[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Rules and Regulations]
[Pages 37030-37056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18287]
[[Page 37029]]
_______________________________________________________________________
Part VI
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 101 and 120
Food Labeling: Warning and Notice Statement: Labeling of Juice
Products; Final Rule
Hazard Analysis and Critical Control Point (HACCP); Procedures for the
Safe and Sanitary Processing and Importing of Juice; Extension of
Comment Period; Proposed Rule
Federal Register / Vol. 63, No. 130 / Wednesday, July 8, 1998 / Rules
and Regulations
[[Page 37030]]
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 Statement; Labeling of Juice
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revising its food
labeling regulations to require a warning statement on fruit and
vegetable juice products that have not been processed to prevent,
reduce, or eliminate pathogenic microorganisms that may be present. FDA
is taking this action to inform consumers, particularly those at
greatest risk, of the hazard posed by such juice products. FDA expects
that providing this information to consumers will allow them to make
informed decisions on whether to purchase and consume such juice
products, thereby reducing the incidence of foodborne illnesses and
deaths caused by the consumption of these products.
DATES: Effective September 8, 1998; however, compliance for juice other
than apple juice or apple cider is not required until November 5, 1998.
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
In the Federal Register of August 28, 1997 (62 FR 45593), FDA
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 of all juice products. In the notice of intent, the agency
invited comment on the appropriateness of its strategy to: (1) Initiate
rulemaking on a mandatory Hazard Analysis and Critical Control Point
(HACCP) program for some or all juice products; (2) propose that the
labels or the labeling of juice products not specifically processed to
prevent, reduce, or eliminate pathogens 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 consumption of fresh juices. The
agency stated that it would address comments received within 15 days of
publication of the notice of intent as part of any rule proposed by the
agency and would consider all comments to the notice of intent received
after 15 days in any final rulemaking.
FDA considered the comments received within 15 days of the notice
of intent and other information available to the agency. Based on this
information, FDA tentatively concluded in a proposed rule (``the HACCP
proposal'') (63 FR 20450, April 24, 1998) that the most effective way
to ensure the safety of juice products is to process the products under
a system of preventive control measures. Consequently, in the HACCP
document, the agency proposed to require that juice products be
processed under HACCP programs.
Although FDA had tentatively concluded that HACCP is the most
effective means of ensuring the safety of juice products, it also
tentatively concluded in a proposed rule (``the juice labeling
proposal'') (63 FR 20486, April 24, 1998), that there is an immediate
need to inform consumers of the health risks associated with the
consumption of juice products not processed to prevent, reduce, or
eliminate pathogens that may be present. As fully discussed in the
juice labeling proposal, FDA proposed that packaged untreated juice
products\1\ bear a warning statement informing at-risk consumers of the
hazard posed by untreated juices to allow them to make informed
decisions on whether to purchase and consume such products. Interested
parties were given until May 26, 1998, to comment.
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\1\ As discussed in the juice labeling 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.
In the remainder of this document, products not processed to
prevent, reduce, or eliminate pathogens will be referred to as
``untreated juice products.'' In addition, processing to ``prevent,
reduce, or eliminate'' pathogens will be referred to as processing
to ``control'' pathogens.
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FDA prepared a single Preliminary Regulatory Impact Analysis (PRIA)
that addressed both the juice labeling proposal and the HACCP proposal
(63 FR 24254, May 1, 1998). Interested parties were given until May 26,
1998, to comment on aspects of the PRIA relating to the juice labeling
proposal and until July 8, 1998, to comment on aspects of the PRIA
relating to the HACCP proposal. Elsewhere in this issue of the Federal
Register, FDA is announcing a 30-day extension of the comment period on
the juice HACCP proposal to August 7, 1998.
FDA received approximately 85 responses to the notice of intent,
each containing one or more comments. FDA addressed some of these
comments in the juice labeling proposal. FDA subsequently received
approximately 150 responses to the juice labeling proposal, each
containing one or more comments. Responses to the notice of intent and
to the juice labeling proposal were received from industry, trade
organizations, consumers, consumer interest groups, academia, and State
government agencies. Some of the comments supported the proposal. Other
comments opposed the proposal or suggested modifications of various
provisions of the proposal. The agency discusses below the significant
comments bearing on the proposed labeling regulation and, when
applicable, any revisions to the proposed regulation made in response
to these comments. Responses to the notice of intent that bear on the
juice labeling proposal and that were not addressed in that proposal
are also addressed in this document. For simplicity, the agency's
discussion does not categorize comments with regard to whether they
were received in response to the notice of intent or in response to the
juice labeling proposal.
Proposed Sec. 101.17(g)(6) of the juice labeling proposal states
that the requirements of that regulation would 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, where the ``pertinent microorganism'' is
the most resistant microorganism of public health significance that is
likely to occur in the juice. This provision is directly linked to the
process controls for pathogen reduction (the pathogen reduction
performance standard; proposed Sec. 120.24 that is part of the agency's
HACCP proposal. This standard is pivotal in both the juice labeling and
juice HACCP proposals, and interested persons could comment on the
standard in response to either or both proposals.
FDA received several requests to extend the comment period, e.g.,
for an additional 30 days, for an additional 45 days, or for an
additional 60 days. Some of these requests discussed the fact that the
proposed pathogen reduction performance standard was an important
[[Page 37031]]
provision of both the juice labeling proposal and the HACCP proposal
and stated that 30 days was an insufficient time to address that
standard. In a memorandum dated June 5, 1998, from the Deputy Director
of FDA's Regulations Policy and Management Staff to the Dockets
Management Branch, FDA extended the comment period until June 22, 1998,
for those persons who had requested an extension, in accordance with
Sec. 10.40(b)(3) (21 CFR 10.40(b)(3)). Thereafter, in a memorandum
dated June 10, 1998, FDA extended the comment period until June 22,
1998, for all interested persons. The agency's memoranda noted that
comments submitted to the juice labeling rule must be received in the
Dockets Management Branch on or before 4:30 p.m., e.d.t., June 22,
1998, and that no other extensions would be considered. The public was
notified of both extensions by placing copies of the two memoranda in
the agency's public docket.
In this document FDA addresses those comments that were received on
or before 4:30 p.m., e.d.t., June 22, 1998, in response to the notice
of intent, in response to the juice labeling proposal, or in response
to the HACCP proposal that bear on the proposed warning statement
requirement or on the proposed pathogen reduction performance standard.
However, in this document, FDA does not address any comments, received
either in response to the notice of intent or in response to the juice
labeling proposal, that bear on aspects of the HACCP proposal other
than the pathogen reduction performance standard (proposed
Sec. 120.24). Those comments will be addressed in any final rule that
the agency issues with respect to the HACCP proposal.
As noted, since the publication of the notice of intent in August
1997, FDA has intended to propose two regulations, a juice HACCP
regulation and a juice warning statement regulation, that in
combination with one another, as well as certain educational programs,
would establish a comprehensive program to ensure the safety of fresh
juice. As discussed in the juice labeling proposal, the warning
statement requirement is designed to provide public health information
during the development and implementation of a HACCP rule. FDA
recognizes that as a result, certain provisions of the juice labeling
proposal and the juice HACCP proposal are very closely linked,
including the scope of each rule (e.g., what is defined as ``juice'')
and the pathogen reduction standard (the so-called ``5-log standard'').
See also comment 40. The agency is also aware that the comment period
announced in the juice HACCP proposal is continuing, and in fact,
elsewhere in this issue of the Federal Register, the agency is
announcing a 30-day extension of that comment period to August 7, 1998.
Thus, comments are likely to be made on the HACCP proposal, including
on these common issues, after the publication of this final rule.
Although there are these overlapping issues in the two juice
rulemakings, FDA believes that the public health risk presented by
untreated juice is such that it is essential that the warning statement
rulemaking be completed and the rule implemented promptly. In order to
complete the warning statement rulemaking, the agency must consider and
respond to all significant comments on the juice labeling proposal,
including those comments that relate to issues presented in both the
HACCP and warning statement rulemakings. Thus, this final rule
addresses and responds to all significant comments made on the juice
labeling proposal; the resolution of these comments is based upon the
administrative record of this proceeding at this time. Once the comment
period closes on the HACCP proposal, FDA will evaluate all comments
received on that proposal and utilize such information to develop a
final HACCP rule for juice, if such a rule is supported by the record.
To the extent that the agency's analysis of the record for the HACCP
proceeding results in the resolution of a common issue or issues in a
way that differs from the issue's resolution in this final rule, FDA
will initiate the amendment of the juice labeling regulation to ensure
conformance with any final HACCP rule.
II. Rationale for Warning Statement
A. Risk Associated with Consumption of Juices
In the notice of intent and the juice labeling proposal, FDA
documented that certain juices have been the vehicle for outbreaks of
foodborne illness (62 FR 45593). Consequently, in the juice labeling
proposal, FDA proposed to require a warning statement for juice
products to alert consumers, especially those at greatest risk, of the
potential hazard so that they may make informed decisions on whether to
purchase and consume such juice products.
1. Some comments contended that FDA has not conducted an adequate
risk assessment and, therefore, has no basis to require a warning
statement.
The agency performed a detailed evaluation of the hazards posed by
untreated juices, which was filed in the administrative record of the
HACCP proposal and was included as an appendix to the PRIA (Ref. 1).
This evaluation was based on available scientific information and was
appropriate to the circumstances. FDA believes that this evaluation
provided an adequate assessment of risks and a sufficient basis for
requiring a warning statement.
2. Many of the comments contended that the health hazard associated
with juice products is not sufficient to justify a warning statement.
Some of the comments asserted that the health hazard is limited to
apple juice and, therefore, the remedies should be limited to apple
juice. Another comment asserted that FDA's estimate of the risk of
foodborne illness is inaccurate because that estimate did not consider
recent steps taken by members of the juice industry to address
microbial contamination. Some comments argued that most of the
outbreaks have occurred because of poor manufacturing practices and
suggested that FDA increase its inspection of food manufacturers rather
than issue regulations to require a warning statement.
The agency does not agree with the comments that contend that the
health hazard associated with the consumption of fresh juices is
insufficient to justify requiring a warning statement. Risk is a
function of two factors: Likelihood of occurrence of an event and
severity of the event. As discussed in the HACCP proposal (63 FR 20450
at 20459), severity is the seriousness of the consequences of exposure
to the hazard. Considerations of severity (e.g., impact of sequelae and
magnitude and duration of illness or injury) can be helpful in
understanding the public health impact of the hazard. Likelihood of
occurrence of a hazard is generally judged based on processing
experience, epidemiological data, and information in the technical
literature.
As discussed in the juice labeling proposal, there are documented
cases of foodborne illness associated with the consumption of various
juice products contaminated with microorganisms such as Escherichia
coli O157:H7, Salmonella species, Cryptosporidium, and Vibrio cholerae.
These various microorganisms, which were found in apple juice, apple
cider, orange juice, and frozen coconut milk, were associated with
foodborne illness throughout the United States (e.g., in CA, CO, MA,
NY, CT, NJ, MD, and WA) over a 6-year period (i.e., 1991 to 1996).
[[Page 37032]]
Furthermore, some of the illnesses associated with certain untreated
juice have been very severe (e.g., cases of long-term reactive
arthritis and severe chronic illness); in one case, consumption of
contaminated juice has resulted in death. As is the case with most food
associated disease, because of the likelihood of underreporting, it is
assumed that these outbreaks represent a fraction of the outbreaks and
sporadic cases that actually occur.
Importantly, the comments did not provide the agency with
additional data that either contradict FDA's detailed hazard evaluation
(Ref. 1) or that could be used to reevaluate the health risks
associated with consumption of untreated juice products. Therefore, the
comments have not persuaded FDA that there is insufficient risk to
warrant requiring a warning statement for untreated juice products.
The agency recognizes the recent steps taken by members of the
juice industry to address microbial contamination. However, FDA notes
that industry practices may vary. The agency is not aware that all
members of the juice industry are addressing the potential for
microbial contamination in an equally effective manner. Accordingly,
the agency continues to see a need for a comprehensive Federal
regulatory approach for all juice products.
FDA tentatively concluded in the HACCP proposal (63 FR 20450 at
20456) that a preventive system, such as HACCP, appears to offer the
most effective long-term solution to control the significant microbial
hazards, along with other hazards, that have become a problem with
juice. Increased inspection, while having some beneficial impact on the
safety of juices, is resource intensive to the agency. Even if funds
were available to the agency for this purpose, the agency tentatively
concluded in the HACCP proposal that increased inspection likely would
not be the best way for the agency to utilize its resources to protect
the public health. It is ultimately the responsibility of manufacturers
to ensure that their products are safe.
Current good manufacturing practices (CGMP's) are plantwide
operating procedures that also address sanitation. Although FDA
supports the use of CGMP's, the agency also tentatively concluded in
the proposed HACCP rule that the use of CGMP's alone would not be
sufficient to control the problems with juices because CGMP's do not
concentrate on the identification and prevention of food hazards.
Based on information the agency has received in response to the
juice labeling proposal, FDA has concluded that the use of CGMP's and
increased FDA inspections by themselves do not adequately address the
safety of juices. Labeling addresses the need to provide a warning to
consumers until juice processors implement measures to control
pathogens.
3. Comments stated that the results of FDA's 1997 national cider
mill survey indicate that the health risk posed by cider is not
sufficient to warrant a warning label. Although the results of the
survey have not been published, these comments asserted that no
pathogenic bacteria were found in the cider samples evaluated by the
agency.
These comments refer to a 1997 assignment in which FDA inspected
fresh unpasteurized apple cider operations and collected in-line
product for microbiological analysis at 237 establishments in 32
States. Although FDA has not issued its summary of results from this
assignment, the agency notes that this assignment generated
microbiological data at several stages of operation in these facilities
including the incoming apples, wash water, apples taken after washing
but before processing, and finished cider both preserved and
unpreserved. The microbiological analyses at these various steps were
for pathogens such as E. coli 0157:H7 and Salmonella sp. and also for
fecal coliforms and generic E. coli, which are not foodborne pathogens,
but are used as indicators of fecal contamination that could be a
potential source for contamination by pathogens. It was the agency's
intent to consider all of the data generated to assess microbiological
safety factors for cider. The agency does not consider it appropriate
to focus on any one aspect of its findings, i.e., the lack of any
positive finding for pathogens in finished product, for drawing
conclusions about the microbiological safety of cider.
This assignment did not result in the detection of any pathogens in
a finished cider product intended to be sold to the public. However,
FDA's preliminary findings from this assignment show that one firm's
incoming apples tested positive for Salmonella sp. indicating that
microbial hazards that necessitate effective control measures are
reasonably likely to occur on incoming apples. Moreover, FDA's
preliminary findings show that fecal coliforms and E. coli were found
in the wash water used at several firms, indicating that the water is
of poor quality. In addition a small number of finished cider products
tested positive for fecal coliforms and generic E. coli was found in 14
percent of the finished product samples.
These findings further support the agency's action here in that
they establish that risk factors such as pathogenic bacteria and fecal
coliforms can exist in cider processing operations and could give rise
to microbiological safety hazards in finished cider products. The
findings of this FDA assignment clearly do not support the comment's
contention that the health risk posed by cider is insufficient to
justify a warning label.
4. Several of the comments that opposed warning statements on juice
products contended that they are unnecessary. Two of these comments
asserted that FDA should educate the consumer that the problem is not
the juice, but rather, the fact that the juice is contaminated with
animal feces and not properly processed.
FDA does not agree with this comment to the extent that it asserts
that a warning statement should not be part of the Federal response to
the problem of contaminated juice. Juice products that contain
pathogenic microorganisms can be a vehicle for foodborne illness
regardless of whether the microbial contamination arises from the
source fruit or vegetable or from insanitation during manufacture.
FDA's HACCP proposal is designed to ensure the safe and sanitary
processing of juice. The warning statement, which is itself a form of
education, is required only for those juices that have not been
processed to achieve the pathogen reduction performance standard.
Consumers, particularly those at greatest risk, need to know that
untreated juice may contain harmful bacteria that could cause serious
illness so that they may make informed choices. FDA expects that the
warning statement will reduce the risk of illness because some of the
at-risk consumers likely will choose not to expose themselves to the
hazard.
B. Juice Products Versus Other Food Products That May Contain Pathogens
5. Several comments claimed that the agency's actions were
discriminatory in nature and not proportional to the health hazard
posed by unpasteurized juices. These comments questioned why other food
products associated with recent foodborne illnesses are not required to
bear warning statements (i.e., fruits, berries, eggs, melons, poultry,
hamburgers, meat products, seafood, etc.).
The agency disagrees with these comments. Juice products
historically have been consumed by individuals without treatment to
control pathogenic microorganisms. In addition, the presence of some of
the pathogens (i.e., E. coli O157:H7 and Crytosporidium)
[[Page 37033]]
that have been responsible for recent outbreaks of foodborne illnesses
associated with untreated juice products is a relatively new
phenomenon. Therefore, consumers do not associate such pathogens, and
the risk that they present, with the consumption of untreated juice.
Accordingly, in the juice labeling proposal, the agency tentatively
concluded that a juice warning statement is needed to protect the
public health because consumers are unaware of the nature and magnitude
of the hazard.
In contrast, other mechanisms are in place to reduce the risk of
foodborne illness from consumption of many of the foods discussed in
the comments. First, consumers have some awareness that meat and
poultry products have the potential to contain harmful microorganisms;
also, these foods ordinarily are cooked prior to consumption. Moreover,
meat and poultry products that are regulated by the U.S. Department of
Agriculture's Food Safety and Inspection Service (USDA/FSIS) are
subject to that agency's HACCP regulations. In addition, regulations
issued by USDA/FSIS require safe handling instructions on raw meat and
poultry products advising consumers to thoroughly cook the products.
Other products mentioned in the comments are regulated with the
goal of ensuring microbial safety. For example, seafood products are
now required to comply with FDA's HACCP program for seafood products.
Recently, FDA issued draft guidelines for good manufacturing practices
and good agricultural practices regarding raw agricultural commodities
(63 FR 18029, April 13, 1998). In addition, the agency recently
requested public comment on its plan to implement a comprehensive
``farm to table'' strategy to decrease food safety risks associated
with shell eggs (63 FR 27502, May 19, 1998).
Thus, FDA's requirement for a warning statement on untreated juice
products has a rational foundation and is part of a comprehensive
approach to solve a larger problem. The agency therefore finds no merit
in the assertion that the agency's proposed actions are discriminatory
when compared to the regulatory approaches that are already in place or
that are being considered for other food products that have been
associated with foodborne illness.
C. Regulatory Approach
6. Some comments asserted that the purpose of the juice labeling
rule is to force manufacturers to pasteurize juices, particularly apple
cider. Comments from some cider manufacturers contended that their
customers don't want pasteurized cider, and a few of these comments
contended that pasteurizing cider converts the product to apple juice.
While pasteurization is an effective and proven mechanism that has
been shown to satisfy the pathogen reduction standard, it is not the
only mechanism capable of achieving a 5-log reduction. As discussed in
the HACCP proposal, the pathogen reduction performance standard is a
performance-based, rather than process-based, standard. Thus, as
addressed in response to comment 35, mechanisms other than
pasteurization may be used to satisfy the pathogen reduction
performance standard. Thus, FDA disagrees with these comments.
7. Some of the comments argued that a warning statement will not
reduce the hazards associated with unpasteurized juice or make a safer
juice industry.
The agency agrees that a warning statement will not directly reduce
the hazards associated with juice products. However, the purpose of the
warning statement is to provide consumers with information regarding
the potential hazards associated with untreated juice and thereby to
allow consumers, including those most vulnerable, to make informed
choices. Thus, FDA expects that the warning statement will reduce the
risk of illness because some of the at-risk consumers likely will
choose not to expose themselves to the hazard.
The agency also acknowledges that warning statements will not
directly make a safer juice industry. Indeed, it is for that very
reason that the agency concurrently proposed a HACCP program to reduce
or eliminate the hazards associated with juice products.
8. One comment contended that warning labels will encourage
producers to ignore good manufacturing practices (GMP's) because of
their belief that the presence of the warning statement will remove the
producer's liability for the product.
The agency rejects the comment. The presence of the warning
statement does not remove the manufacturers' responsibility of adhering
to GMP's or his liability for the finished product. Regardless of this
final rule, a juice product that is found to contain harmful bacteria
would be adulterated under section 402(a)(1) of the act (21 U.S.C.
342(a)(1)) and thus, illegal.
9. One comment asserted that the requirement for a warning
statement is contrary to agency policy of disallowing adulterated
products to be sold. This comment also asked whether a juice product
that bears the warning statement would be subject to recall if it were
found to be contaminated with pathogenic microorganisms.
The evidence available at this time documents that there is a risk
of foodborne illness from consumption of untreated juice. The agency
does not contend, nor does the validity of the juice labeling proposal
require, a showing that all unpasteurized juice is adulterated. Thus,
FDA disagrees that requiring a warning statement essentially permits
adulterated food to be marketed. As noted, the warning statement is
intended to provide consumers important information not otherwise
available on the label or in labeling (namely, that a risk of serious
illness exists if the products are consumed by certain groups of the
population.) Upon the effective date of this final rule, a covered
product that does not comply with the labeling requirement would be
misbranded under sections 201(n) and 403(a)(1) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)(1)).
Regardless of this final rule, a juice product that is found to contain
harmful bacteria would be adulterated under section 402(a)(1) of the
act (21 U.S.C. 342(a)(1)) and thus, illegal. This adulterated status
would persist regardless of whether product labeling included the
warning statement.
Similarly, although FDA has no express authority to mandate the
recall of adulterated foods, FDA fully expects that any manufacturer
who has distributed an adulterated juice product would voluntarily
recall that product as soon as a microbial contamination problem was
identified.
10. Several comments suggested that FDA should implement HACCP
requirements immediately rather than require warning labels on
untreated juice products. Other comments supported the use of a warning
statement on food products only as an interim measure until the agency
establishes a more comprehensive solution to the problem of microbial
contamination in juice.
In each of the recent agency documents regarding juice (i.e., the
notice of intent (62 FR 45593 at 45594), the juice labeling proposal
(63 FR 20486 at 20487), and the HACCP proposal (63 FR 20450 at 20457)),
FDA tentatively concluded that the implementation of its proposed HACCP
program is the most effective long-term measure for controlling
pathogens and other safety concerns related to the production and
distribution of juice products. As discussed in the juice labeling
proposal, warning statements are intended to serve as a short-term
alternative for almost all untreated juice products until
[[Page 37034]]
HACCP programs that ensure that the juice will be processed in a manner
that meets the pathogen reduction performance standard can be developed
and implemented by the juice industry. Once such HACCP programs are in
place, the agency does not presently foresee the need for a warning
statement on products processed in a manner that meets the pathogen
reduction performance standard, and this final rule is consistent with
that view. However, the agency's proposed HACCP regulations would not
cover: (1) The operation of a retail establishment; or (2) the
operation of a very small business that is also a retail establishment
and that makes juice on its premises, provided that the establishment's
total sales of juice and juice products do not exceed 40,000 gallons
per year, and provided that the establishment sells such juice directly
to consumers or other retail establishments. Thus, it is likely that
not all juice products will be produced under a HACCP system. In
addition, a program as comprehensive as the agency's proposed HACCP
program requires more time to implement than a labeling requirement.
This is particularly true in light of the provision in the juice
labeling proposal that the warning statement requirement may be met, in
the short term, by labeling (i.e., a sign or placard that is displayed
at the point of sale) rather than by application of the warning
statement to the product label (proposed Sec. 101.17(g)(3)). FDA
believes that the warning statement, together with HACCP, makes the
agency's response to this problem a comprehensive solution. Therefore,
the agency is making no changes to its regulatory approach in response
to these comments.
11. Several comments expressed the opinion that use of the terms
``pasteurized'' or ``unpasteurized'' alone is sufficient to inform
consumers of potential risks associated with consumption of juice
products. Some of these comments maintained that use of the term
``fresh, unpasteurized'' would more clearly indicate that the juice is
unprocessed.
Other comments agreed with the agency's rationale in the juice
labeling proposal that a warning statement that merely characterizes
juice as ``pasteurized'' or ``unpasteurized'', without also including
the information about the nature and magnitude of the hazard, would be
incomplete. Some comments noted that unpasteurized juice may have a
reputation among many consumers for being a particularly fresh and
healthful food. These comments contended that it is important to ensure
that product labeling meets both the needs of consumers who are at risk
of serious illness as well as the needs of consumers who prefer to
purchase untreated juice because they perceive such products to be
healthful.
In the juice labeling proposal, the agency fully discussed its
rationale for tentatively concluding that not providing information
about the nature and magnitude of the hazard presented by untreated
juices would constitute misbranding of the product. The agency is
concerned that some consumers do not know the significance of
pasteurization and, therefore, would not be able to make an informed
decision on whether to purchase and consume the products. In focus
group research, FDA determined that, while most participants had a good
understanding of what pasteurization was, a significant number of the
participants did not. The agency acknowledged that indicating whether a
product is ``pasteurized'' or ``unpasteurized'' may be useful to
consumers who are seeking to purchase either type product. However, FDA
tentatively concluded that use of the terms ``pasteurized'' or
``unpasteurized,'' alone, informs the consumer on the type of
treatment, or lack of treatment, that a product has received and would
not give consumers information about the risks presented by untreated
juices. In reaching this tentative conclusion, the agency considered
comments to the notice of intent that expressed opinions similar to the
comments subsequently submitted to the juice labeling proposal. The
latter comments provided no new information to provide a basis for FDA
to change that tentative conclusion. Therefore, FDA is not adopting the
suggested approach that, instead of the warning statement requirement,
the agency require all juice products to be labeled as ``pasteurized''
or ``unpasteurized.'' Nonetheless, as a general matter, statements that
are truthful and not misleading are always permitted under the act.
Thus, manufacturers who choose to make a statement, on the product
label or in labeling, that describes a juice product as ``pasteurized''
or ``unpasteurized'' may do so as long as the statement is factually
accurate and is not presented in a manner that would cause the
statement to be misleading.
12. One comment questioned FDA's proposal to require that untreated
juice products bear a warning statement in light of the fact that the
agency does not require foods containing known allergens, such as
peanuts, to bear a warning statement.
FDA disagrees with the suggestion contained in this comment. The
purpose of a warning statement is to provide consumers with important
information that did not otherwise appear on the product label or in
labeling. FDA recognizes that many foods contain substances (e.g.,
peanuts) that cause an allergic response in those persons sensitive to
the substance. Current food labeling regulations require, in virtually
all cases, a complete listing in the ingredient statement of all of the
ingredients of the food. Consequently, the label of foods containing
such substances already provides sufficient information to allow
sensitive individuals to avoid food products that contain substances to
which they are allergic. Thus, as a general rule, a statement warning
about the potential for an allergic reaction is not needed to protect
the public health. With untreated juice, there is no other disclosure
regarding the potential presence of pathogens in unprocessed juice,
and, due to the relatively recent nature of such risk, sensitive
individuals (which may be as much as 25 percent of the general
population) (Ref. 2) are not aware of the hazard.
13. Some comments contended that warning statements are not
generally effective at preventing the targeted behavior, pointing to
the failure of warnings on other commodities, such as cigarettes and
alcohol, to have the desired effect. Other comments considered it
likely that the proposed warning statements would be effective because
the risks associated with consuming untreated juice are not widely
known or understood and consumers would use the new information to make
informed choices that they were unable to make without the new
information. Some comments advocated the use of brochures or pamphlets
outlining the risks associated with consumption of untreated juices as
an alternative to a warning statement.
In its focus group research on juice labeling, and in recent survey
results (Ref. 3), FDA confirmed that consumers are largely unaware of
the potential hazards of consuming untreated juice. Thus, the proposed
warning statement contains information that is new to consumers. This
fact separates the proposed warning statement from warning statements
on other commodities such as alcohol or tobacco where the information
contained in the statement is already widely known and familiar to most
people. Research on warning statement effectiveness has identified the
lack of new information in the warning statement as the principal
reason that warning
[[Page 37035]]
statements are ineffective (Ref. 4). Participants in the focus groups
said that the information about the risks of untreated juice was new
and would have a substantial impact on their juice product choices.
The agency agrees that the effectiveness of the warning statement
would be enhanced by an educational campaign that provides consumers
with materials such as brochures or pamphlets containing information
giving a fuller context to the hazard. FDA is continuing to provide
educational information to consumers concerning juice. However, the FDA
focus group participants strongly expressed a need for product specific
information that clearly identified a product, on its label, as
``unpasteurized'' and that described the nature of the hazard. The
reasons given by the focus group participants were that this was new
information to them and they considered such information necessary to
make informed choices. Educational materials could be an adjunct to a
warning statement, and the agency encourages firms to develop and
provide them where possible. However, FDA believes that the warning
statement required by this final rule is necessary to adequately and
efficiently communicate to consumers the risks presented by unprocessed
juice. Therefore, FDA declines the suggestion in the comments that
educational materials such as brochures or pamphlets should substitute
for the warning statement.
14. Several of the comments asserted that, in general, a warning
statement would remind consumers of products such as cigarettes, which
are well known to be a health hazard for the general population, or
alcoholic beverages, which are well known to be harmful to the general
population when consumed in excess or to a developing fetus when
consumed by a pregnant woman. In essence, these comments contended that
a warning statement on a juice product, which consumers perceive as
healthful, is inappropriate because it casts that product in the same
light as products that are a known health hazard.
FDA agrees that products such as cigarettes and alcohol have
characteristics that present a known health hazard to the general
population. However, these products also are subject to regulatory
control mechanisms, other than warning statements, commensurate with
their risk. Relative risk aside, FDA believes that the level of risk
associated with untreated juice justifies the requirement for a warning
statement. The focus group research reflects the importance of this
information in that many focus group participants said that the risk
information would have a substantial impact on their juice product
selection. Even participants who said that they would continue to drink
untreated juice products because of the perceived benefits also said
that the information would influence whether they would give such
products to their children.
15. Some comments maintained that a warning statement on covered
juice products would be tantamount to stating that the products contain
pathogens.
FDA does not agree with these comments. The agency's warning
statement is carefully worded to state that the products in question
``may contain'' harmful bacteria. This statement is factually accurate.
16. Some comments pointed out that the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) did not support warning
statements.
The agency disagrees with the comments' view that NACMCF did not
support a warning statement for juice products. In fact, NACMCF stated
that it lacked sufficient data to evaluate the effectiveness of
labeling statements as safety interventions or to help consumers make
informed choices. Therefore, NACMCF declined to endorse labeling as an
interim safety measure and instead endorsed implementation of a
comprehensive HACCP program as a preventive system of hazard control to
ensure the safe and sanitary processing of fruit and vegetable juices
and juice products. As already discussed, the agency has likewise
tentatively concluded in the HACCP proposal that a HACCP program for
juice products is the best long-term strategy for public health
protection; the juice warning statement is intended largely as an
interim measure to inform consumers about the potential risk associated
with untreated juice products until the application of HACCP principles
increases the safety of juice products. Thus, FDA is making no changes
to its regulatory approach in response to these comments.
17. Several comments questioned the precedent set by FDA in
applying a warning label to fresh juice. The comments noted that
requiring this warning label establishes a regulatory trend which, if
continued, would result in virtually all foods carrying warnings.
Having too many warnings on food would make the warnings meaningless.
FDA agrees that too many warning labels on foods could result in
loss of consumer credibility and effectiveness. However, the agency
does not agree that it is establishing a trend toward too many warning
labels. The agency has used the authority under sections 201(n) and
403(a)(1) of the act only rarely to require warnings or other
cautionary label statements. FDA cannot require labeling unless the
need for it meets the statutory criteria of being necessary either to
clarify existing label statements or because of consequences that may
result from customary or usual use of the food.
18. A few comments cited an agency memorandum that is part of the
administrative record of the juice labeling proposal (Ref. 5). These
comments interpreted the memorandum to reflect the agency's opinion
that warning statements are an ineffective method for communicating
with consumers or that the agency does not have data that show that
warning statements are effective in convincing target populations to
avoid a particular substance.
The agency does not agree with these comments. The key point of the
memorandum is that warning statements need to be evaluated in consumer
testing because it is difficult for experts to anticipate consumers'
assumptions and prior beliefs about a product and its potential
hazards. The memorandum identified communication problems encountered
with a variety of proposed warning statements and concluded that the
remedy to these kinds of potential problems is to subject proposed
warning statements to consumer testing to determine if they communicate
as intended. The memorandum underscored the need to test proposed
options for the juice warning statement, and the agency did so, with
the results summarized in a report that is in the administrative record
of this rulemaking. This consumer testing helped the agency to identify
a statement that can inform consumers about a previously unrecognized
hazard without being overly alarming.
In addition, these comments incorrectly suggest that FDA has no
basis for believing that warning statements can be effective. In fact,
the memorandum focuses on the communication effectiveness of warning
statements rather than the broader policy question of how well warning
statements work in the marketplace. The intent of warning statements is
to provide consumers with information necessary to make informed
choices. Qualitative research suggests that warning statements are
effective in alerting vulnerable populations to potential risks but
that consumers' ultimate decisions are based on a variety
[[Page 37036]]
of considerations, including their prior experiences, personal
preferences, the tradeoffs they are willing to make, and their
awareness of particular risks gained by reading warning statements.
Because these comments misinterpret FDA's position, the agency is
making no changes to its regulatory approach in response to these
comments.
19. Some comments expressed the opinion that FDA acted contrary to
public relations research theory by developing script guidelines used
by focus group moderators. This comment asserted that, as a result, the
focus group results were biased by FDA.
FDA disagrees with the assumption underlying this claim of bias--
i.e., that the moderator of the focus groups was given a script. The
agency has extensive experience conducting focus group studies, which
are a qualitative type of research that generates discussion on the
issues in question, allowing for many points of view and differing
levels of interest and knowledge. The agency's goals in conducting
focus group research are to understand how consumers think about the
subject issues, to see how they react to language that the agency and
other interested parties have suggested to convey health-related
messages, and to uncover erroneous beliefs and assumptions about how
consumers will think and respond to proposed communications. In FDA-
sponsored focus group research, the moderator is a professionally
trained neutral party, who is briefed on the subject matter of the
study to the extent necessary to lead the discussion. The moderator
works closely with FDA to ensure that the materials and questions meet
the highest standards for the conduct of qualitative research. The
moderator's guide is a primer to help the moderator cover the topics of
interest rather than a ``script.'' Accordingly, the agency finds no
merit in the assertion in the comment that the focus group studies were
biased.
20. Some comments contended that a warning statement could have a
potentially negative impact on consumers by discouraging the
consumption of all fruit and vegetable juice products, regardless of
whether the products had been processed to control pathogenic
microorganisms. Some of these comments expressed the opinion that this
negative impact could potentially carry over to other healthful
products such as fruits and vegetables.
These comments provided no data or other information to
substantiate the assertion that a warning statement on untreated juice
products will result in a decreased consumption of all juice products
or of fruits and vegetables generally. Nonetheless, FDA will seek to
minimize any remote possibility that consumers' reaction to the juice
warning statement would be to avoid all juice products or to avoid
fresh fruits and vegetables by emphasizing in the agency's ongoing
consumer education initiative that: (1) Most juice products are
processed to control pathogenic microorganisms and therefore are safe;
(2) the warning statement has a limited and targeted scope based on the
distinctive characteristics of untreated juice products; and (3) the
warning statement will be a reliable cue to tell whether a product has
or has not been processed to control pathogenic microorganisms.
Accordingly, FDA concludes that the concerns raised in these comments
provide no basis to alter the agency's regulatory approach.
In the juice labeling proposal, FDA acknowledged that it would take
time for manufacturers to make label changes and deplete existing label
inventories. Accordingly, FDA proposed that, as a temporary alternative
to providing the information on the label, firms could provide the
warning statement in labeling, e.g., signs or placards, at the point of
purchase.\2\ Under proposed Sec. 101.17(g)(3)(i), manufacturers could
provide the warning statement in labeling until January 1, 2000, the
next uniform compliance date for other food labeling changes. To
relieve the burden on small businesses, proposed Sec. 101.17(g)(3)(ii)
provided that small businesses could provide the warning statement in
labeling until January 1, 2001.
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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). Thus, signs and placards that appear at point-of-sale are a
type of labeling.
---------------------------------------------------------------------------
21. Some comments contended that consumers may not notice the
warning in a sign or placard at all. Other comments expressed concern
that the message would not be apparent to the consumer when the product
was ready to be consumed or would not be apparent to other members of
the household who did not have the opportunity to see the sign at the
point of purchase.
Other comments expressed concern that consumers would not correctly
link the warning message with the appropriate juice product. The
comments stated that, for example, a sign may be placed outside a
refrigerator that contains both pasteurized and untreated juice
products and the label of many juice products does not inform the
consumer as to whether the product has been pasteurized. As a
consequence, consumers could choose not to purchase any product at all.
The majority of comments that addressed the issue of labeling as an
interim means of compliance with the warning statement requirement
opposed the length of time that labeling would be allowed. Some
comments pointed out that, if the urgency of the public health concern
justified the shortening of the comment period, then FDA should not
allow an extended time for the warning statement to appear on the
label. Other comments contended that FDA's notice of intent provided
ample notice to firms to prepare for label changes because FDA urged
voluntary compliance at that time.
Some of these comments also opposed the additional time allowed for
small businesses to place the warning statement on the labels of their
products. The comments asserted that the public health concern existed
whether or not the firm was small.
FDA finds merit in these comments. The agency agrees that placards
and signs may be less effective than package labels for the purpose of
communicating product-specific information to consumers. FDA's
experience with the voluntary labeling of fresh fruits and vegetables
in supermarkets also indicates that this is the case. While the agency
found high levels of voluntary nutrition labeling in supermarkets,
consumer research showed that only a small proportion of consumers
reported that they had seen this labeling in stores (Ref. 6).
However, as a practical matter, producers of unpasteurized juice
need time to modify their labels to include the warning statement. In
response to the concerns about the effectiveness of signs and placards,
FDA is reducing the length of time that it will permit manufacturers to
provide the warning statement in labeling. The label change being
required is not complex. FDA believes that small business will not
experience more difficulty than large businesses in making the change.
Therefore, FDA is giving small and large businesses the same amount of
time to make the change. Accordingly, the effective date of this final
rule applies equally to all manufacturers of packaged juices,
regardless of size. Thus, this final rule (Sec. 101.17(g)(4)) provides
that, except for unpackaged juices (which have no label), the required
warning statement may be provided in labeling at point of purchase,
until 1 year from the date of compliance with the final rule. In
essence, this provision provides
[[Page 37037]]
manufacturers the alternative of using labeling for a single juice
season. This flexibility will postpone by a juice season a
manufacturer's need to revise and reprint labels that would be affixed
to packaged untreated juice products.\3\ During this interim period,
the agency's ongoing food safety education campaign will help consumers
to look for, and understand, juice labeling posted at the point of
purchase.
---------------------------------------------------------------------------
\3\ As discussed in section VI of this document, this final rule
establishes a compliance date for apple juice and apple cider that
will closely coincide with the 1998 fresh apple juice season. This
final rule also establishes a compliance date for juice products
other than apple juice and apple cider that will closely coincide
with the 1998 fresh citrus juice season.
---------------------------------------------------------------------------
The agency acknowledges that there are some costs associated with
this revision to the proposed rule. FDA's analysis of the economic
impact of this revision is discussed in section VIII of this document.
22. Some comments suggested that a more appropriate interim measure
than the use of signs or placards would be the application of the
warning statement to the product label via stickers. One comment
estimated the cost of placing stickers with the warning statement on
packaged containers. For 1,000 bottles, the comment estimated the cost
to be $28.25. The estimate in the comment was based on several
assumptions. First, the time and cost to design the sticker is
negligible. Second, the total cost to pay the bottle supplier to apply
the 1,000 labels is 70 cents. Third, there are no printing charges
beyond the basic per unit cost of the label.
FDA acknowledges that firms could comply with the warning statement
requirement through the use of stickers. Many manufacturers may find it
more convenient to apply the warning statement to packaged product by
means of stickers than to provide signs or placards to all retailers
who sell their product.
However, there are costs associated with using stickers to revise a
label. FDA disagrees with the estimate included in the comment because
FDA disagrees with the underlying assumptions presented in the comment.
First, there are always costs of specifying to the printer what the
sticker will say and the way it will look, as well as costs of finding
the printer to produce the stickers. The agency estimates that these
administrative costs are $100. Second, it is not feasible to have
bottle suppliers place labels on bottles this close to the beginning of
the juice seasons. As some comments noted, bottles and labels for this
season are already in inventory and waiting for the beginning of
processing. The agency estimates the cost of applying the labels by
multiplying the average rural hourly cost of labor ($13.00) by the
number of hours it would take to label 10,000 gallon size packages (the
average size of plant that will be using the warning statement) and the
cost of extra equipment needed to apply this volume of labels. The
agency estimates this cost to be $600. Third, printers levy one time
charges for set-up in addition to the basic per unit cost of labels.
The agency has estimated total printing costs for a 10,000 gallon
operation to be $250. Thus, the agency's estimate of the cost of
achieving compliance within 60 days through use of stickers is
approximately $1,000. This is in contrast to the $100 agency estimate
of the cost of achieving compliance through use of signs or placards.
Thus, while FDA considers stickers an acceptable means of revising a
label, in light of the cost differential between labels and placards,
the agency is not persuaded that it should mandate the use of labels
with stickers for the 1998 juice season. Accordingly, FDA is making no
additional changes to its provisions for interim compliance with the
warning statement requirement through labeling in response to these
comments.
23. Some comments that objected to allowing juice product
manufacturers to use labeling while they change labels noted that the
USDA requirement for safe handling instructions on raw meat and
poultry, which was issued in response to a similar public health
concern, was effective 60 days after its publication, with no temporary
allowance for labeling.
FDA acknowledges that the final regulation requiring safe handling
label statements on meat and poultry products (59 FR 14528, March 28,
1994) became effective for comminuted products 60 days after
publication, with no temporary allowance for labeling. However, the
comment failed to fully describe the circumstances surrounding the FSIS
rulemaking. On August 16, 1993 (58 FR 43478), FSIS published an interim
final rule requiring the safe handling statements, with opportunity for
comment. On October 12, 1993 (58 FR 52856), FSIS published a final rule
requiring the safe handling statements, with an immediate effective
date. On November 4, 1993 (58 FR 58922), FSIS withdrew the October 12,
1993, rule as a result of litigation and reproposed its regulations
requiring safe handling instructions. Finally, FSIS published the final
rule cited by the comments, with an effective date of 60 days--i.e.,
May 27, 1994--for comminuted products.\4\ Because the safe handling
statements did not change between October 12, 1993, and March 28, 1994,
the meat and poultry industry had approximately seven and one half
months to prepare new labels. Moreover, in its rulemaking and
subsequent FSIS Directives, FSIS allowed the use of any labels that
bore the safe handling instructions proposed in August 1993, until the
inventory was depleted.
---------------------------------------------------------------------------
\4\ The effective date for all other meat and poultry products
was July 6, 1994.
---------------------------------------------------------------------------
Given these circumstances, the alternative provided
bySec. 101.17(g)(4) that manufacturers may comply with the warning
statement requirement through labeling is, as a practical matter,
similar to the added time that manufacturers received to comply with
the FSIS rule requiring safe handling statements as a result of FSIS'
withdrawal of the October 12, 1993, rule. The agency believes that
these comments require no changes to the provisions of
Sec. 101.17(g)(4).
III. Covered Products
A. Unpackaged Juices
In the juice labeling proposal, FDA proposed to require a warning
statement on packaged juice products not processed to prevent, reduce,
or eliminate pathogens. FDA specifically noted that the agency's
proposal excluded unpackaged juice sold for immediate consumption
(e.g., juice sold by the glass in restaurants, grocery stores or other
food establishments). Comments from the restaurant industry supported
the exclusion from the warning statement requirement of unpackaged
juice sold for immediate consumption. Other comments requested that the
warning statement requirement not exclude unpackaged juice products. In
general, these comments asserted that unpackaged fresh juices pose the
same risk as fresh juices sold in containers.
24. A few comments pointed out that unpackaged juices have
accounted for some of the cases of serious illness that have been
associated with consumption of fresh cider. Another comment expressed
the view that contamination of fresh juices may be more likely in
retail establishments that prepare unpackaged juices than in
manufacturing facilities that prepare packaged juices because personnel
who work in retail establishments may lack relevant training that
ordinarily is provided to personnel who work in manufacturing
facilities. Other comments contended that the agency's proposal that
the warning statement
[[Page 37038]]
requirement apply only to packaged juices would create consumer
confusion. For example, consumers would be unable to distinguish, in
all circumstances, between unlabeled juice that had been processed to
control pathogenic microorganisms and unlabeled juice that had not been
so processed. Most of these comments asserted that the warning
statement requirement should apply equally to packaged and to
unpackaged juices.
As part of its decision to propose to require a warning label on
untreated juice, FDA considered, among other things, the issues raised
in these comments, and tentatively concluded not to specifically
require the labeling of unpackaged juice. As stated in the juice
labeling proposal, this approach is consistent with the agency's food
labeling regulations which do not apply to food distributed to
consumers in unpackaged form unless specifically noted in the
regulations (63 FR 20486 at 20487). Because these comments did not
provide any information that the agency had not considered at the time
it published the proposal, the agency is maintaining its position to
not include unpackaged juice in the scope of the warning labeling
requirement.
B. Apple Juice Products versus Non-Apple Juice Products
Several comments, almost exclusively from citrus juice interests,
asserted that the labeling requirement should apply only to apple juice
and apple juice products and should not apply uniformly to juices of
other fruits, especially citrus fruits, or to vegetable juices. The
comments provided a number of reasons as justification for a
differential application of the warning statement requirements. FDA
discusses these specific comments, and the agency's response, below.
25. Some comments claimed that the extraction methods for citrus
juices justify excluding such juices from the warning statement
requirement. Specifically, comments asserted that the extraction of
apple juice necessarily involves contact of the expressed juice with a
substantial portion of the peel surface for an extended period of time,
during which pathogenic organisms on the peel can pass into the juice.
The comments asserted that, in contrast, the extraction of citrus juice
involves contact of the expressed juice with a small fraction of the
peel surface for a period of time much shorter than that for the
extraction of apple juice, thereby limiting the opportunities for
microorganisms on the peel to pass into the juice. In addition, one
comment stated that the smooth surface and disposable outer peel of
citrus fruit make it easier to sanitize and prepare citrus fruit for
juice extraction. This comment also stated that drops (i.e., fruit that
has fallen to the ground) are not used in the fresh citrus juice
industry, the extraction method typically used allows less than 2
percent of the presanitized peel surface to come into contact with the
juice, and the interior of the citrus fruit is sterile.
FDA does not agree that the described differences in juice
extraction methods, with concomitant differences in peel/juice
exposure, justify the selective application of the warning statement
requirement. The agency acknowledges that the physical characteristics
of citrus fruits may help to facilitate safe and sanitary citrus juice
extraction operations. However, the comments did not include sufficient
data to demonstrate that these factors are sufficient to ensure the
safe and sanitary processing of citrus juices. Moreover, the
significance of the peel-juice contact as a source of pathogens that
may be present in the juice depends on the microbial load on the peel;
that initial microbial load may vary with preextraction conditions. In
addition, the comments provided no substantive information to establish
the rate of transfer of pathogens from peel to expressed juice; thus, a
minimum timeframe for contamination remains unknown.
26. One comment asserted that citrus juices should be exempt from
the warning statement requirement because the citrus industry is
rapidly adopting the following practices to achieve, at a minimum, a 3-
log reduction in microbial count: (1) A grading line to remove
compromised fruit; (2) rinsing stations; (3) washing fruit with
commercial cleaning agent and brush scrubbing; (4) application of
sanitizer; (5) heat dryers; (6) extraction equipment that minimizes the
amount of peel that contacts the juice; and (7) imposition of good
manufacturing practices (GMP's) set out in part 110 (21 CFR part 110).
The agency agrees that the described operations are major pathogen
reduction steps and would likely result in a reduction of pathogen
levels. Indeed, in the HACCP proposal, the agency acknowledged that it
is possible that whole oranges with an intact skin may be processed so
that pathogens on the surface of the fruit are destroyed (63 FR 20450
at 20478). However, once again, the comments provided no data or other
substantive information to verify that such operations have been
adopted industry-wide. In addition, the comments claimed only that
these processing practices allowed the citrus industry to achieve, at a
minimum, a 3-log reduction in microbial count. As noted, both in the
proposed rule (proposed Sec. 101.17(g)(6)) and in this final rule
(Sec. 101.17(g)(7)), the pathogen reduction performance standard would
require a 5-log reduction in pathogens. Moreover, consistent with
customary scientific practices, the method that produces the 5-log
reduction should be validated. Thus, the comments do not establish that
the citrus juice industry is universally or automatically meeting the
pathogen reduction standard established in this final rule.
Accordingly, the comments did not provide a basis for the agency to
exclude citrus juices from the warning statement requirement. However,
as discussed later in this document (see comment 42), the agency
believes that citrus processors should be able to achieve and validate
a 5-log reduction.
27. Some comments asserted that the chemical composition of certain
fruits and vegetables justifies differential application of the warning
statement requirement.
The agency recognizes that various fruits and vegetables differ in
their indigenous chemical composition. In fact, even within a variety
of a particular fruit or vegetable, there can be some variation in
composition depending on growing conditions. However, the comments
provided no data to show how chemical composition of a juice bears on
its safety. The comments also provided no data to show how chemical
attributes that are unique to citrus products will ensure the safety of
fresh citrus juices. Therefore, FDA does not agree that differences in
chemical composition of various fruits and vegetables and their juices
justify the comments' request that certain juices not be subject to the
warning statement requirement.
28. Finally, some comments asserted that differences in the degree
to which citrus juices have been associated with illness outbreaks
justify exempting citrus juices from the warning statement requirement.
The agency disagrees. A 1997 study of recombinant E. coli 0157:H7
growth in apple juice and orange juice indicated that citrus juices
provide an environment for growth of this microorganism (Ref. 9). In
the study, there was only a small decline in numbers of E. coli 0157:H7
inoculated into orange juice over a 24-day period at refrigeration
temperatures. The fact that E. coli 0157:H7 can survive in citrus juice
and the fact that human illnesses from other pathogens have been traced
epidemiologically to citrus juice demonstrates that, if contaminated,
[[Page 37039]]
these juices have potential to cause human illness. Therefore, the
agency finds no basis in the comments to conclude that the level of
association of citrus juices with illnesses of public health
significance is so low as to justify their exclusion from the warning
statement requirement.
29. A few comments questioned whether the warning statement
requirement should apply to carrot juice because there have been no
outbreaks of illness linked to this product.
FDA acknowledges that there are no documented incidents of illness
associated with carrot juice sold commercially. This lack of reported
incidences may be due to lower exposure because of the total amount of
carrot juice consumed. \5\
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\5\ Alternatively, it is possible that this lower rate of
reported incidences is related to some inherent characteristics of
this product. The agency is aware that research shows that carrot
juice contains a broad spectrum of antimicrobial activity due to the
presence of phytoallexins. This activity may be useful as a barrier
to kill or prevent the growth of Listeria monocytogenes in
particular, and may possibly also function to keep in check other
foodborne pathogens and spoilage microorganisms. Nonetheless, the
conditions under which the antimicrobial effects of carrot juice are
manifested have not been fully defined. Accordingly, at this time,
such research does not establish a basis to exclude carrot juice
from the warning statement requirement.
---------------------------------------------------------------------------
FDA believes that this absence of documented instances of illness
does not justify exempting carrot juice from this final rule. According
to information available to FDA, carrot juice is one of the top three
fresh juices sold, following orange and apple juice. Because it is
derived from a root vegetable, carrot juice has the potential to be
directly contaminated with soilborne pathogens. In addition, carrot
juice has a higher pH (i.e., it is less acidic) than juices such as
apple juice or orange juice, and thus, will better support the growth
of microorganisms, including pathogens, which a juice with a more acid
pH is more likely to inhibit. In addition, carrot juice itself is a
rich source of nutrients that will support microbial growth. Therefore,
the agency concludes that there is no basis to exclude carrot juice
from Sec. 101.17.
30. Several comments requested clarification on which products are
covered by the proposed rule. Comments asked whether a final product
that contained a diluted pasteurized juice needed to be labeled if the
final product itself is not pasteurized. Other comments inquired about
citrus oils, juice concentrates not packaged directly for consumer
sale, and lemon and lime juice concentrates that are not sold as
beverages. A few comments asked whether certain juices were subject to
the warning statement requirement because such juices are sold for use
as ingredients in other beverages, such as wine or hard cider.
In considering these comments, FDA identified three questions that
bear on whether a particular juice product is subject to the warning
statement requirement. First, does the product meet the definition of
``juice'' in Sec. 101.17(g)(1)? With respect to the specific products
described in the comments, FDA advises that juice concentrates not
packaged for retail sale to consumers meet the definition of ``juice''
in Sec. 101.17(g)(1). Likewise, lemon and lime concentrates, which
often are sold for use as ingredients in beverages such as a blend or
``punch,'' also meet the definition of ``juice'' under
Sec. 101.17(g)(1). Finally, juices sold for use as an ingredient in
either wine or hard cider, which are beverages, are ``juice'' within
the meaning of Sec. 101.17(g)(1). In contrast, citrus oils are not
``juices'' under Sec. 101.17(g)(1) because they are not aqueous
liquids.
The second question that bears on whether a particular juice
product is subject to the warning statement requirement is whether a
product that is ``juice'' within the meaning of Sec. 101.17(g)(1) has
been processed in a manner that satisfies the pathogen reduction
performance standard in Sec. 101.17(g)(7); if so, such ``juice'' is
exempt from the warning statement requirement. Thus, neither a
pasteurized juice concentrate nor a beverage containing such a
concentrate would be subject to the warning statement requirement, as
proposed, because a pasteurized ``juice'' satisfies the pathogen
reduction performance standard.
The third question that bears on whether a particular juice product
is subject to the warning statement requirement is whether the product
is intended for retail sale to consumers or is being sold for use as an
ingredient in the manufacture of another beverage. FDA acknowledges
that, under proposed Sec. 101.17(g)(1), the requirement for a warning
statement applied to any juice sold as such or used as an ingredient in
another beverage. FDA's proposal to require the warning statement on
juice sold for use as an ingredient in another beverage was intended to
ensure that manufacturers of beverages had access to information about
whether a juice ingredient that they include in their product had been
processed in a manner to satisfy the pathogen reduction performance
standard. Such information is necessary to allow manufacturers of
beverages to comply with the warning statement requirement. However,
after consideration of the comments that questioned whether juice sold
for use as an ingredient is subject to the warning statement
requirement, FDA has reconsidered its proposal.
The warning statement is intended to inform consumers of the
hazards presented by untreated juices so that they may make informed
choices. Although the use of this warning statement on the label or in
labeling of a juice product that is being shipped for use solely in the
manufacture of other foods or that is to be processed, labeled, or
repacked at a site other than originally processed could serve to
inform manufacturers who receive the ingredient that the juice is
untreated, the same goal of providing information to manufacturers
could be accomplished by customary trade practices. For example, a
statement that describes whether the juice has, or has not, been
processed in a manner to meet FDA's pathogen reduction performance
standard could be included on an invoice or product specification
sheet.
Accordingly, in this final rule FDA is adding new Sec. 101.17(g)(3)
to clarify that juice that is not for distribution to retail consumers
in the form shipped and that is for use solely in the manufacture of
other foods or that is to be processed, labeled, or repacked at a site
other than originally processed, is exempt from the warning statement
requirement, provided that for juice that has not been processed in the
manner described in Sec. 101.17(g)(7), the lack of such processing is
disclosed in documents accompanying the juice, in accordance with the
practice of the trade.
C. The Proposed Pathogen Reduction Performance Standard
As discussed in section I of this document, proposed
Sec. 101.17(g)(6) of the juice labeling proposal is directly linked to
the pathogen reduction performance standard that is part of the
agency's HACCP proposal (proposed Sec. 120.24). As discussed in both
the juice labeling proposal and the HACCP proposal, these two proposed
regulations would function together as a comprehensive program to
address the incidence of foodborne illness related to consumption of
fresh juices and to ultimately address the safety of all juice
products.
31. Several comments opposed the pathogen reduction performance
standard that FDA included in both the juice labeling proposal and the
HACCP proposal. Under proposed Sec. 101.17(g)(6), the requirement for a
warning statement would not apply to juice processed in a manner that
[[Page 37040]]
satisfies the pathogen reduction performance standard--i.e., juice
processed such that there is, 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. (The proposals defined the ``pertinent
microorganism'' as the most resistant microorganism of public health
significance that is likely to occur in the juice.) Some comments
asserted that the 5-log performance standard is unnecessary and
unreasonable and questioned the scientific basis of the NACMCF
recommendation of that standard.
Based on information the agency has received in response to the
juice labeling proposal, FDA has concluded that the pathogen reduction
performance standard in proposed Sec. 101.17(g)(6) is the most
appropriate standard to ensure that juice is safe. The agency advises
that no food processing method can be shown scientifically to achieve a
``zero'' probability that a pathogenic microorganism will be present in
the processed food. However, food processing methods can be shown
scientifically to reduce, by mathematical increments (i.e., by
``logs''), the level of pathogens that may be present in food and as a
result to reduce any potential risk of illness from the food. As
explained in the HACCP proposal (63 FR 20450 at 20477), the 5-log
reduction is a performance standard intended to provide assurance that
juice produced consistent with this standard does not pose more than a
tolerable level of risk of illness. FDA notes that the 5-log value was
arrived at by consensus of the Fresh Produce Working Group of the
NACMCF, and subsequently adopted by the NACMCF, as a target that would
provide adequate public health assurances while minimizing the impact
of treatments on the sensory attributes of the juices (Ref. 10).
With respect to the comment that questioned the basis for the
NACMCF's recommendation, FDA advises that the agency relied on the
collective judgment of this group of experts. The comment did not
present specific challenges to the scientific basis underlying NACMCF's
recommendation, nor did it provide a basis, data, or other information
to support any other performance standard.
For these reasons, these comments have not persuaded FDA to make
any changes to the pathogen reduction performance standard in proposed
Sec. 101.17(g)(6).
32. One comment suggested that a zero tolerance for E. coli O157:H7
would be more appropriate than the adoption of a performance standard.
Another comment requested that a ``safe harbor'' bacterial load level
be added to or used in lieu of the 5-log reduction criteria.
FDA disagrees with these comments. In general, FDA would consider a
food product that contains pathogenic microorganisms to be adulterated
under section 402(a)(1) of the act because it would contain a poisonous
or deleterious substance that may render the food injurious to health.
In contrast, FDA considers a total bacterial plate count as an
indication that the food may have been prepared, packed or held under
insanitary conditions. FDA would generally conduct an inspection of the
processing facility to determine whether insanitary conditions exist in
the facility. If insanitary conditions are found in the facility, any
food produced under such conditions would be adulterated under section
402(a)(4) of the act.
The agency advises that while it could conceivably issue a
tolerance for E. coli O157:H7, FDA has authority under section
402(a)(1) of the act to take regulatory action against any juice that
contains a pathogenic microorganism that may render the juice injurious
to health. Further, it would be impractical for juice processors to
establish procedures to ensure actual compliance with such a tolerance
because it would be necessary to channel a significant portion of the
end product into testing to provide a statistically valid indication of
compliance. Finally, a zero tolerance means the pathogens are
undetectable in the food. For microbiological methods this is about one
pathogen per 100 grams. For E. coli O157:H7, this is not a safe level.
In contrast, the performance standard is a way to ensure that the
presence of E. coli O157:H7 is much lower than that. In addition, the
performance standard required in proposed Sec. 101.17(g)(6) is a tool
that can be applied in a practical manner to processing to ensure that
all the juice has been processed to control pathogens.
Regarding the use of a ``safe harbor'' bacterial load level, FDA
considers a ``safe harbor'' bacterial load level to mean a maximum
total bacterial count. As discussed, under section 402(a)(4) of the
act, very high aerobic plate counts may indicate that the food has been
prepared, packed, or held under insanitary conditions, which may
contribute to increased risk of pathogen occurrence and outgrowth. FDA
has established regulations in part 110 concerning CGMP in
manufacturing, packing, or holding human food that already apply to
juice. Because these regulations directly address appropriate
conditions for preparing, packing, and holding food, a ``safe harbor''
bacterial load level would not directly address such conditions, FDA
concludes, based on comments received in response to the juice labeling
proposal, that establishing a ``safe harbor'' bacterial load level is
not necessary.
33. One comment stated that the proposed pathogen reduction
performance standard is premature given that the source of E. coli
0157:H7 contamination in apples is not known. Additional comments
questioned whether E. coli 0157:H7 could be found anywhere other than
in bovine manure.
The agency disagrees that the proposed pathogen reduction
performance standard is premature because the source of E. coli O157:H7
is unknown. First, although E. coli will likely be the ``pertinent''
microorganism of public health concern for apple juice, it may not be
the ``pertinent'' microorganism for other juices. Second, in some
outbreaks, a likely source has been determined (Ref. 11). Although E.
coli O157:H7 may be found in bovine manure, there are other possible
sources for this pathogen, such as deer manure (Ref. 12). Third,
regardless of its source, E. coli O157:H7 is a pathogen that has been
found to be present in fresh juice, including apple juice (Ref. 12). In
fact, the agency's proposed pathogen reduction performance standard is
a logical response to the comment's assertion that the source of E.
coli O157:H7 in products such as apple juice is unknown. The knowledge
that E. coli and other pathogens have been found in juice and have
caused illness indicates that a processor must take steps (i.e.,
pathogen reduction steps to achieve the performance standard) to ensure
that juice is safe. These steps must include prevention of
contamination, destruction of any pathogens of concern that may be
present, or both. If future research determines new sources of E. coli
O157:H7 or other pathogens in juice products, processors could then
develop appropriate measures to prevent contamination from these
sources and apply measures that are determined to be effective toward
the pathogen reduction performance standard.
34. Several comments requested clarification on which aspects of a
process could be included for the purpose of meeting the proposed
pathogen reduction performance standard. Respondents asked about the
appropriate place in the production operation to start measuring
pathogen reduction and whether specific farming,
[[Page 37041]]
harvesting, and processing practices may be counted toward meeting the
proposed pathogen reduction performance standard.
The pathogen reduction process control can begin at the point at
which the processor has control over the preparation of the product.
The 5-log reduction may be accomplished cumulatively (e.g., through a
combination of special culling, use of appropriate sanitizers, and
specific extraction methods) or by a one-step process (e.g.,
pasteurization). The 5-log reduction standard is designed to achieve
appropriate microbial risk reduction under all conditions that may be
encountered in the manufacture of juice, including the conditions in
which the fruit is grown and harvested. Therefore, farming, harvesting,
and processing practices may be considered in achieving the 5-log
reduction, so long as the processor has control over these activities
and the control measures are effective.
35. FDA received a number of comments regarding achievement of the
proposed pathogen reduction performance standard. Some comments
expressed the opinion that the rule would in essence require
pasteurization. Other comments asked about options for achieving the 5-
log reduction, such as ultraviolet (UV) radiation, pulsed light, or
sodium benzoate. Additionally, several comments indicated that
instituting a ``no dropped fruit'' policy, using potable water, and
following CGMP's would provide an adequate measure of safety for juice
products.
FDA disagrees that the proposal would require pasteurization of
juice products. While pasteurization currently may be the most
practical process to achieve the proposed pathogen reduction
performance standard, it is not the only alternative. A manufacturer
who demonstrates that the measures discussed in the comments (i.e., use
of UV radiation, pulsed light, and sodium benzoate) are effective in
controlling pathogenic microorganisms may apply such measures in
achieving the pathogen reduction performance standard.
FDA agrees that the various steps proposed in the comments (e.g.,
``no dropped fruit'') have the potential to contribute to the reduction
of microbial contamination. Animal manure, whether applied as
fertilizer or from animals (e.g., cows, deer) present in orchards, can
be a source of E. coli O157:H7. Not using produce that has come into
contact with the ground reduces the risk of this contamination.
However, there are other possible sources of contamination that may not
be avoided as easily. For example, dust, insects, and birds may be
vectors of contamination. Likewise, a water supply that does not meet
the requirements of Sec. 110.37(a) (21 CFR 110.37(a)) that any water
that contacts food or food-contact surfaces be safe and of adequate
sanitary quality may also be a source of contamination.
FDA believes that these comments require no changes to its proposed
regulations.
36. Other comments asserted that adherence to State-enforced GMP's,
quality assurance programs (QAP's), or HACCP programs, or any validated
HACCP program should be as acceptable as a means of satisfying FDA's
proposed pathogen reduction performance standard as would be adherence
to the proposed Federal (i.e., FDA) HACCP program.
FDA recognizes that State GMP's, QAP's, and HACCP programs can
serve as a useful foundation to assist processors in achieving public
health goals and may in fact allow a manufacturer to attain the
performance standard required by proposed Sec. 101.17(g)(6).
Nonetheless, these programs vary from State to State and may not exist
in some States. Therefore, juice that is in interstate commerce may be
subject to one or more State requirements or to no State requirements.
Accordingly, FDA continues to see a need for a comprehensive Federal
regulatory approach for all juice products.
The agency encourages processors to develop and use an appropriate
HACCP program in the processing of juice. However, FDA emphasizes that
it had tentatively concluded in the HACCP proposal that an appropriate
HACCP program must include control measures that will produce, at a
minimum, a 5-log reduction in a pertinent microorganism. As noted, the
warning statement will not be required on products produced under a
HACCP program validated to achieve the pathogen reduction performance
standard described in proposed Sec. 101.17(g)(6).
37. Several comments questioned why, as part of its HACCP program,
the agency is proposing a pathogen reduction performance standard
rather than requiring pasteurization. A few comments contended that to
ensure the safety of juices, the agency should require that all juices
be pasteurized. Other comments suggested that not all 5-log reduction
methods are equally effective and that some could be less effective
than pasteurization.
The agency does not believe that mandating pasteurization is
necessary. Pasteurization is one method of achieving the pathogen
reduction performance standard proposed in the HACCP rule and
established in this rule as the basis for exemption from the warning
statement requirement. FDA believes that establishing a performance
standard rather than mandating the use of a particular process (such as
pasteurization) provides flexibility in how the pathogen reduction can
occur and will permit the development of new technology. Importantly,
however, a performance standard will not preclude the use of
pasteurization to achieve the standard. The agency recognizes that some
methods may achieve a 5-log reduction in a more direct manner than
other methods (i.e., in one step versus in several steps).
Nevertheless, by its very definition, a 5-log reduction in the
pertinent microorganism is the same reduction--i.e., a reduction by a
factor of 100,000--regardless of the method used.
For these reasons, in this final rule, FDA is maintaining its
performance standard approach rather than mandating pasteurization.
38. A few comments stated that pasteurization would not solve all
the problems with juice and could provide a false sense of security to
consumers.
The agency agrees with these comments. Pasteurization does not
address all problems that may occur during the manufacture of juice and
that have an adverse effect on public health. Recognition of the
multiplicity of hazards that are reasonably likely to occur and of the
need for their control is the basis for the agency's HACCP proposal.
39. One comment stated that the juice labeling rule was not
necessary because the pH in cider is too low for pathogens to grow in
it.
The agency agrees that acidic pH is generally considered to be an
unfavorable environment for the survival of pathogens. However, as
discussed in detail in both the labeling and HACCP proposals, there are
documented cases of outbreaks of disease caused by E. coli 0157:H7 or
other pathogens in apple juice and apple cider. Indeed, these outbreaks
are of particular concern because apple cider typically has an acidic
pH (i.e., a pH of approximately 3.5 to 4.0), due to the presence of
malic and lactic acids in apples. Contrary to longstanding beliefs
regarding microbial tolerance of acidic environments, the available
evidence shows that E. coli 0157:H7 strains are tolerant of acid pH,
particularly when held under refrigerated conditions consistent with
juice manufacturing (Ref. 13). Therefore, the agency believes
[[Page 37042]]
that while acidity may be lethal or inhibitory to some pathogens, it
cannot be relied upon as a control measure to reduce the risk of
foodborne illness.
40. A few comments asked that FDA provide a grace period on
labeling compliance for processors using a validated HACCP program
without the pathogen reduction performance standard until the proposed
HACCP rule for juices becomes final.
As discussed in the HACCP proposal, the agency has tentatively
concluded that an adequate HACCP program for juice must include the
pathogen reduction performance standard in proposed Sec. 120.24.
Accordingly, the agency incorporated this standard into the juice
labeling proposal in proposed Sec. 101.17(g)(6). As discussed above,
there are no data or other information in the comments to the juice
labeling proposal that demonstrate that the proposed pathogen reduction
performance standard is not the appropriate standard.
FDA acknowledges that comments that are submitted to the HACCP
proposal may persuade the agency to implement an alternative to the
pathogen reduction performance standard set out in the HACCP proposal.
However, in the interim between the issuance of this final rule and any
final rule based on the HACCP proposal, it is the agency's best
judgment, based on the information in the administrative record of this
proceeding, that any HACCP program that does not satisfy the proposed
pathogen reduction standard--i.e., a 5-log reduction in the pertinent
microorganism--cannot be considered adequate for safe juice production,
and thus, cannot provide the basis for exempting a product from the
warning statement requirement. Accordingly, in this final rule, FDA is
retaining (as Sec. 101.17(g)(7)(i)(A)) the provision of proposed
Sec. 101.17(g)(6) that the requirement for a warning statement 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.
However, in recognition of the fact that the agency has not
completed its rulemaking on the HACCP proposal, in this final rule FDA
is broadening the exemption from the warning statement requirement in
proposed Sec. 101.17(g)(6) to include (as Sec. 101.17(g)(7)(i)(B))
juice processed in a manner that will achieve or exceed any pathogen
reduction performance standard ultimately established in any final
regulation requiring the application of HACCP principles to the
processing of juice. In the event that the agency's judgment when it
completes the HACCP rulemaking is that the interim pathogen reduction
performance standard is more strict than necessary, this amendment will
automatically ensure that manufacturers would be able to use the final
HACCP pathogen reduction performance standard in determining whether
their juice products require the warning statement. In the event that
the agency's judgment when it completes the HACCP rulemaking is that
the interim pathogen reduction performance standard should be altered,
FDA will take the appropriate steps to amend this rule.
41. A few comments stated that a HACCP program (without a
performance standard) is adequate because there is no evidence of
foodborne illness in fresh apple juice or cider from processors using
HACCP programs with GMP's, sanitation standard operating procedures
(SSOP's), and raw material standard operating procedures (SOP's).
The issues raised in these comments are beyond the scope of this
labeling document. The agency notes that it has tentatively concluded
in the HACCP proposal that an appropriate HACCP program must include
control measures that will produce, at a minimum a 5-log reduction in a
pertinent microorganism. The basis for the proposed requirement was
discussed in that proposal (63 FR 20450 at 20477). FDA will respond to
these comments fully in the HACCP final rule.
42. Several comments requested guidance on how to determine if
their process meets the 5-log reduction.
There are essentially two ways for processors to determine if their
process accomplishes a 5-log reduction in a pertinent microorganism.
Processors or other entities (such as researchers or a State) may test
a particular process with a known level of the target pathogen or an
appropriate surrogate microorganism that possesses similar properties
to the target pathogen and determine whether the process is reducing
the microorganism to the appropriate level. Alternatively,
manufacturers of processing equipment or sanitizers may test the
process that they are recommending for juice processing and supply the
applicable information on their product to the juice processor.
Consistent with customary scientific practices, the method that
produces the 5-log reduction should be validated.
As discussed in the HACCP proposal (63 FR 20450 at 20478), the
agency noted that it may be feasible for a processor to achieve a 5-log
reduction in a target pathogen in citrus juice using a combination of
CGMP's, sanitation SOP's, and the following three measures: (1) Culling
and grading, (2) washing, brushing, and sanitizing, and (3) appropriate
methods of extraction. If this procedure is validated, it is unlikely
that processors of fresh orange juice, and perhaps other fresh citrus
fruit juices, will have to implement pasteurization in order to achieve
a 5-log reduction in pathogenic bacteria.
In fact, the agency believes that citrus processors should be able
to achieve and validate a 5-log reduction without pasteurization. To
provide more detail, a system that could achieve a 5-log reduction
without pasteurization would likely include, at a minimum: Strict
control of incoming material to ensure fruit are intact and clean
(including not using dropped fruit); effective employee hygiene and
facility sanitation; appropriate chemical sanitizers; juice extraction
equipment that minimizes contact of juice with peel; refrigeration
immediately after juicing; and bottling in a closed system to minimize
environmental contamination. FDA would be willing to meet with
manufacturers or groups of manufacturers to discuss and evaluate their
proposed processes.
In addition, the agency will make available, in accordance with
part 20 of the agency's regulations (21 CFR part 20), information on
various processes that it learns have been validated to achieve a 5-log
reduction in order to help processors meet the performance standard.
43. One comment requested a definition of ``moderate abuse
conditions.''
Moderate abuse conditions, as described in the HACCP proposal (63
FR 20450 at 20478), occur when unusual circumstances arise during
regular handling of the product. Unloading a truck on a hot day where
the product may sit on a loading dock for a short period of time is one
example of moderate abuse. Another example of moderate abuse is
illustrated by a consumer who purchases a product on a warm day, places
it in a car, and then runs errands before refrigerating the product. In
FDA's view, moderate abuse does not include exposure to high
temperatures for extended periods of time.
IV. The Warning Statement
A. General Comments
In the juice labeling proposal, FDA tentatively concluded that
certain informational elements were essential to the warning statement,
i.e., the statement of the hazard, a description of
[[Page 37043]]
why the product may have the hazard, and an identification of the
consumers at greatest risk. Consequently, FDA proposed to require the
following warning statement on covered products:
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.
In this final rule, FDA is replacing the phrase ``which can cause
serious illness * * *'' with the phrase ``that can cause serious
illness * * *''. This change provides clarity and is not a substantive
change.
44. Some comments generally opposed the language in the warning
statement on the grounds that it is frightening, confusing or
misleading. Some of these comments contended that consumers associate
warning statements with products such as pesticides, poisons, or
carcinogens.
The agency's intent in requiring a warning statement on untreated
juices is to inform consumers that such juices may contain harmful
bacteria that can cause serious illness in children, the elderly, and
persons with weakened immune systems. This statement will ensure that
consumers have the information that they need to make informed choices.
To achieve this goal, the statement needs to present information about
the hazard. By its very nature, any statement that informs consumers
about a hazard, particularly a hazard that consumers do not expect,
would be, to some extent, ``frightening.''
FDA conducted consumer focus group research to anticipate the
likely impact of these statements on the public. This research tested
variations in wording to evaluate whether different statements and
specific words would produce exaggerated or inappropriate consumer
understanding.
Some participants initially considered the warning statement to be
alarming because it appeared to contradict their assumption, based on a
lifetime of experience consuming these products, that all juices are
safe and healthful foods. However, most of the focus group participants
who were alarmed by the statements mistakenly assumed that juice
products that they routinely consumed were not processed to control
pathogenic microorganisms. After receiving information that untreated
juice comprises less than 5 percent of all juice consumed, and that
most juice products in supermarkets are processed to control pathogenic
microorganisms, focus group participants were much less alarmed by the
warning statements. Importantly, after receiving this information, many
focus group participants appreciated the warning statement because they
recognized that it would help them distinguish juice products that were
more safe from those that are less safe because the latter products may
contain pathogenic microorganisms. Even consumers of untreated juice
products such as unpasteurized apple cider were reassured to know that
the warning statement would be applied to a narrow and distinctive
segment of juice products that had characteristics that specifically
warranted the statement because such products had not been processed to
control pathogenic microorganisms.
Based on this focus group research, FDA concludes that giving
consumers accurate information on untreated juices to better inform
their choices is likely to have the desired effect.
45. One comment suggested that the warning statement be changed to
reflect that contamination of unpasteurized cider is the cause of a
potential hazard. The comment contended that FDA's proposed statement
seems to suggest that the presence of harmful bacteria is a matter of a
statistical chance and is inherent in the cider, rather than a
consequence of contamination of the cider.
FDA disagrees with this comment. While FDA has determined that the
fact that bacteria may be present in juice is a material fact within
the meaning of section 201(n) of the act, the agency is not persuaded
that the process by which the bacteria came to be present is also
material information. The comment did not provide a rationale for why
the information on what causes bacteria to be present in juice is
material with respect to the health hazard. Therefore, the agency is
not making this suggested change.
B. Comments on the Term ``Warning''
46. Some comments that supported the use of the word ``WARNING'' in
the warning statement asserted that this very explicit term is
necessary so that consumers notice and give appropriate attention to
the hazard message. Other comments recommended specific alternatives to
the term ``WARNING,'' such as ``NOTICE,'' ``CONSUMER ADVISORY,''
``CONSUMER ALERT,'' ``HAZARD NOTICE,'' ``HAZARD ADVISORY,'' or ``HAZARD
ALERT.'' Some of these comments suggested that the term ``WARNING'' be
used only for apple juice and that an alternative term, such as
``NOTICE,'' ``ATTENTION,'' or ``CONSUMER ADVISORY'' be used for juice
products that pose a lower risk than that posed by apple juice. One
comment noted that for oysters a consumer advisory rather than a
warning statement is used to inform consumers of the hazard associated
with Vibrio vulnificus which has a 50 percent mortality rate associated
with illness. Comments acknowledged that the use of the same term for
all juice products, even those perceived to be of lower risk, may
nonetheless be necessary in the interest of uniformity.
FDA disagrees with those comments that suggested that another term
be substituted for ``warning'' because the results of the focus group
research support the use of the term ``warning.'' Focus group
participants examined warning statements that used four signal words,
i.e., ``WARNING,'' ``NOTICE,'' ``CAUTION,'' AND ``ATTENTION.''
Participants preferred ``WARNING'' and ``CAUTION'' over ``NOTICE'' and
``ATTENTION'' because these terms were perceived to be stronger and
more likely to cause consumers to read the message; participants
believed that the word ``WARNING'' was the strongest term. In addition,
in identifying their preferred warning statement, most participants
preferred the message preceded by the signal word ``WARNING.'' Other
terms recommended in the comments, such as ``CONSUMER ADVISORY,'' were
not tested in the agency's consumer research. Terms such as ``CONSUMER
ADVISORY'' or ``CONSUMER ALERT'' are moderate signal terms, falling
between the stronger signal terms tested (``WARNING'' and ``CAUTION'')
and the weaker signal terms tested (``NOTICE'' and ``ATTENTION'').
Consumers in the focus groups clearly preferred a strong signal to
alert them to the warning statement. The term ``WARNING'' was viewed as
a simple and unambiguous signal because it is a familiar word that most
people readily understand. The comments that suggested alternative
terms to ``WARNING'' did not provide consumer data or a compelling
rationale to support their recommendations. FDA has conducted several
studies of warning messages (in addition to juice) and has concluded
that consumer testing of proposed language enhances the likelihood that
warning messages will correctly communicate critical information (Ref.
5). Accordingly, because the relevant comments provided no consumer
data or compelling rationale to support the use of alternative signal
words, FDA has concluded that the warning statement for juice products
should utilize the signal word ``warning,'' a signal that is supported
by consumer research data. Furthermore, the agency believes that
[[Page 37044]]
warning is the more suitable term because it is consistent with past
agency regulations (e.g., Sec. 101.17(a), (b), (d)(1), and (e)) that
use a term stronger than ``notice.''
The purpose of the warning statement is to inform consumers of the
risks presented by certain juice products, thereby allowing them to
make better decisions about the purchase and consumption of such
products. This goal can only be achieved to the extent that consumers
read and process the warning statement. Accordingly, FDA believes that
it is appropriate to require the signal term that consumers say would
be most likely to cause them to read the statement. Therefore, FDA is
retaining ``warning'' as the signal word for the statement required by
this rulemaking.
C. Comments on the Phrase ``Has Not Been Pasteurized''
47. Some comments stated that the phrase ``has not been
pasteurized'' is inappropriate in the context of the warning statement
because it is misleading. A few of these comments asserted that
pasteurization provides a safer product than other processes that would
satisfy FDA's proposed pathogen reduction performance standard. These
respondents contended that the use of ``has not been pasteurized'' is
potentially harmful because consumers might believe that all products
that did not bear such a warning statement had been pasteurized and
were equally safe.
The agency disagrees with these comments. FDA maintains that
products processed in a manner to achieve the pathogen reduction
performance standard would achieve an appropriate level of safety,
whether they had been processed by pasteurization or by some other
means. Products that have not been processed to achieve the pathogen
reduction performance standard would require the warning statement.
Therefore, the agency concludes that the message that the consumers
would take from the warning statement is that products bearing the
warning may have potential hazards, whereas those not bearing the
statement are processed to ensure safe products.
48. Some comments contended that the term ``has not been
pasteurized'' is too narrow a term for the warning statement. While the
comments did not oppose the term ``pasteurized,'' the comments asserted
that consumers should be made aware that pasteurization is not the only
means by which juice products can be processed safely. The comments
argued that technology can move quickly, and that use of the term
``pasteurized'' would limit the development of new technology for
processing juice to destroy pathogenic microorganisms. Therefore, two
of the comments suggested the following language: ``this product has
not been pasteurized or otherwise treated * * *.''
FDA acknowledges that the term ``has not been pasteurized'' is not
technically precise in the context of the warning statement, because
products that have not been pasteurized, but have been otherwise
processed to meet the pathogen reduction performance standard, do not
need to bear the warning statement. In other words, the warning
statement will not be required on all juice products that have not been
pasteurized because those products subject to a process that achieves
the 5-log reduction standard, other than pasteurization, do not need to
bear the warning statement. However, as discussed in the juice labeling
proposal, FDA proposed the phrase because consumer focus group
participants understood the term ``has not been pasteurized'' better
than the term ``has not been specifically processed.'' Moreover, as
discussed in the juice labeling proposal, the agency believes that the
more important message, i.e., that juice products not treated to remove
pathogens present some risk, particularly for certain population
groups, will be clearly understood by consumers. The comments did not
provide information to show that consumers would be confused by the
warning statement. Therefore, the agency is not adopting this suggested
modification to the warning statement.
D. Comments on the At-Risk Groups
Most comments supporting the proposed labeling requirements
generally supported the proposed description of the consumers at risk,
although some comments suggested that these groups should be better
defined.
49. One comment maintained that the warning statement should be
modified unless specific data can be presented on the risks and those
at risk. Another comment questioned whether ``children'' meant persons
under 18. Another comment suggested that the term ``children'' be
replaced with the term ``infants.'' This comment noted that when
botulism was a concern in honey, only parents of children under 1 year
old had to be concerned. Other comments stated that the term
``children'' was appropriate because there is no scientific basis for
excluding older children and because parents will recognize that
infants and young children are included in the broad category of
``children.''
Some comments questioned what is meant by the term, ``elderly.''
One comment suggested that the term ``elderly'' be replaced with the
term ``senior (50 years or older),'' whereas another comment
recommended that ``elderly'' be replaced with ``senior (55 years or
older).''
FDA disagrees that the word ``infants,'' which ordinarily refers to
children less than 1 year old, should replace ``children'' in the
warning statement because some of the foodborne illnesses associated
with consumption of juice occurred in children older than 1 year.
Therefore, FDA concludes that use of the word ``infants'' in lieu of
``children'' would be misleading.
In the juice labeling proposal, FDA relied on a task force report,
from the Council for Agricultural Science and Technology (CAST), that
concluded that certain groups (i.e., young children, the elderly, and
persons who are immunocompromised) are at greatest risk of serious
illness from exposure to foodborne pathogens (63 FR 20486 at 20489).
The report did not define a precise age range for either ``children''
or ``the elderly.'' The comment that questioned whether specific data
was available to support FDA's description of the at-risk groups did
not provide any data on which to refine the descriptive terms used in
the report.
FDA recognizes that the terms ``children'' and ``elderly'' are not
precise. They are terms chosen by the Council for Agricultural Science
and Technology to reflect groups that, in general, have an immune
system that is either incompletely developed or beginning to decline.
Although the exact age at which a child's immune system is fully
developed is not precisely defined and will depend on the individual
development of the child, the task force report indicated that the
incompletely developed immune system of infants and children younger
than 5 makes this age group especially susceptible to foodborne
illness. In addition, the report noted that the infective dose may be
related to body weight, which would be less for younger children.
Nonetheless, the median age of persons who experienced illness in a
recent outbreak of E. Coli O157:H7 infections associated with juice
products was five (Ref. 14); thus, as many individuals older than 5
years experienced illness as did those under 5 years. Therefore, the
agency believes that the descriptive term for ``children'' in the
warning statement should not be limited, e.g., to ``young children'' or
to children 5 years and under.
[[Page 37045]]
Likewise, the task force report stated that elderly individuals
undergo a decrease in immune function that makes them more susceptible
to foodborne illness than the general population. The report both
indicated that this decrease in the immune system can occur as early as
50 to 60 years of age and designated the term ``elderly'' to mean an
individual over 65. Because the range given by the task force was so
wide, the agency tentatively concluded that it had no basis for
identifying a specific age for its category of ``elderly'' in the
warning statement.
In the juice labeling proposal, FDA asked for comments on whether
the age groups for children and the elderly could be better defined.
Although some of the comments to the proposal suggested that the
warning statement specify particular ages, the comments did not provide
a substantive basis for any of these recommended ages. Accordingly, FDA
is making no changes to the terms ``children'' or ``the elderly'' in
the warning statement.
50. One comment stated that either the risk groups should be better
defined or no risk groups should be mentioned at all.
FDA disagrees with this comment. Although the at-risk groups are
not described as precisely as some might wish, as noted, there are few
available data to identify the ages of children and adults who are at
high risk. FDA has concluded that it is preferable to identify the at-
risk groups with slightly imprecise terms than not to designate such
groups at all. Therefore, FDA rejects this comment.
51. Several comments suggested that pregnant women be included as
at-risk consumers. Only one comment provided any rationale for this
addition, stating that pregnant women, who during their pregnancies
have impaired immune systems, allegedly do not recognize that they are
at greater risk of infection. Another comment pointed out that pregnant
women are at risk of having miscarriages if they are infected with
Listeria.
FDA disagrees with the suggestions that pregnant women be included
in the at-risk groups. FDA acknowledges that the CAST report noted that
the immune system of a pregnant woman is altered to some extent
compared to that of a non-pregnant woman. In looking at the populations
at greatest risk from foodborne pathogens, CAST identified pregnant
women as a group at risk from L. monocytogenes, a widely distributed
pathogen that has been associated with miscarriages. Nonetheless, there
is no evidence that pregnant women or their fetuses are at any greater
risk of serious illness from the foodborne pathogens associated with
juices than the general population. The agency notes that Listeria has
not been identified in the documented cases of illnesses associated
with consumption of untreated juices. Therefore, FDA has no basis for
determining that risk to a pregnancy from Listeria is any greater from
the consumption of juices than from the consumption of all other foods.
52. Several comments stated that the term ``serious illness''
should be replaced with ``life threatening illness.'' These comments
asserted that it is important that high risk consumers are adequately
informed of the potential risks and therefore, the language should be
explicit enough so that they will avoid the product. According to one
comment, the language should be explicit enough so that consumers will
overcome the presumption that the warning is meant for someone else.
FDA disagrees with these comments. The term ``serious illness'' is
an accurate description of the hazard. Moreover, the FDA focus group
research tested a variety of messages that included the phrases
``serious illness'' and ``life-threatening illness.'' The participants
preferred a phrase such as ``serious illness'' because it conveyed a
significant consequence without being too extreme. In addition,
participants viewed ``serious illness'' as a strong statement for
persons with weakened immune systems or immature immune systems such as
young children. In contrast, participants viewed terms such as ``life-
threatening'' or ``death'' as less credible. Thus, in addition to being
objectively conceived, FDA focus group research confirmed that the
phrase ``serious illness'' is subjectively understood. Accordingly, FDA
is making no changes in response to these comments.
E. Comments on the Entire Warning Statement
53. In contrast to the comments that suggested alternatives for
specific words or phrases in the proposed warning statement, a few
comments suggested alternative wording for the entire warning
statement. As examples, comments suggested statements such as the
following:
This is a natural product that has not been pasteurized or
otherwise treated. There is a slight risk that it may inadvertently
contain harmful bacteria that can cause serious illness in children,
the elderly and persons with weakened immune systems.
CONSUMER ADVISORY: 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.
NOTICE: This product has not been processed to eliminate the
possibility of harmful bacteria and, therefore, could cause serious
illness to those with weak immune systems, and young children.
Attention: This is a fresh juice. It has not been pasteurized.
There is a small possibility it could be harmful to those with weak
immune systems.
None of these comments provided a compelling rationale for why the
suggested statement was more appropriate than FDA's proposed statement.
FDA's statement was developed and refined based on focus group
research that tested multiple warning statements. Because the comments
that suggested alternative wording for the entire statement did not
provide a sufficient basis to dispute the findings of the focus group
studies, FDA is not adopting any of these general suggestions.
F. Comments on Prominence and Placement
54. In the juice labeling proposal, the agency tentatively
concluded that the warning statement should appear on the food label in
a manner that makes it readily observable and likely to be read.
Accordingly, FDA proposed that the statement appear prominently and
conspicuously on the information panel or on the principal display
panel (PDP) of the product label. Under Sec. 101.2(c) (21 CFR
101.2(c)), information required to appear on the PDP and information
panel must appear prominently and conspicuously in a type size no less
than one-sixteenth inch. The agency also proposed that the word
``warning'' immediately precede the statement, appear in capital
letters and bold type, and that the statement be set off in a box by
use of hairlines.
In this final rule, FDA is revising proposed Sec. 101.17(g)(4) (now
Sec. 101.17(g)(5)) to remove the provision that the term ``WARNING''
immediately precede the remainder of the warning statement. FDA is
making this change, which is not substantive, because it is redundant
with the requirements of Sec. 101.17(g)(2), which explicitly places the
term ``WARNING'' in front of the remainder of the statement.
55. One comment urged FDA to require that the warning statement
appear on the PDP and not the information panel. The comment neither
disputed the rationale that FDA presented in the juice labeling
proposal in support of its proposal to allow the warning statement to
appear on either the information panel or the PDP nor gave a reason for
its request. Therefore,
[[Page 37046]]
the agency is making no changes in the location of the warning
statement in response to this comment.
56. One comment maintained that the statement should not be set off
by hairlines and that the agency should follow the same guidelines that
it used for other informational statements such as those for saccharin
and phenylalanine.
The agency disagrees with this comment. The agency's recent
experience with the Nutrition Facts panel has been that the use of
hairlines (i.e., enclosing the critical information in a box) greatly
increases the prominence of the information. Also, focus group research
has shown that such boxes help consumers distinguish the message from
other information on the food label. As noted, the warning statement
will achieve its purpose only if it is seen and read by consumers.
Therefore, the agency is making no changes in response to this comment.
57. A few comments that supported the use of warning statements on
juice products stated that a minimum type size of one-sixteenth inch is
too small to attract consumer attention. One comment asserted that the
proposed type size is too small to be read by many of the elderly, who
are one of the at-risk groups targeted by the warning statement. The
comment recommended a type size no smaller than 8-point on labels.
Another comment suggested a minimum type size of three-sixteenth inch.
The agency does not have data from the comments or elsewhere that
indicate that consumers are unable to obtain the information from other
warning statements required in Sec. 101.17 and thus, has no reason to
believe that consumers would not be able to obtain information from the
warning statement in this rule. Accordingly, FDA is making no change to
the minimum type size requirements for warning statements for
unprocessed juice products.
V. Other Issues
58. A few comments urged FDA to require pasteurized juices to bear
a label informing consumers that the product had been pasteurized.
These comments contended that juices that have been pasteurized, i.e.,
heat treated, have lost some of their ``beneficial'' nutrients, e.g.,
pectin, and certain enzymes and vitamins, and that consumers have a
right to this information. The comments further stated that requiring
pasteurized juices to bear a label indicating that the product was
pasteurized would prohibit manufacturers of pasteurized juice from
labeling their products as ``fresh.''
The agency does not object to manufacturers voluntarily labeling
their product as ``pasteurized,'' when the product has, in fact, been
heat treated in accordance with the practice of the trade. However, to
require the term ``pasteurized'' on juice products the agency would
have to find that such information was material in light of
representations made about the product, or with respect to consequences
that may result from use of the product. The comments did not provide
the agency with any information on which to make either of these
findings. Therefore, the agency is not requiring that the term
``pasteurized'' or any similar term, i.e., heat treated, appear on the
label of juice that has been pasteurized. The agency advises that
labeling a pasteurized juice product as ``fresh'' is a misbranding
violation under section 403 of the act. Such products are subject to
regulatory enforcement action.
59. Some comments questioned whether the requirement for a warning
statement would apply to products that were manufactured by producers
who process their own fruit and sell the resulting fresh juice products
directly to consumers at their own retail markets, such as a roadside
stand.
Whether the warning statement applies to these products depends on
two factors: The ``retail'' status of the producer and the jurisdiction
of the FDA.
The source of FDA's authority here is the act. Under the act, FDA's
jurisdiction extends to those products, and the manufacturers and
distributors of regulated products, that satisfy a necessary connection
with interstate commerce. (See 21 U.S.C. 301 and 304.) Juice that is a
product of solely intrastate activities (e.g., source of components,
location of sales, etc.) is not subject to FDA's jurisdiction and thus,
would not be subject to the warning statement requirement.
Nonetheless, in such circumstances, FDA customarily works with
State regulatory agencies such as local health departments, who, like
FDA, have a mission to protect the public health. Elsewhere in this
final rule, FDA has addressed several comments submitted to the juice
labeling proposal that described actions already taken by the States to
work with producers to ensure the safety of juice products.
60. Several comments asked whether the responsibility for providing
a placard or sign, which is an acceptable interim mechanism for
manufacturers of packaged juices to comply with the juice labeling
rule, lay with a manufacturer who produces the juice and sells it to a
wholesaler or retailer or lay with the retailer who actually sells the
juice to individual customers.
Under the applicable law, regulations, and agency policy, the firm
that is identified as the manufacturer or distributor on the product
label bears the principal responsibility to ensure that the product
meets all applicable legal requirements, including labeling. However,
retailers and wholesalers also have legal responsibility to ensure that
products they sell are properly labeled. The legal basis for this
shared responsibility is as follows.
Section 301 of the act (21 U.S.C. 331) prohibits the interstate
shipment of a misbranded food and also prohibits the misbranding of a
food after interstate shipment. In the case of the juice labeling rule,
a juice product that is required to, but does not, bear the warning
statement is misbranded within the meaning of sections 403(a)(1) and
201(n) of the act. A manufacturer or distributor who ships a misbranded
juice product would violate section 301(a) of the act. Likewise, a
retailer who fails to provide required labeling containing a warning
statement would violate section 301(k). As is FDA's general practice,
the agency would evaluate on a case-by-case basis any situation
involving a possible misbranding of a covered juice product to
determine whether any regulatory action was warranted.
61. Some comments asked whether States would be responsible for
enforcing the warning statement requirement for products in intrastate
commerce.
State enforcement activities related to this final rule will depend
upon the specifics of each State's law (e.g., does that law provide for
the automatic adoption of Federal regulations or does that law require
a separate State process to establish a State standard?) and the
exercise of the State's enforcement discretion.
As a practical matter, the agency is aware that a number of States
have already begun to work with producers to improve the safety of
juice products. One of FDA's goals in establishing a Federal
requirement is to assist States in their efforts and to provide a model
to encourage consistency in approach.
62. One comment strongly urged FDA to exempt all growers who
process juice and sell directly to consumers at their own retail
markets regardless of sales volume. The comment based the request on
the belief that the labeling proposal exempted from the warning
statement requirement growers who processed their own fruit and sold
less than 40,000 gallons of the resulting juice products
[[Page 37047]]
directly to consumers and other retailers.
FDA is clarifying that its proposal to require warning statements
on untreated juice products did not exempt juices produced by
processors that sold less than 40,000 gallons. On the contrary, the
agency proposed in the juice labeling proposal that the warning
statement appear on the packages of all untreated juice products.
Growers, in general, who process their own fruits and sell the
resulting juice products commercially are not exempted by FDA from the
warning statement requirement based on sales volume. The comment failed
to provide the agency with a basis on which to exempt small growers
from the labeling requirement, and therefore, the agency declines to do
so.
63. Several comments objected to the abbreviated time for comments
on the juice labeling proposal. One comment specifically asserted that
the shortened comment period resulted in a denial of procedural due
process to the industry and the public.
The juice labeling proposal provided interested persons with 30
days to comment on the proposal. In the proposed rule, the agency
articulated the basis for its decision under Executive Order 12889 and
FDA's regulations, Sec. 10.40(b), for shortening the comment period to
30 days. Subsequently, several interested persons requested an
extension of the time for comments. As discussed above, the agency
ultimately extended, on June 10, 1998, under the authority of
Sec. 10.40(b)(3), the period for comments from all interested persons
to June 22, 1998. The agency believes that this comment period is
consistent with customary practice and agency regulations. The agency
believes that the public health urgency that underlies this rulemaking
is sufficient justification under Executive Order 12889 to shorten the
comment period from 75 days, a conclusion not challenged in the
comments. The agency also believes that the comment schedule of this
rulemaking is in compliance with due process. FDA's process here is
consistent with the requirements of the Administrative Procedure Act (5
U.S.C. 553). Such requirements are consistent with due process. (See
Bell Lines, Inc. v. U.S., 263 F. Supp. 40 (D. W. Va. 1967).)
VI. Effective Date
In the juice labeling proposal, FDA proposed that any final rule
based on the proposal become effective 60 days after its date of
publication in the Federal Register.
64. The majority of comments that addressed the proposed effective
date supported a 60-day effective date because of the public health
concern presented by untreated juices. A few comments asked that the
agency change the effective date. One comment suggested that the
effective date be changed from 60 to 120 days to allow small processors
time to implement HACCP-based programs. Another comment asserted that
the 60-day effective date was appropriate if FDA wanted to reach the
1998 apple cider season. That comment suggested, however, that the
effective date for other juices be extended to 150 days.
As discussed in the juice labeling proposal, the agency has
determined that the urgency of the public health concern with untreated
juices requires the mandating of a warning statement as soon as
possible, and, in particular, in time for the 1998 ``cider season.''
The comments did not provide any information that contradicted FDA's
tentative conclusion that an effective date of 60 days would be needed
to coincide with the beginning of the fresh juice season for apple
juice and apple cider. Accordingly, the agency is retaining the 60-day
effective date for this final rule. Apple juice and apple cider must
comply on the effective date of the final rule.
The overarching public health goal of this rulemaking is to provide
information about the potential hazards of untreated juice products to
consumers at the beginning of the next applicable ``juice season.''
Apple juice and orange juice are the two most consumed juices in the
United States, and together account for approximately 80 percent of all
juice consumed in the United States (63 FR 24254 at 24365). As
discussed in the PRIA (63 FR 24254 at 24273), information available to
FDA indicates that the season for apple cider production runs primarily
from September through December. Other information available to FDA
indicates that the fresh juice season for citrus fruit generally runs
from November through June (Ref. 15). Thus, the agency's public health
goal can be achieved by establishing a compliance date for citrus juice
products that coincides with the start of the fresh citrus juice
season. FDA is not aware that the fresh juice season for any juice
other than apple juice or apple cider begins as early as the apple
juice and apple cider season. Accordingly, in this final rule, FDA is
establishing a compliance date for all juices other than apple juice or
apple cider at 120 days after the date of publication of the final
rule.
As discussed above, in this final rule, Sec. 101.17(g)(4) provides
that the required warning statement may be provided in labeling at the
point of purchase on a temporary basis until 1 year from the date of
compliance with the final rule. In essence, this provision provides
manufacturers the alternative of using labeling (e.g., signs or
placards) for a single juice season. This flexibility will postpone by
a juice season a manufacturer's need to revise and reprint labels that
would be affixed to packaged untreated juice products.
VII. Summary of Provisions
In this final rule, FDA is revising its food labeling regulations
by requiring a warning statement on fruit and vegetable juice products
that have not been processed to prevent, reduce, or eliminate
pathogenic microorganisms that may be present. FDA is taking this
action to inform consumers that such juices may contain harmful
bacteria that can cause serious illness in children, the elderly, and
persons with weakened immune systems. FDA expects that providing this
information to consumers will allow them to make informed decisions on
whether to purchase and consume untreated juice products, thereby
reducing the incidence of foodborne illnesses and deaths caused by the
consumption of these products. The requirement that untreated juice
products bear a warning statement is part of a comprehensive program,
which may include the establishment of HACCP principles proposed for
the processing of juice products, to address the incidence of foodborne
illness related to consumption of fresh juices and to ultimately
address the safety of all juice products.
This juice labeling final rule includes the following revisions to
the juice labeling proposal:
(1) Section 101.17(g)(1) has been revised to remove the provision
that any juice sold as such or used as an ingredient in beverages is
subject to the warning statement requirement. This proposed provision,
which specified those products that are subject to the warning
statement requirement, became redundant with the final provisions of
Sec. 101.17(g)(2) and (g)(3).
(2) Section 101.17(g)(2) has been revised to reflect that, in
addition to any juice that has not been processed to satisfy the
pathogen reduction performance standard in Sec. 101.17(g)(7), the
warning statement requirement applies to any beverage containing juice
where neither the juice ingredient nor the beverage has been processed
to satisfy that standard. This, together with the exemption in
Sec. 101.17(g)(3), clarifies how FDA intended to cover juice used as an
ingredient.
[[Page 37048]]
(3) New Sec. 101.17(g)(3) establishes an exclusion from the warning
statement requirement for certain juice that is not for distribution to
retail consumers in the form shipped and that is for use solely in the
manufacture of other foods or is to be processed, labeled, or repacked
at a site other than originally processed. A warning statement is not
required for such juice even if it has not been processed in the manner
described in Sec. 101.17(g)(7), so long as the lack of such processing
is disclosed in documents accompanying the juice, in accordance with
the practice of the trade.
(4) Under Sec. 101.17(g)(4), the compliance date for the rule
depends on the nature of the juice. For apple juice and apple cider,
the compliance date is 60 days after the date of publication in the
Federal Register; for all juices other than apple juice and apple
cider, the compliance date is 120 days after the date of publication in
the Federal Register.
(5) Under Sec. 101.17(g)(4), manufacturers of packaged juices may
comply with the rule by means of point-of-sale labeling, e.g., through
the use of signs or placards, for up to 1 year after the date for
compliance with the rule. In essence, this provision provides all
manufacturers, regardless of size, the alternative of using labeling
for a single juice season.
(6) The provision in proposed Sec. 101.17(g)(4) (now
Sec. 101.17(g)(5)) that the term ``WARNING'' immediately precede the
remainder of the warning statement has been deleted because it is
redundant with the requirements of Sec. 101.17(g)(2).
(7) The provision in proposed Sec. 101.17(g)(6) (now
Sec. 101.17(g)(7)) establishing the processing standard for juices to
be exempt from the warning statement requirement has been broadened. It
now includes juice processed in a manner that will achieve or exceed
any pathogen reduction performance standard established in any final
regulation requiring the application of HACCP principles to the
processing of juice.
VIII. Final Regulatory Impact Analysis
FDA has examined the impacts of this final rule under Executive
Order 12866. Executive Order 12866 directs Federal agencies to assess
the costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). According
to Executive Order 12866, a regulatory action is ``significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs or if it
raises novel legal or policy issues. FDA finds that this final rule is
a significant regulatory action as defined by Executive Order 12866.
In addition, FDA has determined that this rule is not a significant
rule under the Unfunded Mandates Reform Act of 1995 (UMRA) requiring
benefit-cost and other analyses. Under UMRA significant rule is defined
as ``a Federal mandate that may result in the expenditure by State,
local and tribal governments in the aggregate, or by the private
sector, of $100,000,000 (adjusted annually for inflation) in any 1
year.''
Finally, in accordance with the Small Business Regulatory
Enforcement and Fairness Act, the Administrator of the Office of
Information and Regulatory Affairs of the Office of Management and
Budget (the Administrator) has determined that this final rule is not a
major rule for the purpose of congressional review. A major rule for
this purpose is defined as one that the Administrator has determined
has resulted or is likely to result in an annual effect on the economy
of $100 million or more; a major increase in costs or prices for
consumers, individual industries, Federal, State, or local government
agencies, or geographic regions; or significant adverse effects on
competition, employment, investment, productivity, innovation, or on
the ability of U.S.-based enterprises to compete with foreign-based
enterprises in domestic or export markets.
In the Federal Register of May 1, 1998 (63 FR 24254), FDA published
a Proposed Regulatory Impact Analysis (PRIA) analyzing the benefits,
costs, and regulatory options of proposed regulations regarding warning
statement requirements and HACCP for juice. FDA received several
comments on the PRIA from juice processors, trade associations, and
consumers. In this document, FDA is finalizing the labeling provisions.
FDA intends to publish a final rule on the HACCP requirements at a
later date. Thus, FDA is only analyzing the impacts of the warning
statement requirement.
A. Regulatory Alternatives
1. Prohibit Display of Warning Statement on Signs
FDA received several comments objecting to the proposed provisions
that would temporarily allow the use of signs or other labeling to
communicate the warning statement.
65. Several comments stated that FDA did not accurately address the
costs or benefits of this proposed provision. For example, some
comments asserted that signs with the warning statement will
communicate that all of the juice in a refrigerated case is subject to
the warning statement and thereby impose costs on processors of
pasteurized juice. Some other comments said that signs with the warning
statement may not be close enough to the product to be effective in
achieving the benefits that the agency seeks. FDA believes that the
problems mentioned by these comments will not be significant. Both
retailers and sales representatives of products to which the warning
statements do not apply have a financial interest in ensuring that the
warning statements (particularly in sign or placard form) are not used
in a way that would create the appearance that the warning statement
applies to a broader set of products than required by this rule. For
example, retailers may place signs on individual shelves rather than
over entire refrigerated cases. In some stores that do sell untreated
juice, the untreated juice products are sold in separate refrigerators
in the produce section while pasteurized juice is sold with the other
refrigerated products. Thus, products that need to be accompanied by
the warning statement may be physically separated from other juices.
Also, the sign or placard could specify by name the products covered by
the warning statement. For these reasons, the agency disagrees with
these comments and declines to adjust estimates of the benefits or
costs of the rule based on them.
2. Require a 5-Log Process
66. Some comments said that requiring a process to achieve a 5-log
reduction in pathogens as the alternative to the warning statement on
untreated juice is too expensive an alternative for small businesses
that wish to avoid the warning statement. One comment from a small
juice processor said that implementing pasteurization to achieve a 5-
log reduction would cost $30,000. Some other comments asserted that all
juice should be required to be pasteurized.
In the PRIA, FDA provided an estimate of the cost of pasteurization
equipment developed especially for small juice processors ($18,200).
The agency does acknowledge that this may be a significant cost for
some small businesses. Although the agency is encouraging juice
processors to implement pasteurization or other process controls
sufficient to achieve a
[[Page 37049]]
5-log reduction in pathogens, FDA is not mandating a 5-log reduction at
this time. Instead, this final rule permits processors to produce
untreated juice and offer it for sale accompanied by the warning
statement until a final HACCP regulation (if one is established) is in
place. The agency believes that requiring a warning statement on
untreated juice is the least stringent regulatory approach acceptable
for untreated juice. Processors (especially processors of very small
volumes of juice) may find that including the warning statement on
untreated juice is a less expensive alternative to implementing a 5-log
pathogen reduction process.
However, as noted, FDA believes that requiring pasteurization of
all juice would unnecessarily restrict innovation and new product
development. Such activities are important to maintain competitiveness
in the food industry. Additionally, the agency believes that consumer
choice would be unnecessarily restricted by requiring all firms to
implement a single type of processing technology. Until the agency has
the opportunity to review all comments received in response to the
HACCP proposal, the agency is satisfied that the proposed approach is
the best balance between achieving the intended benefits and allowing
flexibility for production.
3. Require Preventive Controls
67. Some comments suggested that FDA should implement GMP or HACCP
(preventive control) requirements immediately rather than require
warning statements on untreated juice products. Other comments
supported the use of a warning statement on food products only as an
interim measure until the agency establishes a more comprehensive
solution to the problem of microbial contamination in juice. FDA
recognizes the importance of preventive controls and has tentatively
concluded that it is essential to implement a HACCP regulation for
juice. The agency also believes that it is essential to communicate the
risks associated with untreated juice to consumers during the
considerable amount of time that will be required for the agency to
finalize and implement an inherently more complex HACCP regulation for
juice.
4. Require Brochures
68. As described earlier, some comments supported the use of
brochures or pamphlets outlining the risks associated with the
consumption of untreated juices as an alternative to a label warning
statement. FDA declines to require brochures as an alternative in this
rule because the focus group research shows that brochures would
generate fewer benefits than the approach taken in this rule. FDA
further notes that requiring the distribution of a brochure with each
package of juice is likely to be at least as costly as placing stickers
on each package label.
5. Change Length of Time Signs are Allowed
69. Some comments opposed the length of time that signs with the
warning statement would be allowed (until January 1, 2000, the next
uniform compliance date for other food labeling changes and until
January 1, 2001 for small businesses) under the proposed rule. These
comments claimed that signs would be less effective than labels in
communicating the warning information.
FDA finds merit in these comments. The agency agrees that placards
and signs may be less effective than package labels for the purpose of
communicating product-specific information to consumers. However, as a
practical matter, producers of untreated juice need time to modify
their package labels to include the warning statement. In response to
the concerns about the effectiveness of signs and placards, in this
final rule, FDA is reducing the length of time that the warning
statement may be provided in labeling such as signs or placards. FDA
has concluded that a full juice season provides all firms, whether
large or small, sufficient time to comply with the label requirement.
Accordingly, this final rule provides that the required label statement
may be provided in labeling at point of purchase, for a period of 1
year from the date for compliance with the final rule. The interim use
of signs, placards, or other labeling for 1 year from the date when
compliance is required will, in essence, provide manufacturers the
flexibility to use labeling for a single juice season.
B. Benefits
1. Estimates of Juice Consumption
70. One comment stated that FDA had underestimated the amount of
untreated juice consumed and, therefore, had underestimated the number
of cases of illness that would be addressed by the rule. FDA disagrees
that the cases of illness addressed by the rule have been
underestimated as a result of the agency's consumption estimates. FDA
did not estimate the number of cases of illness based on consumption;
instead, the agency estimated the number of cases of illness by
multiplying confirmed illnesses associated with juice by factors
accounting for the under reporting on foodborne illness. Thus, FDA does
not agree with this comment.
2. Recent Activity Not Accounted For
71. Some comments asserted that the agency's estimates of illness
are outdated because these estimates do not take into account the
recent steps that the industry and State governments have taken to
reduce risk associated with juice.
FDA has used the most up-to-date information available on foodborne
illness associated with juice. Complete data from the Centers for
Disease Control and Prevention for 1997 are not available. The agency
acknowledges that industry and State governments have been working to
reduce the public health risks associated with consumption of untreated
juice, and FDA encourages these efforts and hopes that they continue.
However, because FDA has no evidence that the industry and State
government efforts have sufficiently minimized the risk associated with
juice, the agency believes that the warning statement is needed to
inform the choices of consumers. Further, the rule will provide an
incentive to continue to improve upon these efforts. Where these
efforts of industry achieve a 5-log reduction in pathogens, those
processors using such processes are not required to apply the warning
statement to their products.
3. Value of Information
72. Some comments said that consumers would value the information
in the warning statement because it would increase their ability to
make informed choices.
FDA agrees that to the extent that the warning statement lowers the
cost to consumers of obtaining information, there is a benefit to
consumers in addition to the reduction in illnesses estimated in the
PRIA. Although FDA is unable to quantify this benefit, it is
appropriately counted as an unquantified benefit of the final rule.
4. Impact of Warning Statement on Lawsuits
73. One comment claimed that the warning statement will protect
processors from lawsuits and bad publicity because consumers of the
product will be taking responsibility for the risk associated with the
product. Another comment said that the warning statement will encourage
more lawsuits because the warning statement will suggest to consumers
that the juice may be the cause of their symptoms.
State liability laws and their interpretations vary. These
conflicting comments provided no specifics on these issues. FDA is not
able to evaluate the impact of the warning statement on the filing or
adjudication of lawsuits. For this reason, the agency has not made
[[Page 37050]]
any changes to the benefits or costs estimated for this rule based on
these comments.
5. Benefits Summary
Table 1 shows the quantified benefits estimated for the labeling
rule in both the PRIA and Final Regulatory Impact Analysis (FRIA (see
section VIII of this document)). No comments persuaded the agency to
change the quantified benefits of the rule. There are two additional
unquantified benefits that, as a result of comments, the agency
acknowledges. The first unquantified benefit is the value of the
warning information to consumers regardless of changes in their
consumption patterns; the agency is unable to quantify this benefit.
Second, the agency believes that there will be some increase in
benefits resulting from requiring the warning statement on package
labels sooner than originally proposed; the agency is unable to
quantify this benefit.
Table 1.--Quantified Benefits for Labeling Rule as Estimated in PRIA and
FRIA
------------------------------------------------------------------------
PRIA high FRIA high
PRIA low estimate FRIA low estimate estimate estimate
------------------------------------------------------------------------
$1 million $1 million $6 million $6 million
------------------------------------------------------------------------
C. Costs
1. Effect of Warning Statement on Untreated Juice Sales
FDA received comments regarding the impact of the warning statement
on sales of untreated juice. These effects stem from either consumer
reaction, retailer response, or both.
74. Some comments said that the warning statement will have a
negative effect on sales of untreated juice. FDA acknowledges this
possible effect. In fact, the agency intends for the warning statement
to reduce the consumption of untreated juice by consumers who are most
at risk. The inevitable consequence of this goal is to have a negative
effect on the sales of untreated juice.
FDA received one comment demonstrating that a market for
unpasteurized juice does exist and may not be significantly harmed by
the warning statement requirement of this rule. This comment from a
juice processor stated that he produces both pasteurized and
unpasteurized cider. The unpasteurized cider is sold accompanied by a
leaflet warning consumers of the risk associated with untreated juice.
This processor reports that 70 percent of his sales continue to come
from unpasteurized cider.
FDA applauds this processor's responsible actions. The agency is
not, in this rule, prohibiting the sale of untreated juice, nor does
the agency believe that the warning statement will dissuade all
consumers from purchasing untreated juice. FDA believes that at-risk
consumers should carefully consider the consumption of untreated juice
and the availability of the warning statement will allow informed
decisionmaking by consumers. It is quite possible that this processor
will see no change in the demand for either type of juice as a result
of this rule, since the processor was already providing consumers with
the warning information and offering them a product that has been
subject to a 5-log reduction in pathogens. In fact, the agency believes
that the experience of this processor shows that this rule will not
have the extreme consequences described by some of the comments.
75. Some comments said that the warning statement will confuse
consumers, that at-risk consumers will not be deterred from consuming
untreated juice, and that consumers who are not at risk will be
deterred from consuming juice.
FDA disagrees with these comments because the agency believes that
the warning statement communicates a clear, appropriately targeted
message. Importantly, the agency does not claim that all at-risk
consumers will stop consuming untreated juice. FDA's estimates of
consumption changes range from an expected 5 percent to a maximum of 16
percent. The comments that referred to a larger than 16 percent decline
in consumption and sales during the last cider season were based on the
effects of adverse publicity surrounding the outbreaks associated with
untreated apple juice and cider, not on the effects of labeling. Any
costs that resulted from adverse publicity that occurred before the
agency first became involved in this issue are not attributable to this
rulemaking. FDA believes that the decline in sales experienced by some
producers in response to adverse general publicity are not indicative
of the potential effects of labeling that provides true and not
misleading information. Moreover, these sales declines have already
occurred and cannot occur again for the same processors. However, the
agency acknowledges that some consumers who are not at high risk may
choose not to purchase untreated juice because of the warning
statement. The agency believes that consumers are better off whenever
they make better informed choices, and that better informed choices
demonstrate unambiguously an increase in net societal benefits.
76. Some comments from juice processors said that retailers will
refuse to sell products with warning statements. Some comments said
that virtually all chain and large grocery stores have stopped selling
untreated apple juice because of the publicity of the illnesses
associated with untreated apple juice. In addition, some comments from
citrus processors said that retailers would refuse to carry citrus
juice with the warning statement just as apple juice processors have
experienced. These comments stated that they expected a 50 percent
reduction in sales because retail stores would not even offer consumers
the choice of untreated juice with the warning statement. Some comments
said, because of their concern that the warning labels will have a
negative impact on citrus juice (including pasteurized as well as
citrus fruit sold), that the warning statement would cause catastrophic
damage to the Florida citrus industry.
FDA acknowledges that retailers may have this reaction to juice
products with the warning statement. Like consumers who may decide not
to purchase untreated juice because of the warning statement, retailers
may decide not to buy untreated juice from wholesalers or processors
for retail sale. The agency believes that the warning statement will
have a minor effect on the choice of retailers to carry untreated juice
products. For the most part retailers have already made a decision
about carrying untreated apple juice based on the publicity of the
illnesses associated with untreated apple juice. Also, the agency's
estimates of the impact of the juice HACCP and warning statement
proposals in the PRIA were based on the agency's conjecture that citrus
processors may be able to achieve and validate a 5-log reduction
without pasteurization (63 FR 20450 at 20478). If processors of
untreated citrus juices are able to accomplish this then the citrus
industry will experience little effect of this warning statement rule
because citrus juices would then not require the warning statement. The
agency does not believe that this rule
[[Page 37051]]
will have a significant impact on the citrus industry.
77. Some comments said that retailers will refuse to place signs
bearing warning statements so that processors will have to place the
warning statements on the juice package. One comment representing
retailers indicated that retailers did not want the agency to permit
the warning statement to appear on signs.
If the only issue is whether the warning statement appears on signs
or on package labels, then retailers could make it a condition of sale
that the warning statement be on the product package so that they do
not have to deal with signs. The agency believes that these issues are
best left to the market to determine. Regardless of how these issues
are resolved, they do not result in costs of the rule that should be
included in the FRIA.
A reduction in sales of untreated juice as a result of the warning
statement is not a social cost of the rule if the effect of the warning
statement is to restore consumers to a correct understanding of the
actual risk posed by consumption. In fact, all estimated gains to
public health reflect the agency's belief that the effect of the
warning statement is to enable consumers to more correctly account for
this risk. However, if the warning statement results in exaggerated
consumer risk perceptions, then the warning statement would result in
excess reduction in the demand for untreated juice and new, unintended
social costs. These new social costs would include reductions in both
consumers' and producers' surplus. Thus, the magnitude of net social
benefit depends on the extent to which the warning statement changes
consumer risk perceptions so as to result in a new demand that
overshoots or undershoots the socially optimal demand.
2. Effect of Warning Statement on Pasteurized Juice Sales
78. Some comments asserted that the warning statement will have a
negative effect on the sales of pasteurized juice. One comment stated
that the warning label would eliminate the competitive edge that
untreated juice has over pasteurized juice. Another comment said that
the warning statement will eliminate consumer confusion about the
difference in risk between pasteurized and unpasteurized products.
FDA agrees that the warning statement referring specifically to
unpasteurized products will provide consumers with more information and
increase consumers' ability to make informed choices between the two
types of juice. Comments that claimed that the warning statement would
negatively affect sales of pasteurized juice provided no information or
other justification for such statements. Likewise, the agency is
unaware of any research showing that warning statements referring to
one type of product have a negative impact on the sale of products to
which the warning statement does not apply. FDA agrees with the comment
that untreated juice will lose some competitive advantage with
pasteurized juice. In fact, FDA believes it likely that the warning
statement will have a small but positive effect on sales of pasteurized
juice because the most likely alternative for consumers who wish to
avoid juices covered by the warning statement (i.e., untreated juice)
is the purchase and consumption of pasteurized juice, because the
closest substitute for unpasteurized juice is probably pasteurized
juice.
3. Effect of Warning Statement on International Trade
79. Some comments said that the warning statement could act as a
non-tariff trade barrier both to U.S. processors who are interested in
exporting untreated juice and to foreign processors who import
untreated juice into the United States.
FDA disagrees with these comments. This rule is not a prohibited
trade barrier. U.S. trade obligations permit the agency to establish
measures that regulate the safety of imported foods as long as the
measures are consistent with the Sanitary and Phytosanitary (SPS)
agreement. Trade agreements administered by the World Trade
Organization (WTO) require that WTO members not apply measures that are
more restrictive to imported goods than to domestic goods, without
science-based justification. This is not the case with this rule.
Further the trade agreements require that measures be based on risk
assessment, appropriate to the circumstances, taking into account
available scientific information, relevant processes and production
methods; and other relevant factors. The agency believes it carried out
a comprehensive and science-based evaluation of the risks in making its
decision to require a warning statement. The agency recognizes that its
decision can impact trade, but believes that the resulting measure is
fully consistent with the rights and obligations of the WTO agreements.
4. Cost of Label Change
80. Some comments stated that the warning statement should appear
on product labels within 60 days of publication of the final rule.
These comments said that label changes could be made by very small
businesses easily, quickly, and at very low cost. Some other comments
said that if the warning statement were required to be included on
product labels this season, processors would suffer extreme hardship
and expense. These comments requested more time before the warning
statement is required to be placed on labels.
In the PRIA, FDA estimated the cost of label changes for compliance
periods of different lengths. In light of these conflicting comments,
the agency has further considered the costs of including the warning
statement on package labels. As a result of these investigations, FDA
is revising the estimate of the administrative costs of the label
change in the case of this rule.
The comments outlined the activities and changes that are specific
to the juice warning statement situation and identified the activities
involved for this rule that are different from those for most label
changes. The estimate for administrative costs in the PRIA was based on
a model for calculating costs of labeling changes based on more
comprehensive changes in food labels. FDA is convinced that the label
change involved in this specific rule is simpler and therefore requires
a lesser effort (Ref. 14). Because the agency is prescribing the exact
words to be used in the warning statement and because affected
processors have been so significantly alerted to FDA's intent to
establish the rule, the administrative costs of determining the need to
and manner in which to comply should be greatly reduced from other
labeling change situations. FDA estimates that the administrative costs
of making this label change would require 8 labor hours. At $13 per
labor hour, the estimated administrative cost is approximately $100 for
a 1-year compliance period. Table 2 shows the label change costs for
different compliance periods as estimated in the PRIA and in this FRIA.
[[Page 37052]]
Table 2.--Integrated Label Change Costs per SKU for Different Lengths of the Compliance Period
----------------------------------------------------------------------------------------------------------------
Item 2 Months PRIA 2 Months FRIA 6 Months PRIA 6 Months FRIA 1 Year PRIA 1 Year FRIA
----------------------------------------------------------------------------------------------------------------
Administrative
Costs $6,000 $700 $1,800 $200 $900 $100
Redesign Costs $1,500 $1,500 $450 $450 $450 $450
Inventory Loss $800 $800 $250 $250 $0 $0
Total Integrated
Labels $8,300 $3,000 $2,500 $900 $1,350 $550
----------------------------------------------------------------------------------------------------------------
81. Some comments suggested that stickers could be used to
supplement existing labels within 2 months. The agency has investigated
the cost of using stickers to augment the package labels so as to
include the warning statement on packages without changing labels
existing in inventory. Stickers would result in no redesign or
inventory loss. However, there would be administrative costs for
designing, ordering and coordinating placement of the stickers. The
agency believes that the administrative cost for using stickers is
significantly lower than that for integrated label changes in the same
period of time. In addition to administrative costs, use of stickers
would result in costs for printing the stickers and labor and equipment
needed to apply the stickers. Table 3 shows the estimated cost for
stickers for a very small juice processor producing approximately
10,000 gallons of juice per season. This size plant is typical of the
processors likely to be affected by this rule.
Table 3.--Label Sticker Costs
------------------------------------------------------------------------
Item Cost
------------------------------------------------------------------------
Administrative Costs $100
Printing Costs $250
Application Costs $600
Total Stickers $1,000
------------------------------------------------------------------------
5. Costs Summary
FDA has relied on the most recent data available to estimate risks
of foodborne illness from untreated juice and the costs associated with
this rulemaking. Information about baseline risk is somewhat older than
information about cost; hence, estimates of baseline risk do not
account for changes that may have occurred since public concern about
the safety of untreated juice arose. However, cost estimates treat as
``sunk'' those expenditures that firms and consumers have made in
recent years in response to concerns about the risks associated with
untreated juice.
The quantifiable costs of this final rule include the cost of signs
or placards, earlier implementation of pathogen controls to avoid
warning statements, and changing container labels to include the
warning statement.
In this final rule, FDA is requiring that the warning statement
appear on products sooner than the proposed rule would have required.
The costs estimated in the PRIA were based on a 2-year compliance
period. The costs of label changes estimated in this FRIA are based on
a 1-year compliance period (2,980 firms x $550 per firm = $1,639,000).
As discussed earlier, the agency acknowledges one category of
unquantified costs that result from responses to the comments,
specifically, the transaction cost of the working of the legal system
for increased product liability lawsuits. The agency believes this cost
will be small.
Table 4 shows the quantified costs estimated for the rule in the
PRIA and FRIA.
Table 4.--Costs Estimated for Rule in PRIA and FRIA
------------------------------------------------------------------------
Cost PRIA Estimate FRIA Estimate
------------------------------------------------------------------------
Signs and Placards $398,000 $398,000
Earlier Implementation of
Pathogen Controls to Avoid
Warning Statement $2,688,000 $2,688,000
Container Labels $1,301,000 $1,639,000
Total $4,387,000 $4,725,000
------------------------------------------------------------------------
IX. Final Regulatory Flexibility Analysis
FDA has examined the impacts of this final rule under the
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C.
601-612) requires federal agencies to consider alternatives that would
minimize the economic impact of their regulations on small businesses
and other small entities. In compliance with the Regulatory Flexibility
Act (RFA), FDA finds that this final rule will have a significant
impact on a substantial number of small entities.
The agency has evaluated comments on the juice labeling proposal
and on the Preliminary Regulatory Impact Analysis (PRIA) and Initial
Regulatory Flexibility Analysis (IRFA) on matters that bear on small
business impacts. The agency's responses to these comments are set out
in the next section; that section is followed by a summary of the
estimates of costs of this final rule to small businesses.
A. Responses to Comments
1. Warning Statement Effect on Viability of Small Businesses
82. Some comments asserted that the warning statement will harm the
viability of small farm businesses. Some of these comments said that
the price of purchasing, installing, and operating pathogen controls
(so as to avoid application of the warning statement) was too much for
small businesses to pay.
[[Page 37053]]
FDA acknowledges that the initiation of new pathogen controls may
be a significant expenditure for some small businesses. However, the
agency believes that the public health risk associated with untreated
juice is significant enough to warrant requiring all juice either to be
subject to pathogen controls or to bear a statement warning consumers
of the health risks associated with untreated juice. These public
health risks exist regardless of the size of the producer--small or
large. Very few untreated juice processors are stand-alone businesses.
Instead, virtually all are side businesses of orchards that use fruit
not sent to packing houses for making juice. This primary business--
growing fruit for whole packing--should not be adversely affected by
this rule.
2. Expense of Label Changes for Small Businesses
83. As noted, some comments stated that the warning statement
should be required to appear on product labels within 60 days of
publication of the final rule. These comments said that label changes
could be made by very small businesses easily, quickly, and at very low
cost. Other comments asserted that if the warning statement was
required to be included on product labels this season, processors would
suffer extreme hardship and expense. These comments requested more time
before the warning statement was required to be placed on labels.
As described in the FRIA above, FDA has revised the estimate of the
administrative costs of the label change in the case of this rule. The
agency has determined that it is appropriate to reduce the length of
time that manufacturers will be permitted to provide the required
warning statement in labeling, (e.g., on signs and placards) to up to 1
year from the date for compliance with the rule. This will allow the
warning statement to appear on signs and placards for one juice season.
3. Coverage of Small Juice Processors
84. One comment requested that processors of less than 40,000
gallons of juice annually be exempt from the rule. The comment stated
that small farmers use untreated juice production as an automatic
stabilizer to augment their income from the sale of whole fruit,
probably when growing conditions are bad. According to the comment, not
all fruit grown in an orchard meets the size, shape and other standards
necessary for it to be sold as whole fruit. It is not unusual for these
culls to amount to 10 percent of the harvest; when crop growing
conditions are less favorable (e.g., due to hail damage), the
percentage of culls is greater. Farmers may sell culls to large
processors for processed juice and other highly processed fruit
products, or they may use culls to produce their own untreated juice.
The comment asserted that culls used for untreated juice production
return 300 percent to 400 percent more than culls sold for highly
processed products. Other comments, however, said that small businesses
should not be exempt from the rule.
FDA's labeling proposal did not exempt any juice processors. The
agency understands that small businesses may lose some income as a
result of this rule. The agency believes, however, that it is essential
that consumers be informed of the risk associated with the consumption
of untreated juice regardless of the size of the processor. The risk
faced by the consumer is related only to the product and not to the
size of the product's processor. The agency has sought to craft this
rule in the most cost-effective manner in order to minimize the rule's
burden on processors while still attaining the goals of the rule. Given
this fact, the agency is not aware of any rational basis related to the
rule's goal that would justify completely excluding small processors
from the labeling requirement.
4. Level Playing Field for Business
85. Some comments asserted that the proposed rule gave unfair
advantages to large corporations. Other comments claimed that the
proposal would give undue consideration to small businesses. Comments
on both sides of this issue requested that the agency establish ``a
level playing field'' for business. FDA interprets a request for a
``level playing field'' as a request for equitable treatment. The RFA
(as amended in 1995) and Executive Order 12866 require that FDA address
the issue of equity. The agency has considered these issues, including
regulatory alternatives that would reduce the burden on small
businesses, and has determined that the risks to public health
associated with untreated juice are such that small processors should
not be excluded from the labeling requirement.
B. Objectives
The RFA requires a succinct statement of the purpose and objectives
of any rule that will have a significant impact on a substantial number
of small entities.
This rule responds to the need to alert consumers to the potential
risk of foodborne illness from consumption of juice products not
pasteurized or otherwise processed to destroy pathogens that may be
present; these pathogens pose a risk of serious foodborne illness. FDA
is requiring warning statements for such juice products to inform
consumers of the potential hazard of pathogens in such products; such
labeling is not required for juice that is processed to achieve a 5-log
reduction in the pertinent microorganism. If FDA finalizes a rule
requiring the application of HACCP principles to the processing of
juice, the warning statement will no longer be required for those
products that achieve a pathogen reduction that is equal to, or greater
than, the standard established in a HACCP final rule.
C. Definition of Small Business and Number of Small Businesses Affected
The RFA requires a statement of the definition of small business
used in the analysis and a description of the number of small entities
affected.
Table 5 shows the definition of small business for each type of
establishment affected by the rule and an estimate of the number of
small entities of each type. The agency has applied the Small Business
Administration (SBA) definitions of small business for this analysis.
Table 5.--Approximate Number of Small Establishments Covered by This Rule
----------------------------------------------------------------------------------------------------------------
Percentage of No. of Small
Standard Industry SBA Definition of Small Category Establishments
Type of Establishment Classification Codes by Category Defined as Covered by
Small by SBA Rule
----------------------------------------------------------------------------------------------------------------
Juice manufacturers in the OEI 2033, 2037 Less than 500 employees 75% 20
Roadside-type apple juice 2033, 2037 Less than 500 employees 100% 1,600
makers
Roadside-type orange juice 2033, 2037 Less than 500 employees 100% 300
makers
Grocery stores and 5411 Less than $20 million 85% 1,100
supermarkets processing at of annual sales
point of sale
[[Page 37054]]
Total 3,020
----------------------------------------------------------------------------------------------------------------
D. Description of Impact on Small Entities
1. Costs to Small Entities
Table 6 shows the average cost for small entities that can
reasonably predict, based on the proposed rule, that they will be
required to implement an adequate HACCP program and will therefore
implement 5-log pathogen controls (to avoid use of the warning
statement) earlier than they would if the warning statement was not
required for products without validated 5-log pathogen process
controls. Table 6 also shows the average cost for small entities that
will not expect to implement 5-log pathogen controls in the future.
These entities will be required to adopt the warning statement for
their products. The private costs to small businesses of the warning
statement also include the lost revenue that results from a reduction
in sales. These costs are not societal costs and are therefore not
included in the costs estimated in the FRIA.
Table 6.--Average Cost of Compliance for Small Entities
----------------------------------------------------------------------------------------------------------------
Cost for Entities Cost for Entities
Item Covered by HACCP not Covered by
Rule HACCP Rule
----------------------------------------------------------------------------------------------------------------
Sign or Placard $100
Container Label Change $550
Lost Sales Resulting From Warning Statement (for 5-16% loss on average
sales of $20,000) $1,000-$3,200
Early Implementation of 5-Log Pathogen Controls to Avoid Labeling $16,000
Total $16,000 $1,650-$3,850
----------------------------------------------------------------------------------------------------------------
The impacts that the costs will have on a firm will vary depending
on the total revenue derived from juice by a firm and the profit
(return on sales) associated with juice production. Data on food
manufacturing firms indicates that 75 percent of firms have a return on
sales of less than 5 percent.
2. Professional Skills Required for Compliance
The RFA requires a description of the professional skills required
for compliance with this rule. Compliance will require managerial
skills necessary to design, order, and utilize signs and labels.
3. Recordkeeping Requirements
The RFA requires a description of the recordkeeping requirements of
the rule. There are no recordkeeping requirements.
E. Description of Outreach to Small Entities
The RFA requires a description of the outreach activities taken by
the agency to inform small entities about the rule and to encourage
comments from small businesses.
In addition to publishing the proposed rule in the Federal
Register, the agency published the rule on the FDA world-wide web site
to make the text of the rule more easily and widely accessible. The web
site contains instructions about how to submit comments to the agency.
FDA officials have on several occasions made speeches and presentations
at meetings where small entities have been represented by trade
associations, legal counsel, and academic juice specialists who are
providing assistance to small entities for commenting and complying.
FDA has also made a number of special mailings of the rule to small
entities requesting individual paper copies and has fielded a number of
phone inquiries about the rule.
F. Minimizing the Burden on Small Entities
The RFA requires an evaluation of any regulatory overlaps and
regulatory alternatives that would minimize the costs to small
entities.
1. On Requiring a 5-Log Process
86. Some comments said that requiring a process to achieve a 5-log
reduction in pathogens as the alternative to the warning statement on
untreated juice was too expensive an alternative for small businesses
that wish to avoid the warning statement. One comment asserted that
implementing pasteurization to achieve a 5-log reduction would cost
$30,000. Other comments claimed that all juice should be required to be
pasteurized.
In the PRIA, FDA provided an estimate of the cost of pasteurization
equipment developed especially for small juice processors ($18,200).
The agency understands that this may be a significant cost for some
small businesses. Although the agency is encouraging juice processors
to implement pasteurization or other process controls sufficient to
achieve a 5-log reduction in pathogens, at this time, FDA is not
mandating a 5-log reduction. Instead, this final rule permits
processors to produce untreated juice and offer it for sale accompanied
by the warning statement until a final HACCP regulation (if one is
established) requires such processors to implement process controls
sufficient to achieve a 5-log reduction in pathogens. The agency
believes that requiring a warning statement on untreated juice is the
least stringent regulatory approach acceptable for untreated juice.
Processors (especially processors of very small volumes of juice) may
find that including the warning statement on untreated juice is a less
expensive alternative to implementing a 5-log pathogen reduction
process.
However, as noted earlier, FDA believes that requiring
pasteurization of all juice would unnecessarily restrict innovation and
new product and process development. Such activities
[[Page 37055]]
are important to maintain competitiveness in the food industry.
Additionally, the agency believes that consumer choice would be
unnecessarily restricted by requiring all firms to implement a single
type of processing technology. At this time, the agency is satisfied
that the proposed approach is the best balance between achieving the
intended benefits to consumers and allowing flexibility for production.
2. Change Length of Time Signs are Allowed for Small Businesses
The proposed rule would have allowed the use of signs or placards
until January 1, 2000, the next uniform compliance date for other food
labeling changes, and until January 1, 2001 for small businesses to
relieve the burden on such businesses.
87. Some comments opposed the length of time that signs with the
warning statement would be permitted. These comments asserted that
signs would be less effective than labels in communicating the hazard
information. Some of these comments also opposed the additional time
allowed for small businesses to comply with the requirement that the
warning statement appear on the labels of their products. The comments
asserted that the public health concern with untreated juice existed
whether the producing firm was large or small. Other comments supported
giving small businesses additional time to place warning statements on
packages.
The agency agrees that placards and signs may be somewhat less
effective than labels for the purpose of communicating product-specific
information to consumers. However, as a practical matter, producers of
untreated juice need time to modify their labels to include the warning
statement. In response to the concerns about the effectiveness of signs
and placards, in this final rule, FDA is reducing the length of time
that manufacturers will be allowed to provide the warning statement in
labeling. The label change is not complex. FDA believes that small
businesses will not experience more difficulty than large businesses in
making the change. Therefore, FDA is giving small and large businesses
the same amount of time to make the change. Accordingly, this final
rule provides that the required warning statement may be provided in
labeling at point of purchase until 1 year from the date that firms
must comply with the requirements of the final rule. The interim use of
labeling (e.g., signs or placards) for 1 year will, in essence, provide
manufacturers the option of using labeling for a single juice season.
G. Summary of Regulatory Flexibility Analysis
FDA has examined the impact of the rule on small businesses in
accordance with the RFA. This analysis, together with the FRIA and
remainder of the preamble, constitutes the Final Regulatory Flexibility
Analysis. FDA has determined that this rule will have a significant
impact on a substantial number of small entities.
X. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (63 FR 20486 at 20491). No
new information or comments have been received that would affect the
agency's previous determination that this action is of a type that does
not individually or cumulatively have a significant impact on the human
environment (21 CFR 25.30(k)). Thus, neither an environmental
assessment nor an environmental impact statement is required.
XI. Paperwork Reduction Act of 1995
FDA concludes that the labeling requirements 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
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)).
XII. References
1. Williams, R., T. Wilcox, B. Timbo, D. Street, C. Nardinelli,
P. McCarthy, G. Jackson, M. T. Hendricks, and E. Elliot,
``Preliminary Investigation Into the Morbidity and Mortality Effects
Associated With the Consumption of Fruit and Vegetable Juices,''
October 31, 1997.
2. Miller, A. J., R. C. Whiting, and J. L. Smith, ``Use of Risk
Assessment to Reduce Listeriosis Incidence,'' Food Technology,
51:100-103, 1997.
3. FDA memorandum, ``Consumer Awareness of Unpasteurized Juice
as a Risk,'' Brenda M. Derby to Elizabeth Campbell, June 22, 1998.
4. Stewart, D. W. and I. M. Martin, ``Intended and Unintended
Consequences of Warning Messages: A Review and Synthesis of
Empirical Research,'' Journal of Public Policy and Marketing,
13(1):1-19, 1994.
5. FDA memorandum, Alan S. Levy to Kenneth Falci, June 26, 1997.
6. FDA memorandum, ``Consumer Awareness of Voluntary Labeling,''
Brenda M. Derby to Elizabeth Campbell, June 22, 1998.
7. Fratamico, P. M., M. Y. Deng, T. P. Strobaugh, S. A. Palumbo,
``Construction and Characterization of Escherichia coli 0157:H7
Strains Expressing Firefly Luciferase and Green Fluorescent Protein
and Their Use in Survival Studies,'' Journal of Food Protection,
60(10):1167-1173, 1997.
8. FDA Memorandum, Robert L. Buchanan to the Record, June 15,
1998.
9. Centers for Disease Control, ``Salmonella typhimurium
Outbreak Traced to a Commercial Apple Cider--New Jersey,'' Morbidity
and Mortality Weekly Report, 24:87-88, 1975.
10. 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.
11. Miller, L. G. and C. W. Kaspar, ``Escherichia coli 0157:H7
Acid Tolerance and Survival in Apple Cider,'' Journal of Food
Protection, 57(6):460-464, 1994.
12. 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.
13. FDA Memorandum, David Zorn to Elizabeth Campbell, June 18,
1998.
14. FDA Memorandum, David Zorn to The Record, June 19, 1998.
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 authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 101 is 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.
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.
(2) The label of:
(i) Any juice that has not been processed in the manner described
in paragraph (g)(7) of this section; or
[[Page 37056]]
(ii) Any beverage containing juice where neither the juice
ingredient nor the beverage has 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 that can cause serious illness in
children, the elderly, and persons with weakened immune systems.
(3) The warning statement required by this paragraph (g) shall not
apply to juice that is not for distribution to retail consumers in the
form shipped and that is for use solely in the manufacture of other
foods or that is to be processed, labeled, or repacked at a site other
than originally processed, provided that for juice that has not been
processed in the manner described in paragraph (g)(7) of this section,
the lack of such processing is disclosed in documents accompanying the
juice, in accordance with the practice of the trade.
(4) 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) For apple juice or apple cider, the warning statement may
appear in labeling, including signs or placards, until September 8,
1999;
(ii) For all juices other than apple juice or apple cider, the
warning statement may appear in labeling, including signs or placards,
until November 5, 1999.
(5) The word ``WARNING'' shall be capitalized and shall appear in
bold type.
(6) 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.
(7)(i) The requirements in this paragraph (g) shall not apply to a
juice that has been processed in a manner that will produce, at a
minimum, a 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, of the following magnitude:
(A) A 5-log (i.e., 100,000-fold) reduction; or
(B) A reduction that is equal to, or greater than, the criterion
established for process controls by any final regulation requiring the
application of Hazard Analysis Critical Control Points (HACCP)
principles to the processing of juice.
(ii) For the purposes of this paragraph (g), the ``pertinent
microorganism'' is the most resistant microorganism of public health
significance that is likely to occur in the juice.
Dated: July 2, 1998.
Michael A. Friedman,
Acting Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 98-18287 Filed 7-6-98; 3:34 pm]
BILLING CODE 4160-01-F
