U.S. Food and Drug Administration

DRAFT, ICTA 10/ 14 November 17, 2003

Dr. Mark McClellan, Commissioner

U.S. Food and Drug Administration

14-71 Parklawn Building, 5600 Fishers Lane

Rockville, MD 20857

Stephen S. Sundloff, Director

Center for Veterinary Medicine, FDA

7519 Standish Place
Rockville Maryland 20855-0001
FEDERAL EXPRESS

Re: genetically engineered ornamental fish - URGENT, RESPONSE REQUESTED BY DEC. 1

Dear Commissioner McClellan and Director Sundloff,

In prior communications to FDA staff, the Center for Food Safety (CFS) has alerted FDA to the proposed commercialization of genetically engineered (GE) ornamental fish varieties in the United States. To date, CFS has had no response regarding the agency’s regulatory oversight of these varieties. Given the imminent likelihood that these fish could soon appear in U.S. retail markets, CFS [[and the other undersigned non-profit public interest groups,]]]] are seeking FDA’ s direct involvement on an urgent basis.

It is well-known through the media that ornamental fish have been engineered to be fluorescent. These fish already have been sold in Taiwan, Hong Kong, and Malaysia (key articles attached from Pew AgBiotech website and The Straits Times, Singapore). Their sale in Japan and Singapore was stopped by authorities there due to potential environmental risks. The Singapore Agri-Food and Veterinary Authority (AVA) took the drastic step of confiscating the flourescent fish in retail shops. Singapore requires all GE fish to first be approved by the Genetic Modification Advisory Committee and these fish reportedly have not gone through this process to date. A great deal of interest has been expressed in importing them and selling them in the huge U.S. market. A news report quoted an American tropical fish dealer as claiming that “it will be the greatest thing since popped corn” and indicated that distribution is planned through big chains such as Petco and Petsmart. Such sales now appear imminent.

At least one company, Yorktown Technologies, has a proposal pending before the California Fish and Game Commission (CFGC) seeking a regulatory exemption allowing the unregulated sale of GE fluorescent zebrafish (CFGC letter attached). This proposal will be considered at the Commission’s December 4-5, 2003, meeting, after being delayed from the planned Nov. 6 meeting. Initial indications are that the Commission may be likely to approve the proposal. Most other states would require no prior approval whatsoever. Statements from the Florida Department of Agriculture and Consumer Service (FDACS) indicate that GE ornamental fish already are being sold in Florida (FDACS letter attached). In any event, we are informed by the responsible California official that Yorktown Technologies has announced a January 5, 2004, “rollout” date on which they will commence a national campaign to sell these fish (Edward Pert, Chief, Fisheries Program Branch, CDFG, pers. comm, Nov. 4, 2003.) Other companies of which we are not aware also may be involved in this or other GE ornamental fish commercialization efforts.

It is urgent that FDA step in promptly and publicly advise Yorktown Technologies; the ornamental fish industry generally; the CFGC, FDACS, and other state officials about the legal requirement that no GE fish may be transported into or within the United States or commercialized without FDA approval under the New Animal Drug Application (NADA) provisions of the Federal Food, Drug, and Cosmetic Act. Only through FDA’s use of these provisions will a national-scale analysis be applied to the potential impacts of these novel non-native fish as required by the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). Failure to apply FDA regulatory requirements will allow piecemeal, generally unanalyzed, commercialization to occur and pose serious potential environmental risks. This is what Singapore AVA officials were concerned about and CFS has no doubt that the FDA will apply at least an equivalent level of scrutiny to this potentially precedent-setting action. Proactive steps by FDA are not only prudent, but urgently necessary. Once these GE species are sold in any one state there is no effective way to stop them being transported to every other state.

Numerous invasions of non-native fish, including dozens of ornamental and bait species have occurred across the United States throughout its history and in many cases have caused serious economic and environmental damage. According to the U.S. Fish and Wildlife Service ornamental have been major factors in the endangerment of native species, including but not limited to the Moapa dace, desert pupfish, White River spinedace, and Railroad valley springfish. Ornamental fish are routinely dumped into our nation’s marine and fresh water bodies by aquarium owners who no longer wish to keep them. All fisheries experts would agree that the commercial sale of a GE ornamental fish virtually guarantees that unauthorized releases of that fish will occur. (Indeed, GE fluorescent fish already reportedly have been illegally dumped into reservoirs in Singapore.) Their novelty and fluorescence will make them extremely attractive for broad commercialization as baitfish. Released into the wild, and when used as bait, they are likely to be consumed by predatory fish, birds, and mammals and thereby enter the animal and human food chains. Even the zebrafish proposed by Yorktown Technologies already have invaded in their non-transgenic form in several warmsprings and other warm-water locations around the United States (see USGS attachment and excerpt from U.S. Congress Office of Technology Assessment report). The fluorescent variety could readily invade in more areas, particularly if it is broadly marketed and achieves wide popularity.

As you know, FDA has already announced its intent to regulate the proposed commercialization of GE fish under the NADA provisions. It is well known that this applies to the proposal to commercialize GE salmon. It may not be as well known to the ornamental fish industry that FDA, in a cooperative effort with the White House’s Council on Environmental Quality (CEQ) and Office of Science and Technology Policy (OSTP) and other Federal agencies, have determined that the NADA requirements also apply to ornamental fish and FDA has primary regulatory jurisdiction over their proposed commercialization. The CEQ and OSTP “Case Studies of Environmental Regulation for Biotechnology” were published in January, 2001. The “Sidebar No. I.A on Ornamental Fish (Goldfish)”, posted on the FDA Center for Veterinary Medicine Biotechnology webpage, state clearly that regulation of GE ornamental fish will follow the same basic process as GE salmon, i.e., pre-market approval under a NADA. (As the CEQ/OSTP salmon case study makes clear, whether the fish is intended as food or not is irrelevant to the applicability of the NADA requirements.) In addition, that goldfish sidebar contains a wealth of background information on environmental risks of ornamental fish. In the event that Yorktown Technologies already is going through the NADA process, the public needs to be at least generally advised of this, as FDA’s policies need more explicitness. Further, any NADA process in this novel, precedent-setting area must be accompanied by a full environmental impact statement (EIS) prior to a final agency decision.

The importance of this matter cannot be stressed enough. If FDA somehow fails to regulate the proposal of Yorktown Technologies it will set a precedent for all other GE fish producers and the floodgates will almost literally be opened. Regardless of the merits of the Yorktown proposal, FDA must consider the broad scope of potential impacts of the other GE fish that are in the development stage. They must be regulated under the NADA provisions and with full NEPA and ESA compliance. If they are allowed to get into the nation’s commercial marketplaces as well as millions of private aquaria it would be impossible to recall them. Again, there will be no way to stop their release in to the environment or into the animal and human food chains. FDA must not allow such an irrevocable step to occur for what would be both the first GE animal ever approved for commercialization as well as the first GE retail consumer product.

Please respond substantively to this urgent request by December 1. For further information regarding this request, please contact: Peter T. Jenkins, CFS, Attorney/Policy Analyst, Tel:

Sincerely,

[[For other signers??]]]

Andrew Kimbrell, Executive Director

Center for Food Safety and International Center for Technology Assessment

660 Pennsylvania Ave. SE, Suite 302

Washington, DC 20003 USA

Tel: 202.547.9359 ext. 13

Fax: 202.547.9429

Enclosures

CC (by FedEx): Eric Flamm, Senior Science Policy Advisor, FDA

John Matheson, Toxicologist [[ OSC/OSCOD, MS HFV-200 RME474 Rockville MD 20855]]

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