|Sponsor||Rep. Dingell, John D.|
|Committee||Energy and Commerce|
|Date||July 29, 2009 (111th Congress, 1st Session)|
|Staff Contact||Adam Hepburn|
The House is scheduled to consider H.R. 2749 on July 30, 2009 under a closed rule. H.R. 2749 was introduced on June 8, 2009, by Rep. John Dingell (D-MI). A different version of this bill was reported by the Committee on Energy and Commerce by voice vote on June 17, 2009. This bill failed under suspension of the rules on July 29, 2009 by a vote of 280-150.
H.R. 2749 would require the Department of Health and Human Services (HHS) to strengthen federal efforts related to ensuring the safety of commercially distributed food. The bill would also broaden the Food and Drug Administration's (FDA's) authority to regulate food products and requires FDA to assess fees on food facilities, as well as importers and exporters of food products, to cover the costs of registering and inspecting facilities.
H.R. 2749 makes several amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) in several which are described below.
Exemptions: The bill exempts the portions of facilities and farms regulated by USDA (livestock and poultry, for example) from the provisions of the legislation described below. Facilities which produce alcohol and facilities regulated by States under USDA-equivalent requirements would also be exempt.
Registration of Food Facilities: The bill expands the current registration requirements for food facilities by requiring them to register annually with HHS. Currently, food facilities only have to register once. H.R. 2749 also authorizes FDA to suspend or cancel the registration of a facility if there is a violation of the FDCA that could result in a serious adverse health consequences or death. The bill also authorizes an annual registration fee of $500 for every food facility (domestic and foreign). There would be a per company cap of $175,000. Farms would not have to register.
Hazard Analysis, Testing, and Food Safety Plan: H.R. 2749 requires all registered domestic and foreign food facilities to identify hazards and implement preventive controls to prevent or reduce to acceptable levels those identified hazards. Each owner or operator is required to implement a written food safety plan describing its hazard analysis and preventive controls before the owner enters into interstate commerce. The owner or operator also must maintain records documenting its steps to implement, correct, monitor and revise its food safety plan. The bill also requires that companies include a description of the facility's product testing programs in this plan.
Performance Standards: The bill would require FDA to determine the most significant food-borne contaminants, and their resulting hazards, at least every two years. The FDA may issue guidance documents or regulations to prevent these hazards and report to Congress on such.
Safety Standards for Produce: The legislation would give FDA the authority to set standards for the safe growing, harvesting and packaging of fruits and vegetables. It would require the Secretary to issue a proposed rule within 18 months and a final rule within three years.
Risk-based Inspection Schedule: The bill would establish a risk-based inspection schedule for domestic and foreign food facilities. Specifically, high-risk facilities would have to be inspected every six months to one year, low-risk facilities would have to be inspected every 18 months to three years, and warehouses would have to be inspected every five years.
Records Access: The bill would give FDA access to a broad set of documents during inspections and food-related emergencies. H.R. 2749 allows FDA to request that companies transmit their food safety plans and a limited set of supporting documents to the agency. Access to farms records is restricted under this provision, unlike those of food processors/manufacturers.
Food Traceability: H.R. 2749 states that before the Secretary of Agriculture can issue proposed regulations establishing new food traceability requirements, FDA would have to conduct an information gathering process to determine the feasibility and cost/benefit of the system. Any system must allow the Secretary to conduct the traceback within two business days. The Secretary would also be allowed to exempt restaurants and farms from the traceability requirements. Farmers markets are exempt from the traceability requirements.
Re-inspection Fee: The bill establishes a new user fee to be assessed against companies or operators that fail facility inspections and therefore require FDA to conduct an additional inspection by the FDA.
Expedited Food Importation: The bill would allow FDA to create an expedited entry program for food imports. In establishing who qualifies for the program, FDA would consider the personnel of the importers, security of the supply chain, preventive controls, and vendor/supplier information.
Recalls: H.R. 2749 provides the FDA with recall procedures for food that is deemed to be dangerous. The basis for this determination would be if the Secretary has "reason to believe" the food poses a health risk.
Intervention: H.R. 2749 would require the Secretary of Agriculture to enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses. The bill would also require the creation of a national public education program on food safety. This section additionally mandates that the Department of Health and Human Services conduct food safety research.
Quarantine Authority: The bill would give FDA the authority to restrict the movement of food within a State (quarantine) if there is credible evidence that the food presents an imminent threat of serious adverse health consequences or death.
Penalties: Regarding criminal penalties associated with the food sections of the FDCA, the bill would make anyone who knowingly violates them eligible for 10 years in prison. H.R. 2749 also sets forth civil penalties for violations relating to food for individuals and companies, ranging from $20,000 to $7.5 million.
Exportation Certificate Program: The legislation would allow FDA to charge a user fee to cover the cost of providing export certificates. Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certificate for products regulated by the FDA. A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.
Registration of Commercial Importers: The bill requires commercial importers of food to register with the FDA annually. FDA would be authorized to charge these importers a registration fee of $500.
Subpoena Authority: H.R. 2749 would grant FDA the authority to compel the production of documents and testimony of witnesses.
Extraterritorial Jurisdiction: The bill explicitly states that the provisions of the FDCA apply internationally.
The Department of Agriculture (USDA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Environmental Protection Agency (EPA) all share jurisdiction over federal food safety efforts. The Federal Food, Drug, and Cosmetic Act (FDCA), was passed by Congress in 1938 and gave authority to the FDA to oversee the safety of food, drugs, and cosmetics.
The American food supply is one of the safest in the world. Nonetheless, according to statistics published by CDC, the incidences of diseases caused by food borne pathogens did not significantly change in 2008, compared with the previous three years. This apparent lack of success in decreasing these illnesses has lead to an increased legislative effort to monitor and track the food supply.
In 2006, the two most common sources of outbreaks were the norovirus and Salmonella. Approximately 1,270 food borne disease outbreaks occurred in 2006, resulting in 27,634 illnesses and 11 deaths. According to the CDC, "Foodborne illnesses are a major health burden in the United States. Most of these illnesses are preventable, and analysis of outbreaks helps identify control measures. Although most cases are sporadic, investigation of the portion that occur as
part of recognized outbreaks can provide insights into the pathogens, food vehicles, and food-handling practices associated with foodborne infections."
However, Members, especially those from agricultural districts, have raised concerns with this legislation. Generally, the bill broadens the size and scope of government, imposes numerous mandates, and raises new taxes on small businesses. Some Members may have the following specific concerns with the bill:
Fees: H.R. 2749 would establish registration and re-inspection fees for food facilities. Members may be concerned that this essentially amounts to a food tax as these costs are passed through to consumers.
FDA Regulation of Agriculture: The bill would authorize and direct the FDA to regulate agricultural production practices, effectively telling farmers how to farm. Fruit and vegetable producers specifically would be subject to regulatory burdens. Agricultural groups such as the California Farm Bureau have expressed concern over these issues.
Records Access: The bill includes broad recordkeeping authorities that may impose significant regulatory burdens for the food industry. No consideration is given to risks associated with the product produced at the regulated facility when developing the record keeping requirements. The bill further lacks protections from disclosure of proprietary information.
Quarantine Authority and Mandatory Recall: The bill's quarantine authority allows FDA to quarantine a geographic area if there is credible evidence that food poses a health risk. The provision does not account for economic losses suffered by food producers, processors or distributors in the quarantine area. Some Members may be concerned that if the FDA ultimately lifts the quarantine for lack of confirmatory evidence, the agency has no obligation, authority or means to indemnify producers for their losses. Similarly, the bill allows FDA to act on suspicion to require a producer to cease distribution of food. No consideration is given in the legislation to indemnification for economic damages if the FDA was wrong.
According to CBO, implementing H.R. 2749 would cost $2 billion over five years subject to appropriations. H.R. 2749 would also impose a number of mandates on individuals and entities involved in producing, manufacturing, processing, packing, transporting, distributing, receiving, holding, importing, or exporting articles of food.
The gross costs for FDA to administer the new activities authorized under H.R. 2749 would be about $3.5 billion over five years and partially covered by fees, according to CBO.