01-18826. Amendment/Extension 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: Mike Mendelsohn, 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. 910W13, 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-50875A. 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-93. Amendment/Extension. Monsanto Company, 700 Chesterfield Parkway North, St. Louis, MO 63198. This EUP allows the shipment of 7.4 pounds of the Cry3Bb protein insecticide in seeds shipped Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR13L) in corn plants on 4,000 acres of field corn for trials in 1) Breeding and observation nursery, 2) inbred seed increase production, 3) line per se and hybrid yield trial, 4) insect efficacy trials, 5) product characterization, performance and labeling trials, 6) insect resistance management trials, 7) non-target organisms and benefit trials, and 8) seed treatment trials corn rootworm. The program is authorized only in the States, Territories, and Possessions of Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin. However, test plots must not be near the habitats of the following beetles in the following counties: 1) American burying beetle in Kansas (Doniphan, Douglas, Montgomery, Pottawatomie, Riley, and Saline Counties) and Oklahoma (Bryan, Cherokee, Haskell, Latimer, Le Flore, Muskogee, Sequoyah and Tulsa Counties), 2) the delta green ground beetle in California (Solano County), and 3) the valley elderberry longhorn beetle in California (Butte, Colusa, Dorado, Fresno, Glenn, Madera, Mariposa, Merced, Placer, Sacramento, San Joaquin, Solano, Stanislaus, Sutter, Tehama, Yolo and Yuba Counties). The EUP is effective from April 27, 2001 to plantings through April 2002 and associated activities such as collection of field data, harvesting and processing of seed after last planting, and containment activities such as destruction of volunteer corn plants. A tolerance exemption has been established for residues of the active ingredient in or on corn.

Comments: Twenty-nine comments received from private citizens, the National Grain and Feed Association, Gardens/MiniFarms Network, the Hawaii Office of Environmental Quality Control, the County of Hawaii, and the Union of Concerned Scientists. The National Grain and Feed Association supports biotechnology but cited concern regarding the 660 foot (ft) buffer, notification of neighboring farms, chain of custody issues, and the intermingling of grain from this EUP with food/feed grain. Comments/issues/concerns raised by citizens included: protection of certified organic farming industry from genetic drift and proof of non-contamination of heirloom seeds, allergenicity, labeling of genetically engineered (GE) food, request for proof of protection of Hawaiian local insect and animal population, a request to reply to Congresswoman Patsy Mink of Hawaii and Mayor Harry Kim of Hilo, Hawaii, and general opposition to testing. The Union of Concerned Scientists (UCS) urged EPA to publish in the Federal Register announcements regarding previous approval of rootworm protected corn EUPs and to delay consideration of this EUP amendment/extension until the release of relevant documents concerning the approvals. UCS indicated that because of ecological and Intermediate Remedial Measures (IRM) concerns and the paucity of data submitted, UCS opposed the registration of this new Bt corn. The State of Hawaii's Office of Environmental Quality Control asked to be notified of the exact location of planting sites in Hawaii and asked that EPA notify the applicant of the reporting requirement for genetically modified organisms (GMOs) under section 321-11.6 of the Hawaii Revised Statutes. The County of Hawaii commented that they were unable to determine exact locations of planting sites and that locations are critical to render informed comments. Further, the County of Hawaii requested EPA to notify the applicant of its obligation to the State of Hawaii under the reporting requirement for GMOs under section 321-11.6 of the Hawaii Revised Statutes. The County of Hawaii requested an opportunity to submit additional comments after testing location information was provided and after the Hawaii State Department of Health has had an opportunity to review the proposal following compliance with the notification requirements of section 321-11.6.

Response to comments: This permit is an amendment/extension of the permit approved last year in which the Agency concluded that there was no significant or irreversible hazards to the environment provided testing does not take place in the vicinity of endangered beetle habitats. The EUP approval letter informs Monsanto that they must obtain State approval before testing. In response to comments made by Hawaii's Office of Environmental Quality Control and the County of Hawaii, we have included language in the EUP approval letters notifying Monsanto of Hawaii's reporting requirement for GMOs under section 321-11.6 of the Hawaii Revised Statutes. Regarding the test locations, the cooperators and participants have been provided and placed in the docket. Monsanto has claimed the participant and cooperator information as confidential business information (CBI) and requests are being processed through the Freedom of Information Act (FOIA). The EUP requires methods to minimize pollen flow, and the Agency is requiring that no testing take place in the vicinity potentially exposed to endangered beetles for the coleopteran active Cry3Bb EUP. A final rule establishing tolerance exemptions for Cry3Bb1 and Cry2Ab2 has been approved and that final rule concluded that there is a reasonable certainty of no harm from consumption of these proteins which were digestible in gastric fluid and are not considered food allergens. The Cry3Bb1 protein is the specific protein in corn being tested under the 524-EUP-93 permit. Monsanto submitted a brief progress report to the Agency titled Nontarget Organism Research with Corn Event MON863 Hybrids: Corn Rootworm Protected Corn (Vector ZMIR13L) dated February 20, 2001. This report was requested by the Biopesticides and Pollution Prevention Division (BPPD) and addresses nontarget organism (specifically invertebrates) monitoring in MON863 corn. Since MON863 is expressed in the roots, effects on soil dwelling organisms are a potential risk. Surveys of above and below-ground arthropods were conducted. Above ground samples included various species of predatory Hemiptera and Coleoptera. Below ground samples included Coleoptera (particularly carabids [ground beetles] and staphalynids [rove beetles]), spiders, and Collembola. Although all of the samples have not been counted and identified, preliminary results suggest that there are no significant effects of lines or treatments. The only adverse effect reported was a reduction in Collembola in the insecticide treated fields. Based upon the preliminary results submitted to the Agency, MON863 does not appear to pose a risk to non-target beneficial arthropods. However, these studies are preliminary and incomplete. Additional years of sampling are needed and a complete report should be submitted to the Agency before a conclusion regarding the potential risks can be determined. Labeling of foods is the responsibility of the Food and Drug Administration (FDA). Questions on food labeling should be addressed to FDA.

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: July 13, 2001.

Janet L. Andersen,

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