Food Safety Modernization Act (FSMA)

The 2011 Federal Food Safety Modernization Act
What Does It Mean For My Food Business?

Overview
On January 5, 2011 the Food Safety Modernization Act (FSMA) was signed into law. The FSMA is a broad reform of the food safety regulations enforced under the federal Food and Drug Administration (FDA) and applied to food facilities. The new provisions allow the FDA to:

  1. order a mandatory recall of any food product FDA reasonably believes will cause severe adverse health consequences, after a company has had the opportunity to take voluntary action;
  2. adopt a risk-based approach to regulating food safety so the agency can focus on the most important food contaminants by periodically reevaluating relevant health data and studies. This includes establishing science-based standards for the safe production and harvesting of fruits and vegetables (related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, water, and intentional and unintentional hazards);
  3. inspect high-risk food facilities (as determined by FDA) at least once every three years;
  4. gain access to a food company’s records to watch for potential risks of foodborne contamination;
  5. require that importers verify that their foreign suppliers are producing food under U.S. food safety standards; and
  6. require food companies to have a written preventative controls plan (including sanitation, training, environmental controls, allergen controls, a recall contingency plan, good manufacturing practices (GMPs), and supplier verification activities) and follow preventive steps to avoid food contamination by identifying the critical points where food could become contaminated and then implementing procedures to prevent that contamination.

What foods are not regulated under this legislation?

Any foods that are under the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) and are not currently regulated by the FDA (which is under the U.S. Department of Health and Human Services):

  1. Federal Meat Inspection Act (21U.S.C. 601 et seq.);
  2. Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and
  3. Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

What foods and food products are currently regulated by FDA and subject to the new legislation?

  1. fish and seafood;
  2. dairy products and shell eggs (but not eggs removed from their shells for processing);
  3. raw agricultural commodities for use as food or components of food;
  4. canned foods;
  5. live food animals;
  6. bakery goods, snack food, and candy; and
  7. food packaging and food contact substances.

What is a high risk food?

The FDA Food Code currently defines high risk or potentially hazardous foods as those that are natural or synthetic and require temperature control because they are in a form capable of supporting the growth of certain bacteria known to cause illness in humans.

This definition will change since the FSMA requires the FDA to develop and publish a list of high-risk foods within one year of its enactment and begin developing regulations for additional record-keeping requirements for these foods within two years.

Food businesses that must comply with this legislation

The FSMA applies to any registered food facility (under Section 415 of the FDA Food, Drug and Cosmetic Act) that processes, manufactures, packs, holds and/or transports food and food products destined for human consumption. This means that all facilities must now register with the FDA every two years to allow FDA to review any changes in their products. Within the first year, these food businesses can expect to see the FDA publish updated guidelines for Good Agricultural Practices.. Furthermore, within the next 18 months, FDA will require all registered facilities to develop a Hazard Analysis Critical Control Points (HACCP) plan, implement  preventative controls, and develop a food safety plan.

Food businesses exempted from this legislation

The FSMA makes some accommodations for small businesses, including small-scale producers and small processors that:

  • direct market more than 50% of their products directly to consumers, stores or restaurants (this includes food sold through farmers’ markets, bake sales, public events and organizational fundraisers)
  • have gross sales (direct and non-direct combined) of less than $500,000
  • sell to consumers, stores, or restaurants that are in-state or within 275 miles of where the products were harvested or processed
  • disclose to consumers the location from which the food originated

*Note that FDA will issue a proposed rule within 9 months clarifying the on-farm activities that would require registration as a food facility (growing, harvesting and/or packing of high risk foods).  The final rule will be issued within 18 months of FSMA’s enactment. In addition, small processors that meet the sales and distribution requirements for exemption will still need to register as a food facility.

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