1 OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

O ctober 21, 2015

PC Code: 117101

MEMORANDUM DP Barcode: D428649

S UBJECT: EFED Registration Review Problem Formulation for Al pha-Chlorohydrin

FR OM: N.E. Federoff, Wildlife Biologist

James Lin, Environmental Engineer

Environmental Risk Branch 2 Environmental Fate and Effects Division (7507P)

T HROUGH: Brian Anderson, Chief Melissa Panger, Senior Science Advisor R. David Jones, Senior Agronomist

Environmental Risk Branch 2 Environmental Fate and Effects Division (7507P)

T O: Matthew Manupella, Chemical Review Manager Cathryn Britton, Team Leader Kevin Costello, Branch Chief Risk Management and Implementation Branch 2

Pesticide Re -evaluation Division (7508P)

T he Environmental Fate and Effects Division (EFED) has completed the preliminary problem

formulation (attached) for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of alphachlorohydrin . The problem formulation describes the preliminary risk hypothesis and the process that will be used during the completion of drinking water and ecological r isk assessments in support of registration review . This document draws on information from studies submitted by the registrants in response to data requirements in order to provide an overview of the environmental fate and ecological effects associated with the use of alpha-chlorohydrin as well as outline uncertainties regarding residues and taxa of concern.2 

# Problem Formulation for the Environmental Fate

, Ecological Risk, Endangered Species, and Drinking

Water Exposure Assessments in Support of the Registration Review of Al pha

- Chlorohydrin

CAS Registry Number: 96

- 24

- 2

PC Code: 117101

DP Barcode: D 428649

Prepared by: N.E. Federoff, Wildlife Biologist

J ames Lin, Environmental Engineer U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division

Environmental Risk Branch I I 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 Reviewed by: Brian Anderson, Branch Chief R. David Jones, Ph.D., Senior Agronomist Melissa Panger, Ph.D., Senior Advisor3 

### T ABLE OF 

### C ONTENTS

1. Purpose

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

2. Description of Regulatory Action

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

3. Conclusions from Previous Assessments

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

3.1. Ecological Risk Assessments

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

3.2. Drinking Water Exposure Assessments

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

3.3. Clean Water Act Programs

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

4. Stressor Source and Distribution

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

4.1. Pesticidal Mechanism of Action

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

4.2. Overview of Pesticide Use and Usage

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

4.3. Environmental Fate and Transport

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

5. Receptors

................................ ................................ ................................ ................................ . 7

5.1. Effects to Terrestrial Species

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

5.1.1. Birds and Mammals

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

5.1.2. Beneficial Insects

................................ ................................ ................................ ...... 9

5.1. 3. Plants

................................ ................................ ................................ ......................... 9

5.2. Effects to Aquatic Species

................................ ................................ ................................ 9

5.2.1. Parent Toxicity

................................ ................................ ................................ ............. 9

5.2.1. 1. Fish

................................ ................................ ................................ ............................ 9

5.2.1.2. Aquatic Invertebrates

................................ ................................ ................................ 9

5.2.1.3. Aquatic Plants

................................ ................................ ................................ ......... 10

5.3. Degradate Toxicity

................................ ................................ ................................ ......... 10

5.4. Incident Database Review

................................ ................................ .............................. 10

6. Ecosystems Potentially at Risk

................................ ................................ ............................. 10

7. Risk Hypothesis

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

8. Analysi s Plan

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

8.1. Measures of Exposure

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

8.2. Measures of Effect

................................ ................................ ................................ ......... 12

8.3. Integration of Exposure and Effects

................................ ................................ ............... 12

8.4. Endangered Species Assessments

................................ ................................ .................. 12

8.5. Drinking Water Assessment

................................ ................................ ........................... 13

9. Endocrine Disruptor Screening Program

................................ ................................ .............. 13

10. Preliminary Identification of Data Gaps

................................ ................................ ........... 13

10.1. Ecological Effects

................................ ................................ ................................ ....... 14

11. References

................................ ................................ ................................ ......................... 164 1. Purpose

The purpose of this problem formulation is to provide an understanding of the environmental fate and ecological effects of the registered indoor uses of alpha

- chlorohydrin

. Alpha

- chlorohydrin i s

a rodenticide that causes reversible infertility in male mammal s at low doses and testicular lesions and/or mortality at high er doses

. This problem formulation provides a plan for analyzing data

relevant to alpha

- chlorohydrin and for conducting environm ental fate and ecological risk, endangered species, and drinking water assessments for all current

, active registrations

. Additionally, this problem formulation is intended to identify data gaps, uncertainties, and potential assumptions used to address tho se uncertainties, relative to characterizing the ecological

risk ass ociated with the registered use of alpha

- chlorohydrin

.

2. Description of Regulatory Action

The Food Quality Protection Act of 1996 mandated the EPA to implement a new program for assessing the risks of pesticides, i.e ., registration review 1 . All pesticides distributed or sold in the

United States must be registered by the Agency . The decision to register a pesticide is based on the consideration of scientific data and other factors showing that it will not cause unreasonable risks to human health, workers, or the environment when used as directed on product labeling. The registration review program is intended to ensure that, as the ability to assess risk evolves and as policies and practice s change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health and the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the new registr ation review program, the Agency periodically reevaluates pesticides to ensure that as change occurs, products in the marketplace can be used safely.

As part of the implementation of the new registration r eview program pursuant to Section 3(g) of

the Fed eral Insecticide, Fungicide and Rodenticide Act (FIFRA), the Agency is beginning its

evaluation to determine whether use of alpha

- chlorohydrin continue s to meet the FIFRA standard for registration. This problem formulation for the environmental fate and e cological risk

assessments in support of the registration review is intended for the initial docket opening, which starts the public phase of the review process.

3. Conclusions from Previous Assessments

3.1. Previous Ecological Risk Assessments

In 2005 alpha

- ch lorohydrin was reviewed under a new chemical screen (D 213183) . It failed the

screen because valid avian r eproduction studies were needed. Literature studies were submitted using Japanese quail (MRID 45690911).

Secondary toxicity testing and determination of residue levels in the target species were required, because secondary exposure of predators and scavengers to poisoned rodents is a major concern

for rodenticides. EFED recommend ed that the registrant develo p a protocol to be reviewed by EFED prior to conducting these tests. Environmental fate data ha ve not been adequately

1 ( http://www.epa.gov/oppsrrd1/registration_review/ )5 addressed; information supplied is either insufficient, obsolete, or inapplicable.

3.2. D rinking Water Exposure Assessments

There are no r egistered outdoor uses of alpha

- chlorohydrin, therefore no drinking water exposure

assessment is needed

.

3.3. Clean Water Act Programs

Alpha

- chlorohydrin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 2 No Total Maximum Daily Load (TMDL) criteria have been developed for alpha

- chlorohydrin

. 3 No a quatic life benchmarks have been

established for alpha

- chlorohydrin

. 4 Any data submitted or otherwise located as part of the registration review process may be used to create aquatic life benchmarks if applicable.

4. Stressor Source and Distribution

Chemical Identity

Alpha

- chlorohydrin is the active ingredient (a

. i

. ) registered to control Norway rats. The a

. i

. exists

as a racemic mixture of R

- and S

- alpha

- chlorohydrin

. The structure, chemical name, and other identifiers are found in the chemical identity table (Table 4.1)

.

Table 4

. 1. Nomenclature of α

- Chlorohydrin

.

Chemical structure

Common name α

- chlorohydrin Company experimental name U

- 5897

IUPAC Name ( RS )

- 3

- chloropropylene glycol

CAS name 3

- chloro

- 1,2

- propanediol CAS registry number 96

- 24

- 2

End

- use product (EP) Epibloc® Rodenticide (1% alpha

- chlorohydrin)

2 http://iaspub.epa.gov/tmdl_water s10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

3 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant _group_name=PESTICIDES

4 http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm6 4.1. Pesticidal Mechanism of Action

Alpha

- chlorohydrin , also known by the trade name Epi b loc ® , is a Restricted Use rodenticide

. It
is a lso a chemical sterilant of male mammals

. Alpha

- chlorohydrin produces male infertility (decreases in sperm count and motility) when given in low oral doses to rats, rams, boars, guinea pigs, hamsters, & monkeys. At the doses used, there is no interference with libido & the antifertility effects are reversible after the agent is withdrawn. At higher doses, testicular pathology and/or mortality can occur.

The active ingredient exists as a racemic mixture of R and S alpha

- chlorohydrin. S alpha

chlorohydrin is converted to S 3

- chlorolactaldehyde which then inhi bits glyceraldehyde 3

- phosphate dehydrogenase , an essential enzyme in sperm glycolysis (Jones 1998).

4.2. Overview of Pesticide Use and Usage

E pibloc ® rodenticide (produced by Gametrics, Ltd. , EPA Reg. No. 42882

- 2 ) is the only registered

label containing alp ha

- chlorohydrin. E pibloc is a unique rodenticide for control of Norway rats only for indoors of industrial and commercial facilities and sanitary sewers. Bait s achets must always be placed in tamper resistant stations except for sanitary sewer placements

. Each bait contains 1% ai (50 mg ai). The label states that it cannot be use d in any facility ( i.e. , schools, libraries, etc.) where children may be present. For use in sanitary sewer, Epibloc label specifies the language below:

Determine where Norway rats will most likely find and consume bait. Generally these areas are manholes, tramlines, tributaries, sewer line junctions or any other accessible places with signs of recent rat activity. Once suitable application points have been determined, place 2 to 4 sachets of prebait at each point. If prebait can be washed away, wire sachets in place. Maintain prebait at application points for at least 2 days. After acceptance of prebait has been established, replace prebait sachets with sachets of Epibloc , use 6 to 10 sachets per application point. Do not apply Epibloc in sewers if heavy rains and/or flooding are forecasted. Sachet is moisture resistant to preserve bait freshness. Collect all uneaten and partial uneaten sachets 5 to 10 days after placem ent.

Epibloc is classified as a restricted use pesticide . A s required by law for retail sale to and use only by Certified Applicators or person s under their direct supervision and only for those uses covered by the Certified Applicator’s certification.

Prebaiting is required with the use of E pibloc . Rats may shy away from unfamiliar food or food that has made them sick without killing them. Prebaiting rats with bait similar to E pibloc but lacking the active ingredient is needed to promote acceptance of E pibloc when it is applied.

4.3. Environmental Fate and Transport

The available physical/chemical and e nvironmental fate properties are summarized in Table 4 .2.7 Table 4.2. General Physical/Chemical Properties and Environmental Fate Parameters of alpha

chlorohydrin

.

Parameter Value Reference

Physical/Chemical Parameters

Molecular mass 110.54 C 3 H 7 ClO 2 Melting point

- 40 ° C The Pesticide properties

Database:

http://sitem.herts.ac.uk/aeru/iu pac/index.htm Density (20 ° C) 1.322 g/cm 3

Water solubility (20°C) 1000g/L

Octanol

- water partition coefficient ( Log P OW ) (20 ° C and pH 7) - 0.85

Persistence in Water

Hydrolysis half

- life Study passed the screen, but was not reviewed.

5. Receptors

Consistent with current methods , the risk assessment w ill rely on a surrogate species approach.

T oxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate to potential effects on a variety of species (receptors) included under these taxonomic groupings.

The Agency evaluates the potential for adverse e ffects as a result of alpha

- chlorohydrin usage. As

described in the Agency’s Overview Document (US EPA, 2004), the most sensit ive endpoint for

each taxon is used for RQ calculations . Assessment endpoints include direct toxic effects on the survival, reproduction, and growth of terrestrial and aquatic life, as well as indirect effects, such as reduction in prey base and/or modifi cation of habitat. The evaluated taxa include freshwater fish, freshwater aquatic invertebrates, birds, small mammals, terrestrial invertebrates, algae, and terrestrial plants.

Acute (short

- term) and chronic (long

- term) toxicity information is characte rized based on registrant

- submitted studies and a comprehensive review of the open literature on alpha chlororhydrin . Other sources of information and reviews of the Ecological Incident Information System (EIIS), are conducted to further refine the charac terization of potential ecological effects associated with exposure. A summary of the available ecotoxicity information and the incident

information is provided below.

Table 5.1 provides a summary of the assessment endpoints identified as measure s of e ffects.

Table 5.1 Measures of Ecological Effects for Alpha

- chlorohydrin

Assessment Endpoint Selected Surrogate Species and Measure of Ecological Effect Comments

Birds Survival Mallard duck oral LD 50 = 331 mg ai/kg

- bw MRID 242999

Survival Mallard duck subacute dietary LC 50 = 5620 ppm Bobwhite q uail subacute dietary LC 50 = 1658 ppm MRID 242999

MRID 2429998 Assessment Endpoint Selected Surrogate Species and Measure of Ecological Effect Comments

Reproduction and growth Treated male Japanese quail had significantly smaller testes but not reduced fertility or impaired reproductive functioning

. NOT a guideline study. MRID 45690911

Mammals Survival Rat LD 50 = 131 mg ai/kg bw MRID 45690902

Reproduction and growth No standard guideline studies were available N/A

Freshwater fish Survival Rainbow trout acute 96

- hr LC 50 = 5000 ppm ai Bluegill sunfish 96

- hr LC 50 = 420 7 ppm ai MRID 246029

MRID 246032

Reproduction and growth N/A N/A

Freshwater

invertebrates Survival Daphnia acute 48

- hr EC 50 = 972 ppm ai MRID 246031

Reproduction and growth N/A N/A

Estuarine/marine

fish Survival N/A N/A

Reproduction and growth N/A N/A

Estuarine/marine

invertebrates Survival N/A N/A

Reproduction and growth N/A N/A

Terrestrial plants Survival and growth N/A N/A

Insects Survival N/A N/A

Aquatic plants Biomass and

Growth Rate N/A N/A

LD 50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; NOAEL =

No observed adverse effect level; LC 50 = Lethal concentration to 50% of the test population; EC 50 = Effect concentration to 50% of the test population; IC 50 = concentration resulting in a 50% inhibition in the test population response ( e.g. , growth) N/A = Not applicable and/or none available

5.1. Effects t o Terrestrial Species

5.1.1. Birds and Mammals

The avian acute oral LD 50 is 331 mg/kg

- bw for the mallard duck. Alpha

- chlorohydrin is categorized as moderately toxic to avian species on an acute oral basis (MRID 242999 ). This was

consistent with the LD 50 s (MRID 45690911) reported for Japanese quail (316 mg/kg

- bw for males and 421 mg/kg

- bw for females).

The most sensitive avian species tested on a subacute 5

- d dietary basis is the bobwhite quail. The

LC 50 is 1658 ppm and is categorized as slightly toxic (MRID 242999 ).9 Treated male Japanese quail had significantly smaller testes than controls but not reduced fertility or impaired reproductive functioning (MRID 45690911)

. This was not a standard guideline study for avian reproduction

. Birds (7 pairs) were given a single dose of alpha

- chlorohydrin (100 and 316 mg/kg treatment groups )

. Multiple sterilants were tested in the study

. Standard avian reproduction testing would not be applicable because the product is a bait contained in bait stations and used on mammals (roden ts).

Acute oral LD 50 data for laboratory rats submitted to the Health Effects Division (HED) for evaluation of human toxicity were used to assess the mammalian acute toxicity of alpha

chlorohydrin . The LD 50 for rats is 131 mg ai/kg ( Glenn and Burr, 1968 ). These results classify alpha

- chlorohydrin as moderate ly toxic to mammals on an acute exposure basis. There were no standard reproduction studies available.

5.1.2. Beneficial Insects

No studies were needed b e cause the product is a bait used in a manner such that little to no exposure potential exists for these organisms

.

5.1.3. Plants

No studies were submitted because the product is a bait used in a manner such that little to no exposure potential exists for plants

.

5.2. Effects t o Aquatic Species

5.2.1. Parent Toxicity

5.2.1.1. Fish

Acute Exposure

The most sensitive freshwater fish species tested for alpha

- chlorohydrin was the bluegill sunfish.

The LC 50 was 4207 ppm for the bluegill sunfish

, which is characterized as practically non

- toxic to

freshwater fish (MRID 246032)

.

Chronic Exposure

No Studies were submitted because the product is a bait used in a manner such that little to no

chronic exposure potential exists to these organisms

.

5.2.1.2. Aquatic Invertebrates

Acute Exposure

A Daphnia magna acceptable study determined the EC 50 to be 972 ppm (MRID 246031 )

, categorizing the chemical as practically non

- toxic to aquatic freshwater invertebrates on an acute10 exposure basis.

Chronic Exposure

No studies have been submitted because the product is a bait used in a manner such that little to

no chronic exposure potential exists to these organisms

.

5.2.1.3. Aquatic Plants

No studies have been submitted because the product is a bait used in a manner such that little to no exposure potential exists to these organisms

.

5.3. Degradate Toxicity

No degradate toxicity studies have been submitted

.

5.4. Incident Database Review

A search was made on June 2 , 201 5 of the Ecological Incident Information System (EIIS, version 2.1) and the Incident Data System (IDS) , which are maintained by the Agency’s Office of Pesticide Programs, and the Avian Incident Montoring System (AIMS), which is maintained by the American Bird Conservancy. There were no incidents for alpha

- chlorohydrin re ported to the Agency

.

It should be noted, that t he lack of reported incidences should not be construed as the absence of incidents. Incident reports for non

- target organisms typically provide information only on mortality events and plant damage. Sublethal effects in organisms such as abnormal behavio r, reduced growth and/or impaired reproduction are rarely reported, except for phytotoxic effects in terrestrial plants. Incidents often are not seen, due to scavenger removal of carcasses, decay in the field, or simply because carcasses may be hard to se e on many sites and/or few people are systematically looking. Poisoned animals may also move off

- site to less conspicuous areas before dying. Incidents may not get reported to appropriate authorities capable of investigating the incident for a variety of reasons including the finder may not know of the importance of reporting incidents, may not know who to call, may not feel they have the time or desire to call, or may hesitate to call because of their own involvement in the kill. Incidents reported may not get investigated if resources are limited or may not get investigated thoroughly, with residue analyses, for example. Also, if kills are not reported and investigated promptly, there will be little chance of documenting the cause, since tissues and re sidues may deteriorate quickly. Reports of investigated incidents often do not get submitted to EPA, since reporting by states is voluntary.

6. Ecosystems Potentially at Risk

For this problem formulation, potential for effects to aquatic and terrestrial ecosystems were
considered. Alpha

- chlorohydrin is expected to pose little risk to terrestrial or aquatic ecosystems
due to its limited use and exposure potential as well as low toxicity to most non

- target organisms

as discussed further in Section 8.1

. E pi bloc is a Restricted Use rodenticide for control of Norway rats only for indoors of industrial and commercial facilities and sanitary sewers. Bait s achets must11 always be placed in tamper resistant stations except for sanitary sewer placements. Potential exposure routes of concern include secondary exposure to predator and scavenger animals from consumption of contaminated carcasses and aquatic systems that could contain alpha

chlorohydrim from use in sanitary sewers. However, as discussed further in Sect ion 8.1, ecological effects from these exposure routes are unlikely to occur due to rapid metabolism of the chemical within target animals (which alleviates the concern for secondary poisoning) and low exposure potential relative to its toxicity in aquatic systems.

7. Risk Hypothesis

A risk hypothesis describes the predicted relationship among the stressor, exposure, and assessment endpoint response along with the rationale for their selection. T he following ecological risk hypothesis is being employed for this national

- level ecological risk assessment:

When used according to the label, alpha

- chlorohydrin may affect non

- target wildlife through secondary exposures to predators and scavengers that consume contaminated carcasses and aquatic organisms from its use in sanitary sewers. However, as previously summarized and discussed further in Section 8.1, risks to non

- target terrestrial and aquatic organisms are expected to be

minimal.

8. Analysis Plan

In order to address the risk hypothesis, the potential for adverse effects on the environment is estimated. The use, environmental fate, and ecological effects are characterized and integrated to

assess the risks. As described below, a full ecological risk assessment will not be needed for alpha

chlorohydrin due to low toxicity and limited exposure potential to non

- target organisms.

8.1. Measures of Exposure

Due to no registered outdoor uses of alpha

- chlorohydrin , the exposure to off

- site non

- target organisms is limited, especially for the indoors of industrial and commercial facilities use.

Most sanitary sewers are enclosed and eventually will be discharged into wastewater treatment plants. The impacts to natural aquatic habitats will be limited. The possible impact may be due

to the co rpses of dead rats that may fall into the sewer and int o the wastewater treatment plant.

The following back of the envelope calculation provides a quick and simple method to quantify any potential aquatic risk. A single Epibloc sachet weighs 5 gram s , which contains 1% alpha

chlorohydrin

. Therefore, the numbe r of sachets that need to wash into a receiving pond to result in

risks of concern can be calculated a ssuming all the sachets are dopped into the sewer leading straight into the receiving standard ecological pond. In order for the aquatic estimated

environ mental concentration (EEC) in the standard EPA pond (1

- h e ctare surface area and 2

- meter depth) to reach the fish LC 50 of 4207 ppm ( i.e. , RQ = 1) more than 1.68 billion sachets are needed. Similarly in order to reach the daph nia LC 50 of 972 ppm, more than 388 million sachets are needed.

In reality

, it would be impossible to apply so many sachets into a sewer system leading to a single water body of the assumed volume ; therefore, aquatic risk can be excluded.12 P otential secondary expo sure and risk to terrestrial animals is expected to be minimal because the compound is reportedly rapidly metabolized in target animals ( D428647 )

.

Since applications are all bait in nature, standard models including T

- REX, TerrPlant, AgDRIFT,

SIP and STIR do not apply.

8.2. Measures of Effect

Ecological effect s data presented in Section 5 are used as measures of direct and indirect effects to biological receptors. Data were obtained from registrant

- submitted studies or from literature studies identified by t he ECOTOXicology database (ECOTOX) . ECOTOX was searched in order to provide more ecological effects data to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemical mixture toxicity data for aquatic l ife, terrestrial plants, and wildlife. ECOTOX was created and is maintained by the USEPA, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory's Mid

- Continent Ecology Division (USEPA

, 2007 a ).

8.3. Integrati on of Exposure and Effects

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. The exposure and toxicity effects data are typically integrated in order to evaluate the risks of adverse ecological effects on non

- target species. For the assessment of risks, the risk quotient (RQ) method is used to compare exposure and measured toxicity values. EECs are divided by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s LOCs (USEPA

, 2004). These criteria are used to indicate the potential to cause adverse direct or indirect effects to non

- target organisms. As noted previously,

where toxicity data are lacking , risk will be presumed. In the case of alpha

- chlorohydrin, RQs were not calculated. However, risks were determined to not be of concern for non

- target organisms

for the followin g 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 (sanitary 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 (see Section 8).

8.4. Endangered Species Assessments

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches de veloped to implement the13 recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report outli nes 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. EPA will address concerns specifi c 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 summa ry 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 Approache s for National

- Level Pesticide 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 Approac hes to assess the potential risks of pesticides to listed species and their designated critical habitat, this ecological problem formulation supporting the Preliminary Work Plan 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 assessment for the registration review of alpha

- chlorohydrn 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 potential for effects exists, once the

sc ientific 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 designated critical habitats, these m ethods will be applied to subsequent analyses of alpha

- chlorohydrin as part of completing this registration review.

8.5. Drinking Water Assessment

There are no registered outdoor uses of alpha

- chlorohydrin, therefore no drinking water exposure

assessment is needed

.

9. Endocrine Disruptor Screening Program

Alpha

- chlorohydrin was not included in the first group of chemicals issued an order to conduct Tier 1 EDSP testing. For additional information on the EDSP program, visit http://www.epa.gov/endo/

.

10. Preliminary Identification o f Data Gaps

No environmental fate testing is required for indoor uses ( except the conditional require ment of hydrolysis study). However, based on the simple calcualtions, the aquatic risk can be excluded ;14 therefore

, no fate guideline studies are required for alpha

- chlorohydrin based on the label uses for the current registration review

.

10.1. Ecological Effects

Table 1 0

. 1 identifies studies by MRIDs that offer dat a for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.

Table 1 0

. 1 Submitted Ecological Toxicity Data for Alpha

- chlorohydrin

.

Guideline Data Requirement Submitted Studies (MRID) Study

Classification Additional

Data

Needed? Current Additional Data Need

850.2100 Avian Acute Oral MRID 242999 Acceptable No

850.2200 Avian Subacute Dietary MRID 242999

MRID 242999 Acceptable Acceptable No

850.2300 Avian Reproduction MRID 45690911 Supplemental No

870.3100 Mammal Acute MRID 45690902 Acceptable No

870.3800 Mammal Reproduction MRID Acceptable No

850.3020 Honey Bee Acute

Contact No No exposure because product is a bait

850.1075 Freshwater Fish

Acute MRID 246032

MRID 246029 Acceptable Acceptable No

850.1400 Freshwater Fish

Chronic No

850.1010 Freshwater

Invertebrate

Acute M RID 246031 Acceptable No

850.1300 Freshwater

Invertebrate

Chronic No

850.1025 Estuarine /Marine

Fish Acute No No exposure of concern

850.1400 Estuarine /Marine

Fish Chronic No No exposure of concern

850.1035 Estuarine /Marine

Invertebrate

Acute No No exposure of concern

850.1350 Estuarine /Marine

Invertebrate

Chronic No No exposure of concern15 Guideline Data Requirement Submitted Studies (MRID) Study

Classification Additional

Data

Needed? Current Additional Data Need

850.4100

850.4150 Terrestrial plants No No exposure of concern

850.4400

850.5400 Aquatic plants No16 11. References

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the

EPA food

- chain (Kenaga) nomogram, and instrument for estimating pesticide residues on plants. Environmental Toxicology and Chemistry 13 (9), 1383

- 1391.

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71

- 1 Avian Single Dose Oral Toxicity

MRID Citation Reference

45532 Fink, R.; Beavers, J.B.; Brown, R.; et al. (1980) Acute Oral LD50

-- Mallard Duck: 3

- Chloro

- 1,2

- propanediol. Final rept. (Unpub

- lished study received Jul 24, 1980 under

42882

- EX

- 1; prepared by Wildlife International, Ltd., submitted by Gametrics, Ltd

., Sausalito, Calif.; CDL:242993

- J)

45690909 Beavers, J.; Fink, R.; Glenn, M.; et al. (1968) Avian Acute Oral: (Epibloc Rodenticide). Unpublished study prepared by Wildlife International, Ltd and The Upjohn Company. 31 p. {OPPTS 850.2100}

71

- 2 Avian Dietary Toxicity

MRID Citation Reference

45530 Fink, R.; Beavers, J.B.; Brown, R.; et al. (1980) Final Report: Eight

- Day Dietary LC50

-

- Bobwhite Quail: Project No. 172

- 101. (Unpublished study received Jul 24, 1980
under 42882

- EX

- 1; pre

- pared by Wildlife International, Ltd., submitted by Gametrics,

Ltd. , Sausalito, Calif.; CDL:242993

- H)

45531 Fink, R.; Beavers, J.B.; Brown, R.; et al. (1980) Eight

- Day Dietary LC50

-- Mallard
Duck: 3

- Chloro

- 1,2

- propanediol. Final rept. (Un

- published study received Jul 24,
1980 under 42882

- EX

- 1; pre

- pared by Wildlife Int ernational, Ltd., submitted by Gametrics, Ltd., Sausalito, Calif.; CDL:242993

- I)

45690910 Beavers, J.; Fink, R. (1980) Avian Dietary Toxicity Test: (Epibloc Rodenticide): Lab Project Number: WI

- 447. Unpublished study prepared by Wildlife International, L td. 36 p. {OPPTS 850.2200}

71

- 4 Avian Reproduction

MRID Citation Reference

45690911 Jones, P.; Kominkova, H.; Jackson, H.; et al. (1976) Avian Reproduction Test: (Epibloc Rodenticide). Unpublished study prepared by American Society for Testing Materials, Bowling Green State University and University of California. 27 p. {OPPTS 850.2300}19 72

- 1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

91302 Vilkas, A.G.; Seminara, J. (1980) The Acute Toxicity of Epibloc (3

- chloro

- 1,2

- propanediol) to the Rainbow Trout,~Salmo~ ?~gairdneri~Richardson: UCCES Project

No. 11507

- 85

- 02. (Un

- published study received Oct 6, 1981 under 42882

- 1; prepared by Union Carbid e Corp., submitted by Gametrics, Ltd., Sausalito, Calif.; CDL:246029

- A)

97838 Vilkas, A.G.; Seminara, J. (1980) The Acute Toxicity of Epibloc (3

- chloro

- 1,2

- propanediol) to the Bluegill Sunfish,~Lepomis~ ?~macrochirus~Rafinesque: UCCES Project No. 11507

- 8 5

- 01. (Un

- published study received Oct 6, 1981 under 42882

- 1; prepared by Union Carbide Corp., submitted by Gametrics, Ltd., Sausalito, Calif.;
CDL:246032

- A)

45690912 Seminara, J. (1980) Freshwater Fish LC

- 50

- Bluegill & Rainbow: (Epibloc Rodenticide): Lab Project Number: 11507

- 85

- 01: 11507

- 85

- 02. Unpublished study prepared by Union Carbide Corporation Environmental Services. 22 p. {OPPTS 850.1075}

72

- 2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

97837 Vilkas, A.G.; Browne, A.M. (1980) The Acute Toxicity of Epibloc (3

- chloro

- 1,2

- propanediol) (99% Active Ingredient) to the Water Flea,~Daphnia magna~Straus: UCCES Project No. 11507

- 85

- 03. (Unpublished study received Oct 6, 1981 under

4 28821; prepared by Union Carbide Corp., Environmental Services, submitted by Gametrics, Ltd., CDL:246031

- A)

45690913 Browne, A. (1980) Aquatic Invertebrate Acute Toxicity, Daphnia: Lab Project Number:

11507

- 85

- 03. Unpublished study prepared by Union Carbide Environmental Services. 12 p. {OPPTS 850.1010}

81

- 1 Acute oral toxicity in rats

MRID Citation Reference

91195 Marshall, J.P.; Walker, D. (1978) The Acute Oral Toxicity of Epi

- bloc Rodenticide in Male Rats: Experiment Reference S78CJ02. (Unpublished study received Jul 10,

1979 under 42882

- 1; prepared by Wickham Research Laboratories, Ltd., England, submitted by Ga metrics, Ltd., Sausalito, Calif.; CDL:238814

- C)

45690902 Glenn, M.; Burr, W. (1970) Acute Oral Toxicity: (Epibloc Rodenticide). Unpublished study prepared by The Upjohn Laboratory. 75 p. {OPPTS 870.1100}20 81

- 2 Acute dermal toxicity in rabbits or rats

MRID Citation Reference

45529 Dean, W.P.; Myer, J.; Marroquin, F. (1980) Acute Dermal Toxicity (LDI50^) Study in
Rabbits: IRDC No. 467

- 003. (Unpublished study received Jul 24, 1980 under 42882

- EX

- 1; prepared by Inter

- national Research and Development Corp., submitted by Gametrics, Ltd ., Sausalito, Calif.; CDL:242993

- G)

91196 Glenn, M.W.; Burr, W.M. (1969) 3

- Chloro

- 1,2

- propanedial (U

- 5897): Acute Dermal LDI50^ in Rabbit. (Unpublished study received Jul 10, 1979 under 42882

- 1; prepared by Upjohn Co., submitted by Gametrics, Ltd., Sausalito, Calif.; CDL:238814

- D)

45690903 Glenn , M.; Burr, W. (1980) Acute Dermal Toxicity; Technical and Formulated: (Epibloc Rodenticide): Lab Project Number: 467

- 003. Unpublished study prepared by The Upjohn Laboratory and International Research and Development Corporation. 39 p. {OPPTS 870.1200}

81

- 3 Acute inhalation toxicity in rats

MRID Citation Reference

45690904 Glenn, M.; Moe, L. (1969) Acute Inhalation Toxicity: (Epibloc Rodenticide). Unpublished study prepared by The Upjohn Company. 12 p. {870.1300}