View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AG63 Publication ID: Fall 2015 
Title: Focused Mitigation Strategies To Protect Food Against Intentional Adulteration 

This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

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: Private Sector 
CFR Citation: 21 CFR 121   
Legal Authority: 21 U.S.C. 331    21 U.S.C. 342    21 U.S.C. 350g    21 U.S.C. 350i    21 U.S.C. 371    21 U.S.C. 374    Pub. L. 111-353   
Legal Deadline:
Action Source Description Date
Final  Judicial  To the Office of the Federal Register for publication  05/31/2016 

Statement of Need:

FDA is taking this action to meet the requirements of the FSMA and to protect food from intentional adulteration when the intent is to cause large-scale public harm.

Summary of the Legal Basis:

FDA’s authority for issuing this rule is provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by sections 103, 105, and 106 of the Food Safety Modernization Act (FSMA). Section 418 of the FD&C Act addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350g). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk. FDA is implementing the intentional adulteration provisions in sections 418, 419, and 420 of the FD&C Act in this rulemaking.


Section 103, 105 and 106 of the FDA, Food Safety Modernization Act require FDA to conduct this rulemaking. 

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 defense plans, setting up training programs, etc.) and recurring costs (e.g., training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduction in the possibility of illness, death, and economic disruption resulting from intentional adulteration of food.


This regulation will directly and materially advance the Federal Government’s substantial interest in reducing the risk for illness and death associated with intentional adulteration of food.

Action Date FR Cite
NPRM  12/24/2013  78 FR 78014   
NPRM Comment Period Extended  03/25/2014  79 FR 16251   
NPRM Comment Period End  03/31/2014 
NPRM Comment Period Extended End  06/30/2014 
Final Rule  06/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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:
Jody Menikheim
Supervisory General Health Scientist
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-1864
Fax:301 436-2633