GENERAL NEWS
last updated:
28 August 2008
Inhibitor Developed for Loma Gill Disease: The North American arm of animal health care company Stirling Products has developed an inhibitor for a parasite that affects farmed trout and salmon - Loma Gill Disease. For more information refer toTheFishSite article by clicking here.
Archived Proceedings from the Annual Eastern Fish Health Workshops now available on-line: The USGS's Leetown Science Center recently made available Eastern Fish Health Workshop Proceedings from the last 12 years. Click here to access these Proceedings.
Alternative iodine and hydrogen peroxide treatment regimes tested for egg disinfection: Utah's Division of Wildlife Resources Fisheries Experiment Station reports on experimental trials conducted on rainbow trout eggs. For details, refer to the latest edition of The Icthyogram by clicking here.
The 14th Annual Aquaculture Drug Approval Coordination Workshop is now history : This year's workshop has come and gone. By all accounts it was quite successful. To read the details, including viewing all presentations and Workshop photos, click here.
Hot off the presses...new oxytetracycline (Terramycin® 200 for Fish) supplemental approval for Phibro Animal Health: Phibro Animal Health today (9 July 2008) received official confirmation from FDA’s Center for Veterinary Medicine that Phibro’s Supplemental New Animal Drug Application for oxytetracycline medicated feed product has been approved for the additional claims of: 1) coldwater disease in all freshwater reared salmonids, 2) columnaris in all freshwater reared Oncorhynchus mykiss, 3) treatment of salmonids for approved diseases at all temperatures (i.e., removal of prohibition of treatments below 9°C). Congratulations to Phibro, CVM and all others involved in bringing this to fruition. For more information on activities regarding this supplemental approval see the most recent AADAP Newsletter and the latest CVM update.
American Fisheries Society (AFS) and AADAP publish an aquaculture drug-use poster: The AFS’s Fish Culture (FCS) and Fish Health Sections (FHS) have partnered with the AADAP program to produce a Quick Reference Guide poster titled “Approved Drugs for Use in Aquaculture.” The poster is intended to serve as a useful outreach product that will hopefully minimize some of the confusion that typically arises regarding what approved drugs are available to fisheries biologists, as well as how and when they may be used. The poster has been made available to all FCS and FHS members. The poster is constructed of a laminated heavy weight paper, measures approximately 2 ft X 3 ft, and is designed for use in, or in close proximity to, fish rearing environments .
The poster is also being made available to non-FCS/FHS folks on a first-come/first-served basis. Anyone who is interested in receiving a copy of the poster should contact Jim Bowker at
406-994-9910 or jim_bowker@fws.gov. Supply is limited so don’t delay!
Aquaculture drug-use poster also available on-line: If you would like to have a look at the poster, and maybe even print it up for yourself, we have placed it on our website. Click here to download a copy.
AQUI-S® use on food fish under INAD 10-541 strictly prohibited: Use of AQUI-S® for food fish is now strictly prohibited under U.S. Fish & Wildlife Service’s INAD 10-541. Isoeugenol (the active ingredient in AQUI-S®) has recently been evaluated by the National Toxicology Program (NTP), an interagency program whose mission is to evaluate chemical agents for potential public health risks. The NTP has concluded that the exposure of male mice to isoeugenol resulted in clear evidence of cancer. As a result of these findings, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has officially rescinded authorization for the “investigational food use” of AQUI-S® under INAD 10-541. Use of AQUI-S® on nonfood fish under INAD 10-541 will not be prohibited, but will be granted only on a case by case basis. Please contact Dave Erdahl (phone: 406-994-9904; email dave_erdahl@fws.gov) with questions or comments.
15th Annual Aquaculture Drug Approval Coordination Workshop planned for Little Rock, Arkansas: The planning and preparations for the 15th Annual Workshop are ongoing and progressing well. The Workshop will be co-hosted by USDA’s Stuttgart National Aquaculture Research Center (SNARC) and USFWS’s Aquatic Animal Drug Approval Partnership (AADAP) Program. The folks at SNARC have set the dates for the Workshop; Tuesday 9 June through Thursday 11 June 2009. Tentatively, both Monday 8 June and Friday 12 June are dates being set aside for associated meetings and extracurricular activities. As more details become available, they will be posted on AADAP’s website on the 2009 Workshop webpage.
New zero-withdrawal anesthetic candidate being sought: Given the recent news regarding the determination by the National Toxicology Program that clear evidence of cancer induction has been demonstrated for isoeugenol (the active ingredient in AQUI-S® ), the aquaculture community is now searching for a new candidate zero- withdrawal anesthetic. These search efforts are being lead by members of the Association of Fish and Wildlife Agencies’ Drug Approval Working Group (DAWG). A new candidate drug has not yet been identified, but several drugs are being considered, including eugenol, metomidate, benzocaine and tricaine methanesulfonate. As new information becomes available, it will be posted on AADAP’s website. For a historical perspective of the DAWG and its members’ activities on AQUI-S® and other zero-withdrawal anesthetics refer to the Feature Article in the latest edition of the AADAP Newsletter.
Florida’s Richloam Hatchery receives recognition for outstanding performance: The Association of Fish & Wildlife Agencies (AFWA) recently sent a letter to the Executive Director of the Florida Fish and Wildlife Conservation Commission commending his staff for “steppin’ up to the plate” by conducting several pivotal efficacy studies on cool and warmwater fish. In particular, Mr. Michael Matthews and his colleagues at the Richloam Fish Hatchery (Florida Bass Conservation Center) were recognized for their exemplary contributions. A copy of the letter sent to the State of Florida, along with other AFWA documents and products, can be viewed on AFWA’s page of AADAP’s website.
Speaking of Richloam Fish Hatchery: Thanks once again to Michael Matthews, Josh Sakmar and Justin Elkins of the Florida Bass Conservation Commission's Richloam FH for all their hard work in conducting pivotal efficacy studies. This past spring Richloam FH completed not one, but two additional pivotal efficacy studies! The first study evaluated chloramine-T treatment (20 mg/L on 3 alternate days) to control mortality caused by external columnaris in bluegill. The second study evaluated Aquaflor® treatment (fed at a rate of 10/kg fish weight for
10 consecutive days) to control mortality caused by systemic columnaris in largemouth bass. Although CVM will of course have the final say on treatment effectiveness following submission of final study reports, preliminary results appear promising as in both studies cumulative percent mortality in control test tanks was higher than in treated test tanks. Thanks for your continuing hard work guys!
More good news from Florida: Thanks to Roy Yanong and his staff at the University of Florida’s Tropical Aquaculture Laboratory for helping out with fish health sampling during the recent Aquaflor® pivotal efficacy study conducted at Richloam FH. We know it's a long drive from Ruskin, Florida to Webster, Florida - but not nearly as long as the trip from Bozeman, Montana to Webster! Thanks for stepping up to help us out!
Welcome aboard! Kelly Winningham of the Arkansas Game and Fish Commission's Andrew Hulsey Fish Hatchery, and Martha Wolgamood and Matt Hughes of the Michigan Department of Natural Resource's Wolf Lake State Fish Hatchery have recently (and willingly!) entered into the pivotal efficacy study do-loop. Kelly is planning to start a 35% PEROX-AID® study on largemouth bass infected with external columnaris in the next couple of weeks, while the folks at Wolf Lake SFH plan to start a 35% PEROX-AID® study on muskellunge infected with external columnaris early this summer. Good luck to all, and thanks much for stepping up to the plate!
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-based species classification system to CVM. The proposed system was developed utilizing information collected on approximately 100 fish species reported in the 2005 Public Aquaculture Production Database (available on AADAP’s website; click here to access); the most common rearing water temperature range for each species was used as the basis for establishing categories. The proposed system groups U.S. publicly cultured finfish into one of four rearing temperature categories: (1) fish, those species reared at water temperatures <12°C; (2) fish, species reared at temperatures between 12-18°C;
(3) fish, species reared at temperatures > 18°C; or (4)coolwater/warmwater “crossover fish” that are reared at temperatures > 12°C (i.e., fish commonly reared in either cool or warmwater). This classification system is intended to provide guidance (to both CVMers and aquaculturists) 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 also when developing data requirements for future drug approvals. Click here to view the complete proposed temperature classification system, including a more detailed description of categories and respective justifications. Stay tuned to learn what CVM’s opinion will be!
DRUG UPDATES
last updated:
11 July 2008
Aqui-S® update:
Aqui-S® as a zero-withdrawal anesthetic: What happened on the way to a New Animal Drug Application: see the Feature Article in the latest edition of the AADAP Newsletter.
Copper sulfate (Triangle Brand Copper Sulfate®) update:
Refer to USDA’s Corner in the latest edition of the AADAP Newsletter.
Halamid® (chloramine-T) update:
Largemouth bass/external columnaris efficacy study accepted as pivotal: Great news! AADAP received word from CVM on 14 April 2008 that one of the chloramine-T studies conducted at Richloam Fish Hatchery (Florida) had been accepted as pivotal. The study was conducted to evaluate the effectiveness of 20 mg/L chloramine-T administered in a daily static bath for 60 min on three consecutive days to control mortality in largemouth bass caused by external columnaris associated with Flavobacterium columnare. In this study, mean cumulative mortality at the end of the 14 day posttreatment period was significantly (p=.010) lower in treated tanks (27%) than in control tanks (35%). Mucho thanks to the Richloam gang for their efforts, and to Mark Gaikowski (USGS/UMESC) for his assistance with data analysis.
Unfortunately, CVM review of a second field study conducted at Richloam Fish Hatchery to substantiate the effectiveness (as demonstrated in the study noted above) of chloramine-T to control mortality in largemouth bass caused by external columnaris was not as positive. AADAP received a letter from CVM on 23 May 2008 informing us that the study was not accepted. However, following a conference call with CVM’s Aquaculture and Biometrics Teams to discuss CVM concerns with respect to the final study report (FSR), it appears that resubmission of a revised FSR may result in study acceptance. Of primary concern was a request by CVM that we reanalyze cumulative mortality data and adjust the number of fish at risk midway through the study in one of the test tanks.
For more information on chloramine- T see Roz’s Corner in the latest issue of the AADAP Newsletter.
Oxytetracycline (OTC) update:
Administrative NADA submitted: On 2 June 2008 Phibro Animal Health submitted an administrative NADA to CVM for the supplemental claims: 1) columnaris disease in freshwater-reared Oncorhynchus mykiss and (2) coldwater disease in all freshwater-reared salmonids. Additionally, the current claim of treatment only above 9°C will be removed, effectively allowing for treatment at any temperature. See the latest "CVM Update" for detailed information on the actual approval. Text provided by Paul Duquette; Phibro Animal Health, Ridgefield Park, New Jersey, USA.
Potassium permanganate update:
Refer to USDA’s Corner in the latest edition of the AADAP Newsletter.
17α-methyltestosterone (17MT) updates:
Effectiveness Final Study Report Resubmitted: In support of a new animal drug application (NADA) for use of 17α-methyltestosterone to produce predominantly male populations of tilapia, AADAP resubmitted to CVM a data package comprising: 1) revised “Final Study Reports” for three field effectiveness studies conducted in 2006 and 2007; (2) a revised “Multi-Site Data Analysis Report”, and (3) a “Report to Justify Reclassifying
17 α-Methyltestosterone Efficacy Treatment Successes”. This data package weighed a meager 60 lbs (!!!) and was resubmitted to CVM on 13 June 2008. The impetus for the resubmission was comments made by the Aquaculture Team in a letter to us dated 1 May 2008. We worked closely with Dr. Susan Story (CVM Aquaculture Team) and Dr. Todd Blessinger (CVM Biometrics Team) to address the comments, and we thank them for their patience and help. Once we figured out what we needed to do, virtually the entire AADAP staff worked on the revisions and prepared the data package for submission. Now we’re back in the wait-and-see mode, and waiting patiently to find out if the effectiveness technical section will be considered complete for this claim. Stay tuned.
For more information on 17MT see Roz’s Corner in the latest AADAP Newsletter.
35% PEROX-AID® (hydrogen peroxide) update:
Research study protocol accepted first time around: First time ever! On 21 April 2008, AADAP submitted to CVM a research study protocol entitled: “The efficacy of 35% PEROX-AID® (35% hydrogen peroxide) to control mortality due to saprolegniasis in freshwater-reared finfish.” On 6 June 2008, AADAP received a protocol concurrence letter from CVM; no revision required!
Fins & Tails, Bits & Bobbers
Automation of INAD reporting being planned: AADAP has begun the process of moving our INAD reporting procedures into the Web-age. Currently, each of the 200+ co-investigators working under INADs held by the U.S. Fish & Wildlife Service (FWS) are responsible for submitting (in hard-copy paper form) 4-6 forms for each treatment event for each INAD in which they are enrolled. AADAP in turn, as required by FDA’s Center for Veterinary Medicine (CVM), must compile the information contained on these forms, and then summarize and report this information to CVM.
To facilitate these activities, all the collected information is currently hand-entered into an AADAP designed database. Inherently, the transcription of information from paper forms to a computer database is extremely labor-intensive. This process also has the inherent potential for transcription errors.
AADAP is currently in the early stages of developing a web-based system for INAD reporting. As envisioned, when the new system is up and running, co investigators under FWS INADs will no longer need to fill out paper forms, but will complete the required “paper-work” totally on-line. As planned, the system will additionally remind (via email) co investigators of their obligations (i.e., reporting requirements) and will contain built in features to eliminate co investigator entry errors.
Given the regulatory hurdles to accomplish this change over, not to mention the development and testing per se of the user interface and web database, implementation of the new INAD reporting system will probably not occur until 2009. So those FWS INAD co investigators with a web-phobia have probably a year or so to prepare. Stay tuned; we’ll keep you informed as we progress, and may even call on a few of you to “test drive” a prototype version.
National INAD Program (NIP) update: The NIP continues to be an extremely successful program for the USFWS and partner facilities/agencies. To date in FY 08 there are over 200 federal, state, private, and tribal facilities participating in 43 different states and one U.S. territory. Currently 13 different INADs are available for use, with several additional INADs “in the works.”
Calendar Year 2007 NIP study submission statistics: NIP participants - please do not feel like the “Lone Ranger” out there when you are filling out your required INAD paperwork. Last year was another busy year for conducting INAD studies, and with your help, we were able to collect a wealth of very useful real-world data. Here are some of the summary statistics from 2007 studies:
- Number of completed study reports submitted to the AADAP Office – 700
- Number of reporting facilities - 136
- Number of INADs used - 12
- Number of treated fish – 72.7 million fish
- Species of fish treated – 18 salmonid species; 29 non-salmonid species; 7 marine species; 1species; and 2 shellfish species
- Number of Quarterly Reports submitted to
FDA/CVM – 52 - Number of Annual Reports submitted to
FDA/CVM – 12
Thank you to everyone for your hard work in contributing data to the AADAP Office, and please be aware that this data is being used to support new and/or expanded drug labels.
Oxytetracycline (OTC) medicated feed INAD #9332 OTC formulation update: OTC INAD participants should please note that the OTC formulation for INAD#9332 has changed from Terramycin® 100 for Fish (TM 100) to Terramycin® 200 for Fish (TM 200). It is also important to note that TM 100 contains 100 g of oxytetracycline per pound of Type A Medicated Article, and TM 200 contains 200 g of oxytetracycline per pound of Type A Medicated Article. While INAD investigators are encouraged to use TM 200 for all future studies, stocks of TM 100 are still available in some locations (e.g., feed manufacturers) and may continue to be used until they are no longer available. Hence, the “take home message” is to please be sure to be aware of which Terramycin® product is being used in your studies, and to determine your dose calculations accordingly.
Additional information for OTC medicated feed INAD #9332 co-investigators: Given today’s (9July 2008) news regarding the new OTC supplemental approval, INAD #9332 co-investigators will need to be aware that very shortly AADAP will be notifying all INAD #9332 participants of changes in the “conditions for use” under the INAD. In essence, those uses now newly approved will no longer be permitted under INAD #9332 authorization. Watch your mail or email for detailed information from AADAP.