FDA Food Safety Modernization Act

The United States Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. The Secretary of Health and Human Services also deals with the FSMA.

Scope

The Department of Health and Human Services (HHS) will require registration and payment of a fee by any "person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food." Individuals who partake in food handling without official registration are subject to a maximum 10 year prison sentence. Registration requires each facility which produces or handles food to maintain records relating to food safety.

The law contains potential exceptions for food grown and consumed at private residences. Likewise, smaller farms that sell directly to consumers can be exempt. For example, food sold at local farmers' markets would not necessarily be subject to the certification requirements.

Specific provisions in the law governing small-farm and farmer's markets provide for FDA authority:

• to exempt farms engaged in low or no risk processing or from co-mingling activities from new regulatory requirements or to modify particular regulatory requirements for such farming operations;
• to minimize the number of different regulatory standards that apply to separate foods;
• to make requirements scale appropriate, and to prohibit FDA from requiring farms and other food facilities to hire outside consultants to write food safety plans;
• to provide for a USDA-delivered competitive grant program for food safety training for farmers, small processors and wholesalers, with emphasis placed upon small and mid-scale farms;
• to prohibit wildlife-threatening enforcement against “animal encroachment” of farms and to require the application of sound science to any requirements that might impact wildlife and wildlife habitat;
• to exempt farmers from extensive and expensive traceability and record-keeping requirements if they sell food directly to consumers or to grocery stores;
• to provide that labeling preserving the identity of the original farm through intervening processors to the consumer can satisfy traceability requirements
• in most cases, to limit farm record-keeping to the first point of sale when the product leaves the farm.

The new law also places more extensive requirements on importers via the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP). Both programs place importers in the front line of defense against bringing unsafe foods into the United States.

Employee protections

The FSMA also includes provisions that protect employees who try to prevent food safety problems. Section 402 of the FSMA prohibits employers engaged in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food from retaliating against employees who disclose violations of the Federal Food, Drug, and Cosmetic Act. This particular portion of the FSMA is administered by the U.S. Department of Labor.

Reaction

According to maplight.org, large trade organizations have joined public health advocates in supporting the bill, while groups aligned with individuals and small farms have generally opposed it. However, after Senate adoption of Jon Tester's amendment, which allows for the possible exemption of producers that sell less than $500,000 a year, many large food companies objected, arguing that the exemption puts consumers at risk.

Food facility registration

Since October 22, 2012, the updated food facility registration system by the US FDA is available. This update requires all facilities previously registered prior to October 1, 2012 to renew registration. Failure to do so is a prohibited act and will lead to refusal of entry for foreign products and illegal trade for domestic facilities.

Every 2 years in even numbered years, every registered facility needs to renew its registration between October 1 and December 31. Registration is accepted by fax, mail and electronics means on the FDA food facility registration website.

See also

• Codex Alimentarius