Food Labeling: Warning and Notice Statement; Labeling of Juice Products

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.

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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.

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\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.

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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.

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\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.

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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

t

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