The House Energy and Commerce Committee is out with a discussion draft of “the Food Safety Enhancement Act of 2009.”
Given who’s signed on to this one, it’s probably the one to watch. Sponsors include Chair Emeritus John D. Dingell, Chairs Henry A. Waxman, Frank Pallone, and Bart Stupak, and Reps. Diana DeGette and Betty Sutton.
The new draft is based on the food reforms contained in H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak and Pallone. Favored bills get heard quickly, and this one gets its first hearing next week, on Wednesday, June 3rd.
"As evidenced by the recent widespread contaminations 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," said Rep. Pallone, Chair of the Health Subcommittee. "This draft builds on legislation introduced earlier this year and will empower the FDA with the resources and authorities it needs to ensure that our food is safe to eat. I look forward to continuing to work with my colleagues and the administration to move this crucial piece of legislation forward
"Our 10 food safety hearings in the Subcommittee on Oversight and Investigations have highlighted the need for an overhaul of our food safety laws," said Rep. Stupak, Chair of the Oversight and Investigations Subcommittee. "The American people deserve a Food and Drug Administration that has both the funding and the regulatory authority needed to protect our food supply and hold the food industry accountable. President Obama and the new FDA leadership have expressed a commitment to food safety reform and I look forward to working with them to return FDA to the gold standard in protecting the public health."
A detailed summary of the draft follows below.
- Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.
- Generates resources to support FDA oversight of food safety: 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.
- Prevents food safety problems before they occur: Requires 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.
- Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.
- Increases inspections of food facilities: Sets 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 is prohibited.
- Improves traceability of food: Enhances 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.
- Enhances the safety of imported food: As an additional layer of protection, FDA can 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.
- Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.
- Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.
- Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.
- Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.
- Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.
- Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.
- Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.
- Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.
- Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.
The draft also requires all importers of food to register annually and sets up a system of unique identification numbers for all regulated facilities. Further, it protects whistle-blowers and gives FDA the power to subpoena records and locate inspectors overseas.