House Committee Releases Draft of Comprehensive Food Safety Legislation

The Food Safety Enhancement Act of 2009 discussion draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009. (See ITT's Online Archives or 02/18/09 news, 09021820, for BP summary of H.R. 759.)

Highlights of the Food Safety Enhancement Act of 2009 discussion draft include:

General Provisions

Importer registry, fee - require all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.

Facility, importer IDs - to enhance information about FDA-regulated entities, create unique identification numbers for all drug, device, and food facilities and importers.

Foreign inspectorate - require FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

Subpoena authority - grant FDA new authority to subpoena records related to possible violations.

Whistleblower protection - prohibit entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

Food Safety

Food facility registry - require all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

Facility registration fee - require registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; require registered facilities to pay for FDA's costs associated with reinspections and food recalls; allow FDA to charge a fee to domestic firms requesting export certificates for exported food.

Increased inspections - set a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection would be prohibited.

Expedited processing for certain importers - permit FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

Safety certification of food - as an additional layer of protection, FDA could require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities would be required to meet strict requirements to protect against conflicts of interest with the firm seeking certification.

Country of origin labeling - require all processed food labels to indicate the country in which final processing occurred. Require food manufacturers to identify the country of origin for all ingredients on their websites. Require country-of-origin labeling for all produce.

Enforcement tools - provide FDA new authority to issue mandatory recalls of tainted foods. Strengthen criminal penalties and establish civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

Facility safety plans - require all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.

Safety plans for fresh produce - direct the FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

Improve food traceability - enhance FDA's ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format - paper or electronic - making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.

Expanded lab testing - require FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Give FDA the ability to require laboratories to send test results to FDA.

Infant formula safety - enhance FDA's ability to assure the safety of new infant formulas before they go on the market.

Food surveillance system - direct the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary would also be directed to identify industry and regulatory approaches to minimize hazards in the food supply.

Detention of unsafe food products - strengthen FDA's authority to administratively detain unsafe food products. Grant FDA "quarantine" authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

Carbon monoxide use in certain food - require FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.

Transparency of GRAS program - require posting on FDA's website of documentation submitted to FDA in support of a "generally recognized as safe" (GRAS) notification.

(See ITT's Online Archives or 03/23/09 news, 09032310, for BP summary on the Committee's plans to move strong food safety legislation. See ITT's Online Archives or 03/09/09 news, 09030915, for BP summary on bipartisan Senate food safety bill. See ITT's Online Archives or 03/03/09 news, 09030310, for BP summary on a House food safety bill, H.R. 999.)

Committee press release available at http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1631:waxman-dingell-and-pallone-release-food-safety-enhancement-act-of-2009-draft&catid=122:media-advisories&Itemid=55.

Summary of discussion draft available at http://energycommerce.house.gov/Press_111/20090526/fsea_summary.pdf.

Text of discussion draft available at http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf.