Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

Docket ID: FDA-2013-N-1425
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)

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.

RIN: 0910-AG63
Impacts and Effects: International
CFR Citation: 21 CFR 121
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2015
Agenda Stage of Rulemaking: Final Rule
Major Rule: Yes
Legal Authorities: 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
Government Levels Affected: Undetermined
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: Yes
Included in Regulatory Plan: Yes
Legal Deadline
JudicialOtherTo the Office of the Federal Register for publication05/31/2016
ActionDateFR Citation
NPRM12/24/201378 FR 78014
NPRM Comment Period Extended03/25/201479 FR 16251
NPRM Comment Period End03/31/2014
NPRM Comment Period Extended End06/30/2014
Final Rule06/00/2016
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Keyword(s): of, of201211, open, of201413
Type: Rulemaking
Docket Status: open
Center: OF
Docket Item Code: N

Primary Documents

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Comment Period Closed
Jun 30, 2014 11:59 PM ET
Proposed Rule
Posted: 03/25/2014
ID: FDA-2013-N-1425-0021
Comment Period Closed
Mar 31, 2014 11:59 PM ET
Posted: 02/25/2014
ID: FDA-2013-N-1425-0014
Comment Period Closed
Mar 31, 2014 11:59 PM ET
Proposed Rule
Posted: 12/24/2013
ID: FDA-2013-N-1425-0002
Comment Period Closed
Posted: 12/18/2014
ID: FDA-2013-N-1425-0145
Comment Period Closed
Posted: 08/04/2014
ID: FDA-2013-N-1425-0099

Supporting Documents

No documents available.


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Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Agency Contact
Jody Menikheim
Supervisory General Health Scientist
240 402-1864
301 436-2633 (Fax)
Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway
College Park, MD 20740
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.