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FDA Annual Report criticized for omitting status of regulations

In August, the US Food and Drug Administration submitted its second Annual Report on Food Facilities, Food Imports and FDA Foreign Offices, as required by the Food Safety Modernization Act, which details the progress FDA has made in protecting petfood and food safety.

However, organizations criticize FDA because the Report does not include the status of some regulations the Food Safety Modernization Act required to be publicized, including:

• Hazard Analysis and Risk-Based Preventive Controls (Section 103);
• Current Good Manufacturing Practices and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (Section 103);
• Produce Safety Regulations (Section 105);
• Protection Against Intentional Adulteration of Food (Section 106); and
• Foreign Supplier Verification Program (Section 301).

As a result, two organizations, the Center for Food Safety and the Center for Environmental Health filed a complaint against Margaret Hamburg, commissioner of FDA, and Jeffrey Zients, acting director of office of management and budget, in the US Federal District Court for the Northern District of California, USA. In the complaint, the two organizations alleged that:

• FDA has missed seven deadlines so far in failing to implement FSMA’s major food safety regulations. FDA has submitted several of these unlawfully delayed regulations to the OMB, where they are still awaiting approval. However, FDA has authority to promulgate the regulations without OMB approval, the organizations say.
• In the complaint, entitled, Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., the organizations further allege that “at least nine additional FSMA deadlines will come due in early 2013” and express concern that “[b]ased on FDA’s lack of progress to date, [the Centers] have serious concerns regarding the likelihood that these future deadlines will be met.”

The groups have asked the court for various relief, including a declaration that FDA has violated FSMA by "failing to promulgate regulations by the statutory deadlines and ordering FDA to promulgate all FSMA regulations as soon as reasonably practicable, according to Court-imposed deadlines," according to reports.

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