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FDA Publishes Operational Strategy for Implementing FSMA
The FDA has published its “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),” which will be considered the Agency’s launching pad for all food safety efforts moving forward. The strategy is an overview of FDA’s new approach to implement FSMA in food and feed facilities, produce safety operations, and import operations. The Agency’s new plan is to “significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industries.” The plan permits voluntary corrections of problems at the facility level (which will be achieved during inspections by FDA communicating with firm management), and at the district level through deficiency letters and follow up to verify correction. With respect to produce safety, the Agency will focus its efforts on “a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliancefrom multiple public and private sources, including partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.” The document also reveals FDA’s approach towards import oversight for which the Agency plans to use new and traditional tools to achieve FSMA compliance, such as commodity specific guidelines, outreach, technical assistance, reliable third-party audits, and compliance incentives such as less frequent or intense inspections for good performers. FDA’s new operational plan is available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm.
FDA Extends Comment Period for Proposed Rule on Sanitary Transportation
After requests from many food companies and trade groups, FDA has extended the comment period for the sanitary food transport rule by 60 days. The comment period is now open until July 30, 2014. Under the Food Safety Modernization Act (FSMA), shippers, receivers, and carriers that transport food by motor or rail vehicles must implement safeguards to prevent food contamination, such as certain refrigeration, cleaning, and protection measures. See the docket for the Sanitary Transportation of Human and Animal Food Proposed rule at http://www.regulations.gov/#!docketDetail;D=FDA-2013-N-0013, and for the Federal Register Notice see 79 Fed. Reg. 29699, [enhanced version available to lexis.com subscribers], (May 23, 2014) at https://www.federalregister.gov/articles/2014/05/23/2014-12002/sanitary-transportation-of-human-and-animal-food-extension-of-comment-period.
Senate & House Appropriations Committees Advise FDA on How to Implement FSMA
The Senate Appropriations Committee said FDA should re-propose all of the produce safety and preventive controls for human and animal foods under FSMA, not just the most controversial parts. In the report for USDA and FDA spending for fiscal year 2015, the Committee expressed concern that FDA is only focusing on addressing portions of the proposed rules, and asked FDA to ensure that the public can comment on all preventative controls for food requirements, accompanied by economic analyses.
The Committee also raised concerns about imports, noting that some food companies have expressed problems and delays with clearing shipments. The Committee suggested ensuring there are sufficient personnel and developing a process by which highly compliant importers may be released with minimal administrative disruption. FDA also was directed by the Committee to publish final advice for pregnant women on seafood consumption, a draft of which was published in early June. Furthermore, the committee approved an amendment to the spending bill that would require labeling of any genetically modified salmon.
The House has also directed FDA in how to implement FSMA. The House report recommends ways to label calories, determine nutrient content for variable standard menu items, and disclose nutrient content using a remote-access menu. Guidance on the use of natural claims on food products was also requested. The House report also cautions FDA’s Dietary Guidelines Advisory Committee about going outside the scope of the panel with evaluations of sustainability, climate change, and other environmental factors. It further indicated that, if the advisory group moves forward with recommendations on those bases, as opposed to purely nutritional science, USDA should reject the recommendations of the committee for labeling. Aside from food for human consumption, the House also requested an update on the ongoing pet jerky treat contamination issue. See the Senate Committee's report at http://www.appropriations.senate.gov/news/committee-approves-fy-2015-spending-allocations-military-construction-and-veterans-affairs, and the House Committee's report at http://appropriations.house.gov/news/documentsingle.aspx?DocumentID=380251.
Read more in the Keller and Heckman LLP Food Regulatory Update.
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