[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