(Cite as: 63 FR 20450)
PROPOSED RULES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 120
RIN 0910-AA43
[Docket No. 97N-0511]
Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and
Sanitary Processing and Importing of Juice
Friday, April 24, 1998
*20450
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt regulations
to ensure the safe and sanitary processing of fruit and vegetable juices and juice
products. The proposed regulation, if adopted, will mandate the application of Hazard
Analysis and Critical Control Point (HACCP) principles to the processing of these foods.
HACCP is a preventive system of hazard control. FDA is proposing these regulations
because there have been a number of outbreaks of illness, including some directly
affecting children, associated with juice products and because a system of preventive
control measures is the most effective and efficient way to ensure that these products
will be safe. Elsewhere in this issue of the Federal Register, FDA is publishing
a warning label proposal for packaged juice.
DATES: Submit written comments by July 8, 1998. For information on the proposed compliance
dates for small businesses and very small businesses see the Supplementary Information
section of this document.
Submit written comments on the information collection requirements by May 26, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit
written comments regarding information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget, New Executive Office Bldg., 725 17th
St. NW., rm. 10235, Washington, DC 20503, Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food Safety and Applied
Nutrition (HFS-306), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-4681.
SUPPLEMENTARY INFORMATION:
The agency proposes to make any final rule based upon this proposal effective 1 year
after its date of publication in the Federal Register. However, by its terms, the
final rule will not be binding on small businesses as defined in proposed s120.1(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 s120.1(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 *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
(MUg/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 MUg/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 *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 *20453
microbial survival differ from those for growth. The NACMCF recognized that, while
the risks associated with specific juices vary, there are safety concerns associated
with juices, especially unpasteurized juices.
The NACMCF concluded that: (1) The history of public health problems associated with
fresh juices indicates a need for active safety interventions, and (2) for some fruit
(e.g., oranges), the need for intervention may be limited to surface treatment, but
for others, additional interventions may be required (e.g., pasteurization of the
juice).
The NACMCF recommended to FDA the use of safety performance criteria instead of mandating
the use of a specific intervention technology. In the absence of known specific
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 super-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 (s146.140) 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 (s110.80(b)(13)(i)), but they are not integral to the
controls outlined in the regulations.
The inspection and surveillance strategies that FDA uses ascertain a manufacturer's
knowledge of hazards and preventive control measures largely by inference (i.e.,
based on whether a company's products are in fact adulterated, or whether conditions
in a plant are consistent with CGMP). It is the manufacturer's responsibility to ensure
that its products are in compliance with the act. However, in the face of new pathogens,
such as E. coli O157:H7, and the risk of illness associated with these pathogens, especially for children, the elderly, and *20454
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 *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 super-5 , assuming consumption of 100 mL of juice daily. However, the
NACMCF did not specify the manner in which this risk reduction should be accomplished,
only the target that must be reached. In section IV.M of this document the agency will
discuss its proposed approach as to how this performance standard will apply to juice.
4. Labeling
A number of comments suggested that labeling to distinguish pasteurized from unpasteurized
juice would enable consumers to make an informed choice. One of the comments requested
warnings to those "at-risk," one urged the publication of warnings in the newspaper, and another wanted labeling with no warning. Rather than labeling, one comment
suggested point of sale information. One comment urged FDA not to require labeling
to distinguish pasteurized from unpasteurized juices.
The NACMCF recommended research on labeling information needed for consumer understanding
and choice of safer juice products. The NACMCF concluded that, while the risks associated
with specific juices vary, there are safety concerns associated with juices generally, especially unpasteurized juices.
Labeling whether a product is pasteurized or unpasteurized is useful information
that the agency encourages processors to place on labels. However, such labeling
would not inform purchasers of unpasteurized product that children, the elderly,
and the immunocompromised are "at-risk" from consuming the product. Without effective consumer
education, the label statements "pasteurized" and "unpasteurized" are likely to have
relatively little meaning to consumers and could even cause confusion because some
consumers might select unpasteurized juice, considering it more "healthy" because it
is less processed. Finally, a labeling requirement that focuses only on whether
a product is pasteurized or unpasteurized does not take into account technologies
other than pasteurization that are adequate to control pathogens, and, thus, such a requirement
could be viewed as restricting the development of new technologies.
The agency outlined interim measures in a notice published August 28, 1997 (62 FR
45593), and elsewhere in this issue of the Federal Register, FDA is issuing a proposal
on labeling for packaged juice. These labeling measures attempt to provide information on the risks that juice that has not been processed to control for pathogens poses
to children, the elderly, and the immunocompromised. The agency is proposing that
the labeling measures be superseded when these juice products are processed under
adequate HACCP programs or are otherwise processed to destroy pathogens (e.g., pasteurization).
It is possible for firms that manufacture juice to control for pathogens. Labeling
a product to alert consumers to possible harmful effects from its consumption must
not substitute for a manufacturer adequately addressing those concerns during processing. FDA is reluctant to rely on labeling as a safety measure and does so only when
its analysis of the countervailing factors reveals that, on balance, labeling provides
the most reasonable approach to protecting the public health. Juice is a product
that is typically consumed by children, as well as adults. Therefore, FDA tentatively
concludes that, for juice, manufacturers need to implement controls for pathogens
to ensure that their products are safe and not rely solely on labeling, except as
an interim measure. FDA requests comment on this tentative conclusion.
5. Education
Other comments from the juice meeting suggested that education would increase the
awareness associated with the safety of juices and of all foods. Some comments suggested
that more industry education or training was needed. Other comments wanted more
consumer education, especially for those at highest risk from foodborne disease.
The NACMCF recommended that the industry be educated on basic food microbiology,
the principles of cleaning and sanitizing equipment, CGMP's, and HACCP. FDA agrees
that industry education can serve a valuable role in controlling potential food hazards
and encourages the industry to take an active part in educating its employees and utilizing
up-to-date technologies. The agency will assist the industry in its education effort.
Concerning consumer education, the agency has launched several initiatives to inform
consumers about the potential hazards presented by juice to at-risk individuals (see
62 FR 45593, August 28, 1997). However, no matter how extensive a consumer education initiative the agency undertakes, it is doubtful that consumer education will reach
all at-risk consumers. Therefore, consumer education alone will not be adequate
to inform the at-risk population of the potential hazards of consumption of juice
that has not been processed to control pathogens. Given that effective processing methods
are available, primary reliance needs to be placed on them to ensure the safety of
juice.
6. The HACCP Option
Many of the attendees at the juice meeting urged FDA to mandate HACCP for juice processors,
whereas others were opposed. A number of the attendees urged use of CGMP's together
with HACCP. Some attendees at the juice meeting recommended that microbiological criteria or performance *20456
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 *20457
food hazards that are reasonably likely to occur.
Labeling was also suggested as an alternative. FDA acknowledges that, from a public
health protection standpoint, there are certain advantages to labeling. Elsewhere
in this issue of the Federal Register, FDA is proposing to require certain labeling,
in the form of a warning statement, for packaged juice products that have not been processed
to control, reduce, or eliminate pathogenic microorganisms that may be present in
such juices. Such labeling will serve to reduce the risk of foodborne illness.
However, such reduction will occur only to the extent that consumers read and understand
the labeling. Accordingly, the agency has tentatively concluded that mandating HACCP
for most juice products will provide more comprehensive public health protection
by greatly reducing the number of juice products that contain dangerous pathogens.
Importantly, manufacturers do have the ability to process juice to control pathogens.
Labeling a product to alert consumers to possible harmful effects from its consumption
is not a substitute for a manufacturer adequately addressing those concerns during processing. Juice is a product consumed by children, as well as by adults. FDA
is reluctant to rely on labeling as a safety measure and does so only when its analysis
of the countervailing factors reveals that, on balance, labeling provides the most
reasonable approach to protect the public health. Here, a situation in which HACCP
offers a real long-term solution to controlling, if not eliminating, hazards in juice,
the agency tentatively believes that labeling is not a reasonable long-term approach.
The agency is soliciting comment on the appropriateness of this tentative conclusion.
The fifth alternative to HACCP that was suggested is education. Industry education
can play a valuable role in the production of safe juices. Consumer education can
play an important part in consumer purchasing choices. However, education is only
effective if people understand and use the information conveyed. Moreover, even an extensive
education program may not reach all consumers. Conversely, mandatory HACCP would
ensure that industry produces safe juice, and that the product that reaches consumers is safe.
For the foregoing reasons, FDA has tentatively concluded that HACCP represents the
appropriate system of controls that is necessary for producing safe juice products.
Therefore, FDA is proposing to add part 120 to its regulations to establish procedures
for implementing HACCP systems for fruit and vegetable juices. As the agency did
with seafood, it is proposing to issue these HACCP regulations under various sections
of the the act, including, most significantly, sections 402(a)(1) and (a)(4) and
701(a) of the act (21 U.S.C. 371(a)).
Section 402(a)(1) of the act states that a food is adulterated if it bears or contains
any poisonous or deleterious substance that may render the food injurious to health.
Section 402(a)(4) of the act states that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to health. It is important
to recognize that section 402(a)(4) of the act addresses conditions that may render a food injurious to health, rather than conditions that have actually caused the
food to be injurious (see United States v. 1,200 Cans, Pasteurized Whole Eggs, etc.,
339 F. Supp. 131, 141 (N.D. Ga. 1972)). The question is whether the conditions under
which the food is processed and held are insanitary and may render the food injurious
to health. The agency tentatively finds that, if a processor of juice products does
not incorporate certain basic controls into its procedures for preparing, packing,
and holding food, it is operating under insanitary conditions that may render the juice
that is produced injurious to health and, therefore, adulterated under the act.
Section 701(a) of the act authorizes the agency to adopt regulations for the efficient
enforcement of the act.
The legal basis for mandating HACCP systems for juice processors is the same as that
for seafood. Additional discussion of the legal basis is set out in the proposed
rule (59 FR 4142 at 4150, January 28, 1994) and final rule (60 FR 65096 at 65098)
for fish and fishery products.
E. Notice of Intent
FDA published a notice of intent on August 28, 1997 (62 FR 45593), that announced
a comprehensive program to address the incidence of foodborne illness related to
consumption of fresh juice and to address ultimately the safety aspects of all juice
products. The agency invited comment on the appropriateness of its strategy to: (1) Initiate
rulemaking on a mandatory HACCP program for some or all juice products, (2) propose
that the labels and labeling of some or all juice products not specifically processed to prevent or eliminate the presence of harmful bacteria bear a warning statement
informing consumers of the risk of illness associated with consumption of the product,
and (3) initiate several educational programs to minimize the hazards associated
with fresh juice. The agency stated that it would consider comments received within 15
days of publication of the notice prior to publication of any proposed rule.
Some comments on the notice suggested that FDA mandate HACCP only for fresh juice
processors. One comment stated that HACCP should be mandated only for firms that
process large quantities of fresh juice. Other comments supported mandatory pasteurization or equivalent treatment of juice, especially apple cider. One comment added that
pasteurization and use of CGMP would preclude the need for the mandatory use of HACCP.
In section II.D of this document the agency has already discussed its reasons for
proposing HACCP. The illnesses discussed in sections I.A and I.B of this document
did not pinpoint problems related solely to fresh juice processors or to the amount
of fresh juice that a firm produced. The comments have not provided any new information
to alter the agency's tentative conclusion that HACCP is necessary to ensure the
safe production of juice. However, FDA requests information on whether there are
categories of juice that should be excluded from the proposed regulation.
FDA has reviewed all of the comments received within 15 days of publication of the
notice and has determined that the comments provided no information that would cause
the agency to conclude that this proposal is inappropriate. The agency has attempted
to address these comments to the extent that they are relevant to this proposal. All
comments received in response to the notice that address the issues in this proposal
will be considered either in this proposal or in any final rule published in response
to this proposal.
F. Fresh Produce Guidance
FDA, working with the U.S. Department of Agriculture (USDA) and the agricultural
community, has developed voluntary good agricultural practice (GAP) and GMP guidance
for fruits and vegetables that has been issued in draft for comment. The guidance,
which is a science-based evaluation of risks, will address potential food safety problems
throughout the food production and distribution system such as sanitation, worker
health, and water quality. This voluntary guidance can be used by both domestic
and foreign fresh fruit and vegetable producers to help ensure the safety of their produce.*20458
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.*20459
The regulations proposed herein are based on the seafood final rule with some modification
to reflect the differences between seafood and juice products and to reflect recent
developments in the application of HACCP. An extensive administrative record was compiled in the seafood proceeding. FDA is incorporating that record as support
for the current proposal. Although the regulations proposed herein differ in some
aspects from part 123, they are not intended to supersede or otherwise alter the
seafood final rule.
2. Advance Notice of Proposed Rulemaking for the Development of HACCP for the Food
Industry
In the Federal Register of August 4, 1994 (59 FR 39888), FDA published an advance
notice of proposed rulemaking (ANPRM) requesting public comment about whether and
how the agency should develop regulations that would establish requirements for a
new comprehensive food safety assurance program, based on HACCP, for both domestically produced
and imported foods. The agency stated its tentative view that, if such regulations
were issued, they would enhance FDA's ability to ensure the safety of the U.S. food
supply. FDA requested comments on a number of specific issues, as well as on all aspects
of such a food safety program.
3. HACCP Pilot Programs
In addition to the ANPRM, FDA also published in the Federal Register on August 4,
1994 (59 FR 39771), a notice announcing that it intended to conduct a pilot program
in which volunteers from the food manufacturing industry would use a HACCP system
that FDA would audit. The pilot program was intended to provide information that FDA could
use in deciding whether to propose to adopt regulations and in developing and implementing
a regulatory system in which food manufacturers are required to perform the food safety aspects of their operations based on HACCP principles. In the notice, FDA
invited individual firms that wished to participate in the program to submit letters
of interest. Approximately 50 firms expressed initial interest in participating in
the pilot program, and 11 firms were selected to participate. In 1997 FDA completed the
pilot program at six firms and published a second interim report.
4. HACCP for Meat and Poultry
On July 25, 1996, USDA published a final rule (61 FR 38806) that, among other things,
required that each meat and poultry establishment develop and implement written sanitation
standard operating procedures (Sanitation SOP's) and a system of HACCP controls designed to improve the safety of their products. The effective date for the Sanitation
SOP's was January 27, 1997, and for the HACCP regulations was January 26, 1998.
FDA has reviewed the meat and poultry HACCP regulations and has incorporated portions of them as appropriate in the proposed HACCP regulations for juice.
D. Issues from the ANPRM
FDA received approximately 150 comments in response to the August 4, 1994, ANPRM.
The comments represented the views of consumers, consumer organizations, health
professionals, academicians, food industry officials, trade associations, and foreign,
State, and local government agencies. The agency has attempted to address these comments
to the extent that they are relevant to this proposal.
1. The agency asked in the ANPRM how the responsibility for food safety should be
shared between the food industry and government. Comments generally agreed that
the food industry is responsible for producing safe food products. All respondents
on this issue recognized that the Government's role is to verify industry compliance with
any applicable safety regulations.
FDA agrees that it is the manufacturer's responsibility to ensure that the food that
it produces is safe, and that it is the Government's role to verify that manufacturers
are fulfilling their responsibility. Through use of a HACCP system, both the firm
and FDA are able to better fulfill their roles. The proposed regulation in part 120
underscores the division of roles. Under the proposed regulation, industry is charged
with examining all aspects of production, identifying hazards that are reasonably
likely to occur, and establishing measures that will control or minimize those hazards.
HACCP records enable the agency to inspect the production facility more efficiently
and to verify that the firm is operating in accordance with its HACCP plan. They
also give the agency insight into whether any problems that have occurred have been identified
and appropriately addressed.
It is important that the juice industry focus on its responsibility to produce safe
food. Recent outbreaks evidence that some members of the industry have not kept
up with the need to evaluate the hazards presented by juice and to design processes
to address those hazards. Firms need to be aware of the emerging problems presented by
their raw materials and to decide whether, and if so what, steps are necessary to
address these problems. Firms may decide that it is necessary to incorporate a step
designed to kill bacteria into their process (e.g., pasteurization), that there are alternative
steps that they can take to ensure the safety of their products, or that, given the
nature of the raw materials, no steps are necessary. Firms also need to monitor
the process that they decide to employ to ensure that it is functioning adequately and
appropriately. FDA notes that some firms have already addressed food safety concerns
and have implemented HACCP systems.
Moreover, given the heightened concerns about these products, Government needs to
be in a position to fulfill its role of verifying that industry is doing its job.
Given the sporadic and variable way in which the problems that have been associated
with juice arise, sampling and end-product testing of juice products will not enable it
to do so. Other steps that will give Government insights into the production itself
appear to be in order.
2. FDA requested comment in the ANPRM about the likelihood of occurrence of a hazard
that would warrant HACCP-type control. Generally, the comments consistently identified
two features that would characterize a properly formulated definition of likelihood: Processing conditions and nature of hazard. The majority of comments offered
by the food industry stipulated that the necessary condition for likelihood of occurrence
of the hazard appropriate to trigger HACCP control must not be speculative, as in
worst-case scenarios, but be real, practical, and intrinsic to the processing or hazards
demonstrably present for specific commodities. Several responses recommended that
the question be referred to broadly based expert panels to establish the likelihood
of risk.
According to the NACMCF, each potential hazard is evaluated based on the severity
of the potential hazard and its likely occurrence (Ref. 55). Severity is the seriousness
of the consequences of exposure to the hazard. Considerations of severity (e.g.,
impact of sequelae and magnitude and duration of illness or injury) can be helpful in
understanding the public health impact of the hazard. Likelihood of occurrence of
a hazard is generally judged based on processing experience, epidemiological data,
and information in the technical literature.
The agency agrees with the comments that stated that the processing conditions and
the nature of the hazard are key elements in assessing the *20460
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 s 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 *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 super-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 *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 s120.1(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 s 156.145. These
standardized juices are generally described as the liquid extracted or expressed
from a fruit or vegetable. However, prune juice (s146.187) 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.*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 s120.1(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 (s120.1(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 (s120.1(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 s101.9(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 s120.3(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 s120.1(b)(2), FDA intends to use the definitions for the
terms "unit," "food product," "person," and "full-time equivalent employee" in *20464
s101.9(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 s120.3 that the definitions and
interpretations of terms in section 201 of the act (21 U.S.C. 321), in s 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 s120.3.
The agency is proposing to include in s120.3 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 s123.3: "critical limit" (s120.3(d)), "food hazard" (s120.3(e)), "importer" (s120.3(f)), "shall" (s120.3(j)), and "should" s120.3(k)).
However, FDA is proposing to modify the term "preventive measure" to "control measure"
(s120.3(b)) and to modify its definition from that used in the seafood HACCP regulation
(s123.3(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 s120.3(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 s123.3(k) with specific product
application. To apply these definitions to juice and to avoid listing specific processes,
the agency is proposing in s120.3(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"
(s120.3(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" (s120.3(g)(2)(ii)). For purposes of this rule,
the agency has tentatively decided that a retail establishment as set out in proposed s120.3(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 *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 s123.3. FDA is proposing in s120.3(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" (s120.3(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 s123.3. FDA is proposing in s120.3(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 s123.11 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 s123.11(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 (s123.11(c)). Section 123.11(b) sets forth requirements for
sanitation monitoring.
FSIS's regulations for meat and poultry require that official establishments develop,
implement, and maintain written SOP's for sanitation (9 CFR 416.11). Each official
establishment must take appropriate corrective action when it or FSIS determines
that the SOP's have failed to prevent direct contamination or adulteration of product (9
CFR 416.15). Each establishment must maintain daily records that are initialed and
dated to document the implementation and monitoring of the SOP's and any corrective
actions taken (9 CFR 416.16). Finally, FSIS verifies the adequacy and effectiveness of
the SOP's (9 CFR 416.17).
Insanitary facilities or equipment, poor food handling, improper personal hygiene,
and similar insanitary conditions create an environment in which products may become
contaminated with microorganisms, including pathogens. However, sanitation controls
may be difficult to fit into HACCP plans. Sanitation covers the whole processing environment,
not just CCP's. A prerequisite program is an appropriate mechanism for a situation,
such as sanitation, that does not lend itself well to HACCP controls. Therefore, sanitation SOP's are a type of prerequisite program that is essential to provide
a solid foundation for HACCP systems. The agency tentatively concludes that sanitation
SOP's are an essential foundation for HACCP systems for juice.
The second prerequisite program is one that provides control over materials that
are entering the plant. The SOP requirements of both the seafood and FSIS regulations
are limited to sanitation. However, the pilot program experience has suggested the
utility of controls on incoming material. A processor could use incoming material prerequisite
program SOP's, in a manner similar to the sanitation SOP's, i.e., to cover a range
of processing factors, not just CCP's. Although use of incoming material SOP's may not obviate the need for some CCP's in a HACCP plan, FDA anticipates that their
use could help to ensure the safety of the food produced.
Incoming material controls for raw produce could be invaluable in establishing the
conditions under which produce needs to be grown (including pesticide application)
and harvested to provide assurance to the processor that the raw produce will not
present hazards that the processor will otherwise need to control. For example, the processor's
incoming material SOP's could specify that the processor will only purchase carrots
that have not been fertilized with manure during growth. Another example is that
the incoming material control could specify that the processor will only accept apples
that have been picked from the tree, and that dropped apples are unacceptable. A
simple solution to control the possible *20466
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 s120.6(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 s123.11(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 (s123.11(b)(1)). Based on the foregoing, FDA is proposing a similar requirement in s120.6(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 s123.11(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 s120.6(a)(5).
The other provisions of s123.11(b) are based on CGMP and encompass basic sanitation
principles. Based on its consideration of the factors that it cited in arriving
at s123.11(b), the agency tentatively concludes that it is appropriate to require
in s120.6(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 s120.6(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 (s123.11(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 s120.6(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 (s123.11(c)). Monitoring
to *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 s120.6
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 s120.12.
Proposed s120.6(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 s123.11(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 s123.6(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 s120.7 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 s120.7 to require that juice processors use the same considerations
in their hazard analysis as required of seafood and meat and poultry processors (i.e.,
that they determine where hazards are introduced, and which hazards need to be controlled) because these considerations raise the fundamental issues that must
be considered in identifying the hazards present in any processing operation.
Finally, under the proposed regulation, the hazard analysis must be developed by
an individual trained in HACCP. Training is critical to the successful implementation
of HACCP systems. A trained individual will be able to understand and apply HACCP
principles to the hazard analysis.
The hazard analysis serves several purposes. It can identify any modifications to
a process or product that are necessary to ensure or improve the product's safety.
It can also provide the basis for determining CCP's. A specific analysis of a process
is necessary because aspects of the process that represent significant hazards in one
operation may not present significant hazards in another operation even though the
two operations produce the same or a similar product. Differences in equipment and
incoming materials are generally the basis for these variations. For example, processors
will use different equipment and incoming materials if producing juice from concentrate
than if they are producing the same juice from raw materials.
A summary of the deliberations and the rationale developed during the hazard analysis
should be kept for future reference. This information will be useful during reviews
and updates of the hazard analysis and the HACCP plan.
Although under both seafood HACCP and meat and poultry HACCP a hazard analysis is
required, a written hazard analysis is only required under the meat and poultry regulation.
In the seafood HACCP final rule, the agency presented its reasons for not requiring a written hazard analysis (60 FR 65096 at 65118). It stated:*20468
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 s120.7 that the hazard analysis be written
and maintained as a record in accordance with proposed recordkeeping requirements
(s120.12). 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 s101.4, 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 s120.7(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 s120.7(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 s123.6(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 s120.7(b).
F. HACCP Plan
1. The HACCP Plan
The seafood HACCP regulation requires in s123.6(b) that processors have and implement
a written HACCP *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 s120.8(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 s120.7. 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 s120.8(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 s120.8(a) is similar to provisions in both s123.6(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 s120.8(a) that the HACCP plan be
developed by an individual or individuals who have been trained in accordance with proposed
s120.13.
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 s120.8 that the HACCP plan be maintained in accordance with the recordkeeping
requirements of s 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 s123.6(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 s120.8(b)(1) to require that the plan list the food hazards
that are reasonably likely to occur as identified in accordance with s 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
s120.8(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 s120.8(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 s120.8(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 s120.8(b)(5) that processors include in their HACCP plan
any corrective action plans that have been developed in accordance with proposed
s120.10(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 *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 s120.8(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
s120.11. 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 s120.8(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 s113.3(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 s120.8(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
s120.6, 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 s 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 s120.8(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 s120.6, 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 s123.6(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 s120.9 that failure of a juice processor to have and to
implement a HACCP system that complies with s120.8 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 *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, s123.7(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 s 123.7(c). The steps in s123.7(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 (s123.7(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 s120.10 that it requires in
s123.7 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 s120.10 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 s120.8(b)(5)), or (2) the procedures outlined in proposed s120.10(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 s120.10(a) that processors may develop written
corrective action plans, which become part of their HACCP plans in accordance with
s120.8(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 s 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 s120.10(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 s120.10(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 s120.10(b)(2) requires that processors perform or obtain a review to determine
the acceptability of the affected product for distribution. This is fundamental
to determining the final outcome of the affected product. In some instances product
may simply need to be reprocessed, while at other times, the product may not be considered
adulterated. For example, if the pasteurization process did not reach the minimum
temperature specified by the CL, the juice can be diverted and rerouted through the pasteurizer for *20472
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 s120.10(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 s120.13, 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 s120.10(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 s120.10(b)(4) processors must take corrective action, when necessary,
to correct the cause of the deviation. As discussed for proposed s120.10(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 s120.10(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 s120.10(b)(5) reflects these
principles.
Finally, proposed s120.10(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 s120.10(b). The agency is proposing that these records be subject to the verification requirements in proposed s120.11(a) and the recordkeeping
requirements of s120.12. 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 (s123.8(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 s120.11(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 s120.11(a) sets forth the minimum requirements for verification activities.
Proposed s120.11(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 s120.11(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 s120.11(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 s120.11(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.*20473
Proposed s120.11(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 (s120.11(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 s120.11(a)(iv)(C)).
Proposed s120.11(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 s120.11(a)(2) that processors document, in records that are subject
to the recordkeeping requirements of s120.12, 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 s120.11(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 s120.11(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 s120.11(b) requires that the plan validation be performed by an individual
or individuals who have been trained in accordance with s120.13. The validation is
fundamental in determining whether the HACCP plan is adequate to control food hazards
that are reasonably likely to occur. HACCP plan validation may result in a need to
alter other aspects of the HACCP system and the prerequisite program SOP's. The
activities involved in plan validation are not routine activities but require an
understanding of the principles of HACCP and of plan development. This understanding is obtained
through training.
Initial validation of the HACCP plan is necessary to ensure that all significant
hazards have been identified, and that, if the HACCP plan is properly implemented,
these hazards will be effectively controlled. Subsequent validation of the HACCP
plan ensures that the plan continues to be effective.
Validation is especially important whenever any changes occur that could affect the
hazard analysis or alter the HACCP plan and prerequisite program SOP's in any way.
Without these assessments and subsequent changes, the HACCP plan may not control
the hazards that it should, and unsafe juice may be distributed. Therefore, the agency
tentatively concludes that validation of the HACCP plan is necessary to ensure that
juice processed in accordance with the plan will not have been processed under conditions
whereby it may have been rendered injurious to health.
The NACMCF states that the HACCP plan should be updated and revised as needed (Ref.
55). Changes in sources of incoming materials, formulations, processing, distribution,
and consumer use usually occur over time. New technologies may be developed. New
concerns that previously were not considered hazards reasonably likely to occur may
become apparent. For example, E. coli O157:H7 was not recognized as a human pathogen
before 1982 (Ref. 10), and the impact of its acid tolerance was not well understood. *20474
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 s120.11(b) that records of the plan validation
be subject to the requirements of s120.12.
Proposed s120.11(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 s120.11(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 s 120.11(c). The list is identical to that
proposed in s120.11(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 s120.11(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 s120.11(c) that the validation be performed by an individual
or individuals who have been trained in accordance with proposed s120.13. 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 s123.9 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 (s123.9(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 (s123.9(b)). Off site provisions for storage of records from processing
facilities that seasonally pack are allowed, provided that the records are reasonably
accessible (s123.9(b)(3)). All records must be available for official review (s123.9(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 s120.12 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 s120.12(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 s120.12(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 s120.12(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 s120.12(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 s120.12(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 *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 s120.7). 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 s120.12(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
s120.12(c)(1) provides that the signatures signify that these records have been accepted
for incorporation into the HACCP system by the firm.
In s120.12(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 s120.11(d)(1). As was discussed fully in the "Verification and Validation" section
of this preamble, FDA is proposing in s 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 (s123.6(d)).
The agency is proposing in s120.12(d) requirements for record retention. Proposed
s120.12(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 s120.12(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 s120.12(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 s120.12(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 s120.12(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 s120.12(d)(3) that electronic records are considered to be on-site if they are accessible from an on-site location
and comply with proposed s120.12(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 s120.12(d)(4) that, if the processing facility is closed for a prolonged
period between seasonal packs, the records may be transferred to some other reasonably
accessible *20476
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 s120.12(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 s120.12(e) is intended
to be flexible enough to cover State officials if their agency adopts any final regulation
by reference.
Proposed s120.12(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 s120.12(f) as are found
in s123.9(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 s 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 s123.10 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 s120.13(a) that only an individual who has met specified
training requirements can be responsible for certain functions. Those functions are
listed in proposed s120.13(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 s120.13(a) for simplicity and is not imposing
any additional requirement through this list.
Proposed s120.13(b) requires that the individual performing the functions listed
in proposed s120.13(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 s120.13(b) that the training be at least equivalent to that received
under standardized curriculum recognized as adequate by FDA.
FDA is also proposing in s120.13(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 *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 s120.13(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 s123.12. According to s123.12(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 (s123.12(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 (s123.12(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 s123.12 are appropriate for and applicable to juice, and is proposing the same
requirements in s120.14 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
s120.14 essentially tracks s123.12. 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 super-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 s120.24.
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., 10 super5 ) reduction in the most resistant microorganism of public health significance
that is likely to occur in the juice for at least as long as the shelf life of the
product under normal and moderate abuse conditions. The agency requests comment
on the appropriateness of the 5 log reduction performance standard and if other approaches,
such as establishing a minimal acceptable risk standard for juices, could be used
that would ensure the safety of the juice. The agency requests comments on what
such a minimal acceptable risk standard should be and how it would be implemented. The
agency also invites interested persons to submit scientific data concerning the acceptability
of a 5 log reduction requirement or whether a more or less stringent performance standard (e.g., 3 or 7 log reduction) for specific juices would be more appropriate
or whether different approaches consistent with a minimal acceptable risk standard
for juices might be appropriate for specific juices based on their unique characteristics.
In the absence of known specific pathogen-product associations, the NACMCF recommended
the use of E. coli O157:H7 or L. monocytogenes as the target organism, as appropriate.
This recommendation is based on the number of known outbreaks of E.coli in juice as described in section I.A of this document and the ubiquitous nature of L. monocytogenes.
E. coli is known to be unusually acid resistant (Refs. 60 and 61), and L. monocytogenes
is relatively heat resistant (Refs. 62 and 63). Therefore, depending on the type of juice, one of the two NACMCF recommended target organisms will likely
be the most resistant microorganism of public health *20478
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 s 120.5)
and sanitation SOP's (proposed s120.6) 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 s120.24 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 *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
s120.24, 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.
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Table 1.--Estimated Annual Recordkeeping Burden
21 CFR Sections No. of Annual Hours per Total
Recordkeepers Frequency Recordkeeper Hours
-------------------------------------------------------------------------------
120.6(c) ......................... 600 1 [FN2] .................... 4 4,800
[FN2]
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 [FN2] .................... 8 4,800
[FN2]
120.8(a) and
120.12(a)(3) and
(c) ............................ 600 1 [FN2] .................... 8 4,800
[FN2]
120.8(b)(7) and
120.12(a)(4)(i) ................ 600 ...... 14,600 ........... 0.01 .. 87,600
120.11(b) and
120.12(a)(5) ................... 600 ........... 1 .............. 4 ... 2,400
120.11(a)(1)(iv) ................. 600 .......... 52 ............ 0.1 ... 3,120
120.10(c) and
120.12(a)(4)(ii) ............... 600 .......... 12 ............ 0.1 ..... 720
120.14(a)(2) ..................... 308 ........... 1 .............. 4 ... 1,232
120.12(e) .......... 182 [FN3] ................... 1 .............. 4 ..... 728
Totals:First year 111,400 Subsequent years 97,000
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FNThere are no operating and maintenance cost or capital costs associated
with this collection of information.
FN2 First year only.
FN3 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
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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
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5. Centers for Disease Control, "Salmonella typhimurium Outbreak Traced to a Commercial
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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
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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
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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 *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
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.
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
s120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages shall be processed
in accordance with the requirements of this part. Juice means the aqueous liquid
expressed or extracted from one or more fruits or vegetables, purees of the edible
portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.*20482
(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.
s120.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food,
Drug, and Cosmetic Act, s101.9(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.
s120.5 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.
s120.6 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
s120.12.
(d) Relationship to Hazard Analysis and Critical Control Point (HACCP) plan. Prerequisite
program SOP controls may be included in the HACCP plan required under s120.8(b).
However, to the extent that they are implemented in accordance with this section,
they need not be included in the HACCP plan.
s120.7 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, *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 s120.13 and shall be subject to the recordkeeping requirements of
s120.12.
(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.
s120.8 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 s120.7. The HACCP plan shall be developed
by an individual or individuals who have been trained in accordance with s120.13 and
shall be subject to the recordkeeping requirements of s120.12. 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 s120.7, 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
s120.10(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 s120.11;
and
(7) Provide for a recordkeeping system that documents the monitoring of the critical
control points in accordance with s120.12. 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 s120.6, they are not required
to be included in the HACCP plan.
s120.9 Legal basis.
Failure of a processor to have and to implement a Hazard Analysis and Critical Control
Point (HACCP) system that complies with ss120.6, 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.
s120.10 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
s120.8(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 s120.13;
(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 s120.11, by an individual
or individuals who have been trained in accordance with s120.13, to determine whether
modification of the HACCP plan is required to reduce the risk of recurrence of the
deviation, and to modify the HACCP plan as necessary.
(c) All corrective actions taken in accordance with this section shall be fully documented
in records that are *20484
subject to verification in accordance with s120.11(a)(1)(iv)(B) and the recordkeeping
requirements of s 120.12.
s120.11 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 s120.13, 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 s120.10. 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 s120.10 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 s120.12.
(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 s120.13 and shall be subject to the recordkeeping requirements of s120.12.
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 s120.13
and shall be subject to the recordkeeping requirements of s120.12.
s120.12 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 s120.6);
(2) The written hazard analysis required by s120.7;
(3) The written HACCP plan required by s120.8;
(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 s120.11.
(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 *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 s120.12(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 s20.81 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 s20.61 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.
s120.13 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 s120.7;
(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 s 120.8;
(3) Validating and modifying the HACCP plan in accordance with the corrective action
procedures specified in s120.10(c)(5) and the validation activities specified in
s120.11(b) and (c); and
(4) Performing the record review required by s120.11(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.
s120.14 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
s120.12.
(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
s120.20 General.
This subpart augments subpart A of this part by setting forth specific requirements
for process controls.
s120.24 Process controls.
In order to meet the requirements of subpart A of this part, processors of juice
products, except those subject to the requirements of part 113 or 114 of *20486
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., 10
super5 ) 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]