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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter July/August 2000 Volume XV, No IV

Last year, a new Division of Epidemiology was created in the CVM's Office of Surveillance and Compliance (OS&C.) Most of the Division staff members previously had been part of OS&C's Division of Epidemiology and Surveillance. William S. Calvert, M.P.H. joined as Division of Epidemiology Director in January 2000.

Over the last ten to fifteen years, there has been increasing recognition of the need for epidemiological expertise within the Center. This new Division was established to be a major contributor to CVM's mission by providing technical and epidemiological support for the regulatory and research activities of the Center. Division scientists serve as consultants to FDA and other Federal and State agencies regarding epidemiological issues such as antimicrobial resistance and tissue residues. Also, the Division of Epidemiology assists in developing regulatory policy and study protocols, overseeing study execution, analyzing and evaluating findings, and training and mentoring epidemiologists for the future. Other Division activities include evaluating surveillance and post-marketing data and initiating appropriate public health actions.

The Division of Epidemiology is unique in CVM since its current funding comes completely from the President's Food Safety Initiative. This is a reflection of the increasing importance of epidemiologic expertise in addressing food safety issues. For example, the Division's growth is linked to the expansion of the National Antimicrobial Resistance Monitoring System for enteric bacteria (NARMS-EB). NARMS-EB is an interagency collaboration established between FDA, CDC, and USDA to prospectively monitor trends in antimicrobial resistance of human and animal enteric pathogens. The NARMS-EB program provides descriptive data on the extent and temporal trends of antimicrobial susceptibility in salmonella and other enteric organisms from human and animal populations, facilitates the identification of resistance in humans and animals as it arises, provides timely information to veterinarians and physicians, prolongs the life span of approved drugs by promoting the prudent use of antimicrobial drugs, and identifies areas for more detailed investigation.

In addition to NARMS-EB, other Division activities include working on tissue residues, microbial ecology, and microbiology issues; implementing the concepts laid out in the "Framework" Document ("A Proposed Framework For Evaluating And Assuring The Human Safety Of The Microbial Effects Of Antimicrobial New Animal Drugs Intended For Use In Food-Producing Animals"); and reviewing various regulatory documents and related actions. The Division also is participating in formal risk assessment projects (such as the risk assessment on fluoroquinolone resistance in Campylobacter from poultry); post-approval monitoring programs; committee work at multiple levels, including international efforts; and contributing to the FDA response to foodborne disease outbreaks.

Before joining CVM, Mr. Calvert held a variety of positions both within and outside the government. From late 1989 until he came to CVM, Mr. Calvert was with FDA's Center for Drug Evaluation and Research where he directed a staff that developed information technology solutions and infrastructure in support of pharmacovigilance and pharmacoepidemiology efforts. He received his M.P.H. degree in epidemiology and biostatistics from the University of South Carolina. In an interview with the FDA Veterinarian, Mr. Calvert said that he "looks forward to meeting the many challenges and public health issues that confront us." He continued by saying that "as a new Division we will first have to develop our 'culture' and infrastructure so that it will continue to support the quality tradition of our roots, while still allowing us to increase our numbers and grow into our new responsibilities. Over the next year we will continue with many of our current activities. We will be looking for more and better sources of data, such as the expansion of NARMS-EB, and we will continue to develop and share epidemiological expertise. Finally, we will be looking for new ways to work with others who share our public health goals."

Staff members of the Division of Epidemiology include: Dr. Charles E. Eastin II, Dr. Marcia L. Headrick, Ms. Kathy S. Hemming, Dr. Roger A. Jones, Dr. Joseph C. Paige, Dr. Terry Proescholdt, Dr. Linda E. Silvers, and Ms. Teresa R. Thomas. There are two additional staff members currently on temporary duty assignments within CVM: Dr. Katherine A. Hollinger and Dr. Charlotte D. Spires.