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American ShipperShippingTrade and Compliance

FDA proposes enhanced food safety regs

   The U.S. Food and Drug Administration on Friday proposed two new food safety rules to help prevent the spread of foodborne illnesses.
   The proposed rules specifically implement the FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days.
   The rules, when implemented, will build on steps taken during the Obama administration, including the first egg safety rule protecting consumers from Salmonella and stepped up testing for E. coli in beef as well as existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.
   Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community.
   “The FDA Food Safety Modernization Act is a common sense law that shifts the food safety focus from reactive to preventive,” said Health and Human Services Secretary Kathleen Sebelius, in a statement. “With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families.”
   It’s estimated that one in six Americans suffer from a foodborne illness every year. Of those, nearly 130,000 are hospitalized and 3,000 die from their illness.
   The first rule proposed by FDA would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. The FDA is proposing that many food manufacturers be in compliance with the new preventive controls rules one year after the final rules are published in the Federal Register but small and very small businesses would be given additional time.
   A second proposed rule calls for enforceable safety standards for the production and harvest of produce on farms. This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables.
   The FDA proposes that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register, while small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.
   “We know one-size-fits-all rules won’t work,” said Michael R. Taylor, FDA’s deputy commissioner for foods and veterinary medicine. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”
   Additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards to strengthen the quality of third-party food safety audits overseas.
   “Improving oversight of imported food is an important goal of FSMA. Approximately 15 percent of the food consumed in the United States is imported, with much higher proportions in certain higher risk categories, such as produce,” the agency said. \
   The FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed today for human food.
   Industry groups are analyzing the proposed rules and preparing comments. 
   “We will work closely with members across the produce industry, leading food safety scientists, other stakeholders and the FDA to ensure the proposed rules are practical and effective for enhancing produce food safety,” said David Gombas, senior vice president of food safety and technology, for the Washington-based United Fresh Produce Association.
   To read more about FDA’s food safety enforcement efforts, read the December American Shipper article “Improving import clearance.”

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Chris Gillis

Located in the Washington, D.C. area, Chris Gillis primarily reports on regulatory and legislative topics that impact cross-border trade. He joined American Shipper in 1994, shortly after graduating from Mount St. Mary’s College in Emmitsburg, Md., with a degree in international business and economics.
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