[Federal Register Volume 66, Number 145 (Friday, July 27, 2001)]
[Notices]
[Pages 39163-39165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18826]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-50875A; FRL-6791-5]


Amendment/Extension of an Experimental Use Permit

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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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; (703) 308-8715; e-mail address: [email protected].

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.

[[Page 39164]]

 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 (703) 305-5805.

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

[[Page 39165]]

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.

[FR Doc. 01-18826 Filed 7-26-01; 8:45 am]
BILLING CODE 6560-50-S