[Federal Register Volume 63, Number 79 (Friday, April 24, 1998)]
[Proposed Rules]
[Pages 20450-20486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11025]



[[Page 20449]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Parts 120 and 101



Hazard Analysis and Critical Control Point (HACCP); Procedures for the 
Safe and Sanitary Processing and Importing of Juice; Food Labeling: 
Warning Notice Statements; Labeling of Juice Products; Proposed Rules

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

RIN 0910-AA43
[Docket No. 97N-0511]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt 
regulations to ensure the safe and sanitary processing of fruit and 
vegetable juices and juice products. The proposed regulation, if 
adopted, will mandate the application of Hazard Analysis and Critical 
Control Point (HACCP) principles to the processing of these foods. 
HACCP is a preventive system of hazard control. FDA is proposing these 
regulations because there have been a number of outbreaks of illness, 
including some directly affecting children, associated with juice 
products and because a system of preventive control measures is the 
most effective and efficient way to ensure that these products will be 
safe. Elsewhere in this issue of the Federal Register, FDA is 
publishing a warning label proposal for packaged juice.

DATES: Submit written comments by July 8, 1998. For information on the 
proposed compliance dates for small businesses and very small 
businesses see the Supplementary Information section of this document.

    Submit written comments on the information collection requirements 
by May 26, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Submit written comments regarding information 
collection to the Office of Information and Regulatory Affairs, Office 
of Management and Budget, New Executive Office Bldg., 725 17th St. NW., 
rm. 10235, Washington, DC 20503, Attention: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:
    The agency proposes to make any final rule based upon this proposal 
effective 1 year after its date of publication in the Federal Register. 
However, by its terms, the final rule will not be binding on small 
businesses as defined in proposed Sec. 120.1(b)(1) until 2 years after 
the date of publication of a final rule in the Federal Register; and 
for very small businesses as defined in proposed Sec. 120.1(b)(2), the 
final rule will not be binding until 3 years after the date of its 
publication in the Federal Register.

I. Concerns With Juice

A. Microbial Outbreaks

    The Seattle-King County Department of Public Health and the 
Washington State Department of Health reported on October 30, 1996, an 
outbreak of Escherichia coli O157:H7 infections epidemiologically 
associated with drinking a particular brand of unpasteurized apple 
juice, or juice mixtures containing unpasteurized apple juice, 
purchased from a coffee shop chain, grocery stores, and other locations 
(Ref. 1). A case was defined as hemolytic uremic syndrome (HUS) or a 
stool culture yielding E. coli O157:H7 in a person who became ill after 
September 30, 1996, after drinking the particular brand of juice within 
10 days before illness onset. There were at least 66 cases of illness, 
with 14 cases of HUS and the death of one child, associated with this 
outbreak (Ref. 2). Cases occurred in British Columbia, California, 
Colorado, and Washington. E. coli O157:H7 isolates cultured from a 
previously unopened container of the particular brand of apple juice 
had a deoxyribonucleic acid (DNA) ``fingerprint'' pattern (restriction 
fragment length polymorphism) indistinguishable from case-related 
isolates (Ref. 1).
    Various juices have been documented as vehicles for causing 
outbreaks from microorganisms. A 1967 outbreak from contaminated water 
added to orange juice concentrate affected approximately 5,200 persons 
and was caused by an unidentified virus and possibly other contaminants 
(Refs. 3 and 4). About 300 people became ill from Salmonella 
typhimurium in cider made from apples, including some that had been 
picked up from the ground in an orchard fertilized with manure, in a 
1974 outbreak in New Jersey (Ref. 5). A 1991 outbreak of Vibrio 
cholerae was associated with coconut milk contaminated during 
manufacturing in Thailand (Ref. 6). There have been two Cryptosporidium 
outbreaks related to drinking apple cider, the first in Maine in 1993 
and the other in New York State in 1996. In the first case, the apples 
used for cider came from trees near a cow pasture (Ref. 7), and in the 
second case, water used for rinsing came from a well that tested 
positive for coliforms (Ref. 8). In 1995 there was an outbreak in 
Florida that was caused by Salmonella hartford in unpasteurized orange 
juice (Ref. 9).
    E. coli O157:H7 has been recognized relatively recently as a human 
pathogen and has been a source of a number of outbreaks related to 
juice. Thirteen and possibly 14 children had bloody diarrhea and 
developed HUS in Toronto, Canada, between September 15 and 25, 1980. 
The children's illnesses were associated with drinking fresh apple 
juice. The children's stools were examined for enteropathogenic E. 
coli, Campylobacter, Salmonella, Shigella, and Yersinia. None of these 
organisms were found. E. coli O157:H7 is the suspected causative 
organism. Conclusive testing for that organism was not done because E. 
coli O157:H7 was not recognized as a human pathogen before 1982 (Ref. 
10).
    A 1991 E. coli O157:H7 outbreak in southeast Massachusetts 
conclusively showed that fresh-pressed unpasteurized apple juice can 
transmit E. coli O157:H7 bacteria. In this outbreak, 23 individuals had 
diarrhea, 16 had bloody diarrhea, and 4 developed HUS (Ref. 11).
    In Connecticut, a 1996 outbreak of E. coli O157:H7 illness was 
associated with drinking a particular brand of apple cider. There were 
14 cases of illness (including 7 hospitalized), with 3 cases of HUS 
associated with the outbreak (Ref. 8).
    There was a small outbreak of E. coli O157:H7 illness in Washington 
State in 1996 that was related to apple cider made at a church event. 
This outbreak occurred during the same time as the unpasteurized apple 
juice outbreak described in previous paragraphs. The apples were washed 
in a chlorine solution, but it was not reported how much chlorine was 
used. Six people became ill, but no estimate was given on how many 
people may have drunk the apple cider (Ref. 12).
    FDA's recall data also provide evidence of microbial hazards in 
juice. There were 85 cases of illness in 1994 resulting in a recall of 
orange juice that had fermented and contained Bacillus cereus and yeast 
(Ref. 13).
    State investigations provide additional evidence of microbial 
hazards in juice. A 1989 outbreak in New York was caused by the 
presence in orange juice of Salmonella typhi that originated from an 
infected worker and

[[Page 20451]]

resulted in 69 illnesses with 21 individuals hospitalized (Ref. 14). 
The State of Washington reported that in 1993 one individual was 
hospitalized from home-made carrot juice found to contain Clostridium 
botulinum (Ref. 15). A 1993 Ohio outbreak caused by yeast or some other 
unknown toxicant in orange juice resulted in 23 illnesses (Ref. 16). A 
home-made watermelon drink contaminated with Salmonella spp. caused 
illness in 18 individuals in a 1993 Florida outbreak (Ref. 17). The 
State of Colorado reported two outbreaks of gastrointestinal illness 
from fresh squeezed orange juice at a mountain resort (Ref. 18). There 
were food handlers that were ill in both Colorado instances, and a 
virus was suspected as the causative agent.
    The evidence shows that certain juices have been the vehicle for 
outbreaks of foodborne illnesses. Although fruit juice is acidic, and 
thus would generally be considered to inhibit the growth of most 
microorganisms, most juice-related outbreaks have been associated with 
fruit juices.

B. Illnesses From Nonheat-treatable Hazards

    Illnesses that have been caused by hazards that can not be reduced 
to acceptable levels by heat treatments have also been associated with 
juice. Tin in canned tomato juice caused illness in 113 individuals in 
1969 (Ref. 19). Soil nitrate had resulted in a high nitrate content in 
the tomatoes, and this high nitrate content accelerated detinning in 
the cans. In 1984, 11 persons became ill from consuming elderberry 
juice prepared by staff of a religious/philosophic group that contained 
poisonous parts of the plant (Ref. 20). A 1990 guanabana juice outbreak 
was caused by the presence of toxic guanabana seed material and caused 
illness in nine individuals (Ref. 21). A 1997 outbreak was caused by 
tin in pineapple juice (Ref. 22).
    In 1992 an 18-month-old child with a blood lead level of 36 
micrograms per deciliter (<greek-m>g/dL) was found in a routine county 
health department blood lead monitoring program. Investigation of this 
incident by the county health department revealed that the only 
significant source of lead exposure for this child was lead in imported 
fruit juice packed in 12-ounce, lead-soldered cans (Ref. 23). Analysis 
by the State health department of multiple flavors of the fruit juices 
in lead-soldered cans available to the child found lead levels ranging 
from 160 to 810 parts per billion (ppb). An exposure assessment 
performed by the county health department estimated that the child 
consumed about three cans of these fruit juices per day and estimated 
that the child's daily lead intake from these fruit juices was 
approximately 600 <greek-m>g/day (Ref. 23). As a result of this 
incident, FDA announced an emergency action level of 80 ppb for lead in 
fruit beverages (such as juices, nectars, and drinks) packed in lead-
soldered cans (58 FR 17233, April 1, 1993). The agency subsequently 
banned the use of lead-soldered cans (60 FR 33106, June 27, 1995).
    Recalls also provide evidence of nonheat-treatable hazards in 
juice. In 1988 a fruit punch drink was recalled because of the presence 
of tin caused by the acidity of the drink reacting with the tin coating 
of the cans (Ref. 24). The product had been packaged in the wrong 
container.
    There were 10 recalls between 1990 and 1995 for fruit juice or 
beverages containing fruit juice because of the presence of food 
ingredients that were inadvertently added to the product, not declared 
on the label, or not suitable for the food. Food ingredients involved 
with these recalls were natamycin (Ref. 25), sulfites (Ref. 26), FD&C 
yellow No. 5 (Refs. 27 through 33), and salt (Ref. 34).
    Five recalls between 1991 and 1997 were caused by improper 
sanitation procedures or faulty equipment. In 1991 sodium hydroxide 
from a clean-in-place system contaminated the caps of a citrus punch 
drink (Ref. 35). In 1992 three persons became ill, with 1 hospitalized, 
from a sodium hydroxide sanitizing agent that got into fruit drink 
product containers during cleaning (Ref. 36). In 1993 cracks in a heat 
exchanger allowed an orange flavored soft drink containing pear juice 
to come in contact with copper pipe fittings and, thus, to become 
contaminated with copper (Ref. 37). In 1994 milk was found in orange 
juice from filler lines that were not cleaned between milk and juice 
production (Ref. 38). In 1997 the presence of an alkaline cleaning 
solution in a berry juice caused gastrointestinal distress in several 
persons (Ref. 39).
    Companies have recalled fruit drinks because pieces of glass or 
plastic were found in their products. The presence of glass in products 
is typically caused by the use of glass bottles, which can chip or 
shatter during the production process (Refs. 40 through 42). The 
plastic was present from the company's practice of draping plastic bags 
over the side of the bottle loading bin (Ref. 43).
    One company recalled apple-prune juice and prune juice in 1996 
because of unacceptable levels of lead (Refs. 46 and 47). The cause was 
contaminated imported prune juice.
    In response to the establishment of maximum levels for patulin in 
apple juice by several foreign governments, FDA initiated a sampling 
survey to determine the levels commonly found in domestic and imported 
apple juice. Patulin may be present in juice made from moldy apples. In 
March 1997 the agency found inordinately high levels of patulin in 
apple juice from a processor in Washington State (Ref. 48). The level 
of patulin found in the product was sufficient to pose a health hazard, 
especially considering the fact that apple juice is commonly used by 
infants and young children (Ref. 49). All affected products that had 
left the plant had been used in the manufacture of fermented apple 
cider. Patulin could not be detected in fermented product, and it was 
assumed that the patulin was destroyed through the fermentation 
process.
    Therefore, as the foregoing discussion reveals, the evidence 
demonstrates that juice and juice beverages are susceptible to chemical 
and physical hazards as well as microbiological hazards.

C. Underreporting

    There is wide agreement that the laboratory-confirmed cases from 
outbreaks and recalls understate the actual number of juice-related 
cases, but no consensus exists on the size of the understatement. 
Individuals may not manifest all symptoms or have severe enough 
symptoms to necessitate medical attention. Medical personnel may simply 
treat an individual's symptoms without determining the underlying 
cause. The laboratory-confirmed cases only represent those cases where 
individuals sought medical attention, and where medical personnel 
performed the necessary testing and reported the case to a government 
agency.
    While the actual number of juice-related illnesses is unknown, FDA 
has derived an estimate of the total number by multiplying the average 
number of laboratory-confirmed cases by factors that account for under-
reporting. The factors are based on the relationships between annual 
outbreak cases and published estimates of the number of foodborne 
illnesses. For example, using these adjustment factors, it is estimated 
that the average 16 annual laboratory-confirmed cases of Salmonella 
represents 4,900 to 7,600 actual cases (Ref. 50). For E. coli O157:H7, 
an average 22 laboratory-confirmed cases per year may actually 
represent 2,200 to 4,300 total juice-related cases (Ref. 50). 
Therefore, the agency assumes that the

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actual number of illnesses from the outbreaks described in sections I.A 
and I.B of this document is much greater than the confirmed number of 
illnesses. (For a more complete discussion of these estimates, see the 
agency's preliminary regulatory impact analysis and Ref. 50)

D. Pesticides

    Pesticides are usually applied to plants to combat insects, plant 
diseases, and weed growth to assist in the growth of the fruit or 
vegetable. A food is considered adulterated under section 402(a)(2)(B) 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
342(a)(2)(B) if pesticide residues are present above the Environmental 
Protection Agency (EPA) established tolerances, or if EPA has not 
established a tolerance for use of the pesticide on the particular 
plant. FDA annually monitors a wide variety of foods for pesticide 
residues.
    In 1994 FDA sampled 1,411 domestic fruits and fruit products, 
including apple juice and other fruit juices, for pesticide residues 
and found that less than 1 percent were violative for being over 
tolerance and less than 1 percent were violative for having no 
tolerance (Ref. 51). None of the 122 samples of apple juice or 44 
samples of other fruit juices were violative. Out of 1,795 samples of 
domestic vegetables and vegetable products tested, FDA found that less 
than 1 percent of samples were over tolerance, and that 2 percent were 
violative for having no tolerance.
    FDA also tested 1,940 imported fruits and fruit products in its 
1994 pesticide residue monitoring program. Less than 1 percent of the 
items tested were over tolerance and 3 percent were violative for 
having no tolerance. None of the 110 fruit juices sampled were 
violative. The agency sampled 2,460 imported vegetables and vegetable 
products and found that less than 1 percent were violative for being 
over tolerance and 4 percent for having no tolerance.
    In its 1995 pesticide monitoring program FDA found less than 1 
percent of 1,437 samples of domestic fruits and fruit products to be 
violative for being over tolerance and 1 percent to be violative for 
having no tolerance (Ref. 52). Of the 110 apple juices and 22 other 
fruit juices sampled, only a single apple juice sample was found to be 
violative, because of the presence of a pesticide with no established 
tolerance. Analysis of 1,585 samples of domestic vegetable and 
vegetable product produced results similar to the results found in 
1994, i.e., less than 1 percent of samples were over tolerance, and 
approximately 2 percent were violative because there were no tolerances 
for the pesticide residues that FDA found.
    The agency sampled 1,757 imported fruits and fruit products for 
pesticides in 1995 and found that less than 1 percent were violative 
for being over tolerance, and that 3 percent were violative for having 
no tolerance. Of the 19 apple juices and 52 other fruit juices tested, 
2 apple juice samples were violative because they contained pesticides 
for which there were no established tolerances. The agency sampled 
2,535 imported vegetables and vegetable products and found that 1 
percent were violative for being over tolerance, and that 3 percent 
were violative for having pesticide residues for which there was no 
tolerance. Some of these samples contained both residues over tolerance 
and residues with no tolerance.
    Although there are no documented outbreaks caused by unlawful 
pesticide residues, chronic exposure to pesticide residues that do not 
conform to EPA tolerances increase risks to the public health. 
Therefore, juice processors must determine whether the possible 
presence of unlawful pesticide residues is a hazard that is reasonably 
likely to occur.

E. FDA's Public Meeting

    As a result of the October 1996 apple juice outbreak from E. coli 
O157:H7, FDA held a public meeting on December 16 and 17, 1996 
(hereafter referred to as the juice meeting) (see notice of meeting (61 
FR 60290, November 27, 1996)), to review the current science, including 
technological and safety factors, relating to fresh juices and to 
consider measures necessary to provide safe fruit juices to the public. 
Interested persons were given until January 3, 1997, to submit written 
comments on the notice. On January 2, 1997 (62 FR 102), FDA extended 
the comment period to February 3, 1997, in response to several requests 
for an extension.
    The purpose of the juice meeting was to provide a forum for an 
information exchange on current industry practices for the production 
of juice products and on developments in the science underlying the 
production of safe juices. Experts from industry, academia, and the 
regulatory and consumer sectors presented information on illnesses and 
the epidemiology of outbreaks arising from contaminated juices; 
concerns about emerging pathogens; the E. coli O157:H7 outbreak in 
October 1996 caused by contaminated apple juice; procedures for 
processing juices; and new and existing technology to remove or 
decrease the number of pathogens or other contaminating microorganisms. 
Time was available for questions and comments from all attendees.
    The meeting provided an opportunity to: (1) Consider how FDA's 
regulatory program for fresh juice and juice products should be 
revised,(2) discuss and exchange information on relevant safety issues, 
(3) to identify research needs where appropriate, (4) consider whether 
additional consumer education is necessary, and (5) consider whether 
other measures are needed to reduce the risk of future outbreaks of 
illness from juice.
    FDA received over 180 comments from industry (with a number of 
these describing themselves as small businesses), consumers, consumer 
organizations, trade organizations, scientific/technical companies, 
academic institutions or organizations, State agencies, a local 
government agency, and members of Congress. Although most of the 
comments concerned apple juice specifically, many comments pertained to 
juices in general, and some referred only to citrus juices. Most 
comments were concerned with changes in processing to improve the 
safety of juices. Among the changes suggested were requiring 
pasteurization of juices, requiring HACCP, or establishing current good 
manufacturing practices (CGMP's) in juice processing. The agency has 
attempted to address the comments made at the meeting or submitted in 
response to the Federal Register notice in this proposal. If there are 
any significant concerns that the agency has not addressed, these 
concerns should be brought to the agency's attention in comments on 
this proposal.
    The Fresh Produce Subcommittee (FPS) of the National Advisory 
Committee on Microbiological Criteria for Foods (NACMCF) attended the 
public meeting. The FPS met after the public meeting and made 
recommendations to the NACMCF. The NACMCF subsequently met to discuss 
the issues that were raised at the meeting. Based on information that 
was presented at the meeting and on the FPS's expertise, the full 
NACMCF made several recommendations (Ref. 53). The NACMCF stated that 
there are many aspects that affect pathogen control, such as 
agricultural practices; product handling; equipment used; growing 
location, including produce obtained from below ground (carrots), on 
ground (e.g., tree drops), or picked from trees; pH; acidulants; method 
of processing; degree of animal contact; refrigeration; packaging; and 
the distribution system. It stated that, in determining the best 
control mechanisms, it is important to remember that the conditions for

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microbial survival differ from those for growth. The NACMCF recognized 
that, while the risks associated with specific juices vary, there are 
safety concerns associated with juices, especially unpasteurized 
juices.
    The NACMCF concluded that: (1) The history of public health 
problems associated with fresh juices indicates a need for active 
safety interventions, and (2) for some fruit (e.g., oranges), the need 
for intervention may be limited to surface treatment, but for others, 
additional interventions may be required (e.g., pasteurization of the 
juice).
    The NACMCF recommended to FDA the use of safety performance 
criteria instead of mandating the use of a specific intervention 
technology. In the absence of known specific pathogen-product 
associations, the NACMCF recommended the use of E. coli O157:H7 or 
Listeria monocytogenes as the target organism, as appropriate. This 
recommendation was based on the premise that these organisms are two of 
the most difficult to control (i.e., by juice acidity or heat 
lethality), and that, by controlling them, other pathogenic organisms 
will likely be controlled. The NACMCF suggested that a tolerable level 
of risk may be achieved by requiring interventions that have been 
validated to achieve a cumulative 5 log reduction in the target 
pathogen or a reduction in yearly risk of illness to less than 
10<SUP>-5</SUP>, assuming consumption of 100 milliliters (mL) of juice 
daily.
    In addition, the NACMCF stated that HACCP and safety performance 
criteria should form the general conceptual framework to ensure the 
safety of juices, and that control measures should be based on a 
thorough hazard analysis. The NACMCF also stated that validation of the 
process must be an integral part of this framework. The NACMCF 
recommended mandatory HACCP for all juice products, and that processors 
should implement and strictly adhere to industry CGMP's. The NACMCF 
also recommended industry education programs addressing basic food 
microbiology, the principles of cleaning and sanitizing equipment, 
CGMP's, and HACCP.
    The NACMCF recommended further study in several areas:
    (1) The efficacy of new technologies and intervention strategies 
for safety;
    (2) The contamination, survival, and growth of pathogens on produce 
with or without breaks in skin, with or without areas of rot, and 
within the core;
    (3) How produce becomes contaminated with human pathogens, 
including the relevant microbial ecology during production and 
processing of juice. In particular, the NACMCF stated that there is an 
urgent need for these types of studies on E. coli O157:H7 in apple 
juice;
    (4) The baseline incidence of human pathogens on fruits and 
vegetables, particularly on those used in juice processing; and
    (5) Labeling information needed for consumer understanding and 
choice of safer juices and juice products.
    On the basis of all the testimony presented at the December 16 and 
17, 1996, meeting, the NACMCF agreed that there is a need to understand 
the differences among all juice and juice products (e.g., citrus versus 
other). A significant problem identified by the NACMCF is that 
consumers presently do not have a means to clearly differentiate 
between unpasteurized and pasteurized products, and that terms used to 
refer to juice products do not always have universal meanings. For 
example, the term ``cider'' is perceived to be an unpasteurized product 
whereas the term ``juice'' is often perceived to be pasteurized.
    The NACMCF also stated that traditional heat treatments given to 
juices and juice products have been designed to achieve shelf 
stability, to remove water (i.e., concentration), or to affect other 
quality-related factors, and that these treatments, commonly referred 
to as ``pasteurization,'' are greatly in excess of a process needed to 
inactivate foodborne pathogens.
    Because of the lack of sufficient data to evaluate the 
effectiveness of labeling statements as safety interventions or to 
inform consumer choice, the NACMCF stated that it could not strongly 
endorse labeling as an interim safety measure.
    Although the NACMCF did not endorse labeling as an interim safety 
measure, elsewhere in this issue of the Federal Register FDA is 
proposing interim labeling measures for packaged juice. The agency sets 
forth its reasons for proposing to adopt these measures in that 
proposal.

II. Consideration of How to Address Problems

A. Current Regulation of Juice

    FDA has established labeling regulations and standards of identity 
for a number of juices. 21 CFR 101.30 pertains to percentage juice 
declaration for beverages that contain fruit or vegetable juice. Common 
or usual name regulations for nonstandardized beverages that contain 
fruit or vegetable juice are found in 21 CFR 102.33. Standards of 
identity are found in part 146 (21 CFR part 146) for a number of fruit 
juices and beverages and in part 156 (21 CFR part 156) for tomato 
juice. The standard of identity for pasteurized orange juice 
(Sec. 146.140) states that ``The orange juice is so treated by heat as 
to reduce substantially the enzymatic activity and the number of viable 
microorganisms.'' Pasteurized orange juice must be labeled as such.
    In the 1997 Food Code, FDA articulated its policy regarding 
unpasteurized apple juice (Ref. 54). The code states that food 
establishments (e.g., nursing homes) that serve apple juice, apple 
cider, or other beverages that contain apple juice to segments of the 
population that are highly susceptible to disease (e.g., the elderly) 
should serve juice that has been pasteurized or that is in a 
commercially sterile, shelf-stable form, in a hermetically sealed 
container.

B. The Current Inspection System

    Juice processors, like other food processors, are subject to 
periodic unannounced, mandatory inspection by FDA. This inspection 
system provides the agency with a picture of conditions at a facility 
at the time of the inspection. However, assumptions must be made about 
conditions at the facility before and after that inspection, as well as 
about important factors beyond the facility that have a bearing on the 
safety of the finished product. The reliability of these assumptions 
over the intervals between inspections can create questions about the 
adequacy of the system.
    FDA's inspections are based, in part, upon its regulations on CGMP 
in the manufacturing, packing, or holding human food in part 110 (21 
CFR part 110). For the most part, these regulations set out broad 
statements of general applicability to all food processing on matters 
such as sanitation, facilities, equipment and utensils, processes, and 
controls. HACCP-type controls are listed as one of several options 
available to prevent food contamination (Sec. 110.80(b)(13)(i)), but 
they are not integral to the controls outlined in the regulations.
    The inspection and surveillance strategies that FDA uses ascertain 
a manufacturer's knowledge of hazards and preventive control measures 
largely by inference (i.e., based on whether a company's products are 
in fact adulterated, or whether conditions in a plant are consistent 
with CGMP). It is the manufacturer's responsibility to ensure that its 
products are in compliance with the act. However, in the face of new 
pathogens, such as E. coli O157:H7, and the risk of illness associated 
with these pathogens, especially for children, the elderly, and

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the immunocompromised, FDA tentatively concludes that, at least for 
juices, new measures to control microbial, chemical, and physical 
hazards are necessary to ensure that finished products comply with the 
act's standards.

C. Alternatives

    Comments from the juice meeting suggested several alternatives to 
ensure that juice products are safe. These alternatives are discussed 
in sections II.C.1 through II.C.6 of this document along with their 
impact on the current situation with juice.
1. Increased Inspection
    Continuous visual inspection of juice production is not a viable 
alternative because few hazards associated with juice are detectable 
through visual inspection.
    Another possibility is to direct significant additional resources 
toward increasing the frequency of FDA's inspection of juice 
manufacturers, as well as increasing the agency's sampling, laboratory 
analysis, and related regulatory activities with respect to these 
products. While many samples of domestic and imported juice products 
are collected each year for analysis in FDA laboratories, and this 
sampling is designed to represent a broad range of products and to 
target known problems, the product sampled represents only a small 
fraction of the total poundage of the juice products consumed in this 
country. Substantially more expenditures would be needed to increase 
laboratory analyses to statistically significant levels.
    Even if the funds for increased FDA inspection and increased 
sampling and analysis were available, this approach alone would not 
likely be the best way for the agency to spend its limited resources to 
protect the public health. Reliance on end-product testing involves a 
certain amount of inefficiency and enormous sample sizes and testing on 
a lot-by-lot basis are necessary to overcome that inefficiency. 
Therefore, this option has significant limitations.
    Some comments from the juice meeting stated that juice safety would 
be improved through more local/State inspection rather than Federal 
inspection.
    FDA agrees that more local/State inspection would help to ensure 
the safety of juices, particularly where because FDA lacks 
jurisdiction, there is no connection between the juice products and 
interstate commerce. However, FDA is not in a position to mandate that 
State and local regulatory agencies conduct additional inspections with 
their limited resources. Further, FDA cannot mandate that a State 
ensure that a firm is complying with FDA's regulations. Therefore, 
increased local/State inspection for juice is not an option upon which 
FDA can rely.
2. CGMP's
    Many comments from the juice meeting urged the implementation of 
industry CGMP's or sanitation standards to increase the safety of 
juices. Some comments provided State rules, model CGMP's, or sanitation 
guidelines for FDA's consideration. Other comments stated that there is 
a need for more industry education on sanitation and hygiene.
    CGMP regulations have a twofold purpose: (1) To provide guidance on 
how to reduce insanitary manufacturing practices and on how to protect 
against food becoming contaminated, and (2) to set out objective 
requirements that enable industry to know what FDA expects an 
investigator to find when he or she visits a food plant (51 FR 22458 at 
22459, June 19, 1986). CGMP's consist generally of broad statements on 
sanitation, facilities, equipment and utensils, processes, and controls 
that are of general applicability to food processing. Therefore, FDA 
issuance of CGMP's for juice would be an approach that could assist 
manufacturers in the production of safe juices.
    FDA encourages the juice industry to use CGMP's to help ensure the 
safety of their juices. As stated previously, the NACMCF recommended 
that processors implement and strictly adhere to industry CGMP's. 
However, the use of CGMP's alone may not be adequate to ensure that 
juices are safe because of the broad based nature of CGMP's. CGMP's are 
directed at plantwide operating procedures and do not concentrate on 
the identification and prevention of food hazards. Therefore, the 
agency tentatively concludes that CGMP's, although useful, will not be 
adequate, without additional measures, to ensure the safety of juices.
3. Mandatory Pasteurization
    The majority of the comments from the juice public meeting 
pertained to pasteurization of juice. A number of comments urged FDA to 
mandate pasteurization or other equivalent treatment of fruit juice to 
ensure its safety. One person who commented reported that customers of 
his apple cider had not complained about a difference in flavor when he 
implemented pasteurization. One comment requested a 2-year grace period 
for small businesses before implementation if pasteurization were to be 
required. Another suggested that pasteurization be required for apple 
cider only if CGMP's and HACCP fail. One comment suggested that 
pasteurization be required only for apple juice, because of the 
difficulty in cleaning apples as compared to other fruits.
    However, most comments opposed mandatory pasteurization of juices 
because of: (1) The expense of pasteurization equipment, (2) preference 
by some consumers for the flavor of unpasteurized over pasteurized 
juice, (3) the safety record of juices, and (4) degradation of 
nutritional value from heat treatment. Many comments from small 
businesses claimed that they would be forced to close their operations 
if pasteurization were required. Some comments also stated an economic 
need for the use of dropped apples (``drops''), with one recommending 
the use of only hand-picked (rather than machine-picked) drops. Other 
comments stated that the use of drops should be prohibited, at least in 
unpasteurized juices.
    FDA is aware of the significant safety advantages of pasteurizing 
juice as well as of the reasons that some processors choose not to 
pasteurize their products. Pasteurization is a heat treatment used to 
kill the vegetative forms of specific bacteria in liquid or semi-liquid 
food products. Pasteurization is an effective and proven technology to 
ensure that juice does not contain pathogens. However, there may be 
other methods that are equally effective. Thus, the NACMCF recommended 
the establishment of safety performance criteria for appropriate target 
organisms rather than the establishment of a specific intervention 
technology. The NACMCF stated that safety performance criteria would be 
most effective.
    For example, whole oranges with an intact skin may be processed so 
that pathogens on the surface of the fruit are destroyed. Because 
pathogens are not reasonably likely to be present in the interior of an 
orange, surface treatment could be adequate to ensure the safety of the 
juice. This example illustrates that if FDA were to mandate 
pasteurization, such action could have the effect of limiting the 
development of new technologies that are as effective as pasteurization 
in particular circumstances but less intrusive and less expensive.
    Therefore, the agency tentatively concludes that relying on safety 
performance criteria, as recommended by the NACMCF, is an approach 
preferable to pasteurization. However, if the use of safety performance 
criteria

[[Page 20455]]

does not significantly decrease the number of microbial outbreaks 
caused by juice, the agency may consider adopting a regulation that 
mandates pasteurization.
    The agency disagrees with the comments that stated that it should 
require that apple juice be pasteurized because apples can be difficult 
to clean. FDA recognizes that pastuerization is a process that has been 
validated to meet NACMCF's recommendations. Manufacturers may be able 
to use other technologies and practices provided that their process is 
validated to achieve a 5-log reduction in the target pathogen. 
Therefore, reliance on safety performance criteria is a better long-
term approach because it provides for the development of new 
technologies.
    A number of comments at the juice meeting urged FDA to consider 
alternatives to pasteurization to increase the safety of juices. 
Alternatives suggested by the comments included extreme isostatic 
pressure, high pressure sterilization, ultra short time-heat exchanger 
processing, ohmic heating, aseptic packaging, modified atmosphere 
packaging, ultrafiltration, high temperature and high pH adjustment of 
wash-water, ultrahigh hydrostatic pressure, electric pulses, 
electromagnetic field, pulsed light, ultraviolet (UV) water treatment, 
UV treatment with photoreactivation, electron beam sterilization, 
irradiation, ozonated water treatment, microbiocidal additives 
(benzoate, sorbate), and pH adjustment. The comments recommended that 
sanitizers or ingredients for washes include use of chlorine, chlorous 
acid, chlorine with emulsifiers, trisodium phosphate, peroxyacetic 
acid, peracetic acid, or dimethyl dicarbonate.
    The agency agrees that there may be a number of agents that can 
reduce the number of microorganisms present in juice. As the NACMCF 
recommended, a tolerable level of risk may be achieved by interventions 
that have been validated to achieve a cumulative 5 log reduction in the 
target pathogens or a reduction in yearly risk of illness to less than 
10<SUP>-5</SUP>, assuming consumption of 100 mL of juice daily. 
However, the NACMCF did not specify the manner in which this risk 
reduction should be accomplished, only the target that must be reached. 
In section IV.M of this document the agency will discuss its proposed 
approach as to how this performance standard will apply to juice.
4. Labeling
    A number of comments suggested that labeling to distinguish 
pasteurized from unpasteurized juice would enable consumers to make an 
informed choice. One of the comments requested warnings to those ``at-
risk,'' one urged the publication of warnings in the newspaper, and 
another wanted labeling with no warning. Rather than labeling, one 
comment suggested point of sale information. One comment urged FDA not 
to require labeling to distinguish pasteurized from unpasteurized 
juices.
    The NACMCF recommended research on labeling information needed for 
consumer understanding and choice of safer juice products. The NACMCF 
concluded that, while the risks associated with specific juices vary, 
there are safety concerns associated with juices generally, especially 
unpasteurized juices.
    Labeling whether a product is pasteurized or unpasteurized is 
useful information that the agency encourages processors to place on 
labels. However, such labeling would not inform purchasers of 
unpasteurized product that children, the elderly, and the 
immunocompromised are ``at-risk'' from consuming the product. Without 
effective consumer education, the label statements ``pasteurized'' and 
``unpasteurized'' are likely to have relatively little meaning to 
consumers and could even cause confusion because some consumers might 
select unpasteurized juice, considering it more ``healthy'' because it 
is less processed. Finally, a labeling requirement that focuses only on 
whether a product is pasteurized or unpasteurized does not take into 
account technologies other than pasteurization that are adequate to 
control pathogens, and, thus, such a requirement could be viewed as 
restricting the development of new technologies.
    The agency outlined interim measures in a notice published August 
28, 1997 (62 FR 45593), and elsewhere in this issue of the Federal 
Register, FDA is issuing a proposal on labeling for packaged juice. 
These labeling measures attempt to provide information on the risks 
that juice that has not been processed to control for pathogens poses 
to children, the elderly, and the immunocompromised. The agency is 
proposing that the labeling measures be superseded when these juice 
products are processed under adequate HACCP programs or are otherwise 
processed to destroy pathogens (e.g., pasteurization).
    It is possible for firms that manufacture juice to control for 
pathogens. Labeling a product to alert consumers to possible harmful 
effects from its consumption must not substitute for a manufacturer 
adequately addressing those concerns during processing. FDA is 
reluctant to rely on labeling as a safety measure and does so only when 
its analysis of the countervailing factors reveals that, on balance, 
labeling provides the most reasonable approach to protecting the public 
health. Juice is a product that is typically consumed by children, as 
well as adults. Therefore, FDA tentatively concludes that, for juice, 
manufacturers need to implement controls for pathogens to ensure that 
their products are safe and not rely solely on labeling, except as an 
interim measure. FDA requests comment on this tentative conclusion.
5. Education
    Other comments from the juice meeting suggested that education 
would increase the awareness associated with the safety of juices and 
of all foods. Some comments suggested that more industry education or 
training was needed. Other comments wanted more consumer education, 
especially for those at highest risk from foodborne disease.
    The NACMCF recommended that the industry be educated on basic food 
microbiology, the principles of cleaning and sanitizing equipment, 
CGMP's, and HACCP. FDA agrees that industry education can serve a 
valuable role in controlling potential food hazards and encourages the 
industry to take an active part in educating its employees and 
utilizing up-to-date technologies. The agency will assist the industry 
in its education effort.
    Concerning consumer education, the agency has launched several 
initiatives to inform consumers about the potential hazards presented 
by juice to at-risk individuals (see 62 FR 45593, August 28, 1997). 
However, no matter how extensive a consumer education initiative the 
agency undertakes, it is doubtful that consumer education will reach 
all at-risk consumers. Therefore, consumer education alone will not be 
adequate to inform the at-risk population of the potential hazards of 
consumption of juice that has not been processed to control pathogens. 
Given that effective processing methods are available, primary reliance 
needs to be placed on them to ensure the safety of juice.
6. The HACCP Option
    Many of the attendees at the juice meeting urged FDA to mandate 
HACCP for juice processors, whereas others were opposed. A number of 
the attendees urged use of CGMP's together with HACCP. Some attendees 
at the juice meeting recommended that microbiological criteria or 
performance

[[Page 20456]]

standards be used in addition to HACCP, with two suggesting a 5 log 
reduction for E. coli O157:H7.
    The NACMCF concluded that HACCP and safety performance criteria can 
provide the general conceptual framework needed to ensure the safety of 
juices, and that validation of the HACCP plan for the juice process 
(i.e., ensuring that the process is adequate to control hazards) must 
be an integral part of this framework. The NACMCF stated that 
processors should establish HACCP control measures based on a thorough 
hazard analysis.
    HACCP is a preventive system of hazard control that places the 
responsibility for identifying safety problems with the manufacturer. 
Use of the HACCP system means that a firm is engaged in continuous 
problem prevention and problem solving, rather than relying on facility 
inspections by regulatory agencies or consumer complaints to detect a 
loss of control. HACCP provides for real time monitoring to assess the 
effectiveness of control. A HACCP system put in place by a manufacturer 
for a particular facility is unique and must reflect the type of juice, 
its method of processing, its packaging, the facility in which it is 
prepared, and the intended consumers.
    As discussed previously, there is sufficient evidence to 
demonstrate that there are significant problems with the presence of 
pathogens in some juice products. Pathogens in juice can be controlled 
by heat treatment. However, there may be other treatments that meet the 
same performance standard that are equally effective (e.g., multiple 
barriers, surface treatment of intact fruit). The use of a HACCP system 
provides flexibility to a processor to use alternative pathogen control 
methods and, thus, encourages the development of new technologies but 
does not dictate either their development or use. Moreover, not only is 
HACCP effective in controlling microbiological hazards, it also is 
effective in preventing chemical and physical hazards. Thus, HACCP is 
particularly well-suited for the juice industry given, as discussed 
previously, the range of hazards that must be addressed in processing 
juice.
    The agency agrees with the comments that urged use of CGMP's 
together with HACCP. CGMP's form the foundation upon which a HACCP 
system is built. Therefore, CGMP's are integral to the HACCP approach.
    Because there are significant concerns with the microbial safety of 
juices, HACCP systems must control pathogens. As will be discussed in 
section IV.M of this document, FDA is proposing a 5 log reduction in 
target pathogens, as the NACMCF recommended, as a necessary step in a 
HACCP plan for juice. Validation of a HACCP system must ensure that the 
process that is employed is adequate to control the relevant pathogens, 
in addition to chemical and physical hazards. Validation of performance 
standards consists of determining the ability of the pathogens in 
question to resist acid and other chemical or heat treatment and the 
ability of the process applied to overcome that resistance. The agency 
requests comment on this approach to safety performance criteria. FDA 
also requests comment on the benefits of requiring a general HACCP 
approach as opposed to those of specifically requiring pasteurization.
7. Alternative Approach
    An alternative approach to mandating HACCP would be to draw a 
distinction between untreated apple cider and all other juices. 
Manufacturers of apple cider would be provided a permanent option 
choosing between labeling or implementing a HACCP program with a 5-log 
pathogen reduction. All juices other than untreated apple cider would 
be provided a permanent option of choosing between labeling, 
implementing a HACCP system, or achieving a 5-log pathogen reduction as 
discussed in section M of this document, entitled ``Pathogen 
Reduction.'' The agency requests comments on this alternative approach 
to a mandatory HACCP program.

D. Decision to Propose HACCP

    The evidence discussed in section I.A of this document shows that 
juices have been a vehicle for pathogens that have caused a number of 
foodborne illnesses. Pathogens can be controlled through heat 
treatment. Information set forth in sections I.B and I.D of this 
document, however, demonstrates that there are many hazards that can 
occur with juice and juice beverages that cannot be controlled through 
heat treatment. Although not all of the problems discussed in section I 
of this document are caused by hazards that could be considered 
reasonably likely to occur in many juice operations, through the use of 
HACCP programs, a firm can evaluate its process to determine if the 
problem could have been controlled.
    As discussed in section I.E of this document, the NACMCF stated 
that HACCP and safety performance criteria can form the general 
conceptual framework needed to ensure the safety of juices. FDA has 
evaluated each of the seven alternatives that have been suggested for 
dealing with the problems with juice. While the agency finds that these 
alternatives are by no means mutually exclusive, FDA has tentatively 
concluded that a preventive system, such as HACCP, appears to offer the 
most effective way to control the significant microbial hazards, along 
with other hazards, that have become a problem with juice.
    Increased inspection, while having some beneficial impact on the 
safety of juices, is resource intensive to the agency. Even if funds 
were available to the agency for this purpose, increased inspection 
would likely not be the best way for the agency to utilize its 
resources to protect the public health. It is ultimately the 
responsibility of manufacturers to ensure that their products are safe. 
A preventive approach, such as HACCP, on the other hand, enhances a 
processor's ability to make safe products because HACCP concentrates on 
examining all aspects of production, identifying hazards that are 
reasonably likely to occur in that production process, and establishing 
measures that will control or minimize those hazards. HACCP also 
enhances FDA's inspections because it allows the agency to inspect the 
production facility more efficiently and then to verify that the firm 
is operating in accordance with the firm's HACCP plan, and it provides 
some assurance that any problems that have occurred have been 
identified and appropriately addressed.
    CGMP's, the second alternative to HACCP, are plantwide operating 
procedures. Although FDA supports the use of CGMP's, it tentatively 
concludes that use of CGMP's alone would not be sufficient to control 
the problems with juices because CGMP's do not concentrate on the 
identification and prevention of food hazards. Nonetheless, CGMP's are 
necessary to provide the foundation on which a HACCP system is built. 
Therefore, the agency tentatively concludes that, while CGMP's are 
important to a HACCP system, they are not an adequate alternative to 
HACCP.
    Mandating pasteurization, the third suggested alternative to HACCP, 
would reduce many microbial hazards in juices but would eliminate the 
incentive to develop alternative methods (e.g., use of multiple 
barriers, surface treatment of fruit) that can accomplish the same 
purpose. FDA does not want to limit innovative approaches to achieving 
food safety. HACCP, on the other hand, allows and encourages firms to 
explore more technologically efficient and more cost-efficient ways of 
managing all of the hazards that they face. Moreover, pasteurization 
only controls microbial hazards. HACCP systems can control all

[[Page 20457]]

food hazards that are reasonably likely to occur.
    Labeling was also suggested as an alternative. FDA acknowledges 
that, from a public health protection standpoint, there are certain 
advantages to labeling. Elsewhere in this issue of the Federal 
Register, FDA is proposing to require certain labeling, in the form of 
a warning statement, for packaged juice products that have not been 
processed to control, reduce, or eliminate pathogenic microorganisms 
that may be present in such juices. Such labeling will serve to reduce 
the risk of foodborne illness. However, such reduction will occur only 
to the extent that consumers read and understand the labeling. 
Accordingly, the agency has tentatively concluded that mandating HACCP 
for most juice products will provide more comprehensive public health 
protection by greatly reducing the number of juice products that 
contain dangerous pathogens.
    Importantly, manufacturers do have the ability to process juice to 
control pathogens. Labeling a product to alert consumers to possible 
harmful effects from its consumption is not a substitute for a 
manufacturer adequately addressing those concerns during processing. 
Juice is a product consumed by children, as well as by adults. FDA is 
reluctant to rely on labeling as a safety measure and does so only when 
its analysis of the countervailing factors reveals that, on balance, 
labeling provides the most reasonable approach to protect the public 
health. Here, a situation in which HACCP offers a real long-term 
solution to controlling, if not eliminating, hazards in juice, the 
agency tentatively believes that labeling is not a reasonable long-term 
approach. The agency is soliciting comment on the appropriateness of 
this tentative conclusion.
    The fifth alternative to HACCP that was suggested is education. 
Industry education can play a valuable role in the production of safe 
juices. Consumer education can play an important part in consumer 
purchasing choices. However, education is only effective if people 
understand and use the information conveyed. Moreover, even an 
extensive education program may not reach all consumers. Conversely, 
mandatory HACCP would ensure that industry produces safe juice, and 
that the product that reaches consumers is safe.
    For the foregoing reasons, FDA has tentatively concluded that HACCP 
represents the appropriate system of controls that is necessary for 
producing safe juice products. Therefore, FDA is proposing to add part 
120 to its regulations to establish procedures for implementing HACCP 
systems for fruit and vegetable juices. As the agency did with seafood, 
it is proposing to issue these HACCP regulations under various sections 
of the the act, including, most significantly, sections 402(a)(1) and 
(a)(4) and 701(a) of the act (21 U.S.C. 371(a)).
    Section 402(a)(1) of the act states that a food is adulterated if 
it bears or contains any poisonous or deleterious substance that may 
render the food injurious to health. Section 402(a)(4) of the act 
states that a food is adulterated if it has been prepared, packed, or 
held under insanitary conditions whereby it may have been contaminated 
with filth, or whereby it may have been rendered injurious to health. 
It is important to recognize that section 402(a)(4) of the act 
addresses conditions that may render a food injurious to health, rather 
than conditions that have actually caused the food to be injurious (see 
United States v. 1,200 Cans, Pasteurized Whole Eggs, etc., 339 F. Supp. 
131, 141 (N.D. Ga. 1972)). The question is whether the conditions under 
which the food is processed and held are insanitary and may render the 
food injurious to health. The agency tentatively finds that, if a 
processor of juice products does not incorporate certain basic controls 
into its procedures for preparing, packing, and holding food, it is 
operating under insanitary conditions that may render the juice that is 
produced injurious to health and, therefore, adulterated under the act. 
Section 701(a) of the act authorizes the agency to adopt regulations 
for the efficient enforcement of the act.
    The legal basis for mandating HACCP systems for juice processors is 
the same as that for seafood. Additional discussion of the legal basis 
is set out in the proposed rule (59 FR 4142 at 4150, January 28, 1994) 
and final rule (60 FR 65096 at 65098) for fish and fishery products.

E. Notice of Intent

    FDA published a notice of intent on August 28, 1997 (62 FR 45593), 
that announced a comprehensive program to address the incidence of 
foodborne illness related to consumption of fresh juice and to address 
ultimately the safety aspects of all juice products. The agency invited 
comment on the appropriateness of its strategy to: (1) Initiate 
rulemaking on a mandatory HACCP program for some or all juice products, 
(2) propose that the labels and labeling of some or all juice products 
not specifically processed to prevent or eliminate the presence of 
harmful bacteria bear a warning statement informing consumers of the 
risk of illness associated with consumption of the product, and (3) 
initiate several educational programs to minimize the hazards 
associated with fresh juice. The agency stated that it would consider 
comments received within 15 days of publication of the notice prior to 
publication of any proposed rule.
    Some comments on the notice suggested that FDA mandate HACCP only 
for fresh juice processors. One comment stated that HACCP should be 
mandated only for firms that process large quantities of fresh juice. 
Other comments supported mandatory pasteurization or equivalent 
treatment of juice, especially apple cider. One comment added that 
pasteurization and use of CGMP would preclude the need for the 
mandatory use of HACCP.
    In section II.D of this document the agency has already discussed 
its reasons for proposing HACCP. The illnesses discussed in sections 
I.A and I.B of this document did not pinpoint problems related solely 
to fresh juice processors or to the amount of fresh juice that a firm 
produced. The comments have not provided any new information to alter 
the agency's tentative conclusion that HACCP is necessary to ensure the 
safe production of juice. However, FDA requests information on whether 
there are categories of juice that should be excluded from the proposed 
regulation.
    FDA has reviewed all of the comments received within 15 days of 
publication of the notice and has determined that the comments provided 
no information that would cause the agency to conclude that this 
proposal is inappropriate. The agency has attempted to address these 
comments to the extent that they are relevant to this proposal. All 
comments received in response to the notice that address the issues in 
this proposal will be considered either in this proposal or in any 
final rule published in response to this proposal.

F. Fresh Produce Guidance

    FDA, working with the U.S. Department of Agriculture (USDA) and the 
agricultural community, has developed voluntary good agricultural 
practice (GAP) and GMP guidance for fruits and vegetables that has been 
issued in draft for comment. The guidance, which is a science-based 
evaluation of risks, will address potential food safety problems 
throughout the food production and distribution system such as 
sanitation, worker health, and water quality. This voluntary guidance 
can be used by both domestic and foreign fresh fruit and vegetable 
producers to help ensure the safety of their produce.

[[Page 20458]]

III. The HACCP System

    The HACCP concept is a systematic approach to the identification 
and assessment of the risk (likelihood of occurrence and severity) of 
biological, chemical, and physical hazards from a particular food 
production process or practice and the control of those hazards. HACCP 
is a preventive strategy for food safety. Under it, the food producer 
develops a plan that anticipates and identifies the points in the 
production process where a failure would likely result in a food hazard 
being created or allowed to persist. These points are referred to as 
critical control points (CCP's). Under HACCP, identified CCP's are 
systematically monitored to ensure that critical limits (CL's) are not 
exceeded, and records are kept of that monitoring. Corrective actions 
are taken when control of a CCP is lost, including proper disposition 
of the food produced during that period, and these actions are 
documented. The effectiveness of HACCP is also systematically verified 
by the processor.
    HACCP has been endorsed by the NACMCF as an effective and rational 
means of ensuring food safety. HACCP also is recognized in the 
international food safety community as the state-of-the-art means to 
ensure the safety and integrity of food. In particular, the Committee 
on Food Hygiene of the United Nations' Codex Alimentarius Commission 
(Codex) has endorsed the HACCP concept as a worldwide guideline. The 
European Union (EU) and other countries around the world have begun to 
require that foods produced within their borders be processed in a 
HACCP system. HACCP also is required for shipment of some foods (e.g., 
seafood) into EU countries.

A. Five Preliminary Steps of HACCP

    The NACMCF recommends a process for developing a HACCP system that 
includes: (1) Assembling a HACCP team, (2) describing the food and its 
distribution, (3) identifying the intended use and consumers of the 
food, (4) developing a flow diagram, and (5) verifying the flow diagram 
(Ref. 55). These steps have been identified by the NACMCF as the ``five 
preliminary steps'' of HACCP. Although the agency is not proposing to 
mandate that processors use these preliminary steps, processors will 
greatly benefit from using these preliminary steps in developing their 
HACCP systems. The NACMCF advises that the preliminary tasks should be 
accomplished before the application of HACCP principles to a specific 
process (Ref. 55).

B. The Seven Principles of HACCP

    The NACMCF has developed the following seven principles that 
describe the HACCP concept:
1. Conduct a Hazard Analysis
    The first step in the establishment of a HACCP system for a food 
production process or practice is the identification of the hazards 
associated with the product. The NACMCF defines a hazard as a 
biological, chemical, or physical factor that may cause a food to be 
unsafe for consumption. The hazard analysis step should include not 
only a written identification of the hazard but a written assessment of 
the likelihood that the hazard will occur and its severity if it does 
occur. This analysis should also involve the identification of CCP's 
along with control measures for each identified hazard.
2. Determine the CCP's
    A CCP is a point, step, or procedure at which control can be 
applied, so that a potential food hazard can be prevented, eliminated, 
or reduced to acceptable levels. Points in the manufacturing process 
that may be CCP's include heat treatment, chilling, specific sanitation 
procedures, product formulation control, prevention of cross 
contamination, and certain aspects of employee and environmental 
hygiene.
3. Establish Critical Limits
    This step involves establishing parameters that must not be 
exceeded for each control measure associated with a CCP. Critical 
limits (CL's) can be thought of as boundaries of safety for each CCP 
and may be set for control measures such as temperature, time, physical 
dimensions, moisture level, water activity, pH, and available chlorine. 
A CL is used to distinguish between safe and unsafe operating 
conditions at a CCP. For example, the minimum temperature and time 
combination that will kill pathogens in a heat treatment step is the CL 
for that CCP.
4. Establish Monitoring Procedures
    Monitoring is a planned sequence of observations or measurements to 
assess whether a CCP is under control (i.e., operating within its CL) 
and to produce an accurate record of the monitoring for use in future 
verification procedures. An unsafe food may result if a process is not 
properly controlled and a deviation occurs. Because of the potentially 
serious consequences of a CL deviation, monitoring procedures must be 
effective. Continuous monitoring is possible with many types of 
physical and chemical methods. When it is not possible to monitor a CL 
on a continuous basis, monitoring intervals must be established that 
are frequent enough to permit the manufacturer to determine whether the 
step/process/procedure designed to control the hazard is working.
5. Establish Corrective Actions
    While the HACCP system is intended to prevent deviations in a 
planned process from occurring, total prevention can rarely, if ever, 
be achieved. Therefore, there needs to be a corrective action plan in 
place to fix or correct the cause of the deviation to ensure that the 
CCP is brought under control, to ensure that there is appropriate 
disposition of any food produced during a deviation, and to ensure that 
records are made of the corrective actions taken. Out of control 
situations should be used to identify opportunities for improvement of 
the process to prevent future occurrences.
6. Establish Verification Procedures
    This process involves the application of methods, procedures, 
tests, and evaluations, other than monitoring, to determine the 
adequacy of, and compliance with, the HACCP system. The major infusion 
of science in a HACCP system centers on proper identification of the 
hazards, CCP's, and CL's and the institution of proper verification 
procedures.
7. Establish Recordkeeping and Documentation Procedures
    This principle requires the preparation and maintenance of written 
HACCP records that list the hazards, CCP's, and CL's identified by the 
firm, as well as the monitoring, recordkeeping, and other procedures 
that the firm intends to use to implement the system. This principle 
also requires the maintenance of records generated during the operation 
of the HACCP system.

C. History of the Use of HACCP

1. HACCP for Fish and Fishery Products
    On December 18, 1995, FDA published a final rule in the Federal 
Register (60 FR 65096) on procedures for the safe and sanitary 
processing and importing of fish and fishery products (part 123 (21 CFR 
part 123)) (seafood final rule). The regulations require that seafood 
processors develop, implement, and document sanitation control 
procedures and mandate the application of HACCP principles to the 
processing of seafood. The effective date for the seafood final rule 
was December 18, 1997.

[[Page 20459]]

    The regulations proposed herein are based on the seafood final rule 
with some modification to reflect the differences between seafood and 
juice products and to reflect recent developments in the application of 
HACCP. An extensive administrative record was compiled in the seafood 
proceeding. FDA is incorporating that record as support for the current 
proposal. Although the regulations proposed herein differ in some 
aspects from part 123, they are not intended to supersede or otherwise 
alter the seafood final rule.
2. Advance Notice of Proposed Rulemaking for the Development of HACCP 
for the Food Industry
    In the Federal Register of August 4, 1994 (59 FR 39888), FDA 
published an advance notice of proposed rulemaking (ANPRM) requesting 
public comment about whether and how the agency should develop 
regulations that would establish requirements for a new comprehensive 
food safety assurance program, based on HACCP, for both domestically 
produced and imported foods. The agency stated its tentative view that, 
if such regulations were issued, they would enhance FDA's ability to 
ensure the safety of the U.S. food supply. FDA requested comments on a 
number of specific issues, as well as on all aspects of such a food 
safety program.
3. HACCP Pilot Programs
    In addition to the ANPRM, FDA also published in the Federal 
Register on August 4, 1994 (59 FR 39771), a notice announcing that it 
intended to conduct a pilot program in which volunteers from the food 
manufacturing industry would use a HACCP system that FDA would audit. 
The pilot program was intended to provide information that FDA could 
use in deciding whether to propose to adopt regulations and in 
developing and implementing a regulatory system in which food 
manufacturers are required to perform the food safety aspects of their 
operations based on HACCP principles. In the notice, FDA invited 
individual firms that wished to participate in the program to submit 
letters of interest. Approximately 50 firms expressed initial interest 
in participating in the pilot program, and 11 firms were selected to 
participate. In 1997 FDA completed the pilot program at six firms and 
published a second interim report.
4. HACCP for Meat and Poultry
    On July 25, 1996, USDA published a final rule (61 FR 38806) that, 
among other things, required that each meat and poultry establishment 
develop and implement written sanitation standard operating procedures 
(Sanitation SOP's) and a system of HACCP controls designed to improve 
the safety of their products. The effective date for the Sanitation 
SOP's was January 27, 1997, and for the HACCP regulations was January 
26, 1998. FDA has reviewed the meat and poultry HACCP regulations and 
has incorporated portions of them as appropriate in the proposed HACCP 
regulations for juice.

D. Issues from the ANPRM

    FDA received approximately 150 comments in response to the August 
4, 1994, ANPRM. The comments represented the views of consumers, 
consumer organizations, health professionals, academicians, food 
industry officials, trade associations, and foreign, State, and local 
government agencies. The agency has attempted to address these comments 
to the extent that they are relevant to this proposal.
    1. The agency asked in the ANPRM how the responsibility for food 
safety should be shared between the food industry and government. 
Comments generally agreed that the food industry is responsible for 
producing safe food products. All respondents on this issue recognized 
that the Government's role is to verify industry compliance with any 
applicable safety regulations.
    FDA agrees that it is the manufacturer's responsibility to ensure 
that the food that it produces is safe, and that it is the Government's 
role to verify that manufacturers are fulfilling their responsibility. 
Through use of a HACCP system, both the firm and FDA are able to better 
fulfill their roles. The proposed regulation in part 120 underscores 
the division of roles. Under the proposed regulation, industry is 
charged with examining all aspects of production, identifying hazards 
that are reasonably likely to occur, and establishing measures that 
will control or minimize those hazards. HACCP records enable the agency 
to inspect the production facility more efficiently and to verify that 
the firm is operating in accordance with its HACCP plan. They also give 
the agency insight into whether any problems that have occurred have 
been identified and appropriately addressed.
    It is important that the juice industry focus on its responsibility 
to produce safe food. Recent outbreaks evidence that some members of 
the industry have not kept up with the need to evaluate the hazards 
presented by juice and to design processes to address those hazards. 
Firms need to be aware of the emerging problems presented by their raw 
materials and to decide whether, and if so what, steps are necessary to 
address these problems. Firms may decide that it is necessary to 
incorporate a step designed to kill bacteria into their process (e.g., 
pasteurization), that there are alternative steps that they can take to 
ensure the safety of their products, or that, given the nature of the 
raw materials, no steps are necessary. Firms also need to monitor the 
process that they decide to employ to ensure that it is functioning 
adequately and appropriately. FDA notes that some firms have already 
addressed food safety concerns and have implemented HACCP systems.
    Moreover, given the heightened concerns about these products, 
Government needs to be in a position to fulfill its role of verifying 
that industry is doing its job. Given the sporadic and variable way in 
which the problems that have been associated with juice arise, sampling 
and end-product testing of juice products will not enable it to do so. 
Other steps that will give Government insights into the production 
itself appear to be in order.
    2. FDA requested comment in the ANPRM about the likelihood of 
occurrence of a hazard that would warrant HACCP-type control. 
Generally, the comments consistently identified two features that would 
characterize a properly formulated definition of likelihood: Processing 
conditions and nature of hazard. The majority of comments offered by 
the food industry stipulated that the necessary condition for 
likelihood of occurrence of the hazard appropriate to trigger HACCP 
control must not be speculative, as in worst-case scenarios, but be 
real, practical, and intrinsic to the processing or hazards 
demonstrably present for specific commodities. Several responses 
recommended that the question be referred to broadly based expert 
panels to establish the likelihood of risk.
    According to the NACMCF, each potential hazard is evaluated based 
on the severity of the potential hazard and its likely occurrence (Ref. 
55). Severity is the seriousness of the consequences of exposure to the 
hazard. Considerations of severity (e.g., impact of sequelae and 
magnitude and duration of illness or injury) can be helpful in 
understanding the public health impact of the hazard. Likelihood of 
occurrence of a hazard is generally judged based on processing 
experience, epidemiological data, and information in the technical 
literature.
    The agency agrees with the comments that stated that the processing 
conditions and the nature of the hazard are key elements in assessing 
the

[[Page 20460]]

likelihood of a hazard occurring. It would be futile for processors to 
attempt to control for every theoretical hazard because doing so would 
entail assessing hazards that the processor could not reasonably 
anticipate would actually occur. The assessment of the likelihood of 
risk of illness or injury to consumers should be practical for the 
specific commodity and not be speculative. For example, use of 
pesticides on fruits and vegetables is a common practice while these 
foods grow. The presence of pesticides on fruits or vegetables used to 
make juice is considered a hazard if: (1) The pesticide is not approved 
for use on the fruit or vegetable, or (2) it is found in amounts above 
its EPA established tolerance. If a pesticide is applied to fruits or 
vegetables in conformance with EPA regulations, and the appropriate 
period of time has elapsed between application and harvest, the 
presence of the pesticide is not considered to present a hazard that is 
reasonably likely to occur.
    The agency disagrees that it should rely on broadly based expert 
panels to establish likelihood of occurrence of a hazard. Although such 
committees could provide insight into the issue, on balance, the 
insights that they would be likely to provide would not justify the 
expenditure of resources that convening such committees would require. 
However, interested persons are welcome to consider voluntarily the 
question and to submit the results of their consideration to the 
agency.
    3. Comments on the ANPRM stated that because epidemiological 
studies consistently show that microbial pathogens are the most 
significant source of food hazards, issues such as pesticides, heavy 
metals, filth, physical contaminants, and others pale by comparison 
with the immediate health consequences of foodborne microbial 
pathogens. They stated that HACCP is best suited for preventing 
microbial hazards rather than physical or chemical hazards because CCP 
monitoring can be readily established in a timely fashion for pathogens 
and, particularly, for the unsanitary conditions that promote their 
growth.
    The comments added that effects that result from events that occur 
after the food has left the processor's HACCP system are not 
controllable by the processor. The comments said that this fact is 
significant because food service establishments and the lack of 
consumer education have contributed to the majority of incidences of 
foodborne illness reported in current epidemiological data. They stated 
that HACCP systems are essentially localized management tools that will 
not permit any measurable improvement in national or international food 
safety effectiveness and have been implemented voluntarily solely as a 
corporate practice to provide strategic business advantages in 
increasingly competitive markets.
    The comments stated that regulation may be premature because of the 
adequacy and feasibility of presently available analytical tests to 
control all hazards. They stated that, consequently, HACCP is an 
excellent tool but only in the very specific case of high-risk food 
processing that is focused on controlling microbiological risks. The 
comments stated that, instead of misdirecting its efforts, FDA needs to 
look to itself to reinforce food preparation safety awareness at food 
service establishments and to pursue vigorously an enhanced consumer 
education policy on unsafe food practices as the best preventative food 
risk control program.
    FDA agrees that microbial hazards are a significant source of food 
hazards. FDA also agrees that HACCP is an ideal mechanism to deal with 
microbial hazards because it is a system of prevention. Prevention 
makes up for the inadequacies of end-product testing. For example, for 
maximum quality, nonshelf stable juice must be distributed quickly, and 
end-product testing usually takes at least several days to obtain 
results. If pathogens are discovered in the juice after distribution, 
the product must be recalled, and consumers may have already ingested 
product. Finally, the particular samples taken in end product testing 
may not contain pathogens because the pathogens may not be ubiquitous 
in the lot (i.e., there may be low level or sporadic contamination) and 
thus produce false negatives.
    A system of preventive controls, like HACCP, on the other hand, is 
designed to identify and manage conditions where pathogens could be 
present in juice while it is still being processed. HACCP is designed 
to ensure that there is early discovery, and timely correction, of any 
problems that may develop. Although HACCP is well suited for preventing 
microbial hazards, this does not mean, as some of the comments 
asserted, that it is not useful for other types of hazards. As the 
NACMCF has recognized, it is well suited for preventing chemical and 
physical hazards. For example, processors can establish CCP's to 
prevent pieces of glass from contaminating a product when glass bottles 
are used.
    The NACMCF endorses HACCP as an effective and rational means of 
assuring food safety (Ref. 55). According to the NACMCF, its use will 
likely result in measurable improvement in food safety. Under HACCP, 
processors view the processing plant from a prevention perspective and 
thus are in a position to react appropriately to new hazards if they 
arise. In preparing this proposal, FDA has reviewed the history of 
juice related outbreaks. All of these outbreaks might have been 
prevented if a HACCP system of the type that FDA is proposing herein 
had been in use.
    The agency agrees that there are hazards that can occur after food 
has left the processing plant that the processor cannot control. The 
agency has established the Food Code to assist State agencies and food 
workers in retail food establishments and has addressed handling of 
high risk foods in the Food Code. FDA also provides consumer 
information on food safety through a consumer hotline, public affairs 
specialists in FDA's district offices, and various brochures and other 
publications. These efforts are intended to educate consumers on safe 
handling of foods at home. In addition, as described in the interim 
notice, the agency has initiated a consumer education program 
concerning juice that is not treated to prevent or eliminate the 
presence of harmful bacteria.
    4. The agency requested information in the ANPRM on its possible 
role in assisting the food industry in the development of HACCP plans. 
Comments stated that FDA preparation of general background materials on 
HACCP would be beneficial in establishing a common approach to plan 
development, in assisting hazard identification analysis, and in using 
consistent language. They stated that FDA could provide informational 
resources such as examples of HACCP plans adaptable to the individual 
circumstances of a business' operations or consultative documents that 
could serve to guide plan development.
    However, some comments urged that FDA avoid over-regulation. They 
stated that an excessively ambitious regulatory approach will limit the 
effectiveness of any HACCP program.
    The agency agrees that it should avoid over-regulation because such 
an approach can inhibit future developments and new technology in HACCP 
systems and in safe food processing. FDA is proposing a HACCP 
regulation that, if adopted, will be mandatory for juice processors (as 
defined at proposed Sec. 120.3(i)) but that can be used as a model for 
other foods in that it outlines the minimum essential components of a 
HACCP system. To the extent possible, the proposed regulation is in 
harmony with

[[Page 20461]]

the existing HACCP regulations for seafood and meat and poultry.
    FDA has developed the ``Fish & Fisheries Products Hazards & 
Controls Guide'' to assist manufacturers in the implementation of HACCP 
for seafood. The Federal Safety and Inspection Service (FSIS) has 
developed, in conjunction with the International Meat and Poultry HACCP 
Alliance, 13 HACCP models for meat and poultry products, a ``Guidebook 
for the Preparation of HACCP Plans,'' and the ``Meat and Poultry 
Products Hazards and Control Guide.'' However, it is not clear whether 
FDA will be able to provide such detailed information for juice. 
Therefore, in this rulemaking, the agency will attempt to provide 
guidance, to the extent possible, concerning the application of the 
regulation to juice.
    5. Some comments on the ANPRM stated that, if EPA tolerances for 
pesticides in agricultural commodities become HACCP-focused safety 
issues in food processing and service industries, then explicit 
coordination by FDA with EPA is needed to define truly significant 
hazards. They stated that this effort would greatly assist HACCP 
development in such circumstances, so that duplication of effort would 
be avoided, consistency among regulatory requirements would be 
achieved, and impediments to international commerce would be removed.
    FDA has attempted to harmonize its regulations with those of other 
Federal agencies and with Codex. EPA establishes regulations for 
pesticide use and tolerances for pesticide residues, and FDA and USDA 
enforce those tolerances on foods.
    Under section 402(a)(2)(B) of the act, a food is deemed to be 
adulterated if it bears or contains a pesticide chemical residue unless 
a tolerance or an exemption for such pesticide has been established, 
and the quantity of such pesticide on the commodity is within the 
tolerance limits. Pesticide chemical residues for which there is no 
tolerance or exemption are deemed to be unsafe as a matter of law. 
HACCP is intended to protect against unsafe products. Thus, there is no 
reason why pesticide residues and similar types of food safety measures 
should be outside the scope of HACCP.
    6. In the ANPRM, the agency asked if there was a need for 
microbiological criteria in HACCP regulations. Some comments favored 
inclusion of microbiological criteria for known high risk foods because 
such criteria are practical, efficient, and cost effective. However, 
most comments maintained that microbiological criteria, set as national 
standards, are not warranted because: (1) Criteria are discordant with 
HACCP purposes because they depend on end product testing, (2) criteria 
possess inadequate scientific basis, and (3) criteria are preemptive of 
localized development of HACCP systems.
    The agency tentatively agrees with those comments that stated that 
microbiological criteria in HACCP regulations are warranted for some 
foods. Contrary to what many of the comments asserted, effective 
microbial controls depend not on end product testing but on processing 
controls and the establishment of CL's. For example, juice made from 
apples that have fallen on the ground must be processed in some manner 
to destroy pathogens because pathogens are likely to be present and, as 
discussed previously, end product testing may produce false negatives. 
If a regulation is flexible, it should not ``preempt'' the processor's 
development of HACCP, but it can provide the CL's needed for the safe 
processing of food under a HACCP system. However, the agency agrees 
that the decision on which processing controls are to be used must have 
a valid scientific basis.
    Microbial pathogens have emerged as a significant problem in 
unpasteurized juice in recent years. The NACMCF recommended that safety 
performance criteria, rather than a specific intervention technology, 
be mandated for juice (Ref. 53). The safety performance criteria 
recommended by the NACMCF is whether the measures that a juice 
processor employs have been validated to achieve a cumulative 5 log 
reduction in the target organisms or a reduction in yearly risk of 
illness to less than 10<SUP>-5</SUP>, assuming consumption of 100 mL of 
juice daily. As will be discussed in section IV.M of this document, FDA 
is proposing to require that firms include in their HACCP plans 
measures that will produce, at a minimum, a 5 log reduction in target 
pathogens.
    7. Comments on the ANPRM stated that FDA should require end product 
testing records to provide information as to the effectiveness of a 
HACCP program. These comments stated that end product testing was 
practical because mandated testing was a necessary, continuing, and 
recordable validation of the completeness of a HACCP system, thereby 
ensuring that 100 percent control is manifested.
    Comments from the juice meeting also supported the use of end 
product testing. One of the these comments proposed using testing to 
decide whether to pasteurize each lot. Several comments pointed to new 
rapid testing technologies and testing kits for pathogens.
    However, other comments maintained that information generated from 
end product tests would not be useful. One comment stated that end 
product testing activities were counterproductive to a well-planned 
HACCP system. Furthermore, these comments added, any requirements that 
FDA puts forward must be practical, and no process can be regulated 
into 100 percent certainty.
    The agency is not proposing to require end product testing. End 
product testing is most useful where there are high levels of the 
substance being tested, and there is uniformity throughout the lot 
being sampled. Product sampled for testing for microbial hazards, where 
a pathogen (e.g., E. coli O157:H7) is hazardous even at very low 
levels, or for physical hazards (e.g., glass), where the hazard is the 
presence of a discrete unit, may not contain the hazard even under the 
best sampling procedure. In these cases end product testing is likely 
to produce false negatives and, thus, to provide scant protection. It 
is prohibitive to use end product testing adequately in these 
situations because of the amount of testing that is necessary for a 
statistically valid test, and because it would be necessary to channel 
a significant portion of the product for that testing. Therefore, the 
agency has tentatively concluded that use of control measures under a 
HACCP system to prevent hazards from occurring, with subsequent 
monitoring, verification, validation, and recordkeeping, is more 
effective than end product testing in ensuring that food is safe. Thus, 
FDA has not included a requirement for end product testing in this 
proposed rule on juice products.
    8. The agency asked in the ANPRM whether it should mandate HACCP 
for all segments of the food industry. Many comments stated that 
mandatory HACCP regulations for low-risk foods would be inappropriate 
because trying to manage low risk hazards through HACCP would dilute 
agency resources and therefore the effectiveness of HACCP. The comments 
stated that FDA could utilize its resources most efficiently by 
focusing on those high-risk food processing operations identified in 
its 1993 model Food Code as ``Potentially Hazardous.'' They stated that 
the U.S. food supply is already demonstrably the world's safest, so 
that there is no valid reason for requiring HACCP plans of the entire 
industry. The comments stated that enforcement mechanisms in the act 
are, and will continue to be, sufficient without adding to the 
regulatory burden on

[[Page 20462]]

industry. They added that incorporation of HACCP into food industry 
operations should be permitted to proceed on a voluntary basis, unless 
a well-defined need requires implementation through specific authority 
provisions of the act into specific high-risk segments of the food 
industry.
    However, some comments stated that unless all segments of the food 
chain are mandatorily included, adoption of HACCP is unlikely to result 
in measurable enhancement of the safety of the food supply. They stated 
that less than universal coverage would create confusion about what 
should be excluded. The comments stated that any attempt to limit HACCP 
to identified ``high-risk'' processors would hinder efforts to address 
significant public health problems that may arise in the future. They 
concluded that it is not unduly burdensome to mandate HACCP for all. 
The comments maintained that HACCP regulations should be as 
comprehensive as practicable and applied throughout the food chain to 
the fullest extent possible and reasonable, and that HACCP principles 
must be applied from farm to fork.
    FDA disagrees with the comments that stated that HACCP is 
inappropriate for low-risk foods. Both food processors and government 
regulatory agencies would benefit from the use of HACCP systems. The 
U.S.'s excellent record for having a safe food supply does not mean 
that this country should not consider ways of improving on that record. 
In the face of emerging pathogens and other new food hazards, HACCP 
provides a flexible system in which processors reassess their 
procedures on an on-going basis. HACCP also enables processors to meet 
future demands.
    The use of HACCP allows food processors to concentrate their 
efforts on the aspects of the processes that they use where risks are 
highest and provides regulatory agencies with assurance that processors 
are observing prudent processing practices. HACCP also provides 
assurance that problems in the process are likely to be discovered, and 
that unsafe product is unlikely to leave the firm. The complexity of 
HACCP is a function of the number of hazards that must be controlled 
and the nature of the controls for each hazard. Foods that involve few 
hazards will tend to have fewer CCP's, and, conversely, those that have 
multiple hazards will tend to have more complex HACCP plans and 
monitoring requirements.
    FDA is proposing a regulation that will mandate HACCP for juices. 
The agency has tentatively concluded that there is a safety basis to 
require that processors use HACCP systems in the processing of juice. 
As the agency gains experience and additional information from the 
pilot program and from seafood HACCP implementation, it will examine 
the appropriateness of expanding the scope of proposed part 120 (if the 
agency adopts it) to include other foods. Clearly, the agency will 
consider HACCP's use with foods that it has identified as presenting 
likely hazards, as it is doing in this proposal.
    In developing the proposed regulations for juice, FDA came to 
recognize that the elements of a HACCP regulation for juice are really 
no different than those for seafood. This insight suggests that part 
120 can act as a model for HACCP for other parts of the food industry 
should the agency become aware of facts that would justify extending 
the coverage of the regulation. Firms that are interested in 
voluntarily instituting HACCP can use the regulations in part 120 as a 
guide for doing so.
    9. The ANPRM requested information on the criteria that FDA should 
use in deciding whether to cover some or all segments of the food 
industry with a mandatory HACCP rule. Some of the comments stated that 
exclusions cannot be justified on the basis of business size because 
about 75 percent of the food industry would be considered to be small 
businesses. The comments asserted that exclusions can only be judged 
with respect to properly defined risks for the food hazards involved in 
producing the end-product.
    FDA agrees that exemptions from HACCP regulations cannot be 
justified on the basis that a business is small because food hazards 
that are reasonably likely to occur in the production of most foods 
occur regardless of the size of the firm. The agency also agrees that 
any exceptions to mandatory HACCP systems must be based on instances in 
which risks are not reasonably likely to occur. However, FDA is 
required by law to consider ways to assist small businesses when it 
implements regulations. While FDA does not propose to exempt any small 
businesses from the food safety requirements in this proposed rule, FDA 
is considering ways to provide regulatory options that will serve to 
reduce the burden of compliance on such small businesses.

IV. FDA's Proposal

A. Applicability

1. Scope
    The agency tentatively concludes that HACCP is necessary for the 
safe and sanitary production of fruit and vegetable juices to address 
the special concerns discussed previously. Therefore, FDA is proposing 
new Sec. 120.1(a), which states that part 120 applies to juice and 
defines what juice means for purposes of this regulation.
    Fruit and vegetable juices may be used as ingredients in other 
beverages (e.g., flavored bottled waters; juice beverages and 
cocktails). These products often resemble juices, are processed in a 
manner that is similar to juices, and handled by consumers similarly to 
juices. Thus, they can present the same food hazards as juices. 
Therefore, FDA is proposing to require that any juice sold as such or 
used as an ingredient in beverages be processed in accordance with the 
requirements of part 120.
    As stated in section II of this document, FDA has established 
standards of identity for a number of fruit juices in part 146 and for 
tomato juice in Sec. 156.145. These standardized juices are generally 
described as the liquid extracted or expressed from a fruit or 
vegetable. However, prune juice (Sec. 146.187) is prepared from a water 
extract of dried prunes.
    A typical dictionary definition of the term ``juice'' is a fluid 
naturally contained in plant or animal tissue (Ref. 56). As described 
above, the present situation has demonstrated a need to control food 
hazards associated with fruit and vegetable juices. The present 
situation does not include oil extracts of fruits and vegetables (e.g., 
olive oil) because these are not traditionally considered juice. Some 
juices (e.g., banana juice) and fruit nectars, when purees of the fruit 
used, need to be included in any definition FDA proposes because such 
purees are often blended with other juices. If there are food hazards 
associated with extractives of a fruit or vegetable, those food hazards 
will be present in purees of that fruit or vegetable. Concentrates of 
juice and purees also need to be included in the definition because, if 
a hazard is present in the juice or puree, it could also likely be 
present in the juice concentrate. Therefore, the agency is tentatively 
defining ``juice'' as the aqueous liquid expressed or extracted from a 
fruit or vegetable, purees of the edible portions of a fruit or 
vegetable, or any concentrates of such liquid or puree.
    The agency requests comments on the definition of ``juice.'' FDA 
also requests comments on the scope of the regulation and on whether it 
should mandate HACCP for all types of juices, or whether it would be 
sufficient to mandate HACCP for certain types of juices.

[[Page 20463]]

2. Effective Date
    The seafood final rule provided processors 2 years to implement 
HACCP. This was done to: (1) Allow time for training of industry 
personnel and regulatory personnel; (2) provide the States with the 
time to have a full opportunity to understand and respond to the 
effects of these regulations; (3) increase the likelihood that more 
agreements with other countries will exist; (4) increase the 
opportunity for processors to engage in ``voluntary'' HACCP inspections 
in advance of the effective date to obtain preliminary, informal 
feedback from the agency on their progress; and (5) allow incorporation 
of modifications made in the final rule and publication of FDA 
assistance materials for the seafood industry (60 FR 65096 at 65169).
    The period of time between publication of the final rule and the 
effective dates of the HACCP regulations for meat and poultry issued by 
FSIS are: (1) Eighteen months for large establishments with 500 or more 
employees, (2) Thirty months for smaller establishments with 10 or more 
employees but fewer than 500, and (3) Forty-two months for very small 
establishments with fewer than 10 employees or annual sales of less 
than $2.5 million (61 FR 38806).
    A comment from a fresh juice trade association submitted to the 
agency in response to the NACMCF recommendations to FDA on the safety 
of juices, requested that FDA mandate HACCP for all juice products and 
phase this requirement in over a 3-year period from the publication of 
the final rule in a manner similar to the FSIS HACCP regulation. The 
comment requested that FDA consider annual inspections of fresh juice 
firms until the regulation is effective. It stated that the delay in 
implementing HACCP requirements would allow FDA and juice processors 
the ability to review conclusions of specific research and establish 
performance standards based on this research.
    Comments on FDA's notice of intent (62 FR 45593) generally 
supported a phased-in approach for small firms taking 3 to 4 years. 
However, one comment expected that a phase-in approach would take no 
more than 2 years.
    The agency is considering the significant issues surrounding 
orderly implementation of HACCP. FDA must balance the need for 
immediate implementation of HACCP, because of its associated food 
safety benefits, against the costs of implementation and consider 
options to minimize the burden to small businesses. The proposed 
timeframe for implementation of these regulations attempts to balance 
these competing concerns. The implementation of HACCP may be more 
burdensome for small firms than for large firms. Large firms tend to 
have quality control personnel already in place. In addition, many 
regulatory requirements are less burdensome for a large firm in 
proportion to output than they are for a small firm.
    FDA recognizes that HACCP systems cannot be developed and 
implemented overnight. The HACCP system of controls can involve new 
ways of thinking and performing on a routine basis.
    The agency issued a notice on August 28, 1997 (62 FR 45593), that 
provided interim measures, and elsewhere in this issue of the Federal 
Register, FDA is proposing to require labeling for juice to address the 
agency's immediate public health concerns. If finalized, these measures 
will require labeling on juice to provide information that juice 
unprocessed to control pathogens poses risks to children, the elderly, 
and the immunocompromised. The agency is proposing that the labeling 
measures be superseded once packaged juice products are processed under 
adequate HACCP programs, or are otherwise processed in a manner to 
destroy pathogens (e.g., pasteurization). Therefore, as proposed, 
before the applicable effective date, juice will be processed to 
control for pathogens or, if not, will bear labeling to alert consumers 
that such processing has not occurred. After any applicable effective 
date, processors will use HACCP systems in the production of juice.
    The agency has considered the precedents established by other HACCP 
regulations and the comments submitted on juice. There are two 
significant differences between the HACCP regulation that FDA is 
proposing for juice and the HACCP regulations for seafood and for meat 
and poultry. First, FDA has issued interim guidance suggesting that 
juice that has not been processed to control pathogens be labeled 
accordingly. Elsewhere in this issue of the Federal Register, the 
agency is proposing to require such labeling. Second, at the present 
time, FDA's available resources would make it very difficult, if not 
impossible, to implement a comprehensive inspection program for the 
entire juice industry. A phased in approach for compliance will thus 
ease the burden not only on small businesses but also on the agency 
itself. Accordingly, FDA is proposing that the regulations proposed 
herein generally be effective 1 year after the date of publication of 
the final rule, with special provisions that will extend the phase-in 
to up to 3 years after publication of the final rule. This proposed 
phase-in approach will permit the regulated industry time to accomplish 
the training of personnel and adjust its activities to include 
necessary HACCP activities and takes into account the needs of smaller 
businesses.
    The agency proposes to establish a timetable for phasing in HACCP 
based on business size. FDA proposes in Sec. 120.1(b) that the 
effective date be 1 year following publication of the final rule. The 
agency is proposing that, by its terms, the regulation will not be 
binding until 2 years following the date of publication of the final 
rule for small businesses employing fewer than 500 persons 
(Sec. 120.1(b)(1)). This is based on the definition of a small business 
used by the Small Business Administration. In addition, the agency is 
proposing that, by its terms, the regulation will not be binding until 
3 years following the date of publication of the final rule for very 
small businesses that have either total annual sales of less than 
$500,000, or that have total annual sales that are greater than 
$500,000 but total annual food sales of less than $50,000, or that 
employ fewer than an average of 100 full-time equivalent employees and 
that sold fewer than 100,000 units of the product in the United States 
(Sec. 120.1(b)(2)). These criteria are consistent with those that the 
agency has used in its regulation on small firms and compliance with 
the nutrition labeling rules that implement the Nutrition Labeling and 
Education Act (the 1990 amendments) (61 FR 40963) (see Sec. 101.9(j)(1) 
and (j)(18)) (21 CFR 101.9(j)(1) and (j)(18)). In the 1990 amendments 
context, these criteria represent the outcome of three hearings in 
different parts of the country, an act of Congress, and informal 
rulemaking by FDA. Thus, FDA tentatively concludes that food 
manufacturers agree with and understand the definition of very small 
businesses. As discussed in the next section of this document, for 
purposes of this proposed rule, the agency has tentatively decided that 
a retail establishment as set out in proposed Sec. 120.3(h)(2)(iii) 
includes a very small processor that makes juice on its premises and 
directly sells this juice both to consumers and other retailers 
provided that total juice sales do not exceed 40,000 gallons per year.
    In implementing proposed Sec. 120.1(b)(2), FDA intends to use the 
definitions for the terms ``unit,'' ``food product,'' ``person,'' and 
``full-time equivalent employee'' in

[[Page 20464]]

Sec. 101.9(j)(18)(vi). These definitions are as follows: (1) ``Unit'' 
means the packaging or, if there is no packaging, the form in which a 
food product is offered for sale to consumers; (2) ``food product`` 
means food in any size package that is manufactured by a single 
manufacturer or that bears the same brand name, that bears the same 
statement of identity, and that has similar preparation methods; (3) 
``person'' means all domestic and foreign affiliates, as defined in 13 
CFR 121.401, of the corporation, in the case of a corporation, and all 
affiliates, as defined in 13 CFR 121.401, of a firm or other entity, 
when referring to a firm or other entity that is not a corporation; and 
(4) ``full-time equivalent employee'' means all individuals employed by 
the person claiming the exemption. The number of full-time equivalent 
employees is determined by dividing the total number of hours of salary 
or wages paid directly to employees of the person and of all of its 
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e., 
40 hours x 52 weeks).
    FDA is committed to its mission of ensuring that food is safe and 
not misbranded. This commitment is the basis for proposing interim 
labeling measures. The agency tentatively finds that a phase-in HACCP 
implementation is necessary because of the logistical effort required 
to manage a fundamental change in work processes, roles, and 
responsibilities for smaller processors. The proposed implementation 
schedule reflects the abilities of processors of varying sizes to 
implement HACCP, and the time needed by industry to develop HACCP plans 
and train employees.
    Upon the proposed implementation date, processors must be ready to 
operate their HACCP system, and FDA will conduct inspection activities 
according to HACCP principles to ensure that the HACCP system is 
operating acceptably. FDA requests comment on its proposed phased-in 
implementation of HACCP.

B. Definitions

    FDA is proposing in the introductory paragraph of Sec. 120.3 that 
the definitions and interpretations of terms in section 201 of the act 
(21 U.S.C. 321), in Sec. 101.9(j)(18)(vi), and in part 110 be 
applicable to such terms when used in part 120, except where they are 
redefined in Sec. 120.3.
    The agency is proposing to include in Sec. 120.3 all definitions 
applicable to juice that are in the seafood HACCP regulation. The 
following terms have proposed definitions that are the same as their 
definitions in Sec. 123.3: ``critical limit'' (Sec. 120.3(d)), ``food 
hazard'' (Sec. 120.3(e)), ``importer'' (Sec. 120.3(f)), ``shall'' 
(Sec. 120.3(j)), and ``should'' Sec. 120.3(k)).
    However, FDA is proposing to modify the term ``preventive measure'' 
to ``control measure'' (Sec. 120.3(b)) and to modify its definition 
from that used in the seafood HACCP regulation (Sec. 123.3(i)) to 
conform with recent NACMCF changes in terminology (Ref. 55). The term 
``control measure'' is used because not all hazards can be prevented, 
but virtually all can be controlled to some degree. The new NACMCF 
definition describes the control measures as actions or activities 
rather than as chemical, physical, or other factors. Further, the term 
``control'' is clarified to mean prevention, elimination, or reduction 
of hazards. The agency tentatively concludes that the recent NACMCF 
definition better describes the measures that processors must take. 
Therefore, FDA is proposing that ``control measure'' means any action 
or activity that can be used to prevent, eliminate, or reduce a hazard.
    The NACMCF also recently modified its definition for ``critical 
control point'' (Ref. 55). The modified definition incorporates the new 
definition of ``control measure'' and emphasizes the essential or 
critical nature of the step. Thus, FDA tentatively concludes that the 
recent NACMCF definition better characterizes the term. Therefore, the 
agency is proposing in Sec. 120.3(c) that ``critical control point'' 
means a point, step, or procedure in a food process at which a control 
measure can be applied and at which control is essential to reduce an 
identified food hazard to an acceptable level.
    The seafood HACCP regulation defines ``processing'' in 
Sec. 123.3(k) with specific product application. To apply these 
definitions to juice and to avoid listing specific processes, the 
agency is proposing in Sec. 120.3(h)(1) to define ``processing'' as 
activities that are conducted by a processor that are directly related 
to the production of juice products.
    As with the seafood HACCP regulation, there are certain handlers of 
juice products that are not covered by the proposed definition. FDA has 
tentatively concluded that harvesting, picking, or transporting raw 
agricultural ingredients of juice products, without otherwise engaging 
in processing, should not be included in the term ``processing'' 
(Sec. 120.3(h)(2)(i)). FDA has developed voluntary GAP guidance that 
has been issued in draft for comment and will apply to these 
activities. The agency believes that growers will find GAP's useful and 
that the regulations that it is proposing in this rulemaking will, if 
adopted, reinforce use of both FDA and specific industry GAP's, thus 
affecting harvesting, picking, or transporting indirectly through 
processor and importer controls over raw materials and imported 
shipments (e.g., preventive controls such as the purchasing of raw 
materials only from farms that engage in proper handling of produce).
    The agency notes that, with FSIS, it published an ANPRM (61 FR 
59372, November 22, 1996) concerning transportation and storage 
requirements for potentially hazardous foods. In that ANPRM, FDA and 
FSIS requested information and comments on approaches that the two 
agencies should take to foster food safety improvements in the 
transportation and storage of potentially hazardous foods. While juice 
has not historically been considered a potentially hazardous food, 
recent illnesses associated with juice necessitate reconsideration of 
whether this food should not be included in that category. FSIS and FDA 
are reviewing the comments received in response to the joint 
transportation notice and will decide whether rulemaking is warranted. 
FDA invites comment on whether its approach to transportation is 
adequate.
    The agency has also tentatively decided to exclude the operation of 
a retail establishment from the definition of ``processing'' 
(Sec. 120.3(g)(2)(ii)). For purposes of this rule, the agency has 
tentatively decided that a retail establishment as set out in proposed 
Sec. 120.3(h)(2)(iii) includes a very small processor that makes juice 
on its premises and directly sells juice to consumers and other 
retailers provided that total juice sales do not exceed 40,000 gallons 
per year.
    FDA has traditionally refrained from directly regulating retail 
establishments, although it has authority to do so. FDA provides 
training and other forms of technical assistance to States and local 
governments who inspect retail food establishments through the agency's 
retail Federal/State cooperative program. A major part of that 
cooperative program involves the development of model codes, some of 
which have been widely adopted by States and local governments. FDA has 
consolidated those model codes into a single, updated food code for the 
retail sector. Appropriate controls are included in the food code that 
can be applied to address juice hazards at retail. FDA will continue to 
operate through the Federal/State cooperative mechanism and, 
consequently, has not proposed to regulate juice retailers in

[[Page 20465]]

this proposal. However, elsewhere in this issue of the Federal 
Register, the agency is proposing to require labeling statements for 
packaged juice products including those sold by retailers that have not 
been pasteurized or otherwise processed to reduce, eliminate, or 
control pathogens. The proposed labeling requirement would apply to 
packaged untreated juice products produced in retail establishments for 
immediate consumption (such as grocery stores and very small 
processors) and would serve to inform consumers of the risk of 
untreated juices. (Retail processors selling unpackaged juice on-site 
for immediate consumption, such as restaurants and juice bars, would be 
exempt from both HACCP and labeling.) FDA notes that 2 of the outbreaks 
associated with apple cider (an outbreak of E. Coli. 0157:H7 infection 
and an outbreak of cryptosporidosis involving very small apple cider 
mills, refs. 8, 8A, and 11) would have fallen under the retail 
exclusion. Under the proposed labeling rule, the cider mills would have 
been required to label their apple cider. FDA seeks comment on whether 
the provisions of the food code in combination with the labeling 
statements will provide adequate public health protection. In addition, 
in formulating its proposal to include in the definition of retailer a 
processor that sells less than 40,000 gallons per year, the agency 
considered two other alternatives on which it requests comments. The 
first alternative would be to subject these establishments to the HACCP 
requirements and to provide a 3-year effective date. The second 
alternative would be to subject these establishments to the HACCP 
requirements and to provide a 5-year effective date. The agency is also 
soliciting comment on the appropriateness of including these 
establishments in the retail exemption as well as the appropriateness 
of the other two options considered.
    The agency is proposing to define the term ``control,'' even though 
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(a), 
that ``control'' means to prevent, eliminate, or reduce. This 
definition is consistent with the use of the term ``control'' in the 
definition for ``control measure'' (Sec. 120.3(b)) and describes more 
specifically what is to be accomplished in the control of food hazards.
    FDA is also proposing to define the term ``monitor,'' even though 
it was not included in Sec. 123.3. FDA is proposing in Sec. 120.3(g) to 
define ``monitor'' as conducting a planned sequence of observations or 
measurements to assess whether a process, point, or procedure is under 
control and producing an accurate record of those observations or 
measurements for use in verification. This definition is identical with 
that of the NACMCF (Ref. 55). The agency tentatively concludes that 
defining this term will assist juice processors to be aware of what 
activities constitute monitoring of the various components of the HACCP 
system and prerequisite programs; and comply with the monitoring and 
recordkeeping requirements necessary for acceptable verification of 
HACCP.

C. CGMP's

    Section 120.5 of the proposed regulations references the umbrella 
CGMP regulations in part 110 as providing general guidance to such 
matters as facility design, materials, personnel practices, and 
cleaning and sanitation procedures. Because part 110 provides guidance 
of general applicability to all foods, including juice, the agency 
intends that this guidance will continue to apply to juice processors 
even if FDA adopts the proposed regulations in part 120.

D. Prerequisite Program Standard Operating Procedures

    The available evidence, including FDA's experience with the HACCP 
pilot programs, points to the effectiveness of two programs that do not 
fall within the parameters of traditional HACCP. FDA will refer to 
these programs in this document as ``prerequisite programs.'' The first 
of these programs is that the firm have in place SOP's designed to 
ensure plant sanitation.
    The seafood final rule requires in Sec. 123.11 that the processor 
monitor certain sanitation measures and document both the monitoring 
activities and any corrective actions taken when such monitoring finds 
an insanitary condition that may contribute to the likelihood of 
product becoming hazardous. While seafood processors are not required 
under Sec. 123.11(a) to develop and implement written sanitation or 
prerequisite program SOP's, processors must maintain sanitation control 
records that, at a minimum, document that certain monitoring 
requirements have been met, and that corrective actions are taken when 
necessary (Sec. 123.11(c)). Section 123.11(b) sets forth requirements 
for sanitation monitoring.
    FSIS's regulations for meat and poultry require that official 
establishments develop, implement, and maintain written SOP's for 
sanitation (9 CFR 416.11). Each official establishment must take 
appropriate corrective action when it or FSIS determines that the SOP's 
have failed to prevent direct contamination or adulteration of product 
(9 CFR 416.15). Each establishment must maintain daily records that are 
initialed and dated to document the implementation and monitoring of 
the SOP's and any corrective actions taken (9 CFR 416.16). Finally, 
FSIS verifies the adequacy and effectiveness of the SOP's (9 CFR 
416.17).
    Insanitary facilities or equipment, poor food handling, improper 
personal hygiene, and similar insanitary conditions create an 
environment in which products may become contaminated with 
microorganisms, including pathogens. However, sanitation controls may 
be difficult to fit into HACCP plans. Sanitation covers the whole 
processing environment, not just CCP's. A prerequisite program is an 
appropriate mechanism for a situation, such as sanitation, that does 
not lend itself well to HACCP controls. Therefore, sanitation SOP's are 
a type of prerequisite program that is essential to provide a solid 
foundation for HACCP systems. The agency tentatively concludes that 
sanitation SOP's are an essential foundation for HACCP systems for 
juice.
    The second prerequisite program is one that provides control over 
materials that are entering the plant. The SOP requirements of both the 
seafood and FSIS regulations are limited to sanitation. However, the 
pilot program experience has suggested the utility of controls on 
incoming material. A processor could use incoming material prerequisite 
program SOP's, in a manner similar to the sanitation SOP's, i.e., to 
cover a range of processing factors, not just CCP's. Although use of 
incoming material SOP's may not obviate the need for some CCP's in a 
HACCP plan, FDA anticipates that their use could help to ensure the 
safety of the food produced.
    Incoming material controls for raw produce could be invaluable in 
establishing the conditions under which produce needs to be grown 
(including pesticide application) and harvested to provide assurance to 
the processor that the raw produce will not present hazards that the 
processor will otherwise need to control. For example, the processor's 
incoming material SOP's could specify that the processor will only 
purchase carrots that have not been fertilized with manure during 
growth. Another example is that the incoming material control could 
specify that the processor will only accept apples that have been 
picked from the tree, and that dropped apples are unacceptable. A 
simple solution to control the possible

[[Page 20466]]

presence of unlawful pesticide residues on fruits and vegetables is to 
establish SOP's for incoming material control that ensure that any 
pesticides that have been used on the produce are approved for that 
use, are used at the appropriate level, and that appropriate time has 
elapsed between application and harvest.
    As discussed previously, FDA is developing GAP and GMP guidance 
that has been issued in draft for comment. The guidance will address 
potential food safety problems throughout the food production and 
distribution system such as sanitation, worker health, and water 
quality.
    A manufacturer also could use controls on the packaging materials 
that it receives. Proper packaging is essential if a processor is to 
minimize the possibility of the occurrence of hazards after juice has 
been processed. Juice that is not packed in hermetically sealed 
containers may be subject to contamination from a number of sources. 
The processor also needs to ensure that the container coating that it 
uses will not deteriorate through reasonable storage. Evidence in 
section I.B of this document showed examples where the acid content of 
some juices corroded the tin lining of the container, and the tin was 
present in sufficient concentration to be toxic. Incoming material 
controls will mean that the processor will act to ensure that packaging 
materials are safe and suitable before accepting them.
    Incoming material controls for ingredients that a processor may add 
to juice can also be helpful. For example, if a processor is purchasing 
juice or juice concentrate from a supplier for use in a multi-juice 
beverage, it is essential that that juice have been processed under an 
adequate HACCP system and have not been contaminated during 
transportation. Thus, incoming material SOP's will lead the processor 
to establish controls on ingredients as criteria for acceptance in the 
plant.
    However, the agency is not proposing to provide for the use of 
incoming materials SOP's in part 120 at this time and requests comment 
on this issue. FDA is seeking comment on whether incoming material 
SOP's can be utilized in a similar relationship to the HACCP system as 
the sanitation SOP's. Do interested persons see value in FDA requiring 
that these SOP's be written, monitored, and verified? How do these 
SOP's relate to FDA's draft guidance on fresh produce? What are 
reasonable procedures for acceptance of incoming materials that could 
be incorporated into SOP's?
1. Sanitation SOP's
    FDA is proposing in Sec. 120.6(a)(1) to require that processors 
have and implement SOP's that address sanitary conditions and practices 
before, during, and after processing. Good sanitation practices are 
critical to the prevention of microbiologically related foodborne 
illnesses. FDA's CGMP regulations for food in part 110 set out general 
principles of sanitation that should be followed in plants that 
manufacture, package, label, or hold human food. They address such 
matters as personal hygiene and cleanliness among workers who handle 
food, the suitability of the plant design to sanitary operations, and 
the cleaning of food-contact surfaces. The proposed sanitation SOP's 
relate to the entire facility, not just to a limited number of CCP's. 
FDA tentatively concludes that this step is necessary to fully 
implement section 402(a)(4) of the act and yet at the same time not 
overload the HACCP system. FDA invites comments on this approach.
    FDA did not elect to make the development of a written sanitation 
SOP mandatory for seafood because it recognized that some processors 
may be able to achieve satisfactory sanitary conditions and practices 
without having to commit their sanitary control procedures to writing 
(60 FR 65096 at 65149). In the seafood final rule, FDA concluded that 
as long as there were records demonstrating that the plant was being 
kept in sanitary condition, it was not necessary to require written 
sanitation SOP's, even though the agency strongly recommended that a 
processor have them. The agency requests comment on whether it should 
require for juice HACCP that sanitation SOP's be written.
    In the evidence discussed in section I.A of this document, there 
were several instances where contaminated water was the cause of the 
outbreak. The water that the processor used was contaminated and when 
produce was washed with it before juicemaking, the water contaminated 
the produce, resulting in contaminated juice. Therefore, the safety of 
the water that comes into contact with food or food contact surfaces is 
an important factor that a processor must consider to maintain proper 
sanitation and prevent contamination of the product and plant. The 
seafood HACCP regulation in Sec. 123.11(b) lists eight sanitary 
conditions and practices that processors must monitor, and monitoring 
the safety of the water that comes into the plant is one of them 
(Sec. 123.11(b)(1)). Based on the foregoing, FDA is proposing a similar 
requirement in Sec. 120.6(a)(1).
    In section I.B of this document, FDA recounted the evidence 
demonstrating, that several outbreaks were caused by cleaning solution 
directly contaminating the juice. Sanitation SOP's for seafood in 
Sec. 123.11(b)(5) require that processors protect food from 
adulteration with cleaning compounds. Given that cleaning compounds, 
sanitizing agents, pesticides, and other materials can pose a similar 
threat if not properly used in a juice processing facility, FDA is 
proposing a parallel requirement in Sec. 120.6(a)(5).
    The other provisions of Sec. 123.11(b) are based on CGMP and 
encompass basic sanitation principles. Based on its consideration of 
the factors that it cited in arriving at Sec. 123.11(b), the agency 
tentatively concludes that it is appropriate to require in 
Sec. 120.6(a) that juice processors address the same sanitary 
conditions and practices in their SOP that must be monitored by seafood 
processors. FDA requests comment on the proposed matters that must be 
addressed in the sanitation SOP, and whether others are necessary for 
juice.
2. Other Requirements for Prerequisite Program SOP's
    FDA is proposing in Sec. 120.6(b) that processors monitor 
sanitation conditions and practices during processing with sufficient 
frequency to ensure, at a minimum, conformance with those conditions 
and practices specified in part 110 that are appropriate both to the 
plant and to the food being processed. The seafood HACCP regulation 
requires sanitation monitoring (Sec. 123.11(b)). Because prerequisite 
programs potentially include facility-wide control points and provide a 
foundation for HACCP systems, processors need to monitor the 
performance of the SOP's to ensure that they are functioning as 
designed, and that they are corrected if there is a problem.
    The agency is proposing in Sec. 120.6(c) that processors maintain 
records that document the monitoring that they do under the 
prerequisite program SOP's and any corrections to those SOP's that they 
make. Monitoring and recording of conditions and practices under the 
prerequisite program SOP's are as much keys to the success in improving 
those conditions as is the development by a processor of the SOP's. As 
in the case of HACCP records, FDA is proposing to require that 
processors engage in systematic monitoring of their own sanitation 
practices and conditions. This proposed requirement is similar to what 
is required for sanitation SOP's for seafood (Sec. 123.11(c)). 
Monitoring to

[[Page 20467]]

ensure that sanitation is under control is the responsibility of all 
processors. Monitoring records help processors to see trends, and also 
allow the regulator to assess a processor's compliance over a period of 
time, not just at the time of an inspection.
    FDA believes that the records bearing on the monitoring of relevant 
sanitation conditions and practices and the agency's access to such 
records are essential if proposed Sec. 120.6 is to be an effective 
regulatory strategy. Therefore, as with HACCP records, the agency 
tentatively concludes that these records be subject to the 
recordkeeping requirements in proposed Sec. 120.12.
    Proposed Sec. 120.6(d) provides the option to juice processors to 
include prerequisite program SOP controls in the HACCP plan. However, 
if these controls are implemented as part of the prerequisite program 
SOP's, there is no need to include them in the HACCP plan. The control 
must be in the HACCP plan or in the prerequisite program SOP but need 
not be in both places. This proposed provision is similar to 
Sec. 123.11(d) for seafood. It is intended to provide manufacturers 
with flexibility in how they address the issues involved in the 
prerequisite controls.
    The agency requests comment on its proposed approach to 
prerequisite program SOP's.

E. Hazard Analysis

1. The Hazard Analysis
    The seafood HACCP regulation in Sec. 123.6(a) requires that every 
processor conduct, or have conducted for it, a hazard analysis to 
determine whether there are food hazards that are reasonably likely to 
occur for each kind of fish and fishery product processed by that 
processor and to identify the preventive (i.e., control) measures that 
the processor can apply to control those hazards. Section 123.6(a) 
reflects the fact that food hazards can be introduced both within and 
outside the processing plant environment, including before, during, and 
after harvest. A food hazard that is reasonably likely to occur is one 
that, based on the evidence and insights provided by experience, 
illness data, scientific reports, and other information, has a 
reasonable possibility of occurring in the particular food if 
appropriate controls to protect against the hazard are not put in 
place. Thus, ensuring that a food will be safe involves identifying 
these hazards and preparing for them. The FSIS HACCP regulation for 
meat and poultry, in 9 CFR 417.2(a)(1), also requires that a hazard 
analysis be done.
    According to the NACMCF, a thorough hazard analysis is the key to 
preparing an effective HACCP plan (Ref. 55). If the hazard analysis is 
not done correctly, and the hazards warranting control within the HACCP 
system are not identified, the plan will not be effective regardless of 
how well it is followed.
    The hazard analysis involves hazard identification and evaluation. 
According to the NACMCF, each potential hazard is evaluated based on 
the severity of the potential hazard and the likelihood of its 
occurrence (Ref. 55). The NACMCF defined severity as the seriousness of 
the consequences of exposure to the hazard. They stated that 
consideration of the likelihood of its occurrence is usually based upon 
a combination of experience, epidemiological data, and information in 
the technical literature, and that when conducting the hazard 
evaluation, it is helpful to consider the likelihood of exposure and 
the severity of the potential consequences if the hazard is not 
properly controlled. The NACMCF also stated that consideration should 
be given to the effects of short term, as well as long term, exposure 
to the potential hazard.
    The seafood HACCP regulation does not differentiate between hazards 
that cause acute harm and hazards that cause harm through chronic 
exposure. FDA stated in the seafood final rule that:
    HACCP should be the norm, rather than the exception, for 
controlling safety related hazards in the seafood industry. Existing 
standards for such contaminants as drug residues, pesticides, and 
industrial contaminants, are established to ensure that their 
presence in foods does not render the food unsafe. Processors of 
fish and fishery products are obliged to produce foods that meet 
these standards.
    Processors are obliged to exercise control over all food safety 
hazards that are reasonably likely to occur.
    An important principle is that the processor has the burden of 
determining the reasonable likelihood of a hazard's occurrence, 
regardless of whether it is a chronic or an acute exposure hazard. In 
determining whether a chronic hazard is reasonably likely to occur, a 
processor should consider whether it is reasonably likely that, without 
some form of control, the food will contain a contaminant in sufficient 
quantity to cause it to be adulterated under the act (e.g., it exceeds 
a Federal tolerance for a pesticide residue).
    The agency tentatively concludes that the requirement for a 
processor to conduct a hazard analysis is appropriate for juice 
processors. The evidence presented in section I of this proposal 
demonstrates that hazards are reasonably likely to occur in the 
processing of juice. Therefore, FDA is proposing to require in 
Sec. 120.7 that processors develop a hazard analysis to determine 
whether there are food hazards that are reasonably likely to occur for 
each type of juice processed and to identify the control measures that 
the processor can employ to control those hazards. The agency requests 
comments on how processors should consider the severity of the hazard, 
as the NACMCF discussed, along with its likelihood of occurrence, in a 
hazard analysis.
    FDA is also proposing in Sec. 120.7 to require that juice 
processors use the same considerations in their hazard analysis as 
required of seafood and meat and poultry processors (i.e., that they 
determine where hazards are introduced, and which hazards need to be 
controlled) because these considerations raise the fundamental issues 
that must be considered in identifying the hazards present in any 
processing operation.
    Finally, under the proposed regulation, the hazard analysis must be 
developed by an individual trained in HACCP. Training is critical to 
the successful implementation of HACCP systems. A trained individual 
will be able to understand and apply HACCP principles to the hazard 
analysis.
    The hazard analysis serves several purposes. It can identify any 
modifications to a process or product that are necessary to ensure or 
improve the product's safety. It can also provide the basis for 
determining CCP's. A specific analysis of a process is necessary 
because aspects of the process that represent significant hazards in 
one operation may not present significant hazards in another operation 
even though the two operations produce the same or a similar product. 
Differences in equipment and incoming materials are generally the basis 
for these variations. For example, processors will use different 
equipment and incoming materials if producing juice from concentrate 
than if they are producing the same juice from raw materials.
    A summary of the deliberations and the rationale developed during 
the hazard analysis should be kept for future reference. This 
information will be useful during reviews and updates of the hazard 
analysis and the HACCP plan.
    Although under both seafood HACCP and meat and poultry HACCP a 
hazard analysis is required, a written hazard analysis is only required 
under the meat and poultry regulation. In the seafood HACCP final rule, 
the agency presented its reasons for not requiring a written hazard 
analysis (60 FR 65096 at 65118). It stated:

[[Page 20468]]

    The agency recognizes that the best way for it to verify a 
processor's hazard analysis is indirectly, through its own 
evaluations of whether a processor ought to have a HACCP plan, and 
whether a HACCP plan appropriately identifies the food safety 
hazards and CCP's that are reasonably likely to occur. In other 
words, it is the end product of the hazard analysis, the HACCP plan 
and its implementation, that should be judged by the regulator. For 
this reason, the agency is not requiring that hazard analyses be 
performed according to a standardized regimen, or that they be 
documented in writing for FDA review.
    Even though FDA is not requiring that the hazard analysis be 
available to the agency, there may be cases in which it would be to 
the processor's advantage to have a carefully documented written 
hazard analysis to show to FDA. Such documentation may prove useful 
in resolving differences between the processor and the agency about 
whether a HACCP plan is needed and about the selection of hazards, 
CCP's, and CL's. Written hazard analyses may also be useful to 
processors in that they may help provide the rationale for the 
establishment of CL's and other plan components. Having the basis 
for these decisions available may be helpful when processors 
experience changes in personnel, especially those associated with 
the HACCP process, and in responding to unanticipated CL deviations.
    FDA believes that the position taken in the seafood HACCP 
regulation continues to be appropriate for seafood. The agency notes 
that the ``Fish & Fisheries Products Hazards & Controls Guide'' assists 
processors in the development of their HACCP plans, including the 
hazard analysis. It lists numerous potential hazards and guides seafood 
processors through the hazard analysis. However, as discussed 
previously, it is not clear whether, given the limitations on its 
resources, FDA will be able to provide such detailed information for 
juice. Therefore, the agency tentatively concludes that a requirement 
for a written hazard analysis is appropriate for juice.
    Moreover, most firms in the FDA pilot program reported that 
preparing a written hazard analysis, including a list of preventive 
measures, helped them conduct a more scientific analysis rather than 
just a qualitative one; they also reported that the written hazard 
analysis provided a means of communicating to employees the public 
health significance of the hazards that were being controlled (Ref. 
57). Thus, FDA believes that processors likely will conduct a more 
appropriate hazard analysis if they have to document it. If the hazard 
analysis has not been conducted properly, the HACCP plan will likely be 
inadequate. Therefore, FDA tentatively concludes that HACCP plans alone 
may not be adequate without a documented hazard analysis.
    Accordingly, FDA is proposing to include in Sec. 120.7 that the 
hazard analysis be written and maintained as a record in accordance 
with proposed recordkeeping requirements (Sec. 120.12). The agency 
requests comments on its approach of requiring a written hazard 
analysis.
2. Evaluation of Hazards
    Section 123.6(c) requires that processors consider in the hazard 
analysis whether any food safety hazards are reasonably likely to occur 
as a result of natural toxins, microbiological contamination, chemical 
contamination, pesticides, drug residues, decomposition, parasites, 
unapproved use of direct or indirect food or color additives, and 
physical hazards. In 9 CFR 417.2(a)(3), FSIS lists these same 
considerations where food safety hazards might be expected to arise and 
adds zoonotic diseases to the list.
    FDA has reviewed the food hazards that are reasonably likely to 
occur in juice. For the most part, the hazards that processors should 
consider in doing a hazard analysis for this type of food are the same 
as those that FDA and USDA have listed in the regulations for seafood, 
meat, and poultry (Ref. 58). However, unlike seafood, meat, and 
poultry, pesticides may be intentionally applied to fruits, vegetables, 
and other plant products during their growth. All pesticides applied to 
produce must be approved for use on that plant, and the residue levels 
of the pesticides at the time of harvest must be within tolerances. 
Therefore, processors must ensure that any pesticide residues on plant 
foods are lawful for that food and are within tolerances.
    The presence of possible allergens in foods is a second possible 
hazard that was not considered in HACCP regulations for seafood or meat 
and poultry. Food ingredients must be declared on the label in 
accordance with Sec. 101.4, and individuals sensitive to particular 
ingredients may avoid consuming them by checking the ingredient list. 
However, there is a possibility that traces of undeclared food 
materials could be present in food products from foods run previously 
on the same equipment as used for the juice or on nearby equipment. The 
presence of even traces of certain food ingredients can cause life 
threatening reactions in sensitive individuals. For example, dairies 
may process juice using the same equipment that they use to process 
milk. Therefore, dairies processing juice in this manner must consider 
whether traces of milk are present in the juice. The same principle 
holds for processors producing several types of juices on the same 
equipment. A hazard analysis should determine whether a food hazard is 
created as a result. FDA tentatively concludes that a hazard analysis 
should consider the potential presence of undeclared food ingredients 
that could be possible allergens.
    Therefore, FDA is proposing in Sec. 120.7(a) that in evaluating 
which food hazards are reasonably likely to occur, consideration should 
be given, at a minimum, to the following: (1) Microbiological 
contamination, (2) parasites, (3) chemical contamination, (4) unlawful 
pesticide residues, (5) decomposition in food where a food hazard has 
been associated with decomposition, (6) natural toxins, (7) unapproved 
use of direct or indirect food or color additives, (8) presence of 
undeclared allergens, and (9) physical hazards. The agency requests 
comment on these hazards and any others that should be included in the 
regulation.
3. Other Considerations
    The agency is proposing in Sec. 120.7(b) that processors should 
evaluate product ingredients, processing procedures, packaging, 
storage, and intended use; facility and equipment function and design; 
and plant sanitation, including employee hygiene, to determine the 
potential effect of each on the safety of the finished food for the 
intended consumer. These are factors that a prudent processor should 
consider in conducting a hazard analysis. The seafood HACCP regulations 
at Sec. 123.6(a) did not list specific items or factors that processors 
should consider when conducting a hazard analysis. The preamble to the 
final rule for those regulations stated that, as of December 1995, the 
methodology for conducting a hazard analysis was not sufficiently 
standardized to justify mandating what the hazard analysis must 
include. The preamble encouraged processors to study the NACMCF 
guidance on the subject. The agency tentatively concludes, however, 
that including in the codified text the minimum elements that the 
processor should consider in developing a hazard analysis will assist 
processors. This material is included to be helpful and does not 
constitute a substantive change from the seafood HACCP regulation. FDA 
requests comment on proposed Sec. 120.7(b).

F. HACCP Plan

1. The HACCP Plan
    The seafood HACCP regulation requires in Sec. 123.6(b) that 
processors have and implement a written HACCP

[[Page 20469]]

plan whenever a hazard analysis reveals one or more food safety hazards 
that are reasonably likely to occur. FSIS has established a similar 
requirement for meat and poultry (9 CFR 417.2(b)).
    FDA is proposing to require in Sec. 120.8(a) that every juice 
processor have and implement a written HACCP plan whenever a hazard 
analysis reveals that one or more food hazards are reasonably likely to 
occur during processing, as described in Sec. 120.7. This could include 
adapting a model or generic-type plan to a processor's specific 
situation. This proposed requirement is in keeping with Principle 7 of 
the NACMCF guidelines that firms prepare and maintain written HACCP 
records (Ref. 55).
    The agency is also proposing in Sec. 120.8(a)(1) and (a)(2) that a 
HACCP plan be specific to each location where juice is, and to each 
type of juice that is, processed by that processor. The plan may group 
types of juice products together, or group types of production methods 
together, if the food hazards, CCP's, CL's, and procedures required to 
be identified and performed are essentially the same for the products 
or methods being grouped, provided that any required features of the 
plan that are unique to a specific product or method are clearly 
delineated in the plan and are observed in practice. Proposed 
Sec. 120.8(a) is similar to provisions in both Sec. 123.6(b) of the 
seafood HACCP regulation and 9 CFR 417.2(b) of the HACCP regulation for 
meat and poultry.
    A plan is specific to each location because the likely hazards, 
CCP's, CL's, and monitoring procedures can vary from one facility to 
another depending on such factors as type of equipment, conditions and 
procedures, personnel, and location. A plan also should be specific to 
each type of juice for the same kinds of reasons. Hazards can vary 
depending on the type of fruit or vegetable used to make the juice, pH, 
and other factors. The agency has tentatively concluded, however, that 
some types of juices can be grouped together in a HACCP plan if the 
hazard analysis reveals that the juices present similar hazards, their 
processing includes the same CCP's, or there are other appropriate 
commonalities in their production. Grouping would reduce the paperwork 
burden on some processors without altering the benefits attainable 
through HACCP. The agency requests comment on this approach.
    A valid HACCP plan delineates the procedures to be followed in 
processing the juice. Thus, FDA tentatively concludes that the HACCP 
plan needs to be developed by individuals who not only are 
knowledgeable in juice processing but who have been trained in HACCP. 
This activity requires specialized training in the principles of HACCP, 
various aspects of food science, and the knowledge of criteria of 
existing regulations and guidelines. Therefore, the agency is proposing 
in Sec. 120.8(a) that the HACCP plan be developed by an individual or 
individuals who have been trained in accordance with proposed 
Sec. 120.13.
    Seafood and meat and poultry processors are required to have a 
written HACCP plan that is subject to certain recordkeeping 
requirements. An adequate recordkeeping system is the key to HACCP. In 
addition, adequate records allow the processor to be able to reference 
the HACCP plan as necessary. Thus, FDA tentatively concludes that, 
because of the plan's importance in a HACCP system, the HACCP plan for 
juice must also be subject to certain recordkeeping requirements. 
Therefore, the agency is also proposing in Sec. 120.8 that the HACCP 
plan be maintained in accordance with the recordkeeping requirements of 
Sec. 120.12.
2. The Contents of the HACCP Plan
    As discussed previously, the NACMCF has developed seven principles 
that describe the HACCP concept and what constitutes a HACCP plan. Both 
Sec. 123.6(c) and 9 CFR 417.2(c) include minimum requirements for the 
contents of HACCP plans for seafood and meat and poultry, respectively, 
that are based on these seven principles. FDA is proposing to require 
similar minimum criteria for HACCP plans for juice products.
    The agency is proposing in Sec. 120.8(b)(1) to require that the 
plan list the food hazards that are reasonably likely to occur as 
identified in accordance with Sec. 120.7 and that thus must be 
controlled for each type of product. This list identifies the hazards 
that will be controlled by adhering to the HACCP plan in the processing 
of that type of juice.
    Consistent with the HACCP principles identified by the NACMCF, FDA 
is proposing in Sec. 120.8(b)(2) that processors list the CCP's for 
each of the identified food hazards, including, as appropriate, CCP's 
designed to control hazards that could occur or be introduced inside 
the processing plant environment, and CCP's designed to control food 
hazards introduced outside the processing plant environment, including 
hazards that occur before, during, or after harvest. Complete and 
accurate identification of CCP's is fundamental to controlling food 
hazards (Ref. 55). Hazards may be caused by improper processing or by 
events outside the processor's direct control. These hazards are 
controlled by the CL's, monitoring, control procedures, and 
recordkeeping that are done as part of HACCP.
    In Sec. 120.8(b)(3), FDA is proposing, consistent with the NACMCF 
principles, that processors list the CL's that must be met at each of 
the CCP's. CL's must be met to ensure that the relevant hazard is 
controlled or avoided. According to the NACMCF, each CCP will have one 
or more control measures to ensure that the identified hazards are 
prevented, eliminated, or reduced to acceptable levels (Ref. 55). Each 
control measure has one or more associated CL's. Thus, some CL's can be 
set to reflect regulatory levels established by FDA or EPA in the form 
of action levels, regulatory limits, or tolerances for contaminants 
such as pesticide residues, natural toxins, and other contaminants.
    According to the NACMCF, monitoring serves three main purposes 
(Ref. 55). First, monitoring is essential to food safety management in 
that it facilitates tracking of the operation. If monitoring indicates 
that there is a trend towards loss of control, then action can be taken 
to bring the process back into control before a deviation from a 
critical limit occurs. Second, monitoring is used to determine when 
there is loss of control and thus a deviation at a CCP (i.e., exceeding 
or not meeting a CL). When a deviation occurs, an appropriate 
corrective action must be taken. Third, it provides written 
documentation for use in verification.
    Proposed Sec. 120.8(b)(4) requires that processors list the 
procedures, and the frequency with which they are to be performed, that 
will be used to monitor each of the CCP's to ensure compliance with the 
CL's. Monitoring steps are necessary to ensure that the CCP is in fact 
under control and to produce an accurate record of what has occurred at 
the CCP. The frequency of monitoring affects the level of confidence 
that a firm has in the safety of its product, with continuous 
monitoring providing the highest level of confidence.
    The agency is proposing in Sec. 120.8(b)(5) that processors include 
in their HACCP plan any corrective action plans that have been 
developed in accordance with proposed Sec. 120.10(a), and that are to 
be followed in response to deviations from CL's at CCP's. As explained 
in more detail in the ``Corrective Actions'' section of this preamble, 
FDA has tentatively concluded that these regulations should provide the 
processor with the option of predetermining corrective actions. 
Predetermined corrective action

[[Page 20470]]

procedures have the potential to facilitate faster action when a 
deviation occurs than would be possible in the absence of such 
procedures and to enable a processor to make a more timely response to 
the deviation when trained or otherwise qualified individuals are not 
readily available.
    Consistent with the NACMCF principles, the agency is proposing in 
Sec. 120.8(b)(6) that processors list the verification and validation 
procedures, and the frequency with which they are to be performed, that 
the processor will use in accordance with proposed Sec. 120.11. As 
explained in more detail in the ``Verification and Validation'' section 
of this preamble, FDA has tentatively concluded that a processor must 
specify in its HACCP plan the verification and validation procedures 
that it will use and the frequency with which it will use those 
procedures. FDA tentatively finds that inclusion of this information in 
the plan is necessary to underscore that a processor has an ongoing 
obligation to ensure that the verification and validation steps it has 
determined are necessary are readily ascertainable by its employees as 
well as by regulatory officials.
    Finally, in Sec. 120.8(b)(7), FDA is proposing that processors 
provide for a recordkeeping system that documents the monitoring of the 
CCP's, and that the records contain the actual values and observations 
obtained during monitoring. Implementing a HACCP system depends on 
adequate records to document the controls at each CCP and the 
corrective actions taken in response to any deviations. FDA has 
tentatively concluded that it is neither possible for processors to 
derive the full benefits of a HACCP system, nor to verify or validate 
the operation of the system, without actual measurement values. 
Notations that heat treatment temperatures are ``satisfactory'' or 
``unsatisfactory,'' without recording the actual times and 
temperatures, are vague and subject to varying interpretations and 
thus, will not ensure that controls are working properly. Also, it is 
not possible to discern trends without actual measurement values.
    The agency requests comments on developing a HACCP plan based on 
the NACMCF principles.
3. Products Subject to Other Regulations
    FDA has already established HACCP type regulations for acidified 
and low acid canned foods. FDA examined this issue in the seafood final 
rule (60 FR 65096 at 65124) and acknowledged that there is no need for 
a processor to restate in its HACCP plan the requirements of part 113 
or 114 (21 CFR part 113 or 114).
    Parts 113 and 114 dictate that low-acid canned foods and acidified 
foods be processed in a manner to become commercially sterile. 
Commercial sterility of thermally processed food is defined in 
Sec. 113.3(e)(1) as a process that renders the food free of: (1) 
Microorganisms capable of reproducing in the food under normal 
nonrefrigerated conditions of storage and distribution, and (2) viable 
microorganisms (including spores) of public health significance. 
Consequently, juice processors who must comply with the requirements of 
part 113 or 114 need not address these particular hazards at all in 
their HACCP plans.
    However, it is important to note that other hazards may be 
reasonably likely to occur in an acidified or low-acid canned juice. 
FDA is proposing to require that these hazards be addressed in the 
HACCP plan, as appropriate. For example, FDA anticipates that the 
possible presence of glass in carrot juice packed in glass containers 
is a hazard that is reasonably likely to occur and thus the agency 
expects this hazard to be addressed in the HACCP plan. Accordingly, to 
clarify what is required of processors of acidified and low-acid canned 
juice products, FDA is proposing to adopt Sec. 120.8(c) for juice 
products subject to other regulations.
4. Relationship to Prerequisite Programs
    All hazards identified during the hazard analysis as being 
reasonably likely to occur need to be addressed by control measures 
that a processor can apply. Determining how the control measures, in 
turn, are to be addressed is a primary consideration in developing the 
HACCP plan. Control measures involve identifying the relevant CCP's and 
CL's as part of the HACCP plan, or, in those limited circumstances 
specified in proposed Sec. 120.6, making appropriate provision in a 
prerequisite program SOP. The safety of the product can be compromised 
if control measures are not properly monitored and addressed.
    As it required for seafood HACCP, FDA is proposing to require that 
processors address plant sanitation by monitoring certain key sanitary 
conditions and practices apart from CCP monitoring activities, either 
by including sanitation controls as part of the HACCP plan, or as part 
of an SOP in accordance with Sec. 120.6, or by adopting some 
combination of these two approaches, at the option of the processor.
    To reflect this approach, the agency is proposing in Sec. 120.8(d) 
to state that sanitation controls may be included in the HACCP plan, 
but that, to the extent that they are monitored in accordance with 
Sec. 120.6, they need not be included in the HACCP plan.
    FDA recognizes that many processing operation sanitation controls, 
such as hand and equipment washing and sanitizing, are critical to the 
safety of the food because they serve to minimize the risk of pathogen 
introduction into finished products that may not be further heat 
treated before consumption. For this reason, some processors may elect 
to include in their HACCP plan the control of sanitation through 
standardized practices in addition to, or in place of, monitoring of 
sanitation conditions and control practices apart from the HACCP plan. 
However, FDA also recognizes that sanitation controls may be difficult 
to fit into HACCP plans, with appropriate CL's and corrective actions 
sometimes being elusive. For this reason, some processors may elect to 
rely exclusively on sanitation controls that are not part of the HACCP 
plan. Either approach is likely to be acceptable, so long as whatever 
approach is chosen is fully implemented and followed. FDA requests 
comment on this view.

G. Legal Basis

    The seafood HACCP regulation states that the failure of a processor 
to have and to implement a HACCP plan that complies with Sec. 123.6(g), 
whenever a HACCP plan is necessary, or otherwise to operate in 
accordance with the requirements of part 123, will render the fish or 
fishery products of that processor adulterated under section 402(a)(4) 
of the act, and potentially section 402(a)(1). Whether a processor's 
actions are consistent with ensuring the safety of food will be 
determined through an evaluation of the processor's overall 
implementation of its HACCP plan, if one is required. The legal basis 
for FDA's proposed mandatory HACCP systems for juice processors is the 
same as that for seafood processors. Additional discussion of the legal 
basis may be found in the proposed rule (59 FR 4142 at 4150) and final 
rule (60 FR 65096 at 65098) for fish and fishery products.
    The agency is proposing in Sec. 120.9 that failure of a juice 
processor to have and to implement a HACCP system that complies with 
Sec. 120.8 or otherwise to operate in accordance with the requirements 
of this part, will have similar consequences as a failure to comply 
with the seafood HACCP regulations. FDA has tentatively determined that 
the hazards, especially microbial hazards, inherent in juice

[[Page 20471]]

processing are such that, unless there is adherence to HACCP 
principles, there cannot be assurance that the product is safe. Thus, 
failure to operate a juice processing operation in accordance with 
HACCP is itself an insanitary condition that may render the juice 
product injurious to health.

H. Corrective Actions

    The fifth HACCP principle, as articulated by the NACMCF, is that 
processors establish the corrective actions that they will take should 
monitoring show a CL deviation. The NACMCF's expectation is that these 
corrective actions should be predetermined and written into the 
processor's HACCP plan. Where there is a deviation from established 
CL's, corrective actions are necessary (Ref. 55).
    Section 123.7 of the seafood regulation permits, but does not 
require, processors to include in their HACCP plans any written 
corrective action plans that they develop. When a deviation from a CL 
occurs, Sec. 123.7(a) requires that the processor either: (1) Follow a 
corrective action plan that is appropriate for the particular 
deviation, or (2) follow the series of actions provided in 
Sec. 123.7(c). The steps in Sec. 123.7(c) constitute a minimum generic 
model for corrective actions.
    Section 123.7(b) of the seafood HACCP regulation defines an 
appropriate action plan as one that addresses both the safety of the 
product that was being processed when the CL failure occurred and the 
cause of the deviation. In this respect, the contents of the corrective 
action plan are consistent with the views of the NACMCF (Ref. 55).
    Action necessary to correct the potential hazard may involve one or 
more of the following steps: Immediately reprocessing the product; 
diverting the product to another use for which it is safe; segregating, 
holding, and having the product evaluated by a competent expert; or 
destroying the product (60 FR 65096 at 65127). To ensure that 
subsequent product is not subjected to the same deviation, the 
corrective action must be sufficient to bring the process back under 
control. FDA advised in the preamble to the seafood final rule (60 FR 
65096 at 65127) that such action may involve, where appropriate, 
adjustments to those process parameters that have an effect on the 
relevant CL (e.g., flow rate, temperature, source of raw materials); 
temporarily diverting product around a point in the process at which 
problems are being encountered; or temporarily stopping production 
until the problem can be corrected.
    Section 123.7(c) of the seafood HACCP regulation describes the 
steps that a processor must take whenever there is a deviation from a 
CL, but the processor has not prepared a corrective action plan for 
that situation. If the processor does not have a corrective action plan 
for a particular deviation, then the processor must: (1) Segregate and 
hold the affected product for as long as necessary, (2) perform or 
obtain a review by a trained individual to determine the affected 
product's acceptability for distribution, (3) take corrective action to 
ensure that no product enters commerce that is either injurious to 
health or is otherwise adulterated as a result of the deviation, (4) 
take corrective action to correct the cause of the deviation, and (5) 
have a trained individual perform a timely reassessment to determine 
whether the HACCP plan needs to be modified to reduce the risk of 
recurrence of the deviation and modify the HACCP plan as necessary.
    As stated in a previous paragraph , these steps constitute a 
minimum generic-type corrective action plan. The objectives of these 
steps are the same as those of a preconceived plan: To ensure that 
adulterated product does not enter commerce and to correct the cause of 
the deviation. Because it is a generic-type plan that is intended to be 
applicable to any situation, some of the steps, such as segregating and 
holding the affected product (Sec. 123.7(c)(1)), might not be necessary 
if the corrective action had been predetermined. This aspect of the 
generic-type plan may provide processors with an incentive to 
predetermine corrective actions whenever practical.
    FDA is proposing essentially the same requirements in Sec. 120.10 
that it requires in Sec. 123.7 of the seafood HACCP regulation because 
the agency is not aware that a juice processor has any options other 
than those that are available to the seafood processor. The processor 
can either follow its own established corrective action plan, as 
appropriate for the particular deviation, or follow the generic 
provisions of the regulation that are applicable to any food. Thus, FDA 
tentatively concludes that the seafood HACCP requirements for 
corrective actions are applicable to juice processing.
    Proposed Sec. 120.10 sets forth the corrective action procedures 
that a processor must take whenever a deviation from a CL occurs. A 
processor may take corrective action either by following: (1) A 
corrective action plan as identified in the HACCP plan (see proposed 
Sec. 120.8(b)(5)), or (2) the procedures outlined in proposed 
Sec. 120.10(b). Predetermined plans provide processors with benefits, 
such as faster action when a deviation occurs, less need to justify to 
management the appropriateness of the corrective action after it has 
been taken, and a more timely response to the deviation than is 
possible when trained or otherwise qualified individuals are not 
readily available to make determinations, and a plan is not available.
    The agency is proposing to provide in Sec. 120.10(a) that 
processors may develop written corrective action plans, which become 
part of their HACCP plans in accordance with Sec. 120.8(b)(5), by which 
they predetermine the corrective actions that they will take whenever 
there is a deviation from a CL. According to the NACMCF, specific 
corrective actions should be developed in advance for each CCP and 
included in the HACCP plan (Ref. 55). The agency is also proposing in 
Sec. 120.10(a) that a corrective action plan that is appropriate for a 
particular deviation is one that describes the steps to be taken and 
assigns responsibility for taking those steps, to ensure that: (1) No 
product enters commerce that is either injurious to health or is 
otherwise adulterated as a result of the deviation, and (2) the cause 
of the deviation is corrected. These two considerations are essential 
because they represent the reasons for taking corrective actions (i.e., 
protecting the public health and correcting the problem at hand).
    In Sec. 120.10(b), FDA is proposing the steps that processors must 
take when a deviation from a CL occurs, and they do not have a 
corrective action plan that is appropriate for that deviation. First, 
under proposed Sec. 120.10(b)(1), any CL deviation will require the 
segregation and holding of the affected product until the significance 
of the deviation can be determined. FDA tentatively finds that this 
step is necessary to ensure that products that may be injurious to 
health do not enter commerce until the deviation's impact on safety has 
been determined.
    Proposed Sec. 120.10(b)(2) requires that processors perform or 
obtain a review to determine the acceptability of the affected product 
for distribution. This is fundamental to determining the final outcome 
of the affected product. In some instances product may simply need to 
be reprocessed, while at other times, the product may not be considered 
adulterated. For example, if the pasteurization process did not reach 
the minimum temperature specified by the CL, the juice can be diverted 
and rerouted through the pasteurizer for

[[Page 20472]]

reprocessing at acceptable temperatures. However, if the juice contains 
a pesticide above an established tolerance level, the juice is deemed 
to be adulterated.
    FDA is also proposing to require in Sec. 120.10(b)(2) that the 
safety determination be made by an individual who has adequate training 
or experience to perform such a review. Adequate training may or may 
not include training in accordance with proposed Sec. 120.13, but the 
individual's training must be sufficient to qualify him or her to make 
the public health determinations of this nature. For example, an 
individual must have some training to understand that pasteurized juice 
must have been processed to reach a minimum time and temperature 
combination and know methods of reprocessing to remedy problem 
situations. Adequate training in this context requires only knowledge 
of how to perform the particular operation responsibility rather than 
training in the concepts of HACCP.
    Under proposed Sec. 120.10(b)(3), processors must take corrective 
action, when necessary, with respect to the affected product to ensure 
that no product enters commerce that is either injurious to health or 
is otherwise adulterated as a result of the deviation. Under proposed 
Sec. 120.10(b)(4) processors must take corrective action, when 
necessary, to correct the cause of the deviation. As discussed for 
proposed Sec. 120.10(a), the actions called for under these two 
provisions are essential to any corrective action plan because they 
address one of the two reasons for taking corrective actions, that is, 
correcting the problem at hand.
    FDA is proposing in Sec. 120.10(b)(5) to require that a trained 
person validate the HACCP plan that was in use at the time of the 
deviation to determine whether it needs to be modified to reduce the 
risk of recurrence of the deviation and to modify the HACCP plan as 
necessary. It is critically important that processors learn as much as 
possible from the occurrence of a deviation, and that they take the 
steps necessary to ensure that such deviation will not be repeated. 
Proposed Sec. 120.10(b)(5) reflects these principles.
    Finally, proposed Sec. 120.10(c) requires that processors maintain 
records of all corrective actions that they take following either the 
corrective action procedures in the HACCP plan or those specified in 
Sec. 120.10(b). The agency is proposing that these records be subject 
to the verification requirements in proposed Sec. 120.11(a) and the 
recordkeeping requirements of Sec. 120.12. The records need to reflect 
all actions taken in response to a deviation (i.e., provide the 
specifics about the actions taken and not simply refer to a written 
procedure). Such information helps the processor to determine if there 
are recurring problems that it needs to address. The information also 
will enable both the processor and the regulator to identify factors 
that may help prevent problems in the future.
    The agency requests comments on its proposed approach to corrective 
actions.

I. Verification and Validation

    The seafood HACCP regulation requires that every processor verify 
that the HACCP plan is adequate to control food safety hazards that are 
reasonably likely to occur, and that the plan is being effectively 
implemented (Sec. 123.8(a)). Section 123.8 includes requirements for 
reassessment of the HACCP plan and for various other verification 
activities, including reviewing monitoring records, reviewing records 
of corrective actions, and reviewing calibration records. Section 123.8 
also requires, in certain circumstances, that processors who had 
concluded that no HACCP plan was necessary reassess that judgment and 
reevaluate their HACCP analysis.
    The meat and poultry HACCP regulation requires that every 
establishment validate the HACCP plan's adequacy in controlling the 
food safety hazards identified during the hazard analysis and verify 
that the plan is being effectively implemented (9 CFR 417.4(a)). 
Section 417.4 includes requirements for initial validation, ongoing 
verification activities, reassessment of the HACCP plan, and 
reassessment of the hazard analysis for processors that do not need a 
HACCP plan.
    According to the NACMCF (Ref. 55), there are four aspects to 
verification. One is verifying whether the facility's HACCP system is 
functioning according to the HACCP plan. Another aspect is the initial 
validation of the HACCP plan to determine whether the significant 
hazards have been identified, and whether, if the HACCP plan is 
properly implemented, these hazards will be effectively controlled. The 
third aspect consists of documented validations that are done after the 
initial development and implementation of the HACCP plan. The fourth 
aspect of verification deals with a periodic verification of the HACCP 
system by an unbiased, independent authority.
1. Verification
    The agency is proposing in Sec. 120.11(a) to require that every 
processor verify that the HACCP system is being implemented according 
to design. According to the NACMCF, a functioning HACCP system requires 
little end-product sampling because appropriate monitored safeguards 
are inherent to the process. Therefore, rather than relying on end-
product sampling, firms need to conduct frequent reviews of their HACCP 
plan to verify that it is being correctly followed, to review CCP 
records, and to ensure that appropriate risk management decisions and 
product dispositions are made when process deviations occur.
    Proposed Sec. 120.11(a) sets forth the minimum requirements for 
verification activities. Proposed Sec. 120.11(a)(1) deals with ongoing 
verification activities. These ongoing activities are in keeping with 
the NACMCF's view that verification needs to take the form of 
``frequent reviews.'' Frequent reviews relate primarily to whether the 
HACCP plan is functioning effectively on a day-to-day basis.
    The agency is proposing to require in Sec. 120.11(a)(1)(i) that a 
processor review any consumer complaint that it receives to determine 
whether the complaint relates to the performance of the HACCP plan or 
reveal the existence of unidentified CCP's. Although the absence of 
consumer complaints does not, by itself, verify the adequacy of a HACCP 
system, those consumer complaints alleging a safety problem that a 
processor does receive can be of value as a verification tool and 
should be used for that purpose.
    Proposed Sec. 120.11(a)(1)(ii) provides for the calibration of 
process-monitoring instruments as a verification activity. Calibration 
provides assurance that an instrument is measuring correctly. 
Calibration is an important activity and involves readily defined 
procedures, usually provided by the instrument manufacturer, that can 
easily be included in the plan.
    Proposed Sec. 120.11(a)(1)(iii) provides that the processor may 
perform periodic end-product or in-process testing. FDA acknowledges 
the shortcomings of product testing, especially microbiological 
testing, as a process control. However, the agency recognizes that many 
processors will find that product testing may be included in their 
verification activities, and the agency encourages incorporation of 
testing into HACCP systems, where appropriate. For example, in cases 
where a processor is obtaining fruits and vegetables from unknown 
sources, and there is no assurance that pesticides have been correctly 
applied, product testing for pesticide residues is an appropriate step 
in a HACCP plan.

[[Page 20473]]

    Proposed Sec. 120.11(a)(1)(iv) provides for a review by a trained 
individual of all records that document monitoring of CCP's, the taking 
of corrective actions, the calibration of any process control 
instruments, and the performance of any end-product or in-process 
testing. As proposed, the review must include signing and dating of the 
records. The primary purpose of the record review is the periodic 
verification that the HACCP plan is appropriate and is being properly 
implemented. This review of these records must occur with sufficient 
frequency so as to ensure that any problems in the design and 
implementation of the HACCP plan will be promptly uncovered, and that 
modifications to the plan or process will be promptly made.
    FDA tentatively concludes that a weekly review of HACCP monitoring 
and corrective action records (Sec. 120.11(a)(1)(iv)(A) would provide 
the industry with the necessary flexibility to handle a highly 
perishable commodity like fresh juice without interruption, while still 
facilitating timely feedback of information. FDA's experience with low-
acid canned foods and acidified foods has demonstrated that timely 
review of these kinds of records is a critical verification tool.
    However, this principle need not apply to the review of records of 
such verification activities as process control instrument calibration 
and product testing. The frequency of these activities will be variable 
and dependent upon the HACCP plan. For example, pesticide testing of 
fruits and vegetables may only need to be done when the source of the 
produce is new or unfamiliar to the firm. Consequently, the agency 
tentatively concludes that setting a specific review frequency for 
these records is not warranted and thus is only proposing that the 
review be conducted within a reasonable time after the records are made 
(see proposed Sec. 120.11(a)(iv)(C)).
    Proposed Sec. 120.11(a)(1)(v) requires that processors take 
appropriate corrective action whenever any verification procedure, 
including the review of a consumer complaint, reveals the need to do 
so. This proposed provision is essentially a reminder to processors 
that information obtained through verification may require a corrective 
action.
    FDA is proposing in Sec. 120.11(a)(2) that processors document, in 
records that are subject to the recordkeeping requirements of 
Sec. 120.12, the calibration of process-monitoring instruments and the 
performance of any periodic end-product and in-process testing, in 
accordance with paragraphs (a)(1)(iv)(B) and (a)(1)(iv)(C). For a 
processor's HACCP controls to work, the instruments and equipment that 
it relies upon in monitoring CCP's, such as thermometers, temperature-
recording devices, and computer software, must be accurate and 
reliable. FDA has tentatively concluded that the best way to ensure 
such accuracy and reliability for juice is to require that the 
processor's monitoring procedures include steps necessary to verify the 
reliability of these instruments and devices. The proposed requirement 
that records of end-product testing be kept is consistent with the 
general recordkeeping principles of HACCP.
    The agency requests comment on its proposed verification procedures 
for juice.
2. Validation of the HACCP Plan
    The agency is proposing, in Sec. 120.11(b) to require that juice 
processors validate that their HACCP plan is adequate to control the 
food hazards that are reasonably likely to occur in their products; 
this validation is required at least once during the year after 
implementation and at least annually thereafter or whenever any changes 
occur that could affect the hazard analysis or alter the HACCP plan and 
prerequisite program SOP's in any significant way. The proposed 
requirement that HACCP plan validation be conducted at least once 
during the year after implementation is based on a recommendation from 
the NACMCF (Ref. 55). This process consists of reviewing the CL's to 
verify that the limits at CCP's are adequate to control the hazards 
that are likely to occur.
    The proposed requirement that the HACCP plan be validated at least 
annually, or whenever any relevant changes occur, is based on the 
NACMCF view that validation must occur on a regular basis (Ref. 55), 
although the NACMCF does not specify timeframes. Validation should be 
conducted on a regular basis, even in the absence of a recognized 
change, to ensure that the plan continues to address all of the 
reasonably likely food hazards with appropriate control limits and 
monitoring procedures. Processors should conduct the review at 
intervals that are appropriate for their processes, although FDA is 
proposing to require that this interval not exceed 1 year.
    Proposed Sec. 120.11(b) provides examples of changes that could 
trigger a validation. These include changes in raw materials or source 
of raw materials; product formulation; processing methods or systems, 
including computers and their software; packaging; finished product 
distribution systems; or the intended use or consumers of the finished 
product. These examples are derived from the NACMCF materials on the 
``five preliminary steps'' that form the basis for the HACCP plan (Ref. 
55). A change in any of these areas could necessitate a change in the 
plan to respond to any new hazards that may have been introduced or to 
maintain preventive control over existing ones. It is important to 
recognize that this list is not all inclusive.
    Proposed Sec. 120.11(b) requires that the plan validation be 
performed by an individual or individuals who have been trained in 
accordance with Sec. 120.13. The validation is fundamental in 
determining whether the HACCP plan is adequate to control food hazards 
that are reasonably likely to occur. HACCP plan validation may result 
in a need to alter other aspects of the HACCP system and the 
prerequisite program SOP's. The activities involved in plan validation 
are not routine activities but require an understanding of the 
principles of HACCP and of plan development. This understanding is 
obtained through training.
    Initial validation of the HACCP plan is necessary to ensure that 
all significant hazards have been identified, and that, if the HACCP 
plan is properly implemented, these hazards will be effectively 
controlled. Subsequent validation of the HACCP plan ensures that the 
plan continues to be effective.
    Validation is especially important whenever any changes occur that 
could affect the hazard analysis or alter the HACCP plan and 
prerequisite program SOP's in any way. Without these assessments and 
subsequent changes, the HACCP plan may not control the hazards that it 
should, and unsafe juice may be distributed. Therefore, the agency 
tentatively concludes that validation of the HACCP plan is necessary to 
ensure that juice processed in accordance with the plan will not have 
been processed under conditions whereby it may have been rendered 
injurious to health.
    The NACMCF states that the HACCP plan should be updated and revised 
as needed (Ref. 55). Changes in sources of incoming materials, 
formulations, processing, distribution, and consumer use usually occur 
over time. New technologies may be developed. New concerns that 
previously were not considered hazards reasonably likely to occur may 
become apparent. For example, E. coli O157:H7 was not recognized as a 
human pathogen before 1982 (Ref. 10), and the impact of its acid 
tolerance was not well understood.

[[Page 20474]]

 Therefore, the agency tentatively concludes that processors must 
maintain records demonstrating that they have been diligent in keeping 
their HACCP plans current. Thus, FDA is proposing to require in 
Sec. 120.11(b) that records of the plan validation be subject to the 
requirements of Sec. 120.12.
    Proposed Sec. 120.11(b) also requires that, where validation shows 
that the HACCP plan is inadequate, the processor modify immediately the 
plan. Failure of a processor to modify immediately its HACCP plan after 
the processor has determined that the plan is inadequate would result 
in the processor operating under insanitary conditions that may render 
the food prepared under the inadequate plan injurious to health and 
thus would render the food adulterated.
    FDA requests comments on its proposed approach to validation of 
HACCP plans for juice.
3. Validation of the Hazard Analysis
    Proposed Sec. 120.11(c) requires that, whenever a juice processor 
has no HACCP plan because a hazard analysis has revealed no food 
hazards that are reasonably likely to occur, the processor reassess the 
adequacy of that hazard analysis whenever there are any changes that 
could reasonably affect whether a food hazard exists. FDA has proposed 
to include examples of such changes in Sec. 120.11(c). The list is 
identical to that proposed in Sec. 120.11(b), on when a plan must be 
validated. Any change in these factors could warrant a validation to be 
certain that a plan is still not needed because, as stated in the 
discussion of proposed Sec. 120.11(b), such changes could introduce new 
hazards.
    FDA has tentatively concluded that, under a mandatory HACCP system 
for juice, the principle of validation applies equally to a decision 
that a HACCP plan is not necessary as it does to a decision that the 
plan is adequate. Circumstances change, and processors must be alert to 
whether factors that effectively exempt them from the requirement to 
have a plan continue to apply.
    The agency is proposing in Sec. 120.11(c) that the validation be 
performed by an individual or individuals who have been trained in 
accordance with proposed Sec. 120.13. The validation is fundamental in 
determining whether the hazard analysis considers all food hazards that 
are reasonably likely to occur. The hazard analysis validation may 
result in a need to alter other aspects of the HACCP system and the 
prerequisite program SOP's. These kinds of activities are not routine 
but require an understanding of the principles of HACCP that is 
obtained through appropriate training.
    The agency requests comment on its proposed approach to validation 
requirements of a hazard analysis in the absence of a HACCP plan.

J. Records

    Implementing a HACCP program involves engaging in adequate 
monitoring of CCP's and documenting the results of that monitoring 
through records. It also involves the taking of appropriate corrective 
actions in response to any deviations and, again, documenting the 
results. HACCP records also include the hazard analysis, the HACCP plan 
itself, and documentation of verification and validation activities. 
Records of prerequisite program SOP's, although not a part of the HACCP 
system, are significant records in a HACCP program in that the SOP's 
may be used in place of HACCP controls. Record systems used by the 
pilot firms in FDA's pilot program included hand written logs, filing 
systems for continuous recording charts and inspection sheets, and 
computer files of data of monitoring results and followup corrective 
actions.
    In Sec. 123.9 of the seafood regulation, FDA established 
requirements for HACCP records. Under this provision, all required 
records must include: (1) The name and location of the processor or 
importer; (2) the date and time of the activity that the record 
reflects; (3) the signature or initials of the person performing the 
operation; and (4) where appropriate, the identity of the product and 
the production code, if any. Processing and other information must be 
entered on records at the time that it is observed (Sec. 123.9(a)(4)). 
Records must be retained for at least 1 year for refrigerated foods and 
for at least 2 years for all other foods, similarly, records relating 
to the general adequacy of equipment or processes being used by a 
processor must be retained for 2 years (Sec. 123.9(b)). Off site 
provisions for storage of records from processing facilities that 
seasonally pack are allowed, provided that the records are reasonably 
accessible (Sec. 123.9(b)(3)). All records must be available for 
official review (Sec. 123.9(c)). Section 123.9 also provides 
information concerning public disclosure of records and maintenance of 
records on computers.
    According to the NACMCF, maintenance of appropriate records is 
fundamental to the success of a HACCP system (Ref. 55). In recognition 
of this fact, FDA is proposing to require in Sec. 120.12 that specific 
records be kept; that HACCP records contain certain necessary 
information; that records be maintained for specific periods of time; 
and that records be available for FDA review.
    The agency is proposing in Sec. 120.12(a) to list the records that 
the processor is required to maintain to document its HACCP system. FDA 
has discussed the basis for requiring that these records be kept in the 
sections addressing each particular provision. The proposed sections 
also state that records shall be maintained. The list of records that 
juice processors are required to maintain is included in 
Sec. 120.12(a), although this list is included simply for simplicity, 
in that the list reflects the record requirements that are set out in 
other sections of the proposed regulation.
    Proposed Sec. 120.12(b) describes the general requirements for 
records. The purpose of the proposed requirements in this provision is 
to ensure that records maintained under part 120 can be readily linked 
to a product and to the timeframe in which the product was 
manufactured. Linking a record to a specific product will be especially 
important when there has been a deviation at a CCP and will enable 
processors to isolate product that has not been processed properly, 
thereby preventing the product from reaching consumers. These records 
will also benefit processors in that only those lots that were 
processed inadequately will need to be recalled or isolated. The agency 
has tentatively concluded that including the name and location of the 
processor or importer; the date and time of the activity that the 
record reflects; the signature or initials of the person performing the 
operation or creating the record; and, where appropriate, the identity 
of the product and the production code, if any, are the minimum 
information necessary to enable the processor to determine what product 
may have been affected by a deviation and to take any appropriate 
actions with respect to that product.
    Proposed Sec. 120.12(b)(3) requires that the record include the 
signature or initials of the person performing the operation or 
creating the record. Requiring that the record be signed by the 
individual who made the observation will ensure responsibility and 
accountability. Also, if there is a question about the record, a 
signature ensures that the source of the record will be known.
    Proposed Sec. 120.12(b)(4) requires that processing and other 
information be entered on records at the time that it is observed and 
that the records contain the actual values and observations obtained 
during monitoring. It is important that information relating to 
observations be recorded immediately

[[Page 20475]]

and that the records contain the actual values and observations to 
enhance accuracy.
    Both the HACCP regulations for seafood and for meat and poultry 
require that the HACCP plan be signed and dated. In the seafood final 
rule (60 FR 65096 at 65124), FDA emphasized the importance of signing 
and dating the HACCP plan. The agency stated that:
    Such a signature would provide direct evidence of management's 
acceptance of the plan for implementation. FDA cannot stress enough 
that for HACCP to succeed, there must be a clear commitment to it 
from the top of the firm on down. Management must set a strong 
example in this regard. A signature requirement will remind 
management of this important responsibility and will signal to all 
employees that the firm regards the HACCP plan as a document to be 
taken seriously. Additionally, the representative's signature, along 
with the date of signing, would serve to minimize potential 
confusion over the authenticity of any differing versions or 
editions of the document that might exist.
    The agency tentatively concludes that this same reasoning applies 
to HACCP plans for juice processing, and that there are significant 
benefits of requiring similar steps for the HACCP plan for juice.
    The agency is also proposing to require that the hazard analysis 
for juice be written (see proposed Sec. 120.7). FDA tentatively 
concludes that the hazard analysis shall be signed and dated in a 
manner similar to what is required for the HACCP plan because of its 
relationship to and importance in the development of an adequate HACCP 
plan.
    Therefore, the agency is proposing to require in Sec. 120.12(c)(1) 
that the hazard analysis and the HACCP plan be signed and dated by the 
most responsible individual on-site at the processing facility or by a 
higher level official of the processor. Proposed Sec. 120.12(c)(1) 
provides that the signatures signify that these records have been 
accepted for incorporation into the HACCP system by the firm.
    In Sec. 120.12(c)(2)(i) through (c)(2)(iii), FDA is proposing to 
require that the hazard analysis and the HACCP plan be dated and signed 
upon initial acceptance, upon any modification, and upon verification 
and validation of the plan in accordance with proposed 
Sec. 120.11(d)(1). As was discussed fully in the ``Verification and 
Validation'' section of this preamble, FDA is proposing in Sec. 120.11 
that the adequacy of the HACCP plan, or, in the absence of a HACCP 
plan, the hazard analysis, be validated at least once during the year 
after implementation and at least annually thereafter or whenever any 
changes occur that could affect the hazard analysis or that could alter 
the HACCP plan and prerequisite program SOP's in any way. These 
verifications, validations, and modifications are necessary to ensure 
that the HACCP program remains current, and that it is responsive to 
emerging problems. The signature of the firm representative will 
document that these validations and modifications are performed as 
required. The requirements for documentation are the same as those 
required for the HACCP plan in the seafood regulation (Sec. 123.6(d)).
    The agency is proposing in Sec. 120.12(d) requirements for record 
retention. Proposed Sec. 120.12(d)(1) states that, in the case of 
perishable or refrigerated products, all required records shall be 
retained at the processing facility or importer's place of business in 
the United States for at least 1 year after the date that they were 
prepared and in the case of frozen, preserved, or shelf-stable 
products, 2 years after the date that they were prepared. These 
timeframes are based on the length of time that these products can be 
expected to be in commercial distribution plus a reasonable time 
thereafter to ensure that the records are available for the processor's 
and FDA's verification activities.
    FDA is proposing in Sec. 120.12(d)(2) that records that relate to 
the general adequacy of equipment or processes being used by a 
processor, including the results of scientific studies and evaluations, 
be retained at the processing facility or the importer's place of 
business in the United States for at least 2 years after the date that 
the processor last used that equipment or process. Under 
Sec. 120.12(a)(5) processors are required to maintain records 
documenting validation of the HACCP plan. If the firm is relying on 
equipment or processes to control hazards that are reasonably likely to 
occur then the firm must have some assurance that the equipment or 
process is adequate for that purpose. Should FDA adopt proposed 
Sec. 120.12(d)(2), a written certification from the equipment 
manufacturer will likely generally be sufficient to establish equipment 
adequacy. However, the processor may need to obtain a written 
scientific evaluation of a process, especially in cases where two or 
more treatments are used to accomplish a 5 log reduction in the target 
pathogen, to ensure that the process is adequate to destroy 
microorganisms of public health significance or to prevent their 
growth. Such an evaluation may also be necessary to ensure the adequacy 
of the pasteurization or refrigerating equipment that the processor is 
using. As with processing records, these records are required to be 
retained for a period of time that reflects the period that the 
products to which they relate can be expected to be in commercial 
distribution.
    The agency realizes that under the proposed requirements for 
recordkeeping, some juice processors may be required to store a 
significant quantity of records, and that there may not be adequate 
storage space in the processing facility for all of these records. 
However, if HACCP is to work, these records must be available for the 
processor's verification activities and for FDA inspections. Therefore, 
the agency is proposing to provide some relief to processors in 
Sec. 120.12(d)(3), which allows for off-site storage of the 
prerequisite program SOP records and records documenting the ongoing 
application of the HACCP plan (i.e., monitoring of CCP's and their CL's 
and corrective actions) 6 months after the date that the monitoring 
occurred, if such records can be retrieved and provided on-site within 
24 hours of request for official review. The records for which FDA is 
proposing to allow off-site storage are the more routine processing 
operation records and thus are of the type that are likely to be 
generated in the greatest numbers. FDA tentatively concludes that the 
proposed relief will benefit processors but will not interfere with the 
purpose for record retention because the records will be readily 
available.
    The use of computers in the food processing industry is increasing. 
Computerized systems within large corporations can be networked, 
allowing for the sending and receiving of information in a secure 
fashion to all of the different food processing facilities of that 
corporation worldwide. This type of system can easily be used to 
maintain all of the processing records from each of the processing 
facilities at corporate headquarters. Therefore, for clarity, FDA is 
proposing in Sec. 120.12(d)(3) that electronic records are considered 
to be on-site if they are accessible from an on-site location and 
comply with proposed Sec. 120.12(g).
    FDA recognizes that some juice processing plants may be closed on a 
seasonal basis. Given the nature of the HACCP system, however, FDA may 
choose to inspect at least the records of a plant even if the plant is 
not in operation. Therefore, FDA is providing in proposed 
Sec. 120.12(d)(4) that, if the processing facility is closed for a 
prolonged period between seasonal packs, the records may be transferred 
to some other reasonably accessible

[[Page 20476]]

location at the end of the seasonal pack but shall be immediately 
returned for official review upon request. This proposed provision will 
give the juice processor some relief, yet will serve to ensure that the 
records in question will be readily available.
    Proposed Sec. 120.12(e) requires that all records required under 
part 120 be available for official review and copying at reasonable 
times. The agency's access to HACCP records is essential to ensure that 
the HACCP system is working, and that the safety of juice is being 
ensured by design. FDA's authority to require maintenance of these 
records, and to provide for agency access to them, was fully discussed 
in the rulemaking on seafood HACCP (60 FR 65096 at 65139). The 
importance of the records in ensuring that juice will not be rendered 
injurious to health has been fully discussed. FDA access to these 
records will expedite the agency's efforts to ensure that the juice 
products in interstate commerce are not adulterated and to identify any 
such products that are. The agency points out that the proposed 
language in Sec. 120.12(e) is intended to be flexible enough to cover 
State officials if their agency adopts any final regulation by 
reference.
    Proposed Sec. 120.12(f) sets forth information concerning public 
disclosure of processing records. The agency concluded in the seafood 
final rule (60 FR 65096 at 65139):
    that records and plans should be protected to the extent 
possible in order to promote the implementation of HACCP across the 
seafood industry. FDA has concluded that the public will benefit 
from the protection of records because it will actually strengthen 
the HACCP system. So long as the legitimate public need to be able 
to evaluate the system can be met through other means, the 
confidentiality of HACCP records and plans generally will foster the 
industry's acceptance of HACCP. Even though HACCP may be mandatory 
under these regulations, in order for it to succeed, processors must 
be committed to it because they see value in it for themselves. Fear 
of public disclosure of matters that have long been regarded as 
confidential business matters could significantly undermine that 
commitment. FDA concludes, therefore, that it is in the public 
interest to foster tailored HACCP plans that demonstrate 
understanding and thought, rather than promote the use of rote plans 
and minimally acceptable standards due to fear of public disclosure.
    FDA understands that it cannot make promises of confidentiality 
that exceed the permissible boundaries established under the Freedom 
of Information Act, nor does the agency wish to do so in this case. 
The agency still does not expect that it will be in possession of a 
large volume of plans and records at any given moment. However, 
given the significant interest in this subject as conveyed by the 
comments, FDA has concluded that the final regulations should 
reflect the fact that the HACCP plans and records that do come into 
FDA's possession will generally meet the definition of either trade 
secret or commercial confidential materials.
    The agency is not aware of any circumstances that would warrant 
different conditions for public disclosure for records for juice HACCP 
than those required for seafood HACCP. Therefore, FDA is proposing the 
same provisions for Sec. 120.12(f) as are found in Sec. 123.9(d).
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA issued 
regulations at part 11 (21 CFR part 11) that provide criteria for 
acceptance by FDA, under certain circumstances, of electronic records, 
electronic signatures, and handwritten signatures executed to 
electronic records as equivalent to paper records and handwritten 
signatures executed on paper. Proposed Sec. 120.12(g) allows for the 
maintenance of records on computers in accordance with part 11. This 
provision simply makes clear the fact that records can be maintained on 
computers.
    The agency requests comments on its proposed approach to 
recordkeeping for juice processors.

K. Training

    In Sec. 123.10 of the seafood HACCP regulation, FDA required that 
certain functions relating to the operation of a HACCP system be 
conducted by an individual who has successfully completed training in 
the application of HACCP principles to fish and fishery product 
processing that is at least equivalent to that received under a 
standardized curriculum recognized as adequate by FDA. Job experience 
that has provided equivalent knowledge is also acceptable. The trained 
individual need not be an employee of the company.
    Training is essential to the effective implementation of a HACCP 
system for juice. Only a trained individual is capable of effectively 
executing certain activities, such as identifying appropriate CCP's, 
how to establish CL's, control measures, corrective actions, and 
recordkeeping procedures. The often seasonal nature, remote location, 
and small size of many juice processors also support the need for 
formalized training.
    However, these conditions also create difficulty recruiting highly 
qualified management and supervisory staff. Given these factors, 
particularly in light of what FDA learned in its pilot program, the 
agency is concerned that a significant portion of the juice industry 
will be unprepared to meet the requirements of a mandatory HACCP 
program without some training (Ref. 59).
    Therefore, FDA is proposing in Sec. 120.13(a) that only an 
individual who has met specified training requirements can be 
responsible for certain functions. Those functions are listed in 
proposed Sec. 120.13(a)(1) through (a)(4). FDA has discussed the basis 
for requiring that a trained individual perform these functions in the 
sections addressing each particular proposed provision. The agency is 
listing the functions that shall be performed by a trained individual 
in Sec. 120.13(a) for simplicity and is not imposing any additional 
requirement through this list.
    Proposed Sec. 120.13(b) requires that the individual performing the 
functions listed in proposed Sec. 120.13(a) have successfully completed 
training in the application of HACCP principles to food processing. The 
agency anticipates that 2- or 3-day training sessions, modeled after 
the Better Process Control Schools currently in place for low acid 
canned food and acidified food manufacturers, will be provided by 
various private organizations and through academia. FDA does not intend 
to run HACCP-training courses for the industry.
    FDA has been extensively involved with a consortium called the 
``Seafood HACCP Alliance'' (the Alliance) consisting of representatives 
from Federal and State agencies, industry, and academia, who have 
worked to create a uniform, core training program that will meet the 
requirements of the seafood HACCP regulations and that will cost very 
little. The training program that has been developed by the Alliance is 
based on the recommendations of the NACMCF. The core curriculum for the 
course consists of basic HACCP principles that are applicable to any 
food and, thus, are also applicable to juice. It is the agency's intent 
to utilize the Alliance materials, as applicable, as the standard 
against which other course materials may be judged. Therefore, the 
agency is proposing in Sec. 120.13(b) that the training be at least 
equivalent to that received under standardized curriculum recognized as 
adequate by FDA.
    FDA is also proposing in Sec. 120.13(b) that job experience may 
qualify an individual to perform these functions if such experience has 
provided knowledge at least equivalent to that provided through the 
standardized curriculum. FDA acknowledges that a short course in HACCP 
has its limitations. For example, a 3-day course might not have 
anything important to offer to an individual who has had significant 
job experience working with or for an individual who is well-versed

[[Page 20477]]

in HACCP. Where a job experience has imparted a level of knowledge at 
least equivalent to that that could be provided by short course 
training, that individual would qualify as a trained individual. FDA 
requests comments on how processors will be able to determine whether 
job experience has provided the individual with the specific knowledge 
and expertise to develop and implement a HACCP program.
    FDA is proposing to provide in Sec. 120.13(b) that the trained 
individual need not be an employee of the processor. Processors may 
utilize consultants or other trained individuals to perform these 
functions if they so choose.

L. Application of Requirements to Imported Products

    The seafood HACCP regulation sets forth requirements for importers 
of fish and fishery products in Sec. 123.12. According to 
Sec. 123.12(a), the importer must either: (1) Obtain fish or fishery 
products from a country that has an active memorandum of understanding 
or similar agreement with FDA that documents the equivalency or 
compliance of the inspection system of the foreign country with the 
U.S. system relative to the products being imported, or (2) have and 
implement written verification procedures, as described in the 
regulation, for ensuring that the products being imported were 
processed in accordance with the requirements of part 123. If the 
importer must engage in affirmative verification steps, records of the 
taking of these steps must be made in English and be on file with the 
importer, and available for inspection by FDA (Sec. 123.12(c)). In the 
absence of assurances that the imported fish or fishery product has 
been processed under conditions that are equivalent to those required 
of domestic processors, the product will appear to be adulterated under 
section 402(a)(4) of the act, and FDA will deny the product entry 
(Sec. 123.12(d)) under section 801(a) of the act (21 U.S.C. 381(a)).
    Many types of juice are imported into the United States. FDA's 
inspection system for imports consists largely of reviewing the customs 
entries for products being offered for entry into the United States, 
engaging in wharf examinations and sample collections for laboratory 
analysis, and automatically detaining products with a history of 
problems (e.g., tamarind and tamarind products, including juice and 
juice concentrate). The same problems that are present in domestically 
produced juice can be present in imported juice and may not be apparent 
from the import review currently conducted by FDA. Consequently, the 
agency tentatively concludes that HACCP controls for juice should apply 
to imported products as well as to domestic products.
    FDA also tentatively concludes that the importer should share 
responsibility with the foreign processor for safety. More often than 
not, it is the U.S. importer, rather than the foreign processor, who 
actually offers imported juice for entry into the United States. While 
many importers are conscientious about the safety of the products that 
they import, others have little understanding of the potential hazards 
associated with their products.
    In the rulemaking process for seafood HACCP, the agency considered 
many options for compliance with HACCP requirements and carefully 
crafted the final regulation to incorporate a number of them. These 
options provide great flexibility for importers to achieve compliance 
and thus, would appear to be suitable for a wide variety of foods. FDA 
tentatively concludes that importer requirements for fish and fishery 
products in Sec. 123.12 are appropriate for and applicable to juice, 
and is proposing the same requirements in Sec. 120.14 because the 
agency is not aware of any circumstances that would necessitate any 
differences in treatment between juice imports and seafood imports. 
Thus, while the agency has made some minor editorial revisions for 
clarity, proposed Sec. 120.14 essentially tracks Sec. 123.12. FDA 
requests comments on the proposed import requirements for juice.

M. Pathogen Reduction

    As discussed previously, one of the NACMCF's recommendations to FDA 
was the use of safety performance criteria instead of mandating the use 
of a specific intervention technology (Ref. 53). Performance standards 
set forth requirements in terms of what is to be achieved by a given 
regulatory requirement, and represent a shift in focus from ``command-
and-control'' regulations because they specify the ends to be achieved 
(producing safe juice products), not the means to achieve those ends.
    The NACMCF suggested that a tolerable level of risk would be 
achieved by requiring interventions that have been validated to achieve 
a cumulative 5 log reduction in the target pathogen or a reduction in 
yearly risk of illness to less than 10<SUP>-5</SUP>, assuming 
consumption of 100 ml of juice daily. In addition, the NACMCF stated 
that HACCP and safety performance criteria should form the general 
conceptual framework needed to ensure the safety of juices, and that 
control measures should be based on a thorough hazard analysis. The 
NACMCF stated that validation of the process must be an integral part 
of this framework.
    Based on the evidence of microbial outbreaks discussed in section 
I.A of this document, FDA tentatively concludes that processors must 
establish controls for pathogen reduction in juice. The requirements of 
parts 113 and 114 mandate a process that exceeds the proposed 
provision, and, therefore, it is not necessary to require that juices 
subject to part 113 or 114 meet the 5 log reduction requirement in 
proposed Sec. 120.24.
    FDA is proposing to require in part 120, subpart B, that juice 
processors, except those subject to the requirements of part 113 or 
114, include in their HACCP plans control measures that are known, or 
can be shown, to produce, at a minimum, a 5 log (i.e., 10<SUP>5</SUP>) 
reduction in the most resistant microorganism of public health 
significance that is likely to occur in the juice for at least as long 
as the shelf life of the product under normal and moderate abuse 
conditions. The agency requests comment on the appropriateness of the 5 
log reduction performance standard and if other approaches, such as 
establishing a minimal acceptable risk standard for juices, could be 
used that would ensure the safety of the juice. The agency requests 
comments on what such a minimal acceptable risk standard should be and 
how it would be implemented. The agency also invites interested persons 
to submit scientific data concerning the acceptability of a 5 log 
reduction requirement or whether a more or less stringent performance 
standard (e.g., 3 or 7 log reduction) for specific juices would be more 
appropriate or whether different approaches consistent with a minimal 
acceptable risk standard for juices might be appropriate for specific 
juices based on their unique characteristics.
    In the absence of known specific pathogen-product associations, the 
NACMCF recommended the use of E. coli O157:H7 or L. monocytogenes as 
the target organism, as appropriate. This recommendation is based on 
the number of known outbreaks of E.coli in juice as described in 
section I.A of this document and the ubiquitous nature of L. 
monocytogenes. E. coli is known to be unusually acid resistant (Refs. 
60 and 61), and L. monocytogenes is relatively heat resistant (Refs. 62 
and 63). Therefore, depending on the type of juice, one of the two 
NACMCF recommended target organisms will likely be the most resistant 
microorganism of public health

[[Page 20478]]

significance. In controlling the target microorganism, other pathogenic 
organisms will likely also be controlled.
    However, because FDA is proposing a performance standard for 
pathogen reduction in lieu of a time/temperature requirement and is 
providing for a cumulative pathogen reduction process, the agency 
recognizes that other microorganisms may be more appropriate targets 
for juice processing. For example, control measures other than 
pasteurization may be more effective for reducing E. coli O157:H7 and 
less effective for another pathogen, and, thus, the most resistant 
pathogen under the circumstances must be the target pathogen.
    Pasteurization is one process that will achieve the 5 log reduction 
performance standard. However, other interventions (e.g., surface 
treatments) may be adequate for some types of produce (e.g., citrus 
fruits). As discussed previously in section I.E of this document, the 
NACMCF concluded that: (1) The history of public health problems 
associated with fresh juices indicates a need for active safety 
interventions; and (2) for some fruit (e.g., oranges), the need for 
intervention may be limited to surface treatment, but for others, 
additional interventions may be required (e.g., pasteurization of the 
juice). Pathogens are not reasonably likely to be present in the 
interior of sound whole oranges or other citrus fruits. In addition, 
the acidic nature of citrus fruits may further inactivate any pathogens 
that may be present. Therefore, any contamination being introduced into 
the juice will come from the surface of the fruit or the food contact 
surfaces of the equipment.
    There are two possible means by which contamination on the surface 
of the fruit can be introduced into the juice. First, the skin of the 
fruit can be damaged allowing any pathogens present to migrate inside 
the orange. An appropriate HACCP program can control this means of 
contamination through grading and culling. This step may be the first 
CCP in a HACCP plan for fresh orange juice production with a critical 
limit of zero defectives.
    Secondly, contamination on the surface of the skin can be 
introduced from cutting into the orange to extract the juice. This 
source may be controlled by washing, brushing, and sanitizing the fruit 
prior to cutting. This step may be a CCP in the processing of fresh 
orange juice with processors establishing critical limits for the 
associated parameters (e.g., temperature of water, type and strength of 
sanitizers, effectiveness of equipment).
    Proper implementation of these two CCP's (i.e., zero defects and 
washing, brushing, and sanitizing the fruit) could potentially achieve 
a three log reduction in microorganisms (Ref. 64). However, as 
proposed, processors must validate that such a reduction in the target 
pathogen is occurring.
    In addition to the two CCP's, processors must implement CGMP's 
(proposed Sec. 120.5) and sanitation SOP's (proposed Sec. 120.6) to 
ensure that the working area and equipment are clean. The most 
important step is sanitation of the extraction equipment which may 
harbor yeasts, molds, and acid tolerant bacteria (Ref. 65). The 1995 
outbreak of Salmonella hartford associated with fresh orange juice was 
most likely related to poor CGMP's (Ref. 9). However, CGMP's and 
sanitation SOP's alone are not sufficient to ensure a 5 log reduction.
    Extraction of orange juice and other citrus juices is generally 
done by either a machine which scores and cores the fruit before 
squeezing or by cutting the fruit in half and reaming out each side. In 
the first instance, the only part of the peel which is exposed to the 
fruit is the cut core. In the second instance, the edge of the knife 
will make contact with the peel and could potentially contaminate the 
fruit through the first half of the cut (in the second half of the cut, 
the knife leaves the fruit after making contact with the peel). If most 
of the surface of the skin of the orange does not contact the interior 
(juice) during extraction and the peel is discarded, such an extraction 
technique may be considered a CCP contributing towards the reduction of 
the potential pathogenic load.
    For purposes of illustration, FDA has simplified some of the 
extraction methods in order to calculate the possible log reduction in 
pathogens that might occur from different methods of extraction. In the 
``coring'' extraction method, using an example of an orange that is 4 
inches in diameter with a \1/2\ inch core cut, there could potentially 
be a 2 log reduction by only allowing contact with the surface area 
contained by a \1/2\-inch circle of the outside of the peel. That is, a 
4-inch orange has about 50 square inches of peel and a \1/2\-inch 
circle contains an area of 0.78 inches so that only 1.6 percent (.78/
50) of the outside would be potentially in contact with the inner part 
of the orange. However, FDA points out that under proposed part 120, 
processors must be able to validate that the reduction in the target 
pathogen is occurring.
    In the cutting method of extraction, there would also be a 
considerable reduction in the amount of potentially contaminated 
produce discarded. If, for example the knives used were 0.01 inch 
thick, the area of the exterior part of the orange that would make 
contact with the interior would be the top half of the circumference of 
the orange multiplied by the width of the knife, or about 0.06 square 
inches with a 4-inch (diameter) orange. Thus, the reduction of 
pathogens could be approximately 3 log (0.06/50) just by discarding the 
orange peel. Again, under proposed part 120, processors must be able to 
validate that this reduction is occurring in the target pathogen.
    Thus, it may be feasible that a processor use a combination of 
CGMP's, sanitation SOP's, and at least the three CCP's discussed 
previously ((1) Culling and grading; (2) washing, brushing, and 
sanitizing; and (3) appropriate methods of extraction) and achieve a 5 
log reduction in a target pathogen for orange juice. If so, it is 
unlikely that processors of fresh orange juice, and perhaps other fresh 
citrus fruit juices, will have to implement pasteurization in order to 
achieve a 5 log reduction in pathogenic bacteria. In addition, FDA 
anticipates that manufacturers of other juices, such as apple juice, 
may be able to use other technologies and practices in lieu of 
pasteurization (such as a combination of eliminating use of drops, 
brushing, washing, and using sanitizers) provided that the process is 
validated to achieve the 5 log reduction in the target pathogen. 
However, the agency points out that under the proposed rule, processors 
must establish CL's for each CCP, monitor CL's to ensure compliance, 
conduct verification and validation procedures, and maintain records of 
these actions. In addition, the 5 log reduction must be of a target 
organism.
    Each type of control measure used in a cumulative process 
introduces a unique variable in attaining the overall target of 
pathogen reduction. The physical parameters of the juice and how the 
product will be handled after it leaves the processing plant, and 
before it is consumed, must be considered in the selection of the 
target organism. Processors must take into consideration time, 
temperature, pH, and Brix parameters and other matters for juice 
products in order to provide adequate pathogen control. Time, 
temperature, juice pH, and Brix directly affect the rate of growth and 
the types of microorganisms.
    The proposed 5 log reduction standard of proposed Sec. 120.24 
requires that this reduction be achieved and persist for at least the 
shelf life of the product when the product is stored under normal and 
moderate abuse

[[Page 20479]]

conditions. Normal handling of juice includes the movement of the juice 
from the plant to retail (e.g., transportation, warehouse storage) and 
consumer handling after purchase (e.g., transport home, setting out on 
a counter or table). Moderate abuse may occur when unusual 
circumstances arise during regular handling. For example, unloading a 
truck on a hot day where the product may sit on a loading dock for a 
short period of time could constitute moderate abuse. In addition, 
moderate abuse could occur if consumers purchase a product on a warm 
day, place it in their car, and run errands before refrigerating the 
product. In FDA's view, moderate abuse does not include exposure to 
high temperatures for extended periods of time.
    The proposed requirement mandates that processors validate that the 
control measures are both appropriate to their operation and 
scientifically sound. In many cases, processors may rely on a written 
certification from the equipment manufacturer or may obtain a written 
scientific evaluation of a process, especially in cases where two or 
more control measures are used to accomplish the 5 log reduction in the 
target pathogen, to ensure that the process is adequate to destroy 
microorganisms of public health significance or to prevent their 
growth. Such an evaluation may also be necessary to ensure the adequacy 
of the pasteurization or refrigerating equipment used by the processor.
    Comments on the notice of intent (62 FR 45593, August 28, 1997) 
addressed the issue of pathogen reduction. One comment stated that a 2 
1/2 log reduction in fruit surface microflora from washing was 
adequate. Some comments asked from what point the 5 log reduction would 
be measured (e.g., washing of produce).
    FDA tentatively concludes that the cumulative 5 log reduction could 
be measured from the point of the processors' initial treatment of the 
intact fruit or vegetable. If pathogens are meaningfully reduced on the 
raw produce through washing or other treatment, and the product is 
processed under an adequate HACCP program, the hazard from the presence 
of pathogens may be controlled. However, this control measure may not 
be adequate or appropriate for all types of produce because of 
differences in surfaces, areas that are difficult to clean, inclusion 
of peel or outer layer in the juice, and tissue fragility.
    The agency requests comments on its approach to pathogen reduction. 
In particular, the agency requests comments on whether all juices 
should be subject to proposed Sec. 120.24, or whether such a 
requirement may not be necessary for certain juices or types of juices. 
FDA also requests comments on whether a 5 log reduction is appropriate 
for all juices, or whether a higher or lower requirement would be 
adequate for some types of juice.

V. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The title, description, and respondent 
description of the information collections are shown below with an 
estimate of the annual recordkeeping burden. Included in the estimate 
is the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing the collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information including the validity of methodology and 
assumptions used; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) ways to minimize the burden 
of the collection of information on respondents, including through the 
use of automated collection techniques when appropriate or other forms 
of information technology.
    Title: Hazard Analysis and Critical Control Point (HACCP) Systems--
Reporting and recordkeeping requirements for processors of fruit and 
vegetable juices under the provisions of 21 CFR part 120.
    Description: Section 402(a)(1) (21 U.S.C. 342(a)(1)) of the Federal 
Food, Drug, and Cosmetic Act (the act) states that a food shall be 
deemed to be adulterated if it bears or contains any poisonous or 
deleterious substance which may render it injurious to health. Section 
402(a)(4) (21 U.S.C. 342(a)(4)) of the act states that a food shall be 
deemed to be adulterated if it has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth, or whereby it may have been rendered injurious to health. The 
proposed regulation set forth in this proposed rule would require 
processors to use Hazard Analysis and Critical Control Point (HACCP) 
methodology to ensure that fruit and vegetable juices are safe under 
the act. HACCP is a preventive system of hazard control.
    Description of Respondents: Businesses or other for profit 
organizations.

             Table 1.--Estimated Annual Recordkeeping Burden            
                                                                        
 21 CFR       No. of          Annual         Hours per                  
Sections   Recordkeepers     Frequency     Recordkeeper     Total Hours 
120.6(c)      600            1\2\               4         4,800\2\      
120.12(a                                                                
 )(1)                                                                   
 and                                                                    
 (a)(2),                                                                
 120.6(c                                                                
 )-(d),                                                                 
 and                                                                    
 120.12(                                                                
 a)(5)        600               1               2           1,200       
120.7                                                                   
 and                                                                    
 120.12(                                                                
 a)(2)                                                                  
 and                                                                    
 (c)(1)       600            1\2\               8         4,800\2\      
120.8(a)                                                                
 and                                                                    
 120.12(                                                                
 a)(3)                                                                  
 and (c)      600            1\2\               8         4,800\2\      
120.8(b)                                                                
 (7) and                                                                
 120.12(                                                                
 a)(4)(i                                                                
 )            600          14,600               0.01       87,600       
120.11(b                                                                
 ) and                                                                  
 120.12(                                                                
 a)(5)        600               1               4           2,400       
120.11(a                                                                
 )(1)(iv                                                                
 )            600              52               0.1         3,120       
120.10(c                                                                
 ) and                                                                  
 120.12(                                                                
 a)(4)(i                                                                
 i)           600              12               0.1           720       
120.14(a                                                                
 )(2)         308               1               4           1,232       
120.12(e                                                                
 )         182\3\               1               4             728       
------------------------------------------------------------------------
                                                                        
Totals:                                                                 
First year 111,400                                                      
Subsequent years 97,000                                                 
------------------------------------------------------------------------

[[Page 20480]]

                                                                        
                                                                        
There are no operating and maintenance cost or capital costs associated 
  with this collection of information.                                  
<SUP>2 First year only.                                                      
<SUP>3 Assuming that producers and importers are subject to official review  
  on a 5-year cycle.                                                    

    The burden for these activities will vary considerably among 
processors and importers of juice and juice products, depending on the 
type and number of products involved, and the nature of the equipment 
or instruments required to monitor critical control points. The burdens 
have been estimated based on the estimated average annual information 
collection burden for seafood HACCP (60 FR 65096 at 65178; December 18, 
1995). As noted in the preliminary regulatory impact analysis for this 
proposal, FDA estimates that there are at least 600 firms producing 
juice products of the type affected by this proposed rulemaking.
    In compliance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information 
collection provisions of this proposed rule to OMB for review. 
Interested persons are requested to submit comments regarding 
information collection by May 26, 1998, to the OMB (address above), 
Attention: Desk Officer for FDA.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.30(j) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Analysis of Impacts

A. Preliminary Regulatory Impact Analysis

    In accordance with Executive Order 12886, FDA has developed a 
single preliminary regulatory impact analysis (PRIA) that estimates 
benefits and costs associated with both this HACCP proposal and the 
warning label proposal for juice. The agency will promptly publish the 
PRIA in the Federal Register.

B. Small Entity Analysis

    In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), FDA has developed a single small entity analysis that estimates 
benefits and costs associated with both this HACCP proposal and the 
warning label proposal for juice. The agency will promptly publish the 
small entity analysis in the Federal Register.

VIII. Request for Comments

    Interested persons may, on or before July 8, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

IX. References

    The following information has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m. Monday through Friday.
    1. Centers for Disease Control and Prevention, ``Outbreak of 
Escherichia coli O157:H7 Infections Associated With Drinking 
Unpasteurized Commercial Apple Juice--British Columbia, California, 
Colorado, and Washington,'' October 1996, MMWR, 45(44):875, November 
8, 1996.
    2. Griffin, P. M., ``Report of O157:H7 Outbreaks Caused by 
Juices,'' Current Science and Technology on Fresh Juices, Transcript 
of Public Meeting, vol. 1:15-27, December 16 and 17, 1996.
    3. Tabershaw, I. R., L. L. Schmelzer, and H. B. Bruyn, 
``Gastroenteritis From an Orange Juice Preparation I, Clinical and 
Epidemiological Aspects,'' Archives of Environmental Health 15:72-
77, 1967.
    4. Schmelzer, L. L., J. M. Gates, M. S. Redfearn, and I. R. 
Tabershaw, ``Gastroenteritis From an Orange Juice Preparation II, 
Field and Laboratory Investigation,'' Archives of Environmental 
Health, 15:78-82, 1967.
    5. Centers for Disease Control, ``Salmonella typhimurium 
Outbreak Traced to a Commercial Apple Cider-- New Jersey,'' MMWR 
24:87-88, 1975
    6. Centers for Disease Control and Prevention, ``Cholera 
Associated With Imported Frozen Coconut Milk--Maryland,'' MMWR 
40(49):844-843, 1991.
    7. Millard, P. S., K. R. Gensheimer, D. G. Addiss, D. M. Sosin, 
G. A. Beckett, A. Houck-Jankoski, and A. Hudson, ``An Outbreak of 
Cryptosporidiosis From Fresh-pressed Apple Cider,'' JAMA 
272(20):1592-1596, 1994.
    8. Centers for Disease Control and Prevention, 1997, ``Outbreaks 
of Escherichia coli O157:H7 Infection and Cryptosporidiosis 
Associated With Drinking Unpasteurized Apple Cider--Connecticut and 
New York,'' MMWR 46(1):4-8, October 1996.
    8A. Memorandum of telephone conversation between Mike Cambridge, 
New York State Health Department, and Clark Nardinelli, FDA, April 
20, 1998.
    9. Cook, K. A., 1996, EPI-AID 95-62 Trip Report: ``Outbreak of 
Salmonella Hartford Infections Among Travelers to Orlando, 
Florida,'' Centers for Disease Control and Prevention Memorandum, 
October 1, 1995.
    10. Steele, B. T., N. Murphy, G. S. Arbus, and C. P. Rance, ``An 
Outbreak of Hemolytic Uremic Syndrome Associated With Ingestions of 
Fresh Apple Juice,'' Journal of Pediatrics 101(6):963-965, 1982.
    11. Besser, R. E., S. M. Lett, J. T. Weber, M. P. Doyle, T. J. 
Barrett, J. G. Wells, and P. M. Griffin, ``An Outbreak of Diarrhea 
and Hemolytic Uremic Syndrome From Escherichia coli O157:H7 in 
Fresh-pressed Apple Cider, JAMA 269(17):2217-2220, 1993.
    12. Whatcom County (Washington) Health Department, Summary of a 
Suspected Outbreak of E. coli O157:H7 Associated With Consumption of 
Unpasteurized Apple Cider, 2 pages, 1996.
    13. Webb, R. W., ``Gastroenteritis in Elementary School Students 
after Drinking Orange Juice, Mobile County,'' Note to Epidemiology 
File, May 10, 1994.
    14. Memorandum of telephone conversation between Mike Cambridge, 
New York State Health Department, and Debra Street, FDA, January 22, 
1997.
    15.Memorandum of telephone conversation between Patty Walker, 
Washington State Health Department, and Debra Street, FDA, January 
15, 1997.
    16.Memorandum of telephone conversation between Susan Karam, 
Ohio State Health Department, and Debra Street, FDA, January 21, 
1997.
    17. Memorandum of telephone conversation between Roberta 
Hammond, Florida State Health Department, and Debra Street, FDA, 
January 21, 1997.
    18. Memorandum of telephone conversation between Pam Shillam, 
Colorado State Health Department, and Debra Street, FDA, January 17, 
1997.
    19. Barker, W. H., and V. Runte, 1972, ``Tomato Juice-associated 
Gastroenteritis, Washington and Oregon,'' American Journal of 
Epidemiology 96(2):219-226, 1969.
    20. Centers for Disease Control, ``Poisoning From Elderberry 
Juice --California,'' MMWR 33(13):173-174, 1984.
    21. Memorandum of telephone conversation between Dr. K. 
Hendricks, Texas State Health Department, and Debra Street, FDA, 
January 16, 1997.
    22. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-680-7, August 12 and 
27, 1997.
    23. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-411/420-2, July 14 
and 30, 1992, and August 12, 1992.
    24. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-346-8, July 14, 20, 
and 27, 1988.
    25. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report

[[Page 20481]]

for firm-initiated recall #F-400/421-1, May 23, 1991, and June 6 and 
19, 1991.
    26. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-189/190-5, January 6 
and 25, 1995.
    27. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-338/339-8, July 6, 7, and 27, 1988.
    28. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-68-9, November 16, 
1988, and December 6 and 14, 1988.
    29. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-092/093-0, October 19, 1989, and 
November 1, 1989.
    30. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-523-0, June 27, 1990, and July 10 
and 18, 1990.
    31. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-107-1, November 14, 1990; December 
31, 1990; January 9, 1991; and February 6, 1991.
    32. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-421-2, July 8, 10, and 22, 1992.
    33. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-285-3, April 1 and 21, 1993.
    34. FDA, Health hazard evaluation, classification and FDA 
Enforcement Report for recall #F-665-5, May 16, 18, and 31, 1995.
    35. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-529-1, September 4, 5, and 18, 
1991.
    36. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-364-2, June 23, 1992, and July 2, 
1992.
    37. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm initiated recall #F-319-3, May 4 and 19, 
1993.
    38. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-250-4, January 13 and 27, 1994, and 
February 9, 1994.
    39. FDA, Health hazard evaluations, classification, and FDA 
Enforcement Report for recall #F-492-7, June 27, 1997, and July 2 
and 16, 1997.
    40. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-427-1, June 3, 11, 
and 19, 1991.
    41. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-781-4, August 9, 10, 
and 24, 1994.
    42. FDA, Health hazard evaluation, classification, and 
Enforcement Report for recall #F-406-7, May 1 and 7, 1997
    43. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for firm-initiated recall #F-584/596-6, June 6, 
7, and 26, 1996.
    44. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-023-7, October 24 and 30, 1996.
    45. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-036-7, October 23 and 30, 1996, and 
November 13, 1996.
    46. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-072-7, November 14 and 20, 1996.
    47. FDA, Health hazard evaluation, classification, and FDA 
Enforcement Report for recall #F-073-7, November 14 and 20, 1996.
    48. Trucksess, M. W., memorandum to Martin J. Stutsman on 
Patulin--97-688-239, Apple Juice Concentrate, March 31, 1997.
    49. Wagstaff, J., memorandum to M. J. Stutsman, and T. C. 
Troxell on the hazard of patulin in apple juice concentrate sample 
97-688-239, April 2, 1997, and July 18, 1997.
    50. Williams, R. T. Wilcox, B. Timbo, D. Street, C. Nardinelli, 
P. McCarthy, G. Jackson, M. T. Hendricks, and E. Elliot, 
``Preliminary Investigation Into the Morbidity and Mortality Effects 
Associated With the Consumption of Fruit and Vegetable Juices,'' 
October 31, 1997.
    51. FDA, ``Pesticide Program Residue Monitoring 1994,'' J. AOAC 
International, vol. 78, September/October 1995.
    52. FDA, 1996, ``Pesticide Program Residue Monitoring 1995.''
     53. National Advisory Committee on Microbiological Criteria for 
Foods, ``NACMCF Recommendations on Fresh Juice,'' April 9, 1997.
    54. U.S. Public Health Service, ``Food Code, 1997 
Recommendations of the United States Public Health Service, Food and 
Drug Administration,'' National Technical Information Service 
Publication PB95-265492, p. 73.
    55. National Advisory Committee on Microbiological Criteria for 
Foods, ``Hazard Analysis and Critical Control Point Principles and 
Application Guidelines,'' August 14, 1997.
    56. Webster's II New Riverside University Dictionary, The 
Riverside Publishing Co., p. 657, 1994.
    57. FDA, ``Hazard Analysis and Critical Control Point (HACCP) 
Pilot Program for Selected Food Manufacturers: Second Interim Report 
of Observations and Comments,'' October 31, 1997.
    58. Davis, S. A., memorandum to file: `` Hazard Analysis and 
Critical Control Point (HACCP) Systems for Juice; Consideration of 
Hazards that are Reasonably Likely to Occur,'' October 21, 1997.
    59. FDA, Hazard Analysis Critical Control Point (HACCP) Pilot 
Program for Selected Food Manufacturers: Interim Report of 
Observations and Comments, June 19, 1996.
    60. Zhao, T., M. P. Doyle, and R. E. Besser, ``Fate of 
Enterohemorrhagic Escherichia coli O157:H7 in Apple Cider With and 
Without Preservatives,'' Applied and Environmental Microbiology, 
59(8):2526-2530.
    61. Miller, L. G., and C. W. Kaspar, ``Escherichia coli O157:H7 
Acid Tolerance and Survival in Apple Cider,'' Journal of Food 
Protection, 57(6):460-464, 1994.
    62. Bradshaw, J. G., J. T. Peeler, J. J. Corwin, J. M. Hunt, J. 
T. Tierney, E. P. Larkin, and R. M. Twedt, ``Thermal Resistance of 
Listeria monocytogenes in Milk,'' Journal of Food Protection, 
48:743-745, 1985.
    63. Doyle, M. P., K. A. Glass, J. T. Beery, G. A. Garcia, D. J. 
Pollard, and R. D. Schultz, ``Survival of Listeria monocytogenes in 
Milk During High-Temperature, Short-Time Pasteurization,'' Applied 
and Environmental Microbiology, 53(7):1433-1438, 1987.
    64. Memorandum of telephone conversation between Mickey Parish, 
University of Florida, and Richard Williams, FDA, December 31, 1997.
    65. Winniczuk, P. P., and M. E. Parish, ``Minimum Inhibitory 
Concentrations of Antimicrobials Against Microorganisms Related to 
Juice,'' Food Microbiol., 14(4):373-381, 1997.

List of Subjects in 21 CFR Part 120

    Fruit and vegetable juice, Food, Imports, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, under 
the Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that title 21 CFR 
chapter I be amended as follows:
    1. Part 120 is added to read as follows:

PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 
SYSTEMS

Subpart A--General Provisions

Sec.
120.1  Applicability.
120.3  Definitions.
120.5  Current good manufacturing practice.
120.6  Prerequisite program standard operating procedures.
120.7  Hazard analysis.
120.8  Hazard Analysis Critical Control Point (HACCP) plan.
120.9  Legal basis.
120.10  Corrective actions.
120.11  Verification and validation.
120.12  Records.
120.13  Training.
120.14  Application of requirements to imported products.

Subpart B--Pathogen Reduction

120.20  General.
120.24  Process controls.
    Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 
381, 393; 42 U.S.C. 241, 242l, 264.

Subpart A--General Provisions


Sec. 120.1  Applicability.

    (a) Any juice sold as such or used as an ingredient in beverages 
shall be processed in accordance with the requirements of this part. 
Juice means the aqueous liquid expressed or extracted from one or more 
fruits or vegetables, purees of the edible portions of one or more 
fruits or vegetables, or any concentrates of such liquid or puree.

[[Page 20482]]

    (b) The regulations in this part shall be effective 1 year after 
the date of publication of the final rule in the Federal Register. 
However, by its terms, this part is not binding on small and very small 
businesses until the dates listed in paragraphs (b)(1) and (b)(2) of 
this section.
    (1) For small businesses employing fewer than 500 persons the 
regulations in this part are binding 2 years after the date of 
publication of the final rule in the Federal Register.
    (2) For very small businesses that have either total annual sales 
of less than $500,000, or if their total annual sales are greater than 
$500,000 but their total food sales are less than $50,000; or the 
person claiming this exemption employed fewer than an average of 100 
full-time equivalent employees and fewer than 100,000 units of juice 
were sold in the United States, the regulations are binding 3 years 
after the date of publication of the final rule in the Federal 
Register.


Sec. 120.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part 
110 of this chapter are applicable to such terms when used in this 
part, except where redefined in this part. The following definitions 
shall also apply:
    (a) Control means to prevent, eliminate, or reduce.
    (b) Control measure means any action or activity that can be used 
to prevent, eliminate, or reduce a hazard.
    (c) Critical control point means a point, step, or procedure in a 
food process at which a control measure can be applied and at which 
control is essential to reduce an identified food hazard to an 
acceptable level.
    (d) Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter must be controlled at a 
critical control point to prevent, eliminate, or reduce to an 
acceptable level the occurrence of the identified food hazard.
    (e) Food hazard means any biological, chemical, or physical 
property that may cause a food to be unsafe for human consumption.
    (f) Importer means either the U.S. owner or consignee at the time 
of entry of a food product into the United States, or the U.S. agent or 
representative of the foreign owner or consignee at the time of entry 
into the United States. The importer is responsible for ensuring that 
goods being offered for entry into the United States are in compliance 
with all applicable laws. For the purposes of this definition, the 
importer is ordinarily not the custom house broker, the freight 
forwarder, the carrier, or the steamship representative.
    (g) Monitor means to conduct a planned sequence of observations or 
measurements to assess whether a process, point, or procedure is under 
control and to produce an accurate record for use in verification.
    (h)(1) Processing means activities that are directly related to the 
production of juice products.
    (2) For purposes of this part, processing does not include:
    (i) Harvesting, picking, or transporting raw agricultural 
ingredients of juice products, without otherwise engaging in 
processing.
    (ii) The operation of a retail establishment; and
    (iii) The operation of a retail establishment that is a very small 
business and that makes juice on its premises, provided that the 
establishment's total sales of juice and juice products do not exceed 
40,000 gallons per year, and that sells such juice:
    (A) Directly to consumers or
    (B) directly to consumers and other retail establishments.
    (i) Processor means any person engaged in commercial, custom, or 
institutional processing of juice products, either in the United States 
or in a foreign country. A processor includes any person engaged in the 
processing of juice products that are intended for use in market or 
consumer tests.
    (j) Shall is used to state mandatory requirements.
    (k) Should is used to state recommended or advisory procedures or 
to identify recommended equipment.


Sec. 120.5  Current good manufacturing practice.

    Part 110 of this chapter applies in determining whether the 
facilities, methods, practices, and controls used to process food are 
safe, and whether the food has been processed under sanitary 
conditions.


Sec. 120.6  Prerequisite program standard operating procedures.

    (a) Sanitation controls. Each processor shall have and implement a 
sanitation standard operating procedure (SOP) that addresses sanitation 
conditions and practices before, during, and after processing and 
relates to the following:
    (1) Safety of the water that comes into contact with food or food 
contact surfaces or that is used in the manufacture of ice;
    (2) Condition and cleanliness of food contact surfaces, including 
utensils, gloves, and outer garments;
    (3) Prevention of cross-contamination from insanitary objects to 
food, food packaging material, and other food contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
processed product;
    (4) Maintenance of hand washing, hand sanitizing, and toilet 
facilities;
    (5) Protection of food, food packaging material, and food contact 
surfaces from adulteration with lubricants, fuel, pesticides, cleaning 
compounds, sanitizing agents, condensate, and other chemical, physical, 
and biological contaminants;
    (6) Proper labeling, storage, and use of toxic compounds;
    (7) Control of employee health conditions that could result in the 
microbiological contamination of food, food packaging materials, and 
food contact surfaces; and
    (8) Exclusion of pests from the food plant.
    (b) Monitoring. The processor shall monitor the conditions and 
practices during processing with sufficient frequency to ensure, at a 
minimum, conformance with those conditions and practices specified in 
part 110 of this chapter that are appropriate both to the plant and to 
the food being processed. Each processor shall correct, in a timely 
manner, those conditions and practices that are not met.
    (c) Records. Each processor shall maintain prerequisite program SOP 
records that, at a minimum, document the monitoring and corrections 
prescribed by paragraph (b) of this section. These records are subject 
to the recordkeeping requirements of Sec. 120.12.
    (d) Relationship to Hazard Analysis and Critical Control Point 
(HACCP) plan. Prerequisite program SOP controls may be included in the 
HACCP plan required under Sec. 120.8(b). However, to the extent that 
they are implemented in accordance with this section, they need not be 
included in the HACCP plan.


Sec. 120.7  Hazard analysis.

    Each processor shall develop, or have developed for it, a written 
hazard analysis to determine whether there are food hazards that are 
reasonably likely to occur for each type of juice processed by that 
processor and to identify the control measures that the processor can 
apply to control those hazards. The hazard analysis shall include food 
hazards that can be introduced both within and outside the processing 
plant environment, including food hazards that can occur before, 
during, and after harvest. A food hazard that is reasonably likely to 
occur is one for which a prudent processor would establish controls 
because experience,

[[Page 20483]]

illness data, scientific reports, or other information provide a basis 
to conclude that there is a reasonable possibility that, in the absence 
of those controls, the food hazard will occur in the particular type of 
product being processed. The hazard analysis shall be developed by an 
individual or individuals who have been trained in accordance with 
Sec. 120.13 and shall be subject to the recordkeeping requirements of 
Sec. 120.12.
    (a) In evaluating what food hazards are reasonably likely to occur, 
consideration should be given, at a minimum, to the following:
    (1) Microbiological contamination;
    (2) Parasites;
    (3) Chemical contamination;
    (4) Unlawful pesticides residues;
    (5) Decomposition in food where a food hazard has been associated 
with decomposition;
    (6) Natural toxins;
    (7) Unapproved use of food or color additives;
    (8) Presence of undeclared ingredients that may be allergens; and
    (9) Physical hazards.
    (b) Processors should evaluate product ingredients, processing 
procedures, packaging, storage, and intended use; facility and 
equipment function and design; and plant sanitation including employee 
hygiene to determine the potential effect of each on the safety of the 
finished food for the intended consumer.


Sec. 120.8  Hazard Analysis Critical Control Point (HACCP) plan.

    (a) HACCP plan. Every processor shall have and implement a written 
HACCP plan whenever a hazard analysis reveals one or more food hazards 
that are reasonably likely to occur during processing, as described in 
Sec. 120.7. The HACCP plan shall be developed by an individual or 
individuals who have been trained in accordance with Sec. 120.13 and 
shall be subject to the recordkeeping requirements of Sec. 120.12. A 
HACCP plan shall be specific to:
    (1) Each location where juice is processed by that processor; and
    (2) Each type of juice processed by the processor. The plan may 
group types of juice products together, or group types of production 
methods together, if the food hazards, critical control points, 
critical limits, and procedures required to be identified and performed 
by paragraph (b) of this section are essentially identical, provided 
that any required features of the plan that are unique to a specific 
product or method are clearly delineated in the plan and are observed 
in practice.
    (b) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List all food hazards that are reasonably likely to occur as 
identified in accordance with Sec. 120.7, and that thus must be 
controlled for each type of product.
    (2) List the critical control points for each of the identified 
food hazards, including as appropriate:
    (i) Critical control points designed to control food hazards that 
could occur or could be introduced inside the processing plant 
environment; and
    (ii) Critical control points designed to control food hazards 
introduced outside the processing plant environment, including food 
hazards that occur before, during, and after harvest;
    (3) List the critical limits that shall be met at each of the 
critical control points;
    (4) List the procedures, and the frequency with which they are to 
be performed, that will be used to monitor each of the critical control 
points to ensure compliance with the critical limits;
    (5) Include any corrective action plans that have been developed in 
accordance with Sec. 120.10(a), and that are to be followed in response 
to deviations from critical limits at critical control points;
    (6) List the validation and verification procedures, and the 
frequency with which they are to be performed, that the processor will 
use in accordance with Sec. 120.11; and
    (7) Provide for a recordkeeping system that documents the 
monitoring of the critical control points in accordance with 
Sec. 120.12. The records shall contain the actual values and 
observations obtained during monitoring.
    (c) Products subject to other regulations. HACCP plans for juice 
need not address the food hazards associated with microorganisms and 
microbial toxins that are controlled by the requirements of part 113 or 
114 of this chapter. A HACCP plan for such juice shall address any 
other food hazards that are reasonably likely to occur.
    (d) Sanitation. Sanitation controls may be included in the HACCP 
plan. However, to the extent that they are monitored in accordance with 
Sec. 120.6, they are not required to be included in the HACCP plan.


Sec. 120.9  Legal basis.

    Failure of a processor to have and to implement a Hazard Analysis 
and Critical Control Point (HACCP) system that complies with 
Secs. 120.6, 120.7, and 120.8, or otherwise to operate in accordance 
with the requirements of this part, shall render the juice products of 
that processor adulterated under section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act. Whether a processor's actions are consistent 
with ensuring the safety of juice will be determined through an 
evaluation of the processor's overall implementation of its HACCP 
system.


Sec. 120.10  Corrective actions.

    Whenever a deviation from a critical limit occurs, a processor 
shall take corrective action by following the procedures set forth in 
paragraph (a) or paragraph (b) of this section.
    (a) Processors may develop written corrective action plans, which 
become part of their Hazard Analysis and Critical Control Point (HACCP) 
plans in accordance with Sec. 120.8(b)(5), by which processors 
predetermine the corrective actions that they will take whenever there 
is a deviation from a critical limit. A corrective action plan that is 
appropriate for a particular deviation is one that describes the steps 
to be taken and assigns responsibility for taking those steps, to 
ensure that:
    (1) No product enters commerce that is either injurious to health 
or is otherwise adulterated as a result of the deviation; and
    (2) The cause of the deviation is corrected.
    (b) When a deviation from a critical limit occurs, and the 
processor does not have a corrective action plan that is appropriate 
for that deviation, the processor shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
    (2) Perform or obtain a review to determine the acceptability of 
the affected product for distribution. The review shall be performed by 
an individual or individuals who have adequate training or experience 
to perform such review. Adequate training may or may not include 
training in accordance with Sec. 120.13;
    (3) Take corrective action, when necessary, with respect to the 
affected product to ensure that no product enters commerce that is 
either injurious to health or is otherwise adulterated as a result of 
the deviation;
    (4) Take corrective action, when necessary, to correct the cause of 
the deviation; and
    (5) Perform or obtain timely validation in accordance with 
Sec. 120.11, by an individual or individuals who have been trained in 
accordance with Sec. 120.13, to determine whether modification of the 
HACCP plan is required to reduce the risk of recurrence of the 
deviation, and to modify the HACCP plan as necessary.
    (c) All corrective actions taken in accordance with this section 
shall be fully documented in records that are

[[Page 20484]]

subject to verification in accordance with Sec. 120.11(a)(1)(iv)(B) and 
the recordkeeping requirements of Sec. 120.12.


Sec. 120.11  Verification and validation.

    (a) Verification. Every processor shall verify that the Hazard 
Analysis and Critical Control Point (HACCP) system is being implemented 
according to design.
    (1) Verification activities shall include:
    (i) A review of any consumer complaints that have been received by 
the processor to determine whether such complaints relate to the 
performance of the HACCP plan or reveal previously unidentified 
critical control points;
    (ii) The calibration of process-monitoring instruments;
    (iii) At the option of the processor, the performance of periodic 
end-product or in-process testing;
    (iv) A review, including signing and dating, by an individual who 
has been trained in accordance with Sec. 120.13, of the records that 
document:
    (A) The monitoring of critical control points. The purpose of this 
review shall be, at a minimum, to ensure that the records are complete 
and to verify that the records document values that are within the 
critical limits. This review shall occur within 1 week (7 days) of the 
day that the records are made;
    (B) The taking of corrective actions. The purpose of this review 
shall be, at a minimum, to ensure that the records are complete and to 
verify that appropriate corrective actions were taken in accordance 
with Sec. 120.10. This review shall occur within 1 week (7 days) of the 
day that the records are made; and
    (C) The calibrating of any process monitoring instruments used at 
critical control points and the performance of any periodic end-product 
or in-process testing that is part of the processor's verification 
activities. The purpose of these reviews shall be, at a minimum, to 
ensure that the records are complete and that these activities occurred 
in accordance with the processor's written procedures. These reviews 
shall occur within a reasonable time after the records are made; and
    (v) The following of procedures in Sec. 120.10 whenever any 
verification procedure, including the review of consumer complaints, 
establishes the need to take a corrective action.
    (2) The calibration of process-monitoring instruments, and the 
performance of any periodic end-product and in-process testing, in 
accordance with paragraphs (a)(1)(iv)(B) through (a)(1)(iv)(C) of this 
section, shall be documented in records that are subject to the 
recordkeeping requirements of Sec. 120.12.
    (b) Validation of the HACCP plan. Every processor shall validate 
that the HACCP plan is adequate to control food hazards that are 
reasonably likely to occur; this validation shall occur at least once 
within 12 months after implementation and at least annually thereafter 
or whenever any changes in the process occur that could affect the 
hazard analysis or alter the HACCP plan and prerequisite program of the 
standard operating procedures (SOP's) in any way. Such changes may 
include changes in the following: Raw materials or source of raw 
materials; product formulation; processing methods or systems, 
including computers and their software; packaging; finished product 
distribution systems; or the intended use or consumers of the finished 
product. The validation shall be performed by an individual or 
individuals who have been trained in accordance with Sec. 120.13 and 
shall be subject to the recordkeeping requirements of Sec. 120.12. The 
HACCP plan shall be modified immediately whenever a validation reveals 
that the plan is no longer adequate to fully meet the requirements of 
this part.
    (c) Validation of the hazard analysis. Whenever a juice processor 
has no HACCP plan because a hazard analysis has revealed no food 
hazards that are reasonably likely to occur, the processor shall 
reassess the adequacy of that hazard analysis whenever there are any 
changes in the process that could reasonably affect whether a food 
hazard exists. Such changes may include changes in the following: Raw 
materials or source of raw materials; product formulation; processing 
methods or systems, including computers and their software; packaging; 
finished product distribution systems; or the intended use or intended 
consumers of the finished product. The validation shall be performed by 
an individual or individuals who have been trained in accordance with 
Sec. 120.13 and shall be subject to the recordkeeping requirements of 
Sec. 120.12.


Sec. 120.12  Records.

    (a) Required records. Processors shall maintain the following 
records documenting the processor's Hazard Analysis and Critical 
Control Point (HACCP) system:
    (1) Records documenting the implementation of the prerequisite 
program of the standard operating procedures (SOP's) (see Sec. 120.6);
    (2) The written hazard analysis required by Sec. 120.7;
    (3) The written HACCP plan required by Sec. 120.8;
    (4) Records documenting the ongoing application of the HACCP plan 
that include:
    (i) Monitoring of critical control points and their critical 
limits, including the recording of actual times, temperatures, or other 
measurements, as prescribed in the establishment's HACCP plan; and
    (ii) Corrective actions, including all actions taken in response to 
a deviation; and
    (5) Records documenting verification of the HACCP system and 
validation of the HACCP plan or hazard analysis.
    (b) General requirements. All records required by this part shall 
include:
    (1) The name and location of the processor or importer;
    (2) The date and time of the activity that the record reflects;
    (3) The signature or initials of the person performing the 
operation or creating the record; and
    (4) Where appropriate, the identity of the product and the 
production code, if any. Processing and other information shall be 
entered on records at the time that it is observed. The records shall 
contain the actual values and observations obtained during monitoring.
    (c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3) 
of this section shall be signed and dated by the most responsible 
individual onsite at the processing facility or by a higher level 
official of the processor. These signatures shall signify that these 
records have been accepted by the firm.
    (2) The records in paragraphs (a)(2) and (a)(3) of this section 
shall be signed and dated:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) Upon verification and validation in accordance with 
Sec. 120.11.
    (d) Record retention. (1) All records required by this part shall 
be retained at the processing facility or at the importer's place of 
business in the United States for, in the case of perishable or 
refrigerated juices, at least 1 year after the date that such products 
were prepared, and for, in the case of frozen, preserved, or shelf-
stable products, 2 years or the shelf life of the product, whichever is 
greater, after the date that the products were prepared.
    (2) Records that relate to the general adequacy of equipment or 
processes used by a processor, including the results of scientific 
studies and evaluations, shall be retained at the processing facility 
or at the importer's place of business in the United States for at 
least 2 years after the date that the

[[Page 20485]]

processor last used such equipment or process.
    (3) Off-site storage of processing records required by paragraphs 
(a)(1) and (a)(3) of this section is permitted after 6 months following 
the date that the monitoring occurred, if such records can be retrieved 
and provided on-site within 24 hours of request for official review. 
Electronic records are considered to be on-site if they are accessible 
from an on-site location and comply with Sec. 120.12(g).
    (4) If the processing facility is closed for a prolonged period 
between seasonal packs, the records may be transferred to some other 
reasonably accessible location at the end of the seasonal pack but 
shall be immediately returned to the processing facility for official 
review upon request.
    (e) Official review. All records required by this part shall be 
available for official review and copying at reasonable times.
    (f) Public disclosure. (1) Subject to the limitations in paragraph 
(d)(2) of this section, all records required by this part are not 
available for public disclosure unless they have been previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter, or 
unless they relate to a product or ingredient that has been abandoned 
and thus, no longer represent a trade secret or confidential commercial 
or financial information as defined in Sec. 20.61 of this chapter.
    (2) Records required to be maintained by this part are subject to 
disclosure to the extent that they are otherwise publicly available, or 
that disclosure could not reasonably be expected to cause a competitive 
hardship, such as generic-type HACCP plans that reflect standard 
industry practices.
    (g) Records maintained on computers. The maintenance of records on 
computers, in accordance with part 11 of this chapter, is acceptable.


Sec. 120.13  Training.

    (a) Only an individual who has met the requirements of paragraph 
(b) of this section shall be responsible for the following functions:
    (1) Developing the hazard analysis, including delineating control 
measures, as required by Sec. 120.7;
    (2) Developing a Hazard Analysis and Critical Control Point (HACCP) 
plan that is appropriate for a specific processor, in order to meet the 
requirements of Sec. 120.8;
    (3) Validating and modifying the HACCP plan in accordance with the 
corrective action procedures specified in Sec. 120.10(c)(5) and the 
validation activities specified in Sec. 120.11(b) and (c); and
    (4) Performing the record review required by Sec. 120.11(a)(1)(iv).
    (b) The individual performing the functions listed in paragraph (a) 
of this section shall have successfully completed training in the 
application of HACCP principles to juice processing at least equivalent 
to that received under standardized curriculum recognized as adequate 
by the Food and Drug Administration or shall be otherwise qualified 
through job experience to perform these functions. Job experience may 
qualify an individual to perform these functions if such experience has 
provided knowledge at least equivalent to that provided through the 
standardized curriculum. The trained individual need not be an employee 
of the processor.


Sec. 120.14  Application of requirements to imported products.

    This section sets forth specific requirements for imported food.
    (a) Importer requirements. Every importer of food shall either:
    (1) Obtain the food from a country that has an active memorandum of 
understanding (MOU) or similar agreement with the Food and Drug 
Administration, that covers the food and documents the equivalency or 
compliance of the inspection system of the foreign country with the 
U.S. system, accurately reflects the relationship between the signing 
parties, and is functioning and enforceable in its entirety; or
    (2) Have and implement written procedures for ensuring that the 
food that such importer receives for import into the United States was 
processed in accordance with the requirements of this part. The 
procedures shall provide, at a minimum:
    (i) Product specifications that are designed to ensure that the 
product is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act because it may be injurious to health or because it 
may have been processed under insanitary conditions; and
    (ii) Affirmative steps to ensure that the products being offered 
for entry were processed under controls that meet the requirements of 
this part. These steps may include any of the following:
    (A) Obtaining from the foreign processor the Hazard Analysis and 
Critical Control Point (HACCP) plan and prerequisite program of the 
standard operating procedure (SOP) records required by this part that 
relate to the specific lot of food being offered for import;
    (B) Obtaining either a continuing or lot specific certificate from 
an appropriate foreign government inspection authority or competent 
third party certifying that the imported food has been processed in 
accordance with the requirements of this part;
    (C) Regularly inspecting the foreign processor's facilities to 
ensure that the imported food is being processed in accordance with the 
requirements of this part;
    (D) Maintaining on file a copy, in English, of the foreign 
processor's hazard analysis and HACCP plan, and a written guarantee 
from the foreign processor that the imported food is processed in 
accordance with the requirements of this part;
    (E) Periodically testing the imported food, and maintaining on file 
a copy, in English, of a written guarantee from the foreign processor 
that the imported food is processed in accordance with the requirements 
of this part; or
    (F) Other such verification measures as appropriate that provide an 
equivalent level of assurance of compliance with the requirements of 
this part.
    (b) Competent third party. An importer may hire a competent third 
party to assist with or perform any or all of the verification 
activities specified in paragraph (a)(2) of this section, including 
writing the importer's verification procedures on the importer's 
behalf.
    (c) Records. The importer shall maintain records, in English, that 
document the performance and results of the affirmative steps specified 
in paragraph (a)(2)(ii) of this section. These records shall be subject 
to the applicable provisions of Sec. 120.12.
    (d) Determination of compliance. The importer shall provide 
evidence that all food offered for entry into the United States has 
been processed under conditions that comply with this part. If 
assurances do not exist that an imported food has been processed under 
conditions that are equivalent to those required of domestic processors 
under this part, the product will appear to be adulterated and will be 
denied entry.

Subpart B--Pathogen Reduction


Sec. 120.20  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for process controls.


Sec. 120.24  Process controls.

    In order to meet the requirements of subpart A of this part, 
processors of juice products, except those subject to the requirements 
of part 113 or 114 of

[[Page 20486]]

this chapter, shall include in their Hazard Analysis and Critical 
Control Point (HACCP) plans control measures that will produce, at a 
minimum, a 5 log (i.e., 10<SUP>5</SUP>) reduction, for a period at 
least as long as the shelf life of the product when stored under normal 
and moderate abuse conditions, in the pertinent microorganism. For the 
purposes of this regulation, the ``pertinent microorganism'' is the 
most resistant microorganism of public health significance that is 
likely to occur in the juice.

    Dated: April 17, 1998.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 98-11025 Filed 4-22-98; 8:45 am]
BILLING CODE 4160-01-F