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U.S. Department of Health and Human Services

Animal & Veterinary

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PERSONNEL CHANGE IN CVM'S ONADE

FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

In January 1998, the Center for Veterinary Medicine announced that Dr. Robert Livingston, who has been Director of the Office of New Animal Drug Evaluation (ONADE), changed positions within the Center to focus his efforts on preparing for upcoming Codex Alimentarius Commission (Codex) meetings, and to work with Dr. Sharon Thompson, CVM Special Assistant for International Affairs, on international drug harmonization issues.

Dr. Andrew Beaulieu, ONADE Deputy Director for Therapeutic and Production Drug Review, was named acting ONADE Director for 90 days starting on January 4, 1998. Following that period, Dr. Margaret Miller, ONADE Deputy Director for Human Food Safety and Consultative Services, will be acting Director for 90 days. CVM has begun nationwide recruitment to permanently fill the vacancy.

According to CVM Director Dr. Stephen Sundlof, "There is a considerable amount of work to be done in the area of international veterinary drug harmonization, and I am pleased that Dr. Livingston has accepted the assignment." Dr. Livingston is ideally suited both professionally and through his experience to contribute to CVM's international effort, Dr. Sundlof added.

In a July 7, 1997 Federal Register notice, the Food and Drug Administration said it is studying the possibility of amending its regulations so the U.S. could consider standards established by the Codex for food safety and veterinary drug residues. Codex is an international body that establishes food safety standards under the joint auspices of the United Nations' World Health Organization and Food and Agriculture Organization.

Dr. Livingston's expertise also will help in supporting the U.S. science-based system of food safety rules at a Codex meeting in May. The Codex Committee on General Principles will meet in Paris to define the "other legitimate factors" that could be used as a basis for establishing Codex standards. Codex currently uses scientific data in setting standards pertaining to public health. The U.S. is concerned that, if non-science factors are introduced into the standard-setting process, it would have an undermining effect on the Codex system and could lead to an increase in non-tariff trade barriers. Dr. Livingston will serve a critical role in helping to prepare the U.S. Codex delegation for the General Principles meeting.

Also, under the Animal Drug Availability Act, passed in 1996, Congress ordered FDA to consider data from foreign governments or international bodies in establishing tolerance levels for veterinary drugs in imported food. The Act directs FDA to consider, in establishing such tolerances, data submitted to the appropriate regulatory authority of any country where the new animal drug is lawfully used or data available from a relevant international organization.

As ONADE director, Dr. Livingston developed a reputation for leading a highly productive and professional organization. As evidence of this, in 1997 ONADE approved a record large number of animal drug applications.

"Dr. Livingston is perhaps the most ardent supporter of my belief that the animal drug approval process is the most powerful regulatory tool we have for assuring the safety of the food supply. Under his leadership, ONADE has become a focused, efficient, entrepreneurial, service-oriented organization, which has earned the respect of FDA, the animal health industry, and the Congress," Dr. Sundlof said.