[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32284-32288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12943]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2014-0278; FRL-9911-16]
Registration Review Proposed and Proposed Interim Decisions;
Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's proposed
registration review decisions and opens a public comment period on the
proposed and proposed interim decisions. Registration review is EPA's
periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, that the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Through this program, EPA is ensuring that each pesticide's
registration is based on current scientific and other knowledge,
including its effects on human health and the environment. This
document also announces the registration review case closure for the
pesticide amitrole (case 0095) and the availability of the amitrole
case closure document. The cancellation of all amitrole product
registrations became effective on April 11, 2014. This case closure for
amitrole is being announced herein with no comment period.
DATES: Comments must be received on or before August 4, 2014.
ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the table in Unit II.A., by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the table in Unit II.A.
For general information on the registration review program,
contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-8015; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all
[[Page 32285]]
the specific entities that may be affected by this action. If you have
any questions regarding the applicability of this action to a
particular entity, consult the Chemical Review Manager for the
pesticide of interest identified in the table in Unit II.A.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the Agency taking?
Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed and proposed interim registration review decisions
for the pesticides shown in the following table, and opens a 60-day
public comment period on the proposed and proposed interim decisions.
Ancymidol (Proposed Interim Decision)
The registration review docket for ancymidol (EPA-HQ-OPP-2011-0482)
opened in June 2011. Ancymidol is a plant growth regulator registered
for treating container-grown herbaceous plants, ornamental woody
shrubs, and bedding plants grown in greenhouses and in outdoor plant-
bedding areas. It is also registered for use as a seed treatment for
ornamental plants, and treated seeds are used to start plants. Use of
ancymidol is limited to nursery grown ornamentals. There are no food,
feed, or residential uses registered for ancymidol. No pesticide
tolerances have been established. EPA conducted a qualitative
assessment for both human health and ecological risks. No risks of
concern were identified in the human health risk assessment. The
ecological risk assessment indicated that there was no reasonable
expectation for any registered use of ancymidol to cause direct or
indirect adverse effects to threatened and endangered species. A ``no
effect'' determination was made for all federally listed species and
designated critical habitat. Ancymidol has not been evaluated under the
Endocrine Disruptor Screening Program (EDSP). Therefore, the Agency's
final registration review decision is dependent upon the result of the
evaluation of potential endocrine disruptor risk. Pending the outcome
of this action, EPA is planning to issue an interim registration review
decision for ancymidol.
DEET (Combined Work Plan and Proposed Interim Decision)
The registration review docket for DEET (N,N-diethyl-meta-
toulamide) is opening (EPA-HQ-OPP-2012-0162) for public comment on a
combined Work Plan and Proposed Interim Registration Review Decision.
DEET is a broad-spectrum insect repellent registered for use against
biting flies, biting midges, black flies, chiggers, deer flies, fleas,
gnats, horse flies, mosquitoes, no-see-ums, sand flies, stable flies,
and ticks. It is currently registered for non-food uses and residential
uses. It can be directly used on clothing, applied to the skin, and
used on horses. EPA conducted a qualitative assessment for both human
health and environmental fate and ecological risks. No risks of concern
were identified. The ecological risk assessment made a ``no effect''
determination for federally listed species and designated critical
habitat. DEET has not been evaluated under the EDSP. Therefore, the
Agency's final registration review decision is dependent upon the
result of the evaluation of potential endocrine disruptor risk. Pending
the outcome of this action, EPA is planning to issue an interim
registration review decision for DEET.
Denatonium Saccharide (Proposed Interim Decision)
The registration review docket for denatonium saccharide (EPA-HQ-
OPP-2008-0441) opened in June 2008. Denatonium saccharide is a
bittering agent in squirrel, vole, dog, and cat repellents used on
outdoor surfaces and structures such as trees, fences, poles, decks,
planters, siding, garbage cans, furniture, seeds, and bulbs. EPA
conducted a qualitative human health risk assessment and did not
identify any risks of concern. The ecological risk assessment
identified potential risks for birds and listed mammals. However, due
to the number of conservative assumptions included in the assessment,
the Agency is not proposing mitigation changes at this time. The risk
assessment for denatonium saccharide did not come to a conclusion of
``no effect'' to listed species. Therefore, consultation with the U.S.
Fish and Wildlife Service (USFWS) on the potential risk of denatonium
saccharide to listed species will be necessary. Denatonium saccharide
has not been evaluated under the EDSP. Therefore, the Agency's final
registration review decision is dependent upon the result of Section 7
Endangered Species consultation with the USFWS and the evaluation of
potential endocrine disruptor risk. Pending the outcome of these
actions, EPA is planning to issue an interim registration review
decision for denatonium saccharide.
Dioctyl Sodium Sulfosuccinate (Proposed Decision)
The registration review docket for DSS (EPA-HQ-OPP-2010-1006)
opened in December 2010. DSS is registered as an insecticide and
miticide in pet shampoos and spray products in combination with
Undecylenic Acid (UDA). As a pesticidal active ingredient, there are no
food uses and, thus, no tolerances are established. DSS is used as an
active ingredient in over the counter stool-softener and laxative
products for infants, children, and adults; it is also used in
pharmaceutical, cosmetic, and food products. EPA has conducted a
qualitative assessment for both human health and ecological risks,
including listed species for DSS. The human health risk assessment did
not
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identify any risks of concern for DSS. The ecological risk assessment
made a ``no effect'' determination for federally listed species and
designated critical habitat. Pursuant to FFDCA Section 408(p)(4), EPA
has exempted DSS from the requirements of the EDSP in an Administrative
Order entitled Exemption of Dioctyl Sodium Sulfosuccinate (DSS) and
Undecylenic Acid (UDA) from the Requirements of the Endocrine Disruptor
Screening Program which is available in the registration review docket.
Gas Cartridges; Inorganic Nitrate--Nitrite, Carbon and Carbon Dioxide,
and Sulfur (Proposed Interim Decision)
Potassium and sodium nitrate, carbon and carbon dioxide, and sulfur
are ingredients in fumigant gas cartridge products, which are available
in small and large sizes. Both sizes are registered to control
burrowing mammals, but only the large gas cartridge is registered to
also control coyotes, red foxes and skunks. Gas cartridges are
registered for outdoor use only. To use the products, the user lights
the fuse, places the cartridge in the burrow or den and seals the
entrance. Animals within the burrow or den are asphyxiated by the
release of carbon dioxide and toxic gases.
The Agency relied on a previous human health risk assessment in
making its registration review decisions and determined that no human
health risks of concern exist for these compounds. The Agency conducted
a new ecological risk assessment for the gas cartridges for
registration review. The risk assessment did find the potential for
adverse effects to a number of endangered species from gas cartridge
use. EPA developed mitigation to address the risk to a number of the
endangered species. In most cases, the mitigation involves the use of
Endangered Species Protection Bulletins. Because the gas cartridges
contain the three compounds, these Bulletins are available for comment
in the Inorganic Nitrate--Nitrite, Carbon and Carbon Dioxide, and
Sulfur Registration Review dockets (EPA-HQ-OPP-2007-1118, EPA-HQ-OPP-
2007-0705, and EPA-HQ-OPP-2008-0176, respectively). Although
implementation of these Bulletins will address risk to some endangered
species from gas cartridge use, risk to a number of other endangered
species remains. Additionally, potassium and sodium nitrate, carbon and
carbon dioxide, and sulfur have not been evaluated under the EDSP.
Therefore, the Agency's final registration review decisions are
dependent upon the result of Section 7 Endangered Species consultation
with the USFWS and the evaluation of potential endocrine disruptor
risk. Pending the outcome of these actions, EPA is planning to issue
interim registration review decisions for sodium and potassium nitrate,
carbon and carbon dioxide, and sulfur.
Metofluthrin (Proposed Interim Decision)
The registration review docket for metofluthrin (EPA-HQ-OPP-2012-
0105) opened in June 2013. Metofluthrin is a Type 1 synthetic
pyrethroid insect repellent and insecticide with products registered
for use in residential and commercial areas, including barns, patios,
porches, campgrounds, stables and kennels to repel adult mosquitoes and
kill bed bugs. The products registered for outdoor use are an
impregnated paper repellent strip, a battery-operated personal outdoor
insect repellent fan, an impregnated fiberglass ring heated by a
candle, and battery-operated automated mister. The registered indoor
use is a soluble concentrate used as a spray to kill bedbugs. There are
no registered food/feed uses for metofluthrin. No pesticide tolerances
have been established. EPA conducted a human health risk assessment and
an ecological risk assessment. No risks of concern were identified in
the human health risk assessment. The ecological risk assessment
indicated that there was no reasonable expectation for any registered
use of metofluthrin to cause direct or indirect adverse effects to
threatened and endangered species. A ``no effect'' determination was
made for all federally listed species and designated critical habitat.
Metofluthrin has not been evaluated under the EDSP. Therefore, the
Agency's final registration review decision is dependent upon the
result of the evaluation of potential endocrine disruptor risk. Pending
the outcome of this action, EPA is planning to issue an interim
registration review decision for metofluthrin.
Polybutene Resins (Proposed Decision)
The registration review docket for polybutene resins (EPA-HQ-OPP-
2009-0649) opened in June 2010. Polybutene is a sticky polymer
registered for use as a bird and small mammal repellent. It is used to
prevent house sparrows, pigeons, and starlings from roosting inside and
outside of buildings, as well as to prevent beavers from attacking
trees and shrubs. There are no food/feed uses and, it is exempt from a
tolerance requirement when used as a sticker agent in packaging of
insect control products used on food crops. Polybutene is approved by
the U.S. Food and Drug Administration (FDA) as an indirect food
additive and is used as an ingredient in cosmetic products that are
applied directly to the skin such as sun block or moisturizer, and that
may be incidentally ingested, such as lipstick. EPA conducted a
qualitative assessment for both human health and environmental fate and
ecological risks. No risks of concern were identified in the human
health risk assessment. The ecological risk assessment indicated that
there was no reasonable expectation for any registered use of
polybutene to cause direct or indirect adverse effects to threatened
and endangered species. A ``no effect'' determination was made for all
federally listed species and designated critical habitat. Pursuant to
FFDCA Section 408(p)(4), EPA has exempted polybutene from the
requirements of the EDSP in an Administrative Order (AO) entitled
Exemption of Polybutene from the Requirements of the Endocrine
Disruptor Screening Program. The AO is available in the registration
review docket.
Sulfur (Proposed Interim Decision)
The registration review docket for sulfur (EPA-HQ-OPP-2008-0176)
opened in March 2008. Sulfur is used as an insecticide and fungicide on
a wide range of field and greenhouse-grown food and feed crops,
livestock, livestock quarters, and indoor and outdoor residential
sites. Sulfur is also registered for use in gas cartridge products,
along with inorganic nitrate/nitrite, carbon, and carbon dioxide. EPA
has conducted a qualitative assessment for both human health and
ecological risks, including listed species for sulfur. Details of the
assessment for the gas cartridge use are summarized under the gas
cartridge heading in this unit. For uses of sulfur other than gas
cartridges, the Agency is making a ``no effect'' determination for all
listed aquatic species, and a ``no effect'' determination for direct
effects to listed terrestrial vertebrates that do not rely on insects
as a primary food source. However, at this time, the Agency is not able
to make an endangered species determination on terrestrial
invertebrates, terrestrial plants, or indirect effects to terrestrial
vertebrates with insects as a primary food source. Sulfur has not been
evaluated under the EDSP. Therefore, the Agency's final registration
review decision is dependent upon the result of Section 7 Endangered
Species consultation with the USFWS and the evaluation of potential
endocrine disruptor risk. Pending the outcome of these actions, EPA is
planning to issue
[[Page 32287]]
an interim registration review decision for sulfur.
Undecylenic Acid (Proposed Decision)
The registration review docket for UDA (EPA-HQ-OPP-2011-0910)
opened in December 2011. UDA is registered as an insecticide and
miticide in pet shampoos and spray products in combination with dioctyl
sodium sulfosuccinate (DSS). As a pesticidal active ingredient, there
are no food uses and, thus, no tolerances are established. UDA is
approved by the FDA as an active ingredient in over the counter anti-
fungal products, and it is also used as a flavoring agent. EPA has
conducted a qualitative assessment for both human health and ecological
risks, including listed species for UDA. The human health risk
assessment did not identify any risks of concern for UDA. The
ecological risk assessment made a ``no effect'' determination for
federally listed species and designated critical habitat. Pursuant to
FFDCA Section 408(p)(4), EPA has exempted UDA from the requirements of
the EDSP in an AO entitled Exemption of Dioctyl Sodium Sulfosuccinate
(DSS) and Undecylenic Acid (UDA) from the Requirements of the Endocrine
Disruptor Screening Program which is available in the registration
review docket.
This notice also announces the registration review case closure for
the pesticide amitrole (case 0095) and the availability of the amitrole
case closure document. The Notice of Receipt of a Request to
Voluntarily Cancel Certain Pesticide Registrations was issued in the
Federal Register of August 28, 2013 (78 FR 53141)(FRL-9396-4), and no
substantive public comments were received during the 180-day comment
period that impacted the Agency's decision to grant the cancellation
request. In the Federal Register of April 11, 2014 (79 FR 20199) (FRL-
9908-31), the Agency published the Cancellation Order for all amitrole
product registrations. Due to the cancellation of all registered
amitrole products in the United States, the Agency closed the
registration review case for amitrole, pursuant to 40 CFR 155.42(c). In
addition to the registration review case closure document, the
registration review docket (EPA-HQ-OPP-2011-0105) for amitrole, also
includes other relevant documents related to the registration review of
this case. This action is not open for public comment.
Table--Registration Review Proposed and Proposed Interim Final Decisions
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Registration review case name and Chemical review manager, telephone number,
No. Pesticide Docket ID No. email address
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Ancymidol (Case 3017).... EPA-HQ-OPP-2011-0482...... Christina Scheltema,
703-308-2201,
[email protected].
Carbon and Carbon Dioxide (Case EPA-HQ-OPP-2007-0705...... Carissa Cyran,
4019). 703-347-8781,
[email protected].
DEET (N,N-diethyl-meta-toulamide) EPA-HQ-OPP-2012-0162...... Susan Bartow,
(Case 0002). 703-603-0065,
[email protected].
Denatonium Saccharide (Case 7625). 703-308-0136,
[email protected].
Dioctyl Sodium Sulfosuccinate EPA-HQ-OPP-2010-1006...... Garland Waleko,
(Case 4029). 703-308-8049,
[email protected].
Inorganic Nitrate--Nitrite (Case EPA-HQ-OPP-2007-1118...... Eric Miederhoff,
4052). 703-347-8028,
[email protected].
Metofluthrin (Case 7445).......... EPA-HQ-OPP-2012-0105...... Veronica Dutch,
703-308-8585,
[email protected].
Polybutene Resins (Case 4076). 703-347-0228,
[email protected].
Sulfur (Case 0031)....... EPA-HQ-OPP-2008-0176...... Tanja Crk,
703-308-8202,
[email protected].
Undecylenic Acid (Case 4095). 703-308-8049,
[email protected].
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The registration review docket for a pesticide includes earlier
documents related to the registration review of the case. For example,
the review opened with a Summary Document, containing a Preliminary
Work Plan, for public comment. A Final Work Plan was placed in the
docket following public comment on the initial docket.
The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in the table in Unit II.A., as well as the
Agency's subsequent risk findings and consideration of possible risk
mitigation measures. These proposed and proposed interim registration
review decisions are supported by the rationales included in those
documents.
Following public comment, the Agency will issue final registration
review decisions or interim registration review decisions for products
containing the pesticides listed in the table in Unit II.A.
The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) required
EPA to establish by regulation procedures for reviewing pesticide
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registrations, originally with a goal of reviewing each pesticide's
registration every 15 years to ensure that a pesticide continues to
meet the FIFRA standard for registration. The Agency's final rule to
implement this program was issued in August 2006 and became effective
in October 2006, and appears at 40 CFR part 155, subpart C. The
Pesticide Registration Improvement Act of 2003 (PRIA) was amended and
extended in September 2007. FIFRA, as amended by PRIA in 2007, requires
EPA to complete registration review decisions by October 1, 2022, for
all pesticides registered as of October 1, 2007.
The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed registration
review decisions. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the proposed decision. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
docket for the pesticides included in the table in Unit II.A. Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.
The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The final registration review decision will explain the
effect that any comments had on the decision and provide the Agency's
response to significant comments.
Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of these pesticides are
provided at: http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm.
B. What is the Agency's authority for taking this action?
Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.
List of Subjects
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Ancymidol, Amitrole, Carbon and Carbon Dioxide,
DEET, Denatonium Saccharide, Dioctyl Sodium Sulfosuccinate, Inorganic
Nitrate--Nitrite, Metofluthrin, Polybutene Resins, Sulfur, and
Undecylenic Acid.
Dated: May 28, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-12943 Filed 6-3-14; 8:45 am]
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