Congress Approves Sweeping Food Safety Legislation
On December 21, 2010, by a vote of 215-144, the U.S. House of Representatives passed the FDA Food Safety Modernization Act (H.R. 2751), giving final approval to legislation that represents the most significant reform of food safety law in more than 70 years. The bill, which was approved by the U.S. Senate over the weekend, will strengthen the U.S. Food and Drug Administration's ("FDA") oversight of food production, distribution, importation, and storage. Its provisions include mandatory recall authority, expanded authority for inspections, and a requirement that all food facilities conduct a hazard analysis. Under the legislation, food producers will face a significant increase in regulatory requirements, creating a burden never before experienced by the industry.
As the first major food safety reform in decades, the bill will bring about several significant changes to this area of the law. Some of the most notable provisions in the legislation are outlined below.
- The FDA is authorized to mandate food recalls, no longer relying on voluntary compliance of food producers and distributors.
- The FDA will be provided with expanded authority for Administrative Detention of food with a lower threshold for utilizing this enhanced authority.
- Small food facilities selling less than $500,000 per year that directly market to consumers in a 275 mile area are exempt from new regulations in the bill.
- Going forward, FDA must conduct more inspections, and must target facilities based on a risk-based schedule, with the highest risk facilities being inspected at least once within five years of enactment and at least once every three years after that.
- Food producers will be required to develop food safety plans that include health hazard analyses and risk-based preventive controls to significantly minimize or prevent contamination of their food products.
- Food importers will come under closer scrutiny and will be required to verify the safety of their imports. Foreign food producers exporting to the U.S. will also be subject to greater inspection requirements, and the FDA will work to enhance the food safety capacity of foreign governments with respect to food products for export to the U.S. market.
- A pilot program will be created to track and trace high risk foods.
- The FDA will be granted greater access to a food facility's records if there is a reasonable probability that its food products are causing sickness or death in humans or animals. FDA is also granted the authority to suspend a food facility's registration in such instances.
- The FDA will set new standards and regulations for the safety of fresh produce and transportation of food; however, the regulation of meat products will continue to be under the USDA's purview.
- Third party laboratories and inspectors may be used in place of FDA personnel.
- The bill increases the funding and staff at the FDA.
- Grocery stores will be required to post information from the FDA's website regarding reportable food.
There are numerous implications for this sweeping legislation.
- The legislation gives the FDA much needed tools to improve the safety and quality of food products distributed in the U.S. The agency must now promulgate regulations clarifying how it will implement the legislation.
- It is likely that there will be a period of uncertainty as food facilities grapple with more stringent regulatory requirements, such as the development of health hazard assessments.
- Complying with the new law could be expensive for food facilities that do not currently have food safety controls in place. If food facilities fail to comply with the new requirements, the cost of non-compliance (i.e., lengthy inspections and mandatory recalls) will be even greater, and could drive non-compliant food facilities out of business.
- The implications of the small facility exemption are not clear. While the legislation exempts small facilities from oversight, however, it is likely that downstream producers will seek to impose certain aspects of the legislation by contract.
- In other sectors of FDA-regulated industry, the agency is placing an increased emphasis on supply chain management. It is likely that as part of their food safety plans, food facilities will be required to demonstrate to the FDA's satisfaction that they are ensuring the quality of food products supplied by their vendors.
- The legislation does not consolidate the authority for food safety in a single agency, nor does it cover products regulated by the USDA. As a result, coordination of competing agencies with jurisdiction over food safety will continue to be a challenge.
- The law will further stimulate growth in food safety products. Disinfectants, diagnostic tests, labels, and tracking systems have enjoyed increased demand after recent outbreaks, and will likely continue to do so, as food producers comply with new regulatory requirements.
- The law levels the playing field between domestic and foreign food facilities by requiring importers to meet the new foreign supplier verification requirements.
The food safety legislation's journey to passage was a long one. In July 2009, the House first passed the Food Safety Enhancement Act (H.R. 2749). In November 2009, the Senate Health, Education, Labor and Pensions Committee reported the Senate companion version of the bill (S. 510), but the legislation was quickly mired in partisan disagreements and languished for a year. The Senate resumed work on the bill in November 2010, and after several amendments and overcoming procedural challenges, passed a version of the legislation that was agreeable to the House. With passage in both chambers, the Food Safety Modernization Act now goes to the White House for the President's signature.
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