What's Shakin'.......
GENERAL NEWS
last updated:
5 May 2008
Announcements for meetings associated with 2008 Aquaculture Drug Approval Coordination Workshop now online. Click here to view.
AQUI-S® use on food fish strictly prohibited: AADAP's authorization for use of AQUI-S® on food fish has been rescinded by CVM. Hence, all use on food fish under INAD 10-541 is strictly prohibited. Click here for details.
Newest Edition (March 2008) of AADAP Newsletter published now available: click here to view.
NTP review of isoeugenol completed: On 28 February 2008 the U.S. National Toxicology Program (NTP) publicly reviewed (and discussed) the results of the subchronic and chronic studies conducted by NTP on isoeugenol (active ingredient of AQUI‑S®). Click here to view the summary report of the NTP study. Scroll down to the AQUI‑S® update of this 'What's Shakin' section for other information on the NTP review of isoeugenol and AQUI‑S®.
14th Annual Aquaculture Drug Approval Coordination Workshop reminder: The 14th Annual Workshop will take place in Bozeman, Montana on the Tuesday, Wednesday and Thursday (29-31 July 2008) immediately before Bozeman’s Sweet Pea Festival (1‑3 August 2008). Be sure, as the time gets closer, to check AADAP’s website for details.
15th Annual Aquaculture Drug Approval Coordination Workshop planned for Arkansas: Although the exact dates and venue have not been finalized, planning for the 15th Annual Workshop is already underway. The Workshop will be co-hosted by USDA’s Stuttgart National Aquaculture Research Center and USFWS’s Aquatic Animal Drug Approval Partnership (AADAP) Program, and will be held in Arkansas in June 2009. As details become available, they will be posted on AADAP’s website.
AADAP’s new publication series: The USFWS’s Aquatic Animal Drug Approval Partnership (AADAP) Program recently unveiled two new publication series. Drug Research Information Bulletins (DRIBs) are short bulletins (two pages maximum) describing techniques or observations developed/made at AADAP’s facilities and/or by AADAP staff at partner facilities. DRIBs are intended to provide short study summations of drug approval‑related research that fish culturists, INAD investigators, and other aquaculture folks will find useful. Unlike the DRIBs, the Drug Research Reports (DRRs) are longer publications (up to 12 pages or more). The DRRs provide a much more detailed report on studies conducted by AADAP and our partners, which typically will pertain directly to the generation of FDA‑required effectiveness or target animal safety data. Access the publications series by clicking here .
U.S. Fish & Wildlife Service has a new Assistant Director for Fisheries and Habitat Conservation (ADFHC): Gary Frazer, the U.S. Fish and Wildlife Service’s recently-appointed Assistant Director for Fisheries and Habitat Conservation (FHC), brings a deep appreciation for science and natural resource stewardship to his position. Prior to assuming the reigns of FHC, Gary was the Fish and Wildlife Service’s Liaison to the U.S. Geological Survey (USGS). In that position, he led the Service’s $7.4 million per year effort to build a nationwide early detection program for the highly pathogenic avian influenza virus. In that program and in his broader role as science liaison, Gary worked tirelessly to expand science partnerships between the Fish and Wildlife Service, USGS and state fish and wildlife agencies, and to ensure the role of science in making informed decisions. Before becoming the science liaison to USGS in 2005, Gary was the Service’s Assistant Director for Endangered Species, where for more than five years he spearheaded the Service’s efforts to conserve biological diversity and recover threatened and endangered species. Underlying Gary’s success in each of these positions is a tremendous respect for science, an unsurpassed commitment to natural resource conservation, and a deep love of family and country. Text provided by William Knapp, USFWS. From all of us here at AADAP, welcome aboard Gary, and we hope to see you here in Bozeman soon!!
FDA’s Center for Veterinary Medicine Management changes: The Center for Veterinary Medicine (CVM) recently announced changes to several middle and upper‑level management positions. On 7 January 2008, Dr. Steve Sundlof (the Director of CVM since 1994) took over the leadership of FDA’s Center for Food Safety and Applied Nutrition. Dr. Bernadette Dunham was named as Dr. Sundlof’s replacement. Dr. Dunham has been with CVM for the past five years, and immediately prior to succeeding Dr. Sundlof, she held the position of Deputy Center Director. Within CVM’s Division of Therapeutic Drugs for Food Animals (which includes aquatic species), there have also been some changes in management. On 3 February 2008, Dr. Joan Gotthardt (former Division Director) transferred to CVM’s Office of Minor Uses and Minor Species. Dr. Gotthardt’s successor has not yet been named. We would like to take this opportunity to congratulate Drs. Sundlof, Dunham and Gotthardt on their career moves and to wish them the very best in this new chapter of their career and lives. We would also like to personally thank them for the significant parts they have played in helping all of us move closer to our goals of obtaining new aquaculture drugs. For more information click here. Best of luck to you all !!!
CVM publishes updated Program Policy and Procedures Manual sections on aquaculture: CVM’s Program Policy and Procedures Manual provides a quick reference to the rules, regulations, and instructions pertinent to all program areas of CVM's responsibilities, including the review of new animal drug applications, and post-market surveillance and compliance activities. The sections were updated on 192008 and include Section 1240.4210 (Extra-label Use of Approved Drugs in Aquaculture), Section 1240.4220 (Drug-Pesticide Issues) and Section 1240.4230 (Regulation of Fish Identification Products). These and all other sections can be accessed by clicking here, or the individual section links above.
Designation of cold, cool, and warmwater fish species proposed to CVM: On 24 October 2007, AADAP, in coordination with the National Aquaculture Drug Research Forum, submitted a proposed temperature classification system to CVM. The proposed system groups U.S. publicly cultured finfish into one of four rearing temperature categories: 1) fish, those species reared at water temperatures less that 12°C; 2) coolwater fish, species reared at temperatures between 12‑18°C; 3) fish, species reared at temperatures greater than 18°C; or 4) coolwater/warmwater “cross-over fish” that are reared at temperatures greater than 12°C. Information collected on approximately 100 species reported in the 2005 Public Aquaculture Production Database (available on AADAP’s website; click here to access) was used to determine the most common rearing water temperature range for each category. This classification system is meant to provide guidance when determining if the use of an approved drug on a specific fish species is in accordance with on-label or off‑label use (e.g., 35% PEROX-AID® approved for use in all freshwater, coolwater finfish), and developing data requirements for future drug approvals. Click here to view the complete proposed temperature classification system. Stay tuned to learn what CVM’s opinion will be!
Live-Attenuated Vaccine for Streptococcus iniae in advanced development stages: Researchers at the University of California San Diego and Aqua Bounty Technologies, in collaboration with Kent Sea Tech Corporation have been testing, with encouraging results, a live-attenuated injectable vaccine for S. iniae. The hope is that the vaccine will work equally well when delivered in feed. Click here for detailed information on the vaccine.
National Aquaculture Drug Research Forum update from February 2008 meeting:
The 6th meeting of the National Aquaculture Drug Research Forum (NADRF) was held in conjunction with Aquaculture America 2008, held in Lake Buena Vista, Florida, USA. The meeting convened at the conclusion the Therapeutic Drug Research Special Session on Sunday, March 10, and was well attended by aquaculture drug researchers, research coordinators, drug and pharmaceutical sponsors, and members of CVM’s Aquaculture, Environmental, and Toxicology Teams. The following agenda items were covered:
- Dr. Steve Yan (Center for Veterinary Medicine; CVM) discussed general data requirements for microbial food safety (Guidance For Industry (GFI #152) and microbiological Acceptable Daily Intake (ADI; GFI #159) assessment in order to expand the use of approved antimicrobial drugs for aquatic species. Dr. Yan stated that although both documents pertain to antimicrobial drugs and related microbiological considerations, the guidance documents each serve a different purpose. GFI #159, which is part of the toxicology assessment, is used to determine whether a microbiological ADI is needed for an antimicrobial drug for its intended use in aquatic or other food animal species. GFI #152, a requirement overseen by the Microbial Food Safety (MFS) Team, provides guidance on preparing a qualitative risk assessment relative to the drug’s potential to induce antimicrobial resistance in human pathogens of concern.
- Mark Gaikowski (U.S. Geological Survey‑Upper Midwest Environmental Sciences Center; UMESC) discussed feed method trial requirements and disseminated a draft feed method position paper he developed that summarizes current CVM thinking and CVM’s guidance document GFI #136 Mark’s document is entitled “Developing Method Transfer Studies for Type C Medicated Feed Assay Methods – A Review,” and it describes: 1) selection of participating laboratories,
2) method demonstration,
3) study feed sample sets, 4) reference concentrations, 5) study methods, and
6) analyzing and reporting results.
- Jim Bowker (U.S. Fish & Wildlife Service‑ Aquatic Animal Drug Approval Partnership; AADAP) discussed establishing a more functional Education and Outreach Team, incorporating an extra-curricular training session to be held in conjunction with the USFWS’s annual Drug Approval Coordination Workshop, and identifying potential training topics. At this time, tentative plans are underway to put together a training session led by representatives from CVM’s Aquaculture and Biometrics Team to discuss conducting studies to evaluate the effectiveness of parasiticides. Other outreach venues suggested included hosting Webinars, recording training sessions and disseminating by CD or DVD at a later date, WebEx Seminars, and recording technical presentations with audio that could be viewed by others at a later date.
- Mark Gaikowski also drafted a “Survey of Parasitic-Related Aquatic Animal Health Issues.” The intent of the survey is to identify priority aquatic health issues caused by external and internal fish parasites. Survey results will help aquaculture drug researchers better prioritize drug approval efforts to treat priority parasite problems. The survey is currently undergoing review by select fish health biologists and aquaculture drug researchers.
- Jim Bowker provided excerpts from a CVM‑accepted protocol that describes in detail methods to count or weigh fish into tanks at the start of a study, and count or weigh fish out of test tanks at the end of a study. The AADAP staff had worked with CVM’s Aquaculture and Biometrics Team to resolve this issue and how it relates to fish discovered missing at the end of a study.
- Mark Gaikowski and Jim Bowker briefly discussed establishing a NADRF product peer‑review process. The extent of such a process will be evaluated and instituted in the near-future.
- The fate of the NADRF was discussed in the context of the fact that the U.S. Joint Subcommittee on Aquaculture’s Working Group on Drugs, Biologics, and Pesticides may soon cease to function as it has in the past (i.e., direct involvement of non-federal epresentatives). There was group consensus that the NADRF is a functional group made up of federal and non‑federal participants that has generated quality products that will help CVM with pre- and post-approval decisions, and that a new home for this Forum will be found in the event that it can no longer be associated with the JSA.
- The next meeting of the NADRF will be held in conjunction with the 14th Annual Aquaculture Drug Approval Coordination Workshop to be held in Bozeman, Montana, USA; 29‑31 July 2008.
DRUG UPDATES
last updated:
7 March 2008
Aquaflor® (florfenicol) updates:
No order too small for Veterinary Feed Directive drugs: Recent approvals for Aquaflor® (florfenicol) for use in catfish and freshwater-reared salmonids have provided much-needed antimicrobial treatments for salmonid and catfish producers. However, the Veterinary Feed Directive (VFD) drug classification for Aquaflor® has created some challenges to feed companies and growers — when only small batches of medicated feed are required.
“Fortunately, the vast majority of prescribed VFDs typically deal in tons of feed shipped and can easily be filled directly by the feed company,” says Steve Sharon, Fish Culture Supervisor, Wyoming Game and Fish Department. “However, the requirement for a feed mill to receive a VFD directly from a veterinarian prior to shipment in a specific prescribed amount can be very problematic if the infected fish lot is small in number, or if the feed poundage prescribed does not fit within 40- to 50-pound increments that a feed company typically ships.”
The Wyoming Game and Fish Department has established its own feed distributorship, which allows the state agency to receive medicated feed directly from the mill and then deliver it to its fish culture facilities as ordered by a veterinarian through a VFD. A company or a wildlife agency can receive fish feed in 40- or 50-pound increments as a feed distributor without the requirement of a VFD order. In turn, the feed distributor can maintain a feed inventory and distribute the exact prescribed amount to a fish-culture facility upon receiving a valid VFD order. According to Sharon, this arrangement has allowed them to fulfill small VFD orders, keep VFD feeds on hand for cyclical fish-health issues and deliver feed quickly to a fish-culture facility after receiving a VFD.
To become a feed distributor, a company or wildlife agency must notify FDA of its intent to become a feed distributorship for VFD feeds and must develop an agreement with a feed company to become a VFD feed distributor as regulated by federal law, Sharon says. It also must establish the feed-distribution point at a location where fish are not reared. The distributor must maintain inventory control, original VFDs and supporting documentation for a minimum of 2 years.
For further information on how to obtain Aquaflor® click here or contact Kasha Cox, US Territory Manager (kasha.cox@spcorp.com) or 662-907-0692.
Text provided by Schering‑Plough Animal Health; Summit, New Jersey, USA.
AQUI-S® updates:
Target Animal Safety studies: In January 2008, CVM reviewed AADAP’s Final Study Report (FSR) on the safety of 40 mg/L AQUI-S® to small fingerling cutthroat trout and found that, “This study demonstrated that there is an adequate margin of safety above 40 mg/L AQUI-S® (i.e., the label dose) for sedation of cutthroat trout to handleable.” Pending acceptance of the validation of the dose verification method, the accepted cutthroat FSR, along with previously accepted rainbow trout FSRs will complete the target animal safety technical section for all freshwater-reared salmonids.
National Toxicology Program Study Review Completed: On behalf of AQUI-S New Zealand, Tom Goodrich attended the National Toxicology Program’s Technical Reports Review Subcommittee meeting held 27-28 February 2008 at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. Among the compounds reviewed was isoeugenol (TR551), which is the active ingredient in the sedative/anesthetic AQUI-S®. The subcommittee was presented with the combined findings of the 90-day (acute) and 2-year (chronic) carcinogenicity studies that had been contracted by NTP/NIEHS between the years 1998-2004. Following the presentation, three designated reviewers provided comments and critiques of the report. In addition, Tom Goodrich and Dr. Mark Toneby (MIT miljölab, Sweden) gave presentations discussing study‑conduct issues and the lack of genotoxicity associated with isoeugenol, respectively. The acceptance of the report conclusions was put to a vote of the committee and was passed “as written” in the draft report. For AQUI-S®, the only significant conclusion was the finding of “clear evidence of carcinogenicity” in the male mouse model.
What does this finding conclusion mean for AQUI-S®? For European registration, nothing; the male mouse only finding is not considered relative to, or predictive of, carcinogenicity in humans, and since their registration process is based on risk assessment, an MRL (maximum residue level) will be assigned to isoeugenol and registration will proceed. Under the U.S. FDA system, this finding may mean the end to the registration process for AQUI-S® for use on food fish, although further discussions with the FDA will ensue to explore any avenue that may remain open. As it relates to the study‑conduct of the NTP studies, there remain unanswered concerns relative to the GLP (good laboratory practice) validity of the 2-year study. While the future may be clouded, AQUI-S NZ remains dedicated to the process and will continue its efforts until resolution is attained.
Text for this section of the AQUI-S® update was provided by Tom Goodrich, U.S. Agent for AQUI‑S NZ, Redmond, Washington, USA.
AADAP’s perspective on the NTP findings: The conducted NTP studies demonstrated clear evidence of carcinogenic activity of isoeugenol in male mice. Although no official comments regarding these results have been offered by U.S. FDA’s Center for Veterinary Medicine (CVM), earlier discussions with CVM suggested that if the NTP studies resulted in clear evidence of carcinogenic activity in any rodent study, this would more than likely be considered evidence of cancer in animals and would probably result in the regulation of isoeugenol as a carcinogen at such time that it were the subject of an Investigational New Animal Drug (INAD) exemption or a New Animal Drug Application.
Regardless of what method one may choose to slice, dice or view the findings of the NTP study as described above, it is clear that these findings have dealt a very serious blow to recent collaborative efforts to pursue FDA‑approval of AQUI-S® for use as a zero-withdrawal anesthetic in aquatic species. Without a doubt, the immediate outlook for continued efforts towards an NADA for AQUI-S® in the U.S. would appear bleak. None-the-less, at this point in time it is still too early to fully comprehend all ramifications of the NTP findings, or to say “...OK, that’s it for AQUI-S®!!” Rest assured that in the next several weeks there will be considerable discussion between members of the Association of Fish and Wildlife Agencies’ Drug Approval Working Group, CVM, and Aqui-S New Zealand to determine 1), if any, options exist for continued work on AQUI-S®; and 2) if AQUI-S® is indeed unapprovable, what potential “replacement compounds” exist towards which we may realistically focus new efforts for a zero-withdrawal anesthetic. In the next issue of the Newsletter, we will fully explore the past, current, and future status of our quest for a zero-withdrawal anesthetic for use in aquatic species.
Calcein (SE‑MARK®) updates:
SE‑MARK® for marking calcified structures of young fish: Aquatic Life Sciences, Inc.’s (ALS) INAD work is continuing with AADAP and collaborators in several hatcheries and agencies building the data for target animal safety and effectiveness. ALS is also working on the Human Food Safety component of the data package.
Text provided by James Brackett, President; ALS, Inc., Ferndale, Washington, USA
Copper sulfate (Triangle Brand Copper Sulfate®) updates:
Status of New Animal Drug Application (NADA) Technical Sections: Refer to USDA’s Corner in the March edition of the AADAP Newsletter.
Halamid® (chloramine-T) updates:
Research Activities: A field study to demonstrate the effectiveness of 20 mg/l chloramine-T for 60 min on three consecutive days to control mortality due to external columnaris in fingerling walleye has been accepted by CVM. The study was conducted at the Iowa Department of Natural Resources Rathbun Fish Culture Research Station (Moravia, Iowa) by Alan Johnson and AADAP staff in June 2006. Acceptance of this study completes the effectiveness technical section for external columnaris in walleye. Review is pending on two chloramine-T pivotal field effectiveness studies conducted at Richloam Fish Hatchery (Florida Bass Conservation Center) for the control of mortality due to external columnaris on largemouth bass. Stay tuned.
Recently published journal articles pertaining to chloramine‑T use in aquaculture: Following are two abstracts of articles recently authored by AADAP staff and published in the North American Journal of Aquaculture.
Bowker JD, DG Carty and MP Bowman. 2008. Inexpensive apparatus to rapidly collect
water samples from a linear-design, plug-flow hatchery raceway. North American
Journal of Aquaculture 70:8-11.
Abstract: In July 2001, we conducted a study to determine whether a target concentration of chloramine-T (a waterborne chemical) could be achieved and maintained for 60 min in linear-design, plug-flow hatchery raceways (devoid of fish) via a charged “flow‑through” treatment methodology. In each of four independent trials, a raceway was charged to achieve the target concentration by turning off the inflow water (creating a static bath) and manually mixing in a premeasured volume of chloramine-T stock solution. Water inflow was then turned on, and the target concentration was maintained by metering additional chloramine-T stock solution into the inflow water with a calibrated chicken‑watering system. To help verify chloramine-T concentrations during treatment, we built an apparatus to rapidly collect many water samples from throughout a raceway. The apparatus comprised three fixed sampling stations, each of which was equipped 9 water collection devices (i.e., 60-mL plastic syringes fitted with fixed-length “suction needles” made of ridged polyvinyl chloride pipe threaded with flexible vinyl tubing) and 9‑11 plastic bottles for storing the collected samples. During each of the four 60-min trials, water samples were collected at elapsed times of 0, 30, and 60; thus, 12 sampling events were conducted during the study. During each sampling event, three people (working simultaneously but independently) collected a total of 29 water samples (27 for chloramine-T dose verification and 2 for quality control). The time for one person to collect 9‑11 water samples (50-60 mL per sample) from one sampling station averaged 1.5 min (SD=.382 min; n=36) and ranged from 0.9 to 2.5 min). The apparatus was inexpensive, easy to build and use, and portable; it ultimately helped us verify the spatial and temporal distribution of chloramine-T in linear design, plug-flow hatchery raceways during 60‑min charged flow‑through treatments.
Bowker JD, DG Carty, L Telles,
B David and D Ovideo. 2008.
Efficacy of chloramine-T to
control mortality in freshwater-reared salmonids diagnosed
with bacterial gill disease.
North American Journal of Aquaculture 70:20-26.
Abstract: Gill disease (BGD), caused by Flavobacterium branchiophilum and other species of yellow-pigmented, filamentous bacteria, is a common and potentially catastrophic disease of hatchery (freshwater)-reared fish. Chloramine-T (Chl-T) is a biocide proven effective for controlling mortality in freshwater-reared fish diagnosed with BGD. However, Chl-T is not approved by the U.S. Food and Drug Administration for such use. To generate data in support of a U.S. approval, we evaluated the effectiveness of Chl-T (administered at 12 mg/L of static bath water for 60min/d on three alternate days) to control mortality caused by BGD in freshwater-reared chum salmon Oncorhynchus keta, Apache trout O. gilae apache, and rainbow trout O. mykiss. For each species, mean percent total mortality in Chl-T-treated tanks (N=3) was significantly less than that in control tanks (N=3): chum salmon=8.9% versus 99.7%, Apache trout=39.2 % versus 97.9%, and rainbow trout=5.7% versus 25.8%. Because the Chl-T regimen administered was efficacious for each species, we conclude that our findings support the approval of Chl-T for use in the USA to control mortality in freshwater-reared salmonids diagnosed with BGD.
Metomidate (Aquacalm®) updates:
Aquacalm® for sedation and anesthesia: INAD work has focused over the last couple of years on ornamental and aquarium fish. However, work on food fish has been carried out in other countries. Further work on food fish is anticipated by Aquatic Life Sciences, Inc. (ALS).
Text provided by James Brackett, President; ALS, Inc., Ferndale, Washington, USA
Oxytetracycline (OTC) updates:
Human Food Safety Technical Section: On 21 December 2007, CVM approved Phibro Animal Health’s 2 July 2007 request for a Human Food Safety Technical Section complete letter. CVM’s letter contained some errors in the FOI, which were corrected and a new Human Food Safety Technical Section complete letter was issued on 6 February 2008.
Medicated Feed Labels: On 28 December 2007, CVM responded to Phibro Animal Health’s 23 July 2007 request for review of Type A, B and C labels for Terramycin® 200 for Fish. CVM’s response requested minor changes in the submitted labels. Phibro Animal Health made all requested changes and resubmitted the labels to CVM on 30 January 2008.
Environmental Safety Technical Section: On 21 February 2008, USGS’s Upper Midwest Environmental Sciences Center (UMESC) received official notice from CVM that the UMESC‑prepared Environmental Assessment was acceptable and hence, the Environment Safety Technical Section for Terramycin® 200 for Fish was considered complete. See USGS’s Corner in the March edition of the AADAP Newsletter.
2008 Approval On Track: Two new label claims 1) a claim for coldwater disease in all freshwater-reared salmonids, and 2) a claim for systemic columnaris in all Oncorhynchus mykiss; and two label revisions/updates 1) addition of the approved Pacific salmon skeletal marking claim, and 2) removal of the water temperature restriction under the current salmonid claim are expected to be approved in 2008. As of the date of this newsletter, Manufacturing, Human Food Safety, Environmental Safety, Animal Safety and Effectiveness Technical Sections are complete. The Label and All Other Information Technical Sections are currently under CVM review, with acceptance expected within 3 - 6 months. CVM is compiling the Freedom of Information summary and expects to complete this task when outstanding technical section reviews are complete.
Text provided by Paul Duquette; Phibro Animal Health, Ridgefield Park, New Jersey, USA.
Ovaprim® (LHRHa + domperidone) updates:
Ovaprim® INAD work: Work on Ovaprim® (used to assist in spawning) by Aquatic Life Sciences, Inc. (ALS) has focused on ornamental and aquarium fish.
Text provided by James Brackett, President; ALS, Inc., Ferndale, Washington, USA
Ovaplant® (sGnRHa) updates:
Ovaplant® INAD work: Work on Ovaplant® (used for advancing, compressing and synchronizing spawning) by Aquatic Life Sciences, Inc. (ALS) has focused on developing target animal safety and effectiveness study protocols. Supportive studies have been completed under the INAD and in other countries. Ongoing discussions are underway with CVM regarding the potential for classifying broodstock as non-food animals.
Text provided by James Brackett, President; ALS, Inc., Ferndale, Washington, USA
Potassium permanganate updates:
Status of New Animal Drug Application (NADA) Technical Sections: Refer to USDA’s Corner in March edition of the AADAP Newsletter.
17α‑methyltestosterone (17MT) updates:
Research/Approval status update meeting held at Aquaculture America 2008: In early February, key players in generating requisite data, and assembling and submitting the New Animal Drug Application (NADA) for 17MT, met to discuss the current status of activities and to plan future activities. The greater part of the meeting involved 1) formulating a plan to complete the target animal safety technical section, 2) discussing ongoing activities to complete the environmental assessment and 3) activities required to validate the transfer of the analytical method (to a private lab) for detection of 17MT in feed.
The USDA’s Stuttgart National Aquaculture Research Center has agreed to conduct the target animal safety studies, and activities are underway to acquire partial funding for this work.
Preliminary work is ongoing to allow for a new revision of the environmental assessment to incorporate the probable requirement to mitigate 17MT discharge to public surface waters.
The research lab that developed the detection method for feed, a private contract lab and the drug sponsor are currently working toward completing the necessary documentation to demonstrate successful method transfer.
35% PEROX-AID® (hydrogen peroxide) updates:
Research Protocol: After making a few changes and edits to the pivotal efficacy protocol entitled, “The Efficacy of 35% PEROX-AID® to Control Mortality Due to Bacterial Gill Disease or External Columnaris in Cool and Warmwater Finfish”, AADAP received a concurrence letter from CVM in February 2008. So, we’re ready to roll with 35%-PEROX-AID® pivotal efficacy studies just in time for the upcoming disease season!