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Senate Expected to Consider Its Food Safety Bill Soon

The Senate is expected to soon begin its consideration of S. 510, the FDA Food Safety Modernization Act, possibly as early as the week of April 19.

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Chairman Harkin of the Senate Health, Education, Labor, and Pensions Committee, expressed his hope that the Senate will soon pass S. 510 in order to get it reconciled with the House and on the President’s desk to be signed into law.

(On November 18, 2009, the Senate Health, Education, Labor, and Pensions Committee unanimously approved S. 510 by ordering it favorably reported with an amendment in the nature of substitute.1)

Like House-Passed Bill, S. 510 Would Require Certification for High Risk Imports, Etc.

According to a Committee press release providing highlights of S. 510, the Committee’s version shares many similarities with H.R. 2749, the food safety legislation passed by the House in July 2009, as it contains the following highlights:

Certification for high-risk imports. S. 510 would allow the FDA to require certification for high-risk foods, and to deny entry to a food that lacks such certification or that is from a foreign facility that has refused U.S. inspectors. It would create a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier could pay a user-fee for expedited entry into the U.S. In addition, S. 510 would require importers to verify the safety of foreign suppliers and imported food.

Increased inspections. The bill would require FDA to inspect all food facilities more frequently, including inspections of high-risk facilities at least once a year and inspections of other facilities at least once every four years.

Hazard analysis and preventive controls. The bill would require all 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 give the Food and Drug Administration (FDA) access to these plans and relevant documentation. These requirements would not apply to restaurants or most farms.

Mandatory recall authority. S. 510 would give FDA the authority to order a mandatory recall of a food product if the food would cause serious adverse health consequences or death and a company had failed to voluntarily recall the product upon FDA’s request.

Administrative detention. It would give FDA the authority to administratively detain any food that was misbranded or adulterated under the Food, Drug, and Cosmetic Act.

Increased FDA resources. S 510 would increase funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility re-inspection, food recalls, and the voluntary qualified importer program.

1An amendment in the nature of a substitute is an amendment that strikes out the entire text of a bill and inserts a different full text. An amendment in the nature of a substitute can be similar to the bill it replaces, or quite different. In this case, it was similar, and only certain minor amendments were made.

(See ITT’s Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, (Ref: 09090120), (Ref: 09082510), (Ref: 09081205), (Ref: 09081015) and (Ref: 09080415), for BP summaries of House-passed H.R. 2749’s provisions on: ceramicware, Bisphenol A, & infant formula; facilities and exporting; food tracing; broker registration and new reasons to detain food; and importer registration, certification for high-risk imports, and increased inspections.

See ITT’s Online Archives or 03/09/09 news, (Ref: 09030915), for BP summary of S. 510 as introduced in the Senate in March 2009.

See ITT’s Online Archives or 11/23/09 news, (Ref: 09112310), for BP summary of the Senate Committee’s approval of its version of S. 510.)

Senator Harkin’s press release (dated 04/07/10) available at http://help.senate.gov/newsroom/press/release/?id=da41287c-c1ab-439c-9d54-1d4005112bc7&groups=Chair.