Pursuant to Section 201(b) of the 2011 Food Safety Modernization Act (FSMA), the Secretary of Health and Human Services is required to provide Congress with an annual account of the Food and Drug Administration's (FDA) collaborative efforts with other agencies and with data on food facilities, food imports, and the FDA's foreign offices. In November, the FDA submitted to Congress its 2013 annual report.
A majority of the report detailed the various programs being undertaken by the FDA in conjunction with other federal, state, or local agencies. These joint efforts include developing a national laboratory proficiency-testing platform and creating multi-jurisdictional Rapid Response Teams. The FDA further disclosed participation in a multi-agency council dedicated to identifying indicators of economically-motivated adulteration of food products.
The report also provided information on the inspection of food facilities based on the 2012 fiscal year. Importantly, the data collected and submitted to Congress in the FDA's report attempted to utilize the high-risk versus non-high-risk classification system created by the FSMA. Among other things, the FSMA requires the FDA to identify the number of high-risk facilities that were supposed to be inspected, the number of high-risk facilities inspected, and the number of high-risk facilities that were not inspected. Based on the old system, in 2012, the FDA inspected or attempted to inspect 24,462 domestic and 1,342 foreign food facilities. Approximately 11,759 of these inspections were of facilities now classified as high-risk. However, the report indicated that because the high-risk versus non-high-risk classification system is new and not yet completely implemented, much of the data for these categories is unavailable. The report repeatedly states that the "FDA is attempting to inspect all initially-identified high-risk facilities in three years (FY 2011-2013), 2 years earlier than directed by [the FSMA]."
The report also included a section on food imports. The FDA physically examined 207,839 of 11,136,599 food import lines in the 2012 fiscal year, or approximately 1.9 percent. However, all food import lines were electronically screened in an effort to aid field inspectors in determining which lines required physical inspection. The FDA recently increased the efficacy of their screening process by using "data analytics from the entire life cycle of a product" in order to identify those needing inspection. Additionally, products subject to refusal based on "existing evidence" may be preemptively stopped at the border until the importer is able to prove compliance.
The FDA further reported that it has 12 foreign offices.