[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Proposed Rules]
[Pages 45593-45596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket No. 97N-0296]


Fruit and Vegetable Juice Beverages: Notice of Intent to Develop 
a HACCP Program, Interim Warning Statement, and Educational Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
comprehensive program to address the incidence of foodborne illness 
related to consumption of fresh juice and to ultimately address the 
safety aspects of all juice products. This document informs consumers, 
juice processors, State and local officials, and other interested 
persons of FDA's plans to publish two proposals and to initiate several 
educational programs to minimize the hazards associated with fresh 
juice. This document will permit all interested persons to take 
advantage of the guidance provided by the upcoming proposals as quickly 
as possible, e.g., in time for the 1997 ``fresh apple cider'' season.

DATES: Submit written comments at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. Background

    Escherichia coli O157:H7 has been recently implicated as a source 
of a number of foodborne disease outbreaks. During the last few years, 
several States have reported outbreaks of E. coli O157:H7 illness as a 
result of consumption of apple juice and cider that were not 
pasteurized or otherwise treated to destroy pathogens (Refs. 1, 2, and 
3). Symptoms have ranged from diarrhea to hemolytic uremic syndrome. In 
October 1996, the Seattle-King County Department of Public Health and 
the Washington State Department of Health reported an outbreak of E. 
coli O157:H7 infections associated with consumption of unpasteurized 
apple juice that occurred in three western States and British Columbia 
and resulted in at least 66 cases of illness and the death of one child 
(Refs. 2 and 4).
    Pathogens other than E. coli O157:H7 present in apple and other 
types of juice and juice products also have been documented as causing 
foodborne illness. There are reported outbreaks attributable to 
Salmonella typhimurium and Cryptosporidium in apple cider (Refs. 3, 5, 
and 6), and Vibrio cholerae in coconut milk (Ref. 7). In addition, 
there are reports of illness from consumption of unpasteurized orange 
juice contaminated with S. hartford (Ref. 8), orange juice drink 
contaminated with S. agona (Ref. 9), orange juice contaminated with 
Bacillus cereus (Ref. 10), and home-made carrot juice contaminated with 
Clostridium botulinum (Ref. 11).
    Both fruit and vegetable juices have been vehicles for outbreaks of 
foodborne illness. Although fruit juice is acidic and thus inhibitory 
to the growth of most microorganisms, fruit juices, rather than 
vegetable juices, have been the source of most juice-associated 
outbreaks. The evidence also suggests that the groups at greatest risk 
of life-threatening illness are children, the elderly, and persons with 
compromised immune systems.
    Illnesses caused by hazards other than microbial contamination have 
also been associated with foods, including juice. From 1990 to 1996, 
there has been one outbreak and 11 recalls of fruit juice or beverages 
containing fruit juice (Refs. 12 and 13). Ingestion of toxic metals as 
well as poisonous parts of the plants used to make the juice have been 
cited as the cause of some juice related illness.
    Five recalls between 1990 and 1995 of fruit juices or beverages 
containing fruit juice were because of the presence of food ingredients 
that were inadvertently added to the product, not declared on the 
label, or not suitable for that food (Ref. 13). Food ingredients 
involved with these recalls were natamycin, sulfites, FD&C yellow No. 
5, and salt.
    Since 1991, there have been five recalls of juice products because 
of improper sanitation procedures or faulty equipment that resulted in 
cross-contamination with ingredients from other foods, minerals such as 
copper, glass, or other hazardous materials. These outbreaks and 
recalls demonstrate that juice and juice beverages may be susceptible 
to many hazards.
    The October 1996 apple juice outbreak from E. coli O157:H7, and the 
agency's concern that the current regulatory program relative to fresh 
juice and juice products may not be adequate to ensure the production 
of safe juice products, persuaded FDA to gather information to help 
address these problems. FDA held a public meeting on December 16 and 
17, 1996, to discuss the current state of the science and to review the 
technological and safety factors relating to the production and 
distribution of fresh juices. The agency was interested in learning 
about all aspects of juice production and distribution in an effort to 
consider how FDA's regulatory program should be revised, and whether 
additional measures are needed to reduce the risk of future outbreaks.
    Experts from industry, academia, and the regulatory and consumer 
sectors presented information on illnesses and the epidemiology of 
outbreaks arising from contaminated juices; current concerns with 
emerging pathogens; the E. coli O157:H7 outbreak in October 1996 caused 
by contaminated unpasteurized apple juice; procedures for processing 
juices; and new and existing technologies to decrease or eliminate the 
number of pathogens or other contaminating microorganisms.
    FDA received over 180 comments, most of which concerned apple juice 
specifically. Many comments pertained to juices in general and some 
referred only to apple juice, apple cider, or citrus juices. Most 
comments were concerned with changes in processing to improve the 
safety of juices. Among the changes recommended were requiring 
pasteurization of juices, requiring a Hazard Analysis and Critical 
Control Point (HACCP) program, and

[[Page 45594]]

establishing current good manufacturing practices (CGMP's) in juice 
processing.
    The National Advisory Committee on Microbiological Criteria for 
Foods (NACMCF) subsequently recommended to FDA, among other things, 
that HACCP and safety performance criteria should form the general 
conceptual framework for assuring the safety of juices, and that 
control measures should be based on a thorough hazard analysis. 
Furthermore, the NACMCF recommended that a mandatory HACCP program be 
established, and that processors implement and strictly adhere to 
industry CGMP's. The NACMCF also recommended that industry education 
programs be developed that address basic food microbiology, the 
principles of cleaning and sanitizing equipment, CGMP's, and HACCP.
    The information FDA obtained through the public meeting, as well as 
the recommendations of the NACMCF, clearly suggest that new measures 
are necessary to ensure that juice is safe. The virulence of new 
pathogens, such as E. coli O157:H7, and the risk of severe illness 
associated with these pathogens, especially for children, the elderly, 
and persons with weakened immune systems, create a need for prompt, 
active intervention. The agency has considered the recommendations 
provided in the comments and by the NACMCF and has developed a proposed 
strategy for ensuring juice safety. This proposed strategy involves 
addressing both the immediate goal of reducing the risk of foodborne 
illness associated with juice products and the long-term goal of 
ensuring that juice products are safe. This proposed strategy, as 
discussed below, involves a three-pronged approach that includes a 
mandatory HACCP program, label warning statements, and educational 
programs targeted at the industry and consumers.

II. Mandatory HACCP Program

    The agency has considered several alternatives recommended in the 
comments in determining whether to initiate rulemaking on a mandatory 
HACCP program for some or all juice products. The alternatives being 
considered include: (1) Increasing the frequency of FDA's inspection of 
juice manufacturers, as well as increasing agency sampling, laboratory 
analysis, and related regulatory activities; (2) issuing CGMP's or 
sanitation standards to increase the safety of juices; and (3) 
mandating pasteurization or other equivalent treatment of juices.
    At this point, the agency believes, based on available data, that a 
mandatory HACCP program is the most effective means of controlling 
microbiological, as well as chemical and physical hazards that may 
occur during juice processing, and that, therefore, such a program may 
be necessary for the safe and sanitary production of fruit and 
vegetable juices. Accordingly, the agency intends to propose a 
regulation that will mandate a HACCP program for some or all fruit and 
vegetable juice products. FDA intends to propose that some or all juice 
processors have and implement a written HACCP plan whenever a hazard 
analysis reveals that one or more food hazards are reasonably likely to 
occur, and that a HACCP plan be specific to each location where juice 
is processed by that processor. Thus, the agency is considering that 
implementation of a HACCP program will be the primary, long-term 
control measure for pathogens and other safety concerns related to the 
production and distribution of juice products.
    Under a mandatory HACCP program, FDA would propose a phase in 
period for implementation of HACCP plans for juice products. The phase 
in approach will permit the regulated industry time to develop a HACCP 
plan, accomplish the training of personnel, and adjust its activities 
to include necessary HACCP activities.
    The forthcoming HACCP proposal will fully discuss all of the issues 
surrounding the safety of fruit and vegetable juices raised in this 
document.

III. Label Warning Statements

    Although FDA has tentatively concluded that additional steps are 
necessary to ensure that juices are safe, the agency recognizes that 
rulemaking and implementation of a HACCP program are time consuming, 
and that a HACCP program for some or all juices would not likely be 
fully implemented for several years. In light of these facts, and the 
immediate concerns raised by the potential for foodborne illness from 
consumption of juice products neither processed in accordance with an 
established HACCP plan, pasteurized, nor otherwise treated to prevent 
or eliminate the presence of harmful bacteria that may be present, the 
agency sees a need for immediate action to ensure that consumers, 
particularly those at greatest risk, are informed of this potential 
hazard. This information can be conveyed through labeling, which can be 
effected by industry much more quickly than it can implement a HACCP 
program.
    Consequently, the agency is considering proposing 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. The agency anticipates that this will be an 
interim measure, until requirements for processing juice products under 
HACCP principles are fully implemented. The agency notes that it is 
considering providing that interventions that have been validated to 
achieve a cumulative 5-log reduction in E. coli O157:H7 or other 
pathogens would obviate the need for a warning label. Based on 
available information, however, the agency considers pasteurization the 
only process validated to meet this standard at this time. However, the 
agency solicits comments on other ways to achieve this reduction. Thus, 
in the absence of a validated HACCP plan, the agency anticipates that a 
warning statement will appear on some or all unpasteurized juice 
products.
    Consumer research data available to the agency suggest that 
consumers need clear and concise information about the nature and 
magnitude of the hazard in the food to understand a warning statement, 
and that certain elements are essential to ensure that the warning 
statement is effective (Ref. 14). These elements include statements 
describing the hazard, explaining why the hazard is present, advising 
how to avoid or alleviate the hazard, and identifying the group at 
risk. Depending on the type of food and the nature of the hazard, each 
of these elements may not be essential in developing an effective 
warning statement.
    To inform consumers effectively of the potential hazard associated 
with some or all juice products, FDA has tentatively concluded that 
three of the elements listed above would need to be reflected in the 
label warning statement. The warning statement for unpasteurized juice 
products could contain: (1) A statement of the hazard, that is, a 
statement about the potential presence of bacteria that can cause 
serious illness; (2) a statement explaining why the hazard is present, 
that is, a statement that the labeled product has not been processed or 
treated to destroy the harmful bacteria; and (3) a statement 
identifying the group at risk, that is, that evidence suggests that 
children, the elderly, and persons with weakened immune systems are at 
greatest risk of serious illness from exposure to harmful bacteria in 
juice and juice products. The agency will request comments on whether 
the warning statements should also include a fourth element, advising 
that at-risk consumers avoid the product.

[[Page 45595]]

    The consumer research data also showed that the first sentence of a 
warning statement is likely to influence a consumer's decision as to 
whether to continue reading the rest of a warning statement. Therefore, 
the agency intends to propose that the first sentence of the warning 
statement clearly state the hazard, i.e., that juice may contain 
pathogens known to cause serious/life-threatening illness. The agency 
recognizes, however, that there may be several ways to incorporate the 
essential elements into the warning statement. For example, the 
following model statements incorporate the three essential elements 
that FDA has tentatively concluded would need to be reflected in the 
label warning statement, but they communicate the information using 
different wording.
    1.WARNING: Unless specifically processed, some juices may contain 
harmful bacteria known to cause serious illness. This product has not 
been specifically processed to destroy such bacteria. The risk of life-
threatening illness is greatest for children, the elderly, and persons 
with weakened immune systems.
    2.WARNING: Some juices have recently been found to contain harmful 
bacteria known to cause life-threatening illness. This product has not 
been specifically processed to destroy such bacteria. Children, the 
elderly, and persons with weakened immune systems should avoid this 
product.
    3. WARNING: This product has not been pasteurized and therefore may 
contain harmful bacteria which can cause serious illness in children, 
elderly, and persons with weakened immune systems.
    The second statement includes the fourth element, advising the at-
risk consumer to avoid the product. FDA believes that any of these 
statements would inform consumers adequately of the potential risk of 
foodborne illness associated with the juice product. Accordingly, FDA 
is considering proposing statements such as these warning statements 
for juice products not pasteurized or otherwise treated to prevent or 
eliminate the presence of harmful bacteria. However, the agency 
recognizes that because these statements are untested, there may be a 
more effective way to alert consumers to the potential hazard.
    The agency is mindful that manufacturers may wish to include 
optional language on the label. For example, in addition to the 
information required by the essential elements, information describing 
the product as ``unpasteurized'' may be included. Handling instructions 
to ensure the safety of the product also may be included, e.g., ``boil 
product prior to serving.'' Similarly, manufacturers of pasteurized 
juice products may wish to include information on the label of their 
product informing the consumer that the product has been pasteurized. 
Because such information may be helpful and convenient for consumers 
searching for pasteurized juices, the agency encourages manufacturers 
of pasteurized juices to include the term ``pasteurized'' on the 
product label. In its labeling proposal, FDA will request comments on 
whether such additional information should be required. The agency 
notes, however, that consistent with the requirements for all label 
statements, any optional information must be truthful and not 
misleading.
    Consistent with the placement and prominence requirements of other 
warning statements, FDA is considering proposing that the statement 
appear prominently and conspicuously on the information panel of the 
immediate container of the product, in type size no less than one-
sixteenth of an inch, and set apart from other printed matter on the 
information panel by hairlines in the configuration of a box. In 
addition, the agency is considering proposing that the word ``WARNING'' 
be in capital letters and in bold type.
    The agency may conduct focus group research to evaluate consumer 
understanding of the proposed warning messages and to ensure that the 
messages are not misleading. The results of any focus group research 
would be considered by the agency in arriving at warning statements 
included in a final regulation.
    In its proposal, the agency will discuss and solicit comment on its 
tentative decision to require an interim warning statement on 
unpasteurized juices, its justification for the required elements of 
the warning statement, and its tentative conclusion that the proposed 
statements adequately inform the consumer of the potential risk 
associated with the juice product. In addition, the agency is 
considering proposing a sunset provision for the mandatory warning 
statement.
    Given the severity of the outbreaks with fresh apple juice that 
occurred during the 1996 season, the agency strongly encourages 
processors of unpasteurized apple juices to immediately and voluntarily 
label their products or provide point of purchase information with any 
of the model statements or a similar statement that includes the 
essential elements discussed above. Although the agency has particular 
concern about the potential for foodborne illness associated with apple 
juice because of the documented contamination with E. coli O157:H7, it 
encourages manufacturers of all types of juice to place warning labels 
on their products that have not been pasteurized. Such labeling may be 
accomplished by the use of stickers, placards, brochures, etc.
    Further, FDA is aware that some State authorities are considering 
the steps that they need to take to protect consumers. The agency 
encourages State and local officials to consider the information in 
this document as guidance as they contemplate requirements for 
untreated juice products during the 1997 season.
    The agency is considering whether to include some or all fruit and 
vegetable juice products that have not been pasteurized or otherwise 
specifically processed to prevent or eliminate the presence of harmful 
bacteria in any future proposal on label warning statements. The agency 
expects that any final rule on a mandatory warning statement will be 
issued prior to the start of the 1998 ``fresh apple juice/cider'' 
season.

IV. Educational Program

    FDA's primary goal is to ensure that the food supply is safe and 
that consumers are protected to the greatest extent possible from 
foodborne illness and other adverse reactions resulting from food 
consumption. The rulemakings that FDA intends to initiate on HACCP and 
on the interim warning statement should help to accomplish this goal 
with respect to juice products. Nevertheless, the benefits of these 
rulemakings will be enhanced if, in conjunction with them, FDA 
initiates educational programs aimed at industry and consumers. 
Consistent with the NACMCF recommendations, the agency believes that 
industry education programs addressing basic food microbiology, the 
principles of cleaning and sanitizing equipment, CGMP's, and HACCP will 
greatly assist juice processors in developing and implementing an 
effective HACCP plan. Given the severity of the outbreaks with 
unpasteurized apple juice and cider and the fact that final rules 
cannot be in place by the 1997 fresh cider season, the agency will use 
the education programs to encourage the industry to label their 
products voluntarily to advise consumers of the risks associated with 
fresh juice. In addition, educating consumers about the risks to 
certain populations associated with the consumption of untreated juice 
and the potential for the presence of pathogens and other hazardous 
substances will help to ensure that consumers fully understand the 
importance of label

[[Page 45596]]

statements and the significance of the appearance of warning statements 
on certain juice products but not on others.
    The agency intends to involve State and local officials in its 
education initiative because it is often the State or local official 
who is in direct contact with the farmer or juice processor. Thus, 
State and local officials can play a significant role in educating and 
assisting juice manufacturers and consumers in understanding the public 
health concerns associated with consumption of untreated juice products 
and in developing measures to reduce the risk.
    To meet its educational objectives, FDA intends to: (1) Enlist the 
aid of State and local officials, industry representatives, trade 
associations, and consumer groups in coordinating consumer and industry 
educational outreach programs; (2) use FDA field public affairs 
specialists to educate consumers and health professionals through 
lectures, meetings, and local media spots; (3) use FDA's home page on 
the World Wide Web to alert consumers to the potential hazard; (4) hold 
public meetings to discuss the issues raised in the impending proposals 
as well as the educational programs discussed in this document; (5) 
distribute ``Dear Consumer'' letters to targeted consumer groups; (6) 
use the FDA CFSAN information line to relay information to consumers 
and health professionals about the public health concern associated 
with untreated juice; (7) distribute camera-ready English and Spanish 
articles and English radio scripts and video news releases to the news 
media nationwide in September 1997 to coincide with the National Food 
Safety Education Program and ``Back to School'' program; and (8) 
distribute letters and articles to State and local officials.

V. Conclusion

    As outlined in this document, FDA has developed a proposed 
comprehensive strategy to address the public health concerns associated 
with consumption of fresh juice and juice products not specifically 
treated to prevent or eliminate the presence of pathogens. The agency 
invites comment on the appropriateness of its strategy on the guidance 
contained in this document and on whether additional or alternative 
regulatory or nonregulatory measures are necessary to adequately 
protect consumers. Comments suggesting additional or alternative 
measures should explain why such measures are needed and suggestions on 
how to implement the measure.
    In addition, the agency solicits comments on the specific wording 
of the warning statement to ensure that the final warning statement 
adequately conveys to consumers the risk of illness associated with 
consumption of the juice product. Furthermore, the agency solicits 
comments on whether to include all or some fruit and vegetable juice 
products that have not been pasteurized or otherwise specifically 
processed to prevent or eliminate the presence of harmful bacteria in 
any future proposal on HACCP or label warning statements.
    Because the details of this strategy will be discussed more fully 
in any future proposals, commenters may choose to wait until that time 
to respond. However, the agency will consider comments received within 
15 days of publication of this notice prior to publication of any 
proposed rule. Because of time constraints, the agency may not be able 
to consider comments received after this date, but these comments will 
be considered as part of the public rulemaking record associated with 
any proposal.

VI. References

    The following references have 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. 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 0157:H7 in 
Fresh-pressed Apple Cider,'' Journal of the American Medical 
Association, 269(17):2217:2220, 1993.
    2. Centers for Disease Control and Prevention, ``Outbreak of 
Escherichia coli 0157:H7 Infections Associated with Drinking 
Unpasteurized Commercial Apple Juice--British Columbia, California, 
Colorado, and Washington, October 1996,'' Morbidity and Mortality 
Weekly Report, 45(44):975, 1996.
    3. Centers for Disease Control and Prevention, ``Outbreaks of 
Escherichia coli 0157:H7 Infection and Crytosporidiosis Associated 
with Drinking Unpasteurized Apple Cider--Connecticut and New York, 
October 1996,'' Morbidity and Mortality Weekly Report, 46(1):4-8, 
1997.
    4. National Advisory Committee on Microbiological Criteria for 
Foods--Fresh Produce Subcommittee Proceedings, December 16, 1996.
    5. Centers for Disease Control, ``Salmonella typhimurium 
Outbreak Traced to a Commercial Apple Cider--New Jersey,'' Morbidity 
and Mortality Weekly Report, 24:87-88, 1975.
    6. Millard, P. S., K. F. Gensheimer, D. G. Addiss, D. M. Sosin, 
G. A. Beckett, A. Houck-Jankoski, and A. Hudson, ``An Outbreak of 
Crytosporidiosis from Fresh-pressed Apple Cider,'' Journal of the 
American Medical Association, 272(20):1592-1596, 1994.
    7. Centers for Disease Control and Prevention, ``Cholera 
Associated with Imported Frozen Coconut Milk--Maryland, 1991,'' 
Morbidity and Mortality Weekly Report, 40(49):844-845, 1991.
    8. Centers for Disease Control and Prevention Memorandum from 
Kim A. Cook, M.D. to Steve Thacker, M.D., October 1, 1995.
    9. FDA Recall Data Memorandum, Dirk J. Mouw to Raymond P. Mars, 
June 2, 1992.
    10. FDA Recall Data Memorandum, M. Anthony Abel to Ronald E. 
Joyce, March 21, 1994.
    11. Memorandum of Telephone Conversation between Debra Street, 
Ph.D., FDA, and P. Walker, Washington State Department of Health, 
January 15, 1997.
    12. Memorandum of Telephone Conversation between Debra Street, 
Ph.D., FDA, and Dr. K. Hendricks, Texas State Department of Health, 
January 16, 1997.
    13. FDA Memorandum to File, B. Timbo, Ph.D., July 14, 1997.
    14. FDA Memorandum, Alan S. Levy, Ph.D. to Kenneth Falci, Ph.D., 
June 26, 1997.

VII. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this document at any time. 
As noted above, the agency will consider comments received by September 
12, 1997, prior to publication of any proposed rule. 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.

    Dated: August 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22977 Filed 8-25-97; 4:44 am]
BILLING CODE 4160-01-F