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Corrections published May 15, 1998
Federal Register: April 24, 1998 (Volume 63, Number 79)
Proposed Rules
Page 20486-20493
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr24ap98-28
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
Docket No. 97N-0524
RIN 0910-AA43
Food Labeling: Warning and Notice Statements; Labeling of Juice
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
warning statements on packaged fruit and vegetable juice products that
have not been processed to destroy pathogenic microorganisms that may
be present. FDA is taking this action because of the recent outbreaks
of foodborne illness and deaths caused by consumption of juice products
that were not pasteurized or otherwise processed to control pathogenic
microorganisms. This requirement for warning labels will serve to
reduce the risk of foodborne illness. Elsewhere in this issue of the
Federal Register, FDA is proposing to require that juice be processed
under a Hazard Analysis and Critical Control Point program (HACCP).
DATES: Submit written comments by May 26, 1998. See section V of the
Supplementary Information section of this document for the proposed
effective date of a final rule based on this document.
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
There recently have been outbreaks of foodborne illness associated
with the consumption of juice and beverages containing juice, i.e.,
juice products, that have not been pasteurized or otherwise treated to
destroy pathogenic microorganisms.\1\ On October 30, 1996, the Seattle-
King County Department of Public Health and the Washington State
Department of Health reported an outbreak of Escherichia coli O157:H7
infections epidemiologically associated with consumption of
unpasteurized apple juice. The outbreak resulted in at least 66 cases
of illness in 3 western States and British Columbia, and the death of 1
child (Refs. 1 and 2).
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\1\ In this proposal, the terms ``juice'' and ``juice products''
are used interchangeably. Thus, ``juice'' refers both to beverages
that are composed exclusively of an aqueous liquid or liquids
extracted from one or more fruits or vegetables and those beverages
that contain other ingredients in addition to juice. Similarly,
``juice product'' refers both to beverages that contain only juice
and beverages that are composed of juice and other ingredients.
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Pathogens other than E. coli O157:H7 may be present in apple and
other types of juice products and have been documented as the cause of
foodborne illness. In particular, outbreaks caused by Salmonella
typhimurium and Cryptosporidium in apple cider (Refs. 3, 4, and 5) and
Vibrio cholerae in coconut milk (Ref. 6) have been reported. In
addition, outbreaks caused by consumption of unpasteurized orange juice
contaminated with S. hartford (Ref. 7), orange juice drink contaminated
with S. agona (Ref. 8), orange juice contaminated with Bacillus cereus
(Ref. 9), and home-made carrot juice contaminated with Clostridium
botulinum (Ref. 10) have been reported.
Because of the agency's concern that its regulatory program for
fresh juices may not be adequate to ensure the production of safe juice
and juice products, and because of the severity of the recent outbreak
of E. coli O157:H7 associated with apple juice, the agency held a
public meeting on December 16 and 17, 1996, to discuss safety issues
presented by juice products. At that meeting, FDA met with interested
parties to review the current science, including technological and
safety factors, relating to fresh juice production and to consider the
measures that would be necessary to provide safe fruit and vegetable
juices. Experts from industry, academia, and the regulatory and
consumer sectors presented information on illnesses and the
epidemiology of outbreaks arising from microbially contaminated juices;
concerns with emerging pathogens; procedures for processing juices; and
new and existing technology to control pathogens in juice products.
In light of the information developed at the public meeting and in
comments received by the agency, as well as other information available
to the agency, FDA has developed a strategy that it believes will
address 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. In the Federal Register of
August 28, 1997 (62 FR 45593), the agency published a notice of intent
(``the notice of intent'') that announced a comprehensive program to
address the incidence of foodborne illness related to consumption of
fresh juice and ultimately to address 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 or labeling of
juice products not specifically processed to prevent, reduce, 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. FDA stated that it
would consider comments received within 15 days of publication of the
notice of intent as part of any rule proposed by the agency.
This document addresses the warning statements for labels of
packaged juice products that have not been specifically processed to
prevent, reduce, or eliminate the presence of harmful pathogens. FDA
has reviewed all the comments received within 15 days of publication of
the notice of intent and has determined that the comments provide no
information that would cause the agency to conclude that this proposal
is inappropriate. In this document, the agency addresses these comments
to the extent that they are relevant to this proposal. Comments in
response to the notice of intent received more than 15 days after
publication of that notice that address issues in this
Page 20487
proposal will be considered in any final rule published in response to
this proposal.
II. The Proposal
A. Rationale for Proposal
As discussed in the notice of intent, implementation of a HACCP
program appears to be the best long-term control measure for pathogens
and for other safety concerns related to the production and
distribution of some or all juice products. Therefore, elsewhere in
this issue of the Federal Register, the agency is publishing a proposal
(``the HACCP proposal'') to require that most juice be processed under
a HACCP program. However, 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 likely not be fully implemented
for several years. During this period of rulemaking and implementation,
the risk of illness caused by pathogens in fresh juice will persist.
The agency is concerned that, unless warned, consumers at greatest risk
could suffer serious illness and even death from the consumption of
juices that have not been treated to prevent, reduce, or eliminate
microbial pathogens. Accordingly, FDA has tentatively concluded that
there is an immediate need to inform consumers of the public health
risks associated with consumption of untreated juice products through
the use of a warning on the label of such products.
Implementation of a labeling requirement can be completed more
quickly than implementation of a mandatory HACCP program. Consequently,
FDA is proposing to require that the labels of packaged juice products
not pasteurized or otherwise specifically processed to prevent, reduce,
or eliminate the presence of pathogens bear a warning statement
informing consumers of the potential risk of foodborne illness
associated with the product. As discussed in more detail in section II
of this document, the agency is also proposing that this labeling
requirement not apply to any juice processed under an adequate HACCP
program or otherwise processed in a manner sufficient to destroy
pathogens, e.g., pasteurization, or to any unpackaged juice sold for
immediate consumption, e.g., products sold by the glass in restaurants,
grocery stores, or other food establishments.
B. Legal Authority for FDA to Require Warning Labels
As a general rule, FDA's authority to require warning labels on
food products derives from sections 201(n), 403(a)(1), and 701(a) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n),
343(a)(1), and 371(a)). Under section 403(a)(1) of the act, a food is
misbranded if its labeling is false or misleading in any particular.\2\
Section 201(n) provides that, in determining whether labeling is
misleading, FDA shall take into account not only representations made
about the product, but also the extent to which the labeling fails to
reveal facts material in light of representations made or suggested in
the labeling, or facts material as to consequences that may result from
use of the product under conditions of use prescribed in the labeling
or under customary or usual conditions of use. Section 701(a) of the
act authorizes FDA to issue regulations for the efficient enforcement
of the act. FDA has relied on the authority of sections 201(n), 403(a),
and 701(a) of the act to require warning labels that alert consumers to
the potential hazards of certain ingredients of foods and dietary
supplements. (See 49 FR 13679, April 6, 1984 (protein products) and 62
FR 2218, January 15, 1997 (iron-containing dietary supplements).)
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\2\ The term ``label'' means any written, printed, or graphic
matter on the immediate container of an article (section 201(k) of
the act). The term ``labeling'' means all labels and other written,
printed, or graphic matter either on any article or its containers
or wrappers, or accompanying such article (section 201(m) of the
act).
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As previously discussed, some juice products have been the vehicles
of outbreaks of illnesses from foodborne pathogens, including E. coli
O157:H7 and Salmonella. The consequences of consuming juice products
that contain pathogenic microorganisms are well documented; such
consumption may result in serious, life threatening illnesses or death
(Refs. 1 to 7). Therefore, the agency tentatively concludes that there
is a risk of serious illness from consuming juice products that have
not been processed in a manner designed to destroy these pathogens.
Given the possible presence of pathogens in untreated juice, and the
potential consequences of consumption of these beverages, the fact that
juice may contain harmful pathogens and the fact that a product has not
been treated to control such pathogens are material facts regarding the
consequences that may result from use of these juice products. Unless
these facts are disclosed to consumers at the time that they are
deciding whether to purchase and consume the juice, the juice products
are misbranded under sections 201(n) and 403(a)(1) of the act.
Accordingly, the agency is proposing to require a warning statement on
the labels of packaged juice products not processed to destroy
pathogens. The agency is not proposing to require warnings for
unpackaged juice (e.g., juice sold by the glass in restaurants or other
food establishments). The proposed regulation does not draw a
distinction between packaged and unpackaged juice products, because, by
its terms, the regulation applies only to packaged juice products and
not the unpackaged products. This approach is consistent with the
agency's food labeling regulations which do not apply to food
distrubuted to consumers in unpackaged form unless specifically noted
in the regulations.
C. Covered Products
In the HACCP proposal, FDA is proposing to define ``juice'' as the
aqueous liquid expressed or extracted from one or more fruits or
vegetables, the puree of the edible portion of one or more fruits or
vegetables, or any concentrate of such liquid or puree. The agency is
proposing that the term ``juice'' have the same definition for purposes
of the warning statement. Furthermore, the agency notes that fruit and
vegetable juices may be used as ingredients in other beverages (e.g.,
diluted juice beverages and flavored bottled waters). Because these
products often resemble juices, are processed in a manner that is
similar to the manner in which juices are processed, are handled by
consumers similarly to juices, and would support pathogen outgrowth
similarly to juices, these foods are likely to present the same food
hazards as juices. Therefore, consistent with its HACCP proposal, the
agency is proposing in Sec. 101.17(g)(1) that the requirement for a
warning statement cover any packaged juice, as defined in section II.C
of this document, sold as such or used as an ingredient in another
beverage. The agency notes that juice processed on premises and sold
for immediate consumption in establishments such as restaurants, in-
store delis, and juice bars are not subject to the requirements of this
proposal.
D. Circumstances in Which Warning Statements Required
In comments that it submitted in response to the public meeting
held on December 16 and 17, 1996, the National Advisory Committee for
Microbiological Criteria for Foods (NACMCF) stated that the history of
public health problems with juice necessitates some safety
Page 20488
interventions by manufacturers. The NACMCF recommended that a tolerable
level of risk may be achieved by requiring interventions that have been
validated to achieve a cumulative 5-log (i.e., 100,000 fold) reduction
in E. coli 0157:H7 or Listeria monocytogenes or a reduction in the
yearly risk of illness to less than 10<SUP>-5</SUP>, assuming
consumption of 100 milliliters of juice daily. However, the NACMCF did
not specify the manner in which this reduction should be accomplished.
As discussed in the HACCP proposal published elsewhere in this
issue of the Federal Register, FDA has tentatively concluded that a 5-
log reduction in the target pathogen is a tolerable level of risk in
juice products. Therefore, for purposes of the HACCP proposal, the
agency is proposing to require that juice made by processors but not
retailers as discussed in that proposal be processed in a manner that
will produce, at a minimum, a 5-log 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. (As set out
in the HACCP proposal, retail establishments includes establishments
that process juice for direct sale to consumers and other retailers, as
long as total annual sales do not exceed 40,000 gallons.) For the
purposes of this regulation, the ``pertinent microorganism'' is the
most resistant microorganism of public health significance that is
likely to occur in juice. (In the remainder of this document this level
of reduction shall be referred to as ``the 5-log reduction.'') FDA
recognizes that pasteurization is a process that can achieve this 5-log
reduction. In addition, manufacturers may be able to use other
technologies and practices (such as a combination of eliminating use of
drops, brushing, washing, and using sanitizers) provided that their
process is validated to achieve the 5-log reduction in the target
pathogen. Therefore, the agency is proposing in Sec. 101.17(g)(2) to
require that all packaged juice that has not been processed in a manner
that will produce the 5-log reduction bear a warning statement alerting
consumers to the potential presence of harmful bacteria.
E. Label Warning Statements
1. Use of Terms ``Pasteurized'' and ``Unpasteurized''
The agency considered whether the use of the terms ``pasteurized''
and ``unpasteurized'' on the label without additional hazard
information, would adequately alert consumers to the microbiological
hazards associated with some juice products. FDA received several
comments in response to the notice of intent regarding the use of these
terms. Some comments suggested that products should be labeled
``unpasteurized'' to distinguish them from pasteurized products. Other
comments opposed warning labels for pasteurized products. According to
one comment, because there have been no public health problems
associated with pasteurized juice, there should be no requirement that
these products declare on their label that they are pasteurized.
However, the comment further asserted that pasteurized juice products
should be permitted to declare that fact voluntarily on their label.
Comments received in response to the notice of intent also
addressed the adequacy of labeling using the terms ``pasteurized'' and
``unpasteurized.'' One comment stated that use of the terms
``pasteurized'' and ``unpasteurized'' alone, without hazard
information, would be ineffective communication if consumers do not
know that pasteurization is a heat treatment designed to kill bacteria
and that these microorganisms, if not eliminated and if consumed, could
cause life threatening illness for some consumers.
FDA tentatively agrees with this comment. Although label statements
indicating whether a product is pasteurized or unpasteurized may be
useful to consumers who are seeking to purchase either type product,
FDA has tentatively concluded that use of such terms would only inform
consumers about the type of treatment, or lack of treatment, that a
juice has received and would not properly inform consumers of the risks
presented by untreated juices. Also, FDA is not aware of the extent to
which consumers understand the terms ``pasteurized'' and
``unpasteurized.'' Thus, the agency is concerned that without effective
consumer education, labeling untreated juice products as simply
``unpasteurized'' may not only have relatively little meaning to
consumers but could even cause confusion. For example, some consumers
may select unpasteurized juice believing that such juice is superior to
pasteurized juice in that it is less processed.
In addition, FDA has tentatively concluded that an untreated
packaged juice product labeled with the term, ``unpasteurized,''
without an accompanying statement that describes the associated
microbiological hazards, or a statement that informs purchasers that
children, the elderly, and the immunocompromised are at greatest risk
of serious illness from consuming such product, would be misbranded
under section 403(a)(1) and 201(n) of the act because such labeling
would not reveal material facts about the consequences that may result
from use of such juice products.
Finally, FDA is concerned that requiring juice products to be
labeled only with the terms ``unpasteurized'' or ``pasteurized'' would
not take into account technologies other than pasteurization that may
be developed to control pathogens in juice. Thus, requiring use of
these terms could be viewed as restricting the development of new
technologies. Several comments suggested that there are alternate
technologies that could be used to control microorganisms in juice
products, e.g., irradiation, high pressure treatment, or pulsed high
energy processes. One comment opposed labeling that would preclude
alternatives to pasteurization to render juice products safe. The
agency agrees with this comment and tentatively concludes that labeling
a product as ``unpasteurized'' may be misleading in that the term does
not distinguish between a product that may contain harmful pathogens
that could result in serious disease and one that is treated using a
method (other than pasteurization) that is capable of achieving a 5-log
reduction in the target pathogen. A product that is processed by a
means other than pasteurization to achieve a 5-log reduction in the
target pathogen does not have the potential microbiological hazard, and
thus, would not require a warning statement, yet that product could not
be labeled ``pasteurized.'' Without additional information, the
consumer would not know how to interpret the label with the term
``unpasteurized.''
Therefore, the agency tentatively concludes that labeling juice as
either ``pasteurized'' or ``unpasteurized'' without hazard information
would not adequately inform consumers about the potential hazard
associated with consumption of juices that have not been processed to
prevent, reduce, or eliminate the presence of pathogenic
microorganisms. Consistent with this tentative judgment, FDA has also
tentatively concluded that language that specifically identifies the
hazard, in the form of a warning statement, is necessary to inform
consumers effectively of the risks associated with the consumption of
fruit and vegetable juices that have not been so processed.
Manufacturers who wish to label their products voluntarily with the
term ``pasteurized'' or with the term ``unpasteurized,'' along with the
warning statement, may do so under the
Page 20489
proposed rule, provided that these terms are used in a truthful and
nonmisleading manner. The agency requests comments on these tentative
conclusions.
2. Essential Elements of Specific Warning Statements
Consumer focus group research available to the agency shows that
certain elements are essential if label warning statements are to
inform consumers effectively of a hazard (Ref. 11). The agency has
previously used this consumer study information to develop effective
warning statements. For example, the agency used this information to
craft a warning statement for iron-containing dietary supplements (see
Sec. 101.17(e) (21 CFR 101.17(e))). As discussed in the final rule that
requires that such supplements bear a warning statement (62 FR 2218,
January 15, 1997), the elements essential for an effective warning
statement are a description of the hazard, handling instructions to
avoid the hazard, and an instructional statement that describes
conditions under which the hazard occurs and what action to take if the
hazard is not avoided.
The consumer research that FDA has reviewed shows that when
consumers generally believe that a product is safe, warning messages
that note that a hazard exists but that do not provide information
about the nature of the hazard, are likely to confuse or frighten them
(Ref. 11). Therefore, because juice products have not historically been
considered by consumers to be hazardous, and because these products are
generally promoted and consumed as an important part of a healthy diet,
it is critical that any warning statement for juice clearly describe
the potential hazard to consumers. In this case, the hazard to be
described is the potential presence of pathogens in the juice that can
cause serious illness. Therefore, the agency tentatively concludes that
to provide effective information to consumers of the hazard associated
with some juice products, a brief description of the particular hazard
should be included in the warning statement. These consumer research
data also show that the first sentence of a warning statement is likely
to influence a consumer's decision as to whether to continue reading
the remainder of the statement (Ref 11). Therefore, FDA is proposing
that the description of the hazard appear in the warning statement and
that such description appear in the first sentence of that statement,
i.e., that juice may contain pathogens known to cause serious, life-
threatening illness.
The second essential element of an effective warning statement is
that it disclose the reason that the labeled product presents the
hazard. As discussed previously, consumer research shows that stating
that a product presents a hazard without further explanation may be
confusing and frightening to consumers. The agency is concerned that
consumers may not find credible a warning on a product that they may
have consumed safely for years. A warning that juice may be hazardous
without an accompanying statement describing why the labeled product
has the potential hazard could imply that all juices are potentially
hazardous. Therefore, the agency tentatively concludes that it is
essential to describe why a particular juice product has the potential
hazard, i.e., because it has not been processed in a way that is
designed to destroy harmful pathogens that could be present.
The final essential element for a warning statement is an
identification of the groups that are at greatest risk of illness.
Existing data show that certain subpopulations are more susceptible to
foodborne illness than others. Specifically, the evidence suggests that
children, the elderly, and persons who are immunocompromised are at
greatest risk of serious illness from exposure to foodborne pathogens
(Ref. 12). As previously discussed, juice has been a vehicle for
foodborne pathogens that have caused serious illness. Therefore, it is
essential that the warning statement for untreated juice specifically
identify the at-risk groups, so that such individuals may choose to
avoid the product.
The agency recognizes that the foregoing elements are somewhat
different from those used in warning statements on other products. For
example, as previously discussed, the warning label for iron-containing
supplements contains handling and instructional statements. Warning
statements for self pressurized containers in Sec. 101.17(a), (b), and
(c), and for protein products under Sec. 101.17(d) also include
handling or instructional statements.
However, the agency tentatively concludes that, for juices,
handling and instructional information is not essential for an
effective warning statement. Under this proposal, the warning statement
will include a description of the hazard, a description of the source
of the hazard, and a description of the at-risk groups. The agency
believes that it is implicit in this description that the at-risk
consumers can avoid the hazard by not consuming the juice product.
However, FDA requests comment on whether the agency should require a
statement explicitly instructing consumers who are at greatest risk to
avoid the product and if so, the basis for such requirement.
Applying the essential elements described above, FDA crafted
examples of warning statements. The following examples illustrate some
of the variation that could occur in statements by applying the
essential elements.
WARNING: Unless specifically processed, some juices may contain
harmful bacteria known to cause serious illness. This product has not
been processed to destroy these bacteria. The risk of life-threatening
illness is greatest for children, the elderly, and persons with
weakened immune systems.
WARNING: This product has not been pasteurized and, therefore, may
contain harmful bacteria that can cause serious illness in children,
the elderly, and persons with weakened immune systems.
The following is an alternative statement that contains the three
essential elements as well as optional instructional and handling
statements.
WARNING: Some juices have been found to contain harmful bacteria
known to cause life-threatening illness. This product has not been
processed to destroy these bacteria. Children, the elderly, and persons
with weakened immune systems should avoid this product. Consumers may
protect themselves by boiling this product before serving.
In order to evaluate the examples of warning statements developed
through use of the essential elements and to test the effectiveness of
such examples in informing consumers of the hazards associated with
untreated juice products, FDA conducted focus group research to
evaluate consumer understanding of several possible warning statements.
Six focus groups were conducted to test possible warning statements
that contained the essential elements as well as the optional handling
instructions (Ref 13). All participants examined and discussed seven
warning statements, including the three examples presented above. Most
participants initially viewed the tested warning statements as very
strong messages that indicated that there is greater risk associated
with unpasteurized juice than these consumers had previously thought.
Because many juice products do not state on the label that the product
has been pasteurized, many of the participants assumed that most juices
are not pasteurized. Once these
Page 20490
consumers understood that most juices are pasteurized, these consumers
no longer believed that the warning statements were extreme.\3\
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\3\ Approximately ninety-eight percent of juice sold in the
United States is pasteurized.
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In comparing and contrasting the various examples of warning
statements, there was strong consensus across the groups regarding the
preferred warning statement. Specifically, the participants strongly
preferred a statement that was short and concise, that clearly stated
that the product was not pasteurized, and that clearly identified the
consumers at greatest risk of illness. The focus group discussions also
provided insight into the clarity of different terminology for
conveying the essential elements. Participants were better able to
understand the warning statement when the term pasteurization was used
rather than a term such as ``specifically processed.'' They also found
the term ``harmful bacteria'' easier to understand than
``microorganisms.'' Finally, for the description of risk groups,
participants preferred the phrase ``weakened immune systems'' to the
alternative ``immune system deficiencies.'' Overall, the participants
emphasized the need for simple, straight-forward language that could be
comprehended by lay people.
In addition, the focus group research showed that inclusion of
handling statements that instructed consumers on how to sterilize
unpasteurized juice by heating it was seen as not particularly
effective. Overall, participants found the statements somewhat
confusing and reacted rather negatively to these instructions. Many
participants questioned why they would pasteurize unpasteurized juice
when they could simply buy pasteurized juice in the first place.
The focus group research also showed that minor wording
differences, such as inclusion of the adjective ``fresh'' in describing
the juice product, had a strong impact on the participants' reaction to
the statements. Participants stated that warnings that described the
product as ``fresh'' were inappropriate because such description
invoked a positive characteristic (being fresh) that changed the tone
of the warning statement in a way that made the statement inconsistent
with a serious warning. The participants believed this inconsistent
tone would create confusion and that consumers would not recognize the
statement as a warning.
Based on these findings FDA has tentatively concluded that
requiring a specific message (i.e., a prescriptive approach) will be
the most effective way to ensure that consumers are not misled and
correctly understand the warning statement. This approach will ensure
that consumers of fresh juice are able to make informed choices about
the products they purchase and consume. In addition, use of a
prescriptive warning statement for fresh juice is consistent with
warning statements for other food products (protein products and iron-
containing dietary supplements, Sec. 101.17(d) and (e) respectively).
Although FDA stated in the notice of intent that it would propose
essential elements of a warning statement, the agency recognized in the
notice that, because the model statements were untested, there could be
a more effective way to alert consumers to the potential hazard. The
focus group research directed at warning statement examples developed
through use of elements demonstrates that allowing variation in the
warning statements may lead to a misleading message. Therefore, after
having conducted focus group research directed at warning statements
for juices that have not been treated to destroy pathogens, and having
analyzed the results of the research, FDA has tentatively concluded
that a prescriptive approach would be more effective than the
``elements approach'' in informing consumers of the potential hazard.
In addition, FDA believes that a regulation to require a warning
statement for untreated juices must be sufficiently clear to allow the
regulated industry to determine that its labeling complies with that
regulation. In addition, the regulation should establish a so-called
``level playing field'' for all products covered by the regulation by
requiring that each product's labeling provide the same information.
FDA has tentatively concluded that by prescribing the specific language
for a warning statement for untreated juice in a regulation would
accomplish these two goals, as well as ensure a message to consumers
that is not confusing, misleading or otherwise ineffective. In
addition, from the agency's perspective, the enforcement of a labeling
rule is more straight forward where the regulation prescribes the
contents of the labeling.
Accordingly, FDA is proposing in Sec. 101.17(g)(2) to require that
juice products not processed in a manner that will produce, at a
minimum, a 5-log reduction in the pertinent microorganism for a period
of at least as long as the shelf life of the product when stored under
normal and moderate abuse conditions, bear the following statement:
WARNING: This product has not been pasteurized and, therefore, may
contain harmful bacteria that can cause serious illness in children,
the elderly, and persons with weakened immune systems.
The agency requests comments on the specific language of the
warning statement. For example, are the categories of at-risk consumers
identified too broadly in the warning statement? Should the at-risk
consumers be more narrowly described, and, if so, on what basis? For
example, is there any basis for describing certain ages for
``children'' and the ``elderly'' or describing a certain level of
``weakened immune system?'' Should the words that alert consumers to
the warning statement be changed from ``WARNING'' to ``ATTENTION,''
``NOTICE,'' ``CONSUMER ADVISORY,'' ``CONSUMER ALERT,'' or ``HAZARD
ADVISORY,'' as suggested by comments to the notice of intent, or to
some other term?
FDA is also interested in receiving in comments the results of any
other available consumer research. FDA will consider the results of
such research in developing any final rule that results from this
proposal.
FDA is proposing the use of the term ``pasteurized'' rather than
``specifically processed'' in the warning statement because the term
``pasteurized'' in the context of the entire statement was better
understood by the focus group participants to describe a process that
makes juice ``safe.'' However, the agency recognizes that the use of
this term could imply to consumers that all juices not bearing the
warning statement have been pasteurized. While such an implication may
not be technically precise for products manufactured under an effective
HACCP plan that does not include pasteurization, FDA has tentatively
concluded that this imprecision is acceptable because the more
important message, i.e., that juice products not bearing the warning
statement can be safely consumed by all population groups, will be
clearly understood by consumers. Nonetheless, the agency solicits
specific comment on whether use of the phrase ``has not been
pasteurized'' is appropriate in this context, or whether alternate
phrasing not identifying a specific process should be used. Comments
that suggest alternate phrasing should include data, information, or a
rationale to support the alternative, as well as evidence that
consumers would not be confused or misled by the alternate phrasing.
Page 20491
3. Placement and Prominence
Section 403(f) of the act requires that mandatory label information
be prominently placed on the label with such conspicuousness (compared
with other words, statements, designs, or devices in the labeling) as
to render it likely to be read and understood by the ordinary
individual under customary conditions of use. FDA has generally
considered the label information panel to be the appropriate location
for warning statements. As discussed in the agency's rulemaking
requiring warning statements on iron-containing dietary supplements (62
FR 2218), consumer focus group studies establish that a warning
statement need not be placed on the principal display panel (PDP) to be
effective in informing consumers of the hazard. Participants in the
focus groups reasoned that the front of the product was used for
marketing purposes and stated that they were accustomed to looking at
the ``back of products'' for nutrition and factual information,
including warning statements (Ref. 11). Consequently, in the case of
iron-containing dietary supplements, the agency required that the
warning statement appear on the information panel.
The agency tentatively concludes that for warning statements on
packaged juice products, the requirement for prominence and
conspicuousness would similarly be met if the statements appeared on
the information panel. However, the agency has tentatively concluded
that it would not object to firms placing the warning statement on the
PDP, because the PDP would provide even greater prominence.
Accordingly, FDA is proposing to require in Sec. 101.17(g)(3) that the
warning statement for juices appear either on the product information
panel or on the PDP.
The requirement in the act for prominent display means that the
warning statement must appear in a manner that makes it readily
observable and likely to be read. The agency notes that Sec. 101.2(c)
(21 CFR 101.2(c)) requires that mandatory information appearing on the
PDP and information panel, including information required by
Sec. 101.17, appear prominently and conspicuously in a type size no
less than one-sixteenth inch. The agency has tentatively concluded that
it is not necessary to repeat type size requirements in the proposed
regulation for warning labels on juice products and, therefore, has not
done so.
Because of the severity of the hazard, FDA has tentatively
concluded that the word ``warning'' in the warning statement should be
as prominent and conspicuous as possible. In the past, when the agency
has required cautionary information on labels, e.g., on products
containing aspartame (39 FR 27317), it utilized bold type to make the
information more prominent. In addition, FDA regulations on nutrition
labeling, Sec. 101.9(d)(1)(iv) (21 CFR 101.9(d)(1)(iv)), require that
certain nutrient information in the nutrition facts panel use bold
type. Therefore, consistent with these examples, the agency is
proposing in Sec. 101.17(g)(4) to require that the word ``WARNING'' be
in bold type to help alert consumers that there is new and critically
important information about the juice products.
In addition, current agency regulations that require a ``warning''
statement on the product label or in labeling (e.g., the statement
required by Sec. 101.17(e) on iron-containing dietary supplements in
solid oral dosage form) or a label ``notice'' statement (e.g., the
statement required by Sec. 101.17(d)(3) on protein products that are
not covered by the requirements of Sec. 101.17(d)(1) and (2)) require
that the identifying term ``WARNING'' or ``NOTICE'' be capitalized and
immediately precede the language of the applicable labeling statement.
Consistent with these examples, the agency is proposing in
Sec. 101.17(g)(4) to require that the capitalized word ``WARNING''
immediately precede the statement.
The agency notes that experience has shown that the prominence of
some labeling information may be enhanced by the use of a box around
the information. The agency's experience with the nutrition facts panel
on food labels has been that the box surrounding the nutrition
information greatly increases the prominence of the information. In
addition, consumer focus group research has shown that boxes around
important messages help consumers to distinguish the message from other
information (Ref. 11). The agency tentatively concludes that the use of
a box around the warning statement for juice will similarly increase
the prominence of the message by setting it off, thereby enhancing the
likelihood that consumers will notice and read the message.
Accordingly, FDA is including in the proposal a requirement
(Sec. 101.17(g)(5)) that the warning statement be set off in a box by
use of hairlines. The agency requests comments on the prominence and
placement of the proposed warning statements.
III. Analysis of Impacts
A. Preliminary Regulatory Impact Analysis
In accordance with Executive Order 12866, FDA has developed a
single preliminary regulatory impact analysis (PRIA) that estimates
benefits and costs associated with both this proposal and the HACCP
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 proposal and the HACCP
proposal for juice. The agency will promptly publish the small entity
analysis in the Federal Register.
IV. Environmental Impact
The agency has determined under 21 CFR 25.30(k) 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.
V. Effective Date
FDA is proposing that any final rule that may be issued based upon
this proposal become effective 60 days after its publication in the
Federal Register. FDA realizes that it will take time for manufacturers
to make label changes and to deplete existing inventories. However, FDA
must balance the need for immediate implementation of a warning
statement requirement because of the food safety benefits associated
with it, with the burden placed on industry to comply with the
requirement. The agency, therefore, is considering options in this
document that will provide information to consumers while reducing the
burden on industry. Accordingly, firms may provide the required warning
statement in labeling at point of purchase, e.g., signs or placards, as
a temporary alternative to providing the information on the label. When
signs or placards are used, the agency is requiring that the type size
of the labeling be in accordance with that required in
Sec. 101.100(a)(2)(ii) (21 CFR 101.100(a)(2)(ii)), i.e., not less than
one-fourth inch in height. The agency is proposing in
Sec. 101.17(g)(3)(i) to allow manufacturers until January 1, 2000, to
provide the warning message on the label itself. This is the next
appropriate uniform compliance date for other food labeling changes.
Furthermore, to
Page 20492
relieve the burden on small businesses, the agency is proposing in
Sec. 101.17(g)(3)(ii) to allow businesses employing fewer than 500
persons until January 1, 2001 to provide the required warning
information on the label. Based on the agency's economic analysis, the
agency believes that this date permits small businesses sufficient time
to provide information on labels without appreciable economic losses.
This definition of a small business is based on that of the Small
Business Administration. The agency requests comments on the effective
date and the compliance dates for this rule.
Because of the severity of the hazard, the agency urges
manufacturers of juice products that have not been processed to
prevent, reduce, or eliminate the presence of pathogenic microorganisms
to begin immediately to label their products with a warning statement
consistent with this proposal. Such labeling can be accomplished by the
use of stickers or placards. FDA recognizes that it is possible that
the requirements for the warning label statement in the final rule may
be different from those in the proposal. However, to encourage
manufacturers to use the warning label statement as soon as possible,
the agency advises that it intends to allow the continued use of any
label or labeling that complies with the proposed regulation and is
printed prior to the date of publication in the Federal Register of any
final rule resulting from this proposal until that inventory is
depleted.
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that the labeling requirements proposed
in this document are not subject to review by the Office of Management
and Budget because they do not constitute a ``collection of
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520). Rather, the proposed warning statement is ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
VII. Comments
Interested persons may, on or before May 26, 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.
The agency notes that the comment period in this document is
shorter than the 75-day period that is customarily provided by FDA for
proposed rules. Likewise, this comment period is less than the 60 days
that is the general rule set out in FDA's procedural regulations,
Sec. 10.40(b)(2) (21 CFR 10.40(b)(2)). As discussed below, FDA believes
that a 30-day comment period is appropriate in these circumstances.
Executive Order 12889 (58 FR 69681, December 30, 1993), which
implemented the North American Free Trade Agreement, states that any
agency subject to the Administrative Procedure Act, should provide a
75-day comment period for any proposed Federal technical regulation or
any Federal sanitary or phytosanitary measure of general application.
However, Executive Order 12889 provides an exception to the 75-day
period where the United States considers the measure necessary to
address an urgent problem related to the protection of human, plant or
animal health. Similarly, FDA regulations establish a 60-day comment
period as agency practice, but provide that the 60-day period may be
shortened if the Commissioner of Food and Drugs finds good cause for
doing so.
As discussed in detail in this document, the available evidence
demonstrates that some juice and juice products have been the vehicles
for outbreaks of serious illness from foodborne pathogens. FDA has
tentatively concluded that effective protection of the public health
requires that consumers be informed as quickly as possible (i.e., in
time for the 1998 ``cider season'') to the hazards associated with
these juice products. FDA has concluded that the urgency of this matter
is sufficient justification for shortening the comment period for this
proposal to 30 days, consistent with Executive Order 12889. Similarly,
this urgency constitutes good cause within the meaning of
Sec. 10.40(b), which justifies shortening the period to 30 days. In
addition, a 30-day comment period is appropriate in these particular
circumstances because interested parties have already been provided
time to comment on the proposed warning label statements that were
published in FDA's August 28, 1997, notice of intent.
VIII. 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. 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,'' Morbidity and Mortality
Weekly Report, 45(44):975, 1996.
2. National Advisory Committee on Microbiological Criteria for
Foods--Fresh Produce Subcommittee, proceedings, December 16, 1996.
3. Centers for Disease Control, ``Salmonella typhimurium
Outbreak Traced to a Commercial Apple Cider--New Jersey,'' Morbidity
and Mortality Weekly Report, 24:87-88, 1975.
4. Millard, P. S., K. F. 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,'' Journal of the
American Medical Association, 272(20):1592-1596, 1994.
5. Centers for Disease Control and Prevention, ``Outbreaks of
Escherichia coli O157:H7 Infection and Cryptosporidiosis Associated
with Drinking Unpasteurized Apple Cider--Connecticut and New York,
October 1996,'' Morbidity and Mortality Weekly Report, 46(1):4-8,
1997.
6. 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.
7. Centers for Disease Control and Prevention, memorandum from
Kim A. Cook to Steve Thacker, October 1, 1995.
8. FDA recall data memorandum, Dirk J. Mouw to Raymond P. Mars,
June 2, 1992.
9. FDA recall data memorandum, M. Anthony Abel to Ronald E.
Joyce, March 21, 1994.
10. Memorandum of telephone conversation between Debra Street,
FDA, and P. Walker, Washington State Department of Health, January
15, 1997.
11. FDA memorandum, Alan S. Levy to Kenneth Falci, June 26,
1997.
12. Council for Agricultural Science and Technology, Foodborne
Pathogens: Risks and Consequences, Ames, Iowa: Council for
Agricultural Science and Technology, Task Force Report No. 122, ch.
3, 1994.
13. Macro International Inc., Focus Group Testing of Warning
Statements on Juice Products Not Pasteurized or Otherwise
Specifically Treated to Eliminate Harmful Bacteria.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug and Cosmetic Act, and under
the authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
Page 20493
2. Section 101.17 is amended by adding paragraph (g) to read as
follows:
Sec. 101.17 Food labeling warning and notice statements.
* * * * *
(g) Juices that have not been specifically processed to prevent,
reduce, or eliminate the presence of pathogens.
(1) For purposes of this paragraph (g), ``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 concentrate of such liquid or puree. Any juice sold as such or used
as an ingredient in beverages shall be labeled in accordance with the
requirements of this paragraph.
(2) The label of any juice that has not been processed in the
manner described in paragraph (g)(7) of this section shall bear the
following warning statement:
WARNING: This product has not been pasteurized and,
therefore, may contain harmful bacteria which can cause serious
illness in children, the elderly, and persons with weakened immune
systems.
(3) The warning statement required by paragraph (g)(2) of this
section shall appear prominently and conspicuously on the information
panel or on the principal display panel of the label of the container,
except that:
(i) The warning statement may appear in labeling, including signs
or placards, until January 1, 2000; after this date, the warning
statement shall appear on the label of the food.
(ii) For products manufactured by businesses employing fewer than
500 persons, the warning statement may appear in labeling, including
signs and placards, until January 1, 2001; after this date, the warning
statement shall appear on the label of the food.
(4) The word ``WARNING'' shall immediately precede the statement,
shall be capitalized, and shall appear in bold type.
(5) The warning statement required by paragraph (g)(2) of this
section, when on a label, shall be set off in a box by use of
hairlines.
(6) The requirements in paragraph (g) of this section shall not
apply to juice processed in a manner that will produce, at a minimum, a
5-log (i.e., 100,000 fold) reduction in the pertinent microorganism for
a period at least as long as the shelf life of the product when stored
under normal and moderate abuse conditions. 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. 98-11026 Filed 4-22-98; 8:45 am
BILLING CODE 4160-01-F
Additional Information April 21, 1998 Press Release