World Aquaculture Magazine - June 2020

WWW.WA S.ORG • WORLD AQUACULTURE • JUNE 2020 41 a risk-based approach using this data, FDA agreed that it was not necssary to test the drug in every single species from a group of related species. This resulted in broad label claims for warm-, cool-, and cold-water species. National AquacultureNewAnimalDrugApplicationCoordinator EarlyWG discussions identified the critical need for a novel position of a national coordinator that would aid the public sector and private aquaculture industries in 1) assisting companies and researchers with making submissions to FDA, 2) avoiding redundancy of work and research, 3) securing the interest and commitment by pharmaceutical and chemical companies to pursue NADA approvals of their products, 4) identifying potential major funding sources for drug research and 5) tracking and reporting on the status of submissions and technical sections required in a NADA (Schnick and Armstrong 1997). The National Aquaculture NADA Coordinator position was filled in 1995 with funding from approximately 20 agencies, organizations and companies. This position continued until May 2010 when it was decided that the position was no longer needed given the collective experience and partnerships that had developed. TheFederal-StateAquacultureDrugApproval PartnershipProject This project was perhaps better known as the Association of Fish andWildlife Agencies (AFWA) Project. The role that the JSA WG played related to this project involved facilitating meetings that brought representatives together from the commercial aquaculture and public hatchery sectors. Priority drug needs for both sectors were discussed, helping to identify where AFWA Project priorities and commercial aquaculture drug needs aligned. The coordination helped provide a greater voice for informing drug companies of potential markets, granting organizations and government officials of the critical need for approved aquaculture drugs. The AFWA Project started in 1994 after initiatives in 1990 by the US Fish and Wildlife Service’s (FWS) Upper Midwest Environmental Sciences Center (UMESC) in La Crosse, Wisconsin. The UMESC and the eventual National Aquaculture NADA Coordinator played key roles in establishing this impactful partnership. The partnership initially involved 38 state natural resource agencies, three federal agencies and the AFWA. The partnership, along with major contributions by 17 drug and chemical sponsors, contributed more than $25 million in funds, materials and resources by 2009 to approve extended drug label claims and new animal drugs important to public and private aquaculture. The partnership contributed an important infusion of funding to support research on eight high priority drugs with multiple potential label claims (Schnick 2011). The original eight priority drugs were benzocaine, chloramine-T, copper sulfate, formalin, hydrogen peroxide, oxytetraycline, potassium permanganate and sarafloxacin. The priority list changed with time, with florfenicol replacing sarafloxacin and eugenol ultimately replacing benzocaine. The major federal research centers that were involved in the drug approval process included UMESC, FWS Aquatic Animal Drug Approval Partnership (AADAP) and USDAAgricultural Research Service’s Stuttgart National Aquaculture Research Center (SNARC). These federal research facilities developed data to meet the major technical sections of NADAs: UMESC for 1) environmental safety studies, 2) environmental assessments, 3) human food safety (analytical method development, residue chemistry studies, and microbial food safety analysis studies), 4) target animal safety studies and 5) effectiveness studies; AADAP for 1) target animal safety studies and 2) effectiveness studies; and SNARC for 1) an environmental assessment, 2) target animal safety studies and 3) effectiveness studies (Schnick 1999, Schnick et al . 1996). As of 2020, five of the original eight high priority drugs as well as other additional drugs of importance to the aquaculture sector achieved approvals or label extensions. Additionally, significant parts of approval packages have been completed for other drugs (see Tables 1 and 2 for details). QualityAssurancePrograms Quality assurance programs educate producers and establish standardized procedures on the proper and legal use of chemotherapeutants. They are farm-level participatory approaches to address any potential concern or emerging issue related to the human safety and quality of aquaculture products. In 1993, the Catfish Farmers of America developed a quality assurance program. Enrollment was initially voluntary but became mandated by some catfish processing plants and was accepted for addressing safety and quality at the first critical control point of raw product entering the plant (Jensen 1993). In 1994, the US Trout Farmers Association developed a voluntary quality assurance programwith a pledge card, producer Hazard Analysis Critical Control Point (HACCP) application form and verifier’s affidavit that a farmmet the requirements for HACCP designation by participation in the quality assurance program (McCraren 1995, Jensen 1998a). Various industry trade organizations and state cooperative extension programs collaborated in developing a video and a fact sheet on “Aquaculture Quality Assurance: Become Involved” in 1994 to increase awareness and participation by farmers. The hybrid striped bass sector developed industry guidance from fish farm to consumer to address quality and safety aspects for their products (Jahncke et al . 1996). The producer quality assurance initiatives became more widespread as a means of addressing new FDAHACCP requirements (Jensen 1998b). TheAquaculturePartnership Aquaculture industry leaders, concerned about increased enforcement and surveillance activities, realized the need for better communication with FDA. Together they created The Aquaculture Partnership (TAP) that provided a yearly or as needed informal forum for exchanging information and discussing industry or regulatory concerns to avert potential problems and dissemination of misinformation. TAP meetings brought together aquaculture industry leaders and upper management officials from FDA. This improved communication created effective early opportunities for regulatory agencies and industry leaders to interact and learn from each other, which was especially helpful during periods of increased attention by FDA or the public media. National AquacultureDrugResearchForum(NADRF) With the recognized need to improve development of research study protocols, data generation and analysis and other research supporting NADAs, the WG created a National Aquaculture Drug Research Forum in 2004. The goals were to facilitate communication between FDA and the research community and identify and solve ( C O N T I N U E D O N P A G E 4 2 )