Aquaculture NADA Coordinator
General Reports
REPORT
ON ROUNDTABLE ON THE NEED FOR A ZERO WITHDRAWAL ANESTHETIC
A
very successful roundtable discussion on the critical need for a zero withdrawal
anesthetic centering on AQUI-SÒ
was held Sunday, August 22, 2004 at the annual meeting of the American Fisheries
Society (AFS) in
1.
Identify
anesthesial procedures needing a zero withdrawal time anesthetic
2.
Identify
potential candidates for a zero withdrawal anesthetic
3.
Identify
current efforts and data gaps for approval of a potential zero withdrawal
anesthetic—AQUI-SÒ
4.
Determine
ways and means to secure
a.
Additional
research support for AQUI-SÒ
for the label claims currently underway and funded
b.
Additional
funding for the label claims not covered by current efforts and funding for
AQUI-SÒ
5.
Determine
ways and means of alerting the fisheries communities to the need for approval,
support, and additional funding for AQUI-SÒ
The
first two purposes were easily accomplished.
The third purpose centered on AQUI-SÒ
label claims currently underway and funded for the initial new animal drug
application approvals. These label
claims include (1) short-exposure procedures for all freshwater and saltwater
salmonids and (2) short-exposure procedures for all coolwater and warmwater
freshwater fish. One of the two
presentations centered on the data that have been generated showing the
effectiveness of AQUI-SÒ
to help perform procedures needing short-exposures to the handeable stage for
freshwater fish (Jim Bowker presenter, U.S. Fish and Wildlife Service).
The Roundtable group discussed the last two purposes in great detail.
The
ways and means for securing additional research support for supportive efficacy
data for the initial label claims underway included:
1.
Get
additional persons to sign up for the investigational new animal drug (INAD)
exemption on AQUI-SÒ
2.
Obtain
information on supportive efficacy data needs for the AQUI-SÒ
INAD through the International Association of Fish and Wildlife Agencies Drug
Approval Working Group
The
ways and means for securing additional funding for potential, additional label
claims (e.g., transport) included:
1.
Advocate
the continued funding of the entities currently involved in the drug approval
effort on AQUI-SÒ
2.
Re-establish
aquaculture drug approvals as a National Conservation Need through
3.
Determine
need for potential, additional label claims (e.g., transport) through a survey
of all potential stakeholders
4.
Address
the label claims not discussed at the Roundtable (i.e., surgical
anesthesia/all fish & shellfish and short-exposure/marine fish (not
salmonids) & shellfish by determining the need and potential support from
its stakeholders
The
ways and means of alerting the fisheries communities to the need for approval,
support, and additional funding for AQUI-SÒ
included:
1.
Meetings
involving stakeholders
2.
Article
on this issue in Fisheries
3.
Fact
sheets on AQUI-SÒ
4.
Pertinent
Websites
5.
Newsletters
from societies and associations involved in fisheries and aquaculture
6.
Seminars
with stakeholders needing AQUI-SÒ
We
will be discussing the ways and means to accomplish our goals on AQUI-SÒ
at the meeting of the Drug Approval Working Group of the International
Association of Fish and Wildlife Agencies on September 27, 2004 in
This
is a good start toward our goal of a zero withdrawal anesthetic approval (i.e.,
AQUI-SÒ).
Let’s work together to gain broad approvals for AQUI-SÒ
for all fish and shellfish.
Rosalie
(Roz) Schnick
National Coordinator for Aquaculture New Animal Drug Applications
Phone: (608) 781-2205
Fax: (608) 783-3507
E-mail: RozSchnick@centurytel.net
Web: http://aquanic.org/aquadrugs/index.htm