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HHS/FDA

RIN: 0910-AA43

Publication ID: Spring 1997

Title: Development of Hazard Analysis Critical Control Points for the Food Industry; Request for Comments; Proposed Rule
Abstract: FDA announced on August 4, 1994, its plans to consider developing regulations that would establish requirements for a new comprehensive food safety assurance program for both domestically produced and imported foods 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. The most serious of these challenges is presented by food 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 HACCP state-of-the-art preventive approach. A first step was taken when FDA published a HACCP regulation for fish and fishery products on December 18, 1995. In additon, USDA published a HACCP regulation for meat and poultry on July 25, 1996. As a further step in response to comments on the ANPR, FDA proposes to publish a HACCP regulation for all foods that FDA regulates, with implementation first for processing of juice. In preparation of this document, FDA is also considering information obtained during HACCP pilot activities, and comments and scientific and technological information relating to fresh juices provided during and after the public meeting on juice held on December 16 and 17, 1996.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: Yes	Unfunded Mandates: No
CFR Citation: 21 CFR 120
Legal Authority: 21 USC 321 et seq 21 USC 342(a)(4) 21 USC 371(a) 42 USC 264

Timetable:

Action	Date	FR Cite
ANPRM	08/04/1994	59 FR 39888
ANPRM Comment Period End	12/02/1994
NPRM	To Be Determined
NPRM Comment Period End	To Be Determined

Additional Information: Previously reported under RIN 0905-AE60.
Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses
Included in the Regulatory Plan: No
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