New Food Defense Regulations

A new FDA regulation was created in order to protect food from being altered or corrupted with the intention of causing public health issues. The rule creates a series of food defense measures that are required to be followed by the owner, operator, or agent in charge of a facility. These measures are designed to protect against any tampering of foods and they have a series of guidelines including the following:

• Create a written food defense plan that includes a vulnerability assessment to identify potential issues and a process for revision, mitigation strategies, a means to monitor food defense, corrective actions, and verification.
• Employ mitigation strategies at each actionable process step to ensure that the any vulnerabilities at each step will be minimized or prevented and the food manufactured or handled by the facility will not be compromised.
• New food defense monitoring procedures will have to be made to keep track of the mitigation strategies and ensure that they are working as intended.
• Corrective action procedures must be created in the event that mitigation processes are not compliant to new food defense rules.
• Establish and implement specified food defense verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility’s food defense system.
• Ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties.
• Establish and maintain certain records, including the written food defense plan (vulnerability assessment, mitigation strategies and procedures for food defense monitoring, corrective actions, and verification) and documentation related to training of personnel. All records are subject to certain general record keeping and record retention requirements.

Compliance Dates

General Compliance – May 27, 2017
Small Business Compliance – May 27, 2020
Very Small Business Compliance – May 27, 2021

• The effective date is 60 days after this final rule is published. However, we are providing for a longer timeline for facilities to come into compliance. Facilities, other than small and very small businesses, have 3 years after the effective date to comply with part 121. Small businesses (i.e., those employing fewer than 500 full-time equivalent employees) have 4 years after the effective date to comply with part 121. Very small businesses (i.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, e.g., held for a fee) have 5 years after the effective date to comply with § 121.5(a).