The Food Safety Modernization bill (“bill”), which will overhaul the nation’s food-safety laws, recently passed both the House and the Senate and was signed into law by President Obama on Tuesday, January 4, 2011. This landmark bill represents the first major change to the nation’s food safety laws since 1938, expands the regulatory authority of the Food and Drug Administration (“FDA”), aims to prevent food-borne illness and strengthen the safety of food produced in the United States and imported from overseas. The bill will affect all whole and processed foods except meat, poultry and some egg products which are regulated by the U.S. Department of Agriculture. Highlights of key provisions of the bill follow:
- Safety Standards for Produce: Gives FDA the power to set national standards for producing and harvesting fresh produce, and the FDA will publish updated safety guidelines for specific fruits, vegetables and designated high-risk produce. The bill also includes exemptions for small food companies and local farms unable to reach standards designed for larger companies.
- Illegal Substance Regulations: The FDA, Department of Homeland Security and Department of Agriculture, will issue regulations to prevent food companies from including illegal substances in their food products.
- Response to Food-Borne Illness Outbreak: The Health and Human Services, Department of Agriculture and the Department of Homeland Security will prepare a response and recovery outline in case of a food-borne illness outbreak and grocery stores will then be responsible for notifying customers of product recalls.
- Mandatory Food Recall Authority: Provides the FDA the power to order a food recall as opposed to the current system whereby the agency arranges a voluntary recall with the company in question.
- Food Facility Inspections: High-risk food production facilities will be inspected every three years while low-risk facilities will be visited within seven years of the law's passing.
- Suspension Power: Grants the FDA power to suspend a food production facility if a possible health risk is suspected. A new registration process will be put in place in which companies must meet updated requirements or risk suspension.
- Hazard Prevention Plans: Food production facilities must alert the FDA of all identified hazardous practices currently in place and their plans to implement preventive measures going forward.
- Records Access & Tracking: FDA will be provided expanded access to food production facility records for tracking purposes. To ensure any contaminated produce is located and recalled in a safe and timely manner, the FDA, in coordination with the produce industry, will create a new method of tracking and tracing fruits and vegetables.
- Whistleblower Protection: A watch dog provision guarantees that employees of entities involved in the manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing of food will be protected when providing information regarding potential violations to the FDA.
- Establish Foreign Office/ Foreign Food Facility Inspections: To improve oversight, the FDA must establish offices in foreign countries that export food to the United States. The Secretary of Health and Human Services will work with foreign governments to streamline the inspection of foreign food facilities. The bill mandates that FDA inspections of foreign food facilities increase.
- Imported Food Certification: Provides the FDA the authority to require certification for high-risk food imports and the FDA can refuse to import food products lacking required certification.
Understanding that safe food is good for business, food retailers, wholesalers and manufacturers expressed support for the bill’s passage as it will better protect the nation’s food supply by making prevention the focus of food safety strategies and providing the FDA with broad new authority as well as the resources to inspect processing plants, order a recall of products when necessary and impose stricter standards for imported foods. The industry additionally expressed support for using certification programs and requiring food safety plans for food manufacturing companies.
Compliance with the new law will be critical if you are an FDA regulated food grower, processor or seller. To determine what your business needs to do to comply, please contact one of the authors.