World Aquaculture Magazine - June 2020

WWW.WA S.ORG • WORLD AQUACULTURE • JUNE 2020 47 to bring drug use in aquaculture into compliance with existing regulations, the impact on the industry’s future was uncertain. US aquaculture had the po- tential to decline or it could continue to expand as a viable protein-producing sector. Ultimately, the courses of action chosen were win-win for both the FDA and aquaculture stakeholder communi- ties. The forthright dialog that was the hallmark of JSAWG interactions and the responsiveness of the aquaculture community that led to curtailing the improper use of drugs and chemicals in aquaculture enabled the FDA to develop novel approaches to address the need for additional drug approvals for aquatic species. The creation of the NADAAquaculture Coordinator and partnerships between aquaculture producers and pharmaceutical sponsors under INADs are just two examples that resulted in major accomplishments over the next 18 years. The vision and ingenuity of diverse participants contributed to addressing myri- ad new issues as both the aquaculture community and FDA strived to succeed despite overwhelming challenges. During the early- to mid-1990s the drug availability crisis situation required close communication and collaboration between federal agencies and industry. The activities of the WGwere based on mutual commitments among federal, state and private sectors to address critical issues. Any participant was free to raise an issue for discussion. Private sector representatives were just as likely to take leadership roles as were government representatives. FDA recognized the need for public-private sector collaborations and supported the cooperative approach to find effective solutions to providing legal access to needed drugs. Early on, it was recognized that federal regulatory scientists, in- dustry leaders and academic experts did not understand the expecta- tions and needs of each other. This condition led to concerted efforts to educate all members on federal law and aquaculture industry ac- tivities. The WG established a unique cooperative national forum for industry, government and academics to address issues of concern to the nation’s aquaculture community. As species groups (particularly the catfish and trout industries) took the lead in developing quality assurance programs, FDA regulatory scientists gained an understand- ing of standard industry practices. Leadership was taken by individu- als with the necessary expertise and who expressed a commitment to take an issue forward regardless of their affiliation. With different people and groups taking the leads for different issues, the WGwas able to accomplish much more than if there was a single lead. The number of active participants reached more than 125 nationwide, rep- resenting a wide diversity of expertise, interests and knowledge that enabled the WG to address a myriad of critical issues with desired outcomes within regulatory compliance boundaries. Through the WG and other venues, the Agency encouraged industry to organize around specific issues, communicate species- specific essential needs and compile existing databases to identify data gaps, all of which helped identify research priorities. Public and private aquaculture interests responded to leverage and extend what the WG, FDA and new drug laws had provided to help them meet their drug approval needs. Efforts intensified by the WG to seek involvement by pharmaceutical and chemical companies as potential NADA sponsors who could also benefit from technical data packages in public master files. This cooperative effort resulted in creation of an independent National Aquaculture NADA Coordinator position funded by government and industry to help coordinate the development of aquaculture new animal drugs, development of federal programs specializing in aquaculture drug research and the collaborative efforts of the AFWA Project. Conclusions It is impossible to accurately determine the full impact of the WG on the US aquaculture community. However, it is possible to make some assumptions based on the number of drug approvals and drug label extensions. First, the WGwas an excellent national forum for discussion and communication that helped reduce the level of frustration for all parties and move forward with solutions. The WG leveraged the diverse expertise and extensive knowledge of numerous participants. The WG provided an environment that encouraged all participants to think “outside the box” and to explore innovative approaches to resolving difficult issues. The WGmaximized use of its limited resources by having multiple WGmembers lead different activities; simultaneously moving forward, while reducing duplication of effort. This led to improvements in efficiency in all areas. With regard to aquaculture and animal drugs, the combined results obtained by participants of the WGwere greater than the sum of its parts. Further, the WG helped foster creation of other groups and new programs that contributed significantly to advancing new animal drug approvals for aquatic species. For 18 years, the WG provided an unequaled mechanism for coordinating the efforts of federal and state agencies, academic institutions, drug companies, aquaculture enterprises and private individuals to increase the legal availability and proper use of animal drugs, biologics and pesticides in aquaculture production. More compounds were approved for aquatic animal use per year during its existence than before it formed or after it disbanded. The unlikely mix of government, industry and academia representatives found common ground in their joint determination to overcome tremendous obstacles and assure that US aquaculture would have approved animal drugs, biologics and pesticides for use in the production of safe and wholesome food for American consumers. Though potential competitors, the various aquaculture species groups devised unique and effective strategies to demonstrate that common objectives can forge alliances to overcome differences to achieve goals beyond the capability of any single member. The WG used a simple strategy to address a complex problem. It identified common interests and used those interests to build cooperative approaches that maximized the efficient use of limited resources to achieve common goals. The strategy resulted in the following: 1) unity in work, 2) willingness to cooperate, 3) non- adversarial, open meetings, 4) strong FDA and industry participation, ( C O N T I N U E D O N P A G E 4 8 ) The year 1990 was a turning point when the importance of aquaculture was recognized as an important food- producing sector in the US. It also meant more scrutiny by the FDA regarding the use of drugs in aquaculture to provide assurances that the resulting food products were safe for consumers. Once FDA decided to take action to bring drug use in aquaculture into compliance with existing regulations, the impact on the industry’s future was uncertain.