Fruit and Vegetable Juice Beverages: Notice of Intent to Develop a HACCP Program, Interim Warning Statement, and Educational Program

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.

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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 life-threatening 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

cross-contamination 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

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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.

[[Page 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/life-threatening 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

[[Page 45596]]

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. Houck-Jankoski, 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