Contents

I. INTRODUCTION

................................ ................................ ................................ ...................... 2

II. SCIENTIFIC ASSESSMENTS

................................ ................................ ................................ ... 3

A. Human Health Assessment

................................ ................................ ................................ ............ 3

B. Environmental Assessment

................................ ................................ ................................ ............ 4

1. Environmental Risk Characterization

................................ ................................ ........................ 4

2. Endangered Species Assessment

................................ ................................ ............................... 4
C. Endocrine Disruptor Screening Program

................................ ................................ ......................... 4

III. INTERIM REGISTRATION REVIEW DECISION

................................ ............................... 5

IV. NEXT STEPS

................................ ................................ ................................ ........................... 52

I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Interim Registration Revie w Decision for the allethrins

, pursuant to 40 CFR § 155.5 6 and § 155.58. A registration review decision is the Agency’s determination that a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fun gicide, and Rodenticide Act (FIFRA). The Agency may issue , when it deems appropriate, a n i nterim registration review decision before completing a registration review

. Among other things, t he interim registration review decision may (1) require new risk mitigation measures ; (2) impose interim risk mitigation measures ; (3) identify data or information required to complete the review ; and (4) include schedules for submitting the required data, conducting the new risk assessment

, and completing the registra tion review

. FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by EPA, based on scientific d ata showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as po licies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effect to human health or the environment

. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as these change s occur, products in the marketplace can be safely used. Information on this program is provided at : http://www.epa.gov/oppsrrd1/registration_review/

. In 2006, the Agency implemented the Registration Review program pursuant to FIFRA Section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration

. The allethrins are part of the pyrethroid class of pesticides and are registered for use to control flying and crawling insects. The allethrins are comprised of four stereoisomers: bioallethrin, s

- bioallethrin, esbiothrin, and d

- allethrin. There are no occupational, food or feed uses o f allethrins. After the issuance of the Registration Review Data Call

- In, all allethrins products with the exception of three end use products were voluntarily cancelled with effective cancellation date s of September 30, 2015 for technical products and Dec ember 31, 2016 for end use products. Only d

- allethrin remains registered for pesticidal use. The remaining registered uses of allethrins are ambient air repellents for control of flying pests, such as mosquitoes, in non

- occupational settings. These product s are formulated and sold as impregnated mats that volatize the active ingredient into the air when heated by a candle or butane cartridge, repelling pests in the immediate area. The Agency completed a Reregistration Eligibility Decision (RED) for allethri ns in June of 2007 and amended it in May 2009 to incorporate an evaluation of allethrin use in commercial animal housing misting systems.

Pursuant to 40 CFR § 155.50, the Agency formally initiated registration review for allethrins ( c ase 0437 ) in March 20 10 . The following timeline highlights significant events that have occurred during the registration review of allethrins :

 March 2010

- Publication of the Allethrins Summary Document, including the Preliminary Work Plan (PWP), for a 60

- day comment period. The Summary Document was accompanied by the scoping document and the problem formulation.3

 August 2010

- Publication of the Final Work Plan (FWP) and EPA’s response to the single public comment received. The FWP did not modify the anticipated risk assessment, data needs, or registration review timeline described in the PWP.

 October 2011

– The allethrins Registration Review Generic Data Call

- In (GDCI) was issued.

 2014

– Through a number of Federal Register Notices, all allethrins products with the

ex ception of three end use products were voluntarily cancelled. The effective cancellation dates are September 30, 2015 for technical products and December 31, 2016 for end use products.

 September 2014

- EPA published qualitative human health and environmental fate and effects risk assessments for allethrins in the allethrins registration review docket for a 60

- day comment period. No comments were received on the documents: Allethrins. Registration Rev iew Preliminary Risk Assessment and EFED Registration Review: Draft Ecological Risk Assessment and Endangered Species Effects D etermination for d

- allethrin

.

 September 2014

- EPA published the Proposed Interim Registration Review Decision for allethrins in the Federal Register (79 FR 57084; FRL

– 9916

– 39) . No comments were received.

For further information on the registration review of allethrins , see EPA’s public docket (EPA

- HQ

OPP

- 20 1 0

- 0 022 ) at www.regulations .gov

.

II. S CIENTIFIC ASSESSMENT S

A summary of the Agency’s human health and environmental risk assessments, is presented below. These risk assessments only assess the impregnated mat use of d

- allethrin because all other uses of allethrins have been cancelled effective December 2016. The risk assessments are located in the registration review docket, EPA

- HQ

- OPP

- 2010

- 0022.

A. Human Health Assessment

The only supported use of allethrins is limited to small

- scale, outdoor residential use. The remaining use pattern is a heating apparatus that emits d

- allethrin from an infused mat for up to four hours across a 15

- foot diameter radius. This use is not intended for enclosed areas. There are no occupational or food uses registered for d

- allethrins and the sole remaining use pattern is not expected to contaminate surface or ground water; thus, dietary, aggregate, and occupational risk assessments were not conducted. EPA evaluated residential exposure only.

Residential handler exposure, both dermal and inhalation, is expected to be negligible as the application activity (e.g., lighting a candle) does not involve typical exposure as would spraying a liquid pesticide or spreading granules. Therefore, EPA condu cted a post

- application inhalation exposure assessment only and concludes that the inhalation risk estimates for the remaining allethrin products are not of concern for adults or children.

For details, see the A llethrins. Registration Review Preliminary Risk Assessment published on 9/24/2014.4

B. Environmental Assessment

1. Environmental Risk Characterization

EPA conducted an environmental fate and effects assessment for d

- allethrin

, the active ingredient in the remaining registered products . EPA considered potential d

- allethrin exposure to non

- target organisms, available information on the toxicity of d

- allethrin, and the registered use of d

- allethrin in the assessment.

Based on the available toxicity data and the low exposure potential from the remaining registered use of d

- allethrin, none of the acute or chronic levels of concern (LOCs) are exceeded for fish, aquatic invertebrates, birds, or mammals. In addition, the likelihood of adversely affecting non

- target insects is expected to be low given the relatively limited “repellency affect area” around the dispensing device (~15 feet in diameter), the likely setting of use ( e.g. , residential backyards), and the short half

- life of d

- allethrin in air. While the A gency does not currently have terrestrial plant toxicity data for allethrins, effects to aquatic and terrestrial plants are not reasonably expected to occur due to the low exposure potential. Therefore, given the types and extent of the registered uses of allethrins, the low poten tial for exposure, and the diffuse nature of use, the Agency believes that registered uses of allethrins should not adversely affect non

- target organisms.

For details of the environmental risk assessment, see the EFED Registration Review: Draft Ecological Risk Assessment and Endangered Species Effects determination for d

- allethrin

, published on 9/24/2014.

2. Endangered Species Assessment

There is no reasonable expectation for the currently registered use of allethrins to cause direct or indirect adverse eff

ects to threatened and endangered species. No adverse modification of critical habitat is expected to occur from use of allethrins. EPA has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species. EPA also has dete rmined that no habitat modification is likely for designated critical habitat for such species. Therefore, EPA has concluded that consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7(a)(2) is no t required. For details, see the September 5, 2014 Draft Ecological Risk Assessment cited above.

C. Endocrine Disruptor Screening Program

EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inclu ding pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Under FFDCA section 408(p), the A gency must screen all pesticide chemicals. Between October 2009 and November 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals and published a second list of chemicals proposed for order issuance in the future. Allethrins was not among the group of 58 pesticide active ingredients on the initial list nor is it proposed on the second list of chemicals to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

- ins for registration review chemicals, including allethrins. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future chemical lists proposed for5

screening, the test guidelines and the Tier 1 screening batte ry, please visit our website: http://www.epa.gov/endo/ . In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of allethrins. Before completing this Regi stration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

I II. INTERIM REGISTRATION REVIEW DECISION

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this I nterim Registration Review D ecision

. Except for the EDSP component of the allethrins registration review case, the Agency has determined the following: (1) no additional data are required at this time; and (2) no changes to the affected registrations or their labeling are needed at this time. In addition, EPA does not expect allethrins to have direct or indirect adverse effects to non

- listed and listed species or to designated critical habitat

. As such, EPA has made a “no effect” determination under the Endangered Species Act (ESA) for all l isted species and designated critical habitat for such species.

IV. NEXT STEPS

EPA will make a final registration review decision for allethrins after an EDSP FFDCA section 408(p) determination has been made.