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From Health Law Daily, December 23, 2013

Food facility measures to protect against intentional adulteration (terrorism) proposed

By Harold M. Bishop, JD

Domestic and foreign food facilities that are required to register with the FDA under the Food, Drug, and Cosmetic Act (FDC Act) would be required to address hazards that may be intentionally introduced by acts of terrorism under an FDA proposal. These registered food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in their food operation. The proposed requirements are part the FDA’s implementation of the FDA Food Safety Modernization Act (FSMA) (P.L. 111-353). The proposal also discusses an approach to addressing economically motivated intentional adulteration. Comments on the proposed rule must be submitted by March 31, 2014.

FSMA implementation. This proposed rule would implement three provisions of the FDC Act, as amended by the FSMA, 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.

Exemptions. The proposed rule contains several exemptions. The proposed rule would not apply to: (1) a “qualified facility” (defined below), except that the facility would be required to provide for official review, upon request, documentation that was relied upon to demonstrate that the facility qualifies for this exemption; (2) the holding of food, except the holding of food in liquid storage tanks; (3) the packing, re-packing, labeling, or relabeling of food where the container that directly contacts the food remains intact; (4) activities of a facility that are subject to section 419 of the FDC Act (Standards for Produce Safety); (5) alcoholic beverages at a facility that meets certain conditions; and (6) the manufacturing, processing, packing, or holding of food for animals other than man. The FDA seeks comments on these exemptions and whether additional exemptions are warranted.

“Qualified facility” defined. As proposed, a “qualified facility” would be a very small business (a business that has less than $10,000,000 in total annual sales of food, adjusted for inflation), or a facility that meets two requirements, i.e., (1) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and (2) the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

Requirements. The proposed rule would establish the following food defense measures that an owner, operator, or agent in charge of a facility would be required to implement to protect against the intentional adulteration of food:

  • Prepare and implement a written food defense plan that includes actionable process steps, focused mitigation strategies, and procedures for monitoring, corrective actions, and verification.

  • Identify any actionable process steps, using one of two procedures, i.e., the FDA-identified key activity types as described in proposed 21 C.F.R. sec. 121.130(a), or their own facility-specific vulnerability assessments as provided in proposed 21 C.F.R. sec. 121.130(b).

  • Identify and implement focused 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.

  • Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.

  • Establish and implement corrective action procedures that must be taken if focused mitigation strategies are not properly implemented.

  • Verify that monitoring is being conducted and appropriate decisions about corrective actions are being made; verify that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing the significant vulnerabilities; and conduct a reanalysis of the food defense plan.

  • Ensure that personnel and supervisors assigned to actionable process steps receive appropriate training in food defense awareness and their respective responsibilities in implementing focused mitigation strategies.

  • Establish and maintain certain records, including the written food defense plan; written identification of actionable process steps and the assessment leading to that identification; written focused mitigation strategies; written procedures for monitoring, corrective actions, and verification; and documentation related to training of personnel.

Compliance dates. As proposed, the effective date is 60 days after a final rule is published. However, FDA is providing for a longer timeline for facilities to come into compliance. Facilities, other than small and very small businesses, would have one year after the effective date to comply. Small businesses (i.e.,those employing fewer than 500 persons) would have 2 years after the effective date to comply. Very small businesses (i.e., businesses that have less than $10,000,000 in total annual sales of food, adjusted for inflation) would be considered a qualified facility and would have 3 years after the effective date to comply.

MainStory: TopStory FDCActNews AdulterationNews FoodNews FoodSafetyNews GMPNews ImportNews RiskNews

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