H.R. 2751 Senate Amendment—Food Safety and Modernization Act of 2010

FLOOR SITUATION

H.R. 2751 is expected to be considered on the House floor on Tuesday, December 21, 2010, under a closed rule that provides for one hour of debate. Rep. Sutton (D-OH) introduced H.R. 2751 on June 8, 2009, and the House approved the legislation on June 9, 2009. However, the Senate used H.R. 2751 as a vehicle and amended it with the Food Safety and Modernization language. The Senate approved H.R. 2751 on December 19, 2010, by unanimous consent. Previously, the House approved the Food and Safety Modernization language on December 8, 2010, as part of H.R. 3082.

EXECUTIVE SUMMARY
H.R. 2751 would amend the Federal Food, Drug, and Cosmetic Act to expand current registration and inspection authority for the Food and Drug Administration.

Small Business Compliance: H.R. 2751 would exempt certain small employers from some of the requirements of the bill, such as registration of food facilities, standards for produce safety, and hazard prevention plans.
Registration of Food Facilities: H.R. 2751 would require biennial facility registration and would authorize or require the Secretary to suspend and/or reinstate registrations.

Hazard Prevention Plans: The bill would require the owner, operator, or agent in charge of a facility to develop a written hazard prevention plan.

Performance Standards: Pursuant to the bill, the Secretary of Health and Human Services would be required, at least every two years, would review and evaluate relevant health data to determine the most significant food borne contaminants. Based on the review and evaluation, the Secretary would be required to issue contaminant-specific and science-based guidance documents, actions levels, or regulations.

Produce Safety: H.R. 2751 would establish safety standards for produce. Within one year of enactment, the Secretary would be required to publish a notice of proposed rulemaking for science-based minimum standards for the safe production and harvesting of those fruits and vegetables that are raw agricultural commodities.
Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry: The bill would require the Secretary of HHS to allocate inspection resources according to the “known safety risks” of the food and countries involved, among other factors.

Inspections of Records: The bill would amend current law to create an additional trigger for inspection.
Tracking and Tracing Food and Recordkeeping: According to the legislation, the Secretary of Health and Human Services would be required to improve the capacity of FDA to track and trace foods in the event of an outbreak. Within 270 days of enactment, the Secretary would be required to establish pilot projects to explore and evaluate methods to prevent or mitigate a food borne illness outbreak.

Fee Collection: The bill would authorize the FDA to collect export certification fees and user fees paid by domestic facilities subject to a reinspection or food recall and fees paid by importers participating in the voluntary qualified importer program or subject to reinspection.

Funding for Food Safety: This section would authorize “such sums as may be necessary” for fiscal years 2011 through 2014 for activities of FDA’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs. In addition, the Secretary would be required to increase the field staff of these three entities with a goal of not fewer than 17,800 government employees.

Voluntary Qualified Importer Program: The bill would require the Secretary of HHS (1) to establish, a voluntary program to expedite review and importation of foods from qualified importers and (2) to issue applicable program guidance.

Surveillance: The bill would require the Secretary of HHS to enhance food borne illness surveillance systems. Appropriations are authorized for these activities at $24 million annually for fiscal year 2011-15. The Secretary shall conduct an assessment of state and local food safety and defense capacities and shall subsequently develop and implement strategies to enhance these capacities. The legislation would authorize food safety capacity grants at $19.5 million for fiscal year 2010 and “such sums as may be necessary” for fiscal year 2011 through fiscal year 2015.

Food Safety Integrated Centers of Excellence: H.R. 2751 would require the Secretary of HHS and the CDC Director to designate five “Integrated Food Safety Centers of Excellence” at selected state health departments to serve as resources for federal, state, and local public health professionals. The bill would authorize “such sums as necessary” to be appropriated to carry out this provision.

Foreign Supplier Verification Program: H.R. 2751 would require each importer to establish risk-based foreign supplier verification activities that: (1) assures that imported food is not adulterated or misbranded and (2) complies with the program of hazard analysis and preventive controls or the produce safety requirements.
Inspection of Foreign Food Facilities: H.R. 2751 would authorize the Secretary of HHS to enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered.

Foreign Offices of the Food and Drug Administration: The Secretary of HHS would be required to establish FDA offices in foreign countries selected by the Secretary.

Training State, Local, Territorial, and Tribal Food Safety Officials: The bill would require the Secretary to set standards and administer training and education programs for employees of state, local, territorial, and tribal food safety authorities. There are authorized to be appropriated such sums as necessary for fiscal year 2011 and fiscal year 2015. The bill would create a new “National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program.” The Secretary of Agriculture would be required to award competitive grants at “such sums as necessary” to carry out the program.

Grant Program for Food Safety: The bill would authorize grants to states, localities, territories, Indian tribes, and certain nonprofit entities for food safety examinations, inspections and investigations, and building laboratory capacity. Congress shall authorize the appropriation of such sums as necessary are for grants from fiscal year 2011 through fiscal year 2015.

Food and Agriculture Coordinating Councils: The bill would require the Secretary of Homeland Security to report on the activities and progress of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council in facilitating public-private partnerships, facilitating information exchange, developing best practices for coordinated preparedness and response, and means to protect the U.S. economy and public health in the event of a food or agricultural incident.
Building Domestic Capacity: H.R. 2751 would establish a number of assessment and reporting requirements regarding domestic capacity to prevent or address food safety threats.

Sanitary Transportation of Food: The bill would require the Secretary of HHS to promulgate regulations to require shippers to use sanitary transportation practices that prevent the adulteration of food.
Food Allergy and Anaphylaxis Management: The bill would require the Secretary of HHS to develop and to make available to local educational agencies (LEAs) guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. It would authorize the Secretary to award non-renewable food allergy management incentive grants, which is authorized for $30 million for fiscal year 2011, and “such sums as may be necessary” for each of four succeeding fiscal years.

Decontamination and Disposal Standards and Plans: The bill would require the Administrator of the Environmental Protection Agency (EPA) to provide support and technical assistance to state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

Building Foreign Government Capacity: The bill would require the Secretary of HHS to develop a comprehensive plan to increase the regulatory capacity of foreign governments and their respective food industries.

Smuggled Food: The bill would require the Secretary of HHS to improve the identification of smuggled food and to take steps to prevent its entry.

MEMBER CONCERNS
Some Members may be concerned that H.R. 2751 would cost the government to spend more money, increase the prices of food, and increase the size of government.

More Spending: CBO estimates that enacting H.R. 2751 would increase spending by $1.4 billion and include the authorization for “such sums as necessary” in numerous programs.

Higher Prices: The bill would levy fees on facilities and exporters. Consumers will end up paying these fees in the form of higher food prices.

More Government Workers: The fees will be used to increase the number of government employees by not fewer than 17,800 employees.
COST

The Congressional Budget Office estimates that spending, subject to appropriations, would increase by $1.4 billion. In addition, the legislation contains a number of mandates on individuals and entities that manufacture, process, pack, transport, distribute, receive, or hold food.
STAFF CONTACT

For more information, contact Brian McManus at 225-2045.

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