FSMA 2013 Annual Report to Congress regarding the use of mandatory recall authority

Section 206 of the Food Safety Modernization Act (“FSMA”) requires the Department of Health and Human Services (“HHS”) to submit a report to Congress regarding the use of the Food and Drug Administration’s (“FDA”) recall authority and any FDA advisories informing consumers that they should not consume certain articles of food.  The FDA may issue a mandatory recall order once the agency first provides the party with an opportunity to stop distributing the potentially dangerous food product.  If the responsible party fails to voluntarily recall or stop distributing the food product, the FDA may proceed under the mandatory recall authority provided to the agency in section 423 of the Federal Food, Drug and Cosmetic Act (“FDCA”).  Prior to the enactment of the FSMA, the FDA had to rely on voluntary recalls or obtain a court order to remove dangerous food items from the food supply chain.

In the 2013 annual report to Congress regarding the use of the FDA’s mandatory recall authority, the FDA reported that from FY 2011 through FY 2013, the FDA issued only one mandatory recall action.  On February 13, 2013, the FDA allowed Kasel Associates Industries, Inc. (“Kasel”) the opportunity to initiate a voluntary recall for some lots of Kasel’s pet treats.  Prior to this date, the FDA and Colorado state inspectors conducted numerous product tests on Kasel’s pet treats and tested environmental samples from Kasel’s facilities.  The tests revealed that many of the environmental samples and all of the pet treats tested positive for Salmonella.  In response to the investigations, Kasel voluntarily recalled certain lots of dog treats that had tested positive.  Kasel did not, however, recall all pet treat products produced at the facility where the environmental samples had tested positive for Salmonella.

As a result, the FDA issued to Kasel the Notification of Opportunity to Initiate a Voluntary Recall letter on February 13, 2013 to Kasel requesting that the company recall all pet treat products produced at its facility for a certain period of time.  On February 19, Kasel announced a voluntary recall of all pet treats produced at its facility for a certain period of time due to potential contamination of salmonella.

For more information, read the FDA’s annual report regarding its mandatory recall authority under the FSMA.

FDA’s draft approach to designating high-risk foods for which additional records are required

On February 4, the FDA issued a draft approach to identifying high-risk foods (“HRFs”) under section 204(d)(2) of the FSMA, which requires the FDA to designate HRFs  for which additional records must be maintained.  The additional records for designated HRFs would allow the FDA to more quickly identify recipients of food when illnesses from food are possible.

Section 204(d)(2)(A) already requires that the designation of HRFs must be based on the following factors:

  • Known safety risks of a particular food;
  • Likelihood that a particular food has a high risk for contamination due to the nature of the processes used to produce the food;
  • The point in the manufacturing process at which the food contamination would occur;
  • Likelihood of contamination and steps taken to reduce that likelihood during the manufacturing process;
  • Likelihood that consuming a particular food would result in foodborne illness from contamination; and
  • Likely severity of foodborne illness from the particular food item.

The FDA’s draft approach would use a decision analysis approach based on multiple criteria to identify foods that should be designated as HRFs.  The approach would put the criteria identified in § 204(d)(2)(A) listed above into a risk model.  The FDA would identify food and hazard pairings and allocate a total risk score for each defined criteria.  If there are foods with multiple risk scores because they are associated with more than one hazard, the FDA would arrive at a total HRF score using each of the individual scores.  Whether or not the food would then be included on the HRF list would depend on the total risk score for foods or food categories.  Read a description of the particular approach.

The FDA invites public comments and any applicable scientific data regarding its draft approach.  The comment period will remain open until April 7, 2014.

FSMA proposed rule on sanitary transportation of human and animal food

On January 31, the FDA issued a proposed rule on sanitary transportation of human and animal food under the FSMA. This proposed rule would require food transporters to use sanitary transportation practices to ensure safety of human and animal food. Specifically, the proposed rule applies to shippers, receivers and carriers who transport food in the United States by motor or rail vehicles, including shippers who initiate a shipment of food entering US commerce by motor or rail vehicles from abroad. The proposed rule would establish the criteria for safe food transportation for vehicles and transportation equipment; transportation operations; information exchange; training; records; and waivers.

The FDA proposed that the final rule would be effective 60 days after it is published. Small businesses—other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts—would have to comply within two years after the publication of the final rule. Other businesses, not otherwise excluded from coverage, would have to comply within one year of the final rule publication. The comment period for the proposed rule is open through May 31, 2014.