Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Proposed Rules 45593

J–105 [Revised]

From Ranger, TX; via McAlester, OK;

Razorback, AR; Springfield, MO; Bradford,

IL; to Badger, WI.

* * * * *

J–131 [Revised]

From San Antonio, TX, via INT San

Antonio 007° and Ranger, TX, 214°T (208°M)

radials; Ranger; Texarkana, AR; Little Rock,

AR; to Pocket City, IN.

* * * * *

J–181 [Revised]

From Ranger, TX; Okmulgee, OK; Neosho,

MO; INT Neosho 049° and Bradford, IL, 219°

radials; to Bradford.

* * * * *

Issued in Washington, DC, on August 21,

1997.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 97–22974 Filed 8–27–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket No. 97N–0296]

Fruit and Vegetable Juice Beverages:

Notice of Intent to Develop a HACCP

Program, Interim Warning Statement,

and Educational Program

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of intent.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

comprehensive program to address the

incidence of foodborne illness related to

consumption of fresh juice and to

ultimately address the safety aspects of

all juice products. This document

informs consumers, juice processors,

State and local officials, and other

interested persons of FDA’s plans to

publish two proposals and to initiate

several educational programs to

minimize the hazards associated with

fresh juice. This document will permit

all interested persons to take advantage

of the guidance provided by the

upcoming proposals as quickly as

possible, e.g., in time for the 1997 ‘‘fresh

apple cider’’ season.

DATES: Submit written comments at any

time.

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

Escherichia coli O157:H7 has been

recently implicated as a source of a

number of foodborne disease outbreaks.

During the last few years, several States

have reported outbreaks of E. coli

O157:H7 illness as a result of

consumption of apple juice and cider

that were not pasteurized or otherwise

treated to destroy pathogens (Refs. 1, 2,

and 3). Symptoms have ranged from

diarrhea to hemolytic uremic syndrome.

In October 1996, the Seattle-King

County Department of Public Health

and the Washington State Department of

Health reported an outbreak of E. coli

O157:H7 infections associated with

consumption of unpasteurized apple

juice that occurred in three western

States and British Columbia and

resulted in at least 66 cases of illness

and the death of one child (Refs. 2 and

4).

Pathogens other than E. coli O157:H7

present in apple and other types of juice

and juice products also have been

documented as causing foodborne

illness. There are reported outbreaks

attributable to Salmonella typhimurium

and Cryptosporidium in apple cider

(Refs. 3, 5, and 6), and Vibrio cholerae

in coconut milk (Ref. 7). In addition,

there are reports of illness from

consumption of unpasteurized orange

juice contaminated with S. hartford

(Ref. 8), orange juice drink

contaminated with S. agona (Ref. 9),

orange juice contaminated with Bacillus

cereus (Ref. 10), and home-made carrot

juice contaminated with Clostridium

botulinum (Ref. 11).

Both fruit and vegetable juices have

been vehicles for outbreaks of foodborne

illness. Although fruit juice is acidic

and thus inhibitory to the growth of

most microorganisms, fruit juices, rather

than vegetable juices, have been the

source of most juice-associated

outbreaks. The evidence also suggests

that the groups at greatest risk of lifethreatening illness are children, the

elderly, and persons with compromised

immune systems.

Illnesses caused by hazards other than

microbial contamination have also been

associated with foods, including juice.

From 1990 to 1996, there has been one

outbreak and 11 recalls of fruit juice or

beverages containing fruit juice (Refs. 12

and 13). Ingestion of toxic metals as

well as poisonous parts of the plants

used to make the juice have been cited

as the cause of some juice related

illness.

Five recalls between 1990 and 1995 of

fruit juices or beverages containing fruit

juice were because of the presence of

food ingredients that were inadvertently

added to the product, not declared on

the label, or not suitable for that food

(Ref. 13). Food ingredients involved

with these recalls were natamycin,

sulfites, FD&C yellow No. 5, and salt.

Since 1991, there have been five

recalls of juice products because of

improper sanitation procedures or faulty

equipment that resulted in crosscontamination with ingredients from

other foods, minerals such as copper,

glass, or other hazardous materials.

These outbreaks and recalls demonstrate

that juice and juice beverages may be

susceptible to many hazards.

The October 1996 apple juice

outbreak from E. coli O157:H7, and the

agency’s concern that the current

regulatory program relative to fresh

juice and juice products may not be

adequate to ensure the production of

safe juice products, persuaded FDA to

gather information to help address these

problems. FDA held a public meeting on

December 16 and 17, 1996, to discuss

the current state of the science and to

review the technological and safety

factors relating to the production and

distribution of fresh juices. The agency

was interested in learning about all

aspects of juice production and

distribution in an effort to consider how

FDA’s regulatory program should be

revised, and whether additional

measures are needed to reduce the risk

of future outbreaks.

Experts from industry, academia, and

the regulatory and consumer sectors

presented information on illnesses and

the epidemiology of outbreaks arising

from contaminated juices; current

concerns with emerging pathogens; the

E. coli O157:H7 outbreak in October

1996 caused by contaminated

unpasteurized apple juice; procedures

for processing juices; and new and

existing technologies to decrease or

eliminate the number of pathogens or

other contaminating microorganisms.

FDA received over 180 comments,

most of which concerned apple juice

specifically. Many comments pertained

to juices in general and some referred

only to apple juice, apple cider, or citrus

juices. Most comments were concerned

with changes in processing to improve

the safety of juices. Among the changes

recommended were requiring

pasteurization of juices, requiring a

Hazard Analysis and Critical Control

Point (HACCP) program, and
45594 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Proposed Rules

establishing current good manufacturing

practices (CGMP’s) in juice processing.

The National Advisory Committee on

Microbiological Criteria for Foods

(NACMCF) subsequently recommended

to FDA, among other things, that

HACCP and safety performance criteria

should form the general conceptual

framework for assuring the safety of

juices, and that control measures should

be based on a thorough hazard analysis.

Furthermore, the NACMCF

recommended that a mandatory HACCP

program be established, and that

processors implement and strictly

adhere to industry CGMP’s. The

NACMCF also recommended that

industry education programs be

developed that address basic food

microbiology, the principles of cleaning

and sanitizing equipment, CGMP’s, and

HACCP.

The information FDA obtained

through the public meeting, as well as

the recommendations of the NACMCF,

clearly suggest that new measures are

necessary to ensure that juice is safe.

The virulence of new pathogens, such as

E. coli O157:H7, and the risk of severe

illness associated with these pathogens,

especially for children, the elderly, and

persons with weakened immune

systems, create a need for prompt, active

intervention. The agency has considered

the recommendations provided in the

comments and by the NACMCF and has

developed a proposed strategy for

ensuring juice safety. This proposed

strategy involves addressing 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.

This proposed strategy, as discussed

below, involves a three-pronged

approach that includes a mandatory

HACCP program, label warning

statements, and educational programs

targeted at the industry and consumers.

II. Mandatory HACCP Program

The agency has considered several

alternatives recommended in the

comments in determining whether to

initiate rulemaking on a mandatory

HACCP program for some or all juice

products. The alternatives being

considered include: (1) Increasing the

frequency of FDA’s inspection of juice

manufacturers, as well as increasing

agency sampling, laboratory analysis,

and related regulatory activities; (2)

issuing CGMP’s or sanitation standards

to increase the safety of juices; and (3)

mandating pasteurization or other

equivalent treatment of juices.

At this point, the agency believes,

based on available data, that a

mandatory HACCP program is the most

effective means of controlling

microbiological, as well as chemical and

physical hazards that may occur during

juice processing, and that, therefore,

such a program may be necessary for the

safe and sanitary production of fruit and

vegetable juices. Accordingly, the

agency intends to propose a regulation

that will mandate a HACCP program for

some or all fruit and vegetable juice

products. FDA intends to propose that

some or all juice processors have and

implement a written HACCP plan

whenever a hazard analysis reveals that

one or more food hazards are reasonably

likely to occur, and that a HACCP plan

be specific to each location where juice

is processed by that processor. Thus, the

agency is considering that

implementation of a HACCP program

will be the primary, long-term control

measure for pathogens and other safety

concerns related to the production and

distribution of juice products.

Under a mandatory HACCP program,

FDA would propose a phase in period

for implementation of HACCP plans for

juice products. The phase in approach

will permit the regulated industry time

to develop a HACCP plan, accomplish

the training of personnel, and adjust its

activities to include necessary HACCP

activities.

The forthcoming HACCP proposal

will fully discuss all of the issues

surrounding the safety of fruit and

vegetable juices raised in this document.

III. Label Warning Statements

Although FDA has tentatively

concluded that additional steps are

necessary to ensure that juices are safe,

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 not likely be fully implemented

for several years. In light of these facts,

and the immediate concerns raised by

the potential for foodborne illness from

consumption of juice products neither

processed in accordance with an

established HACCP plan, pasteurized,

nor otherwise treated to prevent or

eliminate the presence of harmful

bacteria that may be present, the agency

sees a need for immediate action to

ensure that consumers, particularly

those at greatest risk, are informed of

this potential hazard. This information

can be conveyed through labeling,

which can be effected by industry much

more quickly than it can implement a

HACCP program.

Consequently, the agency is

considering proposing that the labels

and labeling of some or all juice

products not specifically processed to

prevent or eliminate the presence of

harmful bacteria bear a warning

statement informing consumers of the

risk of illness associated with

consumption of the product. The agency

anticipates that this will be an interim

measure, until requirements for

processing juice products under HACCP

principles are fully implemented. The

agency notes that it is considering

providing that interventions that have

been validated to achieve a cumulative

5-log reduction in E. coli O157:H7 or

other pathogens would obviate the need

for a warning label. Based on available

information, however, the agency

considers pasteurization the only

process validated to meet this standard

at this time. However, the agency

solicits comments on other ways to

achieve this reduction. Thus, in the

absence of a validated HACCP plan, the

agency anticipates that a warning

statement will appear on some or all

unpasteurized juice products.

Consumer research data available to

the agency suggest that consumers need

clear and concise information about the

nature and magnitude of the hazard in

the food to understand a warning

statement, and that certain elements are

essential to ensure that the warning

statement is effective (Ref. 14). These

elements include statements describing

the hazard, explaining why the hazard

is present, advising how to avoid or

alleviate the hazard, and identifying the

group at risk. Depending on the type of

food and the nature of the hazard, each

of these elements may not be essential

in developing an effective warning

statement.

To inform consumers effectively of

the potential hazard associated with

some or all juice products, FDA has

tentatively concluded that three of the

elements listed above would need to be

reflected in the label warning statement.

The warning statement for

unpasteurized juice products could

contain: (1) A statement of the hazard,

that is, a statement about the potential

presence of bacteria that can cause

serious illness; (2) a statement

explaining why the hazard is present,

that is, a statement that the labeled

product has not been processed or

treated to destroy the harmful bacteria;

and (3) a statement identifying the

group at risk, that is, that evidence

suggests that children, the elderly, and

persons with weakened immune

systems are at greatest risk of serious

illness from exposure to harmful

bacteria in juice and juice products. The

agency will request comments on

whether the warning statements should

also include a fourth element, advising

that at-risk consumers avoid the

product.
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Proposed Rules 45595

The consumer research data also

showed that the first sentence of a

warning statement is likely to influence

a consumer’s decision as to whether to

continue reading the rest of a warning

statement. Therefore, the agency intends

to propose that the first sentence of the

warning statement clearly state the

hazard, i.e., that juice may contain

pathogens known to cause serious/lifethreatening illness. The agency

recognizes, however, that there may be

several ways to incorporate the essential

elements into the warning statement.

For example, the following model

statements incorporate the three

essential elements that FDA has

tentatively concluded would need to be

reflected in the label warning statement,

but they communicate the information

using different wording.

1.WARNING: Unless specifically

processed, some juices may contain

harmful bacteria known to cause serious

illness. This product has not been

specifically processed to destroy such

bacteria. The risk of life-threatening

illness is greatest for children, the

elderly, and persons with weakened

immune systems.

2.WARNING: Some juices have

recently been found to contain harmful

bacteria known to cause life-threatening

illness. This product has not been

specifically processed to destroy such

bacteria. Children, the elderly, and

persons with weakened immune

systems should avoid this product.

3. WARNING: This product has not

been pasteurized and therefore may

contain harmful bacteria which can

cause serious illness in children,

elderly, and persons with weakened

immune systems.

The second statement includes the

fourth element, advising the at-risk

consumer to avoid the product. FDA

believes that any of these statements

would inform consumers adequately of

the potential risk of foodborne illness

associated with the juice product.

Accordingly, FDA is considering

proposing statements such as these

warning statements for juice products

not pasteurized or otherwise treated to

prevent or eliminate the presence of

harmful bacteria. However, the agency

recognizes that because these statements

are untested, there may be a more

effective way to alert consumers to the

potential hazard.

The agency is mindful that

manufacturers may wish to include

optional language on the label. For

example, in addition to the information

required by the essential elements,

information describing the product as

‘‘unpasteurized’’ may be included.

Handling instructions to ensure the

safety of the product also may be

included, e.g., ‘‘boil product prior to

serving.’’ Similarly, manufacturers of

pasteurized juice products may wish to

include information on the label of their

product informing the consumer that

the product has been pasteurized.

Because such information may be

helpful and convenient for consumers

searching for pasteurized juices, the

agency encourages manufacturers of

pasteurized juices to include the term

‘‘pasteurized’’ on the product label. In

its labeling proposal, FDA will request

comments on whether such additional

information should be required. The

agency notes, however, that consistent

with the requirements for all label

statements, any optional information

must be truthful and not misleading.

Consistent with the placement and

prominence requirements of other

warning statements, FDA is considering

proposing that the statement appear

prominently and conspicuously on the

information panel of the immediate

container of the product, in type size no

less than one-sixteenth of an inch, and

set apart from other printed matter on

the information panel by hairlines in the

configuration of a box. In addition, the

agency is considering proposing that the

word ‘‘WARNING’’ be in capital letters

and in bold type.

The agency may conduct focus group

research to evaluate consumer

understanding of the proposed warning

messages and to ensure that the

messages are not misleading. The results

of any focus group research would be

considered by the agency in arriving at

warning statements included in a final

regulation.

In its proposal, the agency will

discuss and solicit comment on its

tentative decision to require an interim

warning statement on unpasteurized

juices, its justification for the required

elements of the warning statement, and

its tentative conclusion that the

proposed statements adequately inform

the consumer of the potential risk

associated with the juice product. In

addition, the agency is considering

proposing a sunset provision for the

mandatory warning statement.

Given the severity of the outbreaks

with fresh apple juice that occurred

during the 1996 season, the agency

strongly encourages processors of

unpasteurized apple juices to

immediately and voluntarily label their

products or provide point of purchase

information with any of the model

statements or a similar statement that

includes the essential elements

discussed above. Although the agency

has particular concern about the

potential for foodborne illness

associated with apple juice because of

the documented contamination with E.

coli O157:H7, it encourages

manufacturers of all types of juice to

place warning labels on their products

that have not been pasteurized. Such

labeling may be accomplished by the

use of stickers, placards, brochures, etc.

Further, FDA is aware that some State

authorities are considering the steps that

they need to take to protect consumers.

The agency encourages State and local

officials to consider the information in

this document as guidance as they

contemplate requirements for untreated

juice products during the 1997 season.

The agency is considering whether to

include some or all fruit and vegetable

juice products that have not been

pasteurized or otherwise specifically

processed to prevent or eliminate the

presence of harmful bacteria in any

future proposal on label warning

statements. The agency expects that any

final rule on a mandatory warning

statement will be issued prior to the

start of the 1998 ‘‘fresh apple juice/

cider’’ season.

IV. Educational Program

FDA’s primary goal is to ensure that

the food supply is safe and that

consumers are protected to the greatest

extent possible from foodborne illness

and other adverse reactions resulting

from food consumption. The

rulemakings that FDA intends to initiate

on HACCP and on the interim warning

statement should help to accomplish

this goal with respect to juice products.

Nevertheless, the benefits of these

rulemakings will be enhanced if, in

conjunction with them, FDA initiates

educational programs aimed at industry

and consumers. Consistent with the

NACMCF recommendations, the agency

believes that industry education

programs addressing basic food

microbiology, the principles of cleaning

and sanitizing equipment, CGMP’s, and

HACCP will greatly assist juice

processors in developing and

implementing an effective HACCP plan.

Given the severity of the outbreaks with

unpasteurized apple juice and cider and

the fact that final rules cannot be in

place by the 1997 fresh cider season, the

agency will use the education programs

to encourage the industry to label their

products voluntarily to advise

consumers of the risks associated with

fresh juice. In addition, educating

consumers about the risks to certain

populations associated with the

consumption of untreated juice and the

potential for the presence of pathogens

and other hazardous substances will

help to ensure that consumers fully

understand the importance of label
45596 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Proposed Rules

statements and the significance of the

appearance of warning statements on

certain juice products but not on others.

The agency intends to involve State

and local officials in its education

initiative because it is often the State or

local official who is in direct contact

with the farmer or juice processor. Thus,

State and local officials can play a

significant role in educating and

assisting juice manufacturers and

consumers in understanding the public

health concerns associated with

consumption of untreated juice

products and in developing measures to

reduce the risk.

To meet its educational objectives,

FDA intends to: (1) Enlist the aid of

State and local officials, industry

representatives, trade associations, and

consumer groups in coordinating

consumer and industry educational

outreach programs; (2) use FDA field

public affairs specialists to educate

consumers and health professionals

through lectures, meetings, and local

media spots; (3) use FDA’s home page

on the World Wide Web to alert

consumers to the potential hazard; (4)

hold public meetings to discuss the

issues raised in the impending

proposals as well as the educational

programs discussed in this document;

(5) distribute ‘‘Dear Consumer’’ letters to

targeted consumer groups; (6) use the

FDA CFSAN information line to relay

information to consumers and health

professionals about the public health

concern associated with untreated juice;

(7) distribute camera-ready English and

Spanish articles and English radio

scripts and video news releases to the

news media nationwide in September

1997 to coincide with the National Food

Safety Education Program and ‘‘Back to

School’’ program; and (8) distribute

letters and articles to State and local

officials.

V. Conclusion

As outlined in this document, FDA

has developed a proposed

comprehensive strategy to address the

public health concerns associated with

consumption of fresh juice and juice

products not specifically treated to

prevent or eliminate the presence of

pathogens. The agency invites comment

on the appropriateness of its strategy on

the guidance contained in this

document and on whether additional or

alternative regulatory or nonregulatory

measures are necessary to adequately

protect consumers. Comments

suggesting additional or alternative

measures should explain why such

measures are needed and suggestions on

how to implement the measure.

In addition, the agency solicits

comments on the specific wording of

the warning statement to ensure that the

final warning statement adequately

conveys to consumers the risk of illness

associated with consumption of the

juice product. Furthermore, the agency

solicits comments on whether to

include all or some fruit and vegetable

juice products that have not been

pasteurized or otherwise specifically

processed to prevent or eliminate the

presence of harmful bacteria in any

future proposal on HACCP or label

warning statements.

Because the details of this strategy

will be discussed more fully in any

future proposals, commenters may

choose to wait until that time to

respond. However, the agency will

consider comments received within 15

days of publication of this notice prior

to publication of any proposed rule.

Because of time constraints, the agency

may not be able to consider comments

received after this date, but these

comments will be considered as part of

the public rulemaking record associated

with any proposal.

VI. 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. Besser, R. E., S. M. Lett, J. T. Weber, M.

P. Doyle, T. J. Barrett, J. G. Wells, and P. M.

Griffin, ‘‘An Outbreak of Diarrhea and

Hemolytic Uremic Syndrome from

Escherichia coli 0157:H7 in Fresh-pressed

Apple Cider,’’ Journal of the American

Medical Association, 269(17):2217:2220,

1993.

2. Centers for Disease Control and

Prevention, ‘‘Outbreak of Escherichia coli

0157: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.

3. Centers for Disease Control and

Prevention, ‘‘Outbreaks of Escherichia coli

0157:H7 Infection and Crytosporidiosis

Associated with Drinking Unpasteurized

Apple Cider—Connecticut and New York,

October 1996,’’ Morbidity and Mortality

Weekly Report, 46(1):4–8, 1997.

4. National Advisory Committee on

Microbiological Criteria for Foods—Fresh

Produce Subcommittee Proceedings,

December 16, 1996.

5. Centers for Disease Control, ‘‘Salmonella

typhimurium Outbreak Traced to a

Commercial Apple Cider—New Jersey,’’

Morbidity and Mortality Weekly Report,

24:87–88, 1975.

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

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

Crytosporidiosis from Fresh-pressed Apple

Cider,’’ Journal of the American Medical

Association, 272(20):1592–1596, 1994.

7. 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.

8. Centers for Disease Control and

Prevention Memorandum from Kim A. Cook,

M.D. to Steve Thacker, M.D., October 1, 1995.

9. FDA Recall Data Memorandum, Dirk J.

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

10. FDA Recall Data Memorandum, M.

Anthony Abel to Ronald E. Joyce, March 21,

1994.

11. Memorandum of Telephone

Conversation between Debra Street, Ph.D.,

FDA, and P. Walker, Washington State

Department of Health, January 15, 1997.

12. Memorandum of Telephone

Conversation between Debra Street, Ph.D.,

FDA, and Dr. K. Hendricks, Texas State

Department of Health, January 16, 1997.

13. FDA Memorandum to File, B. Timbo,

Ph.D., July 14, 1997.

14. FDA Memorandum, Alan S. Levy,

Ph.D. to Kenneth Falci, Ph.D., June 26, 1997.

VII. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

document at any time. As noted above,

the agency will consider comments

received by September 12, 1997, prior to

publication of any proposed rule. 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.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22977 Filed 8–25–97; 4:44 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

DEPARTMENT OF TRANSPORTATION

Coast Guard

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 21

RIN 2900–AF85

Veterans Education: Suspension and

Discontinuance of Payments

AGENCIES: Department of Defense,

Department of Transportation (Coast

Guard), and Department of Veterans

Affairs.

ACTION: Proposed rule.