The Environmental Protection Agency has withheld information from the public about approvals of an experimental genetically modified crop, a nonprofit group said in a Jan. 9 letter to the agency.

EPA approved in April 2000 the experimental plantings of the crop, which Monsanto Co. had requested in December 1999 for 27 states and Puerto Rico, the Union of Concerned Scientists said.

However, the agency has not announced the approvals, UCS said.

The failure to announce issuance of the permits that allow Monsanto to test the products "leaves us in the dark as to what sorts of risk and benefits this product presents," Margaret Mellon, of the Union of Concerned Scientists, told BNA Jan. 12.

EPA said it would announce any issuance of the permits in the Federal Register (64 Fed. Reg. 68,681). Monsanto requested the permits Dec. 8, 1999, for plantings in 1999 and 2000. None of the crops were allowed to be used for food or feed, according to the notice announcing receipt of the request.

In its letter, the Union of Concerned Scientists asked EPA Administrator Carol Browner to release information on the crop approvals, which UCS said were made by EPA more than eight months ago.

The approvals involve corn engineered to produce the Cry3Bb Bacillus thuringiensis toxin to fight the corn rootworm, the letter said.

This plant pesticide is not yet registered for use in the United States.

Monsanto on Dec. 28, 2000, asked EPA to allow more plantings of the crop, on 4,000 acres in 35 states and Puerto Rico (65 Fed. Reg. 82,352).

UCS asked EPA to establish procedures to ensure the public is informed in a "timely fashion" of agency decisions on experimental use permits.

'Prompt Notice.'

Generally, under 40 C.F.R. 172.11(c), the EPA administrator "shall give prompt notice" in the Federal Register of issuance of experimental use permits.

For example, the agency in 2000 announced the issuance of an experimental use permit to Monsanto for a genetically modified pesticidal protein to be tested for use against soybean pests in 13 states (65 Fed. Reg. 38,828). Also, EPA issued a permit for a pesticidal protein in corn in 14 states (64 Fed. Reg. 24,161).

The Union of Concerned Scientists, and public interest and environmental organizations in written comments to EPA, have opposed Monsanto's application to register the protein produced in corn to attack the corn rootworm. They said that the request should be denied because it provided insufficient information (62 DEN A-11, 3/30/00).

The approvals not announced by EPA include three experimental use permits on corn crops, the UCS letter said.

UCS said it learned of EPA's April 2000 approval of the permits from agency staff, following a Dec. 28 Federal Register notice, in which Monsanto sought an amendment to an earlier permit.

Bryan Hurley, spokesman for Monsanto, told BNA Jan. 12 that there were two permit requests. EPA has granted one of the company's experimental use permits, Hurley said. A second request for an experimental use permit is pending, Hurley added.

The second permit would expand on the first, he said.

It is apparently EPA's policy to inform the public of the receipt of requests for experimental use permits of the crops, but not of their approval, Hurley said.

EPA officials were unavailable for comment on the UCS letter Jan. 12.

Experimental use permits are awarded to companies that genetically engineer crops to repel pests. These permits allow the companies to develop data to support a registration of a pesticide, or a genetically modified crop, Mellon said.

It is against the law to use an unregistered pesticide, Mellon said. As a result, it is necessary for companies like Monsanto who want to test new products to obtain these experimental use permits (EUPs) from EPA for the pesticidal crops, Mellon added.

EPA registers plant pesticides, also known as "plant-incorporated protectants." These pesticides, which are separate from the crop itself, include the pesticidal toxin produced by the plant and the genetic material needed to produce the toxin.

The Union of Concerned Scientists is an organization that supports a transition to a sustainable food system.

The corn rootworm beetle is one of the Corn Belt's worst pests, causing about $1 billion each year in reduced yields and pest control costs, the letter said.

Transparency Urged

The group urged EPA to publish information about the approvals immediately, and to delay consideration of experimental use permit extensions, pending release of "relevant documents" concerning the approvals.

"[I]t is deplorable that the agency withheld its approval from the public for months and even entertained an extension of one of the secretly approved EUPs," the letter said.

"It looks to us as though EPA is colluding with industry to avoid the bad publicity that comes with inappropriate approvals of engineered crops."

To address the situation, the Union of Concerned Scientists urged EPA to establish procedures ensuring the public is informed in a timely way of agency decisions on experimental use permits, and registrations, on the crops.

The group also urged the agency to announce the approvals in the Federal Register, and make decision documents available, release health and safety data submitted by Monsanto, and postpone the start of any public comment period on the permits until all relevant documents are placed in the public docket.

Decisions Not Announced to Public

The Union of Concerned Scientists said its scientists had just discovered that EPA has not yet announced approvals--awarded more than eight months ago--of experimental use permits for genetically engineered corn.

At the same time, the group said, EPA is now entertaining a request for the extension of one of the permits whose approval notice has been withheld.

The group pointed to an announcement by EPA on Dec. 8, 1999, of receipt of three applications from Monsanto, requesting EUP's to allow "large-scale" testing of corn that produces the Cry3Bb toxin from Bacillus thuringiensis (Bt) to fight the corn rootworm pest.

On Dec. 22, 1999, EPA announced Monsanto had asked to register the product.

On Dec. 28, 2000, EPA announced it had received another experimental use permit from Monsanto, to plant more of the corn, the letter said.

However, EPA staff indicated the Dec. 28 permit was an amendment to one that had already been approved by EPA in April, the letter said.

EPA had approved all three of Monsanto's permits in April, but did not announce them, the letter added.

The federal government's credibility in regulating the crops is important to groups such as UCS that care about the environment and public health, and also to the biotechnology industry, Mellon said.

Also, trading partners overseas are interested in the credibility of the U.S. regulatory system.

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