United States and China Outline Progress on Agreement on Food and Feed Safety

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue (SED).

“Today's progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products exported to the United States from China,” Secretary Leavitt said. “I'm very pleased with our efforts and commend our Chinese counterparts for their commitment to this important work.”

The MOA, signed during the third session under the SED in December of 2007, established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. Since its signing, HHS’ Food and Drug Administration (FDA) and AQSIQ have planned a joint implementation work strategy and have begun the initial steps called for under the agreement.

The statement describes progress in several important areas:

• Establishment of a mechanism for cooperation on significant events related to food and feed safety, including designated points of contact, emergency contacts, and thresholds for notifications; enhancing the exchange of information on the safety of food and feed safety; and developing a better understanding by both sides of each others’ respective regulatory systems.
• Development of concrete steps that will lead to a system whereby AQSIQ will electronically certify to FDA that specific products sent for export to the United States meet FDA standards for safety and manufacturing quality.
• Focus efforts on inspections and supervision and laboratory testing standards to ensure food and feed safety. The United States agreed to conduct training for Chinese officials on U.S. regulatory standards and requirements.
• Establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.

HHS/FDA and Chinese officials continue to work on implementing a second Memorandum of Agreement signed in December to enhance the safety of a variety of medical products.

For more information on the December 2007 MOA on the Safety of Food and Feed, go to http://globalhealth.gov/news/agreements/ia121107b.html.

To view the Joint Progress Statement Regarding the Five-Year Work Plan under the MOA, visit http://www.fda.gov/bbs/topics/news/international/progress_HHS_China.pdf.

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

Today’s action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.

“Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy – where we stand at the border and try to catch things that are unsafe – to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers,” Secretary Leavitt said.

The Secretary continued, “Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products.”

Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:

• FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.
• Another initiative will offer expedited entry for goods bearing certification by trusted parties.
• FDA will modernize its information technology infrastructure.
• Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.

The increase brings the Administration’s total proposed increase in the FDA's budget for FY 2009 to $404.7 million – a 17.8% boost in funding from FY 2008.

Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:

• Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
• Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
• Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
• Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

“FDA’s mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “FDA has already embarked on an ambitious program to transform the Agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly.”

Consistent with the Administration’s emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.

The budget amendment proposes the following increases for core FDA programs:

Protecting America’s Food Supply (+$125 million)

The increase allows FDA to intensify actions to implement FDA’s Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.

The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA’s international presence, and increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain outbreaks of food-borne illness.

Safer Drugs, Devices, and Biologics (+$100 million)

The increase of $100 million for the FDA’s medical product programs will strengthen FDA’s ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval, and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.

FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import exams and foreign and domestic inspections of medical product manufacturers.

Modernizing FDA Science and Workforce (+$50 million)

The budget amendment also proposes increases to strengthen FDA’s capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA will also improve laboratories and other facilities that are essential to carrying out FDA’s mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.

The program increases listed above include $65 million to modernize FDA’s information technology infrastructure.