News Release

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March 13, 2007
Randy Hines
(608) 783-6451 x398
rkhi...@usgs.gov

Catherine Puckett
(352) 264-3532
cpuck...@usgs.gov

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First New Waterborne Aquaculture Drug in 20 Years Approved

Twelve years of rigorous research by USGS scientists helped lead to the
approval by the Food and Drug Administration (FDA) of the first
waterborne drug for fish diseases in more than 20 years.
The drug, 35% PEROX-AID, a product of EKA Chemical, Inc, in Marietta,
Ga., was approved recently for use in three diseases of freshwater fish
and their eggs that, left untreated, cause significant losses to the $1
billion (2006) U. S. aquaculture industry. State and federal natural
resource agencies responsible for fish hatchery programs benefit from
more effective and efficient production, including endangered and
threatened species broodstock protection, and the public benefits from
healthy fish released into the wild for recreation through restoration
programs.
Private aquaculture will also benefit from approval of the new drug.
According to industry figures, uncontrolled diseases cause around $100
million in losses in the catfish industry alone. Half of the reported
disease cases were attributed to the three diseases this new drug can
treat: bacterial gill disease and external columnaris disease of fish,
and saprolegniasis on fish eggs.
Researchers at the USGS Upper Midwest Environmental Sciences Center
(UMESC) in La Crosse, Wisc., developed the data that resulted in the
approval for the drug, with financial support through the Federal-State
Aquaculture Drug Approval Partnership Project. Dr. Michael Jawson, UMESC
center director, said that this approval is a critical step forward in
helping control diseases in commercially and publicly raised fishes. He
noted that the broad use approval is unique and significant for U.S.
aquaculture in that it covers two fish life stages eggs and fish of a
number of cultured freshwater fish species for three separate diseases.
Fish commonly afflicted with these diseases include trout, salmon,
steelhead, channel catfish, and tilapia.
Rosalie Schnick, National Coordinator for Aquaculture New Animal Drug
Applications, said, The scientists at the Upper Midwest Environmental
Sciences Center did an excellent job completing the major data
requirements for obtaining this most significant approval. The 35%
PEROX-AID approval is a tremendous example of a public research facility
cooperating with a private entity to gain results that will benefit the
propagation of finfish for public good, including fisheries restoration
and enhancement.
USGS scientists completed target animal safety studies on many
freshwater fish species, conducted critical laboratory and field
efficacy studies, and completed a comprehensive environmental assessment
of hydrogen peroxide use in aquaculture. Eka Chemicals, Inc., completed
the requirements for drug manufacturing and worked with Schnick to
complete the requirements for human food safety. Under the Minor Use
Minor Species Animal Health Act as administered by the FDA, Eka
Chemicals, Inc. has an exclusive right for 7 years of marketing for the
approved indications beginning on the date of approval. This privilege
is extended to drug sponsors to encourage the development of drugs with
limited economic potential due to their restricted market. The drug is
expected to be available to commercial and public aquaculture in late
winter or early spring.
USGS began this research in 1994 in response to a request by the
Association of Fish and Wildlife Agencies that state natural resource
agencies needed specific drugs to combat specific fish diseases. Dr.
William Gingerich, the lead researcher on the project, agrees with
Schnick that the approval for this new aquaculture drug is unique
because it is so comprehensive. He credits the Food and Drug
Administration reviewers and policy makers for being open to the concept
of broad drug approvals for aquaculture drugs. Dr. Gingerich and his
team members will be recognized for their achievements today from Eka
Chemicals at a ceremony at the Center. The USGS scientists on Dr.
Gingerichs research team are Verdel Dawson, Mark Gaikowski, Wendy
Larson, Jeffrey Meinertz, Jeffrey Rach, Susan Schleis, Larry Schmidt,
and Theresa Schreier.
For more information on the Aquaculture Drug Research and Development
Program at the USGS Upper Midwest Environmental Sciences Center go to
http://www.umesc.usgs.gov/aquatic/aquaculture_drug.html