2010-15207. Pesticide Product Registrations; Conditional Approvals

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the Agency's issuance, pursuant to the provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of conditional registrations for the pesticide products, MON 89034 and MON 89034 x MON 88017, containing active ingredients that were not in any registered pesticide products at the time of their respective submissions.

FOR FURTHER INFORMATION CONTACT:

Susanne Cerrelli, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0208. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

Pursuant to section 3(c)(2) of FIFRA, a copy of the approved labels, the list of data references, and data or other scientific information used to support these registrations, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Such requests should: Identify the product name and registration number and specify the data or information desired.

Electronic versions of the fact sheets and Biopesticides Registration Action Documents are available at http://www.epa.gov/​oppbppd1/​biopesticides/​pips/​pip_​list.htm.

II. Description of New Active Ingredients

EPA received applications from Monsanto Company, 800 North Lindbergh Boulevard, St. Louis, MO 63167, to register pesticide products (EPA File Symbols 524-LTL and 524-LTA) containing the active ingredients, Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their production (vector PV-ZMIR245) in event MON 89034 corn (Office of Economic Cooperation and Development (OECD)) Unique Identifier: MON-89034-3). At the time of submission of the applications for registration, these active ingredients were not contained in any pesticide products registered with the Agency.

III. Regulatory Conclusions

A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest.

The applications were approved on June 10, 2008 for MON 89034 (EPA Registration Number 524-575) and MON 89034 x MON 88017 (EPA Registration Number 524-576), both for use on corn. The Agency approved the applications after considering data on risks associated with the proposed use of the Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their production (vector PV-ZMIR245) in event MON 89034 corn (OECD Unique Identifier: MON-89034-3), and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature of the plant-incorporated protectants and their pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations, which show that use of the Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their production (vector PV-ZMIR 245) in event MON 89034 corn (OECD Unique Identifier: MON-89034-3) during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticides is in the public interest.

Consistent with section 3(c)(7)(C) of FIFRA, the Agency has determined that these conditional registrations are in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.

IV. Missing Data and Conditions for Submission

A. MON 89034

The following data/information must be submitted to the Agency to support the registration of MON 89034:

1. Insect Resistance Management: Simulation modeling, which addresses the cross-resistance of Cry1A.105, Cry1Fa, and Cry1Ac in the cotton-growing landscape and how such cross-resistance may impact the durability of MON 89034, must be submitted by April 1, 2009 (protocol due by August 1, 2008).

2. Insect Resistance Management: A copy of the MON 89034 grower agreement and associated stewardship documents must be submitted within 90 days of the date of registration.

3. Insect Resistance Management: A written description of a system, which assures that growers will sign grower agreements and persons purchasing MON 89034 will annually affirm that they are contractually bound to comply with the requirements of the insect resistance management program, must be submitted by August 1, 2008.

4. Insect Resistance Management: A description of the compliance assurance program for MON 89034 must be submitted within 90 days of the date of registration.

5. Insect Resistance Management: Annual reports, which focus specifically on annual sales, grower agreements, grower education, compliance assurance program activities, and compliance survey results for MON 89034, must be submitted by January 31st of each year, beginning in 2010.

6. Insect Resistance Management: An annual report, summarizing insect resistance monitoring results for MON 89034, must be submitted by August 31st of each year, beginning in 2010.

B. MON 89034 x MON 88017

The following data/information must be submitted to the Agency to support the registration of MON 89034 x MON 88017:

1. Insect Resistance Management: A copy of the MON 89034 x MON 88017 grower agreement and associated stewardship documents must be submitted within 90 days of the date of registration.

2. Insect Resistance Management: A written description of a system, which assures that growers will sign grower agreements and persons purchasing MON 89034 x MON 88017 will annually affirm that they are contractually bound to comply with the requirements of the insect resistance management program, must be submitted by August 1, 2008.

3. Insect Resistance Management: A description of the compliance assurance program for MON 89034 x MON 88017 must be submitted within 90 days of the date of registration.

4. Insect Resistance Management: A revised Cry3Bb1 monitoring plan, incorporating MON 89034 x MON 88017, must be submitted within 90 days of the date of registration.

5. Insect Resistance Management: For the Cry3Bb1 portion of the product, a discriminating or diagnostic dose assay must be developed, validated, and submitted by January 31, 2010.

6. Insect Resistance Management: For the Cry3Bb1 portion of the product, rootworm damage guidelines must be finalized and submitted by January 31, 2010.

7. Insect Resistance Management: Annual reports, which focus specifically on annual sales, grower agreements, grower education, compliance assurance program activities, and compliance survey results for MON 89034 x MON 88017 must be submitted by January 31st of each year, beginning in 2010.

8. Insect Resistance Management: An annual report, summarizing insect resistance monitoring results for MON 89034 x MON 88017, must be submitted by August 31st of each year, beginning in 2010.

C. MON 89034 and MON 89034 x MON 88017

The following data/information must be submitted to the Agency to support the registrations of both MON 89034 and MON 89034 x MON 88017:

1. Residue Analytical Method (Plants): An independent laboratory validation of the analytical method for the detection of Cry2Ab2 and/or Cry1A.105 must be submitted by April 1, 2009.

2. Aquatic Invertebrate Acute Toxicity Testing (Freshwater Daphnids): A 7 - to 14-day Daphnia study must be performed (as per the 885 Office of Chemical Safety and Pollution Prevention (OCSPP) Harmonized Guidelines)) and submitted by April 1, 2009. Alternatively, a dietary study of the effects on an aquatic invertebrate, representing the functional group of a leaf shredder in headwater streams, can be performed and submitted in lieu of the Daphnia study.

3. Insect Resistance Management: Additional information on cross-resistance of Cry1A.105, Cry1Fa, and Cry1Ac (preferably including binding site models and use of resistant colonies) for the target pests and how such cross-resistance may impact the durability of MON 89034 must be submitted by April 1, 2009 (protocol due by August 1, 2008).

4. Insect Resistance Management: Baseline susceptibility studies and/or a discriminating concentration assay for the Cry1A.105 protein againstEuropean corn borer, southwestern corn borer, and corn earworm and for the Cry2Ab2 protein against southwestern corn borer and corn earworm must be submitted by April 1, 2009.

5. Insect Resistance Management: To support sweet corn uses, baseline susceptibility studies must be conducted on fall armyworm populations collected from sweet corn-growing areas and submitted by April 1, 2010.

V. Response to Comments

EPA published a notice of receipt in the Federal Register of July 25, 2007 (72 FR 40876) (FRL-8129-7), which announced that Monsanto Company had submitted applications to register pesticide products containing the new active ingredients, Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic material necessary for their production (vector PV-ZMIR245) in event MON 89034 corn (OECD Unique Identifier: MON-89034-3), for use on corn. Eight comments were received in response to the notice of receipt. One comment opposed granting Monsanto Company rights to produce, sell, or manufacture pesticide products containing the aforementioned active ingredients, but no scientific basis was provided to support this position. In general, the other seven comments expressed support for the applications from Monsanto Company. Ultimately, none of the eight comments affected the Agency's review or consideration of the applications, or the conclusions the Agency arrived at as a result of such review and consideration. Pursuant to its authority under FIFRA, the Agency conducted a rigorous and comprehensive assessment of the new active ingredients, along with their associated pesticide products, and concluded that use of the pesticides during the conditional registration period will not cause unreasonable adverse effects to human health or the environment and that use of the pesticides is in the public interest.

List of Subjects

• Environmental protection
• Chemicals
• Pests and pesticides

Dated: June 15, 2010.

W. Michael McDavit,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.