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HHS/FDA RIN: 0910-AG63 Publication ID: Spring 2011 
Title: ●Intentional Contamination 
Abstract: The Food Safety Modernization Act of 2010 (PL 111- 353) (FSMA) requires the Secretary of HHS to issue regulations to protect against the intentional adulteration of food. Section 106 requires that for foods that meet a certain threshold, the Secretary issue regulations that specify how a person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food and specify appropriate science based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points. In addition, section 103 of FSMA requires that the Secretary 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. Section 103 specifies that hazards include those that may be intentionally introduced. In this rule FDA will implement section 106 and section 103 as to hazards that are intentionally introduced. This rulemaking is part of a larger agency effort to focus on bolstering food defense throughout the food chain. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: sec 103 and sec 106 of the FDA Food Modernization Safety Act (PL 111-353)   
Legal Deadline:
Action Source Description Date
Final  Statutory    07/04/2012 
Action Date FR Cite
NPRM  10/00/2011    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
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: No 
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