FDA Proposes New Food Safety Rules

Earlier this January the FDA released an announcement detailing proposals for new landmark food safety standards.Food contamination attorneys highlight the new safety rules being enacted to prevent food-borne illnesses.

The preventative proposals are part of the FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama in January 2011. It has been called the most sweeping reform in food safety in the past 70 years. The FSMA rules represent a shift of focus from reactive measures to preventative measures.

Specifically, the proposals will focus on preventing public Salmonella and E.coli contamination, as well as improving standards for any facility that manufactures, processes, packs, or holds human food. The FDA is proposing that food manufacturers create formal plans outlining how they will prevent dangerous bacteria contamination and food-borne illness, and develop corrective action plans should an outbreak occur. The rules will also require manufacturers to adhere to stricter record keeping procedures and implement new safety evaluations. Such safety measures will include requiring that farm workers wash their hands, install portable toilets in their fields, and build fences for keeping out animals. The rules are focusing on addressing the safety of foods produced both domestically and imported.

The farming regulations are science- and risk-based, meant to improve the safety of fruits and vegetables produced and harvested on farms. The new rules come two years after FSMA was signed because the FDA was conducting extensive outreach, including five federal public meetings along with regional, state, and local meetings in 14 states throughout the country. The FDA also gave hundreds of presentations to make sure the new rules would be flexible enough to be properly adhered to by the large number of affected industries.

Additional regulations include written hazard analyses, which will identify and evaluate potential hazards for each type of food manufactured the facility, processes for food allergen and sanitation, and monitoring procedures for documenting and verifying that preventative controls are performed. According to the FDA news release, one in six Americans suffers from a food-borne illness each year. 13,000 of those affected are hospitalized, and an astounding 3,000 Americans die every year from a food-borne illness.

The FDA is arguing that preventing food-borne illness will not only improve public health and reduce medical costs, but it will prevent the expensive disruptions in the food system as well. In 2012 the U.S. food industry enacted several large-scale food recalls and illness outbreaks involving foods ranging from cantaloupes to peanut butter.

The rules will not apply to facilities that store packaged food, nor will it apply to those systems already subject to the Hazard Analysis and Critical Control Point system, such as seafood and juice. Dietary supplement manufacturers will also be exempt.

The FDA was clear that additional rule proposals will soon follow. Other regulations will include improved standards for importers to ensure that food grown and processed overseas meet all U.S. guidelines, and improved oversight of safety audits overseas. An estimated 15% of consumed food in the U.S. is imported. The FDA will also propose new standards for animal food facilities.

Should the proposals be approved, those in the food industry will be faced with costly changes. The FDA estimates that the over-all cost to industry, for the first year alone, will be $701 million. After that, the agency estimates the annualized cost will be $460 million for domestic farms, $170 for foreign farms, and $472 million for industry. FSMA also requests that the FDA increase inspections and hire about 2,000 new inspectors, which could cost the federal government over one billion dollars over a five-year period.

These profound changes will undoubtedly make for a lengthy and complicated approval process. Food and drug contamination lawyers at Pintas & Mullins Law Firm are closely following developments surrounding this issue, and will report as soon as new information comes to light. If you or someone you love was seriously affected by food contamination, you have important legal rights, and should consider seeking guidance of an experienced food-borne illness attorney.

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