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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

S 510, the FDA Food Safety Modernization Act, is still alive

Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor and Pensions Committee, today issued the following statement on the manager’s package for The FDA Food Safety Modernization Act. Harkin has been working on a bipartisan basis with HELP Committee Ranking Member Mike Enzi (R-WY), authors of the FDA Food Safety Modernization Act Dick Durbin (D-IL) and Judd Gregg (R-NH) and lead cosponsors Chris Dodd (D-CT) and Richard Burr (R-NC) on the proposal.

The full manager’s package (over 200 pages) is available here – S. 510 – FDA Food Safety Modernization Act.

“For far too long, the headlines have told the story of why this measure is so urgently needed: foodborne illness outbreaks, product recalls and Americans sickened over the food they eat. This 100-year-old plus food safety structure needed to be modernized,” said Harkin.

“I am pleased that after a great deal of time and effort from members on both sides of the aisle, we have a strong, bipartisan proposal that will overhaul our current food safety system – a system that right now fails far too many American consumers. I am confident that the remaining details will be worked out and am hopeful that the measure will come to the Senate floor as soon as possible.”

The FDA Food Safety Modernization Act passed the HELP Committee without a single dissenting vote on November 18, 2009. The bill is supported by dozens of industry and consumer organizations including the Center for Science in the Public Interest, the Consumer Federation of America, the Grocery Manufacturers of America, the National Association of County and City Health Officials, the National Restaurant Association and the Trust for America’s Health.

Highlights of the manager’s package include: 

Hazard analysis and preventive controls: Requires facilities that manufacture, process, pack or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration, and gives FDA access to these plans and relevant documentation. These requirements do not apply to restaurants or most farms.

Imports: Requires importers to verify the safety of foreign suppliers and imported food. Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors. Creates a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier can pay a user-free for expedited entry into the U.S.

Inspection: Gives FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently.

Mandatory Recall Authority: Gives FDA the authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request.

Regulatory Balance: Achieves new requirements without being excessively burdensome. The legislation provides training for facilities to come into compliance with new safety requirements and includes special accommodations for small businesses and farms. It does not interfere with current organic farming practices and does not change the current definition of farm under the 2002 Bioterrorism Act. Any farm that is not currently required to register with FDA will not be required to do so under this legislation.

Surveillance: Enhances surveillance systems to detect food-borne illnesses.

Traceback: Requires FDA to establish a pilot project to test and evaluate new methods for rapidly tracking foods in the event of a food-borne illness outbreak.

Increased FDA Resources: Increases funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility reinspection, food recalls, and the voluntary qualified importer program.

Well, I have a lot of reading to do tonight.