[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]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-50871A; FRL-6765-1]
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; (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