[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52737-52745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21290]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0213; FRL-8839-2]
Pesticide Product Registrations; Unconditional and Conditional
Approvals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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.
[[Page 52738]]
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 (703) 305-5805.
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, (703)
308-0031, [email protected].
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
[[Page 52739]]
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, (703) 308-0031,
[email protected].
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, (703)
308-0031, [email protected].
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, (703) 308-0031,
[email protected].
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,
[[Page 52740]]
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, (703)
308-0031, [email protected].
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, (703) 605-0513, [email protected].
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
[[Page 52741]]
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, (703) 308-0169,
[email protected].
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[reg]
(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, (703) 308-8263,
[email protected].
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,
[[Page 52742]]
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,
(703) 308-8263, [email protected].
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, (703) 308-8097,
[email protected].
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
[[Page 52743]]
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, (703) 308-9525,
[email protected].
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[reg]-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[reg]EGVM. One comment
opposed the registration of Isomate[reg]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, (703) 308-9525, [email protected].
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[reg]VMB Technical
Pheromone (EPA Registration Number 56336-55) for manufacturing or
formulating use only and one end-use product was registered:
CheckMate[reg]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
[[Page 52744]]
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,
(703) 308-9525, [email protected].
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, (703) 305-6502,
[email protected].
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
[[Page 52745]]
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, (703) 308-8077,
[email protected].
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, (703) 308-8077, [email protected].
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.
[FR Doc. 2010-21290 Filed 8-26-10; 8:45 am]
BILLING CODE 6560-50-S