37030 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

1As 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.

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N–0524]

RIN 0910–AA43

Food Labeling: Warning and Notice

Statement; Labeling of Juice Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

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

products1 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.

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 § 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

§ 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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

§ 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

§ 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).
37032 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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)
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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
37034 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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

§ 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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
37036 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

2The 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.

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 healthrelated 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

§ 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

§ 101.17(g)(3)(ii) provided that small

businesses could provide the warning

statement in labeling until January 1,

2001.

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 (§ 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 37037

3As 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.

4The effective date for all other meat and poultry

products was July 6, 1994.

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.

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.

Given these circumstances, the

alternative provided by§ 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 § 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
37038 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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 NonApple 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 § 101.17(g)(6)) and in this

final rule (§ 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,
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 37039

5Alternatively, 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.

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

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 § 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

§ 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 § 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

§ 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

§ 101.17(g)(1). In contrast, citrus oils are

not ‘‘juices’’ under § 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

§ 101.17(g)(1) has been processed in a

manner that satisfies the pathogen

reduction performance standard in

§ 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 § 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 § 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

§ 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 § 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

§ 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

§ 101.17(g)(6), the requirement for a

warning statement would not apply to

juice processed in a manner that
37040 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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

§ 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

§ 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 § 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,
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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

§ 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

§ 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

§ 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
37042 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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 § 120.24. Accordingly, the

agency incorporated this standard into

the juice labeling proposal in proposed

§ 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 § 101.17(g)(7)(i)(A)) the

provision of proposed § 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 § 101.17(g)(6)

to include (as § 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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
37044 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

warning is the more suitable term

because it is consistent with past agency

regulations (e.g., § 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.
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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 ‘‘lifethreatening 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 § 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 § 101.17(g)(4) (now

§ 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

§ 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,
37046 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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 § 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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, § 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

§ 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,

§ 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

§ 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 § 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 § 101.17(g)(3), clarifies

how FDA intended to cover juice used

as an ingredient.
37048 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

(3) New § 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 § 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 § 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 § 101.17(g)(4),

manufacturers of packaged juices may

comply with the rule by means of pointof-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

§ 101.17(g)(4) (now § 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

§ 101.17(g)(2).

(7) The provision in proposed

§ 101.17(g)(6) (now § 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 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
37050 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

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 low estimate FRIA low estimate PRIA high estimate FRIA high 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 atrisk 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
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 37051

will have a significant impact on the

citrus industry.

77. Some comments said that retailers

will refuse to place signs bearing

warning statements so that processors

will have to place the warning

statements on the juice package. One

comment representing retailers

indicated that retailers did not want the

agency to permit the warning statement

to appear on signs.

If the only issue is whether the

warning statement appears on signs or

on package labels, then retailers could

make it a condition of sale that the

warning statement be on the product

package so that they do not have to deal

with signs. The agency believes that

these issues are best left to the market

to determine. Regardless of how these

issues are resolved, they do not result in

costs of the rule that should be included

in the FRIA.

A reduction in sales of untreated juice

as a result of the warning statement is

not a social cost of the rule if the effect

of the warning statement is to restore

consumers to a correct understanding of

the actual risk posed by consumption.

In fact, all estimated gains to public

health reflect the agency’s belief that the

effect of the warning statement is to

enable consumers to more correctly

account for this risk. However, if the

warning statement results in

exaggerated consumer risk perceptions,

then the warning statement would result

in excess reduction in the demand for

untreated juice and new, unintended

social costs. These new social costs

would include reductions in both

consumers’ and producers’ surplus.

Thus, the magnitude of net social

benefit depends on the extent to which

the warning statement changes

consumer risk perceptions so as to

result in a new demand that overshoots

or undershoots the socially optimal

demand.

2. Effect of Warning Statement on

Pasteurized Juice Sales

78. Some comments asserted that the

warning statement will have a negative

effect on the sales of pasteurized juice.

One comment stated that the warning

label would eliminate the competitive

edge that untreated juice has over

pasteurized juice. Another comment

said that the warning statement will

eliminate consumer confusion about the

difference in risk between pasteurized

and unpasteurized products.

FDA agrees that the warning

statement referring specifically to

unpasteurized products will provide

consumers with more information and

increase consumers’ ability to make

informed choices between the two types

of juice. Comments that claimed that the

warning statement would negatively

affect sales of pasteurized juice

provided no information or other

justification for such statements.

Likewise, the agency is unaware of any

research showing that warning

statements referring to one type of

product have a negative impact on the

sale of products to which the warning

statement does not apply. FDA agrees

with the comment that untreated juice

will lose some competitive advantage

with pasteurized juice. In fact, FDA

believes it likely that the warning

statement will have a small but positive

effect on sales of pasteurized juice

because the most likely alternative for

consumers who wish to avoid juices

covered by the warning statement (i.e.,

untreated juice) is the purchase and

consumption of pasteurized juice,

because the closest substitute for

unpasteurized juice is probably

pasteurized juice.

3. Effect of Warning Statement on

International Trade

79. Some comments said that the

warning statement could act as a nontariff trade barrier both to U.S.

processors who are interested in

exporting untreated juice and to foreign

processors who import untreated juice

into the United States.

FDA disagrees with these comments.

This rule is not a prohibited trade

barrier. U.S. trade obligations permit the

agency to establish measures that

regulate the safety of imported foods as

long as the measures are consistent with

the Sanitary and Phytosanitary (SPS)

agreement. Trade agreements

administered by the World Trade

Organization (WTO) require that WTO

members not apply measures that are

more restrictive to imported goods than

to domestic goods, without sciencebased justification. This is not the case

with this rule. Further the trade

agreements require that measures be

based on risk assessment, appropriate to

the circumstances, taking into account

available scientific information, relevant

processes and production methods; and

other relevant factors. The agency

believes it carried out a comprehensive

and science-based evaluation of the

risks in making its decision to require a

warning statement. The agency

recognizes that its decision can impact

trade, but believes that the resulting

measure is fully consistent with the

rights and obligations of the WTO

agreements.

4. Cost of Label Change

80. Some comments stated that the

warning statement should appear on

product labels within 60 days of

publication of the final rule. These

comments said that label changes could

be made by very small businesses easily,

quickly, and at very low cost. Some

other comments said that if the warning

statement were required to be included

on product labels this season,

processors would suffer extreme

hardship and expense. These comments

requested more time before the warning

statement is required to be placed on

labels.

In the PRIA, FDA estimated the cost

of label changes for compliance periods

of different lengths. In light of these

conflicting comments, the agency has

further considered the costs of including

the warning statement on package

labels. As a result of these

investigations, FDA is revising the

estimate of the administrative costs of

the label change in the case of this rule.

The comments outlined the activities

and changes that are specific to the juice

warning statement situation and

identified the activities involved for this

rule that are different from those for

most label changes. The estimate for

administrative costs in the PRIA was

based on a model for calculating costs

of labeling changes based on more

comprehensive changes in food labels.

FDA is convinced that the label change

involved in this specific rule is simpler

and therefore requires a lesser effort

(Ref. 14). Because the agency is

prescribing the exact words to be used

in the warning statement and because

affected processors have been so

significantly alerted to FDA’s intent to

establish the rule, the administrative

costs of determining the need to and

manner in which to comply should be

greatly reduced from other labeling

change situations. FDA estimates that

the administrative costs of making this

label change would require 8 labor

hours. At $13 per labor hour, the

estimated administrative cost is

approximately $100 for a 1-year

compliance period. Table 2 shows the

label change costs for different

compliance periods as estimated in the

PRIA and in this FRIA.
37052 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

TABLE 2.—INTEGRATED LABEL CHANGE COSTS PER SKU FOR DIFFERENT LENGTHS OF THE COMPLIANCE PERIOD

Item 2 Months PRIA 2 Months FRIA 6 Months PRIA 6 Months FRIA 1 Year PRIA 1 Year FRIA

Administrative Costs $6,000 $700 $1,800 $200 $900 $100

Redesign Costs $1,500 $1,500 $450 $450 $450 $450

Inventory Loss $800 $800 $250 $250 $0 $0

Total Integrated Labels $8,300 $3,000 $2,500 $900 $1,350 $550

81. Some comments suggested that

stickers could be used to supplement

existing labels within 2 months. The

agency has investigated the cost of using

stickers to augment the package labels

so as to include the warning statement

on packages without changing labels

existing in inventory. Stickers would

result in no redesign or inventory loss.

However, there would be administrative

costs for designing, ordering and

coordinating placement of the stickers.

The agency believes that the

administrative cost for using stickers is

significantly lower than that for

integrated label changes in the same

period of time. In addition to

administrative costs, use of stickers

would result in costs for printing the

stickers and labor and equipment

needed to apply the stickers. Table 3

shows the estimated cost for stickers for

a very small juice processor producing

approximately 10,000 gallons of juice

per season. This size plant is typical of

the processors likely to be affected by

this rule.

TABLE 3.—LABEL STICKER COSTS

Item Cost

Administrative Costs $100

Printing Costs $250

Application Costs $600

Total Stickers $1,000

5. Costs Summary

FDA has relied on the most recent

data available to estimate risks of

foodborne illness from untreated juice

and the costs associated with this

rulemaking. Information about baseline

risk is somewhat older than information

about cost; hence, estimates of baseline

risk do not account for changes that may

have occurred since public concern

about the safety of untreated juice arose.

However, cost estimates treat as ‘‘sunk’’

those expenditures that firms and

consumers have made in recent years in

response to concerns about the risks

associated with untreated juice.

The quantifiable costs of this final

rule include the cost of signs or

placards, earlier implementation of

pathogen controls to avoid warning

statements, and changing container

labels to include the warning statement.

In this final rule, FDA is requiring

that the warning statement appear on

products sooner than the proposed rule

would have required. The costs

estimated in the PRIA were based on a

2-year compliance period. The costs of

label changes estimated in this FRIA are

based on a 1-year compliance period

(2,980 firms x $550 per firm =

$1,639,000).

As discussed earlier, the agency

acknowledges one category of

unquantified costs that result from

responses to the comments, specifically,

the transaction cost of the working of

the legal system for increased product

liability lawsuits. The agency believes

this cost will be small.

Table 4 shows the quantified costs

estimated for the rule in the PRIA and

FRIA.

TABLE 4.—COSTS ESTIMATED FOR RULE IN PRIA AND FRIA

Cost PRIA Estimate FRIA Estimate

Signs and Placards $398,000 $398,000

Earlier Implementation of Pathogen Controls to Avoid Warning Statement $2,688,000 $2,688,000

Container Labels $1,301,000 $1,639,000

Total $4,387,000 $4,725,000

IX. Final Regulatory Flexibility

Analysis

FDA has examined the impacts of this

final rule under the Regulatory

Flexibility Act. The Regulatory

Flexibility Act (5 U.S.C. 601–612)

requires federal agencies to consider

alternatives that would minimize the

economic impact of their regulations on

small businesses and other small

entities. In compliance with the

Regulatory Flexibility Act (RFA), FDA

finds that this final rule will have a

significant impact on a substantial

number of small entities.

The agency has evaluated comments

on the juice labeling proposal and on

the Preliminary Regulatory Impact

Analysis (PRIA) and Initial Regulatory

Flexibility Analysis (IRFA) on matters

that bear on small business impacts. The

agency’s responses to these comments

are set out in the next section; that

section is followed by a summary of the

estimates of costs of this final rule to

small businesses.

A. Responses to Comments

1. Warning Statement Effect on Viability

of Small Businesses

82. Some comments asserted that the

warning statement will harm the

viability of small farm businesses. Some

of these comments said that the price of

purchasing, installing, and operating

pathogen controls (so as to avoid

application of the warning statement)

was too much for small businesses to

pay.
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 37053

FDA acknowledges that the initiation

of new pathogen controls may be a

significant expenditure for some small

businesses. However, the agency

believes that the public health risk

associated with untreated juice is

significant enough to warrant requiring

all juice either to be subject to pathogen

controls or to bear a statement warning

consumers of the health risks associated

with untreated juice. These public

health risks exist regardless of the size

of the producer—small or large. Very

few untreated juice processors are

stand-alone businesses. Instead,

virtually all are side businesses of

orchards that use fruit not sent to

packing houses for making juice. This

primary business—growing fruit for

whole packing—should not be adversely

affected by this rule.

2. Expense of Label Changes for Small

Businesses

83. As noted, some comments stated

that the warning statement should be

required to appear on product labels

within 60 days of publication of the

final rule. These comments said that

label changes could be made by very

small businesses easily, quickly, and at

very low cost. Other comments asserted

that if the warning statement was

required to be included on product

labels this season, processors would

suffer extreme hardship and expense.

These comments requested more time

before the warning statement was

required to be placed on labels.

As described in the FRIA above, FDA

has revised the estimate of the

administrative costs of the label change

in the case of this rule. The agency has

determined that it is appropriate to

reduce the length of time that

manufacturers will be permitted to

provide the required warning statement

in labeling, (e.g., on signs and placards)

to up to 1 year from the date for

compliance with the rule. This will

allow the warning statement to appear

on signs and placards for one juice

season.

3. Coverage of Small Juice Processors

84. One comment requested that

processors of less than 40,000 gallons of

juice annually be exempt from the rule.

The comment stated that small farmers

use untreated juice production as an

automatic stabilizer to augment their

income from the sale of whole fruit,

probably when growing conditions are

bad. According to the comment, not all

fruit grown in an orchard meets the size,

shape and other standards necessary for

it to be sold as whole fruit. It is not

unusual for these culls to amount to 10

percent of the harvest; when crop

growing conditions are less favorable

(e.g., due to hail damage), the

percentage of culls is greater. Farmers

may sell culls to large processors for

processed juice and other highly

processed fruit products, or they may

use culls to produce their own untreated

juice. The comment asserted that culls

used for untreated juice production

return 300 percent to 400 percent more

than culls sold for highly processed

products. Other comments, however,

said that small businesses should not be

exempt from the rule.

FDA’s labeling proposal did not

exempt any juice processors. The

agency understands that small

businesses may lose some income as a

result of this rule. The agency believes,

however, that it is essential that

consumers be informed of the risk

associated with the consumption of

untreated juice regardless of the size of

the processor. The risk faced by the

consumer is related only to the product

and not to the size of the product’s

processor. The agency has sought to

craft this rule in the most cost-effective

manner in order to minimize the rule’s

burden on processors while still

attaining the goals of the rule. Given this

fact, the agency is not aware of any

rational basis related to the rule’s goal

that would justify completely excluding

small processors from the labeling

requirement.

4. Level Playing Field for Business

85. Some comments asserted that the

proposed rule gave unfair advantages to

large corporations. Other comments

claimed that the proposal would give

undue consideration to small

businesses. Comments on both sides of

this issue requested that the agency

establish ‘‘a level playing field’’ for

business. FDA interprets a request for a

‘‘level playing field’’ as a request for

equitable treatment. The RFA (as

amended in 1995) and Executive Order

12866 require that FDA address the

issue of equity. The agency has

considered these issues, including

regulatory alternatives that would

reduce the burden on small businesses,

and has determined that the risks to

public health associated with untreated

juice are such that small processors

should not be excluded from the

labeling requirement.

B. Objectives

The RFA requires a succinct

statement of the purpose and objectives

of any rule that will have a significant

impact on a substantial number of small

entities.

This rule responds to the need to alert

consumers to the potential risk of

foodborne illness from consumption of

juice products not pasteurized or

otherwise processed to destroy

pathogens that may be present; these

pathogens pose a risk of serious

foodborne illness. FDA is requiring

warning statements for such juice

products to inform consumers of the

potential hazard of pathogens in such

products; such labeling is not required

for juice that is processed to achieve a

5-log reduction in the pertinent

microorganism. If FDA finalizes a rule

requiring the application of HACCP

principles to the processing of juice, the

warning statement will no longer be

required for those products that achieve

a pathogen reduction that is equal to, or

greater than, the standard established in

a HACCP final rule.

C. Definition of Small Business and

Number of Small Businesses Affected

The RFA requires a statement of the

definition of small business used in the

analysis and a description of the

number of small entities affected.

Table 5 shows the definition of small

business for each type of establishment

affected by the rule and an estimate of

the number of small entities of each

type. The agency has applied the Small

Business Administration (SBA)

definitions of small business for this

analysis.

TABLE 5.—APPROXIMATE NUMBER OF SMALL ESTABLISHMENTS COVERED BY THIS RULE

Type of Establishment Standard Industry

Classification Codes

SBA Definition of Small by

Category

Percentage of

Category

Defined as

Small by SBA

No. of Small

Establishments

Covered by

Rule

Juice manufacturers in the OEI 2033, 2037 Less than 500 employees 75% 20

Roadside-type apple juice makers 2033, 2037 Less than 500 employees 100% 1,600

Roadside-type orange juice makers 2033, 2037 Less than 500 employees 100% 300

Grocery stores and supermarkets processing at

point of sale

5411 Less than $20 million of annual

sales

85% 1,100
37054 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

TABLE 5.—APPROXIMATE NUMBER OF SMALL ESTABLISHMENTS COVERED BY THIS RULE—Continued

Type of Establishment Standard Industry

Classification Codes

SBA Definition of Small by

Category

Percentage of

Category

Defined as

Small by SBA

No. of Small

Establishments

Covered by

Rule

Total 3,020

D. Description of Impact on Small

Entities

1. Costs to Small Entities

Table 6 shows the average cost for

small entities that can reasonably

predict, based on the proposed rule, that

they will be required to implement an

adequate HACCP program and will

therefore implement 5-log pathogen

controls (to avoid use of the warning

statement) earlier than they would if the

warning statement was not required for

products without validated 5-log

pathogen process controls. Table 6 also

shows the average cost for small entities

that will not expect to implement 5-log

pathogen controls in the future. These

entities will be required to adopt the

warning statement for their products.

The private costs to small businesses of

the warning statement also include the

lost revenue that results from a

reduction in sales. These costs are not

societal costs and are therefore not

included in the costs estimated in the

FRIA.

TABLE 6.—AVERAGE COST OF COMPLIANCE FOR SMALL ENTITIES

Item

Cost for Entities

Covered by HACCP

Rule

Cost for Entities not

Covered by HACCP

Rule

Sign or Placard $100

Container Label Change $550

Lost Sales Resulting From Warning Statement (for 5-16% loss on average sales of $20,000) $1,000-

$3,200

Early Implementation of 5-Log Pathogen Controls to Avoid Labeling $16,000

Total $16,000 $1,650-

$3,850

The impacts that the costs will have

on a firm will vary depending on the

total revenue derived from juice by a

firm and the profit (return on sales)

associated with juice production. Data

on food manufacturing firms indicates

that 75 percent of firms have a return on

sales of less than 5 percent.

2. Professional Skills Required for

Compliance

The RFA requires a description of the

professional skills required for

compliance with this rule. Compliance

will require managerial skills necessary

to design, order, and utilize signs and

labels.

3. Recordkeeping Requirements

The RFA requires a description of the

recordkeeping requirements of the rule.

There are no recordkeeping

requirements.

E. Description of Outreach to Small

Entities

The RFA requires a description of the

outreach activities taken by the agency

to inform small entities about the rule

and to encourage comments from small

businesses.

In addition to publishing the

proposed rule in the Federal Register,

the agency published the rule on the

FDA world-wide web site to make the

text of the rule more easily and widely

accessible. The web site contains

instructions about how to submit

comments to the agency. FDA officials

have on several occasions made

speeches and presentations at meetings

where small entities have been

represented by trade associations, legal

counsel, and academic juice specialists

who are providing assistance to small

entities for commenting and complying.

FDA has also made a number of special

mailings of the rule to small entities

requesting individual paper copies and

has fielded a number of phone inquiries

about the rule.

F. Minimizing the Burden on Small

Entities

The RFA requires an evaluation of

any regulatory overlaps and regulatory

alternatives that would minimize the

costs to small entities.

1. On Requiring a 5-Log Process

86. Some comments said that

requiring a process to achieve a 5-log

reduction in pathogens as the

alternative to the warning statement on

untreated juice was too expensive an

alternative for small businesses that

wish to avoid the warning statement.

One comment asserted that

implementing pasteurization to achieve

a 5-log reduction would cost $30,000.

Other comments claimed that all juice

should be required to be pasteurized.

In the PRIA, FDA provided an

estimate of the cost of pasteurization

equipment developed especially for

small juice processors ($18,200). The

agency understands that this may be a

significant cost for some small

businesses. Although the agency is

encouraging juice processors to

implement pasteurization or other

process controls sufficient to achieve a

5-log reduction in pathogens, at this

time, FDA is not mandating a 5-log

reduction. Instead, this final rule

permits processors to produce untreated

juice and offer it for sale accompanied

by the warning statement until a final

HACCP regulation (if one is established)

requires such processors to implement

process controls sufficient to achieve a

5-log reduction in pathogens. The

agency believes that requiring a warning

statement on untreated juice is the least

stringent regulatory approach acceptable

for untreated juice. Processors

(especially processors of very small

volumes of juice) may find that

including the warning statement on

untreated juice is a less expensive

alternative to implementing a 5-log

pathogen reduction process.

However, as noted earlier, FDA

believes that requiring pasteurization of

all juice would unnecessarily restrict

innovation and new product and

process development. Such activities
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations 37055

are important to maintain

competitiveness in the food industry.

Additionally, the agency believes that

consumer choice would be

unnecessarily restricted by requiring all

firms to implement a single type of

processing technology. At this time, the

agency is satisfied that the proposed

approach is the best balance between

achieving the intended benefits to

consumers and allowing flexibility for

production.

2. Change Length of Time Signs are

Allowed for Small Businesses

The proposed rule would have

allowed the use of signs or placards

until January 1, 2000, the next uniform

compliance date for other food labeling

changes, and until January 1, 2001 for

small businesses to relieve the burden

on such businesses.

87. Some comments opposed the

length of time that signs with the

warning statement would be permitted.

These comments asserted that signs

would be less effective than labels in

communicating the hazard information.

Some of these comments also opposed

the additional time allowed for small

businesses to comply with the

requirement that the warning statement

appear on the labels of their products.

The comments asserted that the public

health concern with untreated juice

existed whether the producing firm was

large or small. Other comments

supported giving small businesses

additional time to place warning

statements on packages.

The agency agrees that placards and

signs may be somewhat less effective

than labels for the purpose of

communicating product-specific

information to consumers. However, as

a practical matter, producers of

untreated juice need time to modify

their labels to include the warning

statement. In response to the concerns

about the effectiveness of signs and

placards, in this final rule, FDA is

reducing the length of time that

manufacturers will be allowed to

provide the warning statement in

labeling. The label change is not

complex. FDA believes that small

businesses will not experience more

difficulty than large businesses in

making the change. Therefore, FDA is

giving small and large businesses the

same amount of time to make the

change. Accordingly, this final rule

provides that the required warning

statement may be provided in labeling

at point of purchase until 1 year from

the date that firms must comply with

the requirements of the final rule. The

interim use of labeling (e.g., signs or

placards) for 1 year will, in essence,

provide manufacturers the option of

using labeling for a single juice season.

G. Summary of Regulatory Flexibility

Analysis

FDA has examined the impact of the

rule on small businesses in accordance

with the RFA. This analysis, together

with the FRIA and remainder of the

preamble, constitutes the Final

Regulatory Flexibility Analysis. FDA

has determined that this rule will have

a significant impact on a substantial

number of small entities.

X. Environmental Impact

The agency has previously considered

the environmental effects of this rule as

announced in the proposed rule (63 FR

20486 at 20491). No new information or

comments have been received that

would affect the agency’s previous

determination that this action is of a

type that does not individually or

cumulatively have a significant impact

on the human environment (21 CFR

25.30(k)). Thus, neither an

environmental assessment nor an

environmental impact statement is

required.

XI. Paperwork Reduction Act of 1995

FDA concludes that the labeling

requirements in this document are not

subject to review by the Office of

Management and Budget because they

do not constitute a ‘‘collection of

information’’ under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). Rather, the warning statement is

‘‘public disclosure of information

originally supplied by the Federal

government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)).

XII. References

1. Williams, R., T. Wilcox, B. Timbo, D.

Street, C. Nardinelli, P. McCarthy, G. Jackson,

M. T. Hendricks, and E. Elliot, ‘‘Preliminary

Investigation Into the Morbidity and

Mortality Effects Associated With the

Consumption of Fruit and Vegetable Juices,’’

October 31, 1997.

2. Miller, A. J., R. C. Whiting, and J. L.

Smith, ‘‘Use of Risk Assessment to Reduce

Listeriosis Incidence,’’ Food Technology,

51:100–103, 1997.

3. FDA memorandum, ‘‘Consumer

Awareness of Unpasteurized Juice as a Risk,’’

Brenda M. Derby to Elizabeth Campbell, June

22, 1998.

4. Stewart, D. W. and I. M. Martin,

‘‘Intended and Unintended Consequences of

Warning Messages: A Review and Synthesis

of Empirical Research,’’ Journal of Public

Policy and Marketing, 13(1):1–19, 1994.

5. FDA memorandum, Alan S. Levy to

Kenneth Falci, June 26, 1997.

6. FDA memorandum, ‘‘Consumer

Awareness of Voluntary Labeling,’’ Brenda

M. Derby to Elizabeth Campbell, June 22,

1998.

7. Fratamico, P. M., M. Y. Deng, T. P.

Strobaugh, S. A. Palumbo, ‘‘Construction and

Characterization of Escherichia coli 0157:H7

Strains Expressing Firefly Luciferase and

Green Fluorescent Protein and Their Use in

Survival Studies,’’ Journal of Food

Protection, 60(10):1167–1173, 1997.

8. FDA Memorandum, Robert L. Buchanan

to the Record, June 15, 1998.

9. Centers for Disease Control, ‘‘Salmonella

typhimurium Outbreak Traced to a

Commercial Apple Cider—New Jersey,’’

Morbidity and Mortality Weekly Report,

24:87–88, 1975.

10. Centers for Disease Control and

Prevention, ‘‘Outbreaks of Escherichia coli

O157:H7 Infection and Cryptosporidiosis

Associated With Drinking Unpasteurized

Apple Cider—Connecticut and New York,

October 1996,’’ Morbidity and Mortality

Weekly Report, 46(1):4–8, 1997.

11. Miller, L. G. and C. W. Kaspar,

‘‘Escherichia coli 0157:H7 Acid Tolerance

and Survival in Apple Cider,’’ Journal of

Food Protection, 57(6):460–464, 1994.

12. Centers for Disease Control and

Prevention, ‘‘Outbreak of Escherichia coli

O157:H7 Infections Associated with Drinking

Unpasteurized Commercial Apple Juice—

British Columbia, California, Colorado, and

Washington, October 1996,’’ Morbidity and

Mortality Weekly Report, 45(44):975, 1996.

13. FDA Memorandum, David Zorn to

Elizabeth Campbell, June 18, 1998.

14. FDA Memorandum, David Zorn to The

Record, June 19, 1998.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.17 is amended by

adding paragraph (g) to read as follows:

§ 101.17 Food labeling warning and notice

statements.

* * * * *

(g) Juices that have not been

specifically processed to prevent,

reduce, or eliminate the presence of

pathogens. (1) For purposes of this

paragraph (g), ‘‘juice’’ means the

aqueous liquid expressed or extracted

from one or more fruits or vegetables,

purees of the edible portions of one or

more fruits or vegetables, or any

concentrate of such liquid or puree.

(2) The label of:

(i) Any juice that has not been

processed in the manner described in

paragraph (g)(7) of this section; or
37056 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 /Rules and Regulations

(ii) Any beverage containing juice

where neither the juice ingredient nor

the beverage has been processed in the

manner described in paragraph (g)(7) of

this section, shall bear the following

warning statement:

WARNING: This product has not been

pasteurized and, therefore, may contain

harmful bacteria that can cause serious

illness in children, the elderly, and persons

with weakened immune systems.

(3) The warning statement required by

this paragraph (g) shall not apply to

juice that is not for distribution to retail

consumers in the form shipped and that

is for use solely in the manufacture of

other foods or that is to be processed,

labeled, or repacked at a site other than

originally processed, provided that for

juice that has not been processed in the

manner described in paragraph (g)(7) of

this section, the lack of such processing

is disclosed in documents

accompanying the juice, in accordance

with the practice of the trade.

(4) The warning statement required by

paragraph (g)(2) of this section shall

appear prominently and conspicuously

on the information panel or on the

principal display panel of the label of

the container, except that:

(i) For apple juice or apple cider, the

warning statement may appear in

labeling, including signs or placards,

until September 8, 1999;

(ii) For all juices other than apple

juice or apple cider, the warning

statement may appear in labeling,

including signs or placards, until

November 5, 1999.

(5) The word ‘‘WARNING’’ shall be

capitalized and shall appear in bold

type.

(6) The warning statement required by

paragraph (g)(2) of this section, when on

a label, shall be set off in a box by use

of hairlines.

(7)(i) The requirements in this

paragraph (g) shall not apply to a juice

that has been processed in a manner

that will produce, at a minimum, a

reduction in the pertinent

microorganism for a period at least as

long as the shelf life of the product

when stored under normal and

moderate abuse conditions, of the

following magnitude:

(A) A 5-log (i.e., 100,000-fold)

reduction; or

(B) A reduction that is equal to, or

greater than, the criterion established for

process controls by any final regulation

requiring the application of Hazard

Analysis Critical Control Points

(HACCP) principles to the processing of

juice.

(ii) For the purposes of this paragraph

(g), the ‘‘pertinent microorganism’’ is

the most resistant microorganism of

public health significance that is likely

to occur in the juice.

Dated: July 2, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–18287 Filed 7–6–98; 3:34 pm]

BILLING CODE 4160–01–F