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HHS/FDA

RIN: 0910-AG36

Publication ID: Spring 2011

Title: Hazard Analysis and Risk-Based Preventive Controls
Abstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the terms 'small business' and 'very small business.' The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership. FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR Part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan. This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w).
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Yes	Unfunded Mandates: No
CFR Citation: 21 CFR 110
Legal Authority: 21 USC 342 21 USC 371 42 USC 264 PL 111-353, (signed on January 4, 2011)

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernizaton Act.	07/04/2012

Overall Description of Deadline: Not later than 9 months after the date of enactment of the FDA Food Safety Modernization Act.

Timetable:

Action	Date	FR Cite
NPRM	10/00/2011

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes
Agency Contact: John F. Sheehan Director, Office of Food Safety, Division of Plant and Dairy Food Safety Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-315), 5100 Paint Branch Parkway , College Park, MD 20740 Phone:240 402-1488 Fax:301 436-2632 Email: john.sheehan@fda.hhs.gov