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HHS/FDA | RIN: 0910-AA43 | Publication ID: Spring 1999 |
Title: Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices | |
Abstract: The Food and Drug Administration (FDA) announced in an advance notice of proposed rulemaking of August 4, 1994, its plans to consider the development of regulations establishing requirements for a new comprehensive food safety assurance program that would be based on the principles of Hazard Analysis Critical Control Points (HACCP). The new food safety program would respond to new challenges, such as new food processing and packaging technologies, new food distribution and consumption patterns, exposure to industrial chemicals and chemical waste, the increasing importation of foods, new microbial pathogens, and resource constraints. Current information shows that the most serious of these challenges is presented by food-borne pathogens. The number of recognized food-borne pathogens has broadened considerably, as has the awareness of long-term complications from certain food-borne illnesses--such as arthritis, heart disease, and kidney and neurological damage. To meet such challenges, FDA intends to shift the focus of its food safety assurance program away from periodic visual inspection and end-product testing and toward prevention of food safety risks and problems, utilizing the state-of-the-art HACCP preventive approach. A first step was taken when FDA published a HACCP regulation for fish and fishery products on December 18, 1995. Consistent with FDA's HACCP efforts, USDA published a HACCP regulation for meat and poultry on July 25, 1996. FDA proposed on April 24, 1998 to adopt a HACCP regulation for the processing of juice. The agency simultaneously proposed to require a warning statement on the labels or in labeling for juice products that have not been processed to reduce, control, or eliminate the presence of harmful bacteria. Such labeling would serve to reduce the risk of food-borne illness, pending development of a final HACCP rule for juice. As part of the development of the HACCP proposal, FDA considered information obtained during agency HACCP pilot activities, and comments and scientific and technological information relating to fresh juices provided during and after an agency public meeting on juice held on December 16 and 17, 1996. On July 8, 1998, the agency finalized the warning statement requirement. FDA held two technical scientific workshops, one November 12, 1998, in Lake Alfred, Florida and the other November 29, 1998, in Irvine, California, to discuss and clarify issues related to the implementation of the agency's rule requiring a warning statement for certain juice products. The workshops addressed citrus juice production and the methods for measuring and validating such systems. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Yes | Unfunded Mandates: No |
CFR Citation: 21 CFR 120 | |
Legal Authority: 21 USC 321 et seq 42 USC 264 |
Timetable:
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Child RIN List:
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Additional Information: Previously reported under RIN 0905-AE60. | |
Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Federal |
Small Entities Affected: Businesses | |
Included in the Regulatory Plan: Yes | |
Agency Contact: John E. Kvenberg Deputy Director, Office of Compliance (HFS-600) Department of Health and Human Services Food and Drug Administration HFS-10, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Rm 3B064, College Park, MD 20740 Phone:301 436-2359 Fax:301 436-2717 Email: john.kvenberg@cfsan.fda.gov |