F.D.A. finalizes preventive control rules

by Jay Sjerven
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The Food and Drug Administration on Sept. 10 at long last finalized the first two of seven major rules required by Congress under the F.D.A. Food Safety Modernization Act (F.S.M.A.) of 2011. The F.D.A. said the rules constituted the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities. 

Jay Sjerven, Sosland Publishing Co.
Jay Sjerven

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Stephen Ostroff, acting F.D.A. commissioner.

The preventive controls rules focus on implementing modern food manufacturing processes for both human and animal foods. The rules will ensure that food companies are taking action and working with the F.D.A. to prevent hazards to consumers during food manufacture rather than waiting to act until a disease outbreak has occurred.

The preventive controls rules require human and animal food manufacturing plants to develop and implement written food safety plans that indicate the possible problems that may affect the safety of products and outline steps plant management would take to prevent or minimize the likelihood of the problems occurring.

This means food companies will be accountable for monitoring plant production processes, identifying any potential hazards that may occur in the products and preventing the hazards. Under the rules, the F.D.A. will be able to assess the systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and will better protect the safety of manufactured food.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine.

Once all seven F.S.M.A. rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health, Mr. Taylor said.

The preventive control rules incorporated the advice and took into account the concerns of stakeholders, and the food industry expressed its support of the measures while urging Congress and the Obama administration to recognize their import to the nation by ensuring the F.D.A. is appropriated sufficient funds to implement them properly.

“We welcome the final F.S.M.A. rules for preventative controls for human and animal food and commend F.D.A. for the deliberative and inclusive approach it took in developing these regulations,” said Pamela G. Bailey, president and chief executive officer, Grocery Manufacturers Association, Washington. “F.S.M.A. ensures that prevention is the cornerstone of our nation’s food safety strategy, places new responsibilities on food and beverage manufacturers, and provides the F.D.A. with the authorities it needs to further strengthen our nation’s food safety net.”

Ms. Bailey said the G.M.A. was proud of its work in support of F.S.M.A., including educating food and beverage manufacturers on what it will take to comply with the law.

Kraig R. Naasz, president and c.e.o., American Frozen Food Institute, added, “We appreciate and value the collaborative working relationships cultivated by F.D.A. during the development of these rules, and we believe a comprehensive, systemic approach to food safety will continue to provide Americans with the safest possible food supply.”

Consumer advocates also both welcomed the F.D.A.’s finalizing the preventive controls rules and urged Congress to appropriate the funds necessary for their successful implementation.

“It has been a long, slow slog, but our country has now taken a major step toward creating a truly modern food safety system, and that’s good news for consumers,” said David Plunkett, senior food safety attorney, Center for Science in the Public Interest. “This transformative rule focuses on preventing illnesses rather than just responding after people are sick. Now, Congress must fund F.D.A. so it can actually conduct inspections and help industry comply with the new requirements.”

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