[Federal Register Volume 63, Number 79 (Friday, April 24, 1998)]
[Proposed Rules]
[Pages 20486-20493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11026]


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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 10-5, 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