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          Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional AdulterationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
					
		
		March 2019


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2018-D-1398
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  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 [2].

We implemented these intentional adulteration provisions through a rule entitled “*Mitigation Strategies to Protect Food Against Intentional Adulteration*” (IA rule).We published the final rule in the *Federal Register* of May 27, 2016.  (81 FR 34166).

The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121, as shown in Table 1.

**Table 1. Subparts Established in 21 CFR Part 121**

Subpart
			TitleA
			General ProvisionsB
			ReservedC
			Food Defense MeasuresD
			Requirements Applying to Records That Must Be Established and MaintainedE
			Compliance

As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule depends on your particular business.

**Table 2. Compliance Dates for IA Rule Based on Size of Business**

Size of Business
			Compliance DateVery Small
			July 26, 2021Small
			July 27, 2020Other businesses that do not qualify for exemptions
			July 26, 2019

The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies.  (21 CFR 121.1).

Acts of intentional adulteration may take several forms: acts intended to cause wide scale public health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA).  Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality. The other forms are typically not intended to cause wide scale public health harm, although some public health harm may occur because of the adulteration.  For example, acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA is intended to obtain economic gain.  In the spectrum of risk associated with intentional adulteration of food, attacks intended to cause wide scale public health harm to humans are ranked as the highest risk.  Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, consumers, or competitors, or acts of EMA [3].

This document is directed to those persons who are subject to the Intentional Adulteration (IA) requirements of 21 CFR part 121 (you).  Identifying significant vulnerabilities at your facility and implementing mitigation strategies and mitigation strategy management components enables you to apply a proactive and systematic approach to your food defense program to protect your food from intentional adulteration intended to cause wide scale public health harm.

*This draft guidance, when finalized, will represent the current**thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.*

**Download the Guidance**

Related Information

Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
	FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
	Constituent Update: FDA Releases Third Installment of the Draft Guidance for the Intentional Adulteration rule (02/13/2020)
	Constituent Update: FDA Extends Comment Period for Third Installment of the Draft Guidance for the Intentional Adulteration Rule (05/27/2020)
	Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism*See additional information on commenting: Stakeholders Will Be Able to Comment on First Two Volumes of the Intentional Adulteration Rule Draft Guidance Together*

[1] This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

[3] As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable process step—even if that act is not intended to cause wide scale public health harm. (81 FR at 34183).


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-1398.

                                                                                  Content current as of:
      05/27/2020
         
                  
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