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![handle is hein.cbhear/fdsysates0001 and id is 1 raw text is: AUT-ENTICATED
US. GOVERNMENT
INFORMATION
GP
DEPARTMENT OF THE INTERIOR, ENVIRON-
MENT, AND RELATED AGENCIES APPRO-
PRIATIONS FOR FISCAL YEAR 2014
U.S. SENATE,
SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS,
Washington, DC.
NONDEPARTMENTAL WITNESSES
[CLERK'S NOTE.-The subcommittee was unable to hold hearings
on nondepartmental witnesses. The statements and letters of those
submitting written testimony are as follows:]
PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF FISH VETERINARIANS
Dear Chairman Reed and members of the subcommittee: We are writing in sup-
port of the U.S. Fish and Wildlife (FWS) Aquatic Animal Drug Approval Partnership
(AADAP) program. Current proposed budget cuts will effectively eliminate the crit-
ical services that AADAP provides to all fisheries professionals and the aquaculture
industry in the United States. The American Association of Fish Veterinarians
(AAFV) is an association of licensed veterinarians that works in the area of aquatic
animal medicine. A central function of our organization is to advance the quality
and stature of clinical fish veterinary practice and provide safe and effective treat-
ments for fish. We rely heavily upon the AADAP program to assist in the approval
process for new animal drugs used in the various aspects of fish medicine and the
aquaculture industry. We respectfully request through this letter that current levels
of funding at $1,790,000 and current full-time equivalents (FTEs) of the staff be
maintained to continue AADAP's mission.
The AADAP program works in a unique partnership with Federal, State, and pri-
vate enterprise to provide safe and efficacious drugs and other tools used to work
with fisheries resources in the United States. In the early 1990s, the Federal Food
and Drug Administration (FDA) announced that all fisheries drugs would need to
go through the same approval process that is required of other animal species. The
aquatic animal industry is small in comparison to terrestrial animal species produc-
tion and thus it does not attract investment by private drug companies as the in-
vestment returns are limited. Fisheries professionals have had to step up to the
challenge and take on the drug registration process on their own. The development
and approval of new animal drugs is quite complicated and expensive. The New Ani-
mal Drug Application (NADA) process has six study sections that must be completed
favorably to FDA standards prior to approval which takes many years of research
to complete and considerable investment of time and financial resources. Although
we all participate in this process, the AADAP program has taken up the lead in co-
ordinating the National Investigational New Animal Drug (INAD) Program (NIP).
Through the years, the NIP has allowed for a wealth of important ancillary efficacy
and target animal safety data to be generated and this has been used in supporting
new animal drug approvals for drugs and therapeutants that we can use.
Many species of fish are produced by the U.S. aquaculture industry which in-
cludes the FWS, State, and private fish hatcheries. These fish are used for rec-
reational and commercial fishing and for private sales with one commonality, most
of these fish like other veterinary species are considered a food animal. The food
animal classification carries a special stigma with the FDA and the general public
which requires these fish to be produced in safe and unadulterated manner. People
want to know that the fish they caught or the one they bought in the grocery store
is safe. This health and human safety issue is a huge responsibility for aquatic ani-
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