More than a year after first clearing the U.S. Senate's Committee on Health, Education, Labor, & Pensions, S 510, the FDA Food Safety Modernization Act, was passed today by the Senate.  The bill represents a substantial overhaul of the U.S. Food and Drug Administration's oversight and regulation of food safety matters.

Provisions of the bill, which have enjoyed fairly broad support from both industry and consumer groups, would increase the FDA's inspection powers and resources, including adding a substantial number of new field staff. Some key changes include:

  • Mandatory recalls. The FDA would be granted the power to impose mandatory food recalls in certain situations.
  • Increased inspections. Both foreign and domestic facilities would be inspected more frequently by FDA.  FDA would identify and target higher-risk facilities for the most frequent inspections.
  • Traceability. The U.S. Department of Health and Human Services would be required to develop pilot programs that would seek to enhance the traceability of both raw agricultural commodities and processed foods.
  • HACCP plans. The bill also generally requires food facilities to develop and implement written HACCP (Hazard Analysis and Critical Control Point) plans. Facilities would need to undertake food safety hazard analyses, put in place preventative measures at critical control points, monitor the effectiveness of those measures, and update plans as necessary to substantially lessen or eliminate food safety problems. To assist regulated facilities, FDA would be required to "promulgate regulations [and a guidance document] to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls..."
  • Coordination with other agencies. The bill encourages FDA to work closely with state and local agencies to monitor potential food safety and defense issues. FDA would also be required to work with other federal agencies to develop a national agricultural and food defense strategy.
  • Regulations concerning high-risk raw agricultural commodities. FDA, in coordination with the U.S. Department of Agriculture (USDA), would develop rules governing certain aspects of the growing, harvesting, sorting, packing and storage of certain high-risk raw agricultural commodities—in effect mandating certain farming, harvesting and packing practices for growers and packers of the affected raw produce types.
  • Imported foods. One particular focus of the bill is imported foods. Food importers would need to perform risk-based verifications to assure that their suppliers are complying with the new HACCP requirements. The bill creates a new "Voluntary Qualified Importer Program," which would expedite the review and inspection of foods imported for use by program participants. Importers would also need to provide certifications for certain imported food shipments—from either an agency of the country of origin or other specified international agencies—which indicate the food articles comply with the requirements of the Federal Food, Drug, and Cosmetics Act. The bill outlines the steps for certain foreign agencies and third-party auditors to become authorized to perform these inspections and certifications.

Last Minute Amendments

  • An amendment proposed by Sen. Jon Tester (D-MT) to limit applicability of large portions of the bill to "Very Small Businesses", defined as businesses selling less than $500,000 worth of food each year, was integrated into the final bill.
  • Amendments proposed by Sen. Tom Coburn (R-OK) to temporarily ban earmarks and to remove portions of the bill he believed would eliminate needless bureaucracy were defeated.

What is Not Covered

The bill only covers food articles within the jurisdiction of FDA, and therefore does not regulate meat, poultry, or shelled eggs under the jurisdiction of USDA's Food Safety and Inspection Service.  Additionally, the bill specifically exempts alcohol-related facilities from most requirements in the bill.

Next Steps

The House passed a similar bill, the Food Safety Enhancement Act (HR 2749), more than a year ago. The biggest difference between the House bill and the Senate bill is funding.  The House bill would be funded by collecting fees from inspected facilities whereas the Senate bill would be funded from the general Treasury funds.  In any case, the Congressional Budget Office estimates the net budget impact would be negligible.  It is likely that the House will take up and attempt to pass the Senate's bill in place of its own.

We will continue to monitor and report as the bill moves through the House and towards passage.  Final language of the bill should be available shortly on the Library of Congress Web site.

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