[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Notices]
[Pages 46510-46513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15602]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0122; FRL-7726-7]


Issuance of Experimental Use Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has granted experimental use permits (EUPs) to the 
following pesticide applicants. 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: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (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 person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2005-0122. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket telephone number is (703) 305-5805.

[[Page 46511]]

    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. EUP

    EPA has issued the following EUPs:
    524-EUP-96. Amendment/Extension. Monsanto Company, 800 North 
Lindbergh Blvd., St. Louis, MO 63167. This EUP allows the use of 3.63 
pounds of the insecticides Bacillus thuringiensis Cry3Bb1 protein and 
the genetic material necessary for its production (vector ZMIR39) in 
corn and Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic 
material necessary for its production (vector PV-ZMCT01) in corn on 
4,683 acres of corn for breeding and observation, inbred seed increase 
production, line per se, hybrid yield and herbicide tolerance trials, 
insect efficacy trials, product characterization and performance 
trials, insect resistance management trials, nontarget organisms and 
benefit trials, seed treatment trials, swine growth and feed efficiency 
trials, dairy cattle feed efficiency trials, beef cattle growth and 
feed efficiency trials, and cattle grazing feed efficiency trials. The 
program is authorized only in the States of Alabama, California, 
Colorado, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, 
Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Mexico, New 
York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, 
Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, and 
Wisconsin. The EUP is effective from February 18, 2005 to March 1, 
2006, and allows associated activities such as collection of field 
data; harvesting and processing of seed after last planting. A 
tolerance has been established for residues of the active ingredient in 
or on corn.
    No comments were submitted in response to the notice of receipt for 
this permit application, which was published in the Federal Register on 
January 12, 2005 (70 FR 2160) (FRL-7688-8).
    68467-EUP-7. Amendment/Extension. Mycogen Seeds, c/o Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. 
This EUP allows the use of 2,734.85 grams Cry34Ab1 and 10.88 grams 
Cry35Ab1 of the insecticides Cry34/35Ab1 proteins and the genetic 
material necessary for their production (from the insert of plasmid 
PHP17662) in corn on 3,096 acres of corn for breeding and observation 
nursery, agronomic observation trials, glufosinate herbicide tolerance 
study, efficacy trial, and insect resistance management studies. The 
program is authorized only in the States of Hawaii, Illinois, Indiana, 
Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New 
York, North Dakota, Ohio, Pennyslvania, Puerto Rico, South Dakota, 
Texas, and Wisconsin. The EUP is effective from January 21, 2005 to 
April 30, 2006, and allows associated activities such as collection of 
field data; harvesting and processing of seed after last planting. A 
tolerance has been established for residues of the active ingredient in 
or on corn.
    29964-EUP-5. Amendment/Extension. Pioneer Hi-Bred International, 
Inc., P.O. Box 552, Johnston, IA 50131-0552. This EUP allows the use of 
1,813.6 grams Cry34Ab1 and 47.2 grams Cry35Ab1 of the insecticides 
Cry34/35Ab1 proteins and the genetic material necessary for their 
production (from the insert of plasmid PHP17662) in corn on 5,115 acres 
of corn for breeding and observation nursery, agronomic observation 
trials, herbicide tolerance study, efficacy trial, insect resistance 
management studies, non-target organism studies, regulatory studies, 
research seed production, and inbred seed increase. The program is 
authorized only in the States of Arkansas, California, Colorado, 
Delaware, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Maryland, 
Michigan, Minnesota, Missouri, Nebraska, North Carolina, North Dakota, 
Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, 
Washington, and Wisconsin. The EUP is effective from January 25, 2005 
to April 30, 2006, and allows associated activities such as collection 
of field data; harvesting and processing of seed after last planting. A 
tolerance has been established for residues of the active ingredient in 
or on corn.
    One comment was submitted in response to the notice of receipt for 
these permit applications, which was published in the Federal Register 
on March 10, 2004 (69 FR 11431) (FRL-7346-6). This comment was 
addressed in the notice of issuance relating to the first year of these 
permits which was published in the Federal Register of December 22, 
2004 (69 FR 76732) (FRL-7688-7).
    67979-EUP-3. Issuance. Syngenta Seeds, Inc., P.O. Box 12257, 
Research Triangle Park, NC 27709-2257. This EUP allows the use of 2.91 
grams of the Cry1Ab Bacillus thuringiensis Cry1Ab protein and the 
genetic material necessary for its production (via elements of p2062) 
in corn on 294 acres of corn to evaluate the control of various 
lepidopteran insect pests. The program is authorized only in the States 
of Arizona, Arkansas, California, Florida, Hawaii, Illinois, Indiana, 
Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, 
Missouri, Nebraska, New Mexico, North Carolina, Ohio, Puerto Rico, 
South Dakota, Texas, and Wisconsin. The EUP is effective from May 6, 
2004 to August 15, 2005, and allows associated activities such as 
collection of field data; harvesting and processing of seed after last 
planting. A tolerance has been established for residues of the active 
ingredient in or on corn.
    Fourteen comments were submitted in response to the notice of 
receipt for this permit application, which was published in the Federal 
Register on November 5, 2003 (68 FR 62586) (FRL-7325-9). Commenters 
included private citizens and regional non-govermental organizations. 
All commenters objected to an EUP issuance. Commenters expressed 
concern regarding human health; unapproved corn in the food supply; 
non-target organisms; genetic stability of the plant-incorporated 
protectant; invasive species; endangered species; Bt protein in soil; 
insect resistance management and the impact of this EUP on the use of 
foliar Bt; impacts on organic crops and farmers; identity preservation, 
the labeling of products and consumer choice in avoiding genetically 
engineered crop consumption; legal liability of the permittee, the need 
of informing nearby farmers of testing and the secrecy of test sites; 
and the need for post-approval monitoring.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that genetically modified crops and food 
should be banned completely. Pursuant to its authority under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), EPA conducted a 
comprehensive reassessment of the Cry1Ab protein and the genetic 
material necessary for their production in all crops, which is located

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at http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm. EPA 
has concluded that there is a reasonable certainty that no harm will 
result from dietary exposure to this protein as expressed in 
genetically modified corn. The Cry1Ab tested under this permit is 
covered by the tolerance exemption under 40 CFR 180.1173. No human 
health, environmental, or insect resistance management adverse effects 
are anticipated as a result of Cry1Ab expression in transgenic corn and 
the proposed testing which is of limited scope and duration.
    The Agency recognizes the commenter's concerns regarding test plot 
location information and is currently considering this issue. EPA 
sponsored a workshop with broad public participation and input to 
identify best approaches to regulatory improvements pertaining to 
plant-incorporated protectant (PIP) EUPs. The workshop, titled Plant-
Incorporated Protectant Experimental Use Permit: Process and 
Compliance, was held at the Crystal City Hilton in Arlington, Virginia 
on February 10 and 11, 2004. Proceedings can be found at http://www.epa.gov/pesticides/biopesticides/pips/pip-eup-workshop.htm.
    Regarding comments pertaining to organic agriculture, the National 
Organic Program (NOP) prohibits use of genetically modified organisms 
in the production of organic crops. A farmer who wishes to produce 
organic crops, must follow the rules of the NOP which essentially means 
only organic inputs or approved synthetic inputs can be used. If an 
organic farmer purchased and grew Bt corn, the resulting crop could not 
be certified organic. However, if this farmer purchased approved corn 
varieties and followed the other requirements for organic products 
under NOP, the fact that some portion of the crop was pollinated by Bt 
corn from a crop planted outside the boundaries of an appropriately 
segregated organic crop would not adversely impact the farmer's ability 
to sell the crop as organic.
    Under 7 CFR 205.202(c) of the NOP final rule, ``any field or farm 
parcel from which harvested crops are intended to be sold, labeled or 
represented as ``organic'' must have distinct, defined boundaries and 
buffer zones to prevent the unintended application of a prohibited 
substance applied to adjoining land that is not under organic 
management.'' The supplementary information published with the NOP 
final rule discusses this issue:
    ``Drift has been a difficult issue for organic producers from 
the beginning. Organic operations have always had to worry about the 
potential for drift from neighboring operations, particularly drift 
of synthetic chemical pesticides. As the number of organic farms 
increases, so does the potential for conflict between organic and 
nonorganic operations.
    It has always been the responsibility of organic operations to 
manage potential contact of organic products with other substances 
not approved for use in organic production systems, whether from the 
nonorganic portion of a split operation or from neighboring farms. 
The organic system plan must outline steps that an organic operation 
will take to avoid this kind of unintentional contact.
    When we are considering drift issues, it is particularly 
important to remember that organic standards are process based. 
Certifying agents attest to the ability of organic operations to 
follow a set of production standards and practices that meet the 
requirements of the Act and the regulations. This regulation 
prohibits the use of excluded methods in organic operations. The 
presence of a detectable residue of a product of excluded methods 
alone does not necessarily constitute a violation of this 
regulation. As long as an organic operation has not used excluded 
methods and takes reasonable steps to avoid contact with the 
products of excluded methods as detailed in their approved organic 
system plan, the unintentional presence of the products of excluded 
methods should not affect the status of an organic product or 
operation.
    Issues of pollen drift are also not confined to the world of 
organic agriculture. For example, plant breeders and seed companies 
must ensure genetic identity of plant varieties by minimizing any 
cross-pollination that might result from pollen drift. Under 
research conditions, small-scale field tests of genetically 
engineered plants incorporate various degrees of biological 
containment to limit the possibility of gene flow to other sexually 
compatible plants. Federal regulatory agencies might impose specific 
planting requirements to limit pollen drift in certain situations. 
Farmers planting nonbiotechnology-derived varieties may face similar 
kinds of questions if cross-pollination by biotechnology-derived 
varieties alters the marketability of their crop. These discussions 
within the broader agricultural community may lead to new approaches 
to addressing these issues. They are, however, outside the scope of 
this regulation by definition'' (65 FR 80556 December 21, 2000).
    67979-EUP-4. Issuance. Syngenta Seeds, Inc., P.O. Box 12257, 
Research Triangle Park, NC 27709-2257. This EUP allows the use of 15.53 
grams of the insecticide Modified Cry3A Bacillus thuringiensis protein 
and the genetic material necessary for its production (via elements of 
pZM26) in Event MIR604 corn (SYN-IR6[oslash]4-5) on 575 acres of corn 
for breeding and observation, efficacy field trials, agronomic 
observation, inbred and hybrid production, regulatory field trials 
(e.g. IRM and non-target insect field trials). The program is 
authorized only in the States of Colorado, Hawaii, Illinois, Indiana, 
Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, 
Missouri, Nebraska, Ohio, Puerto Rico, South Dakota, Texas, and 
Wisconsin. The EUP is effective from March 23, 2005 to October 15, 
2006, and allows associated activities such as collection of field 
data; harvesting and processing of seed after last planting. A 
tolerance has been established for residues of the active ingredient in 
or on corn.
    Three comments were submitted in response to the notice of receipt 
for this permit application, which was published in the Federal 
Register on September 1, 2004 (69 FR 53440) (FRL-7370-7). Two comments 
were received from private citizens who objected to an EUP issuance. 
The commenters were concerned with pollen flow and biodiversity, 
organic farming, neighbors to the test plots, and potential impacts on 
the sale of commodities in foreign agricultural markets.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that genetically modified crops and food 
should be banned completely. Pursuant to its authority under the FFDCA, 
EPA conducted a comprehensive reassessment of the modified Cry3A 
protein and the genetic material necessary for its production in corn. 
EPA has concluded that there is a reasonable certainty that no harm 
will result from dietary exposure to this protein as expressed in 
genetically modified corn. The modifed Cry3A tested under this permit 
is covered by the tolerance exemption under 40 CFR 174.456. No human 
health, environmental, or insect resistance management adverse effects 
are anticipated as a result of modified Cry3A expression in transgenic 
corn and the proposed testing which is of limited scope and duration.
    Regarding comments pertaining to organic agriculture, as discussed 
in EUP 67979-EUP-3, the NOP prohibits use of genetically modified 
organisms in the production of organic crops. A farmer who wishes to 
produce organic crops, must follow the rules of the NOP which 
essentially means only organic inputs or approved synthetic inputs can 
be used. If an organic farmer purchased and grew Bt corn, the resulting 
crop could not be certified organic. However, if this farmer purchased 
approved corn varieties and followed the other requirements for organic 
products under the NOP, the fact that some portion of the crop was 
pollinated by Bt corn from a crop planted outside the boundaries of an 
appropriately segregated organic crop would not adversely impact the 
farmer's

[[Page 46513]]

ability to sell the crop as organic. The United States Department of 
Agriculture (USDA) discussed the issue of drift onto organic fields in 
the Federal Register of December 21, 2000 (65 FR 80556), which is 
quoted in EUP 67979-EUP-3 in response to a comment on application. 
USDA's discussion of this issue is also relevant and responsive to the 
related comment on application 67979-EUP-4.
    The third comment was submitted by a grower group in support of 
issuing the EUP. The grower group cited corn farmers' need for new 
products and technology, IRM benefits, reduction in chemical inputs, 
environmental benefits, and improved farmer profitability. They also 
cited the need for market competition for Bt corn rootworm products to 
provide more choice and lower costs.


    Authority: 7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.


    Dated: July 26, 2005.
Phil Hutton,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

[FR Doc. 05-15602 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-S