01-5574. Amendment of an Experimental Use Permit

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has granted an experimental use permit (EUP) to the following pesticide applicant. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.

FOR FURTHER INFORMATION CONTACT:

By mail: Alan Reynolds, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Office location, telephone number, and e-mail address: 1921 Jefferson Davis Hwy., Rm. 910W46, Crystal Mall #2, Arlington, VA; [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who conduct or sponsor research on pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this action, consult the designated contact person listed for the individual EUP.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number OPP-50871A. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

II. EUP

EPA has issued the following EUP:

524-EUP-91. Amendment. Monsanto Company, 700 Chesterfield Parkway North, St. Louis, Mo. 63198. The amendment to this EUP allows the use of the plant-pesticide Bacillus thuringiensis Cry1Ac protein and the genetic material necessary for its production (vectors PV-GMBT01 and PV-GMBT02) in soybean . Notice of the original issuance of the EUP was published in the Federal Register on June 22, 2000 (65 FR 38828) (FRL-6592-5). On June 2, 2000, the EUP was amended to modify the containment provisions. Notice of receipt of an amendment was published in the Federal Register on August 30, 2000 (65 FR 52730) (FRL-6739-5). On January 5, 2001, the EUP was amended to allow the planting of an additional 19 acres of soybean to evaluate control of velvetbean caterpillar, stem borer, and soybean looper; to preform phenotypic observations; maintain the lines through seed production; and to preform efficacy trials. Additional acreage under this amendment to the program is authorized only in the State of Puerto Rico. This amendment is effective from January 5, 2001 to May 31, 2001. This amendment is issued with the limitation that all treated crops will be genetically contained and destroyed or used for research purposes only. Twelve comments were received in reply to the Federal Register notice announcing receipt of this application. The Federal Register notice announcing receipt of this application indicated that 22.0 acres would be tested in the States of Hawaii and Puerto Rico. All comments encouraged EPA not to approve the amendment. One or more commentors offered the following comments: 1) Hawaii has a unique and isolated environment that needs to be protected from the introduction of foreign organisms; 2) rare and endangered species in Hawaii need to be protected, including the Kamehameha butterfly; 3) long-term effects on Hawaiian soils need to be addressed including competition with native bacteria and soil insects; 4) any effects on non-target species including pollinators and native insects exposed to Bt crops need to be addressed; 5) biotech crops have not been adequately tested for food uses and there is no evidence biotech food is safe; 6) effects of biotech crops on children are unknown; 7) biotech products should be labeled (at the supermarket); 8) organic farmers adversely affected by biotech should be compensated; 9) butterfly populations harmed by biotech should be restored; 10) ecological concerns including outcrossing and genetic drift need to be addressed; 11) adequate containment provisions are needed for the program.

After the Federal Register notice announcing this application was issued, Monsanto revised the program to eliminate the proposed acreage in Hawaii. Therefore, all comments and issues raised for the Hawaiian acreage are no longer germane for this EUP.

Based on submitted information, no significant or irreversible hazards to endangered species or non-target organisms in Puerto Rico are anticipated for this limited acreage, contained, crop destruct program.

Because the EUP has crop destruct provisions and is for non-food use only, no human dietary exposure is expected. As such, food safety issues (including food labeling, effects on children, and allergenicity concerns) are not germane for this EUP. There is no evidence that organic growers have been adversely affected by any EPA-registered Bt crop.

Outcrossing and genetic drift are unlikely due to the genetic containment provisions of the EUP, the lack of wild soybean relatives in test areas, and the low rate of soybean cross-pollination (soybeans are self-pollinated). All Cry1Ac soybeans grown under this EUP are required to be isolated from non-transgenic soybeans (not part of the program) by at least 6 meters. In addition, the following containment procedures are part of the experimental program: 1) Seeds will be stored in color-coded, marked bags in a secure location; 2) leftover seed will be destroyed or returned to Monsanto; 3) seeds will be double packaged for transport; 4) no plant material will be removed from the experimental sites without authorization; 5) field equipment and machinery will be throughly cleaned of any plant material and leftover seeds on-site before leaving the field; 6) soybeans are self-pollinating and have low potential for outcrossing (no special pollen-containment is needed); 7) seeds may be harvested for further research and harvesting equipment will be thoroughly cleaned; 8) all remaining plant material after harvest will be destroyed; 9) trial sites will be planted with a different crop the following year or left fallow; 10) trial sites will be monitored for 1 year to ensure no soybean regrowth or volunteers (those found will be eliminated).

Persons wishing to review this EUP are referred to the designated contact person. Inquiries concerning this permit should be directed to the person cited above. It is suggested that interested persons call before visiting the EPA office, so that the appropriate file may be made available for inspection purposes from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

Authority: 7 U.S.C. 136.

List of Subjects

• Environmental protection
• Experimental use permits

Dated: February 6, 2001.

Janet L.Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.