World Aquaculture Magazine - June 2020

40 JUNE 2020 • WORLD AQUACULTURE • WWW.WA S.ORG clearly understanding their respective organization’s role, which was a critical step if an initiative was to be successful. The WGwas also instrumental and creative in fostering numerous new initiatives consistent with the working group’s goals. Many of these efforts have had lasting impacts, benefitting FDA in its regulatory role and the aquaculture community through improved communications, facilitation of drug approvals and compliance with new food safety regulations. In Part One we provided an example of the Low Regulatory Priority (LRP) determinations. Also prominent among these intiatives were the following: Investigational NewAnimalDrug (INAD)Trials The WGwas the initial focal point for aquaculture producers to learn about the data requirements to support the approval of new animal drug applications (NADAs). In addition, FDA conducted INADworkshops and provided training materials. FDA piloted a process whereby aquaculture facilities could use an unapproved drug under an INAD to generate data to support drug approval if the facility followed protocols agreed to by FDA. The investigational trials required coordinated efforts by many parties, including a sponsor, monitor, investigator, manufacturer and FDA. As the FDA’s workload increased with more studies coming in, the Agency increased the number of reviewers for aquaculture submissions. The Agency hired an aquatic animal health professional and expanded staff from a single scientific reviewer dedicated to aquaculture submissions to a four-member aquaculture review team in 2001. FDA also involved subject matter experts in human food safety and environmental science to evaluate relevant information submitted to INADs and NADAs. The Agency also formed an internal working group to improve regulatory coordination of aquaculture drugs, including coordination of work across the different technical sections required for a NADA. FDA officials were active in all WGmeetings and helped lead the creation of the National Aquaculture Research Forum described in more detail below. CropGrouping FDA used the WG to encourage industry to develop data to evaluate the use of crop grouping to assess whether a few selected fish species could be used as surrogates for all or most of the cultured fishes in the US to determine a drug’s safety and effectiveness. Taking T his is the second part of a two-part article. Part One was published in the March 2020 issue of World Aquaculture . This article highlights the major accomplishments and influence that the Working Group on Quality Assurance in Aquaculture Production (WG), later renamed the Working Group on Aquaculture Drugs, Biologics and Pesticides, realized to advance the approval of animal drugs by the Food and Drug Administration (FDA; the Agency) for the aquaculture community in the United States (US). From 1990 through 2008, the WG functioned under the auspices of the federal coordinating Joint Subcommittee on Aquaculture (JSA), currently named Subcommittee on Aquaculture, under the National Science and Technology Council (NSTC) of the Office of Science and Technology Policy (OSTP) in the Executive Office of the President. The WG offers a unique case study for adopting creative novel public-private sector strategies to solve complex problems. Significant Activities Facilitated Through the Working Group With only a couple of notable exceptions, the WG itself did not prepare reports, position papers or recommendations. The first exception to the no-product approach was the development and printing of 5,000 copies of the publication “Federal Regulation of Drugs, Biologicals, and Chemicals Used in Aquaculture Production” to provide this information in a singular, readily assessible place for the aquaculture community (National Agricultural Library 1992). The second was the compilation and printing of 10,000 copies of the first ever “Guide to Drug, Vaccine and Pesticide Use in Aquaculture,” co-authored by the federal agencies with authorities for these compounds (Texas Agricultural Extension Service 1994). Both of these work products were published by the United States Department of Agriculture (USDA) on behalf of the JSA. The value of the WGwas derived from its role as a public forum for the exchange of information, discussion of issues and coordination of activities related to the availability and appropriate use of animal drugs, biologics and pesticides. Because of the broad range of groups attending, WG discussions usually provided a multi-faceted perspective of the efforts necessary to accomplish any given objective. Participants benefited by more How Innovative Collaboration Increased Aquaculture Drug Approvals in the United States — Part 2 Kevin Greenlees, Gary Jensen, Jennifer Matysczak, Rosalie Schnick and Gary Stefan The value of the WG was derived from its role as a public forum for the exchange of information, discussion of issues and coordination of activities related to the availability and appropriate use of animal drugs, biologics and pesticides. Because of the broad range of groups attending, WG discussions usually provided a multi-faceted perspective of the efforts necessary to accomplish any given objective. Participants benefited by more clearly understanding their respective organization’s role, which was a critical step if an initiative was to be successful.