FDA Notifies New FSMA Draft Guidance on Food Defense and Adulteration

FDA has notified new FSMA guidelines on Food Defense and Adultration , Mitigation strategies to protect Food Against Intentional Adulteration also known as IA rule are applicable 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 . These organizations are 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) . Exemptions include very small business, packing, repacking, labeling, relabeling of primary food packages, farm ,manufacturers /processors and packers of food for animals and some alcoholic beverages. On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.

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