Who needs to comply.

With some exceptions listed below, this rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act. This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities. It does not cover farms. 

What are the compliance dates. 

Very Small Businesses—a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). These businesses would have to comply with modified requirements within five years after the publication of the final rule.

Small Businesses—a business employing fewer than 500 persons would have to comply four years after the publication of the final rule. (July 27, 2020)

Other Businesses—a business that is not small or very small and does not qualify for exemptions would have to comply three years after the publication of the final rule. (July 26, 2019)

What are the exemptions.

  • A very small business. While exempt, the business would be required to provide to FDA, upon request, documentation to demonstrate that the business is very small.

  • The holding of food, except the holding of food in liquid storage tanks

  • The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact

  • Activities that fall within the definition of “farm”

  • Manufacturing, processing, packing, or holding of food for animals

  • Alcoholic beverages under certain conditions

  • 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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