Strategies to Protect Food Against Intentional Adulteration (FSMA) Compliance Information:

Compliance dates for the FSMA Food Defense Rule (Mitigation Strategies to Protect Food Against Intentional Adulteration, 21 CFR 11 and 121) are on the horizon, with the first date arriving three years after the effective date of the rule, or July 26, 2019.

Who must comply, and with which portions of the rule?

Exemptions have been granted to the following industry sectors (from the Federal Register Number 2016-12373, retrieved December 27, 2017):

  • The rule does not apply to a very small business (e., a business, including any subsidiaries or affiliates, averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, e.g., held for a fee), except that the facility is required to provide for official review, upon request, documentation sufficient to show that the facility qualifies for this exemption.
  • This rule does not apply to the holding of food, except the holding of food in liquid storage tanks.
  • This rule does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
  • This rule does not apply to activities of a farm that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
  • This rule does not apply with respect to alcoholic beverages at a facility that meets certain conditions.
  • This rule does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
  • This rule does not apply to on-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices if such activities are the only activities conducted by the business subject to section 418 of the FD&C Act.

Compliance dates for businesses subject to the rule, from the Federal Register Number 2016-12373 (information retrieved December 27, 2017):

  • Facilities, other than small and very small businesses, have 3 years after the effective date to comply with part 121. (July 26, 2019)
  • Small businesses (e., those employing fewer than 500 full-time equivalent employees) have 4 years after the effective date to comply with part 121. (July 27, 2020)
  • Very small businesses (e., businesses that have less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) have 5 years after the effective date to comply with § 121.5(a). (July 26, 2021)