2 

### Endothall Preliminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

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

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

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

TIMELINE

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

NEXT STEPS

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

Appendix

– Additional Areas Considered in the Endothall Registration Review

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

References:

This Preliminary Work Plan summarize s the Environmental Protection Age ncy's current position based on the following documents:

1. EFED Registration Review Problem Formulation for Endothall

. Christina Wende l, James Lin, Donna Kamarei . August 5, 2015

.

2. Endothall: Human Health Risk Assessment in Support of Registration Review, and the Petition to Re

- evaluate Tolerances for Livestock, and Remove the Restriction that Prohibits Livestock from Drinking Treated Water

. Ideliz Negron

- Encarnacion, John Lic cione, Katelynn King, Seyed Tadayon

. December 9, 2015

3. Bead Chemical Profile (BCP ) for Registration Review: Endothall (Case 2245 PC Codes 038901

- 038908)

. Carl Chen, Claire Paisley Jones, Derek Berwald. August 19, 2015.

4. SLUA Endothall and Salts Case (002245). December 31, 2014

.

5. Endothall (038901) EFED Table 1 Report. 8/26/2014.3

6. End othall

- dipotassium (038904) EFED Table 1 Report. 8/26/2014.

7. Endothall, mono (N,N,

- dimethyl alkyl amine) salt (038905) EFED Table 1 Report. 12/3/2014.

8. Endothall (038901) HED Master Label Report. 8/26/2014.

9. Endothall

- dipotassium (038904) HED Master Labe l Report. 8/26/2014.

10. Endothall, mono (N,N,

- dimethyl alkyl amine) salt (038905) HED Master Label Report. 12/3/2014.

11. Estimates of Crop Irrigation for Endothall Registration

. Derek Berwald

. March 26, 2015.

These and other supporting documents for the end othall registration review case may be found in the docket EPA

- HQ

- OPP

- 2015

- 0591 at http://www.regulations.gov

.4

OVERVIEW

The docket for endothall and its salts is now open , initiating the first public comment per iod for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0591 )

. Endothall is a dicarboxylic acid registered for use as an aquatic herbicide , desiccant, and biocide. E ndothall acid (038901) is the active ingredient that forms from the breakdown of t he endothall salts

, and is not applied directly to use sites. T he dipotassium salt (PC 038904) and the mono

- N, N,

- dimethylalkylamine salt (amine salt) (PC 038905) are formulated into pesticide products

. The dipotassium salt is applied directly to water of l akes, ponds, and irrigation canals to control algae and submerged aquatic vegetation

, and also has a use on apple blossoms as a thinner . The amine salt is also applied directly to water to control aquatic weeds and has desiccant use s on potatoes , cotton,

c lover, and alfalfa

. In addition, t he amine salt has an antimicrobial use in water cooling towers to control mollusks

, where it also has activity against slime organisms

. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Prog rams knows about endothall

, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review , and providing an anticipated timeline for completing the registrati on review for endothall.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about endothall and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on endothall. The Agency encourages all interested stakeholders to review the PWP and Appendix and 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 identified in the PWP and Appendix about which the Agency

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

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pe sticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for endot h all

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for endothall

. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in R egistration R eview along with some additional chemical case

- specific information.5

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for endothall. For additional discussion of the anticipated data needs, see the EFED Registration Review Problem Formulation for Endothall and Endothall: Human Health Risk Assessment in Support of Registration Review, and the Petition to Re

- evaluate Tolerances for Livestock, and Remove the Restriction that Prohibits Livestock from Drinking Treated Wate r

.

Table 1: Anticipated Data Needs for the Endothall Registration Review

Guideline Number 1 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI) Data Requirements for the Conventional Uses

835.1230 A dsorption/desorption Coco

- al kylamine cation ; TGAI or PAIRA 12

835.212 0 Hydrolysis Coco

- alkylamine cation ; TGAI or PAIRA 12

835.2240 Aqueous Photolysis Coco

- alkylamine cation ; TGAI or PAIRA 12

835.4100 Aerobic Soil Metabolism Coco

- alkylamine cation ; TGAI or PAIRA 24

835.4300 Aero bic Aquatic Metabolism Coco

- alkylamine cation ; TGAI or PAIRA 24

835.4400 Anaerobic Aquatic Metabolism Coco

- alkylamine cation ; TGAI or PAIRA 24

850.1300 Freshwater invertebrate lifecycle Endothall acid and/or dipotassium salt ; TGAI 12

850.1350 Saltwat er invertebrate life cycle Endothall acid and/or dipotassium salt ; and mono

N,N,

- dimethylalkylamine salt;

TGAI 12

850.1400 Saltwater fish early

- life stage 2 Endothall acid and/or dipotassium salt ; TGAI 12

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline seri es 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 Alternatively, submission of an acceptable acute fathead minnow study for endothall acid can be used to calculate
an acute to chronic ratio (ACR) derived estuarine/marine NOAEC for the acid, and the endpoint can be used for the dipotassium salt.6

Table 1: Anticipated Data Needs for the Endothall Registration Review

Guideline Number 1 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI)

850.2100 Avian acute oral toxicity;

passerine spec ies Mono

- N,N,

- dimethylalkylamine salt; Endothall acid and/or dipotassium salt ; TGAI 12

850.2300 Avian reproduction; bobwhite

quail Endothall acid and/or dipotassium salt ; TGAI 24

850.3020 Honeybee acute contact toxicity

study D ipotassium salt and mono

N, N,

- dimethylalkylamine salt ;

TGAI 12

850.3030 3 Honey bee toxicity of residues

on foliage dipotassium salt and mono

N,N,

- (dimethylalkylamine) salt;

TEP 12

850.3040 3 Field testing for pollinators Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TEP 24

Non

guideline Honey bee adult acute oral

toxicity Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TGAI 12

Non

guideline Honey bee adult chronic oral

toxicity Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TGAI 12

Non

guideline Hone ybee larval acute oral

toxicity Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TGAI 12

Non

guideline Honeybee larval chronic oral

toxicity Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TGAI 12

Non

guideline 3 Residues in pollen and

Nect ar/field residue analysis Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TEP 24

Non

guideline 3 Semi

- field testing for pollinators Dipotassium salt and mono

N,N,

- dimethylalkylamine salt;

TEP 24

3 These studies are anticipated to be included in the DCI. However the need for this data will be determined by EPA based upon the results of the Tier 1 honey bee laboratory studies.7

Table 1: Anticipated Data Needs for the Endothall Registration Review

Guideline Number 1 Study Title 1 Test Material Estimated Timeframe (Months from receipt of DCI) Data Requirements for the Antimicrobial Use

85 0.3300 Activated Sludge Respiration

Inhibition Mono

- N,N,

- dimethylalkylamine salt; TGAI 12

835.3110 Ready Biodegradation 4 Mono

- N,N,

- dimethylalkylamine salt; TGAI 12

835.3220 Porous Pot Study 4 Mono

- N,N,

- dimethylalkylamine salt; TGAI 12

835.3240 Simulati on Test

– Aerobic

Sewage Treatment 4 Mono

- N,N,

- dimethylalkylamine salt; TGAI 12

835.3280 Simulation Test

– Assess

Biodegradability in Wastewater 4 Mono

- N,N, dimethylalkylamine salt; TGAI 12
Outstanding Data Requirements from GDCI

- 038905

- 26118 5

850.1350 Sa ltwater invertebrate life cycle Mono

- N,N,

- dimethylalkylamine salt; TGAI Due March 12, 2008

850.2300 Avian reproduction; mallard

duck Mono

- N,N,

- dimethylalkylamine salt ; TGAI Due March 12, 2009 Outstanding Data Requirements from GDCI

- 038905

- 27006 6

860.134 0 Residue analytical method s

( plants and livestock ) Endothall monomethyl ester Due September 4, 2010

860.1500 Crop field trials (alfalfa) Mono

- N,N,

- dimethylalkylamine salt; TEP Due

September 4, 2010 TGAI = technical grade active ingredient; TEP = typical end

- use product ; PAIRA = Pure Active Ingredient Radiol abeled

4 O nly one of the four biodegradation studies is needed (Ready Biodegradation, Porous Pot Study, or Simulation Test

– Aerobic Se wage Treatment, or Simulation Tes t

– Assess Biodegradability in Wastewater ). All of these studies are anticipated to be included in the DCI, however t he results of the A ctivated S ludge R espiration I nhibition (ASRI) test will determine which of biodegradation studies is needed

. 5 The studies listed in this section were previousl y required through a generic data call

- in issued March 12, 2007 and

are s till outstanding. These studies will not be included in the anticipated Registration Review DCI because they

are already required through the earlier DCI.

6 The studies listed in thi s section were previously required through a generic data call

- in issued September 4, 2008 and are s till outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the earlier DCI.8

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program

. All pesticides distributed or sold in the United States (U.S.) gene rally must be registered by the Environmental Protection Agency (EPA or the Agency), 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 registratio n 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 science, 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. Informatio n on this program is provided on EPA’s website

. 7

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

, and will review each registered
pes ticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CFR 155.40

. T he Agency will consider benefits information and data as required by FIFRA. The p ublic 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 t o make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of e ndothall

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for endothall

.

Table 2: Chemical Facts for Endothall
PC code 038901 (Endothall, acid), 038904 (endothall, dipotassium salt ), 038905 (endothall, mono

- N,N

- dimethylalkylamine salt) Case Number 2245 CAS Number 145

- 73

- 3 (Endothall, acid), 2164

- 07

- 0 (endothall, dipotassium salt), 6 6330

- 88

- 9 (endothall, mono

- N,N

- dimethylalkylamine salt) Year first registered Endothall, acid and endothall, mon o

- N,N

- dimethylalkylamine salt

were registe red i n the early 1960’s; endothall, dipotassium salt was registered in the early1970’s Pesticide Type Herbicide Chemical class Dicarboxylic acid R eregistration Eligibility Decision (R E D) September 30, 2005

7 http://www2.epa.gov/pesticide

- reevaluation9 Table 2: Chemical Facts for Endothall
Tolerance Reassessment Eligibility Decision (TRED) Not applicable

– the tolerance reassessment was included in the RED.

Cumulative group Not applicable. Endothall has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation Tolerances for endothall are established in 40 CFR 180.293 and an interim tolerance is established in 40 CFR 180.319. Dual

- use Endothall mono

- N,N

- dimethylalkylamine salt has an antimicrobial use as an industrial biocide

- molluscicide use to control freshwater and salt water mussels in water cooling towers and also has activity against slime organisms. Non

- pesticidal uses There are no identified non

- pesticidal uses of endothall. Pesticide Re

- evaluation Division, Chemical Review Manager Garland Waleko, waleko.garland@epa.gov , 703

- 308

- 8049

Antimicrobials Division, Chemical Review Manager Donna Kamarei, kamarei.donna@epa.gov , 703

- 347

- 0443

Registration Division, Product Manager K athryn Montague, montague.kathryn@epa.gov , 703

- 305

- 1234

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for endothall. Please see the Bead Chemical Profile (BCP) for Registration Review: Endothall (Case 2245 PC Codes 038901

- 038908) in the registration review docket for more details

.

Table 3 : Endothall Use and Usage Information Summary of Use The endothall acid (038901) is the active ingredient that forms from the breakdown of t he endothall salts. The dipotassium salt (PC 038904) is applied to water to control aquatic vegetation and is used as an apple blossom thinner . The amine salt (PC 038905) is applied
to water to control aquatic weeds and is used as a desiccant on alfalfa an d clover (grown for seed), cotton, and po tatoes; additionally there is an antimicrobial use in water c ooling towers to control mollusks , where it also has activity against slime organisms. Use Sites Aquatic applicatio ns are made to lakes, ponds and canal s. The d esiccant is used on potatoes, cotton, alfalfa, and clover , and is an apple blossom thinner . The a ntimicrobial use is in water co oling towers to control mollusks and slime organisms

. Summary of Usage The agricultural use of endothall has decreased in recent years, to 4,500 pounds in the period 2004

- 2008 on cotton and potatoes. No usage was reported on potatoes from 2009

- 2013 and only 150 pounds on cotton. No data are available on usage on alfalfa and10 Table 3 : Endothall Use and Usage Information
clover. EPA has very limited usage data for the aquatic uses of endothall , with the except ion of use in golf course ponds. In 2011, 3,000 pounds were applied , the most recent year for which EPA has data. The other aquatic uses comprise the majority of endothall use and have the potential to be large. Fo r example, in Florida alone, 220,000 pounds were estimated to be used in the period 2004

- 2005. Formulation Type(s) Granular, soluble concentrate Application Method(s) Aquatic: granular formulations are applied by centrifugal or blower

- type spreaders mou nted to boats or helicopters; Liquid formulations by hand wands/gun sprayers, drip or metering systems, injection, and a erial equipment

. Terrestrial: liquid formulations are applied as a broadcast by ground , air blast, or aerial equipment. Technical Reg istrant (s) United Phosphorous Inc (UPI) No. of Registrations Section 3 registrations 8 : 1 technical endothall acid (PC 038901), 4 dipotassium salt s (038904)

, and 5 amine salts (038905)

. Section 24c registrations : 4 dipotassium salts (038904) (Florida and N ew York), 3 amine salts (038905) (Florida and New York). Section 18 registrations : 1 endothall acid (PC 038901), Idaho Department of Agriculture Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

 C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application rates ; frequency of applica tion, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

 U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

.

 M edian and 90 th percentile reported use rates (lbs ai/ A ) fr om usage data

– national, state, and county

.

 Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

 Usage/use information for non

- agricultural uses

.

 Typical application interval (days)

.

 S tate or loca l use restrictions

.

 F oreign technical registrants not listed above who supply technical endothall to the US market

.

8 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website ( http://oaspub.epa.gov/pestlabl/ppls.home ).11

RECENT ACTIONS

A tolerance petition for endothall on meat, milk, poultry, and eggs to remove the livestock watering restrictions for aqu atic uses was submitted to the Agency and announced in the January 14, 2015 Federal Register (80 FR 1911). The Health Effects Division completed a risk assessment for this use, dated December 9, 2015 that will serve as the scoping document and registration review risk assessment.

A new use on apple blossoms as a thinner was added and assessed by HED in an a ssessment dated March 18, 2013 (77 FR 50686). EFED also completed an assessment for this new use, dated March 19, 2013

, with a February 4, 2014 Addendu m.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for endothall was completed on Dec ember 9, 2015 for a tolerance petition for endothall on meat, milk, poultry, and eggs to remove livestoc k watering restrictions for aquatic uses and in support of registration review

. T he most recent ecological and environmental fat e risk assessment was completed in March 2013 updated in February 2014 for the new use on apple tree blossoms

. Findings and con clusions from these risk assessments are summarized in the EFED Registration Review Problem Formulation for Endothall and Endothall: Human Health Risk Assessment in Support of Registration Review, and the Petition to Re

- evaluate Tolerances for Livestock, a nd Remove the Restriction that Prohibits Livestock from Drinking Treated Water

. During registration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of endothall. For human health, EPA has conduct ed a revised dietary, residential

, and occupational risk
assessment s for a tolerance petition to remove livestock watering restrictions for aquatic uses and for registration review

. If toxicological endpoints ar e revised based on the ecological data that

are anticipated to be required for registration review

, they will be considered in the new
assessment , as well as any changes to the standard operating p rocedures or default exposure assumptions

.

T able 4 below s ummarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and the HED risk assessment

.

Table 4: Anticipated /Completed Risk Assessments for the Endothall Registration Review Type of Risk Assessment Conduct ? Note s
Eco logical and Environmental Fate12

Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Yes The Agency will evaluate risks to federally listed threatened and endangered species from e ndothall according to the Joint Interim Approaches developed by EPA and the Services (U.S. Fish and Wildlife Service and National Marine Fisheries)

. T he planned risk assessment for the registration review of endothall will describe the level of ESA analysi s completed for this particular registration review case. Incidents Will check

for updates For a discussion of reported ecological incidents for

endothall , see page 19 of the Problem Formulation. Human Health Dietary Food Yes Complete

. Risk estimates f or all food and water uses are below the level of concern

. Drinking water Yes Occupational Handlers (m ixer s, loader s, applicators ) Yes Complete. Estimates for o ccupational handler risk for aquatic products indicate that some short

- and intermediate

- te rm inhalation risks exceed the level of

concern at the maximum PPE ( i.e., engineering controls ). Post

- application Yes A quantitative occupational post

- application inhalation exposure assessment was not performed at this time. Residential Handlers No Residential handler assessments were not conducted because the end

- use products specify the use of PPE. Standard HED assumptions for residential handlers do not include the use of PPE. Post

- application Yes Complete

. Risk estimates for post application exposures are below the level of concern. Other Aggregate Yes T he combined risk from dietary /drin k ing water and exposure from incidental ingestion of treated water from swimming was evaluated

. Residential s hort

- term ag gregate risk is not of concern; acu te aggregate risk was not assessed, and intermediate

- term exposure is not expected. The chronic dietary assessment serves as the chronic aggregate assessment. Endothall is classified as

“ Not likely to be carcinogenic to humans ” through the oral, dermal and inhalation routes of exposure; a quantitative cancer aggregate assessment is not needed Cumulative No EPA has not made a common mechanism of toxicity finding for endothall. Tolerances Yes Updated /new tolerances are recommended for several commodities

.13

Incidents Yes Incidents for endothall and salts were last reviewed in 2004. Based on the low frequency and severity of incident cases reported

, there does not appear to be a concern at this time that would warrant further investigation

.

Guidance for Com mente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

 Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not a lready reported to the Agency

.

 Water quality m onitoring data (see Appendix for further details)

TIMELINE

EPA has created the following estimated timeline for the completion of the endothall registration review in Table 5 below

.

Table 5: Projected Endot hall Registration Review Timeline
Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2015

- December Close Public Comment 2016

- February Case Development Final Work Plan 2016

- May Issue DCI 2016

- July

- Sep tember Data Submission 2018

- July

- September 6 0

- day Public Comment Period for Draft Risk Assessments 9 2020

- January

- March

Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review Decision 2020

- October

- Decembe r

Registration Review Decision and Begin Post

- Decision Follow

- up 2021

Total (years) 6

NEXT STEPS

After the 6 0

- day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration review of endothall.

9 The regulations governing Registration Review generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assess ment s

.14



### Appendix

– Additional Areas Considered in the Endothall Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency wher e your comments, data submissions, or reference to sou rces of additional information c ould be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent fea sible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRL s ) and may modify tolerance levels to do so, when possible

. Growers and other stakeholders are asked to

c omment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Endothall is not ident ified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 10 In addition, n o Total Maximum Daily Load s (TMDL) have been developed for endothall

. 11 More information on impaired water bodies and TMDLs can be found at the Agency’s website

. 12 The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaire d Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 13 in order to ensure they can be used quantitatively or qualitatively in pesticide risk
assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help addres s potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to endothall compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population

10 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

11 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant _group_name=PESTICIDES

12 http://www.epa.gov/owow/tmdl/
13 http://www2.epa.gov/pesticide

- reevaluation/opp

- guidance

- submission

- state

- and

- tribal

- water

- quality

- monitoring

data15

ENDANGERED SPECIES :
A risk assessment that supports a complete endangered species determina tion has not been conducted for endothall. The ecological risk assessment planned during registration review will allow t he Agency to determine whether use of endothall has “no effect” or “may affect” federally listed threatened or endangered species (list ed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

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 a cute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effect s on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies th at assess growth, developmental and reproductive effects in different taxonomic groups. As part of its reregistration decision for endothall

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), endothall is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (includ ing 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.” The EDSP employs a two

- tiered appro ach 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 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 will determine which, if any, of the Tier 2 tests are necessary based on the available data. T ier 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 c hemicals. 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 ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening w as published on June 14, 2013 14 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemi cals.16

For further information on the statu s 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. 15 Endothall is on List 2. List 2 represents the next set of chemicals for which EPA intends to issue test orders/dat a call

- ins in the near future.

HUMAN STUDIES :

Occupationa l and Residentia l

Past endothall risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Handler Exposure Task Force (AHETF ) Database , and HED’s SOP for Residential Exposure Assessments (Draft; 17

- Dec

- 1997, pg 52

- 57) modified in HED’s SWIMODEL V1.0 (W. Dang et al., 27

- March 1999)

. EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases, an d has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. A ll applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued reliance on these studies

.

15 http://www2.epa.gov/endocrine

- disruption