2010-21290. Pesticide Product Registrations; Unconditional and 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)(5) and 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of registrations for pesticide products containing active ingredients that were not in any registered pesticide products at the time of their respective submissions.

FOR FURTHER INFORMATION CONTACT:

A contact person is listed at the end of each registration approval summary and may be contacted by telephone or e-mail. The mailing address for each contact person listed is: Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

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 at the end of the relevant registration approval summary using the instructions provided under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established a docket for each action under the docket identification (ID) number specified for the pesticide of interest as shown in the registration approval summaries. 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 label, the list of data references, the data and other scientific information used to support each registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made pursuant to 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.

Paper copies of the fact sheets, which provide more detail on these registrations, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

II. New Active Ingredients

1. 2-Methyl-1-butanol. Docket number: EPA-HQ-OPP-2009-0125. Description of new active ingredient: EPA received an application from Bull Run Scientific, VBT, Beaufont Springs Dr., Suite 300, Richmond, VA 23225, to register a pesticide product (EPA File Symbol 84565-T) containing the active ingredient, 2-methyl-1-butanol. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on February 3, 2010, for Disposable Bull Run Yellowjacket Trap E (EPA Registration Number 84565-7) for use as an attractant in traps intended to capture hornets and wasps. The Agency approved the application considering data on risks associated with the proposed use of 2-methyl-1-butanol, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of 2-methyl-1-butanol, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of March 16, 2009 (74 FR 11098), which announced that Bull Run Scientific VBT had submitted an application to register a pesticide product containing the new active ingredient, 2-methyl-1-butanol, for use as an attractant in traps intended to capture hornets and wasps. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on December 15, 2009. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Chris Pfeifer, [phone], [e-mail].

2. Calcium acetate. Docket number: EPA-HQ-OPP-2009-0125. Description of new active ingredient: EPA received an application from Bull Run Scientific, VBT, Beaufont Springs Dr., Suite 300, Richmond, VA 23225, to register a pesticide product (EPA File Symbol 84565-T) containing the active ingredient, calcium acetate. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on February 3, 2010, for Disposable Bull Run Yellowjacket Trap E (EPA Registration Number 84565-7) for use as an attractant in traps intended to capture hornets and wasps. The Agency approved the application considering data on risks associated with the proposed use of calcium acetate, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of calcium acetate, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of March 16, 2009 (74 FR 11098), which announced that Bull Run Scientific, VBT had submitted an application to register a pesticide product containing the new active ingredient, calcium acetate, for use as an attractant in traps intended to capture hornets and wasps. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on December 15, 2009. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Chris Pfeifer, [phone], [e-mail].

3. Laminarin. Docket number: EPA-HQ-OPP-2009-0126. Description of new active ingredient: EPA received an application from Laboratoires Goemar SA, Z.AC La Madeline, Avenue General Patton, 35400 Saint-Malo, France c/o SciReg, Inc. 12733 Director's Loop, Woodbridge, VA 22192, to register a pesticide product (EPA File Symbol 83941-E) containing the active ingredient, laminarin. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on February 15, 2010, for vacciplant (EPA Registration Number 83941-2) for use as a Systemic Acquired Resistance (SAR) Inducer. The Agency approved the application considering data on risks associated with the proposed use of laminarin, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of laminarin, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of March 16, 2009 (74 FR 11098), which announced that Laboratoires Goemar SA, Z.AC La Madeline, Ave. General Patton, 35400 Saint-Malo, France c/o SciReg, Inc. 12733 Director's Loop, Woodbridge, VA 22192 had submitted an application to register a pesticide product containing the new active ingredient, laminarin, for use on crops as a SAR Inducer. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on January 5, 2010. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Chris Pfeifer, [phone], [e-mail].

4. S-Abscisic acid (ABA). Docket number: EPA-HQ-OPP-2009-0127. Description of new active ingredient: EPA received an application from Valent Biosciences Corporation, 870 Technology Way, Libertyville, IL 60048, to register a pesticide product (EPA File Symbol 73049-UAE) containing the active ingredient, S-abscisic acid. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on February 28, 2010, for ConTego Pro SL (EPA Registration Number 73049-462) for use as a plant growth regulator. The Agency approved the application considering data on risks associated with the proposed use of S-abscisic acid, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of S-abscisic acid, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of March 16, 2009 (74 FR 11098), which announced that Valent Biosciences Corporation, 870 Technology Way, Libertyville, IL 60048 had submitted an application to register a pesticide product containing the new active ingredient, S-abscisic acid, for use on crops as a plant growth regulator. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on January 26, 2010. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Chris Pfeifer, [phone], [e-mail].

5. Terpene constituents of the extract of Chenopodium ambrosioides near ambrosioides (ECANA) as synthetically manufactured. Docket number: EPA-HQ-OPP-2009-0237. Description of new active ingredient: EPA received an application from AgraQuest, Inc., 1540 Drew Ave., Davis, CA 95618-6320, to register a pesticide product (EPA File Symbol 69592-EL) containing the active ingredient, Extract of Chenopodium ambrosioides near ambrosioides (ECANA) Mimic. (During the application process, the active ingredient name was subsequently changed to Terpene Constituents of the Extract of Chenopodium ambrosioides near ambrosioides (ECANA) as Synthetically Manufactured to more accurately describe its synthetic origin.) At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on June 30, 2010 for QRD 452 (EPA Registration Number 69592-25) for use as an insecticide/acaracide. The Agency approved the application considering data on risks associated with the proposed use of Terpene Constituents of ECANA as Synthetically Manufactured, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of Terpene Constituents of ECANA as Synthetically Manufactured, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: QRD 452, EPA Registration Number 69592-22, was conditionally registered. 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 Agency has considered the available data on the risks associated with the proposed use of Terpene Constituents of ECANA as Synthetically Manufactured, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its 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 Terpene Constituents of ECANA as Synthetically Manufactured during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide 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.

All data requirements, except one product chemistry requirement, have been fully satisfied; and this pesticide product has been granted a conditional registration. The Agency has required submission of an additional Preliminary Analysis per 40 CFR 158.2030 (OPPTS Guideline 830.1700) by June 21, 2011 for QRD 452 (EPA Registration Number 69592-25).

Response to Comments: EPA published a notice of receipt in the Federal Register of July 22, 2009 (74 FR 36215) (FRL-8425-9), which announced that AgraQuest, Inc., 1540 Drew Ave., Davis, CA 95618-6320 had submitted an application to register a pesticide product containing the new active ingredient, Terpene Constituents of ECANA as Synthetically Manufactured, for use on crops as an insecticide and an acaricide. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on April 30, 2010. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Chris Pfeifer, [phone], [e-mail].

6. (Z,Z,E)-7,11,13-Hexadecatrienal. Docket number: EPA-HQ-OPP-2009-0930. Description of new active ingredient: EPA received applications from ISCA Technologies, Inc., 1230 Riverside, CA, 92507, to register pesticide products (EPA File Symbols 80286-RU and 80286-RL) containing the active ingredient (Z,Z,E)-7,11,13-hexadecatrienal. At the time of submission of the applications for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The applications were approved on April 19, 2010, for SPLAT CLM MP (EPA Registration Number 80286-RU) for manufacturing or formulating use only and SPLAT CLM (EPA Registration Number 80286-RL) for use on ornamental and agricultural crops. The Agency approved the applications considering data on risks associated with the proposed use of (Z,Z,E)-7,11,13-hexadecatrienal, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of (Z,Z,E)-7,11,13-hexadecatrienal, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of January 27, 2010 (75 FR 4383) (FRL-8806-5), which announced that ISCA Technologies, Inc. had submitted applications to register pesticide products containing the new active ingredient, (Z,Z,E)-7,11,13- hexadecatrienal, for use on ornamental and agricultural crops. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As these applications were for pesticide products containing a new active ingredient, the proposed decision, risk assessments, and draft labels associated with these pesticide products were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on March 15, 2010. EPA has received 10 comments regarding the applications, all in support of the registration of (Z,Z,E)-7,11,13-hexadecatrienal. Contact: Gina Casciano, [phone], [e-mail].

7. Homobrassinolide. Docket number: EPA-HQ-OPP-2007-1187. Description of new active ingredient: EPA received an application from Repar Corporation of P.O. Box 4321, Silver Spring, MD 20914, to register a pesticide product (EPA File Symbol 69361-17) containing the active ingredient, homobrassinolide. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on June 14, 2010, for Homobrassinolide Technical (EPA Registration Number 69361-17) for manufacturing or formulating use only.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of January 16, 2008 (73 FR 2915) (FRL-8346-7), which announced that Repar Corporation had submitted an application to register a pesticide product containing the new active ingredient, homobrassinolide, for use on all food commodities. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on April 30, 2010. There were no substantive comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: John Fournier, [phone], [e-mail].

8. Ulocladium oudemansii (U3 Strain). Docket number: EPA-HQ-OPP-2010-0553. Description of new active ingredient: EPA received applications from Botry-Zen, Ltd., 21 Willis St., P.O. Box 5664, Dunedin, New Zealand, to register pesticide products (EPA File Symbols 75747-R, and 75747-E) containing the active ingredient, Ulocladium oudemansii (U3 Strain). At the time of submission of the applications for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The applications were approved on October 19, 2009, for Ulocladium oudemansii Technical (EPA Registration Number 75747-1) for manufacturing or formulating use only and BOTRY-Zen® (EPA Registration Number 75747-2) for use on fruit and vegetable crops and ornamental plants. The Agency approved the applications considering data on risks associated with the proposed use of Ulocladium oudemansii (U3 Strain), and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the microbial pesticide and its 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 that show use of Ulocladium oudemansii (U3 Strain), when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of October 29, 2008 (73 FR 64325) (FRL-8386-5), which announced that Botry-Zen, Ltd. had submitted applications to register pesticide products containing the new active ingredient, Ulocladium oudemansii (U3 Strain), for use on fruit and vegetable crops and ornamental plants. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As these applications were for pesticide products containing a new active ingredient, the proposed decision, risk assessments, and draft labels associated with these pesticide products were to have been added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. However, given the Agency finding that Ulocladium oudemansii (U3 strain) has very low toxicity and presents little if any risk to non-target organisms, EPA concluded in October of 2009 that it was in the best interests of the public and the environment to issue the registration for Ulocladium oudemansii (U3 strain) without delay. Therefore, consistent with the Agency's approach for making these registration actions more transparent, EPA issued these two registrations for an initial period of 1 year and, concurrent with such issuance, provided a 30-day public comment period. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on October 20, 2009. As there were no comments received in response to the notice of receipt or during the 30-day public participation process occurring concurrently with the final registration decision, the 1 year time-limitation was removed for EPA Registration Number 75747-1 and EPA Registration Number 75747-2 on January 7, 2010. Contact: Denise Greenway, [phone], [e-mail].

9. Coat protein gene of plum pox virus also known as the CPG-PPV, or plum pox resistance gene (plum pox viral coat protein gene). Docket number: EPA-HQ-OPP-2010-0554. Description of new active ingredient: EPA received an application from Interregional Research Project Number 4 (IR-4) of Rutgers University, 500 College Rd. East, Suite 201 W., Princeton, NJ 08540 on behalf of the United States Department of Agriculture-Agricultural Research Service-Appalachian Fruit Research Station (USDA-ARS-AFRS), 2217 Wiltshire Rd., Kearneysville, WV 25430, to register a pesticide product (EPA File Symbol 11312-I) containing the active ingredient, coat protein gene of plum pox virus. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on May 7, 2010 for C5 HoneySweet Plum (EPA Registration Number 11312-8) for resistance to plum pox virus infection. The Agency approved the application considering data on risks associated with the proposed use of the coat protein gene of plum pox virus, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the plant-incorporated protectant and its 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 showing that the coat protein gene of plum pox virus, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: C5 HoneySweet Plum, EPA Registration Number 11312-8, was conditionally registered. 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 Agency has considered the available data on the risks associated with the proposed use of the coat protein gene of plum pox virus, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its 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 coat protein gene of plum pox virus during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide 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.

All data requirements, except one product analysis requirement, have been fully satisfied; and this pesticide product has been granted a 1 year conditional registration, to expire at midnight of May 7, 2011. The Agency has required submission of an Analysis of Samples validation per 40 CFR 158.2120 (OPPTS Guideline 885.1400) by November 7, 2008 for C5 HoneySweet Plum (EPA Registration Number 11312-8).

Response to comments: EPA published a notice of receipt in the Federal Register of October 29, 2008 (73 FR 64325) (FRL-8386-5), which announced that IR-4 (on behalf of USDA-ARS-AFRS) had submitted an application to register a pesticide product containing the new active ingredient, the coat protein gene of plum pox virus, which induces resistance to plum pox virus infection in C5 HoneySweet Plums. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on April 1, 2010. EPA received 66 comments regarding the application and has prepared a response, which can be found in the docket EPA-HQ-OPP-2010-0554, as discussed in this notice for this particular active ingredient. Contact: Denise Greenway, [phone], [e-mail].

10. Bacillus firmus I-1582. Docket number: EPA-HQ-OPP-2007-0161. Description of new active ingredient: EPA received an application from AgroGreen, Biological Division of Minrav Infrastructures (1993) Ltd. (AgroGreen), 3 Habossem Str, P.O. Box 153, Ashdod 77101, Israel, to register a pesticide product (EPA File Symbol 82608-R) containing the active ingredient, Bacillus firmus I-1582. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on April 28, 2008 for Chancellor (EPA Registration Number 82608-1) for use on all food and non-food commodities (agricultural, commercial and residential sites) as a soil and seed treatment as a nematode suppressant. The Agency approved the application considering data on risks associated with the proposed use of Bacillus firmus I-1582, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the microbial pesticide and its 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 that show use of Bacillus firmus I-1582, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of March 7, 2007 (72 FR 10210) (FRL-8117-7), which announced that RegWest Company, LLC, 30856 Rocky Rd., Greeley, CO 80631-9375 had submitted an application on behalf of AgroGreen, Biological Division of Minrav Infrastructures (1993) Ltd. (AgroGreen), 3 Habossem Str, P.O. Box 153, Ashdod 77101, Israel to register a pesticide product containing the new active ingredient, Bacillus firmus I-1582, for use on all food and non-food commodities (agricultural, commercial and residential sites) as a soil and seed treatment as a nematode suppressant. Subsequently, the company representing the registrant was changed to SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192. There were no comments received in response to the notice of receipt. Contact: Shanaz Bacchus, [phone], [e-mail].

11. Cold pressed neem oil docket number: EPA-HQ-OPP-2007-0996. Description of new active ingredient: EPA received an application from Plasma Power Limited of India, c/o OMC Ag Consulting, 828 Tanglewood Lane, East Lancing, MI 48823, to register pesticide products: (EPA File Symbols 84185-G, 84185-U and 84185-G) containing the active ingredient, Cold Pressed Neem Oil. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on October 15, 2009, for the registration of two products: Plasma Neem Oil Manufacturing Use Product EPA Registration Number 84185-3 for manufacturing or formulating use only and one end-use product was registered: Plasma Neem Oil Biological insecticide, EPA Registration Number 84185-4 for use on several food and non-food crop. The Agency approved the application considering data on risks associated with the proposed use of Cold Pressed Neem Oil, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of Cold Pressed Neem Oil, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: None of the pesticide product(s) have missing data: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of October 24, 2007 (72 FR 60365) (FRL-8152-7), which announced that Plasma Power Limited of India had submitted an application to register pesticide products containing the new active ingredient, Cold Pressed Neem Oil, for use on food and non-food crops. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for pesticide products containing a new active ingredient, the proposed decision, risk assessment, and draft labels associated with these pesticide products were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. However, given the Agency finding that Cold Pressed Neem Oil has very low toxicity and presents little if any risk to non-target organisms, EPA concluded in October of 2009 that it was in the best interests of the public and the environment to issue the registration for Cold Pressed Neem Oil without delay. Therefore, consistent with the Agency's approach for making these registration actions more transparent, EPA issued these two registrations for an initial period of 1-year and, concurrent with such issuance, provided a 30-day public comment period. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on October 15, 2009. As there were no comments received in response to the notice of receipt or during the 30-day public participation process occuring concurrently with the final registration decision, the 1-year time-limitation was removed from EPA Registration No. 84185-3 and EPA Registration No. 84185-4 on February 02, 2010. Contact: Driss Benmhend, [phone], [e-mail].

12. (E,Z)-7,9-Dodecadien-1-yl acetate. Docket number: EPA-HQ-OPP-2010-0020. Description of new active ingredient: EPA received an application from Pacific Biocontrol Corporation, 575 Viewridge Dr., Angwin, CA 94508, to register a pesticide product (EPA File Symbol 53575-GA (containing the active ingredient, (E,Z)-7,9-dodecadien-1-yl acetate. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on March 05, 2010, for only one end-use product was registered: Isomate®-EGVM (EPA Registration Number 53575-36) for use on grapes. The Agency approved the application considering data on risks associated with the proposed use of (E,Z)-7,9-dodecadien-1-yl acetate, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical and its 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 that show use of (E,Z)-7,9-dodecadien-1-yl acetate, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of February 1, 2010 (75 FR 5077) (FRL-8808-3), which announced that Pacific Biocontrol Corporation had submitted an application to register a pesticide product containing the new active ingredient, (E,Z)-7,9-Dodecadien-1-yl acetate, for use on grapes. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on February 1, 2010. EPA received a total of 13 comments on the notice of receipt. Twelve comments supported immediate registration of Isomate®EGVM. One comment opposed the registration of Isomate®EGVM, but did not provide any substantive basis supporting that position regarding the application. EPA has prepared a response, which can be found in the docket as discussed above for this particular active ingredient. Contact: Driss Benmhend, [phone], [e-mail].

13. Lavandulyl senecioate. Docket number: EPA-HQ-OPP-2009-0044. Description of new active ingredient: EPA received an application from Suterra, LLC, 213 SW Columbia Street, Bend, OR, 97702-1013, to register pesticide products: (EPA File Symbols 56336-LA, 56336-LL) containing the active ingredient, lavandulyl senecioate. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on March 1, 2010, for the registration of two products: CheckMate®VMB Technical Pheromone (EPA Registration Number 56336-55) for manufacturing or formulating use only and one end-use product was registered: CheckMate®VMB Dispenser, (EPA Registration Number 56336-57) for use on raisins, table and wine grapes. The Agency approved the application considering data on risks associated with the proposed use of lavandulyl senecioate, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the biochemical pesticide and its 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 that show use of lavandulyl senecioate, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: None of the pesticide product(s) have missing data: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of February 18, 2009 (74 FR 7600) (FRL-8400-3), which announced that Suterra, LLC had submitted an application to register pesticide products containing the new active ingredient, lavandulyl senecioate, for use on raisins, table and wine grapes.

Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for pesticide products containing a new active ingredient, the proposed decision, risk assessment, and draft labels associated with these pesticide products were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on January 29, 2010. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Driss Benmhend, [phone], [e-mail].

14. Trichoderma hamatum isolate 382. Docket number: EPA-HQ-OPP-2010-0489. Description of new active ingredient: EPA received an application from IR-4 of Rutgers University, 500 College Rd., East, Suite 201W, Princeton, NJ 08540 acting as the authorized agent for Sellew and Associates, LLC, 84 Shadybrook Ln., Carlisle, MA 01741, to register a pesticide product (EPA File Symbol 74205-G) containing the active ingredient, trichoderma hamatum isolate 382. At the time of submission of the application for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The application was approved on July 14, 2010 for Trichoderma hamatum isolate 382 (EPA Registration Number 74205-3) for use on soilless potting media and compost in nurseries and greenhouses, for potting seeds and seedlings of ornamentals and vegetables. The Agency approved the application considering data on risks associated with the proposed use of Trichoderma hamatum isolate 382, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the microbial pesticide and its 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 that show use of Trichoderma hamatum isolate 382, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and this pesticide product has been granted an unconditional registration.

Response to comments: EPA published a notice of receipt in the Federal Register of July 22, 2009 (74 FR 36215) (FRL-8425-9), which announced that IR-4 of Rutgers University, 500 College Rd., East, Suite 201W, Princeton, NJ 08540, acting as the authorized agent for Sellew and Associates, LLC, 84 Shadybrook Ln., Carlisle, MA 01741 had submitted an application to register a pesticide product containing the new active ingredient, Trichoderma hamatum isolate 382, for use on soilless potting media and compost in nurseries and greenhouses, for potting seeds and seedlings of ornamentals and food crops. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As this application was for a pesticide product containing a new active ingredient, the proposed decision, risk assessment, and draft label associated with this pesticide product were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on June 1, 2010. There were no comments received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. There were no comments received in response to the notice of receipt. Contact: Ann Sibold, [phone], [e-mail].

15. Trichoderma gamsii (strain ICC 080). Docket number: EPA-HQ-OPP-2009-1003. Description of new active ingredient: EPA received applications from Isagro S.p.A., Centro Uffici San-Edifico D-ala 3, Via Caldera, 21-20153 Milan, Italy, to register pesticide products: (EPA File Symbols 80289-O and 80289-RN) containing the active ingredient, Trichoderma gamsii (strain ICC 080). At the time of submission of the applications for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The applications were approved on February 5, 2010, for: Trichoderma gamsii strain ICC 080 Technical (EPA Registration Number 80289-10) for manufacturing or formulating use only and BiotenTM WP (EPA Registration Number 80289-9) for use on several food and non-food crops, including ornamentals, fruiting vegetables, leafy vegetables, cole crops, legumes, aromatic herbs, cucurbits, berries and small fruits, and turf. The Agency approved the applications considering data on risks associated with the proposed use of Trichoderma gamsii (strain ICC 080), and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the microbial pesticide and its 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 that show use of Trichoderma gamsii (strain ICC 080), when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of October 29, 2008 (73 FR 64325) (FRL-8386-5), which announced that Isagro S.p.A had submitted applications to register pesticide products containing the new active ingredient, Trichoderma gamsii (strain ICC. 080), for use on: Fruit and vegetable crops, ornamentals, and turf. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As these applications were for pesticide products containing a new active ingredient, the proposed decision, risk assessment, and draft labels associated with these pesticide products were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on December 30, 2009. There were no comments for Trichoderma gamsii (strain ICC. 080) received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Susanne Cerrelli, [phone], [e-mail].

16. Trichoderma asperellum (strain ICC 012). Docket number: EPA-HQ-OPP-2009-1004. Description of new active ingredient: EPA received applications from Isagro S.p.A., Centro Uffici San-Edifico D-ala 3, Via Caldera, 21-20153 Milan, Italy, to register pesticide products: (EPA File Symbols 80289-O and 80289-RR) containing the active ingredient, Trichoderma asperellum (strain ICC 012). At the time of submission of the applications for registration, this active ingredient was not contained in any pesticide products registered with the Agency.

Regulatory conclusions: The applications were approved on February 5, 2010, for: Trichoderma asperellum strain ICC 012 Technical (EPA Registration Number 80289-11) for manufacturing or formulating use only and BiotenTM WP (EPA Registration Number 80289-9) for use on several food and non-food crops, including ornamentals, fruiting vegetables, leafy vegetables, cole crops, legumes, aromatic herbs, cucurbits, berries and small fruits, and turf. The Agency approved the applications considering data on risks associated with the proposed use of Trichoderma asperellum (strain ICC 012), and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the microbial pesticide and its 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 that show use of Trichoderma asperellum (strain ICC 012), when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

Missing data & conditions for submission: All data requirements have been satisfied, and these pesticide products have been granted unconditional registrations.

Response to comments: EPA published a notice of receipt in the Federal Register of October 29, 2008 (73 FR 64325) (FRL-8386-5), which announced that Isagro S.p.A had submitted applications to register pesticide products containing the new active ingredient, Trichoderma asperellum (strain ICC 012), for use on: Fruit and vegetable crops, herbs, ornamentals, and turf. Moreover, in order to increase the transparency of the Agency's pesticide registration decisions, the Agency began to implement a public participation process for certain registration actions (i.e., new active ingredients, first food uses, first outdoor uses, first residential uses, and other actions of significant interest to the public) on October 1, 2009. As these applications were for pesticide products containing a new active ingredient, the proposed decision, risk assessment, and draft labels associated with these pesticide products were added to the docket prior to registration to allow a meaningful opportunity for the public to provide substantive comments. The start of the 30-day public participation comment period was announced on the Agency's web site http://www.epa.gov/​pesticides/​regulating/​registration-public-involvement.html on December 30, 2009: There were no comments for Trichoderma asperellum (strain ICC 012) received in response to the notice of receipt or during the 30-day public participation process occurring immediately prior to the final registration decision. Contact: Susanne Cerrelli, [phone], [e-mail].

List of Subjects

• Environmental protection
• Chemicals
• Pests and pesticides

August 18, 2010.

W. Michael McDavit,

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