FDA Draft Guidance for Industry Mitigation Strategies to Protect Food Against Intentional Adulteration

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Draft Guidance for Industry Mitigation Strategies to Protect Food Against Intentional Adulteration[附网盘链接]是于当前发布的FDA标准,适用于United States。

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Draft Guidance for Industry Mitigation Strategies to Protect Food Against Intentional Adulteration[附网盘链接]
Draft Guidance for Industry Mitigation Strategies to Protect Food Against Intentional Adulteration[附网盘链接](截图)

 

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Draft-Not for Implementation Mitigation Strategies to Protect Food Against Intentional Adulteration: 1

Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic.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. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction 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 2

farms that produce milk. 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. 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. 7

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