The Food Safety Modernization Act (FSMA) requires many deliverables from FDA, among them special reports and studies to be submitted to Congress.

 Submitted December 2013

Annual Report to Congress on the Use of Mandatory Recall Authority
Submitted Pursuant to Section 206 of the FDA Food Safety Modernization Act, Public Law 111-353
U.S. Department of Health and Human Services
Food and Drug Administration

Introduction

On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353). Section 206(a) of FSMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 423 (21 U.S.C. § 350l) giving FDA, for the first time, mandatory recall authority with respect to all FDA-regulated foods other than infant formula.[1] FSMA requires the Department of Health and Human Services (HHS) to submit a report to Congress on the use of recall authority under section 423 of the FD&C Act and any public health advisories issued by FDA that advise against the consumption of an article of food on the grounds that it is adulterated and poses an imminent danger to health.  Specifically, FSMA section 206(f) states: 

(1) In general.--Not later than 2 years after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this subsection as the "Secretary") shall submit a report to the Committee [Page 124 STAT. 3944] on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
(2) Content.--The report under paragraph (1) shall include, with respect to the report year--
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 417 of the Federal Food, Drug, and Cosmetic Act, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 423(a) of such Act;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 423(a) of the Federal Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b) of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 423(b) of the Federal Food, Drug, and Cosmetic Act or a public health advisory described in paragraph (1).

The following is the first annual report in response to this mandate since FSMA was enacted on January 4, 2011. It covers the reporting requirements relating to the use of recall authority under section 423 of the FD&C Act. With respect to the further requirement to report on “public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health,” FDA is considering which of its public communications are “public health advisories” as described in FSMA section 206(f) and will include any such advisories in future reports.  

Background

While the American food supply is among the safest in the world, according to recent data from the Centers for Disease Control and Prevention, there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year.  Moreover, each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.  This is a significant public health burden that is largely preventable. FSMA, which was signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by strengthening food safety measures.  Under the new law, FDA now has much more effective enforcement tools to protect the food supply. This includes the authority to issue a mandatory recall order under section 423 of the FD&C Act for any food, other than infant formula,  for which FDA determines there is a “reasonable probability” that the food is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act and that the use of or exposure to that food will cause serious adverse health consequences or death to humans or animals.[2]

In order to issue such a mandatory recall order, FDA must first provide the responsible party with the opportunity to cease distribution and to conduct a voluntary recall of the article of food in question.  If the responsible party refuses to, or does not voluntarily, cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority as set forth in section 423 of the FD&C Act.  Should the Secretary order the responsible party to cease distribution and to give notice to other persons in the distribution chain, the responsible party has the opportunity to request a hearing to be held within 2 days to contest the order and convince FDA that the product should not be recalled. 

Prior to the enactment of FSMA, FDA generally had to rely upon manufacturers’ voluntary recall efforts or obtain a court order to remove contaminated or misbranded foods, other than infant formula, from the food supply.     

Use of Recall Authority  

From fiscal year 2011 through fiscal year 2013, FDA initiated one enforcement action under the mandatory recall authority granted by FSMA. On February 13, 2013, FDA issued a Notification of Opportunity to Initiate a Voluntary Recall letter (notification letter)[3] to Kasel Associates Industries, Inc. (Kasel) for certain lots of the firm’s pet treats.  The affected products included pet treats manufactured at the firm’s Denver facility from April 20, 2012, through September 19, 2012, with lot codes BESTBY20APR2014 to BESTBY03OCT2014 for products with a 2 year expiry, or BESTBY20APR2013 to BESTBY03OCT2013 for products with a 1 year expiry (collectively, affected pet treats). 

In 2012, FDA and State of Colorado inspectors conducted numerous product tests on certain lots of Kasel’s pet treats. In addition, FDA investigators conducted a for cause inspection in September 2012 and collected several samples, including environmental samples, at Kasel’s facility for further testing.  FDA found that all of the finished pet treat product samples tested, and 48 out of 87 environmental samples collected during the inspection, tested positive for Salmonella.  More than ten different species of Salmonella were found in the firm’s products and manufacturing facility, indicating multiple sources of contamination.  In addition, FDA investigators observed problems with the Kasel facility’s general sanitation and cleanliness, including pest infestation, and general disrepair of the building, fixtures, physical facilities, and manufacturing equipment. 

While there were no reports of human illness, FDA received a small number of complaints of illness in dogs who were exposed to the treats.  Because of the multiple positive tests for Salmonella in the firm’s products and in the environmental samples, as well as the production practices and conditions observed at the facility during the inspection, FDA believed that there was a reasonable probability that pet treat products manufactured in the firm’s Denver facility from April 20, 2012, through September 19, 2012, were contaminated with Salmonella. 

In response to the investigations by State of Colorado and FDA officials, Kasel conducted several voluntary recalls in the fall of 2012 for specific lots of dog treat products that tested positive for Salmonella. However, Kasel refused to recall all pet treat products manufactured in the facility from April 20, 2012, through September 19, 2012, including one of the finished product samples that tested positive for Salmonella.  

On February 13, 2013, FDA conducted a follow-up inspection and determined that the firm did implement some corrective actions and therefore an enforcement action, such as a seizure or an injunction, was not required at that time. However, since the pet treat products manufactured in the facility from April 20, 2012, through September 19, 2012, were still on the market and were a potential threat to public health, FDA issued a notification letter to Kasel pursuant to section 423(a) of the FD&C Act. The notification letter provided the firm two business days to inform FDA whether they would conduct the recall voluntarily.  

In response to the notification letter, on February 19, 2013, Kasel issued a press release[4] announcing the voluntary recall of all pet treats that it manufactured from April 20, 2012, through September 19, 2012, due to potential contamination with Salmonella.  The affected pet treat products were sold at various retailers, including Target, Petco, Sam’s Club, and Costco.  Most of the products have a two-year shelf life.  Nutri-Vet, NutriPet, Boots and Barkley, Colorado Naturals, Nature’s Deli, Best Bully Sticks, and Bixbi were among brands affected by this recall.  They are all jerky- type products that contain either pork, chicken, beef, turkey, buffalo, or salmon. Below is the detailed list[5] of all the pet treats affected by the recall.  

Conclusion 

This first annual report required by FSMA section 206 provides data for FY 2011 through FY 2013. It outlines the mandatory recall activities undertaken by FDA during that time period.

[1] Infant formula recalls are conducted under sections 412(e), (f), and (g) of the FD&C Act.