World Aquaculture Magazine - June 2020

42 JUNE 2020 • WORLD AQUACULTURE • WWW.WA S.ORG problems to improve research study submissions. The group identified the value of developing standardized protocols for key data sets for target animal safety and effectiveness, environmental risk assessment, analytical method validation and human food safety for use by the research community. Work focused on disease models, standard research protocols with standard statistical analysis methodologies and effectiveness study design. An antimicrobial resistance working group addressed factors that needed to be considered during development of risk assessments for antimicrobial new animal drugs and helped the group to better understand FDA’s microbial food safety requirements. The forum organized technical sessions at national conferences where researchers could share their experiences conducting research studies for drug approvals to learn from each other. FDA participated in these sessions and helped provide clarity on regulatory requirements and Agency expectations. In 2004 the NADRF also initiated a focus on biologics with USDAAnimal Plant and Health Inspection Service’s Center for Veterinary Biologics. An Aquaculture Biologics Subgroup was created to identify the need for vaccines, bacterins and other biologics and to foster their development for US aquaculture. The NADRF played an important role for coordination because of the cost of research studies and the need to become more efficient with limited resources and expertise. InternationalHarmonization The WG took the initiative, with European representatives and those of other interested countries, to learn about agreements and harmonization protocols and equivalency standards relating to food safety and the use of animal drugs and biologics. The WG organized two international harmonization workshops in 1997 and 1998 to advocate that bilateral and international efforts should include aquaculture therapeutants. These coincided with international efforts to establish international food safety standards and guidelines as well as maximum residue limits and import tolerances that impact international trade. Aquaculture as a food-producing sector could not influence high-level, multi-country harmonization and equivalency negotiations and decisions alone, but needed to be recognized as an important global food-producing sector with specific needs similar to those of other animal agriculture sectors (Jensen 1998c). MinorUse andMinor SpeciesAct of 2004 (MUMS) The MUMS Act is intended to make more drugs legally available to veterinarians and animal owners for treatment of minor animal species (including fish) and minor uses of drugs in major animal species. This law provides innovative ways to bring products to market for these small populations and is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs. Before this legislation was enacted, companies would rarely attempt to bring such drugs to market because the markets were too small to generate an adequate financial return. The continued dialog provided through the WG informed key experts in the aquaculture community of opportunities that this legislation might offer. These experts subsequently became key members of the consortium that advocated for the MUMS Act. The WG subsequently was instrumental in educating the aquaculture community about benefits of the MUMS Act and encouraging their participation in the drug approval process. The previous years of collaboration and cooperation among many in the public and university research communities under WG-enabled aquaculture projects to quickly make the most of incentives afforded by the MUMS Act. Major Results From Collaboration: NewDrugs and Label Claims (1990-2019) The results of all collaborative efforts by all participants in the WG accelerated the rate of aquaculture drug approvals even beyond 2008 when the WG ended. Drug approvals are listed in Table 1, and Table 2 shows where substantial work to support additional drug approvals has been completed. Working Group Termination and Evolution to Continue Activities In 2007, the OSTP, under which the JSA operated, became more engaged with the JSA and expressed concerns that participation of non-governmental entities in JSA andWG activities could be perceived as functioning as an advisory committee to federal agencies. As a result, the JSA adopted a new policy that only federal members and representatives could attend future meetings with the exception of special invitations to non-governmental entities to present information only. The WG decided to discontinue activities as a result of the OSTP’s guidance for how future meetings would need to be conducted. After 18 years of continuous activities and resulting accomplishments, it was reasonable to transition out of the auspices of the JSA. The WG held its last open public-private sector meeting in February 2008. Non-governmental entities also met separately after the last open public meeting to evaluate options for continuing or terminating ongoing projects and activities. The WG’s non-governmental stakeholders decided to continue efforts through a newWorking Group on Aquaculture Drugs, Chemicals, and Biologics under the leadership and organizational structure of the Fish Culture Section of the American Fisheries Society (AFS). Members and participants of the JSAWGwere invited to join the newAFSWG. The AFSWG continued public meetings for several years to advance federal approval of aquaculture drugs, chemicals and biologics to support US aquaculture development. In 2011, the newAFSWG released an updated and expanded version of the original 1994 Guide to Drug, Vaccine, and Pesticide Use in Aquaculture and renamed it the Guide to Using Drugs, Biologics and other Chemicals in Aquaculture (American Fisheries Society Fish Culture Section 2011). The Guide continues to be updated and published by the American Fisheries Society Fish Culture Section (Bowker et al. 2016, Bowker and Trushenski 2019). With termination of the WG, leadership roles and efforts formerly found in the WG transitioned to FWS AADAP and USGS UMESC in the federal government, AFWA by state authorities, and the American Fisheries Society’s Fish Culture Section, among many others. Discussion 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 ( C O N T I N U E D O N P A G E 4 7 )