Pesticides; experimental use permits, etc.: Monsanto Co. et al.,

[Federal Register: August 10, 2005 (Volume 70, Number 153)]

[Notices]

[Page 46510-46513]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr10au05-62]

ENVIRONMENTAL PROTECTION AGENCY

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

Issuance of Experimental Use Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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: mendelsohn.mike@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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.

   2. 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.

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      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.

2. 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

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   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