Food and Drug Administration Globalization Act of 2009

“As evidenced by the recent widespread contamination’s in our food supply, including E. coli in spinach, Salmonella in peppers, and the most recent outbreak of Salmonella in peanut butter, it is clear that we must act now.”

These were the words used by Representative Frank Pallone, Jr., Chair of the Health Subcommittee, in a press release regarding the Food Safety Enhancement Act of 2009. The proposed bill (still in draft form) is the latest in a string of food safety proposals currently in Congress. The Food Safety Enhancement Act is largely based on H.R. 759, the Food and Drug Administration Globalization Act of 2009. As stated, the aim of the bill is, “To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.” (Hmm… I wonder what these mysterious ‘other purposes’ are…)

The Food Safety Enhancement Act is divided into two titles: Food Safety and Miscellaneous. The ‘Food Safety’ title includes four subsections: Prevention, Intervention, Response, and Miscellaneous. The highlights of the bill are as follows:

• Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

• Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with re-inspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.

• Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every 6 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 is prohibited.

• The 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 trace-back (current law permits facilities to hold a record in any format—paper or electronic—making efficient tracing of foods difficult for FDA).

• Regarding imported food, the bill allows the FDA to 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 must meet strict requirements to protect against conflicts of interest with the firm seeking certification.

• Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

• Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

• Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

Whether the Food Safety Enhancement Act, if enacted, will actually reduce food-borne illness outbreaks remains to be seen. Even if it does, one has to wonder what toll will it take on the small farm movement whose resources may be limited. At least on the surface, the sponsors of the bill appear to have good intentions. As Representative Betty Sutton stated, “Americans need to know that the food on their family’s table and in their children’s lunchboxes will be safe.” Let’s hope this isn’t just political lip service.