Tuesday, November 30, 2010

S. 510 FDA Food Safety Modernization Act

The Senate passed the Food Safety Moderination Act (S. 510) 73-25 on Nov 30 and the House passed the bill more than a year ago. The law will restructure food safety, give significant new authority to the Food and Drug Administration, and place new responsibilities on farmers and processors to keep food free from contamination. Small farmers and other independent food producers and distributors are concerned about the legislation.

President Obama Statement

The FDA Food Safety Moderination Act amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Secretary of Health and Human Services (HHS) to inspect records related to food, including to:
(1) allow the inspection of records of food that the Secretary reasonably believes is likely to be affected in a similar manner as an adulterated food; and

(2) require that each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food permit inspection of his or her records if the Secretary believes that there is a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death.

(3) Authorizes the Secretary to suspend the registration of a food facility if the food manufactured, processed, packed, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4) Requires each owner, operator, or agent in charge of a food facility to: (1) evaluate the hazards that could affect food; (2) identify and implement preventive controls; (3) monitor the performance of those controls; and (4) maintain records of such monitoring.

The legislation follows a spate of national outbreaks of food poisoning involving products as varied as eggs, peanuts and spinach in which thousands of people were sickened and more than a dozen died.  Food illnesses affect one in four Americans and kill 5,000 each year and tainted food has cost the industry billions of dollars in recalls, lost sales and legal expenses. The FDA has been inspecting only about 1 percent of imported food products.

The bill would:
Place greater responsibility on manufacturers and farmers to prevent contamination - a departure from the current system, which relies on government inspectors to catch contamination after the fact.

Give the FDA authority to recall food; now, it must rely on food companies to voluntarily pull products off the shelves.

Give the FDA access to internal records at farms and food production facilities.

Set standards for imported foods, requiring importers to verify that products grown and processed overseas meet safety standards. Public health experts say this is urgently needed, given the increase in imported foods.
FDA is an agency within the Department of Health and Human Services and consists of centers and offices, which are listed in menu at left.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health. (FDA, Wash Post, 11/30/2010)

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