Details of FY 2009 Appropriations Law on FDA Food and Medical Product Safety

The following are highlights of the FDA-related provisions in the Explanatory Statement¹ that accompanied H.R. 1105.

Food safety. P.L. 111-8 includes an increase in FY 2009 funding for activities related to food safety. The Explanatory Statement notes that an increase for food safety was provided in FY 2008 regular and supplemental funding. According to the Explanatory Statement, funding increases will, at a minimum, provide FDA with the capability to (partial list):

Increase foreign/domestic inspections - significantly increase the number of domestic and foreign, risk-based, food production and/or processing facility inspections (and other high risk products), significantly increase the number of import food field exams, and achieve greater laboratory capacity to support increases in risk-based inspections and sampling of domestic and imported foods;

Target high-risk products at border - develop and deploy risk-based screening technologies that will allow FDA to target high-risk products at the border;

Enhance traceability - enhance FDA's traceability capabilities for more rapid and precise product tracking, which will allow FDA to contain contaminated product and to provide consumers more specific information when problems occur;

Expand overseas presence - expand its presence in foreign countries. FDA recently opened its first foreign office in China. With this increase, FDA will be able to establish FDA offices in other foreign locations, as appropriate. These offices are intended to enhance the ability of FDA inspectors to enter foreign food facilities and to gain a greater understanding of manufacturing processes overseas, resulting in more rapid identification of and response to any potential food safety issues. The FDA also will be able to assess the ability of foreign government systems to manage food safety risks;

Deploy new screening tools - identify, develop and deploy new screening tools and methods to identify pathogens and other contaminants, including more rapid screening tools to be used by field investigators and analysts;

Create reportable food registry - improve risk communications to the public during food-related events and make it easier to receive adverse events reports, including creating a reportable food registry;

Establish early warning system for pet food - establish an early warning surveillance and notification system to identify adulteration of the pet food supply and outbreaks of illnesses associated with pet food; and

Enhance national food emergency system - enhance FDA's national food emergency system, allowing FDA to develop a risk communication strategy that would result in more rapid responses and reductions in the risk of consumer contamination when food contamination occurs.

Medical product safety. The Explanatory Statement notes that P.L. 111-8 provides a FY 2009 funding increase for medical product safety. An increase for medical product safety was also provided in regular and supplemental fiscal year 2008 funding. According to the Explanatory Statement, funding increases will, at a minimum, provide FDA with the capability to (partial list):

Increase inspections- significantly increase foreign and domestic medical product facility inspections, improve laboratory infrastructure and rapid analysis tools, and conduct many more laboratory analyses and several thousand import exams and samples;

Improve electronic screening of imports - integrate risk-based information into data systems that will support FDA's ability to improve electronic screening of imports and allow the agency to proactively identify problems and risks associated with imported products;

Establish device tracking system - establish a unique device identification system to track devices, facilitate recalls, and support inventory management;

Enable data sharing, enhanced analysis of adverse events - upgrade the agency's information technology to enable data sharing and enhanced analysis of adverse events;

Develop regulated product data warehouse - develop a regulated product information data warehouse that will enable information sharing with other regulatory agencies; and

Implement FDAAA safety requirements - begin to implement the safety requirements outlined in the Food and Drug Administration Amendments Act.

Concern About Contamination of Shrimp Imports with Banned Antibiotics

According to the Explanatory Statement, there is concern about the contamination of farm-raised shrimp imports with banned antibiotics. FDA currently inspects less than 2% of imported shrimp and is strongly encouraged to develop, in cooperation with state testing programs, a program for increasing the inspection of imported shrimp for banned antibiotics.

FDA Encouraged to Aggressively Combat Seafood Fraud

The Explanatory Statement expresses concerns that FDA does not focus sufficient attention on economic integrity issues for seafood, particularly with respect to mislabeling of species, weights, country of origin, and treatment. FDA is encouraged to work with states to more aggressively combat fraud in parts of the seafood industry.

(See ITT's Online Archives or 03/27/09 news, 09032710, for BP summary of Government Accountability Office report on seafood fraud.)

FDA Urged to Take Broader Approach to Safety

The Explanatory Statement urges FDA to take broader approaches to addressing safety issues. In the foods area, for example, FDA might focus on the identification of the most significant food safety hazards, prioritized by risk and the ability to reduce such risks, and develop a plan with findings, resources and tools to address those specific risks. Further, FDA could do a compliance audit for a whole category of foods with significant safety issues, providing the agency with a much more complete understanding of their risks and what needs to be done to address them. (This audit approach also could be taken in other product areas, especially with regard to foreign drug facilities.)

¹The Explanatory Statement is an explanation of the 2009 Omnibus Appropriations Act, including disclosure of congressional earmarks and congressionally directed spending items. The Explanatory Statement has the same effect with respect to the allocation of funds and implementation of the legislation as if it were a joint explanatory statement of a conference committee.

(See ITT's Online Archives or 03/12/09 news, 09031215, for BP summary on the President's signing of P.L. 111-8. See ITT's Online Archives or 03/03/09 news, 09030315, for BP summary on the trade-related provisions in H.R. 1105.)

P.L. 111-8 available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1105enr.txt.pdf.

Explanatory statement available at http://docs.house.gov/rules/omni/jes/divajes_111_hromni2009_jes.pdf.