Final food defense rules target wide-scale public harm and terrorism
For the first time, the FDA will require both domestic and foreign food facilities to prepare and implement a written food defense plan that assesses their potential vulnerabilities to intentional adulteration, including actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective action, and verification. While acts of intentional adulteration may take many forms, including acts of disgruntled employees or economically motivated adulteration, the purpose of the FDA’s Final rule is to protect food from acts (including terrorism) where the desire is to cause wide-scale public health harm. The final version of the rule will publish in the Federal Register on May 27, 2016.
FSMA implementation. The Final rule implements sections 418, 419, and 420 of the federal Food, Drug & Cosmetic Act (FDC Act), as amended by the Food Safety Modernization Act (FSMA) (P.L. 111-353), that relate to the intentional adulteration of food.
Section 418 of the FDC Act (21 U.S.C. §350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FDC Act (21 U.S.C. §350d).
Section 419 of the FDC Act (21 U.S.C. §350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities.
Section 420 of the FDC Act (21 U.S.C. §350i) addresses intentional adulteration in the context of high risk foods and exempts farms, except for farms that produce milk.
Proposed rule. Rather than targeting specific foods or hazards, on December 24, 2013 (78 FR 78014), the FDA decided to combat the potential for wide-scale public harm or terrorism in the food industry by publishing a Proposed rule requiring mitigation (risk-reducing) strategies for processes in certain food facilities required to register with the FDA under the FDC Act (see Food facility measures to protect against intentional adulteration (terrorism) proposed, December 23, 2013).
Food defense measures. The Final rule establishes various food defense measures that an owner, operator, or agent in charge of a facility must implement to protect against the intentional adulteration of food:
Written plan. Prepare and implement a written food defense plan that includes a vulnerability assessment to identify significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.
Vulnerability assessment. Identify any significant vulnerabilities and actionable process steps by conducting a vulnerability assessment for each type of food manufactured, processed, packed, or held at the facility using appropriate methods to evaluate each point, step, or procedure in a food operation.
Mitigation strategies. Identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated.
Mitigation strategies components. The facility owner, operator, or agent must also establish and implement mitigation strategies management components to ensure the proper implementation of each food defense mitigation strategy. These components must include procedures for monitoring the mitigation strategies, corrective action to be taken if mitigation strategies are not properly implemented, and verification activities.
Reanalysis, training and recordkeeping. The facility owner, operator, or agent must also: (1) ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties; (2) establish and maintain certain records, including the written food defense plan and documentation related to training of personnel; and (3) conduct a reanalysis of the food defense plan every three years.
Exempted facilities. The Final rule does not apply to the following:
very small businesses (a business averaging less than $10,000,000 per year, during the three-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, of documentation sufficient to show that the facility qualifies for this exemption;
food holding facilities, except those holding food in liquid storage tanks;
facilities that pack, re-pack, label, or re-label food where the container that directly contacts the food remains intact;
farm activities that are subject to the standards for produce safety contained in section 419 of the FDC Act (21 U.S.C. §350h);
the manufacture of alcoholic beverages at a facility that meets certain conditions;
the manufacturing, processing, packing, or holding of food for animals; and
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.
Effective dates. Facilities, other than small and very small businesses, will have three years after the effective date (60 days from the date of publication in the Federal Register) to comply. Small businesses (fewer than 500 full-time equivalent employees) will have four years after the effective date to comply. Very small businesses must be prepared to comply with FDA requests for official documentation sufficient to show that the facility is exempt within five years of the effective date. These very small businesses must retain this documentation for two years.
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