2 

### Inorganic Polysulfides Prel iminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

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

ANTICIPATED R ISK ASSESSMENTS FOR REGISTRATION REVIEW

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

TIMELINE

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

NEXT STEPS

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

Appendix

– Additional Areas Considered i n the Inorganic Polysulfides Regist ration Review 13

References:

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

1. Combined Problem Formula tion and Preliminary Risk Assessment in Support of the Registration Review of Lime Sulfur

. Milians, K.; Sayer, A. February 25 , 2016.

2. Calcium Polysulfide

. Draft Human Health Risk Assessment for Registration Review

. Doherty, M. December 10, 2015

.

3. Inorganic Polysulfides : Tier 1 (Sco ping) Review of Human Incidents and Epidemiology

. Recore, S; Evans, E. December 2, 2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Inorganic Polysulfides (calcium polysulfide o r lime sulfur) (076702). Chandgoyal, T.; Alsadek, J.; Berwald, D. February

25 , 2016.

5. Ca lcium Polysulfide (076702) Screening Level Usage Analysis (SLUA) . July 15, 2015.3 6. Lime Sulfur (076702) Label Dat a Report. July 14, 2015.

7. Lime Sulfur (076702) HED Master Label Report. July 14, 2015.

These and other supporting documents for the lime sulfur registration review case may be found

in the docket EPA

- HQ

- OPP

- 2016

- 0102 a t http://www.regulations.gov

.4 OVERVIEW

The docket for inorganic polysulfides (PC code 076702, c ase number 4054, docket number EPA

HQ

- OPP

- 2016

- 0102) is now open, initiating the first public comment period for this registration review. The inorganic polysulfides case includes one active ingredient , calcium polysulfide. Calcium polysulfide is also know n by various synonyms such as calcium sulfide and lime sulfur. Hereafter, this document will use the name lime sulfur.

Lime sulfur is a pesticide active ingredient that primarily has fungicidal activity and also has

secondar y activity as an insecticide or acaricide . It is registered for conventional pesticide use to control pow dery mildews, anthracnose, scab and other dis eases, as well as spider mites. Registered use sites include almonds, apples, caneberries, cherries, citrus, hazelnuts, currants and

go oseberries, bearing and non

- bearing fruit trees, grapes, nectarines, peaches, pears, pecans, pineapples, pistachios, plums/prunes, quince, ryegrass, red clover, and alfalfa . Lime sulfur is also registered for use on ornamental plants and for livestock use as a n animal treatment on horses, cattle, sheep, and swine. There are no registered residential uses.

This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs

knows about lime sulfur

, highlighting anticipated data and as sessment 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 registration review for lime sulfur

.

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 lime sulfur and what types of new data or

other i nformation would be helpful for the Agency to receive as it moves toward a decision on lime sulfur

. 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

mak ing 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 Append ix about which the Agency specifically s eeks comments and information. Interested stakeholders could include:

environmental non

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, resident ial, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the a ntici pated data needs for lime sulfur

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

. 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 summar izes a ntici pated data needs for lime sulfur

. For additional discussion of the anticipated data nee ds, please see the document titled Combined Problem Formula tion and Preliminary Risk Assessment in Support of the Registration Review of Lime Sulfur located in

docket EPA

- HQ

- OPP

- 2016

- 0102 at www.regulations.gov

. No additional human health data are anticipated for registration review.

Table 1: Anticipated Data Needs for the Lime Sulfur Registration Review

Guideline

Number 1 Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Non

- GDLN (OECD 213) Tier I honeybee adult acute oral toxicity TGAI 12

850.3030 Tier 1 honeybee toxicity of residues on foliage TEP 12

Non

- GDLN Tier I honeybee adult chronic oral toxicity TGAI 12

Non

- GDLN (OECD 237) Tier I honeybee larval acute oral toxicity TGAI 12

Non

- GDLN Tier I honeybee larval chronic oral toxicity TGAI 12

Non

- GDLN Tier II field trial of residue s in pollen and

nectar 2 TEP 24

Non

- GDLN (OECD 75) Tier II semi

- field testing for honeybee toxicity (tunnel/enclosure or colony feeding) 2 TEP 24

850.3040 Tier III field testing for pollinator toxicity 2 TEP 24

850.4100 Tier II terrestrial plant toxicity, seedling

emergence TEP 12

850.4150 Tier II terrestrial plant toxicity, vegetative vigor TEP 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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.) generally must be registered by the

Environ mental 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 registration review program is intended to make sur e that, as the ability

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

– Ecological Effects Tests

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

- HQ

- OPPT

- 2009

- 0154

- 0028

2 The need for theses anticipated data requirem ents is contingent on results of the tier 1 bee studies (including acute oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, and chronic oral toxicity to larval honey bees)

.6 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 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 pro vided on EPA’s website

. 3

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 pesticide 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 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 infor mation it believes are needed to 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 fo r the registration review of lime sulfur

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for lime sulfur

.

Table 2: Chemical Facts for Lime Sulfur

PC code 076702

Case Number 4054

CAS Number 1344

- 81

- 6 Year first registered Lime s ulfur has been used for over 150 years . It was first registered in the United States in 19 61. Pesticide Type Fungicide, acaricide, and insecticide

Chemical class Inorganic pesticide Reregistration Eligibility Decision (RED) 2005

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable; lime sulfur has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation T his compound is currently exempt from the requirement for a

tolerance under 40 CFR 180.1232.

Dual

- use Not applicable; lime sulfur is registered for conventional pesticidal uses only.

Non

- pesticidal uses Not applicable

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

- reevaluation7 Table 2: Chemical Facts for Lime Sulfur

Pesticide Re

- evaluation Division, Chemical Review Manager Katherine St. Clair

, stclair.katherine@epa.gov , 703

- 347

- 8778

Registration Division, Product Manager and

Reviewer Heather Garvie

, garvie.heather@epa.gov , 703

- 308

- 0034 Lisa Pahel, pahel.lisa@epa.gov

, 703

- 347

- 0459

USE AND USAGE INFORMATION

Table 3 summarizes the use and u sage information for lime sulfur

. For more details, p lease see

the BEAD Chemical Profile (BCP) for Registration Review: I norganic Polysulfides (calcium polysulfide or lime sulfur) (076702) located in docket EPA

- HQ

- OPP

- 2016

- 0102 at www.regulations.gov

.

Table 3 : Lime S ulfur Us e and Usage Information

Summary of Use Lime sulfur is registered for conventional pesticide use as a fungicide, insecticide, or acaricide on certain agricultural crops and for treatment of mange on certain types of livestock

. Use Sites L ime sulfur is registered for use on almonds, apples, blueberries, caneberries, cherries, citrus, hazelnuts, currants and gooseberries, bearing and non

- bearing fruit trees, grapes, nectarines, peaches,

pears, pecans, pineapples, pistachios, plums/prunes, quince, ryegrass, red clover, and alfa lfa . It is also registered for use on ornamental plants and as an animal treatment for mites and scab

disease on horses, cattle, sheep, and swine

. There are no registered residential uses. Summary of Usage In the perio d from 2009 to 201 3, approximately 2, 131,000 pounds of active ingredient (a.i.) were applied over 187,000 acres

annu ally. The to p three crops by average annual usage in pounds of active ingredient (a.i.) per year were apples (900,000 pounds a.i.), grapes (500,000 pounds a.i.), and pears (300, 000 pounds a.i.). Crops with the highest percent crop treated (PCT) included caneberries (45), pears (20), and apples (15). Formulation Type(s) Lime sulfur end use products are formulated as soluble

concentrates and emulsifiable concentrates. Application Method(s) Lime sulfur products can be applied by hand or by ground sprayer equipment. Technical Registrant(s) Lime sulfur registrants include OR

- CAL and Tes senderlo Kerley,

Inc

. No. of Registrations As of February 2016, there are four Section 3 end

- use products registrations

. 4

4 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).8 Table 3 : Lime S ulfur Us e and Usage Information

Restricted Use Lime sulfur i s not c lassified as a restricted use pesticide.

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

• Information on the pounds a.i. applied an d percent crop treated for the uses on alfalfa, clover, curr ant, filbert (hazelnut), nectarines, pineapple, pistachio, quince , and rye.

• Information about the non

- crop uses as an a nimal treatment for mites and scab disease ( e.g

. , dairy catt le swine horses, sheep): quantity applied, frequency of use, importance

, and potential alternatives.

• Information on the uses on ornamentals

.

• Confirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

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

– national, state, and county

.

• Typical application interval (days).

• Foreign technical registrants not listed above who supply te chnical lime sulfur to the US

market.

RECENT ACTIONS

A new use for lime sulfur (thinning fruit in apple blossom orchards ) was registered in 2015.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent human health and ecological risk assessments for lime sulfur were completed in September 2005 in support of the RED , and in December 2015 in support of a new use

, thinning fruit in apple blossom orchards

. For registration review, EPA has completed a draft human health

risk assessment and a partial draft ecological assessment. F indings and conclusions from these

risk assessments are summarized in the document titled Combined Problem Formula tion and Preliminary Risk Assessment in Support of the Registration Review of Lime Sulfur and the

document titled Calcium Polysulfide. Human H ealth Risk Assessment for Registration Review

located in docket EPA

- HQ

- OPP

- 2016

- 0102 at www.regulations.gov

.

The draft ecological risk ass essment does not include a comprehensive pollinator assessment or complet e endangered species assessment. EPA anticipates conducting these assessment s during registration review.

EPA anticipates requiring data to support the p lanned pollinator and endangered species risk

assessments. If toxicological endpoints or points of de parture are revised based on the data that are anticipated to be required for registration review, they will be considered in the new

assessment s
, as will any changes to the standard operating p rocedures or default exposure assumptions

.9 Table 4 summarizes the recently completed registration review human health and ecological

draft risk assessment s and the plan ned pollinator and endangered species assessments as detailed

in the document titled C ombined Problem Formula tion and Preliminary Risk Ass essment in Support of the Registration Review of Lime Sulfur and the document titled Calcium Polysulfide. Human Health Risk Assessment for Registration Review

.

Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Lime Sulfur Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Eco logical and Environmental Fate Comprehensive ecological assessment, including endangered species Yes The Agency anticipates conducting an updated comprehensive ecological risk assessment during registration review for all uses of lime sulfur. The new assessment will incorporate the most up

- to

- date modeling methodologies, updated toxicological endpoints, a nd data submitted under the anticipated registration review data call

- in.

The most recent risk assessments for lime sulfur found

that acute risk quotients (RQs) exceed levels of concern (LOCs) for listed and non

- listed freshwater fish, birds,

and mammals ; however the se assessments also

determined that the likelihood of these aquatic and terrestrial animals actually being exposed to residues of lime sulfur at levels capable of causing adverse effects is

considered low.

Terrestrial plant data are not avai lable for lime sulfur; also, there is some uncertainty regarding the potential risk to terrestrial invertebrates (such as honey bees) if they are exposed to lime sulfur during applications made at bloom to pollinator

- attractive trees, i.e., apples.

Therefo re, d uring registration review, the Agency anticipates conducting a more comprehensive evaluation of potential effects to plants and to honey bees. Risks to federally listed species will be

evaluated as well.10 Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Lime Sulfur Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Incidents Will check for updates For a discussion of reported ecological incidents for

lime sulfur , see Secti on 5 of the document titled

C ombined Problem Formula tion and Preliminary Risk Assessment in Support of the Registration Review of Lime Sulfur

. A total of seven ecological incidents were found that possibly involved lime sulfur. None of the reported incidents involved adverse effects to terrestrial or aquatic animal s ; all involved plant damage. Most of the incidents were

minor.

Human Health Dietary Dietary No T he Agency does not anticipate conducting an updated dietary risk assessment

. The previous assessments determined that there are no dietary risk

concerns. Food No Drinking water No

Occupational Handlers (mixers, loaders, applicators) No T he Agency does not anticipate conducting an updated occupational risk assessment

. The previous

assessments d etermined that there are no occupational

risks of concern. Post

- application No

Residential

Handlers No There are currently no registered or proposed

residential uses for lime sulfur

. Post

- application No

Other Aggregate No An aggregate risk assessment e valuates the combined

risk from dietary and residential exposures.

T he Agency does not anticipate conducting an updated aggregate risk assessment

. The previous

assessments determined that there are no aggregate

human health risks of concern.

Cumulative No Not applicable; lime sulfur has not been identified as

a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances No T his compound is currently exempt from the requirement for a tolerance under 40 CFR 180.1232.11 Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Lime Sulfur Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Incidents Will check for updates Based on the low frequency and low severity of incident cases reported fo r lime sulfur , there does not appear to be a concern at this time that would warrant further investigation

. However, t he Agency will

continue to monitor the incident information and if a concern is triggered, additional analys is will be

included in the risk assessment.

For a discussion of reported human incidents for lime

sulfur , s ee the document titled Ca lcium Polysulfide

. Draft Human Health Risk Assessment for Registration

Review and the document titled Inorganic Polysulfides: Tier 1 (Scoping) Review of Human Incidents and Epidemiology

.

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

• S ubmission of any existing toxicity data not previously submitted to the Agency . This would help give the Agency a more complete understandi ng of the effects of lime sulfur

.

• M aximum annual application rates per acre (maximum lb a

. i

. /A/year) , maximum number of applications p er season and/or year, and minimum application intervals on all labels

.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already 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 o f the lime sulfur regist ration review in Table 5

.

Table 5: Projected Registration Review Timeline for Lime Sulfur

Activity Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period March 201 6

Close Public Comment Period May 2016 Case Development

Issue Final Work Plan August 2016

Issue DCI October

– December 2 01612 Table 5: Projected Registration Review Timeline for Lime Sulfur

Activity Estimated Dat e Data Submission 5 October

– December 201 7 Open 6 0

- day Public Comment Period for Draft Risk

Assessments 6 April

– June 20 19

Registration Review Decision Open 60

- day Public Comment Period for Proposed Registration Review Decision January

- March 202 0

Issue Registration Review Decision and Begin Post

Decision Follow

- up 202 0

Total (years) 4

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 t he re gistration

review of lime sulfur

.

5 Th is estimated date for data submission is based on the study timeframes for the anticipated terrestrial plant toxicity studies and tier 1 bee studies only (including acute oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, and chronic oral toxicity to larval honey be es). The need for the tier 2 bee studies is contingent on the results of the tier 1 bee studies. If tier 2 bee studies are required, this estimated timeline for data submission would need to be extended, and the estimated dates for subsequent activities

in the estimated timeline may also change

. 6 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 assessment s.13 Appendix

– Additional Areas Considered in the Lime Sulfur Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where 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 feasible, 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

comment on any trade irritant issues resu lting 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:

Lime sulfur is not identified as a cause of impairment, as defined under section 303(d) of the

Clean Wate r Act, based on information provided at EPA’s website. 7 In addition, n o Total Maximum Daily Loads (TM DL ) hav e been developed for lime sulfur

. 8 More information on impaired water bodies and TMDLs can be found at EPA’s website

. 9 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 Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 10 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 poli cies. To help address 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 atypi cal, u nusually high exposure to l ime sulfur 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.

7 http://iaspub.epa.gov/tmdl_ waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

8 http://iaspub.epa.gov/tmdl_waters10/attai ns_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

9 http://www.epa.gov/owow/tmdl/

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

- reevaluation/opp

- guidance

- submission

- state

- and

- tribal

- water

- quality

- monitoring

data14 ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determina tion h as no t been

conducted for lime sulfur

. The ecological risk assessment planned during registration review will

allow t he Agency to determine whether use of l ime sulfur has “no effect” or “may affect” federally listed threat ened or endangered species (listed 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

outcom es 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. These 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

, and sex ratios in offspring. For ecological hazard assessments, EPA evaluate s acute tests and chronic studies that assess growth, developmental and reproductive effects in different

taxonom ic groups. As pa rt of its most recent registration and reregistration decision s for lime

sulfur

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk

assessment scenarios from the existing hazard database. However, as re quired by F FDCA section 408(p), lime sulfur is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA ha s 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 such endocrine effects as th e Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required

dete rminations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, a ndrogen, 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. 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 s creen 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 ingredi ents. A second list of chemicals identified for EDSP screening was published on June 14, 2013 11 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 lik ely endocrine disruptors.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.15 For further information on the status of the EDSP, the policies and procedures, the lists of

c hemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website. 12

HUMAN STUDIES :

Occupationa l

Th e current lime sulfur human health risk assessment in support of registration rev iew, as well as past lime sulfur ri sk assessments

, rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine t heir 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) and the Agricultural Reentry Task Force (ARTF) D atabase

. EPA has reviewed all the studies supporting

these multi

- pesticide generic exposure databases, and 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 ti me 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 relian ce on these studies

.

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

- disruption