AFS Fish Culture Section

Summer 2010

Fish Culture Section of the American Fisheries Society PRESIDENT’S MESSAGE Inside this issue:  Workshops…..3-4  MTS Journal..5-6  Alligator Gar….7  Fish News......8-9  Policy Statement

……....11-12  FCS Meeting ..12  FDA Boilerplates

…...….14-23

BY

JESSE TRUSHENSKI

Howdy, fish culturists!    As  I  sit  down  to  write  this  issue’s  President’s  Message,  I  realize,  with  mixed feelings, the 2010 AFS meeting in  Pittsburgh is just around the corner.  On  the one hand, I’m really looking forward  to  the  trip…bragging  just  a  little  about  our  Section  and  the  good  work  we’ve  done  together  over  the  past  year,  watching  my  students  give  the  presentations  they’ve  been  tweaking  and  practicing,  sitting  in  on  the  FCS‐ sponsored  symposium  on  American  Shad  and  river  herring  restoration  (the  largest  symposium  at  the  meeting— nicely  done,  Programming  Chair  Jim  Bowker!),  and  seeing  good  friends  during  and  after  the  meeting.    On  the  other  hand…well,  I’ve  got  a  lot  of  work  to do between now and then!  And that,  dear  FCSers,  is  why  I’m  asking  for  your  help. 

So calling all students and  teachers, employees and  employers, inlaws and  outlaws—what are we  doing well to educate our  future fish culturists, and  what can we be doing  better? 

  This  year,  the  AFS Governing  Board  has  turned  its  attention  to  fisheries  education,  and  I  have  been  asked  to  give  a  presentation  at  this  year’s  retreat  to  discuss  the  state  of  education  opportunities  for  fish  culturists.  Even over my short career as  an  educator,  I  have  seen  changes  to  academic  programs  in  aquaculture.   While  a  few  programs  are  growing,  more  are  contracting  with  retirements  and budget cuts.  As administrators and  bean  counters  pick  up  their  carving  knives,  pieces  of  aquaculture  training  programs  are  carved  away  and  tossed  into the gaping maw of budget shortfalls  and  efforts  to  create  new  programs  in  emerging fields.  Of those programs that  remain,  there  is  great  variation  in  training  and  what  constitutes  the  ‘core  competencies.’  Obviously,  every  educator and institution is going to have  its  own  focus—catfish  are  going  to  get  more playing time than salmonids down  on  the  Mississippi  Delta  and  vice  versa  out in the Pacific Northwest.  But aren’t  there  basic  husbandry  skills  that  every  culturist  should  have?    Are  far  as  I’m  concerned,  nobody  should  leave  the  Fisheries and Illinois Aquaculture Center  (Continued on page 2)

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President’s Message (continued)

While you’re  on our fancy  new  Facebook  site, do a  little  exploring and  add to the  page—it’s  there as a  forum for our  membership,  so make your  mark. 

without  learning  about  water  chemistry,  feed  management,  disease  diagnostics,  and  the  basics  of  tank  vs.  pond  culture.   Hopefully they pick up a few other tips and  tricks  along  the  way.    But  that’s  just  one  person’s  opinion—the  other  day,  I  was  skimming  the  most  recent  edition  of  a  popular  aquaculture  textbook,  and  found  that  of  the  31  chapters,  none  were  dedicated to water quality.  That this most  basic  and  crucial  tenet  of  fish  culture  had  been  overlooked  in  an  introductory  text  got  me  thinking.    What  were  other  educators leaving out?  What was I leaving  out?  And what do our students—and their  employers—wish  that  they  are  learned  before they left our classrooms?  If we are  concerned with the next generation of fish  culturists  and  making  sure  they  are  ready  to  meet  the  modern  challenge  of  raising  more  with  fewer  resources—I  don’t  know  about you, but I’d like to be able to retire  at some point in the distant future—this is  a  dialogue  that  we  need  to  start.    So  calling  all  students  and  teachers,  employees  and  employers,  inlaws  and  outlaws—what  are  we  doing  well  to  educate  our  future  fish  culturists,  and  what can we be doing better?  Drop me a  line  at  [email protected]  or  better  yet,  join  the discussion on our new Facebook page .  While  you’re  on  our  fancy  new  Facebook site, do a little exploring and add  to the page—it’s there as a forum for our  membership, so make your mark.  Upload  some  photos,  add  some  links,  add  your  comments  to  ongoing  discussions.    And  tell a friend!    I’m happy to report that Jim Bowker, Steve  Cooke,  Dave  Erdahl,  Tom  Bell,  Randy  MacMillan,  Roy  Yanong,  Jeff  Hill,  Mary  Fabrizio,  Chris  Guy,  Jim  Garvey,  Steve  Sharon,  and  I  have  finished  drafting  an  “AFS Policy Statement Regarding the Need 

f o r   a n   I m m e d i a t e ‐ R e l e a s e  Anesthetic/Sedative  for  Use  in  the  Fisheries  Disciplines.”    As  you’ll  recall,  we  began writing this document to outline the  inadequacy of current sedative/anesthetic  options for fisheries and the consequences  of  not  having  access  to  an  approved  compound  for  immediate  release.  Our  goal  in  writing  this  document  was  to  create  a  sound,  science‐based  argument  for  the  approval  of  one  of  the  candidate  immediate‐release  sedatives  (benzocaine  or  eugenol)  in  an  expedient  manner.   Currently,  the  draft  is  being  reviewed  by  the  AFS  Resource  Policy  Committee,  and  will  likely  come  before  the  entire  AFS  membership for review later this Fall.  But  as privileged FCS members, you don’t have  to  wait  that  long—the  draft  Policy  Statement Executive Summary is available  right  now  on  pages  11‐12  of  this  newsletter.      Read  the  document,  and  provide  your  feedback  at—yup,  you  guessed  it—the  discussions  page  on  our  Facebook site!   Log  on  today  and  let  us  know  what you think.    Upon  further  reflection,  I  don’t  have  mixed  feelings  about  the  meeting  in  Pittsburgh—it’s  going  to  be  a  busy  meeting, but I can’t wait to go and fly the  FCS flag high.  Hope to see you at the FCS  Business  Meeting  from  4:30‐6:30  on  Sunday, Sept 12th (Westin)!  Best,  Jesse Trushenski 

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2010 WDAFS Student Colloquium The Palouse student subunit of the American Fisheries Society at the University of Idaho is proud to host the 3rd Annual Western Division of the American Fisheries Society Student Colloquium from Thursday, October 14th to Saturday, October 16th. Moscow, ID will be the site of research presentations, an insightful field trip, and networking in an all-student environment. Thursday, October 14th: Welcome Social featuring food and drinks at the 1912 Center in Moscow, ID, from 6-9 pm. Professionals will be invited to enhance your networking opportunities. Friday, October 15th: A full day jet boat tour of Hell’s Canyon. Transportation, breakfast and lunch will be covered. Saturday, October 16th: Student only oral presentations at the University of Idaho followed by a tour of the campus aquaculture facilities. A business lunch will be provided. Closing social will be held from 6-9 p.m. at EcoAnalysts, Inc. and will include food and beverages. Sunday, October 17th (Optional): Opportunity to fly fish for Steelhead. You will need to bring your own gear and purchase an Idaho fishing license. Our experts can take you to some of the best fishing spots in the area. For more details, contact Tim Caldwell ([email protected]) Registration: To register, please email Jeff Reader ([email protected]) the following information: Name, phone number, AFS/School affiliation, when you will be arriving and departing, and whether you are presenting. Cost: $35/student before Friday, September 24h, and $45/person after September 25th. Presentations: If you are presenting (everyone is encouraged to present!), please submit a 200 word abstract by Friday, October 2nd to Amy Long ([email protected]). Abstract formatting guidelines are posted on our website. We look forward to seeing everyone in Moscow! --University of Idaho Palouse student subunit of AFS Questions? Contact Kelly Stockton at [email protected] or at 970-217-2245 Visit PUAFS online at http://www.cnr.uidaho.edu/afs/

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MTS Journal MTS Store Marine Technology Society

MTS Journal Looks at Marine Aquaculture Technology and Issues in the U.S. "With earth’s burgeoning human population to feed we must turn to the sea with understanding and new technology. We need to farm it as we farm the land." --Jacques Cousteau

What is the state of technology for open ocean fish farming? How are U.S. policies and programs helping or hindering the inevitable movement toward sustainable aquaculture in the open ocean? These and a host of other questions are addressed in the May/June issue of the Marine Technology Society Journal, Vol. 44, No. 3. Edited by John S. Corbin, President of Aquaculture Planning and Advocacy LLC and former Manager of the Hawaii Aquaculture Development Program, this timely issue gives historical perspective, describes the current state of affairs, and unveils the technologies of the future. Here are brief overviews of the peer-reviewed papers: 











Sustainable U.S. Marine Aquaculture Expansion, A Nece ssity - In his overview, John Corbin sets the stage for this special issue by providing detailed background information on U.S. seafood consumption, supply, and projected needs. He looks at the potential for future disruption of seafood imports and reviews the status and potential for the development of the expansive and diverse U.S. Exclusive Economic Zone. Site Selection Criteria for Open Ocean Aquaculture - Daniel Benetti, of the University of Miami, and his coauthors focus on site selection criteria for open ocean aquaculture, not only practical considerations like ocean conditions, materials and manpower, but also socioeconomic and political issues. Among other things, they address lessons that aquaculture operations can learn from the Deepwater Horizon oil spill in the Gulf of Mexico. A Ca se Study of an Offshore SeaStation Sea Farm - Gary Loverich discusses the SeaStation cage his company , Ocean Spar LLC, has been developing since 1994, presenting a review of a large commercial cage system operating off Keahole Point, Kona, Hawaii. His paper describes the features that make the cages unique, as well as the challenges that arise when multiple cages are deployed to grow fish at commercial scale . Technology Needs for Improved Efficiency of Open Ocean Cage Culture - Richard Langan, University of New Hampshire, explores the status of aquaculture support systems capable of autonomous operation in the open ocean. Successful farming will require nec essary tasks, such as feeding, maintenance, and observation of stock and the environment to be carried out routinely, even when harsh conditions may keep vessels and personnel on shore. Shellfish Culture in the Open Ocean: Lessons Learned for Offshore Expansion - Daniel Cheney, of the Pacific Shellfish Institute, joins his fellow authors for a look at the state of the art, as well as future prospects and challenges, in shellfish aquaculture, providing three case examples to illustrate the extent and types of open ocean shellfish farming underway. What Can U.S. Open Ocean Aquaculture Learn from Salmon Farming? - The U.S. imported 83% of its seafood needs in 2008. In this paper, John Forster, of Forster Consulting, Inc., explores the history of farmed salmon, which he has been involved with since the late 1960s. He discusses why other countries have been successful and the lessons for the U.S., noting that for open ocean aquaculture to succeed, containment systems must be easily deployed and operated, and governments must create space in their coastal waters.

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Deep Ocean Water Resource s in the 21st Century - Brandon Yoza, University of Hawaii, and his co-authors from Norway, Japan and Hawaii, discuss some cutting edge, large-scale concepts for using deep ocean water for energy generation and offshore aquaculture. They explain how “artificial upwelling”--bringing deep ocean water to the surface mechanically--could enhanc e the ocean food web and restore depleted marine life at all trophic levels. Sustainable Ecological Aquaculture Systems: The Need for a New Social Contract for Aquaculture Development - Barry Costa-Pierc e, University of Rhode Island, describes ecological aquaculture, an emerging, new paradigm for global aquac ulture planning, policy, and development. He argues that policymakers should consider this approach to foster environmentally, economically, and socially responsible aquacult ure. Marine Stock Enhancement, a Valuable Extension of Expanded U.S. Marine Aquaculture Guest editor John Corbin provides a brief comment ary on the history and current status of U.S. marine stock enhanc ement as a valuable tool for coastal fisheries managem ent. He discusses the need for increased research funding, greater infrastructure planning and development, and inclusion of marine stock enhancement in current national oc ean policy and marine spatial planning efforts. U.S. Open Ocean Fish Farming: Are We There Yet? - Randy Cates, of Cates International, Inc., and Hukilau Foods LLC, provides a commercial, offs hore fish farmer's hard-won insights into the state of the technology as well as the status of emerging federal support policies and programs. From his perspective of 10 years of research and commercial experienc e, Cates discusses research needs for open ocean fish farming and highlights areas for innovation that could help successfully establish commercial farming in the U.S. Exclusive Economic Zone.

To Get Your Copy of Thi s I ssue Purchase Vol. 44, No. 3 of the MTS Journal through the MTS Store. or by calling (410) 884-5330 during business hours on the East Coast.

QUESTIONS? Please e-mail or call Susan Branting or Suzanne Voelker at (410) 884-5330. The Marine Technology Society is a 501(c )(3) not -for-profit professional society comprising oc ean engineers, technologists, policy makers and educators. Incorporated in 1963, it provides the oc ean community with forums for the exchange of information and ideas through its peer-reviewed MTS Journal, conferences, newsletters and website (www.mtsociety.org).

Contributions to the Hall of Fame endowment can be made out to the Fish Culture Section and sent directly to the South Dakota Community Foundation 207 East Capitol - Box 296 Pierre, SD 57501

Each donor, regardless of size, will receive a receipt in letter form that the contribution is tax deductible.

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Alligator Gar Who Do You Think You Are? —Justin Wilkens   The  Mississippi  Department  of  Wildlife,  Fisheries  and  Parks  (MDWFP),  North  Mississippi  Fish  Hatchery  (NMFH),  in  cooperation  with  the  U.S.  Fish  and  Wildlife  Service  (USFWS),  Private  John  Allen  National  Fish  Hatchery,  produce  alligator  gar  in  Mississippi.    Alligator  gar  native  to  the  Mississippi  River  Basin  are  collected  by  the  USFWS  to  be  used  as  broodstock.    The  fish  are  transferred  to  their  hatchery  where they are stocked into tanks supplied with temperature controlled water.  The male and female fish  each receives a hormone injection to induce spawning.  The eggs are collected by manually spawning the  fish or by letting the fish tank spawn.  A female weighing over 100 lb may have several hundred thousand  eggs.  After hatch out a portion of the young gar are transferred to NMFH where they are stocked into a  raceway and trained to accept a formulated diet.  After 90‐120 days the fish have grown to 8‐10 inches.   Before stocking each fish receives a coded micro wire tag supplied by the USFWS.  When or if the fish is  collected  later,  the  tag  can  be  removed  and  read.    By  monitoring  stocked  populations  biologists  can  determine the ability of hatchery fish to survive after released and fill in the missing information about the  alligator gar’s life history.   

  In  Mississippi,  alligator  gar  occurs  in  coastal  drainages  including  the  Pascagoula  and  Pearl  River  drainages.  It also occurs in the Yazoo River drainage of the Mississippi River Basin.  The alligator gar is now  very rare or does not occur in the northern part of their range north of the coastal drainages.  Anecdotal  evidence  suggests  that  populations  are  self  sustaining  in  coastal  drainages  but  have  also  declined  over  time.  The alligator gar is listed by the state of Mississippi and the American Fisheries Society as a species of  “Special  Concern”.    The  Mississippi  Comprehensive  Wildlife  Conservation  Plan  lists  the  alligator  gar  as  a  species  of  greatest  conservation  need.    Like  other  states  throughout  the  gar’s  native  range  MDWFP  recognizes the need to conserve and augment declining populations of alligator gar in historical habitat.  A  management plan is currently being written to help provide direction for future actions.    

  Justin Wilkens is the hatchery manager at North Mississippi Fish Hatchery and can be reached via  email  ([email protected])  for  more  information  regarding  this  story.    The  photo  was  taken  by  Laura Dobbins, office assistant, Pvt. John Allen NFH. 

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 CHICAGO – July 13, 2010. Governor Pat Quinn today  announced  a  new  initiative  to  stop  the  spread  of  invasive  Asian  carp  species  into  the  Great  Lakes.  Illinois  is  entering  into  a  public‐private  partnership  that  will  reduce  Asian  carp  populations  where  they  have been discovered in Illinois waters. This first‐of‐ its‐kind  partnership  will  help  enhance  the  commercial  fishing  industry,  create  approximately  180 jobs and relieve pressure on the U.S. Army Corps  of Engineers Electric Barrier System designed to stop  fish from moving further towards Lake Michigan.   “Protecting  the  Great  Lakes  is  vital  to  millions  of  people  from  Illinois  and  throughout  the  Midwest  who  rely  on  these  waterways  for  their  livelihoods,”  said  Governor  Quinn.  “Today’s  agreement  is  one  of  the most aggressive efforts to address the Asian carp  problem, and is a critical step to long‐term economic  sustainability  and  the  success  of  the  commercial  fishing industry.”   Illinois  is  entering  into  an  agreement  with  Chinese  meat  processing  company  Beijing  Zhuochen  Animal  Husbandry Company and Big River Fisheries located  in  Pearl,  Ill.  to  harvest  30  million  pounds  of  carp  from  Illinois  rivers.  Big  River  will  process,  package  and  ship  the  fish  to  Zhuochen  for  resale  in  international  markets  where  the  fish  is  a  delicacy.  The  company  is  expected  to  harvest  at  least  30  million  pounds  of  fish  for  the  purpose  of  this  agreement by the end of 2011.   The  state,  through  the  Illinois  Department  of 

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Commerce and Economic Opportunity, will invest $2  million  in  capital  funds  to  help  Big  River  retrofit  its  existing facility, increase its processing capacity and  expand  to  new  production  facilities  in  Pittsfield,  which will create 61 new jobs and 120 indirect jobs.  Commercial  fishermen,  contracted  by  the  Illinois  Department  of  Natural  Resources,  have  already  started  removing  Asian  carp  in  the  Illinois  River  where populations exist.   “The  high  quality  and  taste  of  the  wild  Asian  carp  from  Big  River  Fish  far  exceeded  our  expectations.  We  see  a  tremendous  market  in  China  for  the  wild  Asian carp,” said Mr. Liang Chang, Chairman, Beijing  Zhuochen  Animal  Husbandry.  “As  Big  River  Fish's  production  capacity  increases,  we  will  be  able  to  expand our marketing efforts in China.”   “Big  River  Fish  can  now  retrofit  and  expand  its  facilities  to  meet  our  production  commitment  to  Zhuochen,” said Mr. Rick Smith, President, Big River  Fish Corp. “The Asian carp can become an economic  engine for Illinois rather than a threat, and we thank  Governor Quinn for his support of our efforts.”   Today’s announcement builds on the state’s existing  efforts to stop the spread of Asian carp. The Illinois  Department  of  Natural  Resources,  in  conjunction  with  the  Asian  Carp  Regional  Coordinating  Committee  (ACRCC),  has  established  an  Asian  Carp  Control  Strategy  Framework,  which  includes  both  short‐ and long‐term actions intended to keep Asian  (Continued on page 9)

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carp  from  establishing  populations  in  the  Great  Lakes. These measures include:   •  Operations  to  reduce  propagule  pressure  on  barriers   •  Increased  fish  collection  efforts  and  population  suppression   • Evaluation of current suppression tools, as well as  future fish suppression activities   •  Emergency  measures  to  prevent  bypass  of  fish  between  the  Des  Plaines  River  and  the  Chicago  Sanitary  and  Ship  Canal  (CSSC),  as  well  as  between  the  Illinois  &Michigan  Canal  and  the  CSSC  during  flood events   • Increased biological control efforts  

• Construction of a third electric barrier   To  view  the  entire  control  framework,  or  to  learn  more  about  the  efforts  of  the  ACRCC,  visit  www.asiancarp.org.   In  June,  a  Bighead  Asian  carp  was  found  in  Lake  Calumet  along  the  Chicago  Area  Waterway  System  (CAWS).  This  is  the  first  physical  specimen  that  has  been  found  in  the  CAWS  above  the  Electric  Barrier  System.  Since  the  find,  Illinois  along  with  the  U.S.  Fish  and  Wildlife  Service  and  commercial  fishermen  have  intensely  sampled  both  Lake  Calumet  and  the  Calumet  River  leading  to  Lake  Michigan.  No  other  Asian  carp  have  been  found  in  the  Chicago  area  waterway system to date.  

Photo credit: USFWS

GENETICALLY ALTERED SALMON MOVING CLOSER TO MARKET Source: www.thefishsite.com

June 30, 2010

US  ‐  The  Food  and  Drug  Administration  (FDA)  is  seriously  considering  whether  to  approve  the  first  genetically  engineered  animal  that  people  would  eat:  salmon  that  can  grow at twice the normal rate. 

 weather. But the pout’s on‐switch keeps production of  the  hormone  going  year  round.  The  result  is  salmon  that can grow to market size in 16 to 18 months instead  of  three  years,  though  the  company  says  the  modified  salmon will not end up any bigger than a conventional  The developer of the salmon has been trying to get approval  fish.  for  a  decade,  but  the  company  now  seems  to  have  submitted most or all of the data the FDA needs to analyse  “You don’t get salmon the size of the Hindenburg,” said  whether the salmon are safe to eat, nutritionally equivalent  Ronald  L.  Stotish,  the  chief  executive  of  AquaBounty.  to other salmon and safe for the environment, according to  “You can get to those target weights in a shorter time”  government and biotechnology industry officials.  he  said,  adding  that  the  benefit  of  the  fast‐growing  salmon would be to help supply the world’s food needs  A public meeting to discuss the salmon may be held as early  using fewer resources.   as this fall.   AquaBounty  told  The  New  York  Times  last  week,  that  According  to  The  New  York  Times,  some  consumer  and  the FDA had signed off on five of the seven sets of data  environmental  groups  are  likely  to  raise  objections  to  required  to  demonstrate  that  the  fish  was  safe  for  approval.  Even  within  the  FDA,  there  has  been  a  debate  consumption  and  for  the  environment.  It  said  it  about whether the salmon should be labelled as genetically  demonstrated, for instance, that the inserted gene  did  engineered (genetically engineered crops are not labelled).   not  change  through  multiple  generations  and  that  the  The  salmon  was  developed  by  the  company  AquaBounty  genetic engineering did not harm the animals.   Technologies  and  would  be  raised  in  fish  farms.  It  is  an  “Perhaps  in  the  next  few  months,  we  expect  to  see  a  Atlantic salmon that contains a growth hormone gene from a  final approval,” Mr Stotish said.  Chinook  salmon  as  well  as  a  genetic  on‐switch  from  the  However, he said it would take two or three years after  ocean pout, a distant relative of the salmon.   approval for the salmon to reach supermarkets.  Normally, salmon do not make growth hormone in cold 

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Don’t miss out on all that’s going on within the FCS, attend the ANNUAL BUSINESS MEETING!

—-and visit us on FACEBOOK!!

September 12, 2010 4:30-6:00 Allegheny 3 (Westin) Pittsburg, PA

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http://www.fisheries.org/afs10/index.php 

http://www.midwest2010.org/index.php

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Public Comment Period Open for Veterinary Feed Directive (VFD) Regulations Help Streamline Regulation of VFD Drug Use in Aquaculture The U. S. Food and Drug Administration’s (FDA) Veterinary Feed Directive (VFD) regulations established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. There is currently one VFD drug in aquaculture, specifically Aquaflor® (florfenicol), which is approved for use in catfish and freshwater-reared salmonids to control mortality due to several diseases. VFD drugs are approved for use in animal feed only if these medicated feeds are administered under a veterinarian’s order and professional oversight. FDA has received a number of informal comments that characterize the current mechanism of accessing and using VFD drugs as being overly burdensome. There is also concern that the procedures for accessing and using VFD drugs will become increasingly problematic as the number of approved VFD drugs increases. Currently, the FDA is undertaking a review of their current VFD regulations in an effort to identify possible changes to the regulations to improve efficiency, and is requesting public comments on all aspects of the VFD regulations. This is your opportunity as a fish culturist to have your voice heard, and to help streamline regulation of VFD drug use in the future. Below is a series of comments on current VFD regulations which have been developed by the Fish Culture Section Working Group on Aquaculture Drugs, Chemicals, and Biologics (WGADCB). Co-chaired by representatives from industry, academia, and federal and state agencies, the mission of the WGADCB is “to enhance the health and production of aquatic animals cultured in the United States through support of the development, and safe and legal use of aquaculture drugs, chemicals and biologics.” To this end, the WGADCB co-chairs will be providing these comments to the FDA. Additionally, the WGADCB is making their comments available as ‘boiler-plate’ text which can be modified or used directly by any individuals or groups in providing their own comments to FDA. If you agree with what is outlined below, please join us in providing FDA with this important feedback. There are several ways to submit your comments to FDA: Electronic comments can be submitted via the Federal eRulemaking Portal. Go to http://www.regulations.gov and follow the instructions for submitting comments. Written submissions can be faxed (301-827-6870) or mailed (for paper, disk, or CD-ROM submissions) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852

All submissions received must include the agency name (U.S. Food and Drug Administration) and docket number for this rule making (FDA-2010-N-0155).

Provide FDA with your comments by August 26th, 2010!

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Comments regarding Veterinary Feed Directive regulations submitted to the U. S. Food and Drug Administration by: Fish Culture Section of the American Fisheries Society, Working Group on Aquaculture Drugs, Chemicals, and Biologics 21CFR Parts 510, 514, and 558 Docket No. FDA-2010-N-0155 The U. S. Food and Drug Administration’s (FDA) Veterinary Feed Directive (VFD), which became effective in January, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is undertaking a review of these requirements in an effort to identify possible changes to improve efficiency, and is requesting public comments on all aspects of the VFD regulations. FDA reaffirmed that certain new animal drugs should be approved for use in animal feed only if these medicated feeds are administered under a veterinarian’s order and professional oversight. Veterinary oversight is important for assuring the safe and appropriate use of certain new animal drugs. FDA has received a number of informal comments that characterize the current mechanism of accessing and using VFD drugs as being overly burdensome. Additionally, there are concerns that the process, in its current form, will become increasingly problematic to administer in the future as the number of approved VFD drugs increases. Comments are to be organized by the major categories listed below. Comments on issues outside one of the categories listed below are to be categorized as G. “Other” A. Conditions that must be met by veterinarians issuing a VFD a. A provision should be made to allow broad discretion for veterinarians to allow use of a VFD drug over an extended period of time at large facilities with many fish rearing units (e.g., provide more leeway in the Date of Treatment, and, if different, date of prescribing the VFD drug; or Number of refills (reorders) if necessary and permitted by the approval). i. Hatcheries that rear fish for stock enhancement may have fewer than 100 fish rearing units. On the other hand, large commercial hatcheries may have several hundred fish rearing units. In either case, some flexibility would allow the veterinarian to write one VFD order to cover the facility in the event the disease event occurs in successive rearing units. At many hatcheries, one rearing unit of sick fish is often an indication that other rearing units of fish will soon become sick from the same pathogen. Such a provision might allow use of a VFD drug (e.g., AQUAFLOR®) on fish at a facility for the duration of the disease period once the disease for which it is approved (e.g., furunculosis in freshwater-reared salmonids) is diagnosed. There might also be a greater possibility of creating antibiotic resistance as the delay would most likely increase the probability of sub-optimal doses. Appropriate diagnosis of the disease in each rearing unit would of course need to be made. ii. Involvement of a veterinarian increases the time to get VFD-medicated feed shipped by 24 – 48 hrs. Relatively few aquaculture programs have the luxury of having a veterinarian who is a practicing fish health biologist on staff and is available to expedite this process. It is our belief that in many cases, the veterinarian comes from a large animal practice and is acting as a third party; even in the context of a valid veterinarian-patient-client relationship, wherein the veterinarian is actively engaged in the diagnostic process, the fish health biologist will likely have had more training and practical experience related to fish diseases. Hence, in practice the fish health biologist often performs the diagnosis, and based on their experience at the hatchery, provides the appropriate treatment recommendation to a veterinarian. The veterinarian is then required to verify (Continued on page 16)

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this information, complete the paperwork, and provide the paperwork to the feed mill hatchery staff, and then hatchery staff can then order the feed. The delay from diagnosis to shipment of VFD -medicated feeds has decreased as those involved become more familiar with the process, but there is still a delay. Rather than face a delay to deliver the antibiotic delivered through a VFD perhaps of several days and watch fish die, a fish culturist often may use a less effective antibiotic that is approved as an “over-the-counter” drug. Ultimately this approach may result in greater mortalities if the over-the-counter antibiotic treatment is ineffective. Not only would there be greater mortalities, but application of an ineffective antibiotic needlessly increases the potential, however small, for antimicrobial resistance to develop. b. Extra-label use of a VFD drug should be permitted. Such use is strictly prohibited under current regulation. At present, AQUAFLOR®, the first new antibiotic approved for use in fish in 20 years, is the only VFD drug approved by FDA. The sponsor (Intervet/Schering Plough) and many fish health biologists and veterinarians think it likely that this product is effective for non-labeled uses (i.e., this drug is being used under an INAD and the information suggests that it is effective in controlling mortality caused by other pathogens in other fish species). A veterinarian should be able to write a “prescription” for extra-label use to allow VFD products to be used more broadly when available information suggests it would be effective (e.g., from peer-reviewed literature, grey literature, and INAD data). As presently applied, the VFD regulations put veterinarians at a disadvantage as they strive to provide adequate animal care to fish. This is particularly the case because approved treatment options for fish, which is considered a minor species, are currently very limited. While the objectives of the VFD process are laudable, present application of these regulations to only one drug that is only applied to a minor species gives the regulation the appearance of an impediment to the aquaculture industry rather than a mechanism to extend the effective life of the drug, reduce antimicrobial resistance, and promote human health. i. This approach is an extension of the discretion currently given to veterinarians who may prescribe non-VFD drugs for extra-label use. The latitude granted to veterinarians for prescribing drugs for extra-label use, including use of drugs in feed, is based on their knowledge and experience of diagnosing and treating diseases; it is not based on the specific nature of the drugs or the application method. B. What must I do with the VFD if I am a veterinarian?

a. No comments C. What are the VFD recordkeeping requirements?

a. No comments D. What are the notification requirements if I am a distributor of animal feed containing a VFD drug? a. Excluding the catfish industry, virtually all fish culturists/fish health biologists complain that they can’t get VFD-medicated feed (i.e., AQUAFLOR®) in small batch sizes or in a timely manner. Often the feed mill will not have AQUAFLOR®-medicated feed in various feed sizes in stock. Establishment of informal (i.e., intra-agency) VFD drug distribution centers has helped to alleviate this situation. Such centers can “stockpile” bags of medicated feed in various sizes and provide such feed to fish culturists upon receipt of a VFD form from the veterinarian. i. FDA should take a proactive approach to help establish VFD distribution centers throughout the country. All such centers should be set up and operate in a consistent manner. ii. A provision should be established to allow the VFD distribution center to top-coat small batchers of feed (e.g., 1 – 5 bags of feed) in a manner similar to that allowed by a VFD feed mill. In addition to helping end-users gain access to the medicated feeds they need in a timely manner, this approach will also help to minimize the length of time a medicated feed is stored prior to use (“shelf-life”), which may be a concern in large distribution centers. iii. Virtually all studies conducted to evaluate the effectiveness and safety of VFD drugs for use in aquaculture have been conducted using top-coated feed. Furthermore, top-coating is recognized (Continued on page 17)

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as an effective procedure for applying other drugs to feed in aquaculture. E. What are the additional recordkeeping requirements if I am a distributor?

a. No comments F. What cautionary statements are required for VFD drugs and animal feeds containing VFD drugs? a. Such labeling is unnecessary because VFD drugs can’t be ordered or purchased without a VFD issued from a veterinarian. It’s redundant, and because this additional labeling is an added expense and logistical hurdle, it’s a disincentive to the sponsor. G. Other a. Make a provision to simplify the ordering process, and thereby minimizing delays in ordering and receiving VFD-medicated feed, by considering one or more of the following: i. Phone-in orders (after initial documentation has been provided by the veterinarian to the VFD licensed feed mill; perhaps a unique code would need to be proved by the feed mill to veterinarians wishing to order VFD medicated feed by phone. ii. Allow electronic signature so orders could be emailed. iii. Make a provision so that faxed copies could be acceptable VFD-medicated feed ordering documents. b. Allow veterinarians to dispense VFD drug premix to allow hatchery staff to top-coat feed for use (rather than purchase VFD-medicated feed from a feed mill or VFD medicated feed distributor). Dispensing VFD drug for top-coat would be done after VFD issuing paperwork has been completed by the veterinarian. c. For application in fish, a minor species, a provision should be established to allow the senior fish health biologist (or designee) responsible for a particular fish culture facility to recommend treatment and inform the veterinarian when treatment with a VFD drug should be initiated. Reasons for this recommendation include: i. There is a lack of qualified veterinarians with fish experience to ensure that a valid veterinarianpatient-client relationship can be established for every fish culture facility. The AVMA and FDA have recognized this need and have engaged in professional development and literacy campaigns to increase awareness of aquaculture among veterinarians and the public (http://fda.gov/download/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/UCM2141 89.pdf; http://www.avma.org/reference/jtua/aquatic_veterinarians_booklet.pdf), however, it is unlikely that these efforts will result in an increase in the number of veterinarians with relevant experience in fish diseases in the near future. ii. Historically, diagnosis of fish health issues in private and public aquaculture have been done by qualified fish health biologists. . Fish health labs are often equipped to perform fish necropsy, bacteriology, virology, parasitology, histology, and disease confirmation procedures ranging from classical morphometric and biochemical tests to advanced polymerase chain reaction and fluorescent antibody tests. Fish health staffs receive formal and informal training over their career to utilize appropriate methodologies to properly diagnose fish diseases and, if necessary, recommend appropriate therapeutic treatment. In most cases, senior fish health biologists are members of fish health sections of professional fisheries societies (e.g., American Fisheries Society, Fish Health Section) and follow procedures described in manuals such as the AFS Blue Book. Fish health biologists involved in fish culture are extremely familiar with the fish and potential disease conditions at facilities that fall under their responsibility and are often in a good position to guide the veterinarian with sound advice and access to facilities and equipment. iii. It is recommended that FDA review VFD regulations and acknowledge that a veterinarian relationship with aquaculture is vastly different than a veterinarian relationship with terrestrial animals, and that perhaps “one size does not fit all.” (Continued on page 18)

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iv. In most cases, only veterinarians employed by a state or federal agency (e.g., U. S. Fish and Wildlife Service Olympia Fish Health Lab, Idaho Department of Fish and Game Eagle Fish Health Lab), large tribal group (e.g, Northwest Indian Fish Commission, Olympia WA), or private contract lab (e.g., Washington Animal Disease Diagnostic Laboratory, Pullman WA) have the resources to perform fish health procedures described above. However, this does not preclude other veterinarians to develop partnerships with those with such resources. d. In many cases, veterinarians issuing a VFD rely on professional fish health biologists to diagnosis disease in fish. For fish, a minor species, FDA should allow the establishment of a valid veterinarian-fish health biologist relationship to allow rapid disease diagnosis and application of the VFD drug. e. Veterinarians cannot get VFD medicated feed orders filled in a timely manner. In some cases it takes 7 – 14 d to get the medicated from feeds in Canada (e.g., BioOregon). This is an unacceptable period of time. It often forces the veterinarian to tell the fish culturist to buy feed from a different feed mill (switching feed type administered to fish is not an advisable practice). The longer the fish culturist must wait for VFD issue feed to be delivered means more dead fish. Because fish often stop feeding as a disease progresses, the “window of opportunity” for a medicated feed to be effective is limited. If end users have to wait a protracted period of time, not only will more fish die while they wait, but the remaining fish may be “too far gone”, i.e., off feed, and the medicated feed will be useless. i. A provision should be made to allow feed to be top-coated with a VFD drug so that it can be made available to feed to sick fish in a timely manner. ii. Major fish losses can be avoided if FDA will consider allowing a VFD medicated feed distributorship, working closely with a veterinarian, to top-coat starter feeds in small aliquots. Doing so would allow the distributorship to have several sizes of small feed on-hand that could be top-coated and shipped to the hatchery in a timely manner. f. Typically, salmonids are treated when they are small (as opposed to catfish, which may be treated when they are near-market size, when disease outbreaks are more common in this industry) and very little medicated feed is required. This is particularly the case with coldwater disease, which typically affects small salmonids (including swim-up fry). Most feed mills make medicated feed in batches of 2,000 lbs and offer feed in 20-kg or 50-lb bags. In virtually all cases, more medicated feed is manufactured and purchased than is needed and a considerable amount will be discarded (either the feed mill or hatchery will “eat the cost” of discarding uneaten feed). Veterinarians should be allowed to issue a VFD which allows the fish culturist to use all the medicated feed purchased within a specified period of time (i.e., throughout the “disease season” of the disease for which the VFD was originally issued) under the initial VFD issued by the veterinarian.

Signatures Jesse Trushenski, WGADCB Co-chair Jim Bowker, WGADCB Co-chair Steve Sharon, WGADCB Co-chair John (Randy) MacMillan, WGADCB Co-chair Mark P. Gaikowski, WGADCB Co-chair

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Newsletter of the Fish Culture Section of the American Fisheries Society October 2009 President............................................Jesse Trushenski Immediate Past-President.................Curry Woods President-elect...................................Jim Bowker Secretary-Treasurer...........................Donna Muhm Committee Chairpersons (Standing): Auditing................................................................................Alan Johnson Hall of Fame.........................................................................Curry Woods Membership.........................................................................Jesse Trushenski Newsletter............................................................................Heidi Lewis Nominating.............................................................,............Curry Woods Program................................................................................Jim Bowker Committee Chairpersons (Ad Hoc): Continuing Education.........................................................Alf Haukenes Student Awards...................................................................Steve Lochmann Student.................................................................................Bonnie Mulligan President’s Appointees: FCS Representative to PFIRM............................................Vince Mudrak FCS Representative to Triennial Program Committee.....Mike Frinsko FCS Representative to Triennial Steering Committee…..John Nickum (‘10) Curry Woods (‘13) FCS Liaison to USAS...........................................................Max Mayeaux FCS Webmaster...................................................................Cortney Ohs Contact Information: Jesse Trushensk[email protected]siu.edu Curry Woods..[email protected]umd.edu Jim Bowker………………………………………[email protected] Donna Muhm.....[email protected]dnr.iowa.gov Alan Johnson........[email protected]dnr.iowa.gov Heidi Lewis.....[email protected]siu.edu Alf Haukenes………………………………………[email protected] Steve Lochmann[email protected]uaex.edu Bonnie Mulligan…………………………………[email protected] Vince Mudrak.........[email protected]fws.gov

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