20486 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

1 In this proposal, the terms ‘‘juice’’ and ‘‘juice

products’’ are used interchangeably. Thus, ‘‘juice’’

refers both to beverages that are composed

exclusively of an aqueous liquid or liquids

extracted from one or more fruits or vegetables and

those beverages that contain other ingredients in

addition to juice. Similarly, ‘‘juice product’’ refers

both to beverages that contain only juice and

beverages that are composed of juice and other

ingredients.

this chapter, shall include in their

Hazard Analysis and Critical Control

Point (HACCP) plans control measures

that will produce, at a minimum, a 5 log

(i.e., 105) reduction, for a period at least

as long as the shelf life of the product

when stored under normal and

moderate abuse conditions, in the

pertinent microorganism. For the

purposes of this regulation, the

‘‘pertinent microorganism’’ is the most

resistant microorganism of public health

significance that is likely to occur in the

juice.

Dated: April 17, 1998.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–11025 Filed 4–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N–0524]

RIN 0910–AA43

Food Labeling: Warning and Notice

Statements; Labeling of Juice

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

require warning statements on packaged

fruit and vegetable juice products that

have not been processed to destroy

pathogenic microorganisms that may be

present. FDA is taking this action

because of the recent outbreaks of

foodborne illness and deaths caused by

consumption of juice products that were

not pasteurized or otherwise processed

to control pathogenic microorganisms.

This requirement for warning labels will

serve to reduce the risk of foodborne

illness. Elsewhere in this issue of the

Federal Register, FDA is proposing to

require that juice be processed under a

Hazard Analysis and Critical Control

Point program (HACCP).

DATES: Submit written comments by

May 26, 1998. See section V of the

SUPPLEMENTARY INFORMATION section of

this document for the proposed effective

date of a final rule based on this

document.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Geraldine A. June, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5099.

SUPPLEMENTARY INFORMATION:

I. Background

There recently have been outbreaks of

foodborne illness associated with the

consumption of juice and beverages

containing juice, i.e., juice products,

that have not been pasteurized or

otherwise treated to destroy pathogenic

microorganisms.1 On October 30, 1996,

the Seattle-King County Department of

Public Health and the Washington State

Department of Health reported an

outbreak of Escherichia coli O157:H7

infections epidemiologically associated

with consumption of unpasteurized

apple juice. The outbreak resulted in at

least 66 cases of illness in 3 western

States and British Columbia, and the

death of 1 child (Refs. 1 and 2).

Pathogens other than E. coli O157:H7

may be present in apple and other types

of juice products and have been

documented as the cause of foodborne

illness. In particular, outbreaks caused

by Salmonella typhimurium and

Cryptosporidium in apple cider (Refs. 3,

4, and 5) and Vibrio cholerae in coconut

milk (Ref. 6) have been reported. In

addition, outbreaks caused by

consumption of unpasteurized orange

juice contaminated with S. hartford

(Ref. 7), orange juice drink

contaminated with S. agona (Ref. 8),

orange juice contaminated with Bacillus

cereus (Ref. 9), and home-made carrot

juice contaminated with Clostridium

botulinum (Ref. 10) have been reported.

Because of the agency’s concern that

its regulatory program for fresh juices

may not be adequate to ensure the

production of safe juice and juice

products, and because of the severity of

the recent outbreak of E. coli O157:H7

associated with apple juice, the agency

held a public meeting on December 16

and 17, 1996, to discuss safety issues

presented by juice products. At that

meeting, FDA met with interested

parties to review the current science,

including technological and safety

factors, relating to fresh juice

production and to consider the

measures that would be necessary to

provide safe fruit and vegetable juices.

Experts from industry, academia, and

the regulatory and consumer sectors

presented information on illnesses and

the epidemiology of outbreaks arising

from microbially contaminated juices;

concerns with emerging pathogens;

procedures for processing juices; and

new and existing technology to control

pathogens in juice products.

In light of the information developed

at the public meeting and in comments

received by the agency, as well as other

information available to the agency,

FDA has developed a strategy that it

believes will address both the

immediate goal of reducing the risk of

foodborne illness associated with juice

products and the long-term goal of

ensuring that juice products are safe. In

the Federal Register of August 28, 1997

(62 FR 45593), the agency published a

notice of intent (‘‘the notice of intent’’)

that announced a comprehensive

program to address the incidence of

foodborne illness related to

consumption of fresh juice and

ultimately to address the safety aspects

of all juice products. The agency invited

comment on the appropriateness of its

strategy to: (1) Initiate rulemaking on a

mandatory HACCP program for some or

all juice products; (2) propose that the

labels or labeling of juice products not

specifically processed to prevent,

reduce, or eliminate the presence of

harmful bacteria bear a warning

statement informing consumers of the

risk of illness associated with

consumption of the product; and (3)

initiate several educational programs to

minimize the hazards associated with

fresh juice. FDA stated that it would

consider comments received within 15

days of publication of the notice of

intent as part of any rule proposed by

the agency.

This document addresses the warning

statements for labels of packaged juice

products that have not been specifically

processed to prevent, reduce, or

eliminate the presence of harmful

pathogens. FDA has reviewed all the

comments received within 15 days of

publication of the notice of intent and

has determined that the comments

provide no information that would

cause the agency to conclude that this

proposal is inappropriate. In this

document, the agency addresses these

comments to the extent that they are

relevant to this proposal. Comments in

response to the notice of intent received

more than 15 days after publication of

that notice that address issues in this
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20487

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).

proposal will be considered in any final

rule published in response to this

proposal.

II. The Proposal

A. Rationale for Proposal

As discussed in the notice of intent,

implementation of a HACCP program

appears to be the best long-term control

measure for pathogens and for other

safety concerns related to the

production and distribution of some or

all juice products. Therefore, elsewhere

in this issue of the Federal Register, the

agency is publishing a proposal (‘‘the

HACCP proposal’’) to require that most

juice be processed under a HACCP

program. However, the agency

recognizes that rulemaking and

implementation of a HACCP program

are time consuming, and that a HACCP

program for some or all juices would

likely not be fully implemented for

several years. During this period of

rulemaking and implementation, the

risk of illness caused by pathogens in

fresh juice will persist. The agency is

concerned that, unless warned,

consumers at greatest risk could suffer

serious illness and even death from the

consumption of juices that have not

been treated to prevent, reduce, or

eliminate microbial pathogens.

Accordingly, FDA has tentatively

concluded that there is an immediate

need to inform consumers of the public

health risks associated with

consumption of untreated juice

products through the use of a warning

on the label of such products.

Implementation of a labeling

requirement can be completed more

quickly than implementation of a

mandatory HACCP program.

Consequently, FDA is proposing to

require that the labels of packaged juice

products not pasteurized or otherwise

specifically processed to prevent,

reduce, or eliminate the presence of

pathogens bear a warning statement

informing consumers of the potential

risk of foodborne illness associated with

the product. As discussed in more detail

in section II of this document, the

agency is also proposing that this

labeling requirement not apply to any

juice processed under an adequate

HACCP program or otherwise processed

in a manner sufficient to destroy

pathogens, e.g., pasteurization, or to any

unpackaged juice sold for immediate

consumption, e.g., products sold by the

glass in restaurants, grocery stores, or

other food establishments.

B. Legal Authority for FDA to Require

Warning Labels

As a general rule, FDA’s authority to

require warning labels on food products

derives from sections 201(n), 403(a)(1),

and 701(a) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

321(n), 343(a)(1), and 371(a)). Under

section 403(a)(1) of the act, a food is

misbranded if its labeling is false or

misleading in any particular.2 Section

201(n) provides that, in determining

whether labeling is misleading, FDA

shall take into account not only

representations made about the product,

but also the extent to which the labeling

fails to reveal facts material in light of

representations made or suggested in

the labeling, or facts material as to

consequences that may result from use

of the product under conditions of use

prescribed in the labeling or under

customary or usual conditions of use.

Section 701(a) of the act authorizes FDA

to issue regulations for the efficient

enforcement of the act. FDA has relied

on the authority of sections 201(n),

403(a), and 701(a) of the act to require

warning labels that alert consumers to

the potential hazards of certain

ingredients of foods and dietary

supplements. (See 49 FR 13679, April 6,

1984 (protein products) and 62 FR 2218,

January 15, 1997 (iron-containing

dietary supplements).)

As previously discussed, some juice

products have been the vehicles of

outbreaks of illnesses from foodborne

pathogens, including E. coli O157:H7

and Salmonella. The consequences of

consuming juice products that contain

pathogenic microorganisms are well

documented; such consumption may

result in serious, life threatening

illnesses or death (Refs. 1 to 7).

Therefore, the agency tentatively

concludes that there is a risk of serious

illness from consuming juice products

that have not been processed in a

manner designed to destroy these

pathogens. Given the possible presence

of pathogens in untreated juice, and the

potential consequences of consumption

of these beverages, the fact that juice

may contain harmful pathogens and the

fact that a product has not been treated

to control such pathogens are material

facts regarding the consequences that

may result from use of these juice

products. Unless these facts are

disclosed to consumers at the time that

they are deciding whether to purchase

and consume the juice, the juice

products are misbranded under sections

201(n) and 403(a)(1) of the act.

Accordingly, the agency is proposing to

require a warning statement on the

labels of packaged juice products not

processed to destroy pathogens. The

agency is not proposing to require

warnings for unpackaged juice (e.g.,

juice sold by the glass in restaurants or

other food establishments). The

proposed regulation does not draw a

distinction between packaged and

unpackaged juice products, because, by

its terms, the regulation applies only to

packaged juice products and not the

unpackaged products. This approach is

consistent with the agency’s food

labeling regulations which do not apply

to food distrubuted to consumers in

unpackaged form unless specifically

noted in the regulations.

C. Covered Products

In the HACCP proposal, FDA is

proposing to define ‘‘juice’’ as the

aqueous liquid expressed or extracted

from one or more fruits or vegetables,

the puree of the edible portion of one or

more fruits or vegetables, or any

concentrate of such liquid or puree. The

agency is proposing that the term

‘‘juice’’ have the same definition for

purposes of the warning statement.

Furthermore, the agency notes that fruit

and vegetable juices may be used as

ingredients in other beverages (e.g.,

diluted juice beverages and flavored

bottled waters). Because these products

often resemble juices, are processed in

a manner that is similar to the manner

in which juices are processed, are

handled by consumers similarly to

juices, and would support pathogen

outgrowth similarly to juices, these

foods are likely to present the same food

hazards as juices. Therefore, consistent

with its HACCP proposal, the agency is

proposing in § 101.17(g)(1) that the

requirement for a warning statement

cover any packaged juice, as defined in

section II.C of this document, sold as

such or used as an ingredient in another

beverage. The agency notes that juice

processed on premises and sold for

immediate consumption in

establishments such as restaurants, instore delis, and juice bars are not subject

to the requirements of this proposal.

D. Circumstances in Which Warning

Statements Required

In comments that it submitted in

response to the public meeting held on

December 16 and 17, 1996, the National

Advisory Committee for Microbiological

Criteria for Foods (NACMCF) stated that

the history of public health problems

with juice necessitates some safety
20488 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

interventions by manufacturers. The

NACMCF recommended that a tolerable

level of risk may be achieved by

requiring interventions that have been

validated to achieve a cumulative 5-log

(i.e., 100,000 fold) reduction in E. coli

0157:H7 or Listeria monocytogenes or a

reduction in the yearly risk of illness to

less than 10-5, assuming consumption of

100 milliliters of juice daily. However,

the NACMCF did not specify the

manner in which this reduction should

be accomplished.

As discussed in the HACCP proposal

published elsewhere in this issue of the

Federal Register, FDA has tentatively

concluded that a 5-log reduction in the

target pathogen is a tolerable level of

risk in juice products. Therefore, for

purposes of the HACCP proposal, the

agency is proposing to require that juice

made by processors but not retailers as

discussed in that proposal be processed

in a manner that will produce, at a

minimum, a 5-log reduction, for a

period at least as long as the shelf life

of the product when stored under

normal and moderate abuse conditions,

in the pertinent microorganism. (As set

out in the HACCP proposal, retail

establishments includes establishments

that process juice for direct sale to

consumers and other retailers, as long as

total annual sales do not exceed 40,000

gallons.) For the purposes of this

regulation, the ‘‘pertinent

microorganism’’ is the most resistant

microorganism of public health

significance that is likely to occur in

juice. (In the remainder of this

document this level of reduction shall

be referred to as ‘‘the 5-log reduction.’’)

FDA recognizes that pasteurization is a

process that can achieve this 5-log

reduction. In addition, manufacturers

may be able to use other technologies

and practices (such as a combination of

eliminating use of drops, brushing,

washing, and using sanitizers) provided

that their process is validated to achieve

the 5-log reduction in the target

pathogen. Therefore, the agency is

proposing in § 101.17(g)(2) to require

that all packaged juice that has not been

processed in a manner that will produce

the 5-log reduction bear a warning

statement alerting consumers to the

potential presence of harmful bacteria.

E. Label Warning Statements

1. Use of Terms ‘‘Pasteurized’’ and

‘‘Unpasteurized’’

The agency considered whether the

use of the terms ‘‘pasteurized’’ and

‘‘unpasteurized’’ on the label without

additional hazard information, would

adequately alert consumers to the

microbiological hazards associated with

some juice products. FDA received

several comments in response to the

notice of intent regarding the use of

these terms. Some comments suggested

that products should be labeled

‘‘unpasteurized’’ to distinguish them

from pasteurized products. Other

comments opposed warning labels for

pasteurized products. According to one

comment, because there have been no

public health problems associated with

pasteurized juice, there should be no

requirement that these products declare

on their label that they are pasteurized.

However, the comment further asserted

that pasteurized juice products should

be permitted to declare that fact

voluntarily on their label.

Comments received in response to the

notice of intent also addressed the

adequacy of labeling using the terms

‘‘pasteurized’’ and ‘‘unpasteurized.’’

One comment stated that use of the

terms ‘‘pasteurized’’ and

‘‘unpasteurized’’ alone, without hazard

information, would be ineffective

communication if consumers do not

know that pasteurization is a heat

treatment designed to kill bacteria and

that these microorganisms, if not

eliminated and if consumed, could

cause life threatening illness for some

consumers.

FDA tentatively agrees with this

comment. Although label statements

indicating whether a product is

pasteurized or unpasteurized may be

useful to consumers who are seeking to

purchase either type product, FDA has

tentatively concluded that use of such

terms would only inform consumers

about the type of treatment, or lack of

treatment, that a juice has received and

would not properly inform consumers

of the risks presented by untreated

juices. Also, FDA is not aware of the

extent to which consumers understand

the terms ‘‘pasteurized’’ and

‘‘unpasteurized.’’ Thus, the agency is

concerned that without effective

consumer education, labeling untreated

juice products as simply

‘‘unpasteurized’’ may not only have

relatively little meaning to consumers

but could even cause confusion. For

example, some consumers may select

unpasteurized juice believing that such

juice is superior to pasteurized juice in

that it is less processed.

In addition, FDA has tentatively

concluded that an untreated packaged

juice product labeled with the term,

‘‘unpasteurized,’’ without an

accompanying statement that describes

the associated microbiological hazards,

or a statement that informs purchasers

that children, the elderly, and the

immunocompromised are at greatest

risk of serious illness from consuming

such product, would be misbranded

under section 403(a)(1) and 201(n) of

the act because such labeling would not

reveal material facts about the

consequences that may result from use

of such juice products.

Finally, FDA is concerned that

requiring juice products to be labeled

only with the terms ‘‘unpasteurized’’ or

‘‘pasteurized’’ would not take into

account technologies other than

pasteurization that may be developed to

control pathogens in juice. Thus,

requiring use of these terms could be

viewed as restricting the development of

new technologies. Several comments

suggested that there are alternate

technologies that could be used to

control microorganisms in juice

products, e.g., irradiation, high pressure

treatment, or pulsed high energy

processes. One comment opposed

labeling that would preclude

alternatives to pasteurization to render

juice products safe. The agency agrees

with this comment and tentatively

concludes that labeling a product as

‘‘unpasteurized’’ may be misleading in

that the term does not distinguish

between a product that may contain

harmful pathogens that could result in

serious disease and one that is treated

using a method (other than

pasteurization) that is capable of

achieving a 5-log reduction in the target

pathogen. A product that is processed

by a means other than pasteurization to

achieve a 5-log reduction in the target

pathogen does not have the potential

microbiological hazard, and thus, would

not require a warning statement, yet that

product could not be labeled

‘‘pasteurized.’’ Without additional

information, the consumer would not

know how to interpret the label with the

term ‘‘unpasteurized.’’

Therefore, the agency tentatively

concludes that labeling juice as either

‘‘pasteurized’’ or ‘‘unpasteurized’’

without hazard information would not

adequately inform consumers about the

potential hazard associated with

consumption of juices that have not

been processed to prevent, reduce, or

eliminate the presence of pathogenic

microorganisms. Consistent with this

tentative judgment, FDA has also

tentatively concluded that language that

specifically identifies the hazard, in the

form of a warning statement, is

necessary to inform consumers

effectively of the risks associated with

the consumption of fruit and vegetable

juices that have not been so processed.

Manufacturers who wish to label their

products voluntarily with the term

‘‘pasteurized’’ or with the term

‘‘unpasteurized,’’ along with the

warning statement, may do so under the
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20489

proposed rule, provided that these terms

are used in a truthful and

nonmisleading manner. The agency

requests comments on these tentative

conclusions.

2. Essential Elements of Specific

Warning Statements

Consumer focus group research

available to the agency shows that

certain elements are essential if label

warning statements are to inform

consumers effectively of a hazard (Ref.

11). The agency has previously used this

consumer study information to develop

effective warning statements. For

example, the agency used this

information to craft a warning statement

for iron-containing dietary supplements

(see § 101.17(e) (21 CFR 101.17(e))). As

discussed in the final rule that requires

that such supplements bear a warning

statement (62 FR 2218, January 15,

1997), the elements essential for an

effective warning statement are a

description of the hazard, handling

instructions to avoid the hazard, and an

instructional statement that describes

conditions under which the hazard

occurs and what action to take if the

hazard is not avoided.

The consumer research that FDA has

reviewed shows that when consumers

generally believe that a product is safe,

warning messages that note that a

hazard exists but that do not provide

information about the nature of the

hazard, are likely to confuse or frighten

them (Ref. 11). Therefore, because juice

products have not historically been

considered by consumers to be

hazardous, and because these products

are generally promoted and consumed

as an important part of a healthy diet,

it is critical that any warning statement

for juice clearly describe the potential

hazard to consumers. In this case, the

hazard to be described is the potential

presence of pathogens in the juice that

can cause serious illness. Therefore, the

agency tentatively concludes that to

provide effective information to

consumers of the hazard associated with

some juice products, a brief description

of the particular hazard should be

included in the warning statement.

These consumer research data also show

that the first sentence of a warning

statement is likely to influence a

consumer’s decision as to whether to

continue reading the remainder of the

statement (Ref 11). Therefore, FDA is

proposing that the description of the

hazard appear in the warning statement

and that such description appear in the

first sentence of that statement, i.e., that

juice may contain pathogens known to

cause serious, life-threatening illness.

The second essential element of an

effective warning statement is that it

disclose the reason that the labeled

product presents the hazard. As

discussed previously, consumer

research shows that stating that a

product presents a hazard without

further explanation may be confusing

and frightening to consumers. The

agency is concerned that consumers

may not find credible a warning on a

product that they may have consumed

safely for years. A warning that juice

may be hazardous without an

accompanying statement describing

why the labeled product has the

potential hazard could imply that all

juices are potentially hazardous.

Therefore, the agency tentatively

concludes that it is essential to describe

why a particular juice product has the

potential hazard, i.e., because it has not

been processed in a way that is designed

to destroy harmful pathogens that could

be present.

The final essential element for a

warning statement is an identification of

the groups that are at greatest risk of

illness. Existing data show that certain

subpopulations are more susceptible to

foodborne illness than others.

Specifically, the evidence suggests that

children, the elderly, and persons who

are immunocompromised are at greatest

risk of serious illness from exposure to

foodborne pathogens (Ref. 12). As

previously discussed, juice has been a

vehicle for foodborne pathogens that

have caused serious illness. Therefore, it

is essential that the warning statement

for untreated juice specifically identify

the at-risk groups, so that such

individuals may choose to avoid the

product.

The agency recognizes that the

foregoing elements are somewhat

different from those used in warning

statements on other products. For

example, as previously discussed, the

warning label for iron-containing

supplements contains handling and

instructional statements. Warning

statements for self pressurized

containers in § 101.17(a), (b), and (c),

and for protein products under

§ 101.17(d) also include handling or

instructional statements.

However, the agency tentatively

concludes that, for juices, handling and

instructional information is not

essential for an effective warning

statement. Under this proposal, the

warning statement will include a

description of the hazard, a description

of the source of the hazard, and a

description of the at-risk groups. The

agency believes that it is implicit in this

description that the at-risk consumers

can avoid the hazard by not consuming

the juice product. However, FDA

requests comment on whether the

agency should require a statement

explicitly instructing consumers who

are at greatest risk to avoid the product

and if so, the basis for such requirement.

Applying the essential elements

described above, FDA crafted examples

of warning statements. The following

examples illustrate some of the variation

that could occur in statements by

applying the essential elements.

WARNING: Unless specifically

processed, some juices may contain

harmful bacteria known to cause

serious illness. This product has not

been processed to destroy these

bacteria. The risk of life-threatening

illness is greatest for children, the

elderly, and persons with weakened

immune systems.

WARNING: This product has not

been pasteurized and, therefore, may

contain harmful bacteria that can

cause serious illness in children, the

elderly, and persons with weakened

immune systems.

The following is an alternative

statement that contains the three

essential elements as well as optional

instructional and handling statements.

WARNING: Some juices have been

found to contain harmful bacteria

known to cause life-threatening

illness. This product has not been

processed to destroy these bacteria.

Children, the elderly, and persons

with weakened immune systems

should avoid this product. Consumers

may protect themselves by boiling

this product before serving.

In order to evaluate the examples of

warning statements developed through

use of the essential elements and to test

the effectiveness of such examples in

informing consumers of the hazards

associated with untreated juice

products, FDA conducted focus group

research to evaluate consumer

understanding of several possible

warning statements.

Six focus groups were conducted to

test possible warning statements that

contained the essential elements as well

as the optional handling instructions

(Ref 13). All participants examined and

discussed seven warning statements,

including the three examples presented

above. Most participants initially

viewed the tested warning statements as

very strong messages that indicated that

there is greater risk associated with

unpasteurized juice than these

consumers had previously thought.

Because many juice products do not

state on the label that the product has

been pasteurized, many of the

participants assumed that most juices

are not pasteurized. Once these
20490 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

3Approximately ninety-eight percent of juice sold

in the United States is pasteurized.

consumers understood that most juices

are pasteurized, these consumers no

longer believed that the warning

statements were extreme.3

In comparing and contrasting the

various examples of warning statements,

there was strong consensus across the

groups regarding the preferred warning

statement. Specifically, the participants

strongly preferred a statement that was

short and concise, that clearly stated

that the product was not pasteurized,

and that clearly identified the

consumers at greatest risk of illness. The

focus group discussions also provided

insight into the clarity of different

terminology for conveying the essential

elements. Participants were better able

to understand the warning statement

when the term pasteurization was used

rather than a term such as ‘‘specifically

processed.’’ They also found the term

‘‘harmful bacteria’’ easier to understand

than ‘‘microorganisms.’’ Finally, for the

description of risk groups, participants

preferred the phrase ‘‘weakened

immune systems’’ to the alternative

‘‘immune system deficiencies.’’ Overall,

the participants emphasized the need

for simple, straight-forward language

that could be comprehended by lay

people.

In addition, the focus group research

showed that inclusion of handling

statements that instructed consumers on

how to sterilize unpasteurized juice by

heating it was seen as not particularly

effective. Overall, participants found the

statements somewhat confusing and

reacted rather negatively to these

instructions. Many participants

questioned why they would pasteurize

unpasteurized juice when they could

simply buy pasteurized juice in the first

place.

The focus group research also showed

that minor wording differences, such as

inclusion of the adjective ‘‘fresh’’ in

describing the juice product, had a

strong impact on the participants’

reaction to the statements. Participants

stated that warnings that described the

product as ‘‘fresh’’ were inappropriate

because such description invoked a

positive characteristic (being fresh) that

changed the tone of the warning

statement in a way that made the

statement inconsistent with a serious

warning. The participants believed this

inconsistent tone would create

confusion and that consumers would

not recognize the statement as a

warning.

Based on these findings FDA has

tentatively concluded that requiring a

specific message (i.e., a prescriptive

approach) will be the most effective way

to ensure that consumers are not misled

and correctly understand the warning

statement. This approach will ensure

that consumers of fresh juice are able to

make informed choices about the

products they purchase and consume. In

addition, use of a prescriptive warning

statement for fresh juice is consistent

with warning statements for other food

products (protein products and ironcontaining dietary supplements,

§ 101.17(d) and (e) respectively).

Although FDA stated in the notice of

intent that it would propose essential

elements of a warning statement, the

agency recognized in the notice that,

because the model statements were

untested, there could be a more effective

way to alert consumers to the potential

hazard. The focus group research

directed at warning statement examples

developed through use of elements

demonstrates that allowing variation in

the warning statements may lead to a

misleading message. Therefore, after

having conducted focus group research

directed at warning statements for juices

that have not been treated to destroy

pathogens, and having analyzed the

results of the research, FDA has

tentatively concluded that a prescriptive

approach would be more effective than

the ‘‘elements approach’’ in informing

consumers of the potential hazard.

In addition, FDA believes that a

regulation to require a warning

statement for untreated juices must be

sufficiently clear to allow the regulated

industry to determine that its labeling

complies with that regulation. In

addition, the regulation should establish

a so-called ‘‘level playing field’’ for all

products covered by the regulation by

requiring that each product’s labeling

provide the same information. FDA has

tentatively concluded that by

prescribing the specific language for a

warning statement for untreated juice in

a regulation would accomplish these

two goals, as well as ensure a message

to consumers that is not confusing,

misleading or otherwise ineffective. In

addition, from the agency’s perspective,

the enforcement of a labeling rule is

more straight forward where the

regulation prescribes the contents of the

labeling.

Accordingly, FDA is proposing in

§ 101.17(g)(2) to require that juice

products not processed in a manner that

will produce, at a minimum, a 5-log

reduction in the pertinent

microorganism for a period of at least as

long as the shelf life of the product

when stored under normal and

moderate abuse conditions, bear the

following statement:

WARNING: This product has not

been pasteurized and, therefore, may

contain harmful bacteria that can

cause serious illness in children, the

elderly, and persons with weakened

immune systems.

The agency requests comments on the

specific language of the warning

statement. For example, are the

categories of at-risk consumers

identified too broadly in the warning

statement? Should the at-risk consumers

be more narrowly described, and, if so,

on what basis? For example, is there any

basis for describing certain ages for

‘‘children’’ and the ‘‘elderly’’ or

describing a certain level of ‘‘weakened

immune system?’’ Should the words

that alert consumers to the warning

statement be changed from

‘‘WARNING’’ to ‘‘ATTENTION,’’

‘‘NOTICE,’’ ‘‘CONSUMER ADVISORY,’’

‘‘CONSUMER ALERT,’’ or ‘‘HAZARD

ADVISORY,’’ as suggested by comments

to the notice of intent, or to some other

term?

FDA is also interested in receiving in

comments the results of any other

available consumer research. FDA will

consider the results of such research in

developing any final rule that results

from this proposal.

FDA is proposing the use of the term

‘‘pasteurized’’ rather than ‘‘specifically

processed’’ in the warning statement

because the term ‘‘pasteurized’’ in the

context of the entire statement was

better understood by the focus group

participants to describe a process that

makes juice ‘‘safe.’’ However, the agency

recognizes that the use of this term

could imply to consumers that all juices

not bearing the warning statement have

been pasteurized. While such an

implication may not be technically

precise for products manufactured

under an effective HACCP plan that

does not include pasteurization, FDA

has tentatively concluded that this

imprecision is acceptable because the

more important message, i.e., that juice

products not bearing the warning

statement can be safely consumed by all

population groups, will be clearly

understood by consumers. Nonetheless,

the agency solicits specific comment on

whether use of the phrase ‘‘has not been

pasteurized’’ is appropriate in this

context, or whether alternate phrasing

not identifying a specific process should

be used. Comments that suggest

alternate phrasing should include data,

information, or a rationale to support

the alternative, as well as evidence that

consumers would not be confused or

misled by the alternate phrasing.
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20491

3. Placement and Prominence

Section 403(f) of the act requires that

mandatory label information be

prominently placed on the label with

such conspicuousness (compared with

other words, statements, designs, or

devices in the labeling) as to render it

likely to be read and understood by the

ordinary individual under customary

conditions of use. FDA has generally

considered the label information panel

to be the appropriate location for

warning statements. As discussed in the

agency’s rulemaking requiring warning

statements on iron-containing dietary

supplements (62 FR 2218), consumer

focus group studies establish that a

warning statement need not be placed

on the principal display panel (PDP) to

be effective in informing consumers of

the hazard. Participants in the focus

groups reasoned that the front of the

product was used for marketing

purposes and stated that they were

accustomed to looking at the ‘‘back of

products’’ for nutrition and factual

information, including warning

statements (Ref. 11). Consequently, in

the case of iron-containing dietary

supplements, the agency required that

the warning statement appear on the

information panel.

The agency tentatively concludes that

for warning statements on packaged

juice products, the requirement for

prominence and conspicuousness

would similarly be met if the statements

appeared on the information panel.

However, the agency has tentatively

concluded that it would not object to

firms placing the warning statement on

the PDP, because the PDP would

provide even greater prominence.

Accordingly, FDA is proposing to

require in § 101.17(g)(3) that the

warning statement for juices appear

either on the product information panel

or on the PDP.

The requirement in the act for

prominent display means that the

warning statement must appear in a

manner that makes it readily observable

and likely to be read. The agency notes

that § 101.2(c) (21 CFR 101.2(c)) requires

that mandatory information appearing

on the PDP and information panel,

including information required by

§ 101.17, appear prominently and

conspicuously in a type size no less

than one-sixteenth inch. The agency has

tentatively concluded that it is not

necessary to repeat type size

requirements in the proposed regulation

for warning labels on juice products

and, therefore, has not done so.

Because of the severity of the hazard,

FDA has tentatively concluded that the

word ‘‘warning’’ in the warning

statement should be as prominent and

conspicuous as possible. In the past,

when the agency has required

cautionary information on labels, e.g.,

on products containing aspartame (39

FR 27317), it utilized bold type to make

the information more prominent. In

addition, FDA regulations on nutrition

labeling, § 101.9(d)(1)(iv) (21 CFR

101.9(d)(1)(iv)), require that certain

nutrient information in the nutrition

facts panel use bold type. Therefore,

consistent with these examples, the

agency is proposing in § 101.17(g)(4) to

require that the word ‘‘WARNING’’ be

in bold type to help alert consumers that

there is new and critically important

information about the juice products.

In addition, current agency

regulations that require a ‘‘warning’’

statement on the product label or in

labeling (e.g., the statement required by

§ 101.17(e) on iron-containing dietary

supplements in solid oral dosage form)

or a label ‘‘notice’’ statement (e.g., the

statement required by § 101.17(d)(3) on

protein products that are not covered by

the requirements of § 101.17(d)(1) and

(2)) require that the identifying term

‘‘WARNING’’ or ‘‘NOTICE’’ be

capitalized and immediately precede

the language of the applicable labeling

statement. Consistent with these

examples, the agency is proposing in

§ 101.17(g)(4) to require that the

capitalized word ‘‘WARNING’’

immediately precede the statement.

The agency notes that experience has

shown that the prominence of some

labeling information may be enhanced

by the use of a box around the

information. The agency’s experience

with the nutrition facts panel on food

labels has been that the box surrounding

the nutrition information greatly

increases the prominence of the

information. In addition, consumer

focus group research has shown that

boxes around important messages help

consumers to distinguish the message

from other information (Ref. 11). The

agency tentatively concludes that the

use of a box around the warning

statement for juice will similarly

increase the prominence of the message

by setting it off, thereby enhancing the

likelihood that consumers will notice

and read the message. Accordingly, FDA

is including in the proposal a

requirement (§ 101.17(g)(5)) that the

warning statement be set off in a box by

use of hairlines. The agency requests

comments on the prominence and

placement of the proposed warning

statements.

III. Analysis of Impacts

A. Preliminary Regulatory Impact

Analysis

In accordance with Executive Order

12866, FDA has developed a single

preliminary regulatory impact analysis

(PRIA) that estimates benefits and costs

associated with both this proposal and

the HACCP proposal for juice. The

agency will promptly publish the PRIA

in the Federal Register.

B. Small Entity Analysis

In accordance with the Regulatory

Flexibility Act (5 U.S.C. 601–612), FDA

has developed a single small entity

analysis that estimates benefits and

costs associated with both this proposal

and the HACCP proposal for juice. The

agency will promptly publish the small

entity analysis in the Federal Register.

IV. Environmental Impact

The agency has determined under 21

CFR 25.30(k) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

V. Effective Date

FDA is proposing that any final rule

that may be issued based upon this

proposal become effective 60 days after

its publication in the Federal Register.

FDA realizes that it will take time for

manufacturers to make label changes

and to deplete existing inventories.

However, FDA must balance the need

for immediate implementation of a

warning statement requirement because

of the food safety benefits associated

with it, with the burden placed on

industry to comply with the

requirement. The agency, therefore, is

considering options in this document

that will provide information to

consumers while reducing the burden

on industry. Accordingly, firms may

provide the required warning statement

in labeling at point of purchase, e.g.,

signs or placards, as a temporary

alternative to providing the information

on the label. When signs or placards are

used, the agency is requiring that the

type size of the labeling be in

accordance with that required in

§ 101.100(a)(2)(ii) (21 CFR

101.100(a)(2)(ii)), i.e., not less than onefourth inch in height. The agency is

proposing in § 101.17(g)(3)(i) to allow

manufacturers until January 1, 2000, to

provide the warning message on the

label itself. This is the next appropriate

uniform compliance date for other food

labeling changes. Furthermore, to
20492 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules

relieve the burden on small businesses,

the agency is proposing in

§ 101.17(g)(3)(ii) to allow businesses

employing fewer than 500 persons until

January 1, 2001 to provide the required

warning information on the label. Based

on the agency’s economic analysis, the

agency believes that this date permits

small businesses sufficient time to

provide information on labels without

appreciable economic losses. This

definition of a small business is based

on that of the Small Business

Administration. The agency requests

comments on the effective date and the

compliance dates for this rule.

Because of the severity of the hazard,

the agency urges manufacturers of juice

products that have not been processed

to prevent, reduce, or eliminate the

presence of pathogenic microorganisms

to begin immediately to label their

products with a warning statement

consistent with this proposal. Such

labeling can be accomplished by the use

of stickers or placards. FDA recognizes

that it is possible that the requirements

for the warning label statement in the

final rule may be different from those in

the proposal. However, to encourage

manufacturers to use the warning label

statement as soon as possible, the

agency advises that it intends to allow

the continued use of any label or

labeling that complies with the

proposed regulation and is printed prior

to the date of publication in the Federal

Register of any final rule resulting from

this proposal until that inventory is

depleted.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that the

labeling requirements proposed in this

document are not subject to review by

the Office of Management and Budget

because they do not constitute a

‘‘collection of information’’ under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501–3520). Rather, the proposed

warning statement is ‘‘public disclosure

of information originally supplied by

the Federal government to the recipient

for the purpose of disclosure to the

public’’ (5 CFR 1320.3(c)(2)).

VII. Comments

Interested persons may, on or before

May 26, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

The agency notes that the comment

period in this document is shorter than

the 75-day period that is customarily

provided by FDA for proposed rules.

Likewise, this comment period is less

than the 60 days that is the general rule

set out in FDA’s procedural regulations,

§ 10.40(b)(2) (21 CFR 10.40(b)(2)). As

discussed below, FDA believes that a

30-day comment period is appropriate

in these circumstances.

Executive Order 12889 (58 FR 69681,

December 30, 1993), which

implemented the North American Free

Trade Agreement, states that any agency

subject to the Administrative Procedure

Act, should provide a 75-day comment

period for any proposed Federal

technical regulation or any Federal

sanitary or phytosanitary measure of

general application. However, Executive

Order 12889 provides an exception to

the 75-day period where the United

States considers the measure necessary

to address an urgent problem related to

the protection of human, plant or

animal health. Similarly, FDA

regulations establish a 60-day comment

period as agency practice, but provide

that the 60-day period may be shortened

if the Commissioner of Food and Drugs

finds good cause for doing so.

As discussed in detail in this

document, the available evidence

demonstrates that some juice and juice

products have been the vehicles for

outbreaks of serious illness from

foodborne pathogens. FDA has

tentatively concluded that effective

protection of the public health requires

that consumers be informed as quickly

as possible (i.e., in time for the 1998

‘‘cider season’’) to the hazards

associated with these juice products.

FDA has concluded that the urgency of

this matter is sufficient justification for

shortening the comment period for this

proposal to 30 days, consistent with

Executive Order 12889. Similarly, this

urgency constitutes good cause within

the meaning of § 10.40(b), which

justifies shortening the period to 30

days. In addition, a 30-day comment

period is appropriate in these particular

circumstances because interested parties

have already been provided time to

comment on the proposed warning label

statements that were published in FDA’s

August 28, 1997, notice of intent.

VIII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Centers for Disease Control and

Prevention, ‘‘Outbreak of Escherichia coli

O157:H7 Infections Associated with Drinking

Unpasteurized Commercial Apple Juice—

British Columbia, California, Colorado, and

Washington, October 1996,’’ Morbidity and

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

2. National Advisory Committee on

Microbiological Criteria for Foods—Fresh

Produce Subcommittee, proceedings,

December 16, 1996.

3. Centers for Disease Control, ‘‘Salmonella

typhimurium Outbreak Traced to a

Commercial Apple Cider—New Jersey,’’

Morbidity and Mortality Weekly Report,

24:87–88, 1975.

4. Millard, P. S., K. F. Gensheimer, D. G.

Addiss, D. M. Sosin, G. A. Beckett, A. HouckJankoski, and A. Hudson, ‘‘An Outbreak of

Cryptosporidiosis from Fresh-pressed Apple

Cider,’’ Journal of the American Medical

Association, 272(20):1592–1596, 1994.

5. Centers for Disease Control and

Prevention, ‘‘Outbreaks of Escherichia coli

O157:H7 Infection and Cryptosporidiosis

Associated with Drinking Unpasteurized

Apple Cider—Connecticut and New York,

October 1996,’’ Morbidity and Mortality

Weekly Report, 46(1):4–8, 1997.

6. Centers for Disease Control and

Prevention, ‘‘Cholera Associated with

Imported Frozen Coconut Milk—Maryland,

1991,’’ Morbidity and Mortality Weekly

Report, 40(49):844–845, 1991.

7. Centers for Disease Control and

Prevention, memorandum from Kim A. Cook

to Steve Thacker, October 1, 1995.

8. FDA recall data memorandum, Dirk J.

Mouw to Raymond P. Mars, June 2, 1992.

9. FDA recall data memorandum, M.

Anthony Abel to Ronald E. Joyce, March 21,

1994.

10. Memorandum of telephone

conversation between Debra Street, FDA, and

P. Walker, Washington State Department of

Health, January 15, 1997.

11. FDA memorandum, Alan S. Levy to

Kenneth Falci, June 26, 1997.

12. Council for Agricultural Science and

Technology, Foodborne Pathogens: Risks and

Consequences, Ames, Iowa: Council for

Agricultural Science and Technology, Task

Force Report No. 122, ch. 3, 1994.

13. Macro International Inc., Focus Group

Testing of Warning Statements on Juice

Products Not Pasteurized or Otherwise

Specifically Treated to Eliminate Harmful

Bacteria.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug and Cosmetic Act, and under the

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 101 be amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

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

U.S.C. 321, 331, 342, 343, 348, 371.
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 / Proposed Rules 20493

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. Any juice sold as such

or used as an ingredient in beverages

shall be labeled in accordance with the

requirements of this paragraph.

(2) The label of any juice that has not

been processed in the manner described

in paragraph (g)(7) of this section shall

bear the following warning statement:

WARNING: This product has not been

pasteurized and, therefore, may contain

harmful bacteria which can cause serious

illness in children, the elderly, and persons

with weakened immune systems.

(3) The warning statement required by

paragraph (g)(2) of this section shall

appear prominently and conspicuously

on the information panel or on the

principal display panel of the label of

the container, except that:

(i) The warning statement may appear

in labeling, including signs or placards,

until January 1, 2000; after this date, the

warning statement shall appear on the

label of the food.

(ii) For products manufactured by

businesses employing fewer than 500

persons, the warning statement may

appear in labeling, including signs and

placards, until January 1, 2001; after this

date, the warning statement shall appear

on the label of the food.

(4) The word ‘‘WARNING’’ shall

immediately precede the statement,

shall be capitalized, and shall appear in

bold type.

(5) The warning statement required by

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

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

of hairlines.

(6) The requirements in paragraph (g)

of this section shall not apply to juice

processed in a manner that will

produce, at a minimum, a 5-log (i.e.,

100,000 fold) reduction in the pertinent

microorganism for a period at least as

long as the shelf life of the product

when stored under normal and

moderate abuse conditions. For the

purposes of this regulation, the

‘‘pertinent microorganism’’ is the most

resistant microorganism of public health

significance that is likely to occur in the

juice.

Dated: April 17, 1998.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–11026 Filed 4–22–98; 8:45 am]

BILLING CODE 4160–01–F