FDA Outlines "Significant Progress" in First Year of Implementing FSMA

(FDA received $50 million above its fiscal year 2011 level, including $39 million for the FSMA, in a fiscal year 2012 appropriations bill that was signed into law on November 18, 2011. The increase was significantly less than the $326 million increase sought by the Administration to implement the FSMA. See ITT’s Online Archives 11111818, 11111714 and 11031554 for summaries of the appropriations bill and FDA’s request for more funding.)

Initial Implementation Steps Completed

During the first year of FSMA, FDA has completed a number of initial implementation steps, including:

Authority to administratively detain food. FDA issued an interim final rule establishing lower criteria for administrative detention for food or feed, as provided for in the FSMA. This new criteria allows FDA to administratively detain food products that it has “reason to believe” (from credible evidence) are adulterated or misbranded for up to 30 days, According to FDA, it has now used this authority three times. (See ITT’s Online Archives 11050424, 11050511 and 11070716, for summaries of FDA’s interim final rule and FDA stating in July 2011 that the new authority was in effect.)

Requiring Prior Notice of imported food. FDA issued an interim final rule that requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. (See ITT’s Online Archives or 11050516 and 11090106 for summary of the interim final rule establishing the new PN element on other countries refusing food and FDA stating it would enforce it starting September 6, 2011.)

FY 2012 fees for facility reinspections, etc. FDA announced the fiscal year 2012 fee schedule for certain domestic and foreign facility reinspections and for failure to comply with recall orders. (The FSMA authorized FDA to charge hourly fees on the food and feed industry for FDA (i) import reinspection activities (including addressing requests to remove a product from an Import Alert, to release detained articles, etc.); (ii) facility reinspections; and (iii) recall activities resulting from a firm's non-compliance with a food recall order. In August, FDA announced the FY 2012 fee rates of $224/hour (or $325/hour if foreign travel is required) and described the circumstances in which they would be applied. FDA later delayed the fees for its import reinspection activities described in (i). See ITT’s Online Archives 11080114, 11091514, 11092922 and 11100412 for summaries of the fees and partial delay.)

Authority to suspend registration of food facilities. FDA has the authority to suspend the registration of food facilities to prevent the import and export into the U.S. in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. (See ITT’s Online Archives 11071915 for summary of FDA’s update to its frequently asked questions document to describe this new FSMA authority.)

Launched product tracing pilots. FDA announced that the Institute of Food Technologists (IFT) will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks. (See ITT’s Online Archives 11090811 for summary of FDA launching the tracing pilots for produce and processed food.)

Guidance to seafood industry on safety hazards. FDA issued its updated guidance to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards. (See ITT’s Online Archives 11042821 for summary of the updated “Fish and Fishery Products Hazard and Control Guidance” (aka the Seafood HACCP guidance.)

Web search for recalls. FDA launched a more consumer-friendly recall search engine on the FDA website. (See ITT’s Online Archives 11041216 for summary.)

FDA-DHS anti-smuggling strategy. FDA and the Department of Homeland Security issued a joint anti-smuggling strategy to help to identify and prevent smuggled foods from entering the U.S. and posing a threat to national security and consumer safety. (See ITT’s Online Archives 11070612 for summary.)

Inspections

Met the FSMA mandate for foreign inspections. FDA states that it met the FSMA mandate for foreign inspections. For domestic inspections, the FSMA mandate is based on a 5-year time period. In the past year, FDA has defined its high risk and non high risk domestic food facility inventories and in FY11, FDA and its State partners conducted more than 20,000 food facility inspections. FDA states that at this rate, it will most assuredly meet the domestic food inspection frequency mandates defined in FSMA. In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit. (See ITT’s Online Archives 11051808 for summary of FDA stating that its foreign facility inspections would increase under the FSMA.)

Outreach and Technical Assistance

FDA states that communication and outreach have played an essential role as FDA implements the various FSMA provisions. Therefore, FDA has participated in more than 350 meetings with industry leaders, farmers, consumers, public officials, and academics on issues such as the following:

Inter-government food safety grants. FDA, the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training and other projects.

Produce safety farm tours, meetings. On produce safety, FDA has worked very closely with USDA, which has an established relationship with farmers, and taken part in 14 farm tours across the country to gather input on how the proposed rules can work feasibly across the diversity of commodities and growing conditions and practices.

Public meetings. FDA held three public meetings on preventive controls, import provisions, and changes to inspection and compliance programs in a preventive controls environment.

International meetings on FSMA impact. FDA has participated in more than 70 meetings globally to discuss the international impact of FSMA. This includes trips by the Deputy Commissioner for Foods to China, Mexico, Canada and the European Union.

Produce Safety Alliance. FDA participated in, and helped fund, the establishment of the Produce Safety Alliance and the Food Safety Preventive Controls Alliance to help industry, especially small and very small firms, to comply with the requirements.

Business outreach. FDA provided information to the business community through the extension services of 49 land-grant colleges and universities.

FSMA webpage. FDA established a FSMA webpage that now has more than 10,000 subscribers, includes more than 100 Frequently Asked Questions by topic, and features videos, webinars, presentations, and print materials.

FSMA Reports to Congress

FDA submitted to Congress the first annual “Report on Food Facilities, Food Imports, and FDA Foreign Offices” and the “Biennial Report to Congress on the Food Emergency Response Network (FERN).” (See ITT’s Online Archives 11092256 for summary.)