GOALS AND OBJECTIVES

KEY ORGANIZATION AND CONTACT

1

Identify, evaluate, prioritize, and promote legal access to drugs, pesticides, and biologics needed for diverse aquaculture species;

Implementation plan:

-         review priority compounds and status annually

-         recruit domestic and international collaborators

-    post information on www

Leader: Roz Schnick , National Aquaculture NADA Coordinator 

Participants: Randy MacMillan, NAA;  David Scarfe AVMA; Larry Elsken, USDA/APHIS/CVB; Joe Hogue, EPA/OP

2

Evaluate and strengthen the development of data for technical sections required for NADA approval

-         develop comprehensive matrix on status of all  technical sectors for all public domain drugs under investigation and post on www

-          identify entities associated with data development and sponsors

-         review standards and protocols and any constraints

-         encourage focused, coordinated and sustainable activities to complete approvals

-         support a National Research Forum to identify research needs, constraints,  and coordinate activities

-         foster communication between FDA-CVM and EPA on environment assessment analysis

Co-leaders: Roz Schnick, National Aquaculture NADA Coordinator  and Bill Gingerich, USGS

Participants: Dave Straus, USDA-ARS; Paul Bowser; NRSP-7; Renate Reimschuessell, FDA/CVM/OR; EPA; Jim Bowker, USFWS; Mark Gaikowski USGS

3

Explore innovative strategies for funding the research needed to facilitate aquaculture drug approvals, chemical registrations, and biologic licensing;

Implementation plan:

-         assemble listing of potential funding sources

-    seek broader input from professional societies

Leader: Max Mayeaux, USDA/CSREES

Participants:  Meg Oeller, NRSP-7; Eric Schwaab, IAFWA; Dave Straus, USDA/ARS; Renate Reimschuessel, FDA/CVM/OR; Roz Schnick

4

Encourage the aquaculture community to assist in defining crop grouping for drug specific applications;

Implementation plan:

-         collaborate with AFS, USGS, USFWS, and NRSP-7 programs

-         seek parameters and opportunities with FDA

-     engage FDA/CVM aquaculture research program

Leader: Bill Gingerich, USGS

 Participants: Randy MacMillan, NAA; Paul Norton, FTFFA;  Eric Parks, Ornamental Fish Growers; John Pitts; Renate Reimschussel, FDA/CVM/OR; Paul Bowser, NRSP-7; Paul Bowser,AFS Fish Health Section

5

Encourage the aquaculture community to assist in defining food/non-food life stages for drug specific applications;

Implementation plan:

-         identify current needs and actions

-         develop data to support non-food life stage groupings

-         seek direction and guidance from FDA/CVM

Participants: Paul Norton, Ornamental Fish Growers-FTFFA, Eric Parks, Baitfish Growers; John Pitts; Dan Herman, NFI

6

Facilitate the funding and support for the National Aquaculture New Animal Drug Approval (NADA) Coordinator from both public and private sectors;

Implementation plan:

-         biannual report and review of accomplishments

-         evaluation of role and responsibilities

-         funding needs analysis

-         update during regular Working Group meetings

Leader: National Aquaculture NADA Coordinator (Roz Schnick)

7

Foster international cooperation, encouraging the pooling of resources, as well as the sharing of data and facilities, leading to aquaculture drug approvals, chemical registrations, and biologic licensing;

Implementation plan:

-         identify foreign sources of pertinent data and information to advance approvals in U.S.

-         monitor and report on activities of international harmonization agencies such as CODEX, VICH, etc.

Co-Leaders: Chuck Eirkson, FDA-CVM; Barbara Montwill, FDA-CFSAN

 Participants:  Chuck Eirkson, FDA;  Larry Elsken, USDA/APHIS/CVB; Gary Jensen, USDA/CSREES; Richard Sellers, AFIA; Stanley Serfling, FDA/CVM/OR

8

Support the continued development of producer quality assurance programs for aquatic species. Foster utilization of producer-based quality assurance programs together with processor-based Hazard Analysis Critical Control Point (HACCP) principles;

Implementation plan:

-         biannual progress reports and updates by industry associations

-         assistance to interested parties

-         reviews of FDA Fish and Fishery Products Hazards Control Guidance and link to QAPs

-         evaluation of Good Aquacultural Practices approaches

-         coordinate exchange of information with the JSA National Aquatic Animal Health Task Force on Aquaculture

Leader: Barbara Montwill, FDA/CFSAN

 Participants: Betsy Hart, NAA; Hugh Warren CFA; Dan Herman, NFI;  Gary Fornshell, USTFA, Curry Woods, SBGA

9

Develop, update and distribute educational publications: 

Implementation plan:

-   Guide to drug, vaccine, and pesticide use in aquaculture,        edited by CSREES with key contributions from APHIS, EPA, FDA-CVM, and FDA-CFSAN

           revise Guide and post on www 1/2004

           update Guide annually

- Technical papers on contemporary topics and reviews of federal monitoring and sampling programs

Co-leaders: Gary Jensen and Max Mayeaux, USDA/CSREES 

 Participants: Larry Elsken, USDA/APHIS/CVB; Joe Hogue, EPA/OP; Kevin Greenlees, FDA/CVM; Barbara Montwill, FDA/CFSAN/OS; David Scarfe, AVMA; Roz Schnick, National Aquaculture NADA Coordinator

10

Monitor, distribute, evaluate, and promote pending Federal legislation, regulations and compliance policies pertaining to aquaculture drugs, pesticides and biologics, and quality assurance;

-         monitor and report Federal Register notices and introduced legislation and associated actions

-         monitor field surveillance activities by FDA related to aquaculture

-    provide overview of timely issues for discussion and review      purposes

Leader: Max Mayeaux, USDA/CSREES

 Participants: Kevin Greenlees, FDA/CVM; Barbara Montwill, FDA/CFSAN/OS; Larry Elsken, USDA/APHIS/CVB; Joe Hogue, EPA; Paul Zajicek, NASAC

11

Maintain electronic matrix on the status of drug approvals, investigational new animal drug (INAD) exemptions and other pertinent aquatic animal health information to encourage and facilitate public access and review.

Implementation plan:

-         CSREES maintain web site for National Aquaculture New Animal Drug Coordinator

-         CSREES maintain home page for working group on JSA site

-         identify links with pertinent federal agency web sites

-         develop home page as an educational outreach site for the public and gateway to other pertinent www links

-         seek continued assistance from AquaNIC to host web sites

Leader: Max Mayeaux, USDA/CSREES

 Participants: Roz Schnick, National Aquaculture NADA Coordinator; Alistair Webb, NRSP-7; Tom Bell, USFWS 

12

Promote the participation of domestic and international agencies,  producer groups, sponsors and academics in the activities of this National Working Group

Implementation plan:

-         develop news releases on activities and accomplishments

-         publicize scheduled meetings and recruit new participants

-         use web site: http://ag.ansc.purdue.edu/aquanic/jsa/wgqaap/wgqaap.htm   and mailgroup (jsaqawg) to distribute information and solicit input in a timely manner

-         plan and convene 1-2 meetings annually

Co-leaders: Kevin Greenlees, FDA/CVM and Gary Jensen, USDA/CSREES

Participants: all members of working group

AFS-FHS

American Fisheries Society-Fish Health Section

AVMA

American Veterinary Medical Association

CFA

Catfish Farmers of America

EPA/OP

Environmental Protection Agency Office of Pesticides

FDA/CFSAN/OS

Food and Drug Administration Center for Food Safety and Nutrition Office of Seafood

FDA/CVM

Food and Drug Administration Center for Veterinary Medicine

FTFFA

Florida Tropical Fish Farms Association

IAFWA

International Association of Fish and Wildlife Agencies

NAA

National Aquaculture Association

NFI

National Fisheries Institute

NRSP-7

National Research Support Project – 7 A National Program to Approve Animal Drugs for Minor Species and Uses

SBGA

Striped Bass Growers Association

USDA APHIS CVB

United States Department of Agriculture Animal Plant & Health Inspection Service Center for Veterinary Biologics

USDA/ARS

United States Department of Agriculture/ Agricultural Research Service

USDA/CSREES

United States Department of Agriculture Cooperative State Research, Education, and Extension Service

USGS

United State Geological Survey

USTFA

United States Trout Farmers Association