Vol FINAL apr for email by FWSdocs


									              U.S. Fish & Wildlife Service
                 The Aquatic Animal Drug Approval Partnership Program
                   “Working with our partners to conserve, protect and enhance the Nation’s fishery
                   resources by coordinating activities to obtain U.S. Food and Drug Administration
                       approval for drugs, chemicals and therapeutants needed in aquaculture”

    Volume 3-1               AADAP NEWSLETTER                                                             March 2007

WHAT’S SHAKIN’                                                  available on the AADAP website. The Database comprises
                                                                finfish production data from all 50 states, the U.S. Fish &
AQUAFLOR® (florfenicol) received FDA-approval for               Wildlife Service, NOAA’s National Marine Fisheries Service
coldwater disease for all freshwater-reared salmonids:          and 19 Native American tribes. Unlike the previous version
Schering-Plough Animal Health (SPAH) recently                   (calendar year 2000 data), the new Database is available to
announced (21 March 2007) that Aquaflor® now has the            all visitors to our website, instead of just those that have
added approved claim for control of mortality caused by         Microsoft Access® loaded on their computer. We hope you
CWD in all freshwater-reared salmonids. Bravo, and thank        take the time to peruse the Database, and please don’t
you, to SPAH for their continued commitment to the U.S.         hesitate to tell us how we can improve it.
aquaculture community. More information...
                                                                Another drug company testing the waters: Frontier
35% PEROX-AID® (hydrogen peroxide) receives FDA                 Scientific, Inc. of Logan, Utah has initiated exploratory
approval: EKA Chemicals Inc. received notice from CVM           discussions with AADAP and others relative to entering the
that 35% PEROX-AID® has been approved as of                     aquatic drug approval arena. A photo-sensitive product of
11 January 2007 for three control claims: (1) fungal            theirs has shown very encouraging antimicrobial activity in
infections in all freshwater finfish eggs, (2) bacterial gill   European laboratory and field studies with rainbow trout.
disease in all freshwater-reared salmonids, and (3)             Several meetings have been held in the last six months,
external columnaris in all freshwater-reared coolwater          including one this past month at Aquaculture 2007 in San
finfish and channel catfish. Congratulations are in order to    Antonio, Texas. The possibilities are exciting – stay tuned!!
Eka Chemical for “staying the course” and all the others
                                                                New INAD for channel catfish pituitary established: On
involved, especially the USGS Upper Midwest
                                                                6 December 2006 AADAP received authorization from
Environmental Sciences Center. Detailed information...
                                                                CVM for the establishment of INAD 11-468 for the use of
13th Annual Drug Approval Coordination Workshop                 channel catfish pituitary to induce gamete maturation
planned: This year’s Workshop will be                           (ovulation and spermiation) in a variety of catfish species.
held 31 July through 1 August 2007 at                           Although potential application of channel catfish pituitary
the Holiday Inn, Bozeman, Montana.                              treatment is likely broad and varied within the catfish
Co-hosts will be the USFWS’s AADAP                              industry, it is of particular significance with respect to the
Program and USDA’s Stuttgart National                           production of hybrid catfish (e.g., channel catfish X blue
Aquaculture Research Center. We hope to persuade                catfish). For more information, click here.
some of USFWS’s (Washington, DC) and CVM dignitaries
                                                                Aquaculture 2007 presentation online: Many of the
to attend and share their perspectives of our collective
                                                                aquaculture drug approval-related presentations given at this
aquaculture drug approval efforts. Tentatively, Dr. Stuart
                                                                year’s conference (San Antonio, Texas, USA; 26 February
Leon, Chief of the USFWS’s Division of National Fish
                                                                through 2 March 2007) have been provided to AADAP and
Hatchery System, and Dr. Bernadette Dunham, Deputy
                                                                are available for your viewing on our website. As we gain
Director of FDA’s Center for Veterinary Medicine and
                                                                permission for other presentations from the same
Director of the Office of Minor Use Minor Species will be
                                                                conference, we will add those to the above noted link.
kicking off this year’s Workshop. One workshop highpoint
will undoubtedly be the celebration of a couple of new FDA      New: AADAP Research Information Bulletins (RIBs):
aquaculture drug approvals. The workshop is a great             Research is an “orderly process by which new knowledge
opportunity to get “up-to-speed” on recent aquaculture drug     or information is obtained in accordance with specific
research activities and the status of initial or expanded       objectives” (Waters and Erman 1990). As such,
approvals. In addition, a short session is scheduled to         aquaculture drug approval research can be academic
discuss current research and commercial status of fish          science- or regulatory science-based (Uchiyama 1995),
vaccines. For more information, please visit our website.       and can include both mensurative and manipulative
We hope to see you in Bozeman. More information...              experiments (Hurlbert 1984). Besides obtaining drug
                                                                approvals, per se, it is perhaps an inherent desire to
2005 Public Sector Aquaculture Production Database is
                                                                contribute “something new” that keeps many of us
now a reality: The new Public Sector Aquaculture
                                                                interested and focused day-in and day-out, year-in and
Production Database (data from calendar year 2005) is now
In 2007, AADAP developed a Research Information                   and metazoan parasites. As soon as INAD authorization is
Bulletin (RIB) series. These in-house bulletins—although          received, all relevant information, including sign-up forms
not necessarily integral to the approval of a specific drug—      will be available on our website.
are brief descriptions of “bits and pieces” of new
                                                                  Oxytetracycline updates:
knowledge and information that we have obtained during
our years of INAD, efficacy and target animal safety work.            Real progress on new therapeutic claims for
                                                                      salmonids: Phibro Animal Health’s Terramycin® 200
Three RIBs have been issued to date: (1) Buffering
                                                                      for Fish, NADA #038-489 - Type A medicated feed, is
oxytetracycline immersion-marking solutions to maintain
                                                                      very close to being amended to include claims for
fish-safe pH levels; (2) A simple way to calculate amount of
                                                                      coldwater disease in all freshwater salmonids and
Aquaflor® premix to add to fish feed to achieve a target
                                                                      systemic columnaris in steelhead (and possibly all
dosage of 10 mg florfenicol/kg fish/day; and (3) Modeling
                                                                      strains/subspecies of Oncorhynchus mykiss). The
the safety of AQUI-S® (40 – 100 mg/L) to small rainbow
                                                                      antimicrobial resistance components of the human food
trout. All three are posted on our website. As always, we
                                                                      safety technical section were just recently accepted by
welcome your questions and comments about the
                                                                      CVM, making that section complete. All components of
information we provide.
                                                                      the environmental safety technical section have been
    Above cited literature:                                           submitted to CVM and are pending review/acceptance.
                                                                      Hence, the only remaining components of the
    Hurlbert, SH. 1984. Pseudoreplication and the design
                                                                      amended New Animal Drug Application to be submitted
    of ecological field experiments. Ecological
                                                                      are administrative in nature, and will be completed by
    Monographs 54(2):187-211.
                                                                      the drug sponsor. Keep your dial set right here for
    Uchiyama M. 1995. Regulatory science—its mission                  news!!
    and goal. Japanese Journal of Toxicology and
                                                                      New claim Terramycin® 200 for Fish to be sought
    Environmental Health 41(4):250-255 (abstract only).
                                                                      for skeletal marking: AADAP, working closely with
    Waters, WE and DC Erman. 1990. Research                           Phibro Animal Health and FDA’s Center for Veterinary
    methods: concept and design. Pages 1–34 In:                       Medicine (CVM), is moving forward to apply substantial
    CB Schreck and PB Moyle (editors). Methods for fish               INAD data, and a few new additional studies, toward a
    biology. American Fisheries Society, Bethesda,                    new claim for the use of oxytetracycline in feed for
    Maryland.                                                         skeletal marking in salmonid finfish. A meeting is being
                                                                      requested with CVM to identify potential data gaps.
New Protocols and SOPs added to JSA’s Research
Forum: Many thanks to those of you who have                           O. mykiss is O. mykiss is O. mykiss: In February
contributed research protocols and standard operating                 2007, the AADAP Program, with concurrence from the
procedures (SOPs) to the JSA Research Forum section of                National Aquaculture Drug Research Forum (NADRF),
the AADAP website. To minimize the time and frustration               submitted a paper to the FDA’s Center for Veterinary
that we collectively face in trying to gain CVM-concurrence           Medicine (CVM) proposing the argument that studies
of research study protocols, several federal and university           accepted for either freshwater-reared rainbow trout
research entities have agreed to “share” their protocols and          (Oncorhynchus mykiss) or freshwater-reared steelhead
SOPs. To date, there are 10 protocols and over 200 SOPs               trout (also O. mykiss) should be acceptable to support
available on the website. Several researchers have                    label claims for all freshwater-reared O. mykiss. If this
already used this resource while developing their own                 argument is accepted by CVM, it will expand approved
research protocols and SOPs. If interested, you can                   label claims on either steelhead trout or rainbow trout
browse for items of interest, or you can use the website’s            to all freshwater-reared O. mykiss.
search function to look for specific key words.
                                                                  Calcein (SE-MARK®) updates:
Hydrogen peroxide INAD requested by AADAP:
                                                                      Product Development Meeting Held:
AADAP, in cooperation with Eka Chemicals, Inc., has
                                                                      Representatives from Aquatic Life Sciences (ALS)
submitted a request for an INAD for 35% PEROX-AID®.
                                                                      Inc. (parent corporation of Western Chemical Inc.),
The request package included an INAD study protocol and
                                                                      members of AADAP and Roz Schnick (National
requested authorization to treat up to 10 million finfish and
                                                                      Coordinator for Aquaculture New Animal Drug
10 million saltwater finfish eggs. The INAD is intended to
                                                                      Applications), met on 20 December 2006 with the
cover investigations relevant to the control of mortalities in:
                                                                      Center for Veterinary Medicine (CVM) to discuss
(1) freshwater and marine finfish, and marine finfish eggs
                                                                      detailed requirements to move ALS’s skeletal marking
caused by fungi of the family Saprolegniaceae; (2)
                                                                      product closer to an approval. Although SE-MARK®
freshwater and marine finfish (other than salmonids
                                                                      has the potential to be administered as an immersion
caused) by bacterial gill disease or other bacteria typically
                                                                      bath or as a feed-based treatment, the decision has
associated with BGD; (3) freshwater cold- and warmwater
                                                                      been made to gain the immersion approval first, then
finfish (except channel catfish) caused by external
                                                                      move on to the feed-based approval. Although the
columnaris; (4) freshwater and marine finfish caused by
                                                                      meeting was not without its “that’s not exactly what I
diseases associated with other external bacteria; and (5)
                                                                      wanted to hear” moments, it was very positive and
freshwater and marine finfish caused by external protozoan

   helped tremendously to establish a clear path toward           earthen pond-reared channel catfish caused by
   an initial approval for use in salmonids.                      systemic columnaris. Studies such as these are easy
                                                                  to design but very difficult to carry out. Some of the
Aquaflor® (florfenicol) updates:
                                                                  challenges Dr. Gaunt must overcome include
   Furunculosis – all freshwater-reared salmonids:                enumerating dead or moribund fish from large earthen
   In November 2006, AADAP submitted what we                      ponds at the end of the study, confirming cause of
   hoped would be the last Final Study Report required            mortality, and staving-off secondary pathogens.
   by CVM to demonstrate the effectiveness of                     Dr. Gaunt has battled these challenges in the past and
   Aquaflor® (dosage, 10 mg florfenicol/kg fish body              has been successful on many occasions. We’re all
   weight/day for 10 consecutive days) to control                 wishing her continued success.
   mortality in all freshwater-reared salmonids due to
                                                               17-α methyltestosterone updates:
   furunculosis (caused by, Aeromonas salmonicida).
   We hope to get a technical section complete letter             Three studies were conducted to demonstrate the
   from CVM very soon!                                            effectiveness of 17-α MT (60 mg/kg feed) to produce
                                                                  predominantly male populations of tilapia. Below is an
   Columnaris – all freshwater-reared salmonids:
   Only one additional study is needed to demonstrate the         update of each study.
   effectiveness of Aquaflor® to control mortality, in all        Study 1: The first study was conducted at SeaPac of
   freshwater-reared salmonids, due to systemic                   Idaho (thanks, Ken Ashley and crew) in Buhl, ID, and all
   columnaris. AADAP is working with Ken Nichols                  phases (in-life, histological evaluation of gonads, data
   (USFWS’s California/Nevada Fish Health Center) and             analysis and final study report) have been completed.
   Dr. Jed (Varney, that is) and the folks at the Bellingham      The study went off without a hitch…well, there was one
   Trout Hatchery (WDFW) to line up what is hoped to be           minor glitch. Analytical verification of the concentration
   the final piece of the puzzle. One successful study will       of MT in the treated feed was 39 mg MT/kg feed. This
   result in a technical section completion for this claim.       relatively “low” concentration was due to storage of the
   Streptococcus iniae – hybrid striped bass: AADAP               treated feed for 9-10 weeks at ambient air temperature.
   initiated a Western Regional Aquaculture Center funded         Otherwise, the study was a success: (a) mean percent
                                                                  males in treated tanks (84%) was significantly greater
   project with Dr. Vaughn Ostland (Kent SeaTech
   Corporation, Mecca, CA) to evaluate different dosage           than mean percent males in control tanks (38%), and
   regimens to control mortality in hybrid striped bass           (b) mean percent males in treated tanks was greater
                                                                  than 80%. The Final Study Report was submitted to
   (HSB) caused by S. iniae. Phase 1 of the project is to
   develop a disease model (injection and immersion) that         CVM in February, 2007.
   meets several predetermined criteria. The in-life phase        Study 2: The second study was conducted at Simaron
   of a first experiment has been completed, and work is          Freshwater Fish in Waller County, TX. The in-life
   being conducted to refine the level of pathogens               phase has been completed, and AADAP’s Miranda
   delivered to test fish. The in-life phase of a second          Dotson is processing, embedding, and sectioning
   experiment should be completed by the end of June              gonads from over 300 fish sampled at the end of the
   2007. Results from these experiments should provide            study. The analytically verified concentration of MT in
   us with the tools necessary to proceed with disease            the treated feed was 56 mg/kg feed. Stay tuned for
   challenge studies in which replicated test tanks of naïve      more results.
   HSB will be treated with different concentrations of
   florfenicol-medicated feed (10, 15 or 20 mg/kg fish) for       Study 3: The third and final study is being conducted
   different durations (10, 15 or 20 d).                          at SeaPac of Idaho, and the in-life phase will be
                                                                  completed in early April. The analytically verified
   Columnaris – channel catfish in raceways: Alan                 concentration of MT in the treated feed was 55 mg/kg
   Johnson (Iowa DNR, Rathbun Fish Culture and                    feed. Stay tuned for more results.
   Research Facility, beautiful Moravia, Iowa) has once
   again established a summer veterinary student intern           Storage of MT-treated feed: Studies conducted by
   position for the purpose of conducting aquaculture drug        Dr. Terry Barry (University of Wisconsin – Madison)
   effectiveness studies. The intern will, in part, focus on      have shown that storage of MT-treated feed at room
   conducting pivotal field effectiveness studies to              temperature will result in a decrease in MT
   demonstrate the effectiveness of Aquaflor® to control          concentration over time. Dr. Barry’s results showed
   mortality in raceway-reared channel catfish caused by          that the MT concentration decreased at a rate of about
   systemic columnaris. Good luck, Alan!                          3% per week. Dr. Barry’s results also showed that
                                                                  MT-treated feed stored in a refrigerator or freezer
   Columnaris – channel catfish in ponds: Dr. Pat                 experienced no such decrease. So, the take-home
   Gaunt (Mississippi State University, College of                message for tilapia producers who use MT-treated feed
   Veterinary Medicine, Thad Cochran National                     for sex reversal is to properly store your MT-treated
   Warmwater Aquaculture Center, Stoneville, MS) has              feed.
   been involved in conducting studies to demonstrate the
   effectiveness of Aquaflor® to control mortality in

AQUI-S® updates:                                                      Planned Efficacy Studies: AADAP is pleased to be
                                                                      working with Michael Matthews and the research crew
   Efficacy: Good news!! AADAP has completed all
                                                                      at the Richlomb Hatchery – Florida Bass Conservation
   studies required by CVM to demonstrate the
                                                                      Center on much needed effectiveness studies on
   effectiveness of 50% isoeugenol (AQUI-S®) to sedate
                                                                      warmwater finfish. A plan is in place to conduct studies
   all freshwater-reared finfish to “handleable.” However,
                                                                      on two different warmwater finfish (largemouth bass
   to obtain an “effectiveness technical section complete”
                                                                      and channel catfish) to demonstrate the effectiveness
   from CVM, a study must be conducted to validate the
                                                                      of chloramine-T to control mortality caused by external
   dose verification method used in the effectiveness
                                                                      columnaris. A special thanks to Michael for
   studies. The dose verification validation study has
                                                                      stepping-up and agreeing to help generate these
   been completed by AQUI-S New Zealand, Ltd., and will
                                                                      important data. Alan Johnson (Iowa DNR, Rathbun
   be submitted to CVM within a few weeks.
                                                                      FC&RF) has also offered to step-up and help conduct a
   Target Animal Safety: More good news!! In                          similar study on musky. Thanks again to Alan!
   December 2006, CVM reviewed AADAP’s Final Study
                                                                  35% PEROX-AID® (hydrogen peroxide) updates:
   Report on the safety of 40 mg/L AQUI-S® to small
   fingerling rainbow trout and found “…the data to be                Efficacy: The following research study protocol has
   acceptable.” Currently, AADAP is in the process of                 been submitted to CVM: “A protocol to evaluate the
   “writing up” a second pivotal AQUI-S® TAS study that               effectiveness of 35% PEROX-AID® (35% active
   was conducted on small fingerling cutthroat trout.                 hydrogen peroxide) to control mortality in cool- and
   Results from the cutthroat trout study (e.g., mortality            warmwater finfish caused by bacterial gill disease or
   and pathologies) were similar to results observed in the           external columnaris.” This protocol was developed so
   rainbow trout study. We are optimistic that the TAS                that AADAP can work towards conducting the
   data generated in the cutthroat trout study will be                necessary studies to complete these efficacy technical
   accepted by CVM, which will complete TAS                           sections for warmwater finfish.
   requirements for an all freshwater-reared salmonid
                                                                      Planned Efficacy Studies: Have we mentioned how
   label claim.
                                                                      pleased we are to be working with Michael Matthews
   Mammalian Toxicology: The National Toxicology                      and the research crew at the Richlomb Hatchery –
   Program has announced the 16-17 May 2007 meeting                   Florida Bass Conservation Center? There are also
   of the Board of Scientific Counselors’ Technical                   plans to work with Michael to conduct studies (the last
   Reports Review Subcommittee. At this meeting,                      missing piece of yet another puzzle) to demonstrate
   results of the toxicology study conducted on                       the effectiveness of 35% PEROX-AID® to control
   isoeugenol will be discussed. Favorable review of the              mortality in largemouth bass caused by external
   isoeugenol data will greatly contribute to completion of           columnaris. Another special thanks to Michael for
   the human food safety technical section for AQUI-S®                stepping-up and agreeing to help generate these very
   use as a zero-withdrawal anesthetic. Keep your                     important data.
   fingers crossed!
                                                                  FEATURE ARTICLE
   Draft Label Claim: AADAP has been working with
   CVM and AQUI-S New Zealand, Ltd. to develop draft              The following article is reprinted from Fish Farming News
   product “label claims” to sedate cold-, cool-, and             (Issue 4 – 2006) with their permission and with permission
   warmwater freshwater finfish to “handleable.” By               from Schering-Plough Animal Health. Although the article
   definition, a product “label” includes information such        was first published prior to the newly added salmonid claim
   as indications for use, product information, limitations,      for AQUAFLOR®, the information is exceptionally relevant
   and cautions, and is a technical section that must be          today.
   completed as part of the administrative New Animal
   Drug Application process. So, yet another piece of the
   puzzle has been put in place.
Chloramine-T updates:
   Efficacy: The following research study protocol was                         Are You Ready for VFD Drugs?
   recently submitted to CVM: “A protocol to evaluate the            Freshwater Salmonid Industry Gets Ready for Using
   effectiveness of chloramine-T (Halamid®) to control                     Next Generation of In-Feed Antibiotics
   mortality in cool- and warmwater finfish caused by
   bacterial gill disease or external columnaris.” This           SUMMIT, N.J., Sept. 11, 2006— Growers, veterinarians
   protocol was developed so that AADAP can work                  and feed mills in the freshwater salmonid industry need to
   towards conducting studies needed to complete the              start familiarizing themselves with regulations governing
   technical sections for coolwater (one more study               the use of what the U.S. Food and Drug Administration
   required) and warmwater (two studies required) finfish.        calls “Veterinary Feed Directive” (VFD) drugs.

“The VFD process is not a complicated matter, but it will               The first VFD drug to be classified and approved by the
                                   be important for everyone in         FDA since the approval of VFD status was tilmicosin, an
 Follow the Path to VFDs           the freshwater-reared                antimicrobial for swine respiratory disease. AQUAFLOR®
 Everyone involved in the          salmonid industry to know            became the second antibiotic in the animal health industry
 production phase of U.S.          and understand the FDA’s             and the first in aquaculture to be given this exclusive status
 aquaculture must understand and
 follow the necessary steps needed rules,” says Dr. Dick Endris         when it was licensed last fall.
 in obtaining and feeding a        of Schering-Plough Animal
                                                                        How it works
 Veterinary Feed Directive (VFD)   Health Corporation.
 drug.                                                                  The starting point for obtaining feed with a VFD drug is with
 Here's how the process works for      The first VFD drug for
                                                                        the producer experiencing sick fish. Producers can get a
 producers:                            aquaculture, AQUAFLOR®
                                                                        VFD order from a diagnosing veterinarian or veterinary
   • Producer or hatchery              (florfenicol) was approved
                                                                        laboratory as long as there is what the FDA calls a
     manager contacts a                for use in catfish last year
     veterinarian for diagnosis and                                     “veterinarian-client-patient relationship” with the producer
                                       [editor’s note: 2005].
     treatment.                                                         or hatchery manager. With the VFD form in hand, the
                                       AQUAFLOR® is expected to
   • Veterinarian works within                                          producer can go to the feed mill to order and obtain the
                                       be approved for use in
     the veterinarian-client-patient                                    VFD-containing feed. (See “sidebars”.)
     relationship to determine that    freshwater salmonids —
     a VFD drug is needed.             trout, arctic char and           Sellers notes that the VFD order authorizes the client to
   • Veterinarian issues a signed      freshwater life stages of        obtain the medicated feed in accordance with the directions
     VFD form to the producer          saltwater fish like salmon —     for use approved by the FDA. There is NO [editor’s
     and/or feed mill.                 in the near future [editor’s     emphasis] “extra-label” or “off label” use for any VFD drug,
   • Producer uses the VFD form        note: approved as of 21          meaning it can be ordered only for the use specified on the
     to order medicated feed from      March 2007].                     product label.
     a feed supplier. The feed
     supplier must have a signed       Developed by Schering-           Responsibility for                   What is a VCP Relationship?
     VFD order on file in order to
     deliver feed.
                                       Plough Animal Health,            compliance falls on the              What exactly is the “veterinarian-
                                       AQUAFLOR® is a fast-             feed mills, veterinarians            client-patient relationship”
   • Licensed feed manufacturers
     or distributors that ship a       acting, broad-spectrum           and producers. “A VFD                needed to obtain an order for a
                                                                                                             new VFD drug?
     VFD feed to another               antibiotic developed             drug means some
     distributor or retailer must      specifically for use in          additional paperwork, but            FDA offers the following
     receive and retain a copy of a    veterinary medicine. Its                                              guidelines:
                                                                        it's not a big deal,”
     written acknowledgement
     stating that the VFD feed         sister product, NUFLOR®          acknowledges Sellers.                 • The veterinarian has assumed
                                       (florfenicol), has been                                                  responsibility for making
     will further be distributed                                        “The VFD form needs to be
                                                                                                                clinical judgments regarding
     only in accordance with FDA       approved by FDA for use in       completed by a vet and                  the health of the animals and
     requirements.                     beef and non-lactating           everything must be legal,               the need for medical
   • The veterinarian issuing the      dairy cattle since 1996.         valid and correct before the            treatment, and the client has
     VFD order, the producer and                                                                                agreed to follow the
                                                                        feed mill can fill that VFD
     the person or company             Why VFDs?                                                                veterinarian's instructions.
     supplying the VFD feed must                                        order.
                                                                                                              • The veterinarian has
                               FDA established the VFD
     retain copies of the signed
                                                                                                                sufficient knowledge of the
     VFD form for a minimum of                                          “Most feed mills serving
                               drug classification to more                                                      animals to initiate at least a
     two years.                                                         the aquaculture industry
                               closely control new                                                              general or preliminary
                                                                        have been through the                   diagnosis of the medical
                               therapeutic products —
                                                                        federal medicated feed                  condition of the animals. This
primarily antimicrobials — and their use in food animals.                                                       means that the veterinarian
                                                                        licensing process, so I'm
The new classification applies only to new in-feed                                                              has recently seen and is
                                                                        confident they know what
therapeutics approved by the FDA after 1999 and                                                                 personally acquainted with
                                                                        they're doing,” he adds.                the keeping and care of the
administered in feed. All products approved before 1999
                                                                                                                animals by virtue of an
have maintained their over-the-counter (OTC) status.                    Feed mills already holding              examination of the animals or
                                                                        a Medicated Feed Mill                   by medically appropriate and
“The VFD allows us to continue adding new drugs to our
                                                                        License (MFML) — a                      timely visits to the premises
health tool box,” stresses Richard Sellers, American Feed                                                       where the animals are kept.
                                                                        license to manufacture
Industry Association.                                                                                     • The veterinarian is readily
                                                                        medicated feed — simply
                                                                                                             available for follow-up
Like catfish farmers, producers of trout and other                      need to file a notification          evaluation, or has arranged
freshwater salmonids will be able to obtain VFD drugs                   letter with the FDA stating          for emergency coverage, in
through normal feed-distribution channels, but they must                its intention to distribute an       the event of adverse reactions
first obtain a signed Veterinary Feed Directive from a                  animal feed containing a             or failure of the treatment
licensed veterinarian.                                                  VFD drug. All VFD orders
                                                                        must be retained by the
He adds that the VFD regulations were developed by a
                                                                        feed mill for a period of two years.
coalition of members in the animal health community to
better control new therapeutic, antimicrobial drugs. The
system aims to reduce antibiotic resistance and prolong
effectiveness of new antimicrobials through judicious use.

Short learning curve                                                 Treatment of salmonids for CWD is no longer an
                                                                     available treatment option under INAD 10-697: As a
Dr. Dave Erdahl, fisheries biologist and branch chief of the
                                                                     result of the recent approval for the use of AQUAFLOR®
Aquatic Animal Health Drug Approval Partnership (AADAP)
                                                                     (florfenicol) to control mortality caused by coldwater
Program of the U.S. Fish and Wildlife Service, Bozeman,
                                                                     disease in salmonids, this treatment option is no longer
Montana, doesn’t think the VFD process will be a major
                                                                     available under INAD 10-697. If your salmonids have CWD
issue for most producers raising trout and other freshwater-
                                                                     and AQUAFLOR® is your drug of choice, you must use the
reared salmonids.
                                                                     approved AQUAFLOR® product. However, please note
“The role of veterinarians in aquaculture is expanding,” he          that INAD 10-697 may still be used for other “non-
says. “There are already a considerable number of                    approved” uses of AQUAFLOR® in cold-, cool-, and
operations working directly with consulting veterinarians or         warmwater species.
veterinarians on staff with state and federal agencies.
                                                                     Ovaplant® is moving to the “front-burner”: Aquatic Life
“Like anything new, it will likely be a bit problematic at first,”   Sciences (ALS) Inc. (parent corporation of Western
he adds, “but I look at the VFD process as a ‘growing pain’          Chemical Inc. and Syndel International, Inc.) and AADAP
for our industry. If we want new products to maintain fish           have recently engaged in serious discussion as to how best
health, we have to get with the program. It’s that simple.”          to move Ovaplant® (for use as a spawning aid) toward an
                                                                     initial approval for use in salmonids. Current strategy is to
Dr. Patricia Gaunt, associate professor, aquatic animal              seek a “conditional approval” under MUMS legislation,
health, Mississippi State University College of Veterinary           thereby reducing overall initial data requirements. A Product
Medicine, says the VFD classification has not proved to be
                                                                     Development Meeting with CVM to discuss a strategy and
a big issue for producers or feed mills in the catfish industry      action plan for Ovaplant® will be requested later this month.
“There is always a learning curve in any new situation,”
Gaunt says of the VFD drug process, “but the rewards of a            USGS’s CORNER
new drug to treat aquatic disease certainly justify the
                                                                     AQUI-S® Human Food Safety Research: Upper Midwest
learning process.
                                                                     Environmental Sciences Center (UMESC) submitted a
“We're also approaching the education process through                letter to CVM requesting selection of isoeugenol as the
diagnostics with the farmer when they bring in diseased              marker residue for AQUI-S®. The request was based on
fish and we explain the VFD process to them,” she adds.              data generated in a AQUI-S® total residue depletion study
                                                                     (conducted at UMESC) using radiolabelled isoeugenol
Growers with questions on the VFD process should contact             where isoeugenol was the primary AQUI-S® residue in
their diagnostic lab, extension service, veterinary college or       extracts from fillet tissue taken from rainbow trout sampled
veterinarian. Information about VFDs and VFD forms are               through a 4 hour depuration period. UMESC also
also available at http://www.aquaflor-usa.com.                       completed the laboratory phase of a study validating a
                                                                     proposed determinative method for the probable AQUI-S®
FINS & TAILS, BITS & BOBBERS                                         marker residue. Validation efforts were rather
Need more information on VFD drugs? AADAP has                        comprehensive and included the use of fillet tissue from
compiled a series of publications and other documents that           nine different fish species. All data indicate that the
address a variety of issues pertaining to Veterinary Feed            method developed at UMESC will fulfill FDA guidelines for
Directive drugs. Click here to access that VFD information.          determinative methods. (Jeff Meinertz; La Crosse, WI,
                                                                     phone 608-781-6291, jmeinertz@usgs.gov)
List of Aquatic Animal Veterinarians: Of particular
importance to aquaculturists, vis-à-vis Veterinary Feed              Chloramine-T Environmental Assessment Submission:
Directive (VFD) drugs, is a website that provides a “listing”        A revised version of the draft Environmental Assessment
of aquatic veterinarians and aquatic animal diagnostic               for the broad use of chloramine-T in U.S. freshwater
laboratories. The website is jointly sponsored by the                aquaculture will be submitted by UMESC to the Center for
American Veterinary Medical Association; GlobalVetLink,              Veterinary Medicine for review by 31 March. (Bill
LC; Aquacultural Underwriting & Management Services,                 Gingerich; La Crosse, WI; phone 608-781-6225,
Ltd; and the National Risk Management Feasibility                    bgingerich@usgs.gov)
Program for Aquaculture (at the Department of Agricultural           USGS Scientists Recognized for Approval of
Economics – Mississippi State University). The website               35% PEROX-AID®: Dave Lovetro of Eka Chemicals, Inc.,
allows users to search for an aquatic veterinarian in their          Marietta, Georgia, recognized nine research staff of the
local area, which should help any user requiring the                 USGS, Upper Midwest Environmental Sciences Center, La
application of a VFD drug to treat their fish.                       Crosse, Wisconsin on Tuesday, 13 March for their efforts to
Is the price of a SE-MARK® (calcein) Detector keeping                secure the approval of 35% PEROX-AID®. Information
you from enrolling in the calcein INAD? AADAP now                    about the drug label and the research produced by UMESC
has an extra SE-MARK® Detector available to be loaned                to support the approval can be accessed at
out to calcein INAD participants. If you would like to use it,       http://www.umesc.er.usgs.gov/ (Bill Gingerich; La Crosse,
please give Tom Bell a phone call (406-994-9911) or drop             WI; phone 608-781-6225, bgingerich@usgs.gov)
him an email.

A welcome back to Mark Gaikowski: First sergeant Mark          additional information on the Workshop, including
P. Gaikowski returned from a year’s tour of duty in            accommodations, program agenda, registration, etc.
Afghanistan with the Wisconsin National Guard in January
                                                               Flavobacterium 2007 Workshop; 2-4 May 2007;
2007 and has rejoined the staff at the Upper Midwest
                                                               Shepherdstown, West Virginia, USA:
Environmental Sciences Center, La Crosse. Welcome
                                                               The U.S. Department of Agriculture’s
back Mark! (Bill Gingerich; La Crosse, WI;
                                                               Agriculture Research Service, in
phone 608-781-6225, bgingerich@usgs.gov)
                                                               cooperation with Clear Springs Foods,
MEETINGS, ETC.                                                 Washington State University and Pennsylvania State
                                                               University – Erie are sponsoring a three-day workshop to
Recently held meetings                                         be held at the U.S. Fish & Wildlife Service’s National
                                                               Conservation Training Center. The scheduled sessions
Aquaculture 2007; 26 February – 2 March 2007; San
                                                               include: genomics and proteomics, pathogenesis, vaccines
Antonio, Texas, USA: As always, the
                                                               and immunity, taxonomy, diagnostics, broodstock
triennial joint-conference of the World
                                                               evaluation for disease resistance and environmental
Aquaculture Society, the National
                                                               flavobacteria. For more information contact Dr. Greg
Shellfisheries Association and the
                                                               Wiens (greg.wiens@ars.usda.gov) .
American Fisheries Society’s Fish Culture
Section was a grand event. And, as is                          48th Western Fish Disease Workshop and American
usually the case, it appeared to be even bigger than           Fisheries Society Fish Health Section Annual Meeting;
previous triennial events. This year’s conference              4-6 June 2007; Moran, Wyoming, USA: This combined
comprised 15 concurrent sessions being held every day for      meeting will be held at the Jackson Lake Lodge in Grand
4 days. Sessions topics were too numerous to count, and        Teton National Park. Agenda and other information can
included such diverse topics as: “Aquaculture Marketing:       be obtained at the meeting webpage. To learn more about
The Big Picture,” “Biotech Aquaculture: Environmental          the Jackson Lake Lodge, go to
Sustainability,” “Physiological Insights toward Improving      http://www.gtlc.com/lodgeJac.aspx.
Fish Culture,” “Therapeutic Drug Research,” and
                                                               7th Nordic Symposium on Fish Immunology; 17-20
“Aquaculture & Disasters: Dealing with the Mayhem.”
                                                               June 2007; University of Stirling, Stirling, Scotland: The
Many of the aquaculture drug approval-related
                                                               seventh international symposium on fish immunology,
presentations given at this year’s conference have been
                                                                              organized by the Nordic Society for Fish
provided to AADAP and are available for your viewing on
                                                                              Immunology (NOFFI), will be held in June
our website. As we gain permission for other presentations
                                                                              2007, at the University of Stirling, Scotland.
from the same conference, we will add those to the above
                                                                              This event is held every three years and as
noted link.
                                                                              with previous meetings, scientists from
Upcoming meetings                                              around the world are invited to attend to discuss recent
                                                               advances in fish immunology. The conference will last for
Fish Immunology Workshop; 15-19 April 2007;
                                                               three and half days and will consist of plenary and keynote
Wageningen University, The Netherlands: The annual
                                                               lectures, and oral and poster presentations covering both
Fish Immunology workshop comprises presentations (30
                                                               basic and applied fish immunology. There will also be a
              minutes to one-hour) by experienced lecturers,
                                                               workshop on the day prior to the conference aimed at PhD
              taking time to thoroughly introduce each
                                                               students and young researchers which will focus on new,
              subject, and two practical afternoons.
                                                               cutting-edge technologies in fish immunology. Registration
              Objective: To provide participants with
                                                               fee will be £75 less for NOFFI members. To join NOFFI
advanced knowledge, both theoretical and practical, on t
                                                               please contact the treasurer, Dr. Jarl Bøgwald, Norwegian
he fish immune system. Emphasis will be placed on innate
                                                               College of Fishery Science, University of Tromsø, N-9037
and acquired immunity, on immune modulation and on
                                                               Tromsø, Norway. E-mail: jarlb@nfh.uit.no. For further
immunity to infection. During the workshop the latest
                                                               details contact Janina Costa or Kim Thompson, Institute of
insights into the evolution of the immune system, and
                                                               Aquaculture, University of Stirling, Stirling, Scotland FK9
related issues such as (experimental) animal welfare and
                                                               4LA Fax: 0044 1786 472133 Tel: 0044 1786 467912 Email:
the influence of stress on the immune response, will be
                                                               noffi@stir.ac.uk. Conference updates may be viewed at
discussed. Level: The workshop is targeting academic and
                                                               NOFFI’s website: http://www.abdn.ac.uk/noffi/.
company researchers as well as management staff in the
aquaculture industry. PhD students are welcome and a           32nd Annual Eastern Fish Health Workshop; 18-22 June
lower registration fee is available to them. The official      2007; Gettysburg, Pennsylvania, USA: The annual
language of the workshop is English. The number of             EFHW will be held this year at the
participants is limited to 30 persons, admitted on a ‘first-   Eisenhower Inn and Conference
come’ basis. Registration fee is 250 € (Ph.D.), 450 €          Center in historic Gettysburg. For
(academic staff) or 550 € (company staff). For all-in          further information, contact Dr. Rocco
registration (including accommodation and all meals) add       Cipriano at phone: 304-724-4432 or
450 € for the whole workshop period. Click here for

email: rcipriano@usgs.gov. Early registration is due 1 May        challenges surrounding the most important mollusc species
2007 (registration form). Abstracts are due 15 April 2007         in wild and farmed situations. Topics will include significant
(abstract and presentation information).                          infectious diseases, disease causation, techniques for
                                                                  sampling for the presence/prevalence of disease,
Salmonid Disease Workshop; 18-29 June 2007;
                                                                  diagnostic techniques and test interpretation, and outbreak
Corvallis, Oregon, USA: This 10-day workshop is
                                                                  investigation. Laboratory sessions will involve the whole
               designed for professionals working in the fish
                                                                  range of technical procedures for diagnosis and
               health field and will emphasize recent
                                                                  demonstrations of significant diseases and conditions,
               advances and developments in our
                                                                  including field exercise. This is a 5-day course, the formal
               understanding of salmonid diseases. The
                                                                  classes of which run on September 13, 14, 17, 18 &19
               workshop includes lectures and laboratory
                                                                  (participants can attend the International Shellfish Festival
exercises with plenty of opportunity for discussion. There is
                                                                  on 15-16 September). More information on registration,
a limit of 20 participants on a first come, first served basis.
                                                                  accommodations, etc. is available on their website at
Graduate students may take the course for 5 credits.
Details can be found at the workshop webpage.
                                                                  13th International EAFP Conference on Diseases of
13th Annual Drug Approval Coordination Workshop; 31
                                                                  Fish and Shellfish; 17-21 September 2007; Grado, Italy:
July-1 August 2007; Bozeman, Montana,
                                                                               This year the European Association of Fish
USA: This year’s Workshop will be held 31
                                                                               Pathologists (EAFP) will hold their 13th annual
July through 1 August 2007 at the Holiday
                                                                               conference at the Conference Centre in Grado,
Inn, Bozeman, Montana, USA. Co-hosts will
                                                                               Italy. Scientific and technical sessions
be the USFWS’s AADAP Program and USDA’s Stuttgart
                                                                               consisting of poster presentations, invited talks,
National Aquaculture Research Center. One workshop
                                                                  keynotes, oral presentations, workshops and an EAFP
highpoint will undoubtedly be a celebration of a couple of
                                                                  general assembly will take place during the conference.
new FDA aquaculture drug approvals. The workshop is a
                                                                  Planned social events include a welcome cocktail party, a
great opportunity to get “up-to-speed” on recent
                                                                  civic reception and the traditional conference banquet. The
aquaculture drug research activities and the status of initial
                                                                  conference is being organized by the council of the EAFP
or expanded approvals. In addition, a short session is
                                                                  and the local organizing committee. Additional information
scheduled to discuss current research and commercial
                                                                  can be found on the conference webpage.
status of fish vaccines. For more information, please visit
our website. We hope to see you then in Bozeman. More             7th International Symposium on Fish Parasites and the
information...                                                    3rd Myxozoan Workshop; 24-28 September 2007;
                                                                  Viterbo, Italy: This year's symposium is
Asian-Pacific Aquaculture 2007; 5-8 August 2007;
                                                                  being held at the Palazzo dei Papi on the
                   Hanoi, Vietnam: This is the first major
                                                                  24th and Domus la Quercia on the 25th
                   aquaculture conference to take place in
                                                                  through the 28th. There are 20 planned
                   Vietnam, and the theme of this year’s
                                                                  sessions on a diversity of topics, including
                   conference is “Prospering from Dynamic
                                                                  "Helminth systematics: from faunistics to DNA barcoding,"
                   Growth.” Conference organizers have
                                                                  "Parasites as biological tags of fish stocks and biology,"
plans for more than 20 sessions, including an aquatic
                                                                  and "Fish parasites control." The deadline for Abstract
animal disease session. The deadline for submission of
                                                                  submissions is 15 May 2007. Additional information can be
abstracts has already passed (15 March). Early
                                                                  found at their website: http://www.7isfp.com. For additional
registration fees are available if you register before 25 May
                                                                  information on the Myxozoan Workshop, click here.
or 12 July. See conference brochure for more details.
                                                                  Health Management of Laboratory Fish course; 17-22
137th Annual Meeting of the American Fisheries
                                                                  September 2007; Salisbury Cove, Maine, USA: This one
Society; 2-6 September 2007; San
                                                                  week course is being offered by the Mount Desert Island
Francisco, California, USA: This year’s
                                                                                         Biological Laboratory of Salisbury
meeting is being held at the Marriott Hotel
                                                                                         Cove. Topics to be discussed
(downtown San Francisco). “Thinking
                                                                                         include general system design and
Downstream and Downcurrent:
                                                                  water quality management, anatomy and histology of fish,
Addressing Uncertainty and Unintended
                                                                  general fish diseases and disease management strategies.
Consequences in Fish and Fisheries” is
                                                                  Faculty from Oregon State and Cornell Universities are
the theme for the conference. Detailed
                                                                  scheduled to conduct the classes. Registration deadline is
information can be obtained at the
                                                                  1 June 2007. For more information refer to the course
conference website.
Mollusc Health and Disease Management Course;
13-19 September 2007; Atlantic Veterinary College
University Of Prince Edward Island, Canada: This
advanced five-day training targets diagnosticians,
scientists, students and professionals of mollusc health
management. The session will address major issues and

Aquaculture CanadaOM 2007; 23-26 September 2007;                ROZ’s CORNER
Edmonton, Alberta, Canada: The 24th annual meeting of
the Aquaculture                                                 This was a good quarter for aquaculture drug approvals!
Association of
                                                                Eka Chemicals, Inc. obtained an approval for
Canada will be held
                                                                35% PEROX-AID® (hydrogen peroxide) for control of
at the Shaw
                                                                mortality in (1) freshwater-reared finfish eggs due to
Conference Centre
                                                                saprolegniasis, (2) freshwater-reared salmonids due to
and the Westin Edmonton. This is Canada’s national forum
                                                                bacterial gill disease, and (3) freshwater-reared coolwater
on business, science and technology of aquaculture. For
                                                                finfish and channel catfish due to external columnaris
more information contact Christopher M. Pearce at
                                                                disease on 11 January 2007. Eka Chemicals, Inc.
PearceC@pac.dfo-mpo.gc.ca or refer to the conference
                                                                recognized the contributors to the approval at Aquaculture
                                                                2007 during my producer session entitled “Aquaculture
Aquaculture Europe 07; 24-27 October 2007; Istanbul,            Drug Approval Successes”. Because no representative
Turkey: This year’s annual meeting of the European              from the Upper Midwest Environmental Sciences Center
                      Aquaculture Society will be held at the   (UMESC) was able to attend the recognition ceremony,
                      World of Wonders City Hotel               Eka Chemicals, Inc. came to La Crosse, Wisconsin on 13
                      (conference portion) and the Istanbul     March 2007 to present the awards directly to the scientists
                      Expo Centre (exhibits portion) both in    who provided the environmental assessment, target animal
Yesilkoy, Istanbul and opposite Istanbul’s Ataturk Airport.     safety, and effectiveness data for the approval.
The conference theme “Competing Claims” addresses the
                                                                Schering-Plough Animal Health (SPAH) obtained an
various levels of competition that aquaculture faces at
                                                                approval for Aquaflor® (florfenicol) for control of mortality
present, but upon which its future development will depend.
                                                                associated with coldwater disease in freshwater-reared
For more information, refer to their website. The
                                                                salmonids on 19 March 2007. The approval of Aquaflor® is
conference comprises 5 thematic sessions, as well as
                                                                the result of cooperation between SPAH and federal and
12 subject-specific sessions, including a “Health
                                                                state researchers: Aquatic Animal Drug Approval
Management and Welfare” session. The deadline for
                                                                Partnership Program (AADAP, Bozeman, Montana),
submission of abstracts has passed (1 April). Early
                                                                UMESC, and the Montana Department of Fish, Wildlife,
registration fees are available if you register before 15 May
                                                                and Parks. SPAH previously recognized AADAP and
or 10 September. See conference webpage for more
                                                                UMESC for contributions to the approval of Aquaflor® for
details, including conference brochure, on-line registration,
                                                                the control of mortality due to enteric septicemia in catfish
accommodations, etc.
                                                                at Aquaculture America 2006 during my producer session.
Caribbean and Latin American Aquaculture 2007;                  Rosalie (Roz) Schnick, National Coordinator for
6-9 November 2007; San Juan, Puerto Rico: The Latin             Aquaculture New Animal Drug Applications, Michigan
American and Caribbean Chapter of the World Aquaculture         State University, La Crosse, Wisconsin.
Society are organizing this year’s conference and have
                        more than 20 sessions planned
                        with one for “fish and shrimp health
                        management” and one on “aquatic
                        animal-derived therapeutic drugs
                        for humans.” The conference is
                        being held at the Condado Plaza
Hotel in San Juan. Submission of abstracts must be made
online by 15 April 2007. Please refer to the conference
website for more details.
Aquaculture America 2008; 9-12 February 2008; Lake
Buena Vista, Florida, USA: The 2008 conference will be
               held at Walt Disney
               World’s Coronado
               Springs Resort. This
               year’s conference is
being held in conjunction with Marine
Ornamentals ’08. The deadline for submission of abstracts
is 3 August 2008. For more information refer to the
conference website.


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