Docket Number EPA

- HQ

- OPP

- 20 1 0

- 0 022

www.regulations.gov



## Allethrins Proposed Interim Registration Review Decision

Case Number 0437

September 2014

Approved by:

___________________________

Richard P. Keigwin, Jr.

Director

Pesticide Re

- evaluation Division

Date:

___________________________2



### Contents

I. INTRODUCTION

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

II. SCIENTIFIC ASSESSMENTS

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

A. Human Health Assessment

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

B. Environmental Assessment

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

1. Environmental Risk Characterization

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

2. Endangered Species Assessment

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

C. Endocrine Disruptor Screening Program

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

III. PROPOSED INTERIM REGISTRATION REVIEW DECISION

................................ ......... 6

IV. NEXT STEPS AND TIMELINE

................................ ................................ ............................. 63

I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Revie w Decision for 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, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue , when it deems ap propriate, a proposed interim 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 registration 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 data 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 policies and practi ces 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 st ereoisomers : bioallethrin, s

- bioallethrin, esbiothrin, and d

- allethrin

. T here are no occupational, food or feed uses of allethrins

. After the issuance of the Registration Review Data Call

- In, a ll allethrins products with the exception of three end use products were voluntarily cancelled with an effective date of September 30, 2015 for technical products and December 31, 2016 for end use products. O nly d

- allethrin remains registered for pesticidal use. The remaining registered uses of allethrins are ambient air repellents for control of flying pests

, such as mosqu itoes

, in non

- occupational settings. These products are formulated and sold as impreg nated mats that volatize the active ingredient into the air when heated by a candle or butane cartridge, effectively repelling pests in the immediate area. The Agency comp leted a Reregistration E ligibility Decision (RED) for allethrins in June of 2007 and a mended 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 initi ated registration review for allethrins ( C ase #

0437 ) in March 2010 . The following timeline highlights significant events that have occurred during the registration review of allethrins :

 March 201 0

- Publication of the Allethrins Summary Document

, including the Preliminary Work Plan (PWP), for a 60

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

.4

 August 2010

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

.

 October 2011

– The allethrins Registration Review Generic Data Call

- In (GDCI) was issued

.

 2014

– Through a number of Federal Register Notices, a ll allethrins products with the exception of three end use products were voluntarily cancelled. T he effective cancellation dates are September 30, 2015 for technical products and December 31, 2016 for end use products.

 September 201 4

- EPA is now publish ing a Proposed Interim Registration Review Decision for allethrins, along with the supporting human health and environmental fate and effects

risk assessments

, in the allethrins registration review docket for a 60

- day com ment period

.

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

- HQ

OPP

- 201 0

- 0 022 ) at www.regulations.gov

.

II. S CIENTIFIC ASSESSMENT S

A summary of the Agency’s human health and e nvironmental risk assessments

, is presented below

. These risk assessments only assess the impregnated mat use of d

- allethrin due to the fact that all

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

- HQ

- OPP

- 201 0

- 0 022

.

A. Human Health Assessment

The only supported u se of allethrins is limited to small

- scale, outdoor residential use. The rema ining

use pattern is a heating apparatus that emit s 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 allethrins and the sole remaining use pattern is not expected to contaminate surface or ground water; thus, dietary

, aggregate , and occupational risk assessment s

w ere 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 conducted a post

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

For details, see the September 5 , 2014 Allethrins. Registration Review Preliminary Risk Assessment.

B. Environmental Assessment

1. Environmental Risk Characterization

EPA c onducted a n environmental fate and effects assessment for d

- allethrin (the active ingredient in

the allethrins repellent candle lanterns )

. EPA consider ed potential d

- allethrin exposure to non

- target5

organisms, available information on the toxicity of d

- allethrin

, and the registered uses of d

- allethrin

in th e 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
i nsects 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 agenc y 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, g iven the type s and extent of the registered use s of

allethrins , the low potential for exposure

, a nd the diffuse nature of use, the A gency believes that registered use s 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

, September 5 , 2014

.

2. Endangered Species Assessment

There is no reasonable expectation for the currently registered use of allethrins to cause direct or indirect adverse effects 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 determined that no habitat modification is likely for designated critical habitat for such species

. T herefore , EPA has

concluded that consultation with the U.S. Fish and Wildlife Service and the National Marine

Fisheries Service unde r ESA section 7(a)(2) is not required. For details, see the September 5 , 2014

Draft Ecological Risk Assessment cited above.

C. E ndocrine Disruptor Screening Program

EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including 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 Agency 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 wi ll 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 for screening, the test guidelines and the Tier 1 screening battery, 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 screeni ng of allethrins . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.6

I II. P ROPOSED INTERIM REGISTRATION REVIEW DECISION

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

. Except for the EDSP component of the allethrins registration review case, the Agency has made the following Proposed Interim Re gistration Review Decision : (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 effect s to non

- listed and listed species or to modify designated critical habitat

. As such, EPA has made a “no effect” determination un der the ESA for all listed species and designated critical habitat for such species.

IV. NEXT STEPS AND TIMELINE

A Federal Register Notice will announce the availability of this P roposed I nterim R egistration

R eview D ecision in the allethrins registration review docket ( EPA

- HQ

- OPP

- 2010

- 0 022 ) and allow a

60

- day comment period . If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its proposed decision, EPA may issue an I nterim R egistration R eview D ecision for allethrins (case 0437 ). Ho wever, a final

decision for allethrins may be issued without having previously issued an I nterim Registration

Review D ecision. A final decision on allethrins registration review case will occur after an EDSP FFDCA section 408(p) determination has been mad e.