[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Pages 13734-13735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5574]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-50871A; FRL-6765-1]


Amendment 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: 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; (703) 605-0515; 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.

 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 (703) 305-5805.

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

[[Page 13735]]

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.

[FR Doc. 01-5574 Filed 3-6-01; 8:45 am]
BILLING CODE 6560-50-S