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Expanding International Outreach in 2012

Merton Smith, OCD, Betty Walters, OCD, and Margarita Brown, OSC, provided training in Mombasa, Kenya for OIE Focal Points for Veterinary Medicinal Products.

Over the next 10 years, FDA will be working to transform itself from a predominantly domestically focused agency operating in a globalized economy, to an internationally focused agency fully prepared for a regulatory environment in which FDA-regulated products know no borders.

CVM’s international activities continue to grow in response to the increasing global market for the products that CVM regulates. The Food Safety Modernization Act (FSMA), with its emphasis on developing more effective controls to better assure the safety of imported food products, requires increasing collaboration with CVM’s regulator counterparts from around the world.

In FY 2012, the International Programs Team began implementing an international strategic plan to most effectively support other national and international regulatory platforms to control animal drugs and feeds and to develop harmonized product standards and conformity assessment procedures. Facilitating the effective exchange of information and fostering necessary collaboration among national authorities around the globe are daily activities for many at CVM.

Participating in OIE – World Organization for Animal Health Activities

In May 2011, CVM was approved by the OIE General Assembly as one of its official Collaborating Centers. This designation facilitates CVM’s ability to enhance animal drug and food safety around the world.

Our technical experts participated in the OIE Regional Meeting on Veterinary Legislation in in Botswana in May 2011; at the OIE Focal Points for Veterinary Products meetings in in Morocco during December 2011; and in March 2012, in Kenya. The CVM representatives provided technical expertise to member countries to assist in strengthening veterinary drug regulatory infrastructures. This technical capacity building helps to assure the availability of safe and effective therapies to prevent and mitigate animal disease, and the safe use of veterinary drugs in food producing animals.

Global Engagement Liaison Activities

Following are examples of CVM leadership by providing liaison activities to advance animal and human health on a global basis.

Animal Feed Cluster Meetings with the European Food Safety Authority. During 2012, CVM and the European Food Safety Authority (EFSA)disclaimer icon held the first of what is expected to be a series of Animal Feed Cluster meetings that allow feed safety experts from both agencies to discuss issues of joint interest, including reviews of safety assessments of a number of animal feed ingredients. At the first Feed Cluster meeting in June, CVM described its work as part of reviewing the safety of new ingredients for use in feed and its efforts to develop policies for the appropriate regulation of animal feed. EFSA described its work in performing risk assessments of feed additives, and of products and substances that can be used in animal feed. CVM and EFSA are planning to continue the Animal Feed Cluster meetings on a regular basis.

Bilateral Meetings on Animal Drug Regulation with European and Canadian Counterparts. CVM provided leadership to the December 2011 and March 2012 quarterly bilateral meetings with the European Medicines Agency (EMA), and the December 2011 and February 2012 quarterly bilateral meetings with the Veterinary Drugs Directorate (VDD) of Health Canada. The agendas included discussions on collaborative efforts in sharing scientific advice and information, post-approval monitoring, Maximum Residue Limits (MRLs), planning for Codex and other food safety related interagency activities, and other current issues related to animal drug regulations and controls. We expect that future activities with the VDD and EMA will continue to strengthen our relationships and provide defined paths to reach higher levels of confidence for the exchange and use of scientific and regulatory information.

Other International Meetings. CVM representatives attended a bilateral meeting in Beijing, China, November 2011 between FDA and the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of the People’s Republic of China. The meeting was part of the plan to execute the objectives of the Memorandum of Agreement on the Safety of Food and Feed signed in 2077 by the Department of Health and Human Services and China. The memorandum provides for annual bilateral discussions concerning how the respective governments could assure the safety of food and feeds exported to the other country.

Meetings at CVM Offices. Representatives from CVM’s Division of Animal Feeds met with a representative from the National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries, Japan, in September 2012 to discuss regulation of animal feeds. CVM representatives met with a delegation from Thailand in August 2012 to discuss FDA regulation of distillers products for use as animal feed ingredients. A Southern Africa Trade Delegation visited CVM in March 2012, for an overview of the U.S. Animal Feed Safety System.

Achievements Related to the Codex Alimentarius Commission and CCRVDF

Representatives from CVM are key participants in a number of Codex Alimentarius activities including: Chair of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) disclaimer icon , and participation in the Codex Electronic Working Group on Animal Feeding.

Codex Alimentarius Commission Meeting. A CVM representative served on the U.S. Delegation at the Codex Alimentarius Commission (CAC) meeting in Italy, July 2012, working toward realizing the CAC’s mission of protecting the health of consumers and ensuring fair practices in food trade. Among other accomplishments, after intense efforts for several years to reach consensus, the U.S. successfully led the Commission in adopting Maximum Residue Limits (MRLs) for ractopamine by a narrow vote of its membership. The same CVM representative, who is the Chair of CCRVDF, also attended the Codex Committee on General Principles meeting in France in April 2012 as part of the U.S. Delegation.

CCRVDF Session. At the CCRVDF session held in May 2012 in Puerto Rico, CVM, serving as the Chair, directed the progress of seven working groups to assure they achieved all identified goals. CVM experts also served as the U.S. Delegate and as technical support within the U.S. Delegation. The CCRVDF Chair facilitated significant further understandings and progressed several issues where sharp divisions existed among 185 member countries. One such issue involved the need to have the CCRVDF participants move forward on risk management advice on a number of compounds for which no Acceptable Daily Intakes (ADIs) or MRLs could be established or recommended by the WHO/FAO Joint Expert Committee on Food Additives disclaimer icon . These compounds represent substantial risks to consumers and the risk management advice being developed within CCRVDF has the potential to set precedents as well as to have significant trade implications. The U.S. Delegate to CCRVDF actively and effectively participated in the EU-led working group that is developing the risk management advice for these compounds.

Codex Task Force on Animal Feeding. The CAC has authorized the restarting of an ad hoc Intergovernmental Codex Task Force on Animal Feeding. The Commission asked the re-established Task Force to develop guidelines on the application of risk assessments for feed hazards with regard to the safety of food produced from animals, and to consider the development of a prioritized list of hazards in feed for food-producing animals that can result in food safety concerns.

At the first physical meeting of the Task Force, in Berne, Switzerland in February 2012, CVM representatives served as Chair and Secretariat for the U.S. delegation. One hundred and thirty-nine delegates from 43 member countries, and others, attended the meeting. The group agreed on text for a draft document on guidelines for risk assessment, and agreed to forward the draft guideline to the July 2012 session of the CAC. In lieu of developing a prioritized list of hazards in feed, as had been requested, the task force agreed to change the focus and purpose of the document to “Guidance for use by governments in prioritizing their national feed hazards.”

Other Key International Activities

Capacity Building Workshops. With leadership and resources from FDA’s Office of International Programs, CVM conducted a number of capacity building activities overseas, including workshops in Mexico, China, Chile, Costa Rica, Paraguay, Canada, European Union and South America in which CVM shared information about appropriate requirements for demonstrating the safety, efficacy, quality, and proper labeling for veterinary drugs. In a related activity, CVM’s International Programs Team is preparing a series of instructional videos on veterinary drug regulations that are directed toward a global audience. The videos are designed to give overseas audiences a solid background of information about the U.S. animal drug approval requirements. Each video covers a specific topic and features an appropriate CVM expert presenting information through PowerPoint slides and narration. The videos will be available by summer 2013.

In addition, a CVM representative serves on the WHO Global Foodborne Infections Network (GFN), disclaimer icon and another representative serves on the GFN Laboratory Subcommittee. GFN is a network of institutions and individuals committed to enhancing the capacity of countries to detect, respond to, and prevent food borne and other enteric infections. GFN provides training, quality assurance testing, electronic discussion group messages, laboratory reagents, and a databank on food borne pathogens that serves as a common repository of salmonella serotypes from various countries. It is searchable by country.

In summary, CVM and FDA support during the year helped build regulatory capacity in various regions of need, including countries seeking to enter safe food products into commerce.

Training Module on Aquaculture Drug Use. Each year the FDA receives numerous inquiries from outside entities asking technical questions about drug uses in aquaculture. Because regulations vary from country to country, it can often be difficult to learn which drugs or chemicals are acceptable to use, or where to look for accurate information. CVM is developing a training module that is written for foreign producers who export their products to the U.S. The module may also be useful to foreign regulators.

The module is designed to clarify how the U.S. regulates drugs for aquaculture. It provides information to identify what drugs may be used, explains how the drugs should be used to prevent unacceptable residues, and tells where to look for the most current information. The module provides a general summary of FDA requirements and recommendations for drug use in aquaculture. It contains information on New Animal Drug Status, Aquaculture Feeds and Additives, Aquaculture Drug Administration and Culture Systems, Judicious Use of Antimicrobials, and United States Regulations, Policies, and HACCP requirements. The module will be translated into Spanish when it is completed. It was in the final editing stages at the end of the year, and will be available on the Joint Institute for Food Safety and Nutrition (JIFSAN) disclaimer icon website when it is complete.

Confronting Antimicrobial Resistance on an International Scale. Antimicrobial resistance is a global public health issue, and there is need for greater international understanding and cooperation to implement domestic and global antimicrobial resistance control strategies. A CVM Office of Research representative served as the American expert on the OIE ad hoc Group on Antimicrobial Resistance, which held its third and fourth meetings in Paris, France in December, 2011 and July, 2012. Our representative successfully negotiated with European Commission colleagues to develop and finalize two chapters of the OIE Terrestrial Animal Health Code, which focus on veterinary prudent use guidelines and risk assessment. These efforts have directly led to the development of science-based international guidelines aimed at minimizing public health impacts of veterinary antimicrobial use, which are aligned with FDA judicious use policies.

CVM manages the U.S. National Antimicrobial Resistance Monitoring System (NARMS), which tracks food borne bacteria for trends in resistance to antimicrobial agents used in veterinary and human medicine. A NARMS representative serves on the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR). disclaimer icon AGISAR’s purposes are to advise the WHO on a strategic framework for containment of food-related antimicrobial resistance, and to outline minimum components required for establishing a program on integrated surveillance of resistant bacteria in the food chain. The NARMS representative led a subcommittee that met over several years to complete the WHO document on harmonized approaches to integrated surveillance systems using elements of mature monitoring programs like the FDA NARMS. The subcommittee’s work was completed in 2012. This work provides a roadmap for countries wishing to build laboratory capacity and implement integrated monitoring programs.

VICH activities. CVM representatives participated in the November 2011 meeting in Tokyo of the Steering Committee of the International Cooperation on the Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH). CVM representatives significantly contributed to the overall goal of VICH: the acceptance of harmonized regulatory guidelines covering the standards and protocols for the studies that should be undertaken to demonstrate safety, efficacy, and quality of veterinary medicinal products that are licensed or approved in the VICH regions. These guidelines provide a basis for expanded international harmonization of registration requirements. The increased agreement covering testing requirements and guidance has facilitated the availability of safe and effective products and also has had a direct, positive impact on global human and animal health.

CVM representatives also participated in the June 2012 meeting in Belgium of the VICH Steering Committee. The Steering Committee serves generally to direct, prioritize and monitor the progress of the VICH Expert Working Groups (EWGs) in developing internationally harmonized guidance. This harmonization process has led to the adoption of 47 guidelines since the VICH was created in 1996. During the 2012 VICH meeting, CVM representatives also met on the side of the VICH meeting with regulators from Canada, Japan, Australia, EU and New Zealand to propose novel opportunities to begin work toward simultaneous and joint evaluations of animal drugs. This side meeting set the stage for future discussions that could further this objective, and that could lead to a major step forward from the current separate evaluations by each country. Additional discussions are planned for the VICH meeting in February 2013 in Washington, DC.

OECD Task Force for the Safety of Novel Foods and Feeds (genetically engineered plants). CVM’s Division of Animal Feeds (DAF) provided scientific and policy expertise regarding feeds derived from genetically engineered (GE) plants at the March 2012 meeting of the Organisation for Economic Cooperation and Development’s (OECD)disclaimer icon Task Force for the Safety of Novel Foods and Feeds in Paris, France in March 2012. A DAF representative served as co-lead author of the recently published “Revised Consensus Document on Compositional Considerations for New Varieties of Soybean [Glycine max (L.) Merr.]: Key Food and Feed Nutrients, Anti-nutrients, Toxicants and Allergens.” This is a compilation document containing data and information relevant to assessment of foods and feeds derived from new soybean varieties. The paper was discussed for the final time in the OECD meeting in March. The U.S. led the development of the paper, through a cross-Center, cross-Agency effort with CVM and CFSAN staff members as co-lead authors, and with input from the entire OECD Task Force.

Working in many international venues during the year, CVM representatives were able to further facilitate progress in developing and implementing international safety standards, improving regulatory processes in the U.S. and other countries, and addressing significant trade barriers and trade issues. Our efforts contributed to progress in enhancing the availability of veterinary drugs to meet therapeutic and production needs. This work has increased the safety of the animal feed and human food supply, and expanded international harmonization and collaboration on critical issues associated with the evaluation and use of veterinary drugs and the marketing of animal feeds and pet foods.

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