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Top Ten New Requirements Food Industry Professionals Need to Know About the FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act was enacted by the U.S. Congress and signed into law by President Obama on January 4, 2011. The law creates the most significant changes to the U.S. food production and distribution system in more than seventy years. It imposes broad new requirements on manufacturers, processors, packers and distributors of food, and grants U.S. FDA sweeping new enforcement powers. To assist food industry professionals, Registrar Corp has analyzed the new law and provides the following information that all food industry professionals should know about the new law:

1. Most of the provisions of the new law require U.S. FDA to issue regulations providing the details. The specific requirements will depend on these regulations to be issued over the next two years. Registrar Corp will provide updates as these regulations are issued.

2. Commencing in 2012, each food facility must renew its U.S. FDA registration biennially (every two years). Renewal registrations will be required during the 4th quarter of every even-numbered year (i.e., 2012, 2014, 2016, etc.). Facilities located outside the United States continue to be required to designate a U.S. Agent for U.S. FDA communications, as established by the U.S. Bioterrorism Act of 2002.

3. As part of each company’s food facility registration, the company will be required to agree to permit inspection by U.S. FDA. The law does not require U.S. FDA to inspect all facilities, but it increases the number of inspections and requires all firms to agree to an inspection upon U.S. FDA request. A company may be required to pay for any required re-inspection. This part of the law will become effective no later than July 4, 2011.

4. The law grants power to U.S. FDA to suspend a company’s food facility registration if U.S. FDA believes that food manufactured, processed, packed, received, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. This part of the law will become effective no later than July 4, 2011. The law also grants U.S. FDA the power to order, rather than merely request, the recall of tainted food.

5. The law imposes new requirements on persons designated in food facility registrations as U.S. Agents for food facilities located outside the U.S. FDA may bill the U.S. Agent for the cost of any re-inspection conducted of the facility.

6. The law directs U.S. FDA to hire a significant number of new field staff to carry out its purposes, between now and 2014. An additional 150 employees will be hired immediately, dedicated to detecting and tracking food threats, as well as “smuggled food.” The law defines “smuggled food” as “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.”

7. Food facilities will be required to develop written plans for hazard analysis, preventive controls and corrective measures, to be updated with each change in operations or every three years, whichever is more frequent. These records must be available for U.S. FDA inspection. Specific regulations will be promulgated by U.S. FDA. Small businesses may be exempt from the more stringent of these requirements. A small business is defined as one with sales of less than $500,000 per year, which must be mostly to local restaurants or retailers and to consumers. The upcoming regulations will provide details.

8. Importers will be required to establish programs to verify the safety of all shipments of imported food, and U.S. FDA may require certifications of safety for each shipment. Regulations implementing these requirements are due by January 4, 2012. U.S. FDA may establish a Qualified Importer program, easing requirements for some importers, by July 4, 2012.

9. U.S. FDA will provide for the recognition of accreditation bodies that accredit laboratories, including laboratories outside the United States, with a demonstrated capability to conduct analytical testing of food products. Regulations implementing this provision are due by January 4, 2013.

10. Registrar Corp will be available to assist you as each of these new requirements take effect and as new regulations are promulgated.

To view the full text of the FDA Food Safety Modernization Act, click here.

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U.S. Senate Passes New Food Safety Bill

WASHINGTON – Today, the U.S. Senate passed a sweeping overhaul of the USA’s food safety system (S.510). The FDA Food Safety Modernization Act, which passed by a vote of 73 to 25, would greatly strengthen the U.S. Food and Drug Administration, and increase requirements on companies in the food industry.

Major points of the FDA Food Safety Modernization Act include:

  • The U.S. FDA would have new powers to demand recall of tainted foods, instead of merely requesting that companies recall products.
  • An increase in the number of U.S. FDA inspections of food processing plants, with an emphasis on foods that are considered most high risk.
  • The U.S. FDA will have increased control over food imports, including increased inspection of foreign processing plants.

For a bill to become law in the USA, it must pass both houses of Congress (the Senate and the House of Representatives), and it must be signed by the President. The House passed a different version of the bill in July 2009. Despite today’s unusual bipartisan support and a strong push from the Obama administration, the FDA Food Safety Modernization Act could stall if it cannot be reconciled between the Senate and House of Representatives. Top House Democrats said that they would consider simply passing the Senate version to speed approval.

The Senate version requires biennial U.S. FDA food facility registration, and does not impose a registration fee.

The House version (The Food Safety Enhancement Act of 2009) requires annual U.S. FDA food facility registration and imposes a $500 registration fee.

Both versions have additional requirements for non-U.S. processors. Registrar Corp will provide you with more information when the final, reconciled bill becomes law. After it becomes law, the U.S. FDA will issue implementing regulations, which we also will advise you about, when those are promulgated.