2 

### Dazomet 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 Assessment s for Registration Review 11

Timeline 14

Next Steps 14

Appendix

– Additional Areas Considered in the Dazomet Registration Review 15

References:

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

1. Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be Conducted in Support of the Registration Review of Dazomet . Panger, M. Aug ust 27,

2013.

2. Dazomet Human

- Health Assessment Scoping Document in Support of Registration Review. Shelat, S, C. Smith and N. Mottl. September 4, 2013.

3. Dazomet: Review of Human Incidents

. Recore, S. and E. Evans. August 29, 2013.

4. BEAD Chemical Profi le for Registration Review: Dazomet (035602)

. Yourman, L., S. Haddad, and D. Berwald

. May 14, 2012.

5. Dazomet ( 035602 ) Screening Level Usage Analysis (SLUA) . March 19, 2012.

6. PRD Label Data Report

. February 13, 2012.3 These and other supporting documents for the dazomet registration review case may be found in

the docket EPA

- HQ

- OPP

- 2013

- 0080 at http://www.regulations.gov

.

In addition, the following documents may be found in the docket EPA

- HQ

- OPP

- 2005

- 0128 at http://www.regulations.gov

.

7. Amended Reregistration Eligibility Decision for Dazomet. May 2009.

8 . Dazomet: Updated Fina l Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). Shelat, S. and C. Smith. April 2009.4 OVERVIEW

The docket for dazomet is now open , initiating the first public comment period for this registration review (docket number EP A

- HQ

- OPP

- 2013

- 0080 )

. Dazomet is a non

- selective soil fumigant with fungicidal, herbicidal, and nematicidal properties used as a pre

- plant soil fumigant for strawberries and tomatoes in California only, and nationally for non

- bearing crops, and for golf course turf

. Dazomet is also an active ingredient in a variety of antimicrobial products. After application dazomet break s down quickly to the primary toxic degradate, methyl isothiocyanate (MITC) gas. MITC is highly volatile and is responsible for the b iocidal properties

of this fumigant

. The MITC case is addressed in a separate Preliminary Work Plan, located in the MITC docket ( EPA

- HQ

- OPP

- 2013

- 0242 ).

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

knows about dazomet , 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 registration review for dazo met

.

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

dazomet . The Agency encourages all interes ted 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 Appen dix about which the Agency specifically seeks comments and information. Interested stakeholders could include:

environmental non

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

The Preliminary Work Plan begins by listing the anticipated data needs for dazomet

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

. Finally, the Appendix to

this document includes identification and discussion of some areas that are c onsidered generally

in R egistration R eview along with some additional dazomet case

- specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for dazomet . For additional discussion of the anticipated data needs, see the Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be Conducted in Support of the Registration Review of Dazomet and

Dazomet Human

- Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the D azomet Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent D azomet (for conventional uses of dazomet )

835.1230 Adsorption/ desorption and leaching TGAI 12

835.1240 Adsorption/ desorption and leaching TGAI 12

850.2100 Avian oral toxicity (passerine) TGAI 12
Anticipated D ata Needs for the Parent D azomet (for antimicrobial uses only)

875.1700 Product use information TEP 12

875.1200 D ermal exposure for open pour mixing/loading paint (occupational) and applying paint (airless sprayer and

brush/roller ; occupational and residential ) TEP 24

875.2400 Post

- application dazomet dermal exposure for finger painting TEP 24

Anticipated Data Needs for the Degradate MITC (for conventional uses of dazomet)

850.6100 Environmental chemistry methods and associated independent laboratory v alidation s for ai r, soil, and

water MITC 12

835.4300 Aerobic aquatic metabolism MITC 24

Non

guideline Honey bee vapor exposure MITC 24

850.1400 Freshwater fish early

- life stage MITC 12

Anticipated Data Needs for the Degradate MITC (for antimicrobial uses of dazomet only)

875.1400 Inhalation exposure for open pour mixing/loading paint (occupational) and applying paint (airless sprayer and

brush/roller ; occupational and residential ) MITC 24

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

- 00286 Table 1: Anticipated Data Needs for the D azomet Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

875.2400 Post

- application dermal exposure ( for painted rooms) MITC 24

835.3110

835.3220

835.3280

835.3240 Ready biodegradability test or one of three biodegradation in activated sludge simulation tests MITC 12

Outstanding Data Requirements from GDCI

- 035602

- 28850 2 (2010 Soil Fumigant Dazomet DCI)

835.8100 Field volatility from soil TEP In review

850.1025 Oyster acute toxicity (shell deposition) MITC In review

850.1035 Mysid acute toxicity MITC In review

850.1075 Fish acute toxicity, freshwater and marine MITC In review

850.2300 Avian reproduction test TGAI In review

850.3020 Honey bee acute toxicity MITC Due April 2014

850.4100 Seedling emergence (Tier II) MITC In review

850.4150 Vegetative vigor (Tier II) MITC In review

850.4400 Aquatic plant growth toxicity (Tier II) MITC In review

870.4200 Carcinogenicity MITC Due April 2014

870.3700 Prenatal developmental toxicity study MITC In review

870.3800 Reproduction and fertility effects MITC Due April 2014

870.6200 Neurotoxicity screening battery MITC In review

2 The studies listed in this section were previously required through a generic data call

- in issued in March 2010 and

are still outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the earlier DCI.7 Table 1: Anticipated Data Needs for the D azomet Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

guideline (numbered

as SS

- 2 on

the

dazomet DCI) Avian acute inhalation

MITC In review

Outstanding Data Requirements from GDCI

- 035602

- 29024 3 (2010 Antimicrobial Dazomet DCI 4 )

875.1200 Dermal Exposure

- Indoor TEP In review

875.1400 Inhalation Exposure

- Indoor MITC Extension requested*

875.1600 Application exposure monitoring data reporting TEP Extension requested*

875.1700 Product Use Information TEP Extension requested*

875.2500 Inhalation Exposure MITC In review

875.2700 Product Use Information TEP Extension requested*

875.2800 Description of human activity TEP Extension requested*

875.2900 Data reporting and calculations TEP Extension requested*

850.1025 Oyster acute toxicity (shell deposition) MITC In review

850.1035 Mysid acute toxicity MITC In review

850.1075 Fish acute toxicity, freshwater and marine MITC In review

860.1520 Processed Food/Feed (paper manufacturing

processes TEP In review

870.3700 Prenatal developmental toxicity study MITC In review

3 The studies listed in this s ection were previously required through a generic data call

- in issued in March 2010 and

are still outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the earlier DCI.

4 The exposure and air concentration monitoring data required by the 2010 antimicrobial dazomet DCI is to support

the following dazomet uses identified by the 2009 Amended Dazomet RED. These uses include: 1) a treatment during the production of pulp and pap er; 2) a materials preservative treatment for paper coatings, non

- food adhesives, epoxy flooring compounds, slurries, and high viscous suspensions; 3) a biocide treatment during petroleum operations; 4) a biocide treatment in recirculating cooling water sy stems; and 5) a remedial wood treatment to utility poles.8 Table 1: Anticipated Data Needs for the D azomet Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

870.3800 Reproduction and fertility effects MITC Due March

2014

870.5395 Mammalian erythrocyte micronucleus test MITC In review

870.4200 Carcinogenicity MITC Due March

2014
TGAI = technical grade active ingredient; TEP = typical end

- use product * The recently submitted extension request will be reviewed prior to issuing the Final Work Plan.

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 Environmental Protection Agency (EPA or the Age ncy), based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability

to assess risk e volves 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 provided on EPA’s website

. 5

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 opene d for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. 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 dazomet

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for dazomet

.

5 http://www.epa.gov/oppsrrd1/registration_review/9 Table 2: Chemical Facts for D azomet

PC code 035602

Case Number 2135

CAS Number 533

- 744

- 4

Year first registered 1967 Pesticide Type N ematicide

, herbicide, fungicide, insecticide , and slimici de

Dazomet class D ithiocarbamate

R eregistration Eligibility Decision (R E D) July 2008; Amended RED date May 2009

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

.

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

40 CFR Citation There are no tolerances established for dazomet. All registered food

uses are pre

- plant. 6

Dual

- use Yes. Dazomet is registered for co nventional and antimicrobial

uses.
Non

- pesticidal uses There are no identified non

- pesticidal uses of dazomet.

Pesticide Re

- evaluation Division, Dazomet Review Manager Dana Friedman, friedman.dana@epa.gov , (703) 347

- 8827

Antimicrobials Division,

Dazomet Review Manager Wanda Henson, henson.wanda@epa.gov

, ( 703 ) 308

- 6345

Registration Division

, Product Manager Shaja Joyner, joyner.shaja@epa.gov

, (703) 308

- 3194

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for dazomet

. Please see the BEAD Chemical Profile for Registration Review: Dazomet (035602 ) in the registration review docket for more

details

.

Table 3: D azomet Use and Usage Information

Summary of Use Dazomet is a non

- selective soil fumigant with fungicidal,

herbic idal, and nematicidal properties. Dazomet is also an active ingredient in a variety of antimicrobial products

. The primary degradate of dazomet is methyl isothiocyanate (MITC). The MITC

6 Dazomet’s volatility in the environment and results of metabolism studies in plants assure that there is no reasonable expectation of finite r esidues to be incurred in/on any raw agricultural commodity when these products are applied according to label directions. Therefore, this fumigant does not require food tolerances and is not subject to the amendments to the FFDCA promulgated under the Fo od Quality Protection Act of 1996. Dazomet: Updated Final Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). Shelat, S. and C.

Smith. April 2009.10 Table 3: D azomet Use and Usage Information

case is addressed in a separate Preliminary Work Plan, located in the MITC docket ( EPA

- HQ

- OPP

- 2013

- 0242 ).

Use Sites Conventional Uses

The conventional uses of dazomet include applications to

strawberries (California only) , tomatoes (California only) , golf greens/tees, nonbearing crops, turf sites (establishing or renovating), ornamental sites (establishing or renovating), field nurseries (establishing or renovating), compost piles and potting

soils.

Antimicrobial Uses

The antimicrobial uses of daz omet include treatment during the production of pulp and paper; a material preservative treatment for paper coatings, non

- food adhesives, epoxy flooring compounds, slurries, and high viscous suspensions; a biocide treatment during petroleum operations and in recirculating cooling water systems; and a remedial wood treatment to utility poles. There are also antimicrobial uses of dazomet in paint and finger paint

. Summary of Usage The Agency has limited data on the use of dazomet. According to the Nursery a nd Floriculture Summary of the USDA, approximately 15,000 pounds of dazomet was used as a soil fumigant in 2003

.

Use information for dazomet is available for golf courses in 2002 (15,500 lbs. a.i.) and 2006 (approximately 6,000 lbs. a.i.). In 2010 in

Cali fornia, 55,511 pounds of dazomet were used on rights

- of

- way; however, there was no information available on use of dazomet for rights

- of

- ways in other states. Formulation Type(s) C onventional Use

The sole end

- use formulation is granular

.

Antimicrobial Use

Formulations are pelleted/tableted, liquid (soluble concentrate and flowable concentrate) solutions, water soluble packaged solids, and ready to use solutions. Application Method(s) Conventional Use

I t is applied as a dry granule and incorporated int o the soil or applied

to the soil surface and watered into the soil to activate it.

Antimicrobial Use

I t can be applied by open pour, metering pump, and water

- soluble packaged solid. Technical Registrant (s) Conventional Use AMVAC Chemical Corporation

Antimicrobial Use11 Table 3: D azomet Use and Usage Information

B uckman Laboratories, Inc., Kemira Chemicals, Inc., Lanxess Corporation No. of Registrations Conventional Use Section 3 products: 2

Antimicrobial Use Section 3 products: 17

Restricted Use Conventional Use

Yes

Antimicrobial 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 ; application methods and equipment ; maximum application rates ; frequency of application , 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 ) from 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

- agricultur al uses

.

• S tate or local use restrictions

.

• F oreign technical registrants not listed above who supply technical dazomet to the US

market

.

In addition, the Agency will continue the dialogue with stakeholders on label issues that have

evolved during the RED label implementation process.

RECENT ACTIONS

A Reregistration Eligibility Decision (RED) was completed for dazomet in July 2008 and amended in May 2009. The Agency determined that dazomet products were eligible for reregistration provid ed a number of risk mitigation measures are adopted and label amendments

are made to reflect these measures. For details on the mitigation measures, see the Amended Reregistration Eligibility Decision (RED) for Dazomet, dated May 2009

. Additionally, the

A gency’s Soil Fumigant Toolbox website contains information on these and other soil fumigants: http://www.epa.gov/pesticides/reregistration/soil_fumigants/ . More information on the

r eregistration process can be found on the following website: http://www.epa.gov/pesticides/reregistration/index.htm

. T he product reregistration process , which starts after completion of a RED, is still ongoing for

dazomet products

.12 ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for dazomet was completed in

2008 in preparation for the RED, and updated in April 2009 for the Amended RED. T he most recent ecological and environmental fate risk assessment was comple ted in April 2008 for the

RED. Findings and conclusions from these risk assessments are summarized in the Problem

Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be Conducted in Support of the Registration Review of Dazomet and Dazomet Human

- Health Assessment Scoping Document in Support of Registration Review

.

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 dazomet

. For human health, EPA anticipates the need to conduct revised occupational and bystander risk

assessment s during registration review for conventional uses, and occupational and residential

assessments for antimicrobial uses

. If toxicological endpoints or points of departure are revised

based on the data that are anticipated to be required for registration rev iew

, they will be

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

.

T able 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

Table 4: Anticipated Risk Assessments for the D azomet Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Y Since dazomet rapidly hydrolyzes to MITC, potential exposure to aquatic receptors is primarily to MITC via surface runoff; consequently, the toxicity data for MITC will be used to assess risk to fish, aquatic invertebrates, and aquatic plants. Terrestria l exposure to birds, mammals, invertebrates can occur through consumption of dazomet granules and/or by

inhalation of MITC.

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

dazomet

, see page 16 of the Problem Formulation.

Human Health Dietary

Food N T he uses of dazomet on strawberries and tomatoes ( California only) are considered non

- food uses, since there is no reasonable expectation of finite residues in/on food crops when dazomet is used as a pre

- plant fumigant. An assessment is not anticipated in registration review

.13 Drinking water N Based on environmental fate data, the residual contents in soils, and monitoring data, the Agency does not expect MITC to adversely impact the drinking water sources such as surface water and ground water , so an assessment is not anticipated in registration review

.

Occupational Handlers (mixers, loaders, applicators) Y For soil fumigant and antimicrobial uses, updates to handler risk assessments are anticipated.

Post

- application Y An updated occupational post

- application risk assessment for some antimicrobial uses is anticipated.

N Based on re

- entry restrictions specified by the 2009

amended RED for the conventional uses of dazomet

, the Agency does not expect risk to re

- entry workers to exceed the Agency’s level of concern.

Residential

Handlers Y For antimicrobial uses only, additional residential handler dermal and inhalation exposure data are required and will be reviewed and incorporated in the

risk assessment in registration review.

Post

- application Y For antimicrobial uses only, additional p ost

application dermal exposure data are required and will be reviewed and incorporated in the risk assessment in registration review. Bystander Y For soil uses

, there is the potential for residential bystander (anyone not involved in the application) inhalation exposure to MITC after a soil fumigation application of dazomet

. A revised residential risk assessment is anticipated in registration review to update ris k to bystanders during and following soil fumigant uses of dazomet products.

Additionally, the Agency anticipates updating the fumigant factors document, which provides a discussion of values and parameters used as the basis

for buffer zone reduction cr edits as well as for establishing Good Agricultural Practices (GAPs) for the fumigants. Buffer zones and GAPs were specified by the 2009 amended RED as measures to mitigate occupational and bystander risk.

Other14 Aggregate N E valuates the combined risk from dietary and residential exposures. No dietary risk is anticipated

from dazomet . Therefore, an aggregate assessment is not anticipated.

Cumulative N Dazomet is not a member of a cumulative group, so no cumulative risk assessment is planned

Tolerances N Dazomet is a pre

- plant soil fumigant so there are no

tolerances established for this chemical.

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

dazomet , see page 8 of the Scoping Document and

Dazomet: Review o f Human Incidents

.

Guidance for Commente 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 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 of the dazomet registration

review in Table 5 below

.

Table 5: Projected Dazomet Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2013

– September

Close Public Comment 2013

– November
Case Development

Final Work Plan 2014

– February

Issue DCI 2014 April

- June

Data Submission 2016 April

- June

6 0

- day Public Comment Period for Draft Risk

Assessments 7 2017 Oct.

– Dec.

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2018 April

- June

Registration Review Decision and Begin Post

- Decision

Follow

- up 2019

7 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

.15 Table 5: Projected Dazomet Registration Review Timeline

Activities Estimated Dat e 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 dazomet

.16 

### Appendix

– Additional Areas Considered in th e D azomet 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 r esidue 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 resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export market s, providing as much specificity as possible regarding

the nature of the concern. Because dazomet is not registered for food/feed uses in the U.S., it

has no U.S. tolerances ; therefore, the Agency does not anticipate any trade irritant issues for it.

Wa ter Quality:

D azomet is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of th e Clean Water Act

. 8 In addition, no Total Maximum Daily Loads (TMDL) have been developed for dazomet

. 9 More information on impaired water bodies and TMDLs can

be found at the Agency’s website

. 10 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 11
in order to ensure they can be used quantitatively or qualitatively in pesticide risk asses sments.

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 environm ental laws, regulations, and policies. 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

atyp ical, unusually high exposure to dazomet 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.

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

9 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

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

11 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm17 ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determination has not been

conducted for dazomet

. The ecological risk assessment planned during registration review will allow the Agenc y to determine whether use of dazomet has “no effect” or “m ay affect” federally listed threatened 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 cons ult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

On June 5, 2013, the Center for Biological Diversity and the Pesticide Action Network North America filed an amended complaint in its laws uit in the United States District Court for the Northern District of California, against the Environmental Protection Agency (EPA) for allegedly failing to undergo consultation with the United States Fish and Wildlife Service and the

National Marine Fisher ies Service regarding the effects of 50 pesticides, including dazomet, on over 100 endangered and threatened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C 11

- 00293 (N.D.Cal.)

.

ENDOCRINE DISRUPTOR SCREE NING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenici ty, 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 evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different

taxonom ic groups. As part of its most recent registration decision for dazomet, 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), dazomet is subject to the endocrine screening part of the Endocrine D isruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a

chemical substance to interact with the estr ogen, 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. 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 ef fect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 6718 chemicals, which contains 58 pesticide active ingredients and 9 iner t ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 12 and includes some pesticides scheduled for Registration Review and chemicals found in water

. For further information on the status of the EDSP, the pol icies and procedures, the list s of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 13

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

HUMAN STUDIES :

Occupationa l and Residentia l

Past dazomet 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) and the Outdoor Residential Exposure Task Force (ORETF) Database

. 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 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

.

Dazomet

- specific Human Studies

Past dazomet risk assessments have relied in part on human studies which involved intentional

exposure to the dazomet degradat e MITC In the course of registration review EPA will

reconsider these studies

, as well as any other research involving intentiona l exposure of human subjects to dazomet and its degradates brought to its attention. If EPA decides to rely on any of

these studies, EPA will ensure that all applicable regulatory requirements are met, including

, but

not limited to

, the requirements for EPA ethics review and Human Studies Review Board review of certain research involving intentional exposure of human subjects.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

13 http://www.e pa.gov/endo/