INCREASING THE NUMBER OF SAFE AND EFFECTIVE THERAPEUTICS FOR AQUACULTURE

• Sponsoring Institution: National Institute of Food and Agriculture
• Project Status: COMPLETE
• Funding Source: AFRI COMPETITIVE GRANT
• Reporting Frequency: Annual
• Accession No.: 1019553
• Grant No.: 2019-67015-29870
• Cumulative Award Amt.: $200,000.00
• Proposal No.: 2018-06922
• Project Start Date: Jul 1, 2019
• Project End Date: Jun 30, 2022
• Grant Year: 2019
• Program Code: [A1221]- Animal Health and Production and Animal Products: Animal Health and Disease

Recipient Organization
CORNELL UNIVERSITY
(N/A)
ITHACA,NY 14853

Performing Department
Microbiology & Immunology

Non Technical Summary
As part of the coordinated effort to generate data to support approval by FDA/CVM, Cornell University researchers will conduct a series of studies under a recently submitted protocol to FDA/CVM (AQS20E-18-SEA-TAS.2b) to evaluate the safety of AQUI-S®20E (10% eugenol) used to sedate marine fish to the handleable stage of anesthesia in saltwater. For our purposes, the term "handleable" will be equivalent to anesthesia stages 3 - 4 as described by Summerfelt and Smith (1990) (that fish become handleable within 3 min or less and recover normal swimming behavior within 5 - 10 min. The objective of these studies is to evaluate the safety of AQUI-S®20E to saltwater-reared marine finfish when overexposed to either the HEC (1×) or 1.5× the highest proposed efficacious dose. The results of these safety studies will be used to complete the target animal safety (TAS) technical section data requirements for marine finfish and ultimately support a New Animal Drug Application to FDA/CVM to approve the use of AQUI-S®20E for sedation in all finfish.This collaborative approach will not stop after the approval of AQUI-S®20E is attained. Protocols for the next prioritized drug will be finalized and submitted to FDA for concurrence in a coordinated and timely fashion. Study topics could include effectiveness, human food safety, and/or target animal safety efforts, whichever technical section needs research conducted. These decisions will be made with stakeholder input as described below. We will continue to work closely with AADAP on more projects chosen by the aquaculture stakeholders, particularly the Drug Approval Working Group (DAWG), to complete as much additional research as possible given the two-year funding provided for this proposal.

Animal Health Component

100%

Research Effort Categories

Basic

(N/A)

Applied

100%

Developmental

(N/A)

Classification

Knowledge Area (KA)	Subject of Investigation (SOI)	Field of Science (FOS)	Percent
315	0810	1150	20%
315	0810	1160	80%

Knowledge Area
315 - Animal Welfare/Well-Being and Protection;

Subject Of Investigation
0810 - Finfish;

Field Of Science
1160 - Pathology; 1150 - Toxicology;

Keywords

aquaculture

drugs

efficacy

fish

minor species

safety

therapeutics

Goals / Objectives
Economic survival of aquaculture producers depends on their ability to treat diseases with approved drugs and the knowledge that such treatment will not harm the species or incur improper drug residues. Production units or farms raising what FDA terms "minor species" typically operate on thin margins. Economic success or even survival depends on optimal health of their livestock. Limiting disease with approved therapeutics allows producers and their veterinarians to treat animals with confidence and assures that the dose selected will perform as intended. All of the long-term goals of this proposal will help support a sustainable and economically healthy aquaculture industry.There is little economic incentive for pharmaceutical firms to invest in disease treatment options for fish farmers and this is addressed by the long-term goals of this proposal: (1) To maintain a viable economic method to assess the safety and effectiveness of drugs for use in the aquaculture industry; (2) To reduce economic loss and improve animal welfare by developing novel management tools to prevent and treat serious diseases in these minor species; (3) To enable a sustainable, healthy U.S. aquaculture industry. The supporting objectives are: (a) Work to ensure the safe and efficacious use of animal health products through the publication of data on the safety, effectiveness, and pharmacokinetics of drugs for aquaculture species; (b) Facilitate FDA/CVM approvals of drugs for aquaculture species; (c) Improve the sustainability of aquaculture by reducing losses due to disease; (d) Maintain an active drug assessment center with the necessary expertise to perform GLP experiments.

Project Methods
The goals of the target animal safety study are to identify the toxic effects of the drug and establish a margin of safety for the labeled dosage regimen. Therefore, animals considered the most sensitive are generally chosen as the test animals to provide the highest likelihood of showing adverse effects. At the start of the in-life phase of the AQUI-S®20E target animal safety (TAS) study conducted in saltwater under the approved protocol, test animals will be small (e.g., 10 - 15 cm in total length) Juvenile striped bass (Morone saxatilis) fingerling that have been acclimated to saltwater. (The initial test animals in this proposal were Atlantic salmon Salmo salar smolts. During the review of the eugenol TAS protocol (AQS20E-18-SEA-TAS.2b) required for this research the U.S. Food and Drug Administration Office of New Animal Drug Evaluation suggested to AADAP that "saltwater finfish species other than salmonids may be more informative in establishing TAS for saltwater finfish than a study in a saltwater salmonid species.") Prior to the start of the trial the striped bass will be maintained in the VMC Aquatics Facility in a recirculation system with salinity adjusted to 32-34 ppt with sea salt (Crystal Sea, Marine Enterprises International, Baltimore, Maryland, USA). Routine monitoring of water quality will indicate any problematic concentrations of ammonia or nitrite. Based on results from previously conducted AQUI-S®20E studies, there is some evidence that smaller fish are more sensitive to drug overexposure than larger fish. These test fish species are relevant to the anticipated use pattern of AQUI-S®20E in saltwater-reared marine finfish and they are (1) commonly reared at hatcheries, (2) an important recreational and commercial species, (3) often used as a representative test species when conducting studies, and (4) available to use as test animals. Inclusion criteria are as follows: (1) There must be an adequate number of appropriate-age, healthy test fish available, and (2) test fish must be acclimated to source water for ≥ 2 d before the exposure period starts. Before the exposure period, 20 reference population fish will be impartially collected and evaluated to establish baseline fish health and histology. Each fish will be individually measured and weighed and a gross external and internal necropsy will be performed. Test fish will be immature; therefore sex of test fish will not be determined nor considered. However, it will be assumed that male and female test fish will be present in near equal proportions.The phases of each TAS study will be conducted in four parts: (1) Evaluate baseline fish size, fish health, and level of histopathologies representative of the reference population. (2) Empirically determine the ET80 (defined as the 80th percentile of Exposure Time (min) of 15 fish individually tested to the handleable stage of sedation) for each exposure concentration (excluding the 0-mg/L control). (3) Select exposure durations for each test concentration (excluding 0-mg/L controls) based on multiples of ET80HEC (HEC is the Highest Effective Concentration of AQUI-S®20E proposed to effectively and safely sedate marine fish to handleable). (4) Conduct the TAS study. Each TAS study will consist of exposing groups of fish to one of three AQUI-S®20E concentrations. At each concentration, groups of fish will be tested at one of four exposure durations. Thus, there will be 12 combinations of "exposure concentration × exposure duration." Each unique exposure regimen will be replicated four times over the course of four "exposure days." There will be a 24-h post-exposure period after each of the exposure days. This process of setting the exposure regimen has been used for multiple AQUI-S®20E studies conducted successfully with freshwater fish (Bowker et al. 2015).Test fish in recovery tanks will be observed for mortality and general behavior during the following three periods: (1) Repeatedly during the first 2 h following exposure to AQUI-S®20E at: approximately 8 - 15 min, 30 min, 60 min, and 120 min post-exposure; (2) Approximately 4 h post-exposure; and (3) Approximately 24 h post-exposure. General behavior will include the swimming activity, ventilation, and feeding behavior of the fish. Examples of abnormal behavior would be head shaking, agitation, or piping. Fish collected during or at the end of the 24 h post-exposure period will be grossly necropsied by masked personnel and the results recorded. Kidney, gill, and liver will be collected and fixed for evaluation by the histopathologist. The remaining tissues (eye, skin, brain, heart, muscle, stomach, intestine, spleen) will also be collected and fixed. If lesions are seen during gross necropsy on tissues other than kidney, gill, or liver, then those other tissues will be included for evaluation by the histopathologist. In summary, during the pre- and post-exposure period, the following parameters will be measured or evaluated and recorded or documented on appropriate forms: daily mortality, water temperature, salinity, DO concentration, pH, general behavior, and fish health status.Data analyses will include: (1) Determining mean and a 95% CI for mean percent survival at each combination of exposure concentration and duration using a generalized linear mixed model; (2) Tabulate or graph fish health and pathology results (gross and histological - if required) to show the relative frequency of occurrence of normal and abnormal external and internal characteristics detected in fish sampled from the reference population; (3) Analyze dichotomized versions of the pathological and non-pathological histological changes with a generalized linear model. In every analysis, exposure tank/recovery tank will be treated as the experimental unit. Tank proportions will be summarized and statistical significance will be indicated when P < 0.10; (4) Calculate and report (a) eugenol concentration of the tub of bulk working solution, (b) eugenol concentration of each exposure container, and (c) overall mean eugenol concentration of all four exposure containers during each replicate to show whether or not the eugenol concentrations administered were within acceptable accuracy limits following the measurement procedure documented in Bowker et al. (2015); and (5) Tabulate or graph water quality results to show that source water quality in reference population tanks, exposure containers, and recovery tanks was suitable for holding and rearing healthy fish. All output from the statistical package, such as such as SAS or R software, used to do the analysis for this study, which is described in detail within the protocol already submitted to the FDA for concurrence, will be submitted with the final study report.

Progress 07/01/19 to 06/30/22

Outputs
Target Audience:Aquaculture producers (i.e. fish farmers) have vested interest in this project, and pharmaceutical companies, particularly those that are aquatic animal drug manufacturers, may be considered significant stakeholders as well. Other groups with interest in aquatic animal drug use include veterinarians and regulators. The active participation of aquatic animal producers, fishery agency personnel, and pharmaceutical companies is essential for the success of each project. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The 2019 AQUAVET® Summer Fellow, DVM student Danielle Scott returned for a second summer and took on even more responsibility conducting the target animal safety study utilizing Good Laboratory Practices. Ms. Scott has drafted the materials and method section of the upcoming journal publication, and will continue to take the lead author position as she starts her PhD program at Colorado State University. Brian Chambers was the second DVM student mentored during the summer of 2019, when he conducted most of the water quality testing and feeding of the striped bass. Xanth El-Sayed was the third DVM student mentored during the summer of 2020, when he also headed up the water quality part of the second sedative safety study. A fourth DVM, Kyara Moran, Cornell Class of 2023, completed many of the 2020 data tables during COVID from her home in Miami. All of students are now well versed in the drug assessment process and have the necessary expertise to perform GLP experiments. How have the results been disseminated to communities of interest?During COVID, the PI was not allowed to leave the state of New York and in-person meetings were severely restricted. The project was mentioned during the Aquatic Drug Approval Coalition (ADAC) quarterly meetings conducted in 2021 and 2022. The ADAC is good example of a partnership supporting aquaculture development and derives its strength from the breadth of membership that includes the lead federal agency (FDA-CVM) that reviews and approves drugs and chemicals to address aquatic animal health issues. The other partners are the National Aquaculture Association, the Association of Fish and Wildlife Agencies, American Fisheries Society, tribal members, federal agencies, aquatic animal drug manufacturers, and consultants working to promote aquatic animal drug and chemical research. Our AQUI-S®20E project process was again discussed during the Multistate Research Project, NECC1702 "Establishment of a Formal Structure for the Minor Use Animal Drug Program" to keep colleagues with similar interests in minor species drug development appraised of our work. The data from the 2020 Pompano study was presented during a virtual Aquatic Animal Drug Approval Partnership program at the end of July 2021. Finally, as stated above, we presented our results at more stakeholder meetings that were postponed or cancelled during the COVID-19 pandemic during 2020 and 2021. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Over the course of the research project we were able to establish the safety of AQUI-S®20E when used to sedate both striped bass and Florida pompano during our USDA NIFA funded study. After submitting responses to FDA inquiries, our data from the striped bass trials we collected in 2019 were accepted by the Office of New Animal Drug Evaluation (ONADE). This first study demonstrates that eugenol is safe for use on striped bass in saltwater when administered in a static bath at a dose of 40 mg eugenol/L for sedation to a handleable condition. There is an adequate margin of safety above 40 mg eugenol/L based on concentration and duration of exposure. However, small (<10 g) striped bass should be monitored closely during exposure due to the narrower margin of safety observed in this study. We used a one year cost extension to finish the data analysis and report compilation for the second AQUI-S®20E trial, where Florida pompano were exposed to the eugenol-based sedative.The second major accomplishment is that we were able to conduct the Florida pompano trials even with the delays getting access to our laboratories because of COVID-19. We completed the histological evaluations, data analysis, final study report writing, and started presenting our results to our stakeholders, which included the 2021 Aquatic Animal Drug Approval Partnership online workshop on July 28, 2021, the Aquaculture America meeting in San Diego on March 2, 2022, and Northeast Aquaculture Conference and Exposition on April 29, 2022. The 2020 target animal safety study utilizing Florida pompano was submitted to the FDA Center for Veterinary Medicine on February 1, 2022. Manuscript preparation has started, which will include a third AQUI-S®20E trial supported with FDA Minor Use Minor Species (MUMS) funding where we used yellow clownfish as a representative species for ornamental fish.

Publications

• Type: Conference Papers and Presentations Status: Other Year Published: 2022 Citation: Getchell, R.G., Danielle M. Scott, Alina Demeter, Xanth El-Sayed, Ana Griefen, Brian Chambers, Niccole Wandelear, Paul Bowser, Philippe Baneux, Drew Kirby, Julie Schroeter, and Marilyn Blair. Aquaculture Policy Session: MORE SAFETY DATA FOR USE OF AQUI-S� 20E (10% EUGENOL) AS A SEDATIVE FOR MARINE FINFISH. Aquaculture America 2022 San Diego, CA March 1-4, 2022
• Type: Conference Papers and Presentations Status: Other Year Published: 2021 Citation: Getchell, R.G., Danielle M. Scott, Ana Griefen, Brian Chambers, Xanth El-Sayed, Adam Frosolone, Niccole Wandelear, Julie, Schroeter, Philippe Baneux, Drew Kirby, and Marilyn Blair. 2020. The Safety of AQUI-S� 20E (10% Eugenol) as a sedative on striped bass, Florida pompano, and yellow clownfish. AADAP Workshop 27-29 July 2021.
• Type: Conference Papers and Presentations Status: Other Year Published: 2022 Citation: Getchell, R.G., Danielle M. Scott, Ana Griefen, Brian Chambers, Xanth El-Sayed, Adam Frosolone, Niccole Wandelear, Julie, Schroeter, Philippe Baneux, Drew Kirby, and Marilyn Blair. 2022. The Safety of AQUI-S� 20E (10% Eugenol) as a sedative on striped bass, Florida pompano, and yellow clownfish. NACE 2022 27-29 April 2022, Portland, ME.

Progress 07/01/20 to 06/30/21

Outputs
Target Audience:Aquaculture producers (i.e. fish farmers) have vested interest in this project, and pharmaceutical companies, particularly those that are aquatic animal drug manufacturers, may be considered significant stakeholders as well. Other groups with interest in aquatic animal drug use include veterinarians and regulators. The active participation of aquatic animal producers, fishery agency personnel, and pharmaceutical companies is essential for the success of each project. Changes/Problems:There were some delays getting access to our laboratories because of COVID-19. We are nearly caught up and have a plan in place to complete our work during the no cost extension. What opportunities for training and professional development has the project provided?The 2019 AQUAVET® Summer Fellow, DVM student Danielle Scott returned for a second summer and took on even more responsibility conducting the target animal safety study utilizing Good Laboratory Practices. Ms. Scott has drafted the materials and method section of the upcoming journal publication. A second DVM, Kyara Moran Cornell Class of 2023, completed many of the 2020 data tables during COVID from her home in Miami. How have the results been disseminated to communities of interest?During COVID, the PI was not allowed to leave the state of NewYork and in-person meetings were not allowed. The project was mentioned during the Aquatic Drug Approval Coalition (ADAC) quarterly meeting conducted in 2021. The ADAC is good example of a partnership supporting aquaculture development and derives its strength from the breadth of membership that includes the lead federal agency (FDA-CVM) that reviews and approves drugs and chemicals to address aquatic animal health issues. The other partners are the National Aquaculture Association, the Association of Fish and Wildlife Agencies, American Fisheries Society, tribal members, federal agencies, aquatic animal drug manufacturers, and consultants working to promote aquatic animal drug and chemical research. Our AQUI-S®20E project process was again discussed during the Multistate Research Project, NECC1702 "Establishment of a Formal Structure for the Minor Use Animal Drug Program" to keep colleagues with similar interests in minor species drug development appraised of our work. Finally, the data from the 2020 Pompano study will be presented during a virtual Aquatic Animal Drug Approval Partnership program at the end of July 2021. What do you plan to do during the next reporting period to accomplish the goals?The research plan during theno costextension is to complete the histological evaluations, data analysis, final study report writing, and we will present our results at more stakeholders meetings that were postponed or cancelled during the COVID-19 pandemic during 2022. When we finish the Final Study Report then we will submit it tothe FDA Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation. Manuscript preparation has started, but is waiting for all the second year data to be tabulated and analyzed.

Impacts
What was accomplished under these goals? We are still finishing the second year of our USDA NIFA study titled, "The Safety of AQUI-S®20E as a Sedative on a Variety of Marine Finfish at Cornell University". During this second year, we had made major progress responding to FDA requests for more information about our data from the striped bass trials we collected in 2019 and we were able to conduct the Florida pompano trials even with the delays getting access to our laboratories because of COVID-19. Proaquatix supplied juvenile Florida pompano by air shipment with United Parcel Service for the 2020 target animal safety study. Our Year Two study report is still in preparation for submission to the FDA Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation. The research plan during theno costextension is to complete the histological evaluations, data analysis, final study report writing, and presenting our results to our stakeholders. Manuscript preparation has started, but is waiting for all the second year data to be tabulated and analyzed.

Publications

• Type: Other Status: Published Year Published: 2020 Citation: USFWS Aquatic Animal Drug Approval Partnership DRUG RESEARCH INFORMATION BULLETIN (DRIB No. 58 July 2020) Safety of AQUI-S�20E (10% Eugenol) as a Sedative for Striped Bass Rod Getchell, Danni Scott, Julie Schroeter, Niccole Wandelear, Shane Ramee, & Marilyn Blair.

Progress 07/01/19 to 06/30/20

Outputs
Target Audience: Aquaculture producers (i.e. fish farmers) have vested interest in this project, and pharmaceutical companies, particularly those that are aquatic animal drug manufacturers, may be considered significant stakeholders as well. Other groups with interest in aquatic animal drug use include veterinarians and regulators. The active participation of aquatic animal producers, fishery agency personnel, and pharmaceutical companies is essential for the success of each project. Skip Bason, the Delmarva Aquatics owner that supplied juvenile striped bass, was integral in the success of the first year of the current study. For the summer of 2020, Great Falls Aquaculture's General Manager, Spencer Gowan, has already been hugely helpful arranging the delivery of barramundi for year two. Our Year One study report also has been readied for submission to the FDA Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation. The effort in getting AQUI-S®20E approved was also on the agenda of the Aquaculture America 2020 Convention in Honolulu where Dr. Getchell presented 2019 research results. The project was mentioned during the Aquatic Drug Approval Coalition (ADAC) quarterly meeting conducted there as well. The ADAC is good example of a partnership supporting aquaculture development and derives its strength from the breadth of membership that includes the lead federal agency (FDA-CVM) that reviews and approves drugs and chemicals to address aquatic animal health issues. The other partners are the National Aquaculture Association, the Association of Fish and Wildlife Agencies, American Fisheries Society, tribal members, federal agencies, aquatic animal drug manufacturers, and consultants working to promote aquatic animal drug and chemical research. Our AQUI-S®20E project was discussed at the March 4, 2020 annual meeting of the Multistate Research Project, NECC1702 "Establishment of a Formal Structure for the Minor Use Animal Drug Program" to keep colleagues with similar interests in minor species drug development appraised of our work. Sitting down with our stakeholders at least twice a year for their input on priority setting and reviewing our performance with them is a must. For our current NIFA-funded project, the Dr. Getchell wrote a column about the AQUI-S®20E sedative project that was published in Fish Farming News (an aquaculture trade newspaper), which was included in every Aquaculture America 2020 (AA2020) attendee's registration package. Reporting data collections and analyses to the broader public regularly, broadly, and succinctly is very important Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The AQUAVET® Summer Fellow, DVM student Danielle Scott received significant training in conducting a target animal safety study utilizing Good Laboratory Practices. She conducted the initial data analysis and was the non-blinded participant in our study. She is excited to help author the upcoming journal publication about the first year study. How have the results been disseminated to communities of interest?The PI wrote a column about the AQUI-S®20E sedative project that was published in Fish Farming News (an aquaculture trade newspaper), which was included in every Aquaculture America 2020 (AA2020) attendee's registration package. Dr. Getchell presented 2019 research results at the Aquaculture America 2020 Convention in Honolulu during the Aquaculture Drug Approval session. What do you plan to do during the next reporting period to accomplish the goals?We will write and submit a journal article summarizing our research. We will present our results at stakeholders meetings that were postponed or cancelled during the COVID-19 pandemic.

Impacts
What was accomplished under these goals? Under the first goal, our work on this new sedative is allowing us to assess the safety of AQUI-S®20E for use in the aquaculture industry; For the second goal, eventual approval of this sedative will improve animal welfare by reducing stress and protecting fish from injury during handling by aquaculture producers; and finally, improvement of animal health is a key to a sustainable industry.

Publications

• Type: Conference Papers and Presentations Status: Accepted Year Published: 2020 Citation: Rodman G. Getchell, Danielle M. Scott, Brian M. Chambers, Niccole Wandelear, Paul R. Bowser, Philippe Baneux, Drew Kirby, H�l�ne Marquis, and Marilyn Blair Aquaculture Drug Updates Session: THE SAFETY OF AQUI-S�20E (10% EUGENOL) AS A SEDATIVE ON A MARINE FINFISH. Aquaculture America 2020 Honolulu, HI February 10, 2020
• Type: Other Status: Published Year Published: 2020 Citation: Getchell, R.G. 2020. Fish Sedative Studies For Safety's Sake. Fish Farming News Vol. 28 No.1 Compass Publications (Industry Trade Newspaper)

Progress 05/01/19 to 04/30/20

Outputs
Target Audience: Aquaculture producers (i.e. fish farmers) have vested interest in this project, and pharmaceutical companies, particularly those that are aquatic animal drug manufacturers, may be considered significant stakeholders as well. Other groups with interest in aquatic animal drug use include veterinarians and regulators. The active participation of aquatic animal producers, fishery agency personnel, and pharmaceutical companies is essential for the success of each project. Skip Bason, the Delmarva Aquatics owner that supplied juvenile striped bass, was integral in the success of the first year of the current study. For the summer of 2020, Great Falls Aquaculture's General Manager, Spencer Gowan, has already been hugely helpful arranging the delivery of barramundi for year two. Our Year One study report also has been readied for submission to the FDA Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation. The effort in getting AQUI-S®20E approved was also on the agenda of the Aquaculture America 2020 Convention in Honolulu where Dr. Getchell presented 2019 research results. The project was mentioned during the Aquatic Drug Approval Coalition (ADAC) quarterly meeting conducted there as well. The ADAC is good example of a partnership supporting aquaculture development and derives its strength from the breadth of membership that includes the lead federal agency (FDA-CVM) that reviews and approves drugs and chemicals to address aquatic animal health issues. The other partners are the National Aquaculture Association, the Association of Fish and Wildlife Agencies, American Fisheries Society, tribal members, federal agencies, aquatic animal drug manufacturers, and consultants working to promote aquatic animal drug and chemical research. Our AQUI-S®20E project was discussed at the March 4, 2020 annual meeting of the Multistate Research Project, NECC1702 "Establishment of a Formal Structure for the Minor Use Animal Drug Program" to keep colleagues with similar interests in minor species drug development appraised of our work. Sitting down with our stakeholders at least twice a year for their input on priority setting and reviewing our performance with them is a must. For our current NIFA-funded project, the Dr. Getchell wrote a column about the AQUI-S®20E sedative project that was published in Fish Farming News (an aquaculture trade newspaper), which was included in every Aquaculture America 2020 (AA2020) attendee's registration package. Reporting data collections and analyses to the broader public regularly, broadly, and succinctly is very important Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The AQUAVET® Summer Fellow, DVM student Danielle Scott received significant training in conducting a target animal safety study utilizing Good Laboratory Practices. She conducted the initial data analysis and was the non-blinded participant in our study. She is excited to help author the upcoming journal publication about the first year study. How have the results been disseminated to communities of interest?The PI wrote a column about the AQUI-S®20E sedative project that was published in Fish Farming News (an aquaculture trade newspaper), which was included in every Aquaculture America 2020 (AA2020) attendee's registration package. Dr. Getchell presented 2019 research results at the Aquaculture America 2020 Convention in Honolulu during the Aquaculture Drug Approval session. What do you plan to do during the next reporting period to accomplish the goals?We will write and submit a journal article summarizing our research. We will present our results at stakeholders meetings that were postponed or cancelled during the COVID-19 pandemic.

Impacts
What was accomplished under these goals? Under the first goal, our work on this new sedative is allowing us to assess the safety of AQUI-S®20E for use in the aquaculture industry; For the second goal, eventual approval of this sedative will improve animal welfare by reducing stress and protecting fish from injury during handling by aquaculture producers; and finally, improvement of animal health is a key to a sustainable industry.

Publications

• Type: Conference Papers and Presentations Status: Accepted Year Published: 2020 Citation: Rodman G. Getchell, Danielle M. Scott, Brian M. Chambers, Niccole Wandelear, Paul R. Bowser, Philippe Baneux, Drew Kirby, H�l�ne Marquis, and Marilyn Blair Aquaculture Drug Updates Session: THE SAFETY OF AQUI-S�20E (10% EUGENOL) AS A SEDATIVE ON A MARINE FINFISH. Aquaculture America 2020 Honolulu, HI February 10, 2020
• Type: Other Status: Published Year Published: 2020 Citation: Getchell, R.G. 2020. Fish Sedative Studies For Safety's Sake. Fish Farming News Vol. 28 No.1 Compass Publications (Industry Trade Newspaper)