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HHS/FDA RIN: 0910-AG36 Publication ID: Fall 2014 
Title: Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive ControlsĀ for Human Food  

This 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. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

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: Private Sector 
CFR Citation: 21 CFR 117   
Legal Authority: 21 USC 342    21 USC 371    42 USC 264    PL 111-353 (signed on Jan. 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 Modernization Act.  07/04/2012 

Statement of Need:

FDA is taking this action to meet the requirements of FSMA and to better address changes that have occurred in the food industry and thereby protect public health. High-profile outbreaks of foodborne illness over the last decade and data showing that such illnesses strike one in six Americans each year have caused a widespread recognition that we need a new modern food safety system that prevents food safety problems in the first place not a system that just reacts once they happen. Section 103 of FSMA amended the Federal Food Drug and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety emphasizing prevention. Section 418 of the FD&C Act requires owners operators or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section. In addition to containing new provisions requiring hazard analysis and risk-based preventive controls this rule would also revise the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110 that were last updated in 1986.

Summary of the Legal Basis:

FDA is relying on section 103 of the FSMA. FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD&C Act, a food is adulterated if it consists in whole, or in part, of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.


An alternative to this rulemaking is not to update the CGMP regulations, and instead issue separate regulations to implement the FDA Food Safety Modernization Act.

Anticipated Costs and Benefits:

FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food safety plans, setting up training programs, implementing allergen controls, and purchasing new tools and equipment) and recurring costs (e.g., auditing and monitoring suppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduced risk of foodborne illness and death from processed foods, and a reduction in the number of safety-related recalls.


This regulation will directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborne illness in the U.S.

Action Date FR Cite
NPRM  01/16/2013  78 FR 3646   
NPRM Comment Period End  05/16/2013 
NPRM Comment Period Extended  04/26/2013  78 FR 24691   
NPRM Comment Period Extended End  09/16/2013 
NPRM Comment Period Extended  08/09/2013  78 FR 48636   
NPRM Comment Period Extended End  11/15/2013 
NPRM Comment Period Extended  11/20/2013  78 FR 69604   
NPRM Comment Period Extended End  11/22/2013 
Supplemental NPRM  09/29/2014  79 FR 58523   
Supplemental NPRM Comment Period End  12/15/2014 
Final Rule  08/00/2015 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Jenny Scott
Senior Advisor
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive, Room 3B014,
College Park, MD 20740
Phone:240 402-1488