Document ID: EPA-HQ-OPP-2007-0705-0040
Agency: epa
Document Type: Notice
Title: Registration Review and Proposed Interim Decisions
Posted Date: 2014-06-04T04:00Z

[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32284-32288]
From the Federal Register Online via the Government Printing 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: 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

[[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

[[Page 32286]]

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
----------------------------------------------------------------------------------------------------------------
 Registration review case name and                                 Chemical review manager,  telephone number,
                No.                   Pesticide Docket ID No.                     email address
----------------------------------------------------------------------------------------------------------------
Ancymidol (Case 3017)....  EPA-HQ-OPP-2011-0482......  Christina Scheltema,
                                                                703-308-2201,
                                                                scheltema.christina@epa.gov.
Carbon and Carbon Dioxide (Case     EPA-HQ-OPP-2007-0705......  Carissa Cyran,
 4019).                                                703-347-8781,
                                                                cyran.carissa@epa.gov.
DEET (N,N-diethyl-meta-toulamide)   EPA-HQ-OPP-2012-0162......  Susan Bartow,
 (Case 0002).                                          703-603-0065,
                                                                bartow.susan@epa.gov.
Denatonium Saccharide (Case 7625).                                                       703-308-0136,
                                                                britton.cathryn@epa.gov.
Dioctyl Sodium Sulfosuccinate       EPA-HQ-OPP-2010-1006......  Garland Waleko,
 (Case 4029).                                          703-308-8049,
                                                                waleko.garland@epa.gov.
Inorganic Nitrate--Nitrite (Case    EPA-HQ-OPP-2007-1118......  Eric Miederhoff,
 4052).                                                703-347-8028,
                                                                miederhoff.eric@epa.gov.
Metofluthrin (Case 7445)..........  EPA-HQ-OPP-2012-0105......  Veronica Dutch,
                                                                703-308-8585,
                                                                dutch.veronica@epa.gov.
Polybutene Resins (Case 4076).                                                       703-347-0228,
                                                                wolf.joel@epa.gov.
Sulfur (Case 0031).......  EPA-HQ-OPP-2008-0176......  Tanja Crk,
                                                                703-308-8202,
                                                                crk.tanja@epa.com.
Undecylenic Acid (Case 4095).                                                       703-308-8049,
                                                                waleko.garland@epa.gov.
----------------------------------------------------------------------------------------------------------------

    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

[[Page 32288]]

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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