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U.S. Department of Health and Human Services

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Guidance for Industry: Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider

Contains Nonbinding Recommendations

September 22, 2005

Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

For questions regarding this document, contact Michael E. Kashtock at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) (301) 436-2022 (Updated phone: 240-402-2022), (Fax) (301) 436-2651, or email michael.kashtock@fda.hhs.gov.

Additional copies are available from:
Office of Plant and Dairy Foods
Division of Plant Product Safety HFS-305
Center for Food Safety and Applied Nutrition
Food and Drug Administration, 5100 Paint Branch Parkway
College Park, MD 20740
http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
September 2005


Contains Nonbinding Recommendations

Guidance for Industry
Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

This letter is intended to inform you of the Food and Drug Administration's (FDA's) concern regarding continuing outbreaks of foodborne illness associated with the consumption of treated (but not pasteurized) and untreated juice and cider, and to remind you of actions that we recommend processors take to enhance the safety of these products.

Recent illness outbreaks due to treated (but not pasteurized) and untreated apple cider occurred in Ohio in 2003, and in New York state in 2004. In addition, a multi-state illness outbreak associated with treated (but not pasteurized) orange juice occurred this year. These outbreaks highlight the need for processors to ensure that they are taking all appropriate steps to comply with applicable food safety requirements.

FDA issued regulations for the safe processing of fruit and vegetable juices in 2001, requiring non-retail juice processors to evaluate their operations using Hazard Analysis Critical Control Point (HACCP) principles and, if necessary, to develop and implement systems of preventive control measures based on HACCP principles. FDA also issued the juice labeling regulation in 1998, which requires retail processors of juice to put a warning label on any container of juice that has not been treated to achieve a 5-log reduction in the most resistant pathogen. These two regulations are intended to improve the safety of fruit and vegetable juices and to ensure that consumers of untreated juice products are adequately informed of the risks associated with consuming these products.

Some of the principal requirements of the HACCP regulation are restated below. Both interstate and intrastate non-retail juice processors, regardless of the size of the business, must follow the HACCP regulation. The HACCP regulation requires that processors achieve a 5-log reduction for the microbe identified as the most resistant microorganism of public health significance that is likely to occur in the juice. This 5-log reduction must take place in one facility just prior to or after packaging, and must be applied directly to the juice, except for citrus juices. Fruit surface treatments may be used to accomplish the 5-log reduction for citrus fruits, but cleaned and undamaged tree-picked fruit must be used. The effectiveness of the surface treatment must be verified by regularly testing the final product for generic E. coli. If two samples in a series of seven tests are positive for E. coli, the HACCP regulation deems the control measures to attain the 5-log reduction to be inadequate, and an alternate process such as pasteurization is to be used until corrective actions are completed.

FDA recommends that retail processors who treat their juice follow these same practices for their 5-log reduction processes. In addition, to the juice labeling regulation, retail processors must follow all applicable state laws and regulations. FDA also reminds retail processors who sell or serve juice that only pasteurized juice should be served or sold to highly susceptible populations in retail establishments such as child care facilities, nursing homes, and hospitals.

For both treated and untreated juice, adherence to good manufacturing practices, including those that address basic sanitation practices, constitutes an essential foundation for the development and implementation of successful HACCP plans. See FDA's current good manufacturing practices (cGMP) regulation.

In addition, in 1998, FDA issued a "Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables," which recommends good agricultural practices (GAPs) that growers, packers, and shippers can use to address common risk factors in their operations and thus, minimize food safety hazards potentially associated with fresh fruits and vegetables.

Given the recent outbreaks cited above, we strongly encourage firms to review their current operations in light of the above requirements and available information regarding pathogen reduction or elimination in the production of treated (but not pasteurized) and untreated juice, including cider. We further encourage firms to modify their operations accordingly, to enhance the safety of these products. As you are aware, food produced under unsanitary conditions whereby it may be rendered injurious to health is adulterated under § 402(a)(4) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 342(a)(4)).

The reduction of foodborne illness associated with treated but not pasteurized and untreated juice, including cider, requires a collaborative effort by FDA and state and local authorities, as states provide critical resources and expertise in the identification and investigation of foodborne illness at the local level. Additionally, FDA will work closely with state regulatory agencies in considering enforcement actions against firms and farms to protect the health of their residents.

We recognize and appreciate the efforts that state regulatory authorities and the industry have taken to date to provide juice that is safe to U.S. consumers, and we are confident that you will continue to work proactively to pursue this goal.

Sincerely,

Terry C. Troxell, Ph.D.
Director, Office of Plant and Dairy Foods
Center for Food Safety and Applied Nutrition