Document ID: EPA-HQ-OPP-2011-0910-0016
Agency: epa
Document Type: Notice
Title: Registration Review Final and Interim Decisions
Posted Date: 2014-09-24T04:00Z

[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57090-57092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22740]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0651; FRL-9916-79]

Registration Review Final and 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 final 
registration review 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 causing 
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.

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: dumas.richard@epa.gov.

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 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 pesticide specific contact person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPP-2014-0651, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    Pursuant to 40 CFR 155.58(c), this notice announces the 
availability of EPA's final registration review decision for dioctyl 
sodium sulfosuccinate (Case 4029), polybutene resins (Case 4076), and 
undecylenic acid (Case 4095) and interim decisions for ancymidol (Case 
3017), DEET (Case 0002), denatonium saccharide (Case 7625), and 
metofluthrin (Case 7445).
    In addition to the final and interim registration review decision 
document, the registration review dockets for ancymidol, DEET, 
denatonium saccharide, dioctyl sodium sulfosuccinate, metofluthrin, 
polybutene resins, and undecylenic acid also include other relevant 
documents related to the registration review of these cases. The 
proposed registration review decisions or interim decisions were posted 
to the respective dockets and the public was invited to submit any 
comments or new information. EPA is addressing the comments or 
information received during the 60-day comment period in the discussion 
for each pesticide listed in this document, see Unit II. for the 
discussions.

         Table--Registration Review Final and Interim Decisions
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.                   ID No.         No., email address
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Ancymidol (Case 3017).........  EPA-HQ-OPP-2011-0  Christina Scheltema,
                                 482.               (703) 308-2201,
                                                    scheltema.christina@epa.gov.
DEET (N,N-diethyl-meta-         EPA-HQ-OPP-2012-0  Susan Bartow, (703)
 toulamide) (Case 0002).         162.               603-0065,
                                                    bartow.susan@epa.gov
                                                    .
Denatonium saccharide (Case     EPA-HQ-OPP-2008-0  Cathryn Britton,
 7625).                          441.               (703) 308-0136,
                                                    britton.cathryn@epa.gov.
Dioctyl sodium sulfosuccinate   EPA-HQ-OPP-2010-1  Garland Waleko, (703)
 (Case 4029).                    006.               308-8049,
                                                    waleko.garland@epa.gov.
Metofluthrin (Case 7445)......  EPA-HQ-OPP-2012-0  Veronica Dutch, (703)
                                 105.               308-8585,
                                                    dutch.veronica@epa.gov.
Polybutene resins (Case 4076).  EPA-HQ-OPP-2009-0  Joel Wolf, (703) 347-
                                 649.               0228,
                                                    wolf.joel@epa.gov.
Undecylenic acid (Case 4095)..  EPA-HQ-OPP-2011-0  Garland Waleko, (703)
                                 910.               308-8049,
                                                    waleko.garland@epa.gov.
------------------------------------------------------------------------

    Ancymidol (Interim Decision). The registration review docket for 
ancymidol (EPA-HQ-OPP-2011-0482) opened in June 2011. EPA issued the 
Proposed Interim Registration Review Decision for ancymidol on June 4, 
2014 and took comments for 60 days. The Agency received one comment 
from the Center for Biological Diversity, which supported the Proposed 
Interim Registration Review Decision. Therefore, EPA is issuing the 
Interim Registration Review Decision for ancymidol. 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

[[Page 57091]]

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 environmental fate and 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 or designated critical habitat. 
EPA made a ``no effect'' determination was 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.
    DEET (Interim Decision). EPA has completed an interim registration 
review decision for DEET (N,N-diethyl-meta-toulamide). The registration 
review docket for DEET opened in June 2014 (EPA-HQ-OPP-2012-0162). EPA 
issued a combined Work Plan and Proposed Interim Decision for DEET on 
June 4, 2014 and took comment for 60 days. The public comments received 
did not affect the Agency's interim 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 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 registration review decision is 
dependent upon the result of the evaluation of potential endocrine 
disruptor risk.
    Denatonium saccharide (Interim Decision). EPA has completed an 
interim registration review decision for denatonium saccharide. The 
registration review docket for denatonium saccharide (EPA-HQ-OPP-2008-
0441) opened in June 2008. EPA issued the proposed interim decision for 
denatonium saccharide on June 4, 2014 and took comment for 60 days. The 
Agency received one comment from the Center for Biological Diversity, 
which supported the Proposed Interim Registration Review Decision. 
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, 
there are no labeling 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.
    Dioctyl sodium sulfosuccinate (Registration Review Decision). EPA 
has completed a registration review decision for dioctyl sodium 
sulfosuccinate (DSS). The registration review docket for DSS (EPA-HQ-
OPP-2010-1006) opened in December 2010. EPA issued the proposed 
decision for DSS on June 4, 2014 and took comment for 60 days. The 
Agency received one comment from the Center for Biological Diversity, 
which supported the proposed registration review decision. 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 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 
section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
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.
    Metofluthrin (Interim Decision). EPA has completed an interim 
registration review decision for metofluthrin. The registration review 
docket for metofluthrin (EPA-HQ-OPP-2012-0105) opened in June 2013. EPA 
opened a 60-day comment period on the proposed interim decision for 
metofluthrin in June 2014. Three comments were received during that 
period. The Center for Biological Diversity commented that it agreed 
with the Agency's proposed decision. Two other comments, from 
California Water Board representatives, expressed the view that 
metofluthrin should undergo a comprehensive ecological assessment, like 
the other pyrethroids. The commenters also expressed concern that 
metofluthrin (particularly the bed bug use and the tabletop mister) had 
the potential to contaminate urban waters. These comments have been 
addressed in a new response to comments document available on the 
docket. None of the comments resulted in changes to the interim 
decision. Metofluthrin is a Type 1 synthetic pyrethroid insect 
repellent and insecticide with products registered for use in 
residential and commercial areas, including barns, stables, and 
kennels. There are no registered food/feed uses. Metofluthrin has 
minimal potential for human health and ecological exposure. No risks of 
concern were identified. In addition, the Agency made a ``no effect'' 
determination for federally listed species and designated critical 
habitat. No additional data or changes to the affected registrations or 
their labeling are needed at this time. Metofluthrin has not been 
evaluated under the EDSP. Therefore, the Agency's final registration 
review decision will be dependent on evaluation of potential endocrine 
disruptor risk.
    Polybutene resins (Registration Review Decision). EPA has completed 
a registration review decision for polybutene resins. The registration 
review docket for polybutene resins (EPA-HQ-OPP-2009-0649) opened in 
June 2010. EPA issued the proposed decision for polybutene resins on 
June 4, 2014 and took comment for 60 days. The Agency received one 
comment from the Center for Biological Diversity, which supported the 
proposed registration review decision. 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

[[Page 57092]]

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 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'' which is 
available in the registration review docket.
    Undecylenic acid (Registration Review Decision). EPA has completed 
a registration review decision for undecylenic acid (UDA). The 
registration review docket for UDA (EPA-HQ-OPP-2011-0910) opened in 
December 2011. EPA issued the proposed decision for UDA on June 4, 2014 
and took comment for 60 days. The Agency received one comment from the 
Center for Biological Diversity, which supported the proposed 
registration review decision. 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.
    Pursuant to 40 CFR 155.57, a registration review decision is the 
Agency's determination whether a pesticide meets, or does not meet, the 
standard for registration in FIFRA. EPA has considered Ancymidol, DEET, 
Denatonium Saccharide, Dioctyl Sodium Sulfosuccinate, Metofluthrin, 
Polybutene Resins, and Undecylenic Acid in light of the FIFRA standard 
for registration. The Ancymidol, DEET, Denatonium Saccharide, Dioctyl 
Sodium Sulfosuccinate, Metofluthrin, Polybutene Resins, and Undecylenic 
Acid Final or Interim Decision documents in the respective dockets 
describe the Agency's rationale for issuing a registration review final 
or interim decision for these pesticides.
    Pursuant to 40 CFR 155.58(c), the registration review case docket 
for Ancymidol, DEET, Denatonium Saccharide, Dioctyl Sodium 
Sulfosuccinate, Metofluthrin, Polybutene Resins, and Undecylenic Acid 
will remain open until all actions required in the final decision have 
been completed.
    Background on the registration review program is provided at: 
http://www.epa.gov/oppsrrd1/registrationreview. Links to 
earlier documents related to the registration review of this pesticide 
are provided at: http://www2.epa.gov/pesticide-reevaluation/individual-pesticides-registration-review.

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.

    Authority:  7 U.S.C. 136 et seq.

    Dated: September 16, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-22740 Filed 9-23-14; 8:45 am]
BILLING CODE 6560-50-P