APPROVAL FOR GENETICALLY ENGINEERED BENTGRASS CREEPS THROUGH AGENCY TURFS
Phillip B. C. Jones
January, 2005

Monsanto Company and The Scotts Company want to market creeping bentgrass (Agrostis stolonifera) genetically modified (GM) for tolerance to the glyphosate herbicide, Roundup®. The companies plan to sell the GM plant for use in commercial grass seed production and on golf courses. Among the benefits attributed to GM bentgrass, the companies claim that it will enhance the uniformity, quality, aesthetics, and playability of golf course turf. Before GM bentgrass can be sold within the United States, however, Monsanto and Scotts must obtain approval for commercial use from the Food and Drug Administration, the Environmental Protection Agency, and the Department of Agriculture.

Monsanto and Scotts Make a Hole in One at the FDA
The Federal Food, Drug, and Cosmetic Act authorizes the FDA to monitor food and feed safety. Monsanto and Scotts provided the agency with a summary of a safety and nutrition evaluation to permit a possible feed use of glyphosate-tolerant bentgrass straw and chaff. Based on the companies’ assessments, the FDA understood that glyphosate-tolerant bentgrass forage derived from the new GM plant does not materially differ in composition and safety from creeping bentgrass forage currently on the market. The agency stated that genetically engineered bentgrass does not raise issues requiring pre-market review or approval by the FDA.

Companies Pitch for a Deuce at the EPA
The EPA regulates two aspects of GM bentgrass. Under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act, the EPA requires the registration of herbicides prior to distribution or sale, unless exempt by EPA regulation. In the case of Roundup®-tolerant GM bentgrass, the EPA must approve a new use or different pattern of use for the herbicide. Monsanto and Scotts filed proposed supplemental labels for Roundup® PRO herbicide for uses in seed production of the GM bentgrass and for general weed control in glyphosate-tolerant bentgrass turf planted on golf courses.

The EPA also establishes residue tolerances for herbicides, an activity authorized by the Federal Food, Drug, and Cosmetic Act. The agency must determine residue tolerances when the use of herbicide on a GM plant may result in increased residues in a food or feed crop for which the herbicide is currently registered, or may result in new residues in a crop for which the herbicide is not currently registered. Here, the EPA determined that it is not necessary to revise the existing tolerance for a minimal use of creeping bentgrass straw and chaff as animal feed.

Deregulation: the Line of Play at APHIS
In April 2003, Monsanto and Scotts advanced their commercialization plans by filing a request with the USDA’s Animal Plant and Health Inspection Service for a determination of nonregulated status for GM bentgrass. The companies asserted that APHIS should not regulate the GM bentgrass because the engineered plant does not present a plant pest risk.

In a preliminary risk assessment, the agency reached the following conclusions: there appear to be no major unintended effects resulting from the introduction of the glyphosate-resistance gene into the creeping bentgrass genome; GM bentgrass is not sexually compatible with any federally acknowledged threatened or endangered species, or with any species on the federal noxious weed list; and GM bentgrass does not differ in pest and pathogen susceptibility or resistance from its parent. APHIS seemed to be on the verge of approving the new plant.

Yet the agency, in its experience, considered GM bentgrass to be unique. Unlike deregulated articles it had previously considered, APHIS characterized GM bentgrass as a widespread perennial species that establishes without cultivation in a variety of habitats. The agency noted that creeping bentgrass can form hybrids with at least 12 other U.S. naturalized or native species of bentgrasses and rabbit’s foot grasses. This raised the possibility that GM bentgrass, or its glyphosate-tolerant progeny, would establish in various urbanized and natural areas.

In January 2004, APHIS opened a 60-day period for public input, soliciting comments and information on whether GM bentgrass presents potential risks to the environment, including a plant pest risk. APHIS’ request garnered over 480 remarks. About 339 expressed support for the deregulation petition, while 134 expressed concern or opposed the petition.

University-based weed and turf grass specialists, golf course superintendents, and golf course operators numbered among the strongest supporters; commenters associated with plant societies, environmental and consumer groups, and certain federal, state, and city officials opposed deregulation. The opposers echoed APHIS’ concerns about the aggressiveness of Agrostis and the possible spread of the glyphosate-tolerant transgene with potential loss of glyphosate for control of invasive perennial grasses.

APHIS reported results of the public comment request in September 2004 and announced its decision to prepare an environmental impact statement to examine potential environmental effects associated with a determination of nonregulated status for GM bentgrass. The agency identified issues that it proposed to explore and opened a 30-day period for public comment on this proposed scope of study.

Genetic and Legal Hazards for GM Bentgrass Commercialization
One of the issues that APHIS identified for further examination in the environmental impact statement process was whether deregulation of GM bentgrass might result in its establishment and persistence in situations where it is unintended or unexpected. On the same day that APHIS released its notice about the proposed environmental document, the Proceedings of the National Academy of Sciences electronically published the study of Lidia Watrud et al. As detailed elsewhere in this ISB News Report, Watrud and her colleagues documented that GM bentgrass’ glyphosate-tolerance trait can indeed spread to unintended or unexpected locations.

On October 5, a group led by the International Center for Technology Assessment and the Center for Food Safety responded to the PNAS paper by filing against the USDA with a request for an immediate injunction. The Center asked a Washington, D.C., federal court to bar the USDA from allowing or approving any further field tests of GM bentgrass and to order the agency to terminate all such current permits for field tests. The injunction request is part of a case filed in January 2003 that seeks to block environmental releases of the engineered bentgrass. A copy of the injunction can be found at the Center for Food Safety’s website (http://www.centerforfoodsafety.org/).

APHIS Plays Through
When they filed a request for an injunction, the plaintiffs had requested a hearing within twenty days. However, the case bogged down as the parties obtained extensions of time to reply to each other’s assertions, and the judge allowed Scotts Company to intervene as another defendant with its own assertions. The twenty-day deadline passed without a hearing.

Meanwhile, APHIS continues to review the petition for deregulation. On November 18, the agency reopened the comment period for an additional two weeks and announced a decision to hold a public meeting to encourage further public participation in defining the scope of the environmental impact study. APHIS plans to announce the date and location of the meeting on its website and in the Federal Register.

When APHIS does complete its environmental document, the agency will make it available for public input. After evaluating these comments, APHIS will either approve the petition in whole or in part, or deny the petition. The agency will then publish a notice in the Federal Register announcing the regulatory status of the GM bentgrass.

Glyphosate-tolerant bentgrass has been under development for about six years and has been released for field tests in over 30 states. Nevertheless, GM bentgrass still has a fair way to go before it appears on golf courses.

Selected References

APHIS (2004) Monsanto Co. and The Scotts Co.; Availability of petition for determination of nonregulated status for genetically engineered glyphosate-tolerant creeping bentgrass. Federal Register 69, 315-317, January 5, 2004

APHIS (2004) Environmental impact statement; Petition for deregulation of genetically engineered glyphosate-tolerant creeping bentgrass. Federal Register 69, 57257-57260, September 24, 2004

APHIS (2004) Environmental impact statement; Petition for deregulation of genetically engineered glyphosate-tolerant creeping bentgrass. Federal Register 69, 67532-67533, November 18, 2004

Phillip B. C. Jones, PhD., J.D.
Spokane, Washington
PhillJones@nasw.org