Document ID: EPA-HQ-OPP-2007-0208-0018
Agency: epa
Document Type: Notice
Title: Pesticide Product Registrations; Conditional Approvals
Posted Date: 2010-06-23T04:00Z

[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Notices]               
[Page 35805-35807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn10-80]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0208; FRL-8831-5]

 
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: (703) 308-8077; e-mail 
address: cerrelli.susanne@epa.gov.

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

[[Page 35806]]

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 (703) 305-5805.
    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.

[[Page 35807]]

    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.

[FR Doc. 2010-15207 Filed 6-22-10; 8:45 am]
BILLING CODE 6560-50-S