2 

### A lpha

- chlorohydrin

– Table of Contents

INTRODUCTION

................................ ................................ ................................ .......................... 4 ALPHA

- CHLOROHYDRIN CHEMICAL FACTS

................................ ................................ ...... 6 USE AND USAGE INFORMATION

................................ ................................ ............................ 6 RECENT ACTIONS

................................ ................................ ................................ ....................... 7 SCIENTIFIC ASSESSMENTS

................................ ................................ ................................ ...... 7 A. Human Health Assessment

................................ ................................ ............................... 7
Hazard Characterization

................................ ................................ ................................ ........ 7 Dietary Exposure and Risk Assessment

................................ ................................ .................. 7
Food Tolerances

................................ ................................ ................................ ..................... 7
Human Health Incidents

................................ ................................ ................................ ......... 8

B. Environmental Assessment

................................ ................................ .............................. 8 Ecological Risk Characterization

................................ ................................ ........................... 8 Threatened and Endangered Species

................................ ................................ ...................... 8 Ecological Incidents

................................ ................................ ................................ ................ 9
C. En docrine Disruptor Screening Program

................................ ................................ ......... 9 COMBINED WORK PLAN, SUMMARY DOCUMENT, AND PROPOSED INTERIM REGISTRATION REVIEW DECISION

................................ ................................ ..................... 10 NEXT STEPS AND TIMELINE

................................ ................................ ................................ .. 11

References:

This Combined Work Plan, Summary Document, and Proposed Interim Registration Review Decision summarize s the Environmental Protection Agency's current position based on the following documents:

1. EFED Registration Review Problem Formulation for Alpha

- Chlorohydrin

. Federoff, N.E.; Lin, James

. October 21, 2015

.

2. Alpha

- Chlorohydrin. Human Health Assessment Scoping Document and Draft Human Health Risk Assessment in Support of Registration Review

. Bloem, Thomas; Godshall, Joshua; Perron, Monique M

. September 29, 2015

.

3. BEAD Chemical Profile (BCP) for Registration Review: Alpha

- Chlorohydrin (PC Code 117101) . Cook, Colwell; Hill, Elizabeth. May 21, 2015.

4. Alpha

- chlorohydrin: Tier I (Scoping) Review of Human Incidents and Epidemiology

. Evans, Elizabeth; Recore, Shann a. August 13, 2015.3

These and other supporting documents for the alpha

- chlorohydrin registration review case may be found in the docket EPA

- HQ

- OPP

- 2015

- 0726 at http://www.regulations.gov

.4

INTRODUCTION

The docket for alpha

- chlorohydrin is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0726 )

. This document is the Environmental Protectio n Agency’s (EPA or the Agency) C ombined Work Plan, Sum mary Document, and Proposed Interim Registration Review Decision for alpha

- chlorohydrin . 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 alpha

- chlorohydri n , highlighting anticipated data and assessment needs and providing an anticipated timeline for completing alpha

- chlorohydrin revie w.

This document includes the Agency’s Proposed Interim Registration Review Decision for alpha

chlorohydrin. A registration review decision is the Agency's determination whether 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 dete rmines it to be appropriate, Int erim Registration Review Decision before completing a registration review. Among other things, the Interim Registration Review Decision may: 1) require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify additional data or other 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. For further information on alpha

- chlorohydrin , additional documents can be found in EPA’s public docket (EPA

- HQ

- OPP

- 2015

- 0726) at www.regulations.gov.

EPA is issuing a Proposed Interim Registration Review Decision for alpha

- chlorohydrin so that it can (1) move forward with aspects of the registration review decision that are complete and (2) implement interim risk mitigation. The Agency is currently working with the U.S. Fish and Wildlife Service and the National Marine Fisheries Servic e to develop methodologies for conducting national endangered species assessments for pesticides. Therefore, although EPA has not yet fully evaluated risks to threatened and endangered species, the Agency will complete its endangered species assessment an d any necessary consultation with the Services for alpha

chlorohydrin prior to completing the alpha

- chlorohydrin registration review. Likewise, the Agency will complete endocrine screening for alpha

- chlorohydrin , pursuant to the Federal Food, Drug, and Co smetic Act (FFDCA) section 408(p), before completing this registration review. Last, EPA will determine whether additional pollinator exposure and effects data are necessary to make a final registration review decision for alpha

- chlorohydrin and issue a d ata call

- in (DCI) to obtain any such data prior to completing the alpha

- chlorohydrin registration review.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about alpha

- chloro hydrin and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on alpha

- chlorohydrin . The Agency encourages all interested stakeholders to review the Combined Work Plan, Summary Document, an d Proposed Interim Registration Review Decision to provide comments and additional information that will help the Agency’s decision

making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas i dentified in the Combined Work Plan, Summary Document, and Proposed Interim Registration Review Decision and Appendix about which the Agency5

specifically seeks comments and information. Interested stakeholders could include: environmental non

- profit or i nterest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The only registered use for alpha

- chlorohydrin is as a tamper

- proof bait statio n/bait application delivery system for elimination of Norway rats. One product (Epibloc® Rodenticide, produced by Gametrics, Ltd.) is currently registered containing alpha

- chlorohydrin, which is classified as a restricted use pesticide (RUP), for retail s ale to and use only by certified applicators or persons under their direct supervision. Alpha

- chlorohydrin is approved for use in and around the indoors of commercial/industrial facilities and sanitary sewers, the label states not to use the product in

an y facility where children may be present, and there are no outdoor uses permitted.

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration 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 risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, a s 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 environment. Changes in science, public policy, and pesti cide 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. Information on this program is provided at www.epa.gov/pesticide

- reevaluation/registration

revie w

- process

. The Agency is implementing the registration review program pursuant to Section 3(g) of FIFRA, and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulation s governing registration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration 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.6

ALPHA

- CHLOROHYDRIN CHEMICAL FACTS

Table 1 provides a summary of the chemical facts for alpha

- chlorohydrin

.

Table 1 : Chemical Facts for alpha

- chlorohydrin
PC code 117101 Case Number 4120 CAS Number 96

- 24

- 2 Year first registered Alpha

- chlorohydrin was originally registered in 1983 and cancelled in 1991 due to maintenance fee non

- payment. It was newly registered in 2006

. Pesticide Type Rodenticide Chemical class Not Applicable R eregistration Eligibility Decision (R E D) The current a lpha

- chlorohydrin registration was registered after November 1984, therefore it was not subject to reregistration. Tolerance Reassessment Eligibility Decision (TRED) Not applicable. There are no food uses for alpha

- chlorohydrin

Cumulative group Unlike other pesticides for which EPA has followed a cumulative risk approac h based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding with alpha

- chlorohydrin. A lpha

- chlorohydrin does not appear to produce a toxic metabolite produced by other substances. 40 CFR Citation There are no established tolerances for alpha

- chlorohydrin. Dual

- use Alpha

- chlorohydrin is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non

- pesticidal uses There are no identified non

- pesticidal uses of a lpha

- chlorohydrin. Pesticide Re

- evaluation Division, Chemical Review Manager Matthew Manupella, manupella.matthew@epa.gov, (703) 347

- 0411

Registration Division

, Product Manager Mark Suarez, suarez.mark@epa.gov, (703) 305

- 0120

USE AND USAGE INFORMATION

Table 2 summarizes the use and usage information for alpha

- chlorohydrin

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Alpha

- Chlorohydrin in the registration review docket for more details

.

Table 2 : A lpha

- chlorohydrin Use and Usag e Information Summary of Use Alpha

- chlorohydrin is a rodenticide that causes male infertility in male mammals at low doses. At high doses testicular lesions and /or death can occur.7 Table 2 : A lpha

- chlorohydrin Use and Usag e Information
Use Sites The alpha

- chlorohydrin product is used in sanitary sewers and inside industrial and commercial facilities. Summary of Usage T his product has not been manufactured nor sold in the United States; consequently, there are no usage data for alpha

chlorohydrin available. Formulation Type(s) Pelleted/Tableted Applicatio n Method(s) The alpha

- chlorohydrin product is a rodenticide bait that can be applied in a sachet ("place pack") in sanitary sewers and inside industrial and commercial facilities for control of Norway rats. Technical Registrant (s) Gametrics, Ltd No. of Registrations 1 Section 3 product 1 Restricted Use Yes

RECENT ACTIONS

There have been no recent actions for alpha

- chlorohydrin.

SCIENTIFIC ASSESSMENTS

A summary of the Agency’s human health risk assessment and the problem formulation for the environmental fate, ecological risk, endangered species, and drinking water exposure
assessments , Alpha

- Chlorohydrin. Human Health Assessment Scoping Document and Draft Human Health Risk Assessment in Support of Registration Review ( September 29, 2015 ) and EFED Registration Review Problem Formulation for Alpha

- Chlorohydrin (October 21, 2015 )

, are presented below. For the detailed risk assessments, see the public docket ( EPA

- HQ

- OPP

2015

- 0726 ) accessed at www.regulat ions.gov

.
A. Human Health Assessment

Hazard Characterization The toxicological database is considered adequate for characterizing hazard and assessing risk from alpha

- chlorohydrin . No additional studies are anticipated to be needed for registration review.

Dietary Exposure and Risk Assessment There are no registered food/feed uses and existing use patterns are not expected to contaminate surface or ground water; thus, a dietary exposure assessment was not conducted and there are no dietary risks of concern.

Food Tolerances
There are no U.S. tolerances established for alpha

- chlorohydrin because alpha

- chlorohydrin is not registered for any food/feed uses.

1 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website ( http://oaspub.epa.gov/pestlabl/ppls.home ).8

Residential and Occupational Exposure and Risk Assessment Residential handler and post

- application exposur es from alpha

- chlorohydrin are expected to be negligible as the registered product is a RUP and not approved for use in residential settings. W hen used in above

- ground bait stations, the bait formulation is confined inside tamper

- resistant plastic bait housing

. Based on the negligible exposure potential of t he currently registered uses of alpha

- chlorohydri n, no toxicological points of departure ( PODs ) have been established.

Occupational handler and post

- application exposures are not anticipated since the products are packaged in an enclosed system. Alpha

- chlorohydrin is approved for use in indoor area s of commercial/industrial faci lities and sanitary sewers, the label states not to use the product in any facility where children may be present, and ther e are no outdoor uses permitted.

EPA believes that residential and occupational exposures to the currently registered uses of alpha

- chlorohydrin do not pose a significant human health risk.

Human Health Incidents A summary report listing incidents for a lpha

- chlorohydrin reported to the OPP Incident Data System (IDS) has been previously conducted on August 13, 2015 . The report covers the time period in the U.S. from 1998 to 2015. The evaluation of incident data for alpha

- chlorohydrin indicates no report ed incidents. Therefore, at this time , there are no remarkable case reports that suggest a plausible association between a moderate or severe health outcome and exposure to alpha

- chlorohydrin. The 2015 review of the incident data does not warrant further investigations at this time.

B. Environmental Assessment

Ecological Risk Characterization Risk characterization is the integration of exposure and ecological effects characterization to determine the potential ecological risk and the likelihood of direct and indirect effects to non

target organisms in aquatic and terrestrial habitats. In the case of alpha

- chlorohydrin, risk was
not quantitatively calculated. However, risks were qualitatively determined to not be of concern for non

- target organisms for the following reasons:

(1) Direct consumption of bait is unlikely to be a concern due to location of use sites (indoor only) and label directions and restricted use designation when used in san itary sewers; (2) Secondary poisoning due to consumption of contaminated carcasses is unlikely due to rapid clearance of the chemical in target animals; and (3) Aquatic contamination is unlikely to reach levels of concern due to the bait location in the case of indoor uses and the low exposure potential for sanitary sewer uses based on the high number of sachets that would need to wash into receiving waters to be a concern ; and (4) Exposure to pollinators is unlikely due to the restricted uses of alpha

- chlorohydrin . T herefore pollinator data will not be required.

Threatened and Endangered Species Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (list ed) species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to implement the9

recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides . The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. E PA will address concerns specific to alpha

- chlorohydrin in connection with the development of its final registration review decision. In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the Services), and USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interim Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper, Interim Approaches for National

- Level Pesti cide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, th e ecological problem formulation supporting Combined Work Plan, Summary Document, and Proposed Interim Registration Review Decision for alpha

- chlorohydrin does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. While the agencies continue to develop a common method for ESA analysis, the planned risk asses sment for the registration review of alpha

- chlorohydrin will describe the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the types of species where the potenti al for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for listed species and their des ignated critical habitats, these methods will be applied to subsequent analyses of alpha

- chlorohydrin as part of completing this registration review.

Ecological Incidents A search was made on June 2, 2015 of the Ecological Incident Information System (EII S, version 2.1) and the Incident Data System (IDS), which are maintained by the Agency’s Office of Pesticide Programs, and the Avian Incident Monitoring System (AIMS), which is maintained by the American Bird Conservancy. There were no incidents for alpha

- chlorohydrin reported to the Agency

.

C. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. Thes e studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss,10

and sex ratios in of

fspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for alpha

- chlorohydrin

, EPA reviewed these data and determined that a qualitative toxicity assessment is appropriate for alpha

- chlorohydrin . However, as required by FFDCA section 408(p), alpha

- chlorohydrin is subject to the endocrine screening part of the Endocrine Disruptor Screeni ng Program (EDSP).

EPA has developed the 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 su ch endocrine effects as the Administrator may designate.” The EDSP employs 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 int eract with 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 systems will proceed to the next stage of the EDSP where EPA wi ll determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship 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 pesticide active ingred ients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 2 and includes some pesticides scheduled for Registration Review and chemicals found in water

. Alpha

- chlorohydrin was not included on eith er list. For further information 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. 3

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of alpha

- chlorohydrin . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

COMBINED WORK PLAN, SUMMARY DOCUMENT, AND PROPOSED INTE RIM 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 endangered species and EDSP component s of the alpha

- chlorohydrin registration review case, the Agency has made the following proposed interim decision: (1) no additional data are anticipated to be required at this time; and (2) no changes to the affected registrations or their labeli ng are needed at this time. EPA has not identified any risks of concern to human health.

2 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final sec ond list of chemicals.
3 http://www.epa.gov/endo/11

NEXT STEPS AND TIMELINE

A Federal Register Notice will announce the availability of this combined Work Plan and Summary Document and Proposed Interim Registration Review Decision for alpha

- chlorohydrin and allow a 60

- day comment period. If there are no significant comments or add itional information submitted to the docket during the comment period that leads the Agency to change its proposed decision, EPA may issue an Interim Registration Review Decision for alpha

chlorohydrin (case 4120). However, a final decision for alpha

- chlor ohydrin may be issued without having previously issued an interim decision. A final decision on the alpha

- chlorohydrin registration review case will occur after an ESA and EDSP FFDCA section 408(p) determination has been made.

EPA has created the followin g estimated timeline for the completion of alpha

- chlorohydrin registration review.

Table 3 : Projected A lpha

- chlorohydrin Registration Review Timeline

Activities Estimated Date Opening the Docket and Combined Work Plan, Summary Document, and Proposed Interim Registration Review Decision Open Public Docket and Public Comment Period for Combined Work Plan, Summary Document, and Proposed Interim Registration Review Decision 201 5

– December

Close Public Comment Period 201 6

– February Interim Registrat ion Review Decision and Begin Post

Decision Follow

- up 2016

- June

Total (years) 0.5