30 November 2009 via www.mondaq.com
Article by Kristin R. Eads, Jennifer Williams Zwagerman and Steven B. Toeniskoetter
Last week, the Senate Health, Education, Labor, and Pensions (HELP) committee unanimously passed the FDA Food Safety Modernization Act (Senate Bill 510). The bill, originally introduced in the Senate in March, is very similar to a House bill, HR 2749 (the Food Safety Enhancement Act of 2009), which passed the House in July.
Provisions of the bill, which has enjoyed fairly broad bipartisan support, 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.
* Traceability. The HHS Secretary 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. These facilities would be 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, the 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 would encourage the FDA to work closely with state and local agencies to monitor potential food safety and defense issues. The 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. The FDA, in coordination with the 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 would create 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 imported food shipments, from either an agency of the country 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.
* Funding. Unlike the House bill, which would fund its activities through fees charged to facilities, this bill would be funded by taxpayers. Additionally, facilities would be required to pay fees to reimburse the FDA for its administrative costs where the FDA needs to reinspect facilities or where the FDA has enforced a mandatory recall.
Due to the health care reform and climate change bills pending before Congress, no vote on this bill is expected until at least January. Because this bill does not regulate meat, poultry or eggs under the jurisdiction of the USDA, there is also the possibility that the bill may be combined with other legislation in order to also cover those food items. One such bill was recently introduced by Sen. Kristen Gillibrand (D-NY), entitled the E. Coli Eradication Act of 2009. This bill would require slaughterhouses, processing establishments, and grinding facilities to test trimmings for the presence of E. coli O157:H7 and provide positive or presumptive test results to the USDA.
Text of the FDA Food Safety Modernization Act (S 510), the Food Safety Enhancement Act (HR 2749), and the E. Coli Eradication Act of 2009 (S 2792) are available on the Library of Congress Web site at http://thomas.loc.gov/.