January 2, 2011
After almost two years of debates, votes, Constitutional issues and political posturing, Congress has approved a sweeping food safety bill that will give the Food and Drug Administration significant new authorities. S. 510, the FDA Food Safety Modernization Act was largely thought to be dead after the Senate approved the bill with revenue raising provisions that House members asserted violated the Constitution’s requirement that all tax legislation originate in the House of Representatives. To remedy the situation, the House chose to attach the food safety bill to a yearlong Continuing Resolution and send it back to the Senate. However, the Senate chose to go with a short term continuing resolution, funding the government until March 2011 leaving the fate of the food safety bill uncertain. After some last minute negotiations, the Senate was able to revive the bill and approve it by unanimous consent on December 19th. The House followed suit and passed the bill on December 21st. The bill is now awaiting President Obama’s signature, which will likely occur in early 2011 when he returns back to Washington.
The bill represents the largest overhaul of the FDA’s food safety authorities since the 1930’s. Some of the major provisions of the bill include:
- Inspections of Records –If there is a reasonable probability that a food, or a related article of food, will cause serious adverse health consequences or death to humans or animals, the Food and Drug Administration (FDA) will be authorized to access relevant records for that food and any related article of food that may be similarly contaminated.
- Registration of Food Facilities –Food facilities as defined in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) must register with FDA and renew registration biennially.
- Hazard Analysis and Risk-Based Preventive Controls –All registered facilities must identify known or reasonably foreseeable hazards and implement preventive controls to significantly minimize or prevent those identified hazards. Those subject to these requirements must have a written plan describing their hazard analysis and preventive controls, which shall be made available to FDA upon request.
- Authority to Collect Fees –Allows FDA to assess fees for compliance failures (recalls and re-inspections) and for participation in a voluntary qualified importer program.
- Targeting Inspection Resources –Requires FDA to allocate food inspection resources according to the risk profile of the facility and other important criteria. Facilities deemed "high risk" would be inspected no less that once every two years. "Low risk" facilities would be inspected no less than once every four years. The legislation gives FDA general direction on risk characteristics, but the agency will have some discretion as it defines the risk categories.
- Enhancing Tracking and Tracing of Food and Recordkeeping –Requires FDA, in coordination with the food industry, to establish pilot projects to test and evaluate new methods for rapidly and effectively tracking and tracing food products to prevent and mitigate foodborne illness outbreaks. FDA shall, in consultation with USDA, establish a product tracing system within the FDA based on these pilots, and shall develop additional recordkeeping requirements for foods determined to be "high risk."
- Mandatory Recall Authority –Gives FDA the authority to order food recalls when firms fail to voluntarily recall products that are either adulterated or contain undeclared allergens and which will cause serious adverse health consequences or death to humans or animals.
- Foreign Supplier Verification Program –Requires importers to perform food safety supplier verification activities to mitigate risks in imported foods and ensure that imported foods are as safe as those manufactured and sold in the United States. Importation of a food by an importer who does not have such a program in place is prohibited. Importers already in compliance with existing seafood, juice, and low-acid canned foods regulations are exempted from this requirement.
- Voluntary Qualified Importer Program –Allows importers to qualify for expedited review and importation of food if they go above and beyond the minimum standards to ensure the safety of imported food.
- Authority to Require Import Certifications for Food –Allows FDA to require certification or other assurance of safety for high-risk food imports. Requires the Secretary of Health and Human Services to consider public health factors when requiring certifications for high risk foods, including (1) known safety risks of the food, (2) known safety risks of the country of origin, (3) inadequate government controls in country of origin, and (4) information submitted by the country of origin related to the quality of it government controls. FDA may refuse admission of a food import lacking required certification.
- Inspection of Foreign Food Facilities –Allows FDA to enter into agreements and arrangements with foreign governments to facilitate the inspection of foreign facilities. Prohibits entry of food from a foreign facility or country that fails to permit inspection by the United States. Also authorizes the Department of Commerce, in coordination with HHS, to assess foreign facilities that import seafood into the United States and provide technical assistance.
Just before closing the doors on the 111th Congress, the House and Senate agreed to a short-term continuing resolution that will fund the Government through March 4, 2011. This came after attempts to pass a yearlong continuing resolution and an omnibus spending bill, both which would have funded the government through the end of the fiscal year. The passage of a short-term continuing resolution means that the new 112th Congress will be responsible for crafting package that will keep the government running through September 2011.
With the House changing leadership from Democrat to Republican, there will be efforts to reduce spending through for FY 2011, and future fiscal years. Republican leaders in the House and Senate are already talking about finding ways to cut the budget by $100 billion for FY 2011 with the ultimate goal of returning to 2008 spending levels. In addition to cutting overall spending, Republicans have vowed to eliminate earmarks for at least the next two years.
All of these factors could have a significant impact on agriculture research funding. Pressure will be mounting to cut the overall cost of government, including the amounts spent on agriculture. And, agriculture research accounts are filled with dozens of earmarks including over $130 million within the National Institute of Food and Agriculture (NIFA). With the current anti-earmark environment, researchers who have depended on earmarked funding will likely need to identify alternative funding sources.
When Congress eliminated earmarks in 2007, funding from earmarks was transferred into the so called "formula funds" for land grant universities, thus preserving the overall investment in agriculture research. Facing the prospect that earmarks may be eliminated, FASS, FASS founding societies, and like-minded agriculture organizations sent letters to the House and Senate urging Congress to preserve agriculture research funding, in the event earmarks were removed. The yearlong continuing resolution approved by the House in late 2010 followed a similar strategy to 2007, but ran into a roadblock in the Senate. This was a positive sign that earmark funding would stay in the agriculture research budget. However, given pressures to reduce overall spending in 2011, it is unclear how the new Congress will treat funds that have historically gone to earmarks.
FASS, along with the Farm Foundation, Riley Memorial Foundation and the Institute of Food Technologists are cosponsoring the Agriculture, Food, Nutrition and Natural Resources R&D Roundtable on March 15, 2011. FASS Washington Representative, Lowell Randel is serving as a Co-Chair for the Program Advisory Committee. Nominations for the event closed in December and over 60 nominations were received, including strong representation from the animal sciences.
On December 3rd, USDA held a stakeholders meeting for the Research, Education and Economics Mission Area. Top leadership from USDA was present, including Secretary Vilsack, Deputy Secretary Merrigan and REE Under Secretary Woteki. The presence of these top officials was a good indication of the support for agricultural research within the highest levels of USDA. Dr. Woteki used the opportunity to discuss her vision for USDA’s science programs and outlined five key challenges for the mission area. They were:
- Articulate the scope and capacity of REE agencies
- Identify key priorities for agricultural science
- Develop guidelines for investment in agricultural science
- Enhance public awareness of agricultural science
- Better communicate research successes and impact on society.
Dr. Woteki also stressed the importance of partnerships with land grant universities, state and private organizations and other federal agencies. She acknowledged the budget challenges that lay ahead and that it will be important to communicate the value of agricultural science and better prioritize to maximize the effectiveness of limited resources.
FASS Washington Representative, and N-CFAR Board Member, Lowell Randel attended the N-CFAR Board Meeting on December 16th. REE Under Secretary Woteki and Peter Schmeissner of the Office of Science and Technology Policy addressed the Board. Dr. Woteki’s remarks were consistent with her presentation at the REE Stakeholder meeting, stressing the need for partnerships and prioritization to meet future challenges in agricultural science. Dr. Schmeissner spoke about OSTP’s role in coordinating the federal government’s overall science effort and the cross cutting nature of agriculture.
The President’s Council of Advisors on Science and Technology will be meeting on January 7, 2011 to address a number of science policy issues. Agriculture research will be on the agenda and USDA REE Under Secretary Cathy Woteki is scheduled to participate. A limited number of spots are available for public comment at the meeting, and Lowell Randel, FASS Washington Representative will be providing comments on behalf of FASS stressing the importance of the animal sciences and the need for increased investments. More information on the PCAST meeting can be found at: http://www.whitehouse.gov/administration/eop/ostp/pcast/meetings/future
During the month of December, there was much activity surrounding the organization of an effort to develop research priorities for animal agriculture. The FASS Board approved the formation of an Executive Committee to embark on a process similar to FAIR 95 and FAIR 2002 to bring together the animal agriculture community to identify research priorities. The formation of the Executive Committee is underway and will include representatives from the FASS Founding Societies, FASS Washington Representatives and representatives from Animal Agriculture Coalition member organizations. It is anticipated that the Executive Committee will begin the planning process in early 2011.
President’s Council of Advisors on Science and Technology meeting in Washington, DC (FASS to provide oral comments.)
Agriculture, Food, Nutrition and Natural Resources R&D Roundtable in Washington, DC (FASS Cosponsored event)
ARS/NIFA Stakeholder Meeting on Food Animal Production in Baltimore, MD