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### DEET – Table of Contents

Introduction 3

Statutory and Regulatory Authority 3

DEET Chemical Facts 4

Use and Usage Information 4

Recent Actions 5

Scientific Assessments 5

Combined Work Plan, Summary Document, and Proposed Interim Registration
Review Decision 9

Next Steps and Timeline 9

References:

This document summarizes the Environmental Pr otection Agency’s current position based on the following documents:

1. Registration Review – Ecological Risk, Environmental Fate, and Endangered Species Assessment for N,N-Diethyl-meta-toluamide (DEET)

. Christine Hartless and James Lin. August 2, 2012.

2. DEET. Revised Human Health Risk Asse ssment in Support of Registration Review. Ronnie Bever, Alexandra LaMay, and Ideliz Negrón-Encarnación. February 27, 2014.

3. DEET: Review of Human Incidents . Shanna Recore. May 3, 2012.

4. BEAD Chemical Profile for Registration Review: DEET (080301). David Brassard, Cynthia Doucoure, and Andr ew Lee. February 29, 2012

These and other supporting documents for the D EET registration review case may be found in the docket EPA-HQ-OPP-2012-0162 at http://www.regulations.gov

.3 INTRODUCTION

The docket for N,N-Diethyl-meta-toluamide (DEET) is now open, initiating the first public comment period for this registration review (docket number EPA-HQ-OPP-2012-0162).
This document is the Environmental Protecti on Agency’s (EPA or the Agency) combined Work

Plan

, Summary Document, and Proposed Interim Regist ration Review Decision for DEET. It is being issued pursuant to 40 CFR Sections 155.50, 155.56, and 155.58. This document explains what EPA’s Office of Pesticide Programs knows about DEET, highlighting anticipated data and assessment needs and providing an anticipated timeline for completing DEET review. It also includes the Agency’s Proposed Interim Registration Review Decision for DEET.

A registration review decision is the Agency ’s determination whether a pesticide meets, or does not meet, the standard for registrati on in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a proposed interim registration re view decision before completi ng a registration review. Among other things, the proposed interim registration re view decision may require new risk mitigation measures, impose interim risk mitigation measur es, identify data or information required to complete the review, and include schedules fo r submitting the required data, conducting the new risk assessment and completing the registration review.

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. DEET was develo ped by the United States (U.S.) Army in 1946 for use by military personnel in insect affected areas and was registered for use by the general public in 1957. DEET is currently registered for non-f ood and residential uses. There is also one registered product for use on horses. There are no registered food or agricultural uses. The Reregistration Eligibility Decision document (RED) for DEET was completed on April 13,

1998. 1 For further information about DEET, additi onal documents can be found in EPA’s public docket (EPA-HQ-OPP-2012-0162) at www.regulations.gov

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STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the U.S. generally must be registered by EPA, based on scientific data showing that they will not cause unreasonable risk s to human health or the environment when used as directed on produc t labeling. The registra tion review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable
adverse effects to human health or the environm ent. Changes in scien ce, public policy, and pesticide use practices will occur over time . Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Inform ation on this program is provided at www.epa.gov/oppsrrd1/registration_review/

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1 Located at http://www.epa.gov/oppsrrd1/REDs/0002red.pdf4 The Agency is implementing the registration re view program pursuant to Section 3(g) of FIFRA, and will review each re gistered pesticide every 15 ye ars to determine whether it

continues to meet the FIFRA standard for re gistration. The regulations governing registration review begin at 40 CFR 155.40. The Agency will c onsider benefits information and data as required by FIFRA. The public phase of registrati on review begins when the initial docket is opened for each case. The docket is the Agency ’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision.

DEET CHEMICAL FACTS

PC code 080301

Case Number 2

CAS Number 134-62-3 Year first registered 1957 Pesticide Type Insect and acarid repellent Chemical class N, N-dialkylamides Reregistration Eligibility Decision (RED) September 1998

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable 40 CFR Citation There are no registered DEET food/feed uses and no established

tolerances for DEET Dual-use Conventional pesticidal uses only Non-pesticidal uses No non-pesticidal uses of DEET

Pesticide Re-evaluation Division, Chemical Review Manager Susan Bartow, Bartow.Susan@epa.gov, (703) 603-0065

Registration Division, Product Manager Richard Gebken, Gebken.Richard@epa.gov, (703) 305-6701

USE AND USAGE INFORMATION

Available data on DEET show that it accounted for the overwhelming majority of insect repellents used in the U.S. in 2005, 2009, and 2012 according to private market research surveys (Table 1.) About 30% of the U.S. population uses DEET annually as an insect repellent (EPA, 1998).

Table 1. DEET Usage in the U.S.

Active Ingredient 2005 2009 2011

Million lb Million lb Million lb

DEET 7.7 6.8 9.2 Source: Kline & Company, 2006, 2010, and 20125 The use of insect repellents such as DEET is intended to provide certain public health benefits. Application of DEET in sect repellents to the skin an d clothing is intended to help prevent bites from mosquitoes, tic ks and other biting in sects that may vector diseases such as Lyme disease, West Nile virus, malaria, yellow fever, dengue feve r, and encephalitis. Please see

the BEAD Chemical Profile for Regi stration Review: DEET (080301) in the registration review

docket for more details.

Summary of Use Broad-spectrum insect re pellant registered for use on the human body, clothing, and on horses to repel biting flies, biting midges, black flies, chiggers, deer flie s, fleas, gnats, horse flies, mosquitoes, no-see-ums, sand flie s, stable flies, and ticks. Use Sites DEET is registered for use on horses (animal treatment); and human skin, hair, clothing, footw ear, shoes and headgear (hats). Summary of Usage DEET accounts for the overwhelming majority of insect repellents used in the United St ates; approximately 30% of the U.S. population uses DEET annually as an insect repellent. Formulation Type(s) Formulations include microencapsulated, pressurized spray (aerosol), impregnated materials (e.g., towelettes, roll on), and ready to use solution (non-aerosol pump sprays, liquids, creams, lotions, and foams). A number of DEET products are also
formulated with sunscreen. Application Method(s) DEET is generally applied using aerosol sprays, non-aerosol sprays, creams, lotions, roll-ons, foams, and towelettes. Technical Registrant(s) Clairant Corporation (8340) and Vertellus Performance Materials, Inc. (51147) No. of Registrations 123 active registrations

Restricted Use No

RECENT ACTIONS

There are no recent actions for DEET.

SCIENTIFIC ASSESSMENTS

A summary of the Agency’s human health and environmental fate and ecological risk

assessments, DEET (N,N-Diethyl-meta-toluamide) – Revised Human Health Risk Assessment in Support of Registration Review (February 27, 2014) and Registration Review – Ecological Risk, Environmental Fate, and Endangered Species A ssessment for N,N-Diet hyl-meta-toluamide (DEET) (August 2, 2012), is presented below. For th e detailed risk assessments, see the DEET public docket (EPA-HQ-OPP-2012-0162) accessed at www.regulations.gov

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A. Human Health Assessment

Hazard Characterization and Risk
The toxicological database is considered ade quate for characterizing hazard and assessing

risk from DEET. No additional studies are anti cipated to be needed for registration review.6 Dietary Exposure Assessment
There are no registered food/feed uses and existing use patterns are not expected to contaminate surface or ground water; thus, a di etary exposure assessment was not conducted.

Food Tolerances
There are no U.S. tolerances established for DEET because DEET is not registered for any food/feed uses.

Residential and Occu pational Exposure
DEET is registered for use as an insect repe llent, and for use on clothing or directly on the skin. There are also registered DEET-impr egnated products, such as tablecloths. DEET products are available in multiple formulations, including aerosol sprays, creams, lotions, and in multiple concentrations. Exposures to DEET may o ccur from deliberate application to the skin and clothing of individuals. Huma n exposure from the repellent-use can be on the order of days or weeks or longer, depending on the individual user’s activity pattern and geographic area. Exposure is expected to be of short- and intermediate-term exposure duration; however, longterm exposures are possible for some individuals in some climates.

Insect repellents are used by/on people of a ll ages. Adults are assumed to experience both dermal and inhalation handler exposures, as we ll as post-application dermal and, potentially, inhalation exposure. Adults are assumed to appl y repellents to themselves or to others. Additionally, for aerosol repellen ts, individuals on whom the products are being applied can experience indirect inhalation e xposure during the application. For children, post-application exposure consists of dermal, (potentially) i nhalation, and hand-to-mouth exposure. An exposure assessment was previously prepared to suppor t the DEET Registration Eligibility Decision (RED). Since no endpoints have been identified for DEET, a quantitative exposure and risk assessment for DEET products, including a reside ntial exposure and risk assessment, is not anticipated to be needed at this time. There is no occupational exposure associated with DEET; therefore, an occupational risk assessment was not conducted ( DEET (N,N-Diethyl-metatoluamide) – Revised Human Health Risk Assessment in Support of Registration Review (February 27, 2014)).

Human Health Incidents
The Office of Pesticide Programs (OPP) Incident Data System (IDS) was used to retrieve pesticide incident data on DEET. The IDS reco rds incidents in one of two modules: Main IDS and Aggregate IDS. Main IDS contains incide nts resulting in higher severity outcomes and provides more detail with regard to case specific s. Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). For the Main IDS, from January 1, 2007 to February 22, 2012, there were 387 exposures reported for single chemical only in the database (382 exposure classified as resulting in a mode rate severity, 4 classified as major severity and 1 classified as an undetermined severity). In the Aggregate IDS, from January 1, 2007 to February 22, 2012, there were 2,769 reporte d incidents involvi ng DEET. DEET is not included in the Agricultural Health Study (AHS).

Overall, there were a large number of inci dents reported involvi ng DEET; however, the
number of incidents is relative ly small when compared to the number of users. Most of the incidents reported to IDS involvi ng DEET were classified as minor severity. Minor severity7 means that a person alleged or exhibited some sy mptoms, but they were minimally traumatic, the symptoms resolved rapidly and usually involved skin, eye or respirator y irritation. Several high severity outcomes are reported in the IDS database . It is important to not e, however, that there are a large number of users of DEET (approximate ly 104 million, based on the estimated use rate
in 1984-1989 2 ) and the number of incidents is relatively small in comparison. It also is unclear if
there is a connection between DEET use and the incidents or if it is a coincidence. While incident information can be an important source of feedback to the Agency, reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an “incident”) ar e largely selfreported and therefore, generally speaking, neithe r exposure to a pesticid e or reported symptom (or the connection between the tw o) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data ( Revised DEET: Review of Human Incidents (June 19, 2012) and DEET (N,N-Diethyl-m eta-toluamide) – Revised Human Health Risk Assessment in Support of Registration Review (February 27, 2014)).

B. Environmental Assessment

Environmental Fate and Exposure
DEET is relatively stable, highly hygroscopic an d sensitive to light. It is expected to be moderately mobile in th e soil column. In surface waters and soil, DEET is expected to degrade at a moderate to rapid rate (the half-life of DEET is measured in days to weeks). The small amounts of DEET retained in air are subject to ra pid photo-oxidation via hydroxy radical-mediated degradation with an estimated half-life between 10 to 15 hours. The bioaccumulation potential of DEET is low; it is neither a persistent, bioa ccumulative toxicant nor a persistent organic pollutant.

Based on the use characteristics and environmen tal fate properties of DEET, runoff, spray drift, leaching, and atmospheric deposition are unlikely to result in aquatic or terrestrial
exposures to non-target plants and organisms.

Ecological Risk Characterization
The results of risk estimation for aquatic orga nisms indicate that registered uses of DEET
will not result in level of concer n (LOC) exceedances for acute risk to fish and invertebrates. Chronic risk quotients (RQs) were not calculated; however, given the large margin of safety
observed for acute effects based on the most cons ervative exposure scenar io, it is unlikely that chronic RQs would approach LOCs. Risks for aqua tic plants are expected to be lower than LOCs, given the mode of action of DEET and the la rge margin of safety demonstrated for other aquatic organisms.

Exposure in terrestrial habita ts would be limited to human skin, clothing, and shoes, as
well as horse skin and hair of horses that rece ived DEET applications. Products formulated as lotions or impregnated wipes are applied dir ectly to human skin. Many other product labels specify recommended spray distances of less than 10 inches from the inte nded application sites (human skin, clothing, and shoes, as well as horse skin and hair). The amount of DEET resulting

2 Veltri, J.C., Osimitz, T.G., Bradford, D.C., and Page, B.C. 1994. Retrospective analysis of calls to Poison Control Centers resulting from exposure to the insect repellent N, N-diethyl-m-toluamide (DEET) from 1985-1989. Clinical Toxicology, 32(1):1-16.8 from human or horse application in the terrestrial environment (a ir, ground, plants, or non-treated animals) is inconsequential. As there is no complete exposure pathway under the currently registered uses, the Agency expects neg ligible risk to terrestrial organisms.

Threatened and Endangered Species
There is no reasonable expecta tion for any registered use of DEET to cause direct or indirect adverse effects to threatened and endang ered species. No adverse modification of critical habitat is expected from the use of DEET. There are no aquatic LOC exceedances based on low environmental exposure and low toxicity to aquati c organisms. Conclusions regarding terrestrial organisms and plants are based on the lack of a complete exposure pathway. As discussed above, exposure is expected to be limite d to human skin, clothing, and horse s. Exposure to listed species is not expected because they would not likely come in direct contact with humans or domestic horses (i.e., the registered use si tes). Therefore, EPA has made a “no effect” determination under the Endangered Species Act (ESA) fo r all listed species and designa ted critical habitat for such species, and has therefore conclude d that consultation with the Fish and Wildlife Service and the
National Marine Fisheries Se rvice under ESA section 7( a)(2) is not required ( Registration Review – Ecological Risk, Environmental Fa te, and Endangered Species Assessment for N,NDiethyl-meta-toluamide (DEET) (August 2, 2012)).

Ecological Incidents
There are no reported incidents for aquatic organisms or plants. A review of the following databases was completed on May 29, 2012: Ecological Incident Information System (EIIS), Aggregate Incident Reports database, Avian Monitoring Information System (AIMS), and the Contaminant Exposure and Effects – Terres trial Vertebrate (CEE-TV). One incident was
listed in the EIIS database and one incident was listed in the A ggregate Incident Report database.

No additional incidents for DEET were identified in the AIMS or the CEE-TV databases. For additional discussion of the reporte d ecological incidents, see the Registration Review – Ecological Risk, Environmental Fate, and Endange red Species Assessment for N,N-Diethylmeta-toluamide (DEET).

C. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA review s numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute,

subchronic and chronic toxici ty, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or syst emic toxicity. These studies include endpoints which may be susceptible to endocrine influenc e, including effects on endocrine target organ histopathology, organ weights, es trus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. Fo r ecological hazard assess ments, EPA evaluates

acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for DEET, EPA reviewed these data and determined that a qu alitative toxicity assessment is appropriate for DEET. However, as required by FFDCA secti on 408(p), DEET is subject to the endocrine screening part of the Endocrine Di sruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredie nts) may have an effect in hu mans or wildlife similar to an9 effect produced by a “naturally occurring estr ogen, or other such endocrine effects as the Administrator may designate.” The EDSP empl oys a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact w ith the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal sy stems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Ti er 2 tests are necessary based on the available data. Tier 2 testing is designe d to identify any adverse endocr ine-related effects caused by the substance, and establish a dose-response relations hip between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. A second list of
chemicals identified for EDSP scr eening was published on June 14, 2013 3 and includes some pesticides scheduled for Registration Review and chemicals found in water

. DEET was not
included on either list. For further informati on on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 4

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of DEET. Be fore completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

COMBINED WORK PLAN, SUMMARY DO CUMENT, AND PROPOSED INTERIM
REGISTRATION REVIEW DECISION

In accordance with 40 CFR Sections 155.50, 155.56, and 155.58, the Agency is issuing this combined Work Plan, Summary Document , and Proposed Interim Registration Review Decision. Except for the EDSP component of the D EET registration review case, the Agency has made the following interim decision: (1) no additi onal data are required at this time; and (2) no changes to the affected registra tions or their labeling are need ed at this time. EPA has not identified any risks of concern to human hea lth. Currently registered uses of DEET are not expected to result in adverse effects for listed and non-listed species, or critical habitat. As such, EPA concludes “no effect” for listed species a nd no adverse modification of designated critical habitat for all currently re gistered uses of DEET.

NEXT STEPS AND TIMELINE

A Federal Register Notice will announce the ava ilability of this combined Work Plan and Summary Document and Proposed Interim Regist ration Review Decision for DEET and allow a 60-day comment period. If there are no signifi cant comments or additional information submitted to the docket during the comment period th at leads the Agency to change its decision, EPA may issue an Interim Registration Revi ew Decision for DEET (case 0002). However, a

3 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

4 http://www.epa.gov/endo/10 final decision for DEET may be issued without having previously issued an interim decision. A final decision on the DEET registration review case will occur after an EDSP FFDCA section 408(p) determination has been made.

EPA has created the following estimated timeline for the completion of DEET registration review.

Registration Review for DEET – Proj ected Registration Review Timeline

Activities Estimated Date Opening the Docket and Combined Work Pla n, Summary Document, and Interim Registration
Review Decision Open Public Docket and Public Comment Period for Combined Work Plan, Summary Document, and Propos ed Interim Registration Review

Decision 2014 – May

Close Public Comment Period 2014 – July Interim Registration Review Deci sion and Begin Post-Decision Follow-up 5 2014 – September

Total (years) 0.5

5 A final decision on the DEET regist ration review case, in accordance with 40 CFR Section155.158, will occur after an EDSP FFDCA section 408(p) determination has been made.