vegetable. However, prune juice (Sec. 146.187) is prepared from a water
extract of dried prunes.
A typical dictionary definition of the term ``juice'' is a fluid
naturally contained in plant or animal tissue (Ref. 56). As described
above, the present situation has demonstrated a need to control food
hazards associated with fruit and vegetable juices. The present
situation does not include oil extracts of fruits and vegetables (e.g.,
olive oil) because these are not traditionally considered juice. Some
juices (e.g., banana juice) and fruit nectars, when purees of the fruit
used, need to be included in any definition FDA proposes because such
purees are often blended with other juices. If there are food hazards
associated with extractives of a fruit or vegetable, those food hazards
will be present in purees of that fruit or vegetable. Concentrates of
juice and purees also need to be included in the definition because, if
a hazard is present in the juice or puree, it could also likely be
present in the juice concentrate. Therefore, the agency is tentatively
defining ``juice'' as the aqueous liquid expressed or extracted from a
fruit or vegetable, purees of the edible portions of a fruit or
vegetable, or any concentrates of such liquid or puree.
The agency requests comments on the definition of ``juice.'' FDA
also requests comments on the scope of the regulation and on whether it
should mandate HACCP for all types of juices, or whether it would be
sufficient to mandate HACCP for certain types of juices.
[[Page 20463]]
2. Effective Date
The seafood final rule provided processors 2 years to implement
HACCP. This was done to: (1) Allow time for training of industry
personnel and regulatory personnel; (2) provide the States with the
time to have a full opportunity to understand and respond to the
effects of these regulations; (3) increase the likelihood that more
agreements with other countries will exist; (4) increase the
opportunity for processors to engage in ``voluntary'' HACCP inspections
in advance of the effective date to obtain preliminary, informal
feedback from the agency on their progress; and (5) allow incorporation
of modifications made in the final rule and publication of FDA
assistance materials for the seafood industry (60 FR 65096 at 65169).
The period of time between publication of the final rule and the
effective dates of the HACCP regulations for meat and poultry issued by
FSIS are: (1) Eighteen months for large establishments with 500 or more
employees, (2) Thirty months for smaller establishments with 10 or more
employees but fewer than 500, and (3) Forty-two months for very small
establishments with fewer than 10 employees or annual sales of less
than $2.5 million (61 FR 38806).
A comment from a fresh juice trade association submitted to the
agency in response to the NACMCF recommendations to FDA on the safety
of juices, requested that FDA mandate HACCP for all juice products and
phase this requirement in over a 3-year period from the publication of
the final rule in a manner similar to the FSIS HACCP regulation. The
comment requested that FDA consider annual inspections of fresh juice
firms until the regulation is effective. It stated that the delay in
implementing HACCP requirements would allow FDA and juice processors
the ability to review conclusions of specific research and establish
performance standards based on this research.
Comments on FDA's notice of intent (62 FR 45593) generally
supported a phased-in approach for small firms taking 3 to 4 years.
However, one comment expected that a phase-in approach would take no
more than 2 years.
The agency is considering the significant issues surrounding
orderly implementation of HACCP. FDA must balance the need for
immediate implementation of HACCP, because of its associated food
safety benefits, against the costs of implementation and consider
options to minimize the burden to small businesses. The proposed
timeframe for implementation of these regulations attempts to balance
these competing concerns. The implementation of HACCP may be more
burdensome for small firms than for large firms. Large firms tend to
have quality control personnel already in place. In addition, many
regulatory requirements are less burdensome for a large firm in
proportion to output than they are for a small firm.
FDA recognizes that HACCP systems cannot be developed and
implemented overnight. The HACCP system of controls can involve new
ways of thinking and performing on a routine basis.
The agency issued a notice on August 28, 1997 (62 FR 45593), that
provided interim measures, and elsewhere in this issue of the Federal
Register, FDA is proposing to require labeling for juice to address the
agency's immediate public health concerns. If finalized, these measures
will require labeling on juice to provide information that juice
unprocessed to control pathogens poses risks to children, the elderly,
and the immunocompromised. The agency is proposing that the labeling
measures be superseded once packaged juice products are processed under
adequate HACCP programs, or are otherwise processed in a manner to
destroy pathogens (e.g., pasteurization). Therefore, as proposed,
before the applicable effective date, juice will be processed to
control for pathogens or, if not, will bear labeling to alert consumers
that such processing has not occurred. After any applicable effective
date, processors will use HACCP systems in the production of juice.
The agency has considered the precedents established by other HACCP
regulations and the comments submitted on juice. There are two
significant differences between the HACCP regulation that FDA is
proposing for juice and the HACCP regulations for seafood and for meat
and poultry. First, FDA has issued interim guidance suggesting that
juice that has not been processed to control pathogens be labeled
accordingly. Elsewhere in this issue of the Federal Register, the
agency is proposing to require such labeling. Second, at the present
time, FDA's available resources would make it very difficult, if not
impossible, to implement a comprehensive inspection program for the
entire juice industry. A phased in approach for compliance will thus
ease the burden not only on small businesses but also on the agency
itself. Accordingly, FDA is proposing that the regulations proposed
herein generally be effective 1 year after the date of publication of
the final rule, with special provisions that will extend the phase-in
to up to 3 years after publication of the final rule. This proposed
phase-in approach will permit the regulated industry time to accomplish
the training of personnel and adjust its activities to include
necessary HACCP activities and takes into account the needs of smaller
businesses.
The agency proposes to establish a timetable for phasing in HACCP
based on business size. FDA proposes in Sec. 120.1(b) that the
effective date be 1 year following publication of the final rule. The
agency is proposing that, by its terms, the regulation will not be
binding until 2 years following the date of publication of the final
rule for small businesses employing fewer than 500 persons
(Sec. 120.1(b)(1)). This is based on the definition of a small business
used by the Small Business Administration. In addition, the agency is
proposing that, by its terms, the regulation will not be binding until
3 years following the date of publication of the final rule for very
small businesses that have either total annual sales of less than
$500,000, or that have total annual sales that are greater than
$500,000 but total annual food sales of less than $50,000, or that
employ fewer than an average of 100 full-time equivalent employees and
that sold fewer than 100,000 units of the product in the United States
(Sec. 120.1(b)(2)). These criteria are consistent with those that the
agency has used in its regulation on small firms and compliance with
the nutrition labeling rules that implement the Nutrition Labeling and
Education Act (the 1990 amendments) (61 FR 40963) (see Sec. 101.9(j)(1)
and (j)(18)) (21 CFR 101.9(j)(1) and (j)(18)). In the 1990 amendments
context, these criteria represent the outcome of three hearings in
different parts of the country, an act of Congress, and informal
rulemaking by FDA. Thus, FDA tentatively concludes that food
manufacturers agree with and understand the definition of very small
businesses. As discussed in the next section of this document, for
purposes of this proposed rule, the agency has tentatively decided that
a retail establishment as set out in proposed Sec. 120.3(h)(2)(iii)
includes a very small processor that makes juice on its premises and
directly sells this juice both to consumers and other retailers
provided that total juice sales do not exceed 40,000 gallons per year.
In implementing proposed Sec. 120.1(b)(2), FDA intends to use the
definitions for the terms ``unit,'' ``food product,'' ``person,'' and
``full-time equivalent employee'' in
[[Page 20464]]
Sec. 101.9(j)(18)(vi). These definitions are as follows: (1) ``Unit''
means the packaging or, if there is no packaging, the form in which a
food product is offered for sale to consumers; (2) ``food product``
means food in any size package that is manufactured by a single
manufacturer or that bears the same brand name, that bears the same
statement of identity, and that has similar preparation methods; (3)
``person'' means all domestic and foreign affiliates, as defined in 13
CFR 121.401, of the corporation, in the case of a corporation, and all
affiliates, as defined in 13 CFR 121.401, of a firm or other entity,
when referring to a firm or other entity that is not a corporation; and
(4) ``full-time equivalent employee'' means all individuals employed by
the person claiming the exemption. The number of full-time equivalent
employees is determined by dividing the total number of hours of salary
or wages paid directly to employees of the person and of all of its
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,
40 hours x 52 weeks).
FDA is committed to its mission of ensuring that food is safe and
not misbranded. This commitment is the basis for proposing interim
labeling measures. The agency tentatively finds that a phase-in HACCP
implementation is necessary because of the logistical effort required
to manage a fundamental change in work processes, roles, and
responsibilities for smaller processors. The proposed implementation
schedule reflects the abilities of processors of varying sizes to
implement HACCP, and the time needed by industry to develop HACCP plans
and train employees.
Upon the proposed implementation date, processors must be ready to
operate their HACCP system, and FDA will conduct inspection activities
according to HACCP principles to ensure that the HACCP system is
operating acceptably. FDA requests comment on its proposed phased-in
implementation of HACCP.
B. Definitions
FDA is proposing in the introductory paragraph of Sec. 120.3 that
the definitions and interpretations of terms in section 201 of the act
(21 U.S.C. 321), in Sec. 101.9(j)(18)(vi), and in part 110 be
applicable to such terms when used in part 120, except where they are
redefined in Sec. 120.3.
The agency is proposing to include in Sec. 120.3 all definitions
applicable to juice that are in the seafood HACCP regulation. The
following terms have proposed definitions that are the same as their
definitions in Sec. 123.3: ``critical limit'' (Sec. 120.3(d)), ``food
hazard'' (Sec. 120.3(e)), ``importer'' (Sec. 120.3(f)), ``shall''
(Sec. 120.3(j)), and ``should'' Sec. 120.3(k)).
However, FDA is proposing to modify the term ``preventive measure''
to ``control measure'' (Sec. 120.3(b)) and to modify its definition
from that used in the seafood HACCP regulation (Sec. 123.3(i)) to
conform with recent NACMCF changes in terminology (Ref. 55). The term
``control measure'' is used because not all hazards can be prevented,
but virtually all can be controlled to some degree. The new NACMCF
definition describes the control measures as actions or activities
rather than as chemical, physical, or other factors. Further, the term
``control'' is clarified to mean prevention, elimination, or reduction
of hazards. The agency tentatively concludes that the recent NACMCF
definition better describes the measures that processors must take.
Therefore, FDA is proposing that ``control measure'' means any action
or activity that can be used to prevent, eliminate, or reduce a hazard.
The NACMCF also recently modified its definition for ``critical
control point'' (Ref. 55). The modified definition incorporates the new
definition of ``control measure'' and emphasizes the essential or
critical nature of the step. Thus, FDA tentatively concludes that the
recent NACMCF definition better characterizes the term. Therefore, the
agency is proposing in Sec. 120.3(c) that ``critical control point''
means a point, step, or procedure in a food process at which a control
measure can be applied and at which control is essential to reduce an
identified food hazard to an acceptable level.
The seafood HACCP regulation defines ``processing'' in
Sec. 123.3(k) with specific product application. To apply these
definitions to juice and to avoid listing specific processes, the
agency is proposing in Sec. 120.3(h)(1) to define ``processing'' as
activities that are conducted by a processor that are directly related
to the production of juice products.
As with the seafood HACCP regulation, there are certain handlers of
juice products that are not covered by the proposed definition. FDA has
tentatively concluded that harvesting, picking, or transporting raw
agricultural ingredients of juice products, without otherwise engaging
in processing, should not be included in the term ``processing''
(Sec. 120.3(h)(2)(i)). FDA has developed voluntary GAP guidance that
has been issued in draft for comment and will apply to these
activities. The agency believes that growers will find GAP's useful and
that the regulations that it is proposing in this rulemaking will, if
adopted, reinforce use of both FDA and specific industry GAP's, thus
affecting harvesting, picking, or transporting indirectly through
processor and importer controls over raw materials and imported
shipments (e.g., preventive controls such as the purchasing of raw
materials only from farms that engage in proper handling of produce).
The agency notes that, with FSIS, it published an ANPRM (61 FR
59372, November 22, 1996) concerning transportation and storage
requirements for potentially hazardous foods. In that ANPRM, FDA and
FSIS requested information and comments on approaches that the two
agencies should take to foster food safety improvements in the
transportation and storage of potentially hazardous foods. While juice
has not historically been considered a potentially hazardous food,
recent illnesses associated with juice necessitate reconsideration of
whether this food should not be included in that category. FSIS and FDA
are reviewing the comments received in response to the joint
transportation notice and will decide whether rulemaking is warranted.
FDA invites comment on whether its approach to transportation is
adequate.
The agency has also tentatively decided to exclude the operation of
a retail establishment from the definition of ``processing''
(Sec. 120.3(g)(2)(ii)). For purposes of this rule, the agency has
tentatively decided that a retail establishment as set out in proposed
Sec. 120.3(h)(2)(iii) includes a very small processor that makes juice
on its premises and directly sells juice to consumers and other
retailers provided that total juice sales do not exceed 40,000 gallons
per year.
FDA has traditionally refrained from directly regulating retail
establishments, although it has authority to do so. FDA provides
training and other forms of technical assistance to States and local
governments who inspect retail food establishments through the agency's
retail Federal/State cooperative program. A major part of that
cooperative program involves the development of model codes, some of
which have been widely adopted by States and local governments. FDA has
consolidated those model codes into a single, updated food code for the
retail sector. Appropriate controls are included in the food code that
can be applied to address juice hazards at retail. FDA will continue to
operate through the Federal/State cooperative mechanism and,
consequently, has not proposed to regulate juice retailers in
[[Page 20465]]
this proposal. However, elsewhere in this issue of the Federal
Register, the agency is proposing to require labeling statements for
packaged juice products including those sold by retailers that have not
been pasteurized or otherwise processed to reduce, eliminate, or
control pathogens. The proposed labeling requirement would apply to
packaged untreated juice products produced in retail establishments for
immediate consumption (such as grocery stores and very small
processors) and would serve to inform consumers of the risk of
untreated juices. (Retail processors selling unpackaged juice on-site
for immediate consumption, such as restaurants and juice bars, would be
exempt from both HACCP and labeling.) FDA notes that 2 of the outbreaks
associated with apple cider (an outbreak of E. Coli. 0157:H7 infection
and an outbreak of cryptosporidosis involving very small apple cider
mills, refs. 8, 8A, and 11) would have fallen under the retail
exclusion. Under the proposed labeling rule, the cider mills would have
been required to label their apple cider. FDA seeks comment on whether
the provisions of the food code in combination with the labeling
statements will provide adequate public health protection. In addition,
in formulating its proposal to include in the definition of retailer a
processor that sells less than 40,000 gallons per year, the agency
considered two other alternatives on which it requests comments. The
first alternative would be to subject these establishments to the HACCP
requirements and to provide a 3-year effective date. The second
alternative would be to subject these establishments to the HACCP
requirements and to provide a 5-year effective date. The agency is also
soliciting comment on the appropriateness of including these
establishments in the retail exemption as well as the appropriateness
of the other two options considered.
The agency is proposing to define the term ``control,'' even though
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(a),
that ``control'' means to prevent, eliminate, or reduce. This
definition is consistent with the use of the term ``control'' in the
definition for ``control measure'' (Sec. 120.3(b)) and describes more
specifically what is to be accomplished in the control of food hazards.
FDA is also proposing to define the term ``monitor,'' even though
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(g) to
define ``monitor'' as conducting a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and producing an accurate record of those observations or
measurements for use in verification. This definition is identical with
that of the NACMCF (Ref. 55). The agency tentatively concludes that
defining this term will assist juice processors to be aware of what
activities constitute monitoring of the various components of the HACCP
system and prerequisite programs; and comply with the monitoring and
recordkeeping requirements necessary for acceptable verification of
HACCP.
C. CGMP's
Section 120.5 of the proposed regulations references the umbrella
CGMP regulations in part 110 as providing general guidance to such
matters as facility design, materials, personnel practices, and
cleaning and sanitation procedures. Because part 110 provides guidance
of general applicability to all foods, including juice, the agency
intends that this guidance will continue to apply to juice processors
even if FDA adopts the proposed regulations in part 120.
D. Prerequisite Program Standard Operating Procedures
The available evidence, including FDA's experience with the HACCP
pilot programs, points to the effectiveness of two programs that do not
fall within the parameters of traditional HACCP. FDA will refer to
these programs in this document as ``prerequisite programs.'' The first
of these programs is that the firm have in place SOP's designed to
ensure plant sanitation.
The seafood final rule requires in Sec. 123.11 that the processor
monitor certain sanitation measures and document both the monitoring
activities and any corrective actions taken when such monitoring finds
an insanitary condition that may contribute to the likelihood of
product becoming hazardous. While seafood processors are not required
under Sec. 123.11(a) to develop and implement written sanitation or
prerequisite program SOP's, processors must maintain sanitation control
records that, at a minimum, document that certain monitoring
requirements have been met, and that corrective actions are taken when
necessary (Sec. 123.11(c)). Section 123.11(b) sets forth requirements
for sanitation monitoring.
FSIS's regulations for meat and poultry require that official
establishments develop, implement, and maintain written SOP's for
sanitation (9 CFR 416.11). Each official establishment must take
appropriate corrective action when it or FSIS determines that the SOP's
have failed to prevent direct contamination or adulteration of product
(9 CFR 416.15). Each establishment must maintain daily records that are
initialed and dated to document the implementation and monitoring of
the SOP's and any corrective actions taken (9 CFR 416.16). Finally,
FSIS verifies the adequacy and effectiveness of the SOP's (9 CFR
416.17).
Insanitary facilities or equipment, poor food handling, improper
personal hygiene, and similar insanitary conditions create an
environment in which products may become contaminated with
microorganisms, including pathogens. However, sanitation controls may
be difficult to fit into HACCP plans. Sanitation covers the whole
processing environment, not just CCP's. A prerequisite program is an
appropriate mechanism for a situation, such as sanitation, that does
not lend itself well to HACCP controls. Therefore, sanitation SOP's are
a type of prerequisite program that is essential to provide a solid
foundation for HACCP systems. The agency tentatively concludes that
sanitation SOP's are an essential foundation for HACCP systems for
juice.
The second prerequisite program is one that provides control over
materials that are entering the plant. The SOP requirements of both the
seafood and FSIS regulations are limited to sanitation. However, the
pilot program experience has suggested the utility of controls on
incoming material. A processor could use incoming material prerequisite
program SOP's, in a manner similar to the sanitation SOP's, i.e., to
cover a range of processing factors, not just CCP's. Although use of
incoming material SOP's may not obviate the need for some CCP's in a
HACCP plan, FDA anticipates that their use could help to ensure the
safety of the food produced.
Incoming material controls for raw produce could be invaluable in
establishing the conditions under which produce needs to be grown
(including pesticide application) and harvested to provide assurance to
the processor that the raw produce will not present hazards that the
processor will otherwise need to control. For example, the processor's
incoming material SOP's could specify that the processor will only
purchase carrots that have not been fertilized with manure during
growth. Another example is that the incoming material control could
specify that the processor will only accept apples that have been
picked from the tree, and that dropped apples are unacceptable. A
simple solution to control the possible
[[Page 20466]]
presence of unlawful pesticide residues on fruits and vegetables is to
establish SOP's for incoming material control that ensure that any
pesticides that have been used on the produce are approved for that
use, are used at the appropriate level, and that appropriate time has
elapsed between application and harvest.
As discussed previously, FDA is developing GAP and GMP guidance
that has been issued in draft for comment. The guidance will address
potential food safety problems throughout the food production and
distribution system such as sanitation, worker health, and water
quality.
A manufacturer also could use controls on the packaging materials
that it receives. Proper packaging is essential if a processor is to
minimize the possibility of the occurrence of hazards after juice has
been processed. Juice that is not packed in hermetically sealed
containers may be subject to contamination from a number of sources.
The processor also needs to ensure that the container coating that it
uses will not deteriorate through reasonable storage. Evidence in
section I.B of this document showed examples where the acid content of
some juices corroded the tin lining of the container, and the tin was
present in sufficient concentration to be toxic. Incoming material
controls will mean that the processor will act to ensure that packaging
materials are safe and suitable before accepting them.
Incoming material controls for ingredients that a processor may add
to juice can also be helpful. For example, if a processor is purchasing
juice or juice concentrate from a supplier for use in a multi-juice
beverage, it is essential that that juice have been processed under an
adequate HACCP system and have not been contaminated during
transportation. Thus, incoming material SOP's will lead the processor
to establish controls on ingredients as criteria for acceptance in the
plant.
However, the agency is not proposing to provide for the use of
incoming materials SOP's in part 120 at this time and requests comment
on this issue. FDA is seeking comment on whether incoming material
SOP's can be utilized in a similar relationship to the HACCP system as
the sanitation SOP's. Do interested persons see value in FDA requiring
that these SOP's be written, monitored, and verified? How do these
SOP's relate to FDA's draft guidance on fresh produce? What are
reasonable procedures for acceptance of incoming materials that could
be incorporated into SOP's?
1. Sanitation SOP's
FDA is proposing in Sec. 120.6(a)(1) to require that processors
have and implement SOP's that address sanitary conditions and practices
before, during, and after processing. Good sanitation practices are
critical to the prevention of microbiologically related foodborne
illnesses. FDA's CGMP regulations for food in part 110 set out general
principles of sanitation that should be followed in plants that
manufacture, package, label, or hold human food. They address such
matters as personal hygiene and cleanliness among workers who handle
food, the suitability of the plant design to sanitary operations, and
the cleaning of food-contact surfaces. The proposed sanitation SOP's
relate to the entire facility, not just to a limited number of CCP's.
FDA tentatively concludes that this step is necessary to fully
implement section 402(a)(4) of the act and yet at the same time not
overload the HACCP system. FDA invites comments on this approach.
FDA did not elect to make the development of a written sanitation
SOP mandatory for seafood because it recognized that some processors
may be able to achieve satisfactory sanitary conditions and practices
without having to commit their sanitary control procedures to writing
(60 FR 65096 at 65149). In the seafood final rule, FDA concluded that
as long as there were records demonstrating that the plant was being
kept in sanitary condition, it was not necessary to require written
sanitation SOP's, even though the agency strongly recommended that a
processor have them. The agency requests comment on whether it should
require for juice HACCP that sanitation SOP's be written.
In the evidence discussed in section I.A of this document, there
were several instances where contaminated water was the cause of the
outbreak. The water that the processor used was contaminated and when
produce was washed with it before juicemaking, the water contaminated
the produce, resulting in contaminated juice. Therefore, the safety of
the water that comes into contact with food or food contact surfaces is
an important factor that a processor must consider to maintain proper
sanitation and prevent contamination of the product and plant. The
seafood HACCP regulation in Sec. 123.11(b) lists eight sanitary
conditions and practices that processors must monitor, and monitoring
the safety of the water that comes into the plant is one of them
(Sec. 123.11(b)(1)). Based on the foregoing, FDA is proposing a similar
requirement in Sec. 120.6(a)(1).
In section I.B of this document, FDA recounted the evidence
demonstrating, that several outbreaks were caused by cleaning solution
directly contaminating the juice. Sanitation SOP's for seafood in
Sec. 123.11(b)(5) require that processors protect food from
adulteration with cleaning compounds. Given that cleaning compounds,
sanitizing agents, pesticides, and other materials can pose a similar
threat if not properly used in a juice processing facility, FDA is
proposing a parallel requirement in Sec. 120.6(a)(5).
The other provisions of Sec. 123.11(b) are based on CGMP and
encompass basic sanitation principles. Based on its consideration of
the factors that it cited in arriving at Sec. 123.11(b), the agency
tentatively concludes that it is appropriate to require in
Sec. 120.6(a) that juice processors address the same sanitary
conditions and practices in their SOP that must be monitored by seafood
processors. FDA requests comment on the proposed matters that must be
addressed in the sanitation SOP, and whether others are necessary for
juice.
2. Other Requirements for Prerequisite Program SOP's
FDA is proposing in Sec. 120.6(b) that processors monitor
sanitation conditions and practices during processing with sufficient
frequency to ensure, at a minimum, conformance with those conditions
and practices specified in part 110 that are appropriate both to the
plant and to the food being processed. The seafood HACCP regulation
requires sanitation monitoring (Sec. 123.11(b)). Because prerequisite
programs potentially include facility-wide control points and provide a
foundation for HACCP systems, processors need to monitor the
performance of the SOP's to ensure that they are functioning as
designed, and that they are corrected if there is a problem.
The agency is proposing in Sec. 120.6(c) that processors maintain
records that document the monitoring that they do under the
prerequisite program SOP's and any corrections to those SOP's that they
make. Monitoring and recording of conditions and practices under the
prerequisite program SOP's are as much keys to the success in improving
those conditions as is the development by a processor of the SOP's. As
in the case of HACCP records, FDA is proposing to require that
processors engage in systematic monitoring of their own sanitation
practices and conditions. This proposed requirement is similar to what
is required for sanitation SOP's for seafood (Sec. 123.11(c)).
Monitoring to
[[Page 20467]]
ensure that sanitation is under control is the responsibility of all
processors. Monitoring records help processors to see trends, and also
allow the regulator to assess a processor's compliance over a period of
time, not just at the time of an inspection.
FDA believes that the records bearing on the monitoring of relevant
sanitation conditions and practices and the agency's access to such
records are essential if proposed Sec. 120.6 is to be an effective
regulatory strategy. Therefore, as with HACCP records, the agency
tentatively concludes that these records be subject to the
recordkeeping requirements in proposed Sec. 120.12.
Proposed Sec. 120.6(d) provides the option to juice processors to
include prerequisite program SOP controls in the HACCP plan. However,
if these controls are implemented as part of the prerequisite program
SOP's, there is no need to include them in the HACCP plan. The control
must be in the HACCP plan or in the prerequisite program SOP but need
not be in both places. This proposed provision is similar to
Sec. 123.11(d) for seafood. It is intended to provide manufacturers
with flexibility in how they address the issues involved in the
prerequisite controls.
The agency requests comment on its proposed approach to
prerequisite program SOP's.
E. Hazard Analysis
1. The Hazard Analysis
The seafood HACCP regulation in Sec. 123.6(a) requires that every
processor conduct, or have conducted for it, a hazard analysis to
determine whether there are food hazards that are reasonably likely to
occur for each kind of fish and fishery product processed by that
processor and to identify the preventive (i.e., control) measures that
the processor can apply to control those hazards. Section 123.6(a)
reflects the fact that food hazards can be introduced both within and
outside the processing plant environment, including before, during, and
after harvest. A food hazard that is reasonably likely to occur is one
that, based on the evidence and insights provided by experience,
illness data, scientific reports, and other information, has a
reasonable possibility of occurring in the particular food if
appropriate controls to protect against the hazard are not put in
place. Thus, ensuring that a food will be safe involves identifying
these hazards and preparing for them. The FSIS HACCP regulation for
meat and poultry, in 9 CFR 417.2(a)(1), also requires that a hazard
analysis be done.
According to the NACMCF, a thorough hazard analysis is the key to
preparing an effective HACCP plan (Ref. 55). If the hazard analysis is
not done correctly, and the hazards warranting control within the HACCP
system are not identified, the plan will not be effective regardless of
how well it is followed.
The hazard analysis involves hazard identification and evaluation.
According to the NACMCF, each potential hazard is evaluated based on
the severity of the potential hazard and the likelihood of its
occurrence (Ref. 55). The NACMCF defined severity as the seriousness of
the consequences of exposure to the hazard. They stated that
consideration of the likelihood of its occurrence is usually based upon
a combination of experience, epidemiological data, and information in
the technical literature, and that when conducting the hazard
evaluation, it is helpful to consider the likelihood of exposure and
the severity of the potential consequences if the hazard is not
properly controlled. The NACMCF also stated that consideration should
be given to the effects of short term, as well as long term, exposure
to the potential hazard.
The seafood HACCP regulation does not differentiate between hazards
that cause acute harm and hazards that cause harm through chronic
exposure. FDA stated in the seafood final rule that:
HACCP should be the norm, rather than the exception, for
controlling safety related hazards in the seafood industry. Existing
standards for such contaminants as drug residues, pesticides, and
industrial contaminants, are established to ensure that their
presence in foods does not render the food unsafe. Processors of
fish and fishery products are obliged to produce foods that meet
these standards.
Processors are obliged to exercise control over all food safety
hazards that are reasonably likely to occur.
An important principle is that the processor has the burden of
determining the reasonable likelihood of a hazard's occurrence,
regardless of whether it is a chronic or an acute exposure hazard. In
determining whether a chronic hazard is reasonably likely to occur, a
processor should consider whether it is reasonably likely that, without
some form of control, the food will contain a contaminant in sufficient
quantity to cause it to be adulterated under the act (e.g., it exceeds
a Federal tolerance for a pesticide residue).
The agency tentatively concludes that the requirement for a
processor to conduct a hazard analysis is appropriate for juice
processors. The evidence presented in section I of this proposal
demonstrates that hazards are reasonably likely to occur in the
processing of juice. Therefore, FDA is proposing to require in
Sec. 120.7 that processors develop a hazard analysis to determine
whether there are food hazards that are reasonably likely to occur for
each type of juice processed and to identify the control measures that
the processor can employ to control those hazards. The agency requests
comments on how processors should consider the severity of the hazard,
as the NACMCF discussed, along with its likelihood of occurrence, in a
hazard analysis.
FDA is also proposing in Sec. 120.7 to require that juice
processors use the same considerations in their hazard analysis as
required of seafood and meat and poultry processors (i.e., that they
determine where hazards are introduced, and which hazards need to be
controlled) because these considerations raise the fundamental issues
that must be considered in identifying the hazards present in any
processing operation.
Finally, under the proposed regulation, the hazard analysis must be
developed by an individual trained in HACCP. Training is critical to
the successful implementation of HACCP systems. A trained individual
will be able to understand and apply HACCP principles to the hazard
analysis.
The hazard analysis serves several purposes. It can identify any
modifications to a process or product that are necessary to ensure or
improve the product's safety. It can also provide the basis for
determining CCP's. A specific analysis of a process is necessary
because aspects of the process that represent significant hazards in
one operation may not present significant hazards in another operation
even though the two operations produce the same or a similar product.
Differences in equipment and incoming materials are generally the basis
for these variations. For example, processors will use different
equipment and incoming materials if producing juice from concentrate
than if they are producing the same juice from raw materials.
A summary of the deliberations and the rationale developed during
the hazard analysis should be kept for future reference. This
information will be useful during reviews and updates of the hazard
analysis and the HACCP plan.
Although under both seafood HACCP and meat and poultry HACCP a
hazard analysis is required, a written hazard analysis is only required
under the meat and poultry regulation. In the seafood HACCP final rule,
the agency presented its reasons for not requiring a written hazard
analysis (60 FR 65096 at 65118). It stated:
[[Page 20468]]
The agency recognizes that the best way for it to verify a
processor's hazard analysis is indirectly, through its own
evaluations of whether a processor ought to have a HACCP plan, and
whether a HACCP plan appropriately identifies the food safety
hazards and CCP's that are reasonably likely to occur. In other
words, it is the end product of the hazard analysis, the HACCP plan
and its implementation, that should be judged by the regulator. For
this reason, the agency is not requiring that hazard analyses be
performed according to a standardized regimen, or that they be
documented in writing for FDA review.
Even though FDA is not requiring that the hazard analysis be
available to the agency, there may be cases in which it would be to
the processor's advantage to have a carefully documented written
hazard analysis to show to FDA. Such documentation may prove useful
in resolving differences between the processor and the agency about
whether a HACCP plan is needed and about the selection of hazards,
CCP's, and CL's. Written hazard analyses may also be useful to
processors in that they may help provide the rationale for the
establishment of CL's and other plan components. Having the basis
for these decisions available may be helpful when processors
experience changes in personnel, especially those associated with
the HACCP process, and in responding to unanticipated CL deviations.
FDA believes that the position taken in the seafood HACCP
regulation continues to be appropriate for seafood. The agency notes
that the ``Fish & Fisheries Products Hazards & Controls Guide'' assists
processors in the development of their HACCP plans, including the
hazard analysis. It lists numerous potential hazards and guides seafood
processors through the hazard analysis. However, as discussed
previously, it is not clear whether, given the limitations on its
resources, FDA will be able to provide such detailed information for
juice. Therefore, the agency tentatively concludes that a requirement
for a written hazard analysis is appropriate for juice.
Moreover, most firms in the FDA pilot program reported that
preparing a written hazard analysis, including a list of preventive
measures, helped them conduct a more scientific analysis rather than
just a qualitative one; they also reported that the written hazard
analysis provided a means of communicating to employees the public
health significance of the hazards that were being controlled (Ref.
57). Thus, FDA believes that processors likely will conduct a more
appropriate hazard analysis if they have to document it. If the hazard
analysis has not been conducted properly, the HACCP plan will likely be
inadequate. Therefore, FDA tentatively concludes that HACCP plans alone
may not be adequate without a documented hazard analysis.
Accordingly, FDA is proposing to include in Sec. 120.7 that the
hazard analysis be written and maintained as a record in accordance
with proposed recordkeeping requirements (Sec. 120.12). The agency
requests comments on its approach of requiring a written hazard
analysis.
2. Evaluation of Hazards
Section 123.6(c) requires that processors consider in the hazard
analysis whether any food safety hazards are reasonably likely to occur
as a result of natural toxins, microbiological contamination, chemical
contamination, pesticides, drug residues, decomposition, parasites,
unapproved use of direct or indirect food or color additives, and
physical hazards. In 9 CFR 417.2(a)(3), FSIS lists these same
considerations where food safety hazards might be expected to arise and
adds zoonotic diseases to the list.
FDA has reviewed the food hazards that are reasonably likely to
occur in juice. For the most part, the hazards that processors should
consider in doing a hazard analysis for this type of food are the same
as those that FDA and USDA have listed in the regulations for seafood,
meat, and poultry (Ref. 58). However, unlike seafood, meat, and
poultry, pesticides may be intentionally applied to fruits, vegetables,
and other plant products during their growth. All pesticides applied to
produce must be approved for use on that plant, and the residue levels
of the pesticides at the time of harvest must be within tolerances.
Therefore, processors must ensure that any pesticide residues on plant
foods are lawful for that food and are within tolerances.
The presence of possible allergens in foods is a second possible
hazard that was not considered in HACCP regulations for seafood or meat
and poultry. Food ingredients must be declared on the label in
accordance with Sec. 101.4, and individuals sensitive to particular
ingredients may avoid consuming them by checking the ingredient list.
However, there is a possibility that traces of undeclared food
materials could be present in food products from foods run previously
on the same equipment as used for the juice or on nearby equipment. The
presence of even traces of certain food ingredients can cause life
threatening reactions in sensitive individuals. For example, dairies
may process juice using the same equipment that they use to process
milk. Therefore, dairies processing juice in this manner must consider
whether traces of milk are present in the juice. The same principle
holds for processors producing several types of juices on the same
equipment. A hazard analysis should determine whether a food hazard is
created as a result. FDA tentatively concludes that a hazard analysis
should consider the potential presence of undeclared food ingredients
that could be possible allergens.
Therefore, FDA is proposing in Sec. 120.7(a) that in evaluating
which food hazards are reasonably likely to occur, consideration should
be given, at a minimum, to the following: (1) Microbiological
contamination, (2) parasites, (3) chemical contamination, (4) unlawful
pesticide residues, (5) decomposition in food where a food hazard has
been associated with decomposition, (6) natural toxins, (7) unapproved
use of direct or indirect food or color additives, (8) presence of
undeclared allergens, and (9) physical hazards. The agency requests
comment on these hazards and any others that should be included in the
regulation.
3. Other Considerations
The agency is proposing in Sec. 120.7(b) that processors should
evaluate product ingredients, processing procedures, packaging,
storage, and intended use; facility and equipment function and design;
and plant sanitation, including employee hygiene, to determine the
potential effect of each on the safety of the finished food for the
intended consumer. These are factors that a prudent processor should
consider in conducting a hazard analysis. The seafood HACCP regulations
at Sec. 123.6(a) did not list specific items or factors that processors
should consider when conducting a hazard analysis. The preamble to the
final rule for those regulations stated that, as of December 1995, the
methodology for conducting a hazard analysis was not sufficiently
standardized to justify mandating what the hazard analysis must
include. The preamble encouraged processors to study the NACMCF
guidance on the subject. The agency tentatively concludes, however,
that including in the codified text the minimum elements that the
processor should consider in developing a hazard analysis will assist
processors. This material is included to be helpful and does not
constitute a substantive change from the seafood HACCP regulation. FDA
requests comment on proposed Sec. 120.7(b).
F. HACCP Plan
1. The HACCP Plan
The seafood HACCP regulation requires in Sec. 123.6(b) that
processors have and implement a written HACCP
[[Page 20469]]
plan whenever a hazard analysis reveals one or more food safety hazards
that are reasonably likely to occur. FSIS has established a similar
requirement for meat and poultry (9 CFR 417.2(b)).
FDA is proposing to require in Sec. 120.8(a) that every juice
processor have and implement a written HACCP plan whenever a hazard
analysis reveals that one or more food hazards are reasonably likely to
occur during processing, as described in Sec. 120.7. This could include
adapting a model or generic-type plan to a processor's specific
situation. This proposed requirement is in keeping with Principle 7 of
the NACMCF guidelines that firms prepare and maintain written HACCP
records (Ref. 55).
The agency is also proposing in Sec. 120.8(a)(1) and (a)(2) that a
HACCP plan be specific to each location where juice is, and to each
type of juice that is, processed by that processor. The plan may group
types of juice products together, or group types of production methods
together, if the food hazards, CCP's, CL's, and procedures required to
be identified and performed are essentially the same for the products
or methods being grouped, provided that any required features of the
plan that are unique to a specific product or method are clearly
delineated in the plan and are observed in practice. Proposed
Sec. 120.8(a) is similar to provisions in both Sec. 123.6(b) of the
seafood HACCP regulation and 9 CFR 417.2(b) of the HACCP regulation for
meat and poultry.
A plan is specific to each location because the likely hazards,
CCP's, CL's, and monitoring procedures can vary from one facility to
another depending on such factors as type of equipment, conditions and
procedures, personnel, and location. A plan also should be specific to
each type of juice for the same kinds of reasons. Hazards can vary
depending on the type of fruit or vegetable used to make the juice, pH,
and other factors. The agency has tentatively concluded, however, that
some types of juices can be grouped together in a HACCP plan if the
hazard analysis reveals that the juices present similar hazards, their
processing includes the same CCP's, or there are other appropriate
commonalities in their production. Grouping would reduce the paperwork
burden on some processors without altering the benefits attainable
through HACCP. The agency requests comment on this approach.
A valid HACCP plan delineates the procedures to be followed in
processing the juice. Thus, FDA tentatively concludes that the HACCP
plan needs to be developed by individuals who not only are
knowledgeable in juice processing but who have been trained in HACCP.
This activity requires specialized training in the principles of HACCP,
various aspects of food science, and the knowledge of criteria of
existing regulations and guidelines. Therefore, the agency is proposing
in Sec. 120.8(a) that the HACCP plan be developed by an individual or
individuals who have been trained in accordance with proposed
Sec. 120.13.
Seafood and meat and poultry processors are required to have a
written HACCP plan that is subject to certain recordkeeping
requirements. An adequate recordkeeping system is the key to HACCP. In
addition, adequate records allow the processor to be able to reference
the HACCP plan as necessary. Thus, FDA tentatively concludes that,
because of the plan's importance in a HACCP system, the HACCP plan for
juice must also be subject to certain recordkeeping requirements.
Therefore, the agency is also proposing in Sec. 120.8 that the HACCP
plan be maintained in accordance with the recordkeeping requirements of
Sec. 120.12.
2. The Contents of the HACCP Plan
As discussed previously, the NACMCF has developed seven principles
that describe the HACCP concept and what constitutes a HACCP plan. Both
Sec. 123.6(c) and 9 CFR 417.2(c) include minimum requirements for the
contents of HACCP plans for seafood and meat and poultry, respectively,
that are based on these seven principles. FDA is proposing to require
similar minimum criteria for HACCP plans for juice products.
The agency is proposing in Sec. 120.8(b)(1) to require that the
plan list the food hazards that are reasonably likely to occur as
identified in accordance with Sec. 120.7 and that thus must be
controlled for each type of product. This list identifies the hazards
that will be controlled by adhering to the HACCP plan in the processing
of that type of juice.
Consistent with the HACCP principles identified by the NACMCF, FDA
is proposing in Sec. 120.8(b)(2) that processors list the CCP's for
each of the identified food hazards, including, as appropriate, CCP's
designed to control hazards that could occur or be introduced inside
the processing plant environment, and CCP's designed to control food
hazards introduced outside the processing plant environment, including
hazards that occur before, during, or after harvest. Complete and
accurate identification of CCP's is fundamental to controlling food
hazards (Ref. 55). Hazards may be caused by improper processing or by
events outside the processor's direct control. These hazards are
controlled by the CL's, monitoring, control procedures, and
recordkeeping that are done as part of HACCP.
In Sec. 120.8(b)(3), FDA is proposing, consistent with the NACMCF
principles, that processors list the CL's that must be met at each of
the CCP's. CL's must be met to ensure that the relevant hazard is
controlled or avoided. According to the NACMCF, each CCP will have one
or more control measures to ensure that the identified hazards are
prevented, eliminated, or reduced to acceptable levels (Ref. 55). Each
control measure has one or more associated CL's. Thus, some CL's can be
set to reflect regulatory levels established by FDA or EPA in the form
of action levels, regulatory limits, or tolerances for contaminants
such as pesticide residues, natural toxins, and other contaminants.
According to the NACMCF, monitoring serves three main purposes
(Ref. 55). First, monitoring is essential to food safety management in
that it facilitates tracking of the operation. If monitoring indicates
that there is a trend towards loss of control, then action can be taken
to bring the process back into control before a deviation from a
critical limit occurs. Second, monitoring is used to determine when
there is loss of control and thus a deviation at a CCP (i.e., exceeding
or not meeting a CL). When a deviation occurs, an appropriate
corrective action must be taken. Third, it provides written
documentation for use in verification.
Proposed Sec. 120.8(b)(4) requires that processors list the
procedures, and the frequency with which they are to be performed, that
will be used to monitor each of the CCP's to ensure compliance with the
CL's. Monitoring steps are necessary to ensure that the CCP is in fact
under control and to produce an accurate record of what has occurred at
the CCP. The frequency of monitoring affects the level of confidence
that a firm has in the safety of its product, with continuous
monitoring providing the highest level of confidence.
The agency is proposing in Sec. 120.8(b)(5) that processors include
in their HACCP plan any corrective action plans that have been
developed in accordance with proposed Sec. 120.10(a), and that are to
be followed in response to deviations from CL's at CCP's. As explained
in more detail in the ``Corrective Actions'' section of this preamble,
FDA has tentatively concluded that these regulations should provide the
processor with the option of predetermining corrective actions.
Predetermined corrective action
[[Page 20470]]
procedures have the potential to facilitate faster action when a
deviation occurs than would be possible in the absence of such
procedures and to enable a processor to make a more timely response to
the deviation when trained or otherwise qualified individuals are not
readily available.
Consistent with the NACMCF principles, the agency is proposing in
Sec. 120.8(b)(6) that processors list the verification and validation
procedures, and the frequency with which they are to be performed, that
the processor will use in accordance with proposed Sec. 120.11. As
explained in more detail in the ``Verification and Validation'' section
of this preamble, FDA has tentatively concluded that a processor must
specify in its HACCP plan the verification and validation procedures
that it will use and the frequency with which it will use those
procedures. FDA tentatively finds that inclusion of this information in
the plan is necessary to underscore that a processor has an ongoing
obligation to ensure that the verification and validation steps it has
determined are necessary are readily ascertainable by its employees as
well as by regulatory officials.
Finally, in Sec. 120.8(b)(7), FDA is proposing that processors
provide for a recordkeeping system that documents the monitoring of the
CCP's, and that the records contain the actual values and observations
obtained during monitoring. Implementing a HACCP system depends on
adequate records to document the controls at each CCP and the
corrective actions taken in response to any deviations. FDA has
tentatively concluded that it is neither possible for processors to
derive the full benefits of a HACCP system, nor to verify or validate
the operation of the system, without actual measurement values.
Notations that heat treatment temperatures are ``satisfactory'' or
``unsatisfactory,'' without recording the actual times and
temperatures, are vague and subject to varying interpretations and
thus, will not ensure that controls are working properly. Also, it is
not possible to discern trends without actual measurement values.
The agency requests comments on developing a HACCP plan based on
the NACMCF principles.
3. Products Subject to Other Regulations
FDA has already established HACCP type regulations for acidified
and low acid canned foods. FDA examined this issue in the seafood final
rule (60 FR 65096 at 65124) and acknowledged that there is no need for
a processor to restate in its HACCP plan the requirements of part 113
or 114 (21 CFR part 113 or 114).
Parts 113 and 114 dictate that low-acid canned foods and acidified
foods be processed in a manner to become commercially sterile.
Commercial sterility of thermally processed food is defined in
Sec. 113.3(e)(1) as a process that renders the food free of: (1)
Microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution, and (2) viable
microorganisms (including spores) of public health significance.
Consequently, juice processors who must comply with the requirements of
part 113 or 114 need not address these particular hazards at all in
their HACCP plans.
However, it is important to note that other hazards may be
reasonably likely to occur in an acidified or low-acid canned juice.
FDA is proposing to require that these hazards be addressed in the
HACCP plan, as appropriate. For example, FDA anticipates that the
possible presence of glass in carrot juice packed in glass containers
is a hazard that is reasonably likely to occur and thus the agency
expects this hazard to be addressed in the HACCP plan. Accordingly, to
clarify what is required of processors of acidified and low-acid canned
juice products, FDA is proposing to adopt Sec. 120.8(c) for juice
products subject to other regulations.
4. Relationship to Prerequisite Programs
All hazards identified during the hazard analysis as being
reasonably likely to occur need to be addressed by control measures
that a processor can apply. Determining how the control measures, in
turn, are to be addressed is a primary consideration in developing the
HACCP plan. Control measures involve identifying the relevant CCP's and
CL's as part of the HACCP plan, or, in those limited circumstances
specified in proposed Sec. 120.6, making appropriate provision in a
prerequisite program SOP. The safety of the product can be compromised
if control measures are not properly monitored and addressed.
As it required for seafood HACCP, FDA is proposing to require that
processors address plant sanitation by monitoring certain key sanitary
conditions and practices apart from CCP monitoring activities, either
by including sanitation controls as part of the HACCP plan, or as part
of an SOP in accordance with Sec. 120.6, or by adopting some
combination of these two approaches, at the option of the processor.
To reflect this approach, the agency is proposing in Sec. 120.8(d)
to state that sanitation controls may be included in the HACCP plan,
but that, to the extent that they are monitored in accordance with
Sec. 120.6, they need not be included in the HACCP plan.
FDA recognizes that many processing operation sanitation controls,
such as hand and equipment washing and sanitizing, are critical to the
safety of the food because they serve to minimize the risk of pathogen
introduction into finished products that may not be further heat
treated before consumption. For this reason, some processors may elect
to include in their HACCP plan the control of sanitation through
standardized practices in addition to, or in place of, monitoring of
sanitation conditions and control practices apart from the HACCP plan.
However, FDA also recognizes that sanitation controls may be difficult
to fit into HACCP plans, with appropriate CL's and corrective actions
sometimes being elusive. For this reason, some processors may elect to
rely exclusively on sanitation controls that are not part of the HACCP
plan. Either approach is likely to be acceptable, so long as whatever
approach is chosen is fully implemented and followed. FDA requests
comment on this view.
G. Legal Basis
The seafood HACCP regulation states that the failure of a processor
to have and to implement a HACCP plan that complies with Sec. 123.6(g),
whenever a HACCP plan is necessary, or otherwise to operate in
accordance with the requirements of part 123, will render the fish or
fishery products of that processor adulterated under section 402(a)(4)
of the act, and potentially section 402(a)(1). Whether a processor's
actions are consistent with ensuring the safety of food will be
determined through an evaluation of the processor's overall
implementation of its HACCP plan, if one is required. The legal basis
for FDA's proposed mandatory HACCP systems for juice processors is the
same as that for seafood processors. Additional discussion of the legal
basis may be found in the proposed rule (59 FR 4142 at 4150) and final
rule (60 FR 65096 at 65098) for fish and fishery products.
The agency is proposing in Sec. 120.9 that failure of a juice
processor to have and to implement a HACCP system that complies with
Sec. 120.8 or otherwise to operate in accordance with the requirements
of this part, will have similar consequences as a failure to comply
with the seafood HACCP regulations. FDA has tentatively determined that
the hazards, especially microbial hazards, inherent in juice
[[Page 20471]]
processing are such that, unless there is adherence to HACCP
principles, there cannot be assurance that the product is safe. Thus,
failure to operate a juice processing operation in accordance with
HACCP is itself an insanitary condition that may render the juice
product injurious to health.
H. Corrective Actions
The fifth HACCP principle, as articulated by the NACMCF, is that
processors establish the corrective actions that they will take should
monitoring show a CL deviation. The NACMCF's expectation is that these
corrective actions should be predetermined and written into the
processor's HACCP plan. Where there is a deviation from established
CL's, corrective actions are necessary (Ref. 55).
Section 123.7 of the seafood regulation permits, but does not
require, processors to include in their HACCP plans any written
corrective action plans that they develop. When a deviation from a CL
occurs, Sec. 123.7(a) requires that the processor either: (1) Follow a
corrective action plan that is appropriate for the particular
deviation, or (2) follow the series of actions provided in
Sec. 123.7(c). The steps in Sec. 123.7(c) constitute a minimum generic
model for corrective actions.
Section 123.7(b) of the seafood HACCP regulation defines an
appropriate action plan as one that addresses both the safety of the
product that was being processed when the CL failure occurred and the
cause of the deviation. In this respect, the contents of the corrective
action plan are consistent with the views of the NACMCF (Ref. 55).
Action necessary to correct the potential hazard may involve one or
more of the following steps: Immediately reprocessing the product;
diverting the product to another use for which it is safe; segregating,
holding, and having the product evaluated by a competent expert; or
destroying the product (60 FR 65096 at 65127). To ensure that
subsequent product is not subjected to the same deviation, the
corrective action must be sufficient to bring the process back under
control. FDA advised in the preamble to the seafood final rule (60 FR
65096 at 65127) that such action may involve, where appropriate,
adjustments to those process parameters that have an effect on the
relevant CL (e.g., flow rate, temperature, source of raw materials);
temporarily diverting product around a point in the process at which
problems are being encountered; or temporarily stopping production
until the problem can be corrected.
Section 123.7(c) of the seafood HACCP regulation describes the
steps that a processor must take whenever there is a deviation from a
CL, but the processor has not prepared a corrective action plan for
that situation. If the processor does not have a corrective action plan
for a particular deviation, then the processor must: (1) Segregate and
hold the affected product for as long as necessary, (2) perform or
obtain a review by a trained individual to determine the affected
product's acceptability for distribution, (3) take corrective action to
ensure that no product enters commerce that is either injurious to
health or is otherwise adulterated as a result of the deviation, (4)
take corrective action to correct the cause of the deviation, and (5)
have a trained individual perform a timely reassessment to determine
whether the HACCP plan needs to be modified to reduce the risk of
recurrence of the deviation and modify the HACCP plan as necessary.
As stated in a previous paragraph , these steps constitute a
minimum generic-type corrective action plan. The objectives of these
steps are the same as those of a preconceived plan: To ensure that
adulterated product does not enter commerce and to correct the cause of
the deviation. Because it is a generic-type plan that is intended to be
applicable to any situation, some of the steps, such as segregating and
holding the affected product (Sec. 123.7(c)(1)), might not be necessary
if the corrective action had been predetermined. This aspect of the
generic-type plan may provide processors with an incentive to
predetermine corrective actions whenever practical.
FDA is proposing essentially the same requirements in Sec. 120.10
that it requires in Sec. 123.7 of the seafood HACCP regulation because
the agency is not aware that a juice processor has any options other
than those that are available to the seafood processor. The processor
can either follow its own established corrective action plan, as
appropriate for the particular deviation, or follow the generic
provisions of the regulation that are applicable to any food. Thus, FDA
tentatively concludes that the seafood HACCP requirements for
corrective actions are applicable to juice processing.
Proposed Sec. 120.10 sets forth the corrective action procedures
that a processor must take whenever a deviation from a CL occurs. A
processor may take corrective action either by following: (1) A
corrective action plan as identified in the HACCP plan (see proposed
Sec. 120.8(b)(5)), or (2) the procedures outlined in proposed
Sec. 120.10(b). Predetermined plans provide processors with benefits,
such as faster action when a deviation occurs, less need to justify to
management the appropriateness of the corrective action after it has
been taken, and a more timely response to the deviation than is
possible when trained or otherwise qualified individuals are not
readily available to make determinations, and a plan is not available.
The agency is proposing to provide in Sec. 120.10(a) that
processors may develop written corrective action plans, which become
part of their HACCP plans in accordance with Sec. 120.8(b)(5), by which
they predetermine the corrective actions that they will take whenever
there is a deviation from a CL. According to the NACMCF, specific
corrective actions should be developed in advance for each CCP and
included in the HACCP plan (Ref. 55). The agency is also proposing in
Sec. 120.10(a) that a corrective action plan that is appropriate for a
particular deviation is one that describes the steps to be taken and
assigns responsibility for taking those steps, to ensure that: (1) No
product enters commerce that is either injurious to health or is
otherwise adulterated as a result of the deviation, and (2) the cause
of the deviation is corrected. These two considerations are essential
because they represent the reasons for taking corrective actions (i.e.,
protecting the public health and correcting the problem at hand).
In Sec. 120.10(b), FDA is proposing the steps that processors must
take when a deviation from a CL occurs, and they do not have a
corrective action plan that is appropriate for that deviation. First,
under proposed Sec. 120.10(b)(1), any CL deviation will require the
segregation and holding of the affected product until the significance
of the deviation can be determined. FDA tentatively finds that this
step is necessary to ensure that products that may be injurious to
health do not enter commerce until the deviation's impact on safety has
been determined.
Proposed Sec. 120.10(b)(2) requires that processors perform or
obtain a review to determine the acceptability of the affected product
for distribution. This is fundamental to determining the final outcome
of the affected product. In some instances product may simply need to
be reprocessed, while at other times, the product may not be considered
adulterated. For example, if the pasteurization process did not reach
the minimum temperature specified by the CL, the juice can be diverted
and rerouted through the pasteurizer for
[[Page 20472]]
reprocessing at acceptable temperatures. However, if the juice contains
a pesticide above an established tolerance level, the juice is deemed
to be adulterated.
FDA is also proposing to require in Sec. 120.10(b)(2) that the
safety determination be made by an individual who has adequate training
or experience to perform such a review. Adequate training may or may
not include training in accordance with proposed Sec. 120.13, but the
individual's training must be sufficient to qualify him or her to make
the public health determinations of this nature. For example, an
individual must have some training to understand that pasteurized juice
must have been processed to reach a minimum time and temperature
combination and know methods of reprocessing to remedy problem
situations. Adequate training in this context requires only knowledge
of how to perform the particular operation responsibility rather than
training in the concepts of HACCP.
Under proposed Sec. 120.10(b)(3), processors must take corrective
action, when necessary, with respect to the affected product to ensure
that no product enters commerce that is either injurious to health or
is otherwise adulterated as a result of the deviation. Under proposed
Sec. 120.10(b)(4) processors must take corrective action, when
necessary, to correct the cause of the deviation. As discussed for
proposed Sec. 120.10(a), the actions called for under these two
provisions are essential to any corrective action plan because they
address one of the two reasons for taking corrective actions, that is,
correcting the problem at hand.
FDA is proposing in Sec. 120.10(b)(5) to require that a trained
person validate the HACCP plan that was in use at the time of the
deviation to determine whether it needs to be modified to reduce the
risk of recurrence of the deviation and to modify the HACCP plan as
necessary. It is critically important that processors learn as much as
possible from the occurrence of a deviation, and that they take the
steps necessary to ensure that such deviation will not be repeated.
Proposed Sec. 120.10(b)(5) reflects these principles.
Finally, proposed Sec. 120.10(c) requires that processors maintain
records of all corrective actions that they take following either the
corrective action procedures in the HACCP plan or those specified in
Sec. 120.10(b). The agency is proposing that these records be subject
to the verification requirements in proposed Sec. 120.11(a) and the
recordkeeping requirements of Sec. 120.12. The records need to reflect
all actions taken in response to a deviation (i.e., provide the
specifics about the actions taken and not simply refer to a written
procedure). Such information helps the processor to determine if there
are recurring problems that it needs to address. The information also
will enable both the processor and the regulator to identify factors
that may help prevent problems in the future.
The agency requests comments on its proposed approach to corrective
actions.
I. Verification and Validation
The seafood HACCP regulation requires that every processor verify
that the HACCP plan is adequate to control food safety hazards that are
reasonably likely to occur, and that the plan is being effectively
implemented (Sec. 123.8(a)). Section 123.8 includes requirements for
reassessment of the HACCP plan and for various other verification
activities, including reviewing monitoring records, reviewing records
of corrective actions, and reviewing calibration records. Section 123.8
also requires, in certain circumstances, that processors who had
concluded that no HACCP plan was necessary reassess that judgment and
reevaluate their HACCP analysis.
The meat and poultry HACCP regulation requires that every
establishment validate the HACCP plan's adequacy in controlling the
food safety hazards identified during the hazard analysis and verify
that the plan is being effectively implemented (9 CFR 417.4(a)).
Section 417.4 includes requirements for initial validation, ongoing
verification activities, reassessment of the HACCP plan, and
reassessment of the hazard analysis for processors that do not need a
HACCP plan.
According to the NACMCF (Ref. 55), there are four aspects to
verification. One is verifying whether the facility's HACCP system is
functioning according to the HACCP plan. Another aspect is the initial
validation of the HACCP plan to determine whether the significant
hazards have been identified, and whether, if the HACCP plan is
properly implemented, these hazards will be effectively controlled. The
third aspect consists of documented validations that are done after the
initial development and implementation of the HACCP plan. The fourth
aspect of verification deals with a periodic verification of the HACCP
system by an unbiased, independent authority.
1. Verification
The agency is proposing in Sec. 120.11(a) to require that every
processor verify that the HACCP system is being implemented according
to design. According to the NACMCF, a functioning HACCP system requires
little end-product sampling because appropriate monitored safeguards
are inherent to the process. Therefore, rather than relying on end-
product sampling, firms need to conduct frequent reviews of their HACCP
plan to verify that it is being correctly followed, to review CCP
records, and to ensure that appropriate risk management decisions and
product dispositions are made when process deviations occur.
Proposed Sec. 120.11(a) sets forth the minimum requirements for
verification activities. Proposed Sec. 120.11(a)(1) deals with ongoing
verification activities. These ongoing activities are in keeping with
the NACMCF's view that verification needs to take the form of
``frequent reviews.'' Frequent reviews relate primarily to whether the
HACCP plan is functioning effectively on a day-to-day basis.
The agency is proposing to require in Sec. 120.11(a)(1)(i) that a
processor review any consumer complaint that it receives to determine
whether the complaint relates to the performance of the HACCP plan or
reveal the existence of unidentified CCP's. Although the absence of
consumer complaints does not, by itself, verify the adequacy of a HACCP
system, those consumer complaints alleging a safety problem that a
processor does receive can be of value as a verification tool and
should be used for that purpose.
Proposed Sec. 120.11(a)(1)(ii) provides for the calibration of
process-monitoring instruments as a verification activity. Calibration
provides assurance that an instrument is measuring correctly.
Calibration is an important activity and involves readily defined
procedures, usually provided by the instrument manufacturer, that can
easily be included in the plan.
Proposed Sec. 120.11(a)(1)(iii) provides that the processor may
perform periodic end-product or in-process testing. FDA acknowledges
the shortcomings of product testing, especially microbiological
testing, as a process control. However, the agency recognizes that many
processors will find that product testing may be included in their
verification activities, and the agency encourages incorporation of
testing into HACCP systems, where appropriate. For example, in cases
where a processor is obtaining fruits and vegetables from unknown
sources, and there is no assurance that pesticides have been correctly
applied, product testing for pesticide residues is an appropriate step
in a HACCP plan.
[[Page 20473]]
Proposed Sec. 120.11(a)(1)(iv) provides for a review by a trained
individual of all records that document monitoring of CCP's, the taking
of corrective actions, the calibration of any process control
instruments, and the performance of any end-product or in-process
testing. As proposed, the review must include signing and dating of the
records. The primary purpose of the record review is the periodic
verification that the HACCP plan is appropriate and is being properly
implemented. This review of these records must occur with sufficient
frequency so as to ensure that any problems in the design and
implementation of the HACCP plan will be promptly uncovered, and that
modifications to the plan or process will be promptly made.
FDA tentatively concludes that a weekly review of HACCP monitoring
and corrective action records (Sec. 120.11(a)(1)(iv)(A) would provide
the industry with the necessary flexibility to handle a highly
perishable commodity like fresh juice without interruption, while still
facilitating timely feedback of information. FDA's experience with low-
acid canned foods and acidified foods has demonstrated that timely
review of these kinds of records is a critical verification tool.
However, this principle need not apply to the review of records of
such verification activities as process control instrument calibration
and product testing. The frequency of these activities will be variable
and dependent upon the HACCP plan. For example, pesticide testing of
fruits and vegetables may only need to be done when the source of the
produce is new or unfamiliar to the firm. Consequently, the agency
tentatively concludes that setting a specific review frequency for
these records is not warranted and thus is only proposing that the
review be conducted within a reasonable time after the records are made
(see proposed Sec. 120.11(a)(iv)(C)).
Proposed Sec. 120.11(a)(1)(v) requires that processors take
appropriate corrective action whenever any verification procedure,
including the review of a consumer complaint, reveals the need to do
so. This proposed provision is essentially a reminder to processors
that information obtained through verification may require a corrective
action.
FDA is proposing in Sec. 120.11(a)(2) that processors document, in
records that are subject to the recordkeeping requirements of
Sec. 120.12, the calibration of process-monitoring instruments and the
performance of any periodic end-product and in-process testing, in
accordance with paragraphs (a)(1)(iv)(B) and (a)(1)(iv)(C). For a
processor's HACCP controls to work, the instruments and equipment that
it relies upon in monitoring CCP's, such as thermometers, temperature-
recording devices, and computer software, must be accurate and
reliable. FDA has tentatively concluded that the best way to ensure
such accuracy and reliability for juice is to require that the
processor's monitoring procedures include steps necessary to verify the
reliability of these instruments and devices. The proposed requirement
that records of end-product testing be kept is consistent with the
general recordkeeping principles of HACCP.
The agency requests comment on its proposed verification procedures
for juice.
2. Validation of the HACCP Plan
The agency is proposing, in Sec. 120.11(b) to require that juice
processors validate that their HACCP plan is adequate to control the
food hazards that are reasonably likely to occur in their products;
this validation is required at least once during the year after
implementation and at least annually thereafter or whenever any changes
occur that could affect the hazard analysis or alter the HACCP plan and
prerequisite program SOP's in any significant way. The proposed
requirement that HACCP plan validation be conducted at least once
during the year after implementation is based on a recommendation from
the NACMCF (Ref. 55). This process consists of reviewing the CL's to
verify that the limits at CCP's are adequate to control the hazards
that are likely to occur.
The proposed requirement that the HACCP plan be validated at least
annually, or whenever any relevant changes occur, is based on the
NACMCF view that validation must occur on a regular basis (Ref. 55),
although the NACMCF does not specify timeframes. Validation should be
conducted on a regular basis, even in the absence of a recognized
change, to ensure that the plan continues to address all of the
reasonably likely food hazards with appropriate control limits and
monitoring procedures. Processors should conduct the review at
intervals that are appropriate for their processes, although FDA is
proposing to require that this interval not exceed 1 year.
Proposed Sec. 120.11(b) provides examples of changes that could
trigger a validation. These include changes in raw materials or source
of raw materials; product formulation; processing methods or systems,
including computers and their software; packaging; finished product
distribution systems; or the intended use or consumers of the finished
product. These examples are derived from the NACMCF materials on the
``five preliminary steps'' that form the basis for the HACCP plan (Ref.
55). A change in any of these areas could necessitate a change in the
plan to respond to any new hazards that may have been introduced or to
maintain preventive control over existing ones. It is important to
recognize that this list is not all inclusive.
Proposed Sec. 120.11(b) requires that the plan validation be
performed by an individual or individuals who have been trained in
accordance with Sec. 120.13. The validation is fundamental in
determining whether the HACCP plan is adequate to control food hazards
that are reasonably likely to occur. HACCP plan validation may result
in a need to alter other aspects of the HACCP system and the
prerequisite program SOP's. The activities involved in plan validation
are not routine activities but require an understanding of the
principles of HACCP and of plan development. This understanding is
obtained through training.
Initial validation of the HACCP plan is necessary to ensure that
all significant hazards have been identified, and that, if the HACCP
plan is properly implemented, these hazards will be effectively
controlled. Subsequent validation of the HACCP plan ensures that the
plan continues to be effective.
Validation is especially important whenever any changes occur that
could affect the hazard analysis or alter the HACCP plan and
prerequisite program SOP's in any way. Without these assessments and
subsequent changes, the HACCP plan may not control the hazards that it
should, and unsafe juice may be distributed. Therefore, the agency
tentatively concludes that validation of the HACCP plan is necessary to
ensure that juice processed in accordance with the plan will not have
been processed under conditions whereby it may have been rendered
injurious to health.
The NACMCF states that the HACCP plan should be updated and revised
as needed (Ref. 55). Changes in sources of incoming materials,
formulations, processing, distribution, and consumer use usually occur
over time. New technologies may be developed. New concerns that
previously were not considered hazards reasonably likely to occur may
become apparent. For example, E. coli O157:H7 was not recognized as a
human pathogen before 1982 (Ref. 10), and the impact of its acid
tolerance was not well understood.
[[Page 20474]]
Therefore, the agency tentatively concludes that processors must
maintain records demonstrating that they have been diligent in keeping
their HACCP plans current. Thus, FDA is proposing to require in
Sec. 120.11(b) that records of the plan validation be subject to the
requirements of Sec. 120.12.
Proposed Sec. 120.11(b) also requires that, where validation shows
that the HACCP plan is inadequate, the processor modify immediately the
plan. Failure of a processor to modify immediately its HACCP plan after
the processor has determined that the plan is inadequate would result
in the processor operating under insanitary conditions that may render
the food prepared under the inadequate plan injurious to health and
thus would render the food adulterated.
FDA requests comments on its proposed approach to validation of
HACCP plans for juice.
3. Validation of the Hazard Analysis
Proposed Sec. 120.11(c) requires that, whenever a juice processor
has no HACCP plan because a hazard analysis has revealed no food
hazards that are reasonably likely to occur, the processor reassess the
adequacy of that hazard analysis whenever there are any changes that
could reasonably affect whether a food hazard exists. FDA has proposed
to include examples of such changes in Sec. 120.11(c). The list is
identical to that proposed in Sec. 120.11(b), on when a plan must be
validated. Any change in these factors could warrant a validation to be
certain that a plan is still not needed because, as stated in the
discussion of proposed Sec. 120.11(b), such changes could introduce new
hazards.
FDA has tentatively concluded that, under a mandatory HACCP system
for juice, the principle of validation applies equally to a decision
that a HACCP plan is not necessary as it does to a decision that the
plan is adequate. Circumstances change, and processors must be alert to
whether factors that effectively exempt them from the requirement to
have a plan continue to apply.
The agency is proposing in Sec. 120.11(c) that the validation be
performed by an individual or individuals who have been trained in
accordance with proposed Sec. 120.13. The validation is fundamental in
determining whether the hazard analysis considers all food hazards that
are reasonably likely to occur. The hazard analysis validation may
result in a need to alter other aspects of the HACCP system and the
prerequisite program SOP's. These kinds of activities are not routine
but require an understanding of the principles of HACCP that is
obtained through appropriate training.
The agency requests comment on its proposed approach to validation
requirements of a hazard analysis in the absence of a HACCP plan.
J. Records
Implementing a HACCP program involves engaging in adequate
monitoring of CCP's and documenting the results of that monitoring
through records. It also involves the taking of appropriate corrective
actions in response to any deviations and, again, documenting the
results. HACCP records also include the hazard analysis, the HACCP plan
itself, and documentation of verification and validation activities.
Records of prerequisite program SOP's, although not a part of the HACCP
system, are significant records in a HACCP program in that the SOP's
may be used in place of HACCP controls. Record systems used by the
pilot firms in FDA's pilot program included hand written logs, filing
systems for continuous recording charts and inspection sheets, and
computer files of data of monitoring results and followup corrective
actions.
In Sec. 123.9 of the seafood regulation, FDA established
requirements for HACCP records. Under this provision, all required
records must include: (1) The name and location of the processor or
importer; (2) the date and time of the activity that the record
reflects; (3) the signature or initials of the person performing the
operation; and (4) where appropriate, the identity of the product and
the production code, if any. Processing and other information must be
entered on records at the time that it is observed (Sec. 123.9(a)(4)).
Records must be retained for at least 1 year for refrigerated foods and
for at least 2 years for all other foods, similarly, records relating
to the general adequacy of equipment or processes being used by a
processor must be retained for 2 years (Sec. 123.9(b)). Off site
provisions for storage of records from processing facilities that
seasonally pack are allowed, provided that the records are reasonably
accessible (Sec. 123.9(b)(3)). All records must be available for
official review (Sec. 123.9(c)). Section 123.9 also provides
information concerning public disclosure of records and maintenance of
records on computers.
According to the NACMCF, maintenance of appropriate records is
fundamental to the success of a HACCP system (Ref. 55). In recognition
of this fact, FDA is proposing to require in Sec. 120.12 that specific
records be kept; that HACCP records contain certain necessary
information; that records be maintained for specific periods of time;
and that records be available for FDA review.
The agency is proposing in Sec. 120.12(a) to list the records that
the processor is required to maintain to document its HACCP system. FDA
has discussed the basis for requiring that these records be kept in the
sections addressing each particular provision. The proposed sections
also state that records shall be maintained. The list of records that
juice processors are required to maintain is included in
Sec. 120.12(a), although this list is included simply for simplicity,
in that the list reflects the record requirements that are set out in
other sections of the proposed regulation.
Proposed Sec. 120.12(b) describes the general requirements for
records. The purpose of the proposed requirements in this provision is
to ensure that records maintained under part 120 can be readily linked
to a product and to the timeframe in which the product was
manufactured. Linking a record to a specific product will be especially
important when there has been a deviation at a CCP and will enable
processors to isolate product that has not been processed properly,
thereby preventing the product from reaching consumers. These records
will also benefit processors in that only those lots that were
processed inadequately will need to be recalled or isolated. The agency
has tentatively concluded that including the name and location of the
processor or importer; the date and time of the activity that the
record reflects; the signature or initials of the person performing the
operation or creating the record; and, where appropriate, the identity
of the product and the production code, if any, are the minimum
information necessary to enable the processor to determine what product
may have been affected by a deviation and to take any appropriate
actions with respect to that product.
Proposed Sec. 120.12(b)(3) requires that the record include the
signature or initials of the person performing the operation or
creating the record. Requiring that the record be signed by the
individual who made the observation will ensure responsibility and
accountability. Also, if there is a question about the record, a
signature ensures that the source of the record will be known.
Proposed Sec. 120.12(b)(4) requires that processing and other
information be entered on records at the time that it is observed and
that the records contain the actual values and observations obtained
during monitoring. It is important that information relating to
observations be recorded immediately
[[Page 20475]]
and that the records contain the actual values and observations to
enhance accuracy.
Both the HACCP regulations for seafood and for meat and poultry
require that the HACCP plan be signed and dated. In the seafood final
rule (60 FR 65096 at 65124), FDA emphasized the importance of signing
and dating the HACCP plan. The agency stated that:
Such a signature would provide direct evidence of management's
acceptance of the plan for implementation. FDA cannot stress enough
that for HACCP to succeed, there must be a clear commitment to it
from the top of the firm on down. Management must set a strong
example in this regard. A signature requirement will remind
management of this important responsibility and will signal to all
employees that the firm regards the HACCP plan as a document to be
taken seriously. Additionally, the representative's signature, along
with the date of signing, would serve to minimize potential
confusion over the authenticity of any differing versions or
editions of the document that might exist.
The agency tentatively concludes that this same reasoning applies
to HACCP plans for juice processing, and that there are significant
benefits of requiring similar steps for the HACCP plan for juice.
The agency is also proposing to require that the hazard analysis
for juice be written (see proposed Sec. 120.7). FDA tentatively
concludes that the hazard analysis shall be signed and dated in a
manner similar to what is required for the HACCP plan because of its
relationship to and importance in the development of an adequate HACCP
plan.
Therefore, the agency is proposing to require in Sec. 120.12(c)(1)
that the hazard analysis and the HACCP plan be signed and dated by the
most responsible individual on-site at the processing facility or by a
higher level official of the processor. Proposed Sec. 120.12(c)(1)
provides that the signatures signify that these records have been
accepted for incorporation into the HACCP system by the firm.
In Sec. 120.12(c)(2)(i) through (c)(2)(iii), FDA is proposing to
require that the hazard analysis and the HACCP plan be dated and signed
upon initial acceptance, upon any modification, and upon verification
and validation of the plan in accordance with proposed
Sec. 120.11(d)(1). As was discussed fully in the ``Verification and
Validation'' section of this preamble, FDA is proposing in Sec. 120.11
that the adequacy of the HACCP plan, or, in the absence of a HACCP
plan, the hazard analysis, be validated at least once during the year
after implementation and at least annually thereafter or whenever any
changes occur that could affect the hazard analysis or that could alter
the HACCP plan and prerequisite program SOP's in any way. These
verifications, validations, and modifications are necessary to ensure
that the HACCP program remains current, and that it is responsive to
emerging problems. The signature of the firm representative will
document that these validations and modifications are performed as
required. The requirements for documentation are the same as those
required for the HACCP plan in the seafood regulation (Sec. 123.6(d)).
The agency is proposing in Sec. 120.12(d) requirements for record
retention. Proposed Sec. 120.12(d)(1) states that, in the case of
perishable or refrigerated products, all required records shall be
retained at the processing facility or importer's place of business in
the United States for at least 1 year after the date that they were
prepared and in the case of frozen, preserved, or shelf-stable
products, 2 years after the date that they were prepared. These
timeframes are based on the length of time that these products can be
expected to be in commercial distribution plus a reasonable time
thereafter to ensure that the records are available for the processor's
and FDA's verification activities.
FDA is proposing in Sec. 120.12(d)(2) that records that relate to
the general adequacy of equipment or processes being used by a
processor, including the results of scientific studies and evaluations,
be retained at the processing facility or the importer's place of
business in the United States for at least 2 years after the date that
the processor last used that equipment or process. Under
Sec. 120.12(a)(5) processors are required to maintain records
documenting validation of the HACCP plan. If the firm is relying on
equipment or processes to control hazards that are reasonably likely to
occur then the firm must have some assurance that the equipment or
process is adequate for that purpose. Should FDA adopt proposed
Sec. 120.12(d)(2), a written certification from the equipment
manufacturer will likely generally be sufficient to establish equipment
adequacy. However, the processor may need to obtain a written
scientific evaluation of a process, especially in cases where two or
more treatments are used to accomplish a 5 log reduction in the target
pathogen, to ensure that the process is adequate to destroy
microorganisms of public health significance or to prevent their
growth. Such an evaluation may also be necessary to ensure the adequacy
of the pasteurization or refrigerating equipment that the processor is
using. As with processing records, these records are required to be
retained for a period of time that reflects the period that the
products to which they relate can be expected to be in commercial
distribution.
The agency realizes that under the proposed requirements for
recordkeeping, some juice processors may be required to store a
significant quantity of records, and that there may not be adequate
storage space in the processing facility for all of these records.
However, if HACCP is to work, these records must be available for the
processor's verification activities and for FDA inspections. Therefore,
the agency is proposing to provide some relief to processors in
Sec. 120.12(d)(3), which allows for off-site storage of the
prerequisite program SOP records and records documenting the ongoing
application of the HACCP plan (i.e., monitoring of CCP's and their CL's
and corrective actions) 6 months after the date that the monitoring
occurred, if such records can be retrieved and provided on-site within
24 hours of request for official review. The records for which FDA is
proposing to allow off-site storage are the more routine processing
operation records and thus are of the type that are likely to be
generated in the greatest numbers. FDA tentatively concludes that the
proposed relief will benefit processors but will not interfere with the
purpose for record retention because the records will be readily
available.
The use of computers in the food processing industry is increasing.
Computerized systems within large corporations can be networked,
allowing for the sending and receiving of information in a secure
fashion to all of the different food processing facilities of that
corporation worldwide. This type of system can easily be used to
maintain all of the processing records from each of the processing
facilities at corporate headquarters. Therefore, for clarity, FDA is
proposing in Sec. 120.12(d)(3) that electronic records are considered
to be on-site if they are accessible from an on-site location and
comply with proposed Sec. 120.12(g).
FDA recognizes that some juice processing plants may be closed on a
seasonal basis. Given the nature of the HACCP system, however, FDA may
choose to inspect at least the records of a plant even if the plant is
not in operation. Therefore, FDA is providing in proposed
Sec. 120.12(d)(4) that, if the processing facility is closed for a
prolonged period between seasonal packs, the records may be transferred
to some other reasonably accessible
[[Page 20476]]
location at the end of the seasonal pack but shall be immediately
returned for official review upon request. This proposed provision will
give the juice processor some relief, yet will serve to ensure that the
records in question will be readily available.
Proposed Sec. 120.12(e) requires that all records required under
part 120 be available for official review and copying at reasonable
times. The agency's access to HACCP records is essential to ensure that
the HACCP system is working, and that the safety of juice is being
ensured by design. FDA's authority to require maintenance of these
records, and to provide for agency access to them, was fully discussed
in the rulemaking on seafood HACCP (60 FR 65096 at 65139). The
importance of the records in ensuring that juice will not be rendered
injurious to health has been fully discussed. FDA access to these
records will expedite the agency's efforts to ensure that the juice
products in interstate commerce are not adulterated and to identify any
such products that are. The agency points out that the proposed
language in Sec. 120.12(e) is intended to be flexible enough to cover
State officials if their agency adopts any final regulation by
reference.
Proposed Sec. 120.12(f) sets forth information concerning public
disclosure of processing records. The agency concluded in the seafood
final rule (60 FR 65096 at 65139):
that records and plans should be protected to the extent
possible in order to promote the implementation of HACCP across the
seafood industry. FDA has concluded that the public will benefit
from the protection of records because it will actually strengthen
the HACCP system. So long as the legitimate public need to be able
to evaluate the system can be met through other means, the
confidentiality of HACCP records and plans generally will foster the
industry's acceptance of HACCP. Even though HACCP may be mandatory
under these regulations, in order for it to succeed, processors must
be committed to it because they see value in it for themselves. Fear
of public disclosure of matters that have long been regarded as
confidential business matters could significantly undermine that
commitment. FDA concludes, therefore, that it is in the public
interest to foster tailored HACCP plans that demonstrate
understanding and thought, rather than promote the use of rote plans
and minimally acceptable standards due to fear of public disclosure.
FDA understands that it cannot make promises of confidentiality
that exceed the permissible boundaries established under the Freedom
of Information Act, nor does the agency wish to do so in this case.
The agency still does not expect that it will be in possession of a
large volume of plans and records at any given moment. However,
given the significant interest in this subject as conveyed by the
comments, FDA has concluded that the final regulations should
reflect the fact that the HACCP plans and records that do come into
FDA's possession will generally meet the definition of either trade
secret or commercial confidential materials.
The agency is not aware of any circumstances that would warrant
different conditions for public disclosure for records for juice HACCP
than those required for seafood HACCP. Therefore, FDA is proposing the
same provisions for Sec. 120.12(f) as are found in Sec. 123.9(d).
In the Federal Register of March 20, 1997 (62 FR 13430), FDA issued
regulations at part 11 (21 CFR part 11) that provide criteria for
acceptance by FDA, under certain circumstances, of electronic records,
electronic signatures, and handwritten signatures executed to
electronic records as equivalent to paper records and handwritten
signatures executed on paper. Proposed Sec. 120.12(g) allows for the
maintenance of records on computers in accordance with part 11. This
provision simply makes clear the fact that records can be maintained on
computers.
The agency requests comments on its proposed approach to
recordkeeping for juice processors.
K. Training
In Sec. 123.10 of the seafood HACCP regulation, FDA required that
certain functions relating to the operation of a HACCP system be
conducted by an individual who has successfully completed training in
the application of HACCP principles to fish and fishery product
processing that is at least equivalent to that received under a
standardized curriculum recognized as adequate by FDA. Job experience
that has provided equivalent knowledge is also acceptable. The trained
individual need not be an employee of the company.
Training is essential to the effective implementation of a HACCP
system for juice. Only a trained individual is capable of effectively
executing certain activities, such as identifying appropriate CCP's,
how to establish CL's, control measures, corrective actions, and
recordkeeping procedures. The often seasonal nature, remote location,
and small size of many juice processors also support the need for
formalized training.
However, these conditions also create difficulty recruiting highly
qualified management and supervisory staff. Given these factors,
particularly in light of what FDA learned in its pilot program, the
agency is concerned that a significant portion of the juice industry
will be unprepared to meet the requirements of a mandatory HACCP
program without some training (Ref. 59).
Therefore, FDA is proposing in Sec. 120.13(a) that only an
individual who has met specified training requirements can be
responsible for certain functions. Those functions are listed in
proposed Sec. 120.13(a)(1) through (a)(4). FDA has discussed the basis
for requiring that a trained individual perform these functions in the
sections addressing each particular proposed provision. The agency is
listing the functions that shall be performed by a trained individual
in Sec. 120.13(a) for simplicity and is not imposing any additional
requirement through this list.
Proposed Sec. 120.13(b) requires that the individual performing the
functions listed in proposed Sec. 120.13(a) have successfully completed
training in the application of HACCP principles to food processing. The
agency anticipates that 2- or 3-day training sessions, modeled after
the Better Process Control Schools currently in place for low acid
canned food and acidified food manufacturers, will be provided by
various private organizations and through academia. FDA does not intend
to run HACCP-training courses for the industry.
FDA has been extensively involved with a consortium called the
``Seafood HACCP Alliance'' (the Alliance) consisting of representatives
from Federal and State agencies, industry, and academia, who have
worked to create a uniform, core training program that will meet the
requirements of the seafood HACCP regulations and that will cost very
little. The training program that has been developed by the Alliance is
based on the recommendations of the NACMCF. The core curriculum for the
course consists of basic HACCP principles that are applicable to any
food and, thus, are also applicable to juice. It is the agency's intent
to utilize the Alliance materials, as applicable, as the standard
against which other course materials may be judged. Therefore, the
agency is proposing in Sec. 120.13(b) that the training be at least
equivalent to that received under standardized curriculum recognized as
adequate by FDA.
FDA is also proposing in Sec. 120.13(b) that job experience may
qualify an individual to perform these functions if such experience has
provided knowledge at least equivalent to that provided through the
standardized curriculum. FDA acknowledges that a short course in HACCP
has its limitations. For example, a 3-day course might not have
anything important to offer to an individual who has had significant
job experience working with or for an individual who is well-versed
[[Page 20477]]
in HACCP. Where a job experience has imparted a level of knowledge at
least equivalent to that that could be provided by short course
training, that individual would qualify as a trained individual. FDA
requests comments on how processors will be able to determine whether
job experience has provided the individual with the specific knowledge
and expertise to develop and implement a HACCP program.
FDA is proposing to provide in Sec. 120.13(b) that the trained
individual need not be an employee of the processor. Processors may
utilize consultants or other trained individuals to perform these
functions if they so choose.
L. Application of Requirements to Imported Products
The seafood HACCP regulation sets forth requirements for importers
of fish and fishery products in Sec. 123.12. According to
Sec. 123.12(a), the importer must either: (1) Obtain fish or fishery
products from a country that has an active memorandum of understanding
or similar agreement with FDA that documents the equivalency or
compliance of the inspection system of the foreign country with the
U.S. system relative to the products being imported, or (2) have and
implement written verification procedures, as described in the
regulation, for ensuring that the products being imported were
processed in accordance with the requirements of part 123. If the
importer must engage in affirmative verification steps, records of the
taking of these steps must be made in English and be on file with the
importer, and available for inspection by FDA (Sec. 123.12(c)). In the
absence of assurances that the imported fish or fishery product has
been processed under conditions that are equivalent to those required
of domestic processors, the product will appear to be adulterated under
section 402(a)(4) of the act, and FDA will deny the product entry
(Sec. 123.12(d)) under section 801(a) of the act (21 U.S.C. 381(a)).
Many types of juice are imported into the United States. FDA's
inspection system for imports consists largely of reviewing the customs
entries for products being offered for entry into the United States,
engaging in wharf examinations and sample collections for laboratory
analysis, and automatically detaining products with a history of
problems (e.g., tamarind and tamarind products, including juice and
juice concentrate). The same problems that are present in domestically
produced juice can be present in imported juice and may not be apparent
from the import review currently conducted by FDA. Consequently, the
agency tentatively concludes that HACCP controls for juice should apply
to imported products as well as to domestic products.
FDA also tentatively concludes that the importer should share
responsibility with the foreign processor for safety. More often than
not, it is the U.S. importer, rather than the foreign processor, who
actually offers imported juice for entry into the United States. While
many importers are conscientious about the safety of the products that
they import, others have little understanding of the potential hazards
associated with their products.
In the rulemaking process for seafood HACCP, the agency considered
many options for compliance with HACCP requirements and carefully
crafted the final regulation to incorporate a number of them. These
options provide great flexibility for importers to achieve compliance
and thus, would appear to be suitable for a wide variety of foods. FDA
tentatively concludes that importer requirements for fish and fishery
products in Sec. 123.12 are appropriate for and applicable to juice,
and is proposing the same requirements in Sec. 120.14 because the
agency is not aware of any circumstances that would necessitate any
differences in treatment between juice imports and seafood imports.
Thus, while the agency has made some minor editorial revisions for
clarity, proposed Sec. 120.14 essentially tracks Sec. 123.12. FDA
requests comments on the proposed import requirements for juice.
M. Pathogen Reduction
As discussed previously, one of the NACMCF's recommendations to FDA
was the use of safety performance criteria instead of mandating the use
of a specific intervention technology (Ref. 53). Performance standards
set forth requirements in terms of what is to be achieved by a given
regulatory requirement, and represent a shift in focus from ``command-
and-control'' regulations because they specify the ends to be achieved
(producing safe juice products), not the means to achieve those ends.
The NACMCF suggested that a tolerable level of risk would be
achieved by requiring interventions that have been validated to achieve
a cumulative 5 log reduction in the target pathogen or a reduction in
yearly risk of illness to less than 10-5, assuming
consumption of 100 ml of juice daily. In addition, the NACMCF stated
that HACCP and safety performance criteria should form the general
conceptual framework needed to ensure the safety of juices, and that
control measures should be based on a thorough hazard analysis. The
NACMCF stated that validation of the process must be an integral part
of this framework.
Based on the evidence of microbial outbreaks discussed in section
I.A of this document, FDA tentatively concludes that processors must
establish controls for pathogen reduction in juice. The requirements of
parts 113 and 114 mandate a process that exceeds the proposed
provision, and, therefore, it is not necessary to require that juices
subject to part 113 or 114 meet the 5 log reduction requirement in
proposed Sec. 120.24.
FDA is proposing to require in part 120, subpart B, that juice
processors, except those subject to the requirements of part 113 or
114, include in their HACCP plans control measures that are known, or
can be shown, to produce, at a minimum, a 5 log (i.e., 105)
reduction in the most resistant microorganism of public health
significance that is likely to occur in the juice for at least as long
as the shelf life of the product under normal and moderate abuse
conditions. The agency requests comment on the appropriateness of the 5
log reduction performance standard and if other approaches, such as
establishing a minimal acceptable risk standard for juices, could be
used that would ensure the safety of the juice. The agency requests
comments on what such a minimal acceptable risk standard should be and
how it would be implemented. The agency also invites interested persons
to submit scientific data concerning the acceptability of a 5 log
reduction requirement or whether a more or less stringent performance
standard (e.g., 3 or 7 log reduction) for specific juices would be more
appropriate or whether different approaches consistent with a minimal
acceptable risk standard for juices might be appropriate for specific
juices based on their unique characteristics.
In the absence of known specific pathogen-product associations, the
NACMCF recommended the use of E. coli O157:H7 or L. monocytogenes as
the target organism, as appropriate. This recommendation is based on
the number of known outbreaks of E.coli in juice as described in
section I.A of this document and the ubiquitous nature of L.
monocytogenes. E. coli is known to be unusually acid resistant (Refs.
60 and 61), and L. monocytogenes is relatively heat resistant (Refs. 62
and 63). Therefore, depending on the type of juice, one of the two
NACMCF recommended target organisms will likely be the most resistant
microorganism of public health
[[Page 20478]]
significance. In controlling the target microorganism, other pathogenic
organisms will likely also be controlled.
However, because FDA is proposing a performance standard for
pathogen reduction in lieu of a time/temperature requirement and is
providing for a cumulative pathogen reduction process, the agency
recognizes that other microorganisms may be more appropriate targets
for juice processing. For example, control measures other than
pasteurization may be more effective for reducing E. coli O157:H7 and
less effective for another pathogen, and, thus, the most resistant
pathogen under the circumstances must be the target pathogen.
Pasteurization is one process that will achieve the 5 log reduction
performance standard. However, other interventions (e.g., surface
treatments) may be adequate for some types of produce (e.g., citrus
fruits). As discussed previously in section I.E of this document, the
NACMCF concluded that: (1) The history of public health problems
associated with fresh juices indicates a need for active safety
interventions; and (2) for some fruit (e.g., oranges), the need for
intervention may be limited to surface treatment, but for others,
additional interventions may be required (e.g., pasteurization of the
juice). Pathogens are not reasonably likely to be present in the
interior of sound whole oranges or other citrus fruits. In addition,
the acidic nature of citrus fruits may further inactivate any pathogens
that may be present. Therefore, any contamination being introduced into
the juice will come from the surface of the fruit or the food contact
surfaces of the equipment.
There are two possible means by which contamination on the surface
of the fruit can be introduced into the juice. First, the skin of the
fruit can be damaged allowing any pathogens present to migrate inside
the orange. An appropriate HACCP program can control this means of
contamination through grading and culling. This step may be the first
CCP in a HACCP plan for fresh orange juice production with a critical
limit of zero defectives.
Secondly, contamination on the surface of the skin can be
introduced from cutting into the orange to extract the juice. This
source may be controlled by washing, brushing, and sanitizing the fruit
prior to cutting. This step may be a CCP in the processing of fresh
orange juice with processors establishing critical limits for the
associated parameters (e.g., temperature of water, type and strength of
sanitizers, effectiveness of equipment).
Proper implementation of these two CCP's (i.e., zero defects and
washing, brushing, and sanitizing the fruit) could potentially achieve
a three log reduction in microorganisms (Ref. 64). However, as
proposed, processors must validate that such a reduction in the target
pathogen is occurring.
In addition to the two CCP's, processors must implement CGMP's
(proposed Sec. 120.5) and sanitation SOP's (proposed Sec. 120.6) to
ensure that the working area and equipment are clean. The most
important step is sanitation of the extraction equipment which may
harbor yeasts, molds, and acid tolerant bacteria (Ref. 65). The 1995
outbreak of Salmonella hartford associated with fresh orange juice was
most likely related to poor CGMP's (Ref. 9). However, CGMP's and
sanitation SOP's alone are not sufficient to ensure a 5 log reduction.
Extraction of orange juice and other citrus juices is generally
done by either a machine which scores and cores the fruit before
squeezing or by cutting the fruit in half and reaming out each side. In
the first instance, the only part of the peel which is exposed to the
fruit is the cut core. In the second instance, the edge of the knife
will make contact with the peel and could potentially contaminate the
fruit through the first half of the cut (in the second half of the cut,
the knife leaves the fruit after making contact with the peel). If most
of the surface of the skin of the orange does not contact the interior
(juice) during extraction and the peel is discarded, such an extraction
technique may be considered a CCP contributing towards the reduction of
the potential pathogenic load.
For purposes of illustration, FDA has simplified some of the
extraction methods in order to calculate the possible log reduction in
pathogens that might occur from different methods of extraction. In the
``coring'' extraction method, using an example of an orange that is 4
inches in diameter with a \1/2\ inch core cut, there could potentially
be a 2 log reduction by only allowing contact with the surface area
contained by a \1/2\-inch circle of the outside of the peel. That is, a
4-inch orange has about 50 square inches of peel and a \1/2\-inch
circle contains an area of 0.78 inches so that only 1.6 percent (.78/
50) of the outside would be potentially in contact with the inner part
of the orange. However, FDA points out that under proposed part 120,
processors must be able to validate that the reduction in the target
pathogen is occurring.
In the cutting method of extraction, there would also be a
considerable reduction in the amount of potentially contaminated
produce discarded. If, for example the knives used were 0.01 inch
thick, the area of the exterior part of the orange that would make
contact with the interior would be the top half of the circumference of
the orange multiplied by the width of the knife, or about 0.06 square
inches with a 4-inch (diameter) orange. Thus, the reduction of
pathogens could be approximately 3 log (0.06/50) just by discarding the
orange peel. Again, under proposed part 120, processors must be able to
validate that this reduction is occurring in the target pathogen.
Thus, it may be feasible that a processor use a combination of
CGMP's, sanitation SOP's, and at least the three CCP's discussed
previously ((1) Culling and grading; (2) washing, brushing, and
sanitizing; and (3) appropriate methods of extraction) and achieve a 5
log reduction in a target pathogen for orange juice. If so, it is
unlikely that processors of fresh orange juice, and perhaps other fresh
citrus fruit juices, will have to implement pasteurization in order to
achieve a 5 log reduction in pathogenic bacteria. In addition, FDA
anticipates that manufacturers of other juices, such as apple juice,
may be able to use other technologies and practices in lieu of
pasteurization (such as a combination of eliminating use of drops,
brushing, washing, and using sanitizers) provided that the process is
validated to achieve the 5 log reduction in the target pathogen.
However, the agency points out that under the proposed rule, processors
must establish CL's for each CCP, monitor CL's to ensure compliance,
conduct verification and validation procedures, and maintain records of
these actions. In addition, the 5 log reduction must be of a target
organism.
Each type of control measure used in a cumulative process
introduces a unique variable in attaining the overall target of
pathogen reduction. The physical parameters of the juice and how the
product will be handled after it leaves the processing plant, and
before it is consumed, must be considered in the selection of the
target organism. Processors must take into consideration time,
temperature, pH, and Brix parameters and other matters for juice
products in order to provide adequate pathogen control. Time,
temperature, juice pH, and Brix directly affect the rate of growth and
the types of microorganisms.
The proposed 5 log reduction standard of proposed Sec. 120.24
requires that this reduction be achieved and persist for at least the
shelf life of the product when the product is stored under normal and
moderate abuse
[[Page 20479]]
conditions. Normal handling of juice includes the movement of the juice
from the plant to retail (e.g., transportation, warehouse storage) and
consumer handling after purchase (e.g., transport home, setting out on
a counter or table). Moderate abuse may occur when unusual
circumstances arise during regular handling. For example, unloading a
truck on a hot day where the product may sit on a loading dock for a
short period of time could constitute moderate abuse. In addition,
moderate abuse could occur if consumers purchase a product on a warm
day, place it in their car, and run errands before refrigerating the
product. In FDA's view, moderate abuse does not include exposure to
high temperatures for extended periods of time.
The proposed requirement mandates that processors validate that the
control measures are both appropriate to their operation and
scientifically sound. In many cases, processors may rely on a written
certification from the equipment manufacturer or may obtain a written
scientific evaluation of a process, especially in cases where two or
more control measures are used to accomplish the 5 log reduction in the
target pathogen, to ensure that the process is adequate to destroy
microorganisms of public health significance or to prevent their
growth. Such an evaluation may also be necessary to ensure the adequacy
of the pasteurization or refrigerating equipment used by the processor.
Comments on the notice of intent (62 FR 45593, August 28, 1997)
addressed the issue of pathogen reduction. One comment stated that a 2
1/2 log reduction in fruit surface microflora from washing was
adequate. Some comments asked from what point the 5 log reduction would
be measured (e.g., washing of produce).
FDA tentatively concludes that the cumulative 5 log reduction could
be measured from the point of the processors' initial treatment of the
intact fruit or vegetable. If pathogens are meaningfully reduced on the
raw produce through washing or other treatment, and the product is
processed under an adequate HACCP program, the hazard from the presence
of pathogens may be controlled. However, this control measure may not
be adequate or appropriate for all types of produce because of
differences in surfaces, areas that are difficult to clean, inclusion
of peel or outer layer in the juice, and tissue fragility.
The agency requests comments on its approach to pathogen reduction.
In particular, the agency requests comments on whether all juices
should be subject to proposed Sec. 120.24, or whether such a
requirement may not be necessary for certain juices or types of juices.
FDA also requests comments on whether a 5 log reduction is appropriate
for all juices, or whether a higher or lower requirement would be
adequate for some types of juice.
V. The Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collections are shown below with an
estimate of the annual recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of the agency's estimate of the burden of the proposed
collection of information including the validity of methodology and
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on respondents, including through the
use of automated collection techniques when appropriate or other forms
of information technology.
Title: Hazard Analysis and Critical Control Point (HACCP) Systems--
Reporting and recordkeeping requirements for processors of fruit and
vegetable juices under the provisions of 21 CFR part 120.
Description: Section 402(a)(1) (21 U.S.C. 342(a)(1)) of the Federal
Food, Drug, and Cosmetic Act (the act) states that a food shall be
deemed to be adulterated if it bears or contains any poisonous or
deleterious substance which may render it injurious to health. Section
402(a)(4) (21 U.S.C. 342(a)(4)) of the act states that a food shall be
deemed to be adulterated if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. The
proposed regulation set forth in this proposed rule would require
processors to use Hazard Analysis and Critical Control Point (HACCP)
methodology to ensure that fruit and vegetable juices are safe under
the act. HACCP is a preventive system of hazard control.
Description of Respondents: Businesses or other for profit
organizations.
Table 1.--Estimated Annual Recordkeeping Burden
21 CFR No. of Annual Hours per
Sections Recordkeepers Frequency Recordkeeper Total Hours
120.6(c) 600 1\2\ 4 4,800\2\
120.12(a
)(1)
and
(a)(2),
120.6(c
)-(d),
and
120.12(
a)(5) 600 1 2 1,200
120.7
and
120.12(
a)(2)
and
(c)(1) 600 1\2\ 8 4,800\2\
120.8(a)
and
120.12(
a)(3)
and (c) 600 1\2\ 8 4,800\2\
120.8(b)
(7) and
120.12(
a)(4)(i
) 600 14,600 0.01 87,600
120.11(b
) and
120.12(
a)(5) 600 1 4 2,400
120.11(a
)(1)(iv
) 600 52 0.1 3,120
120.10(c
) and
120.12(
a)(4)(i
i) 600 12 0.1 720
120.14(a
)(2) 308 1 4 1,232
120.12(e
) 182\3\ 1 4 728
------------------------------------------------------------------------
Totals:
First year 111,400
Subsequent years 97,000
------------------------------------------------------------------------
[[Page 20480]]
There are no operating and maintenance cost or capital costs associated
with this collection of information.
2 First year only.
3 Assuming that producers and importers are subject to official review
on a 5-year cycle.
The burden for these activities will vary considerably among
processors and importers of juice and juice products, depending on the
type and number of products involved, and the nature of the equipment
or instruments required to monitor critical control points. The burdens
have been estimated based on the estimated average annual information
collection burden for seafood HACCP (60 FR 65096 at 65178; December 18,
1995). As noted in the preliminary regulatory impact analysis for this
proposal, FDA estimates that there are at least 600 firms producing
juice products of the type affected by this proposed rulemaking.
In compliance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection provisions of this proposed rule to OMB for review.
Interested persons are requested to submit comments regarding
information collection by May 26, 1998, to the OMB (address above),
Attention: Desk Officer for FDA.
VI. Environmental Impact
The agency has determined under 21 CFR 25.30(j) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Analysis of Impacts
A. Preliminary Regulatory Impact Analysis
In accordance with Executive Order 12886, FDA has developed a
single preliminary regulatory impact analysis (PRIA) that estimates
benefits and costs associated with both this HACCP proposal and the
warning label proposal for juice. The agency will promptly publish the
PRIA in the Federal Register.
B. Small Entity Analysis
In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), FDA has developed a single small entity analysis that estimates
benefits and costs associated with both this HACCP proposal and the
warning label proposal for juice. The agency will promptly publish the
small entity analysis in the Federal Register.
VIII. Request for Comments
Interested persons may, on or before July 8, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
IX. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m. Monday through Friday.
1. Centers for Disease Control and Prevention, ``Outbreak of
Escherichia coli O157:H7 Infections Associated With Drinking
Unpasteurized Commercial Apple Juice--British Columbia, California,
Colorado, and Washington,'' October 1996, MMWR, 45(44):875, November
8, 1996.
2. Griffin, P. M., ``Report of O157:H7 Outbreaks Caused by
Juices,'' Current Science and Technology on Fresh Juices, Transcript
of Public Meeting, vol. 1:15-27, December 16 and 17, 1996.
3. Tabershaw, I. R., L. L. Schmelzer, and H. B. Bruyn,
``Gastroenteritis From an Orange Juice Preparation I, Clinical and
Epidemiological Aspects,'' Archives of Environmental Health 15:72-
77, 1967.
4. Schmelzer, L. L., J. M. Gates, M. S. Redfearn, and I. R.
Tabershaw, ``Gastroenteritis From an Orange Juice Preparation II,
Field and Laboratory Investigation,'' Archives of Environmental
Health, 15:78-82, 1967.
5. Centers for Disease Control, ``Salmonella typhimurium
Outbreak Traced to a Commercial Apple Cider-- New Jersey,'' MMWR
24:87-88, 1975
6. Centers for Disease Control and Prevention, ``Cholera
Associated With Imported Frozen Coconut Milk--Maryland,'' MMWR
40(49):844-843, 1991.
7. Millard, P. S., K. R. Gensheimer, D. G. Addiss, D. M. Sosin,
G. A. Beckett, A. Houck-Jankoski, and A. Hudson, ``An Outbreak of
Cryptosporidiosis From Fresh-pressed Apple Cider,'' JAMA
272(20):1592-1596, 1994.
8. Centers for Disease Control and Prevention, 1997, ``Outbreaks
of Escherichia coli O157:H7 Infection and Cryptosporidiosis
Associated With Drinking Unpasteurized Apple Cider--Connecticut and
New York,'' MMWR 46(1):4-8, October 1996.
8A. Memorandum of telephone conversation between Mike Cambridge,
New York State Health Department, and Clark Nardinelli, FDA, April
20, 1998.
9. Cook, K. A., 1996, EPI-AID 95-62 Trip Report: ``Outbreak of
Salmonella Hartford Infections Among Travelers to Orlando,
Florida,'' Centers for Disease Control and Prevention Memorandum,
October 1, 1995.
10. Steele, B. T., N. Murphy, G. S. Arbus, and C. P. Rance, ``An
Outbreak of Hemolytic Uremic Syndrome Associated With Ingestions of
Fresh Apple Juice,'' Journal of Pediatrics 101(6):963-965, 1982.
11. Besser, R. E., S. M. Lett, J. T. Weber, M. P. Doyle, T. J.
Barrett, J. G. Wells, and P. M. Griffin, ``An Outbreak of Diarrhea
and Hemolytic Uremic Syndrome From Escherichia coli O157:H7 in
Fresh-pressed Apple Cider, JAMA 269(17):2217-2220, 1993.
12. Whatcom County (Washington) Health Department, Summary of a
Suspected Outbreak of E. coli O157:H7 Associated With Consumption of
Unpasteurized Apple Cider, 2 pages, 1996.
13. Webb, R. W., ``Gastroenteritis in Elementary School Students
after Drinking Orange Juice, Mobile County,'' Note to Epidemiology
File, May 10, 1994.
14. Memorandum of telephone conversation between Mike Cambridge,
New York State Health Department, and Debra Street, FDA, January 22,
1997.
15.Memorandum of telephone conversation between Patty Walker,
Washington State Health Department, and Debra Street, FDA, January
15, 1997.
16.Memorandum of telephone conversation between Susan Karam,
Ohio State Health Department, and Debra Street, FDA, January 21,
1997.
17. Memorandum of telephone conversation between Roberta
Hammond, Florida State Health Department, and Debra Street, FDA,
January 21, 1997.
18. Memorandum of telephone conversation between Pam Shillam,
Colorado State Health Department, and Debra Street, FDA, January 17,
1997.
19. Barker, W. H., and V. Runte, 1972, ``Tomato Juice-associated
Gastroenteritis, Washington and Oregon,'' American Journal of
Epidemiology 96(2):219-226, 1969.
20. Centers for Disease Control, ``Poisoning From Elderberry
Juice --California,'' MMWR 33(13):173-174, 1984.
21. Memorandum of telephone conversation between Dr. K.
Hendricks, Texas State Health Department, and Debra Street, FDA,
January 16, 1997.
22. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-680-7, August 12 and
27, 1997.
23. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-411/420-2, July 14
and 30, 1992, and August 12, 1992.
24. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-346-8, July 14, 20,
and 27, 1988.
25. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report
[[Page 20481]]
for firm-initiated recall #F-400/421-1, May 23, 1991, and June 6 and
19, 1991.
26. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-189/190-5, January 6
and 25, 1995.
27. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-338/339-8, July 6, 7, and 27, 1988.
28. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-68-9, November 16,
1988, and December 6 and 14, 1988.
29. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-092/093-0, October 19, 1989, and
November 1, 1989.
30. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-523-0, June 27, 1990, and July 10
and 18, 1990.
31. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-107-1, November 14, 1990; December
31, 1990; January 9, 1991; and February 6, 1991.
32. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-421-2, July 8, 10, and 22, 1992.
33. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-285-3, April 1 and 21, 1993.
34. FDA, Health hazard evaluation, classification and FDA
Enforcement Report for recall #F-665-5, May 16, 18, and 31, 1995.
35. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-529-1, September 4, 5, and 18,
1991.
36. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-364-2, June 23, 1992, and July 2,
1992.
37. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm initiated recall #F-319-3, May 4 and 19,
1993.
38. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-250-4, January 13 and 27, 1994, and
February 9, 1994.
39. FDA, Health hazard evaluations, classification, and FDA
Enforcement Report for recall #F-492-7, June 27, 1997, and July 2
and 16, 1997.
40. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-427-1, June 3, 11,
and 19, 1991.
41. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-781-4, August 9, 10,
and 24, 1994.
42. FDA, Health hazard evaluation, classification, and
Enforcement Report for recall #F-406-7, May 1 and 7, 1997
43. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-584/596-6, June 6,
7, and 26, 1996.
44. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-023-7, October 24 and 30, 1996.
45. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-036-7, October 23 and 30, 1996, and
November 13, 1996.
46. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-072-7, November 14 and 20, 1996.
47. FDA, Health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-073-7, November 14 and 20, 1996.
48. Trucksess, M. W., memorandum to Martin J. Stutsman on
Patulin--97-688-239, Apple Juice Concentrate, March 31, 1997.
49. Wagstaff, J., memorandum to M. J. Stutsman, and T. C.
Troxell on the hazard of patulin in apple juice concentrate sample
97-688-239, April 2, 1997, and July 18, 1997.
50. Williams, R. T. Wilcox, B. Timbo, D. Street, C. Nardinelli,
P. McCarthy, G. Jackson, M. T. Hendricks, and E. Elliot,
``Preliminary Investigation Into the Morbidity and Mortality Effects
Associated With the Consumption of Fruit and Vegetable Juices,''
October 31, 1997.
51. FDA, ``Pesticide Program Residue Monitoring 1994,'' J. AOAC
International, vol. 78, September/October 1995.
52. FDA, 1996, ``Pesticide Program Residue Monitoring 1995.''
53. National Advisory Committee on Microbiological Criteria for
Foods, ``NACMCF Recommendations on Fresh Juice,'' April 9, 1997.
54. U.S. Public Health Service, ``Food Code, 1997
Recommendations of the United States Public Health Service, Food and
Drug Administration,'' National Technical Information Service
Publication PB95-265492, p. 73.
55. National Advisory Committee on Microbiological Criteria for
Foods, ``Hazard Analysis and Critical Control Point Principles and
Application Guidelines,'' August 14, 1997.
56. Webster's II New Riverside University Dictionary, The
Riverside Publishing Co., p. 657, 1994.
57. FDA, ``Hazard Analysis and Critical Control Point (HACCP)
Pilot Program for Selected Food Manufacturers: Second Interim Report
of Observations and Comments,'' October 31, 1997.
58. Davis, S. A., memorandum to file: `` Hazard Analysis and
Critical Control Point (HACCP) Systems for Juice; Consideration of
Hazards that are Reasonably Likely to Occur,'' October 21, 1997.
59. FDA, Hazard Analysis Critical Control Point (HACCP) Pilot
Program for Selected Food Manufacturers: Interim Report of
Observations and Comments, June 19, 1996.
60. Zhao, T., M. P. Doyle, and R. E. Besser, ``Fate of
Enterohemorrhagic Escherichia coli O157:H7 in Apple Cider With and
Without Preservatives,'' Applied and Environmental Microbiology,
59(8):2526-2530.
61. Miller, L. G., and C. W. Kaspar, ``Escherichia coli O157:H7
Acid Tolerance and Survival in Apple Cider,'' Journal of Food
Protection, 57(6):460-464, 1994.
62. Bradshaw, J. G., J. T. Peeler, J. J. Corwin, J. M. Hunt, J.
T. Tierney, E. P. Larkin, and R. M. Twedt, ``Thermal Resistance of
Listeria monocytogenes in Milk,'' Journal of Food Protection,
48:743-745, 1985.
63. Doyle, M. P., K. A. Glass, J. T. Beery, G. A. Garcia, D. J.
Pollard, and R. D. Schultz, ``Survival of Listeria monocytogenes in
Milk During High-Temperature, Short-Time Pasteurization,'' Applied
and Environmental Microbiology, 53(7):1433-1438, 1987.
64. Memorandum of telephone conversation between Mickey Parish,
University of Florida, and Richard Williams, FDA, December 31, 1997.
65. Winniczuk, P. P., and M. E. Parish, ``Minimum Inhibitory
Concentrations of Antimicrobials Against Microorganisms Related to
Juice,'' Food Microbiol., 14(4):373-381, 1997.
List of Subjects in 21 CFR Part 120
Fruit and vegetable juice, Food, Imports, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, under
the Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that title 21 CFR
chapter I be amended as follows:
1. Part 120 is added to read as follows:
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
Subpart A--General Provisions
Sec.
120.1 Applicability.
120.3 Definitions.
120.5 Current good manufacturing practice.
120.6 Prerequisite program standard operating procedures.
120.7 Hazard analysis.
120.8 Hazard Analysis Critical Control Point (HACCP) plan.
120.9 Legal basis.
120.10 Corrective actions.
120.11 Verification and validation.
120.12 Records.
120.13 Training.
120.14 Application of requirements to imported products.
Subpart B--Pathogen Reduction
120.20 General.
120.24 Process controls.
Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e,
381, 393; 42 U.S.C. 241, 242l, 264.
Subpart A--General Provisions
Sec. 120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages
shall be processed in accordance with the requirements of this part.
Juice means the aqueous liquid expressed or extracted from one or more
fruits or vegetables, purees of the edible portions of one or more
fruits or vegetables, or any concentrates of such liquid or puree.
[[Page 20482]]
(b) The regulations in this part shall be effective 1 year after
the date of publication of the final rule in the Federal Register.
However, by its terms, this part is not binding on small and very small
businesses until the dates listed in paragraphs (b)(1) and (b)(2) of
this section.
(1) For small businesses employing fewer than 500 persons the
regulations in this part are binding 2 years after the date of
publication of the final rule in the Federal Register.
(2) For very small businesses that have either total annual sales
of less than $500,000, or if their total annual sales are greater than
$500,000 but their total food sales are less than $50,000; or the
person claiming this exemption employed fewer than an average of 100
full-time equivalent employees and fewer than 100,000 units of juice
were sold in the United States, the regulations are binding 3 years
after the date of publication of the final rule in the Federal
Register.
Sec. 120.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part
110 of this chapter are applicable to such terms when used in this
part, except where redefined in this part. The following definitions
shall also apply:
(a) Control means to prevent, eliminate, or reduce.
(b) Control measure means any action or activity that can be used
to prevent, eliminate, or reduce a hazard.
(c) Critical control point means a point, step, or procedure in a
food process at which a control measure can be applied and at which
control is essential to reduce an identified food hazard to an
acceptable level.
(d) Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified food hazard.
(e) Food hazard means any biological, chemical, or physical
property that may cause a food to be unsafe for human consumption.
(f) Importer means either the U.S. owner or consignee at the time
of entry of a food product into the United States, or the U.S. agent or
representative of the foreign owner or consignee at the time of entry
into the United States. The importer is responsible for ensuring that
goods being offered for entry into the United States are in compliance
with all applicable laws. For the purposes of this definition, the
importer is ordinarily not the custom house broker, the freight
forwarder, the carrier, or the steamship representative.
(g) Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and to produce an accurate record for use in verification.
(h)(1) Processing means activities that are directly related to the
production of juice products.
(2) For purposes of this part, processing does not include:
(i) Harvesting, picking, or transporting raw agricultural
ingredients of juice products, without otherwise engaging in
processing.
(ii) The operation of a retail establishment; and
(iii) The operation of a retail establishment that is a very small
business and that makes juice on its premises, provided that the
establishment's total sales of juice and juice products do not exceed
40,000 gallons per year, and that sells such juice:
(A) Directly to consumers or
(B) directly to consumers and other retail establishments.
(i) Processor means any person engaged in commercial, custom, or
institutional processing of juice products, either in the United States
or in a foreign country. A processor includes any person engaged in the
processing of juice products that are intended for use in market or
consumer tests.
(j) Shall is used to state mandatory requirements.
(k) Should is used to state recommended or advisory procedures or
to identify recommended equipment.
Sec. 120.5 Current good manufacturing practice.
Part 110 of this chapter applies in determining whether the
facilities, methods, practices, and controls used to process food are
safe, and whether the food has been processed under sanitary
conditions.
Sec. 120.6 Prerequisite program standard operating procedures.
(a) Sanitation controls. Each processor shall have and implement a
sanitation standard operating procedure (SOP) that addresses sanitation
conditions and practices before, during, and after processing and
relates to the following:
(1) Safety of the water that comes into contact with food or food
contact surfaces or that is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including
utensils, gloves, and outer garments;
(3) Prevention of cross-contamination from insanitary objects to
food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
processed product;
(4) Maintenance of hand washing, hand sanitizing, and toilet
facilities;
(5) Protection of food, food packaging material, and food contact
surfaces from adulteration with lubricants, fuel, pesticides, cleaning
compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants;
(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the
microbiological contamination of food, food packaging materials, and
food contact surfaces; and
(8) Exclusion of pests from the food plant.
(b) Monitoring. The processor shall monitor the conditions and
practices during processing with sufficient frequency to ensure, at a
minimum, conformance with those conditions and practices specified in
part 110 of this chapter that are appropriate both to the plant and to
the food being processed. Each processor shall correct, in a timely
manner, those conditions and practices that are not met.
(c) Records. Each processor shall maintain prerequisite program SOP
records that, at a minimum, document the monitoring and corrections
prescribed by paragraph (b) of this section. These records are subject
to the recordkeeping requirements of Sec. 120.12.
(d) Relationship to Hazard Analysis and Critical Control Point
(HACCP) plan. Prerequisite program SOP controls may be included in the
HACCP plan required under Sec. 120.8(b). However, to the extent that
they are implemented in accordance with this section, they need not be
included in the HACCP plan.
Sec. 120.7 Hazard analysis.
Each processor shall develop, or have developed for it, a written
hazard analysis to determine whether there are food hazards that are
reasonably likely to occur for each type of juice processed by that
processor and to identify the control measures that the processor can
apply to control those hazards. The hazard analysis shall include food
hazards that can be introduced both within and outside the processing
plant environment, including food hazards that can occur before,
during, and after harvest. A food hazard that is reasonably likely to
occur is one for which a prudent processor would establish controls
because experience,
[[Page 20483]]
illness data, scientific reports, or other information provide a basis
to conclude that there is a reasonable possibility that, in the absence
of those controls, the food hazard will occur in the particular type of
product being processed. The hazard analysis shall be developed by an
individual or individuals who have been trained in accordance with
Sec. 120.13 and shall be subject to the recordkeeping requirements of
Sec. 120.12.
(a) In evaluating what food hazards are reasonably likely to occur,
consideration should be given, at a minimum, to the following:
(1) Microbiological contamination;
(2) Parasites;
(3) Chemical contamination;
(4) Unlawful pesticides residues;
(5) Decomposition in food where a food hazard has been associated
with decomposition;
(6) Natural toxins;
(7) Unapproved use of food or color additives;
(8) Presence of undeclared ingredients that may be allergens; and
(9) Physical hazards.
(b) Processors should evaluate product ingredients, processing
procedures, packaging, storage, and intended use; facility and
equipment function and design; and plant sanitation including employee
hygiene to determine the potential effect of each on the safety of the
finished food for the intended consumer.
Sec. 120.8 Hazard Analysis Critical Control Point (HACCP) plan.
(a) HACCP plan. Every processor shall have and implement a written
HACCP plan whenever a hazard analysis reveals one or more food hazards
that are reasonably likely to occur during processing, as described in
Sec. 120.7. The HACCP plan shall be developed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12. A
HACCP plan shall be specific to:
(1) Each location where juice is processed by that processor; and
(2) Each type of juice processed by the processor. The plan may
group types of juice products together, or group types of production
methods together, if the food hazards, critical control points,
critical limits, and procedures required to be identified and performed
by paragraph (b) of this section are essentially identical, provided
that any required features of the plan that are unique to a specific
product or method are clearly delineated in the plan and are observed
in practice.
(b) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List all food hazards that are reasonably likely to occur as
identified in accordance with Sec. 120.7, and that thus must be
controlled for each type of product.
(2) List the critical control points for each of the identified
food hazards, including as appropriate:
(i) Critical control points designed to control food hazards that
could occur or could be introduced inside the processing plant
environment; and
(ii) Critical control points designed to control food hazards
introduced outside the processing plant environment, including food
hazards that occur before, during, and after harvest;
(3) List the critical limits that shall be met at each of the
critical control points;
(4) List the procedures, and the frequency with which they are to
be performed, that will be used to monitor each of the critical control
points to ensure compliance with the critical limits;
(5) Include any corrective action plans that have been developed in
accordance with Sec. 120.10(a), and that are to be followed in response
to deviations from critical limits at critical control points;
(6) List the validation and verification procedures, and the
frequency with which they are to be performed, that the processor will
use in accordance with Sec. 120.11; and
(7) Provide for a recordkeeping system that documents the
monitoring of the critical control points in accordance with
Sec. 120.12. The records shall contain the actual values and
observations obtained during monitoring.
(c) Products subject to other regulations. HACCP plans for juice
need not address the food hazards associated with microorganisms and
microbial toxins that are controlled by the requirements of part 113 or
114 of this chapter. A HACCP plan for such juice shall address any
other food hazards that are reasonably likely to occur.
(d) Sanitation. Sanitation controls may be included in the HACCP
plan. However, to the extent that they are monitored in accordance with
Sec. 120.6, they are not required to be included in the HACCP plan.
Sec. 120.9 Legal basis.
Failure of a processor to have and to implement a Hazard Analysis
and Critical Control Point (HACCP) system that complies with
Secs. 120.6, 120.7, and 120.8, or otherwise to operate in accordance
with the requirements of this part, shall render the juice products of
that processor adulterated under section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act. Whether a processor's actions are consistent
with ensuring the safety of juice will be determined through an
evaluation of the processor's overall implementation of its HACCP
system.
Sec. 120.10 Corrective actions.
Whenever a deviation from a critical limit occurs, a processor
shall take corrective action by following the procedures set forth in
paragraph (a) or paragraph (b) of this section.
(a) Processors may develop written corrective action plans, which
become part of their Hazard Analysis and Critical Control Point (HACCP)
plans in accordance with Sec. 120.8(b)(5), by which processors
predetermine the corrective actions that they will take whenever there
is a deviation from a critical limit. A corrective action plan that is
appropriate for a particular deviation is one that describes the steps
to be taken and assigns responsibility for taking those steps, to
ensure that:
(1) No product enters commerce that is either injurious to health
or is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(b) When a deviation from a critical limit occurs, and the
processor does not have a corrective action plan that is appropriate
for that deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform or obtain a review to determine the acceptability of
the affected product for distribution. The review shall be performed by
an individual or individuals who have adequate training or experience
to perform such review. Adequate training may or may not include
training in accordance with Sec. 120.13;
(3) Take corrective action, when necessary, with respect to the
affected product to ensure that no product enters commerce that is
either injurious to health or is otherwise adulterated as a result of
the deviation;
(4) Take corrective action, when necessary, to correct the cause of
the deviation; and
(5) Perform or obtain timely validation in accordance with
Sec. 120.11, by an individual or individuals who have been trained in
accordance with Sec. 120.13, to determine whether modification of the
HACCP plan is required to reduce the risk of recurrence of the
deviation, and to modify the HACCP plan as necessary.
(c) All corrective actions taken in accordance with this section
shall be fully documented in records that are
[[Page 20484]]
subject to verification in accordance with Sec. 120.11(a)(1)(iv)(B) and
the recordkeeping requirements of Sec. 120.12.
Sec. 120.11 Verification and validation.
(a) Verification. Every processor shall verify that the Hazard
Analysis and Critical Control Point (HACCP) system is being implemented
according to design.
(1) Verification activities shall include:
(i) A review of any consumer complaints that have been received by
the processor to determine whether such complaints relate to the
performance of the HACCP plan or reveal previously unidentified
critical control points;
(ii) The calibration of process-monitoring instruments;
(iii) At the option of the processor, the performance of periodic
end-product or in-process testing;
(iv) A review, including signing and dating, by an individual who
has been trained in accordance with Sec. 120.13, of the records that
document:
(A) The monitoring of critical control points. The purpose of this
review shall be, at a minimum, to ensure that the records are complete
and to verify that the records document values that are within the
critical limits. This review shall occur within 1 week (7 days) of the
day that the records are made;
(B) The taking of corrective actions. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that appropriate corrective actions were taken in accordance
with Sec. 120.10. This review shall occur within 1 week (7 days) of the
day that the records are made; and
(C) The calibrating of any process monitoring instruments used at
critical control points and the performance of any periodic end-product
or in-process testing that is part of the processor's verification
activities. The purpose of these reviews shall be, at a minimum, to
ensure that the records are complete and that these activities occurred
in accordance with the processor's written procedures. These reviews
shall occur within a reasonable time after the records are made; and
(v) The following of procedures in Sec. 120.10 whenever any
verification procedure, including the review of consumer complaints,
establishes the need to take a corrective action.
(2) The calibration of process-monitoring instruments, and the
performance of any periodic end-product and in-process testing, in
accordance with paragraphs (a)(1)(iv)(B) through (a)(1)(iv)(C) of this
section, shall be documented in records that are subject to the
recordkeeping requirements of Sec. 120.12.
(b) Validation of the HACCP plan. Every processor shall validate
that the HACCP plan is adequate to control food hazards that are
reasonably likely to occur; this validation shall occur at least once
within 12 months after implementation and at least annually thereafter
or whenever any changes in the process occur that could affect the
hazard analysis or alter the HACCP plan and prerequisite program of the
standard operating procedures (SOP's) in any way. Such changes may
include changes in the following: Raw materials or source of raw
materials; product formulation; processing methods or systems,
including computers and their software; packaging; finished product
distribution systems; or the intended use or consumers of the finished
product. The validation shall be performed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12. The
HACCP plan shall be modified immediately whenever a validation reveals
that the plan is no longer adequate to fully meet the requirements of
this part.
(c) Validation of the hazard analysis. Whenever a juice processor
has no HACCP plan because a hazard analysis has revealed no food
hazards that are reasonably likely to occur, the processor shall
reassess the adequacy of that hazard analysis whenever there are any
changes in the process that could reasonably affect whether a food
hazard exists. Such changes may include changes in the following: Raw
materials or source of raw materials; product formulation; processing
methods or systems, including computers and their software; packaging;
finished product distribution systems; or the intended use or intended
consumers of the finished product. The validation shall be performed by
an individual or individuals who have been trained in accordance with
Sec. 120.13 and shall be subject to the recordkeeping requirements of
Sec. 120.12.
Sec. 120.12 Records.
(a) Required records. Processors shall maintain the following
records documenting the processor's Hazard Analysis and Critical
Control Point (HACCP) system:
(1) Records documenting the implementation of the prerequisite
program of the standard operating procedures (SOP's) (see Sec. 120.6);
(2) The written hazard analysis required by Sec. 120.7;
(3) The written HACCP plan required by Sec. 120.8;
(4) Records documenting the ongoing application of the HACCP plan
that include:
(i) Monitoring of critical control points and their critical
limits, including the recording of actual times, temperatures, or other
measurements, as prescribed in the establishment's HACCP plan; and
(ii) Corrective actions, including all actions taken in response to
a deviation; and
(5) Records documenting verification of the HACCP system and
validation of the HACCP plan or hazard analysis.
(b) General requirements. All records required by this part shall
include:
(1) The name and location of the processor or importer;
(2) The date and time of the activity that the record reflects;
(3) The signature or initials of the person performing the
operation or creating the record; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed. The records shall
contain the actual values and observations obtained during monitoring.
(c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3)
of this section shall be signed and dated by the most responsible
individual onsite at the processing facility or by a higher level
official of the processor. These signatures shall signify that these
records have been accepted by the firm.
(2) The records in paragraphs (a)(2) and (a)(3) of this section
shall be signed and dated:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification and validation in accordance with
Sec. 120.11.
(d) Record retention. (1) All records required by this part shall
be retained at the processing facility or at the importer's place of
business in the United States for, in the case of perishable or
refrigerated juices, at least 1 year after the date that such products
were prepared, and for, in the case of frozen, preserved, or shelf-
stable products, 2 years or the shelf life of the product, whichever is
greater, after the date that the products were prepared.
(2) Records that relate to the general adequacy of equipment or
processes used by a processor, including the results of scientific
studies and evaluations, shall be retained at the processing facility
or at the importer's place of business in the United States for at
least 2 years after the date that the
[[Page 20485]]
processor last used such equipment or process.
(3) Off-site storage of processing records required by paragraphs
(a)(1) and (a)(3) of this section is permitted after 6 months following
the date that the monitoring occurred, if such records can be retrieved
and provided on-site within 24 hours of request for official review.
Electronic records are considered to be on-site if they are accessible
from an on-site location and comply with Sec. 120.12(g).
(4) If the processing facility is closed for a prolonged period
between seasonal packs, the records may be transferred to some other
reasonably accessible location at the end of the seasonal pack but
shall be immediately returned to the processing facility for official
review upon request.
(e) Official review. All records required by this part shall be
available for official review and copying at reasonable times.
(f) Public disclosure. (1) Subject to the limitations in paragraph
(d)(2) of this section, all records required by this part are not
available for public disclosure unless they have been previously
disclosed to the public, as defined in Sec. 20.81 of this chapter, or
unless they relate to a product or ingredient that has been abandoned
and thus, no longer represent a trade secret or confidential commercial
or financial information as defined in Sec. 20.61 of this chapter.
(2) Records required to be maintained by this part are subject to
disclosure to the extent that they are otherwise publicly available, or
that disclosure could not reasonably be expected to cause a competitive
hardship, such as generic-type HACCP plans that reflect standard
industry practices.
(g) Records maintained on computers. The maintenance of records on
computers, in accordance with part 11 of this chapter, is acceptable.
Sec. 120.13 Training.
(a) Only an individual who has met the requirements of paragraph
(b) of this section shall be responsible for the following functions:
(1) Developing the hazard analysis, including delineating control
measures, as required by Sec. 120.7;
(2) Developing a Hazard Analysis and Critical Control Point (HACCP)
plan that is appropriate for a specific processor, in order to meet the
requirements of Sec. 120.8;
(3) Validating and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 120.10(c)(5) and the
validation activities specified in Sec. 120.11(b) and (c); and
(4) Performing the record review required by Sec. 120.11(a)(1)(iv).
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed training in the
application of HACCP principles to juice processing at least equivalent
to that received under standardized curriculum recognized as adequate
by the Food and Drug Administration or shall be otherwise qualified
through job experience to perform these functions. Job experience may
qualify an individual to perform these functions if such experience has
provided knowledge at least equivalent to that provided through the
standardized curriculum. The trained individual need not be an employee
of the processor.
Sec. 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported food.
(a) Importer requirements. Every importer of food shall either:
(1) Obtain the food from a country that has an active memorandum of
understanding (MOU) or similar agreement with the Food and Drug
Administration, that covers the food and documents the equivalency or
compliance of the inspection system of the foreign country with the
U.S. system, accurately reflects the relationship between the signing
parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written procedures for ensuring that the
food that such importer receives for import into the United States was
processed in accordance with the requirements of this part. The
procedures shall provide, at a minimum:
(i) Product specifications that are designed to ensure that the
product is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act because it may be injurious to health or because it
may have been processed under insanitary conditions; and
(ii) Affirmative steps to ensure that the products being offered
for entry were processed under controls that meet the requirements of
this part. These steps may include any of the following:
(A) Obtaining from the foreign processor the Hazard Analysis and
Critical Control Point (HACCP) plan and prerequisite program of the
standard operating procedure (SOP) records required by this part that
relate to the specific lot of food being offered for import;
(B) Obtaining either a continuing or lot specific certificate from
an appropriate foreign government inspection authority or competent
third party certifying that the imported food has been processed in
accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported food is being processed in accordance with the
requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign
processor's hazard analysis and HACCP plan, and a written guarantee
from the foreign processor that the imported food is processed in
accordance with the requirements of this part;
(E) Periodically testing the imported food, and maintaining on file
a copy, in English, of a written guarantee from the foreign processor
that the imported food is processed in accordance with the requirements
of this part; or
(F) Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements of
this part.
(b) Competent third party. An importer may hire a competent third
party to assist with or perform any or all of the verification
activities specified in paragraph (a)(2) of this section, including
writing the importer's verification procedures on the importer's
behalf.
(c) Records. The importer shall maintain records, in English, that
document the performance and results of the affirmative steps specified
in paragraph (a)(2)(ii) of this section. These records shall be subject
to the applicable provisions of Sec. 120.12.
(d) Determination of compliance. The importer shall provide
evidence that all food offered for entry into the United States has
been processed under conditions that comply with this part. If
assurances do not exist that an imported food has been processed under
conditions that are equivalent to those required of domestic processors
under this part, the product will appear to be adulterated and will be
denied entry.
Subpart B--Pathogen Reduction
Sec. 120.20 General.
This subpart augments subpart A of this part by setting forth
specific requirements for process controls.
Sec. 120.24 Process controls.
In order to meet the requirements of subpart A of this part,
processors of juice products, except those subject to the requirements
of part 113 or 114 of
[[Page 20486]]
this chapter, shall include in their Hazard Analysis and Critical
Control Point (HACCP) plans control measures that will produce, at a
minimum, a 5 log (i.e., 105) reduction, for a period at
least as long as the shelf life of the product when stored under normal
and moderate abuse conditions, in the pertinent microorganism. For the
purposes of this regulation, the ``pertinent microorganism'' is the
most resistant microorganism of public health significance that is
likely to occur in the juice.
Dated: April 17, 1998.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 98-11025 Filed 4-22-98; 8:45 am]
BILLING CODE 4160-01-F
