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U.S. Department of Health and Human Services

Animal & Veterinary

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by Kevin Greenlees, Ph.D.
FDA Veterinarian Newsletter May/June 1998 Volume XIII, No III

Dr. Greenlees is a toxicologist on the Office of New Animal Drug Evaluation's Division of Human Food Safety Toxicology Team and currently co-chairs the Working Group on Quality Assurance in Aquaculture Production.

In the 1980s, Congress recognized the need to foster the growth and development of aquaculture in the United States. This led to the passage of the National Aquaculture Act of 1980 and National Aquaculture Improvement Act of 1985. A result of this legislation was the creation of the Joint Subcommittee on Aquaculture (JSA).

The JSA is a statutory committee that operates under the control of the National Science and Technology Council (NSTC) of the Office of Science and Technology Policy in the Office of the Science Advisor to the President. The JSA reports to the NSTC's Committee on Health, Safety & Food Research and Development, which is one of nine research and development (R&D) committees established by NSTC to prepare coordinated R&D strategies and budget recommendations for accomplishing national goals. The permanent chair of the JSA is the Secretary of Agriculture, who is currently represented by Dr. Meryl Brussard of USDA's Cooperative State Research, Education and Extension Service (CSREES). Other members of the JSA consist of those Federal Governmental agencies which affect aquaculture.

The work of the JSA is carried out by standing working groups and temporary task forces. One of the first groups was the Working Group for Quality Assurance in Aquaculture Production. Established in November of 1990 under the leadership of Mr. Gary Stefan of the FDA Center for Veterinary Medicine, the Working Group has provided a national forum to address drug, biologic, and pesticide use in aquaculture through education and in the coordination of related efforts in government, industry, and academia.

A key to the Working Group's success has been its broad membership, drawing on all parts of the aquaculture community. The Working Group includes representatives from Federal and State regulatory agencies, academia, major aquacultural trade and industry associations, private aquaculturists, and other members of the aquaculture community. Pharmaceutical industry and international government representatives have been frequent participants. With meeting attendance ranging from 25 to 100 people, and a mailing list of 150, the Working Group has provided a frank forum for the exchange of information between the regulators and the regulated industry.

Much of the early focus of the Working Group was in the development of quality assurance programs in the aquaculture community, and the implementation of quality assurance programs continues to be emphasized. A concentrated effort was made to learn from the established food animal production industries in the application of quality assurance programs to the growing aquaculture industry. The catfish producers were the first to establish a quality assurance program, and were soon followed by the trout producers. The hybrid striped bass producers have more recently developed a quality assurance program, and similar programs continue to spread throughout the aquaculture community. The recent implementation of the Hazard Analysis Critical Control Point (HACCP) programs for aquaculture by FDA and National Marine Fishery Service (NMFS) has emphasized the importance of quality assurance programs in all areas of food animal production.

The need to educate the developing aquaculture community about Federal regulatory requirements produced the 1992 booklet, "Federal Regulation of Drugs, Biologicals, and Chemicals Used in Aquaculture Production." A product of the Working Group, drawing on Federal and private member resources, the booklet was published by the National Agricultural Library. It was intended as "…a guide to Federal requirements associated with marketing and using these compounds. It provides a summary of Food and Drug Administration, Environmental Protection Agency, and Animal Plant Health Inspection Service regulations applicable to these compounds, as well as sources of contact for further information."

Two years later, the above publication was followed with the release of the 1994 booklet, "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture." Published by the Texas Agricultural Extension Service, this document provides detailed information on approved drugs, vaccines and pesticides for use in aquaculture. These documents, developed jointly with the regulatory agencies, have provided exceptional benefit to the aquaculture community.

The Working Group recognized that education is a process that creates the greatest impact when information flows in both directions. A concerted effort was made by the representatives of the aquacultural community to educate the Federal regulatory agencies. Presentations were provided on various aspects of modern aquaculture. Identification and prioritization of critical disease problems and aquaculture drugs for which new animal drug approvals were required led to the development of a prioritized list of drugs for which data could be sought to facilitate approvals. Compounds traditionally used by the aquaculture community were identified and submitted to CVM in order to determine their status as drugs, pesticides, or chemicals. Submitted compounds ranged from urea and tannic acid used to denature the adhesive component of fish eggs to ozone. These efforts served to educate the regulatory agencies on the needs of the aquacultural community, and allow the aquacultural community to clearly understand where it stood in relation to drug and pesticidal use.

The need to conduct investigational studies to gather data for the approval of drugs for aquaculture use led to the development, under the auspices of CVM, of investigational new animal drug (INAD) efforts by aquacultural facilities throughout the country. The Working Group became a focus for the aquacultural community's efforts to coordinate these varied studies, and was pivotal in the creation of a non-governmental INAD representative to coordinate the investigational efforts nationwide. The INAD coordinator position soon evolved into the position of the National Aquaculture New Animal Drug Coordinator, currently exceptionally served by Ms. Rosalie Schnick, formerly of the U.S. Fish and Wildlife Service. Ms. Schnick serves as a liaison for the aquaculture community to the pharmaceutical industry and the regulatory agencies.

More recently, the importance of world-wide aquaculture and its impact on aquaculture within the United States has been recognized. An international workshop on the harmonization of drugs and biologics for aquaculture was organized by the Working Group. The first workshop was held in 1997 as part of the World Aquaculture Society meeting in Seattle, Washington. Participants from countries representing every major continent except Africa attended the all-day session. A second workshop was held this year in Las Vegas in conjunction with the 1998 World Aquaculture Society meeting. Work continues to take advantage of the wealth of knowledge available globally in the advancement of aquaculture.

The Working Group for Quality Assurance in Aquaculture Production is currently co-chaired by Drs. Kevin Greenlees of FDA/CVM and Gary Jensen of USDA/CSREES. A five-year plan has been developed to take the Working Group into the next century. The "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture" is undergoing extensive revisions and the new edition is anticipated this year. Activity continues toward the international harmonization of aquaculture drugs and biologics. Efforts to coordinate the development of data for the approval of needed pharmaceutical and biological tools for the aquaculture industry with potential sponsors for the approved products continue to be a major effort. The Working Group continues to provide a unique forum for discussion and action while advancing the growth and development of U.S. aquaculture.

Quality Assurance Working Group for Aquaculture Production Five-Year Plan

Facilitate the funding and support for the NADA Coordinator from both the public and private sectors;

Continue to identify and prioritize drugs, chemicals, and biologics needed for diverse aquaculture species at two-year intervals;

Explore innovative strategies for funding the research needed to facilitate aquaculture drug approvals, chemical registrations, and biologic licensing;

Encourage the aquaculture community to assist in defining food/non-food fish, crop grouping, and/or life stages for drug-specific applications;

Evaluate the Aquaculture Pesticides Food Animal Residue Avoidance Databank (FARAD) for utilization, software accessibility, and funding;

Update and assist in distributing the educational publications: "Federal Regulation of Drugs, Biologicals, and Chemicals Used in Aquaculture Production" and "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture";

Monitor, evaluate, and discuss pending Federal legislation and regulations pertaining to aquaculture drugs, chemicals, biologics, and quality assurance;

Highlight vaccines as an important component of integrated "herd health" management programs and as a mechanism to reduce drug use; encourage vaccine development and licensing;

Continue to support the development and implementation of producer quality assurance programs for aquatic species; Continue to foster utilization of producer-based quality assurance programs together with processor-based Hazard Analysis Critical Control Point (HACCP) principles;

Use computer technology to create and maintain databases on the status of drug approvals, investigational new animal drug (INAD) exemptions and other pertinent aquatic health information to encourage and facilitate public access and review through the Office of the NADA Coordinator;

Foster international harmonization for the establishment of tolerance levels and for the processes needed for aquaculture drug approvals, chemical registrations, and biologic licensing;

Appraise the potential national and international market value for aquatic health products to encourage pharmaceutical, chemical, and vaccine industry involvement; and

Promote the participation of domestic and international agencies and producer groups in the activities of the Working Group on Quality Assurance in Aquaculture Production.