2 

### Dichlobenil Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessment s for Registration Review 7

Timeline 9

Next Steps 10

Appendix

– Additional Areas Considered in D ichlobenil’s Registration Review 1 1

References:

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

1. EFED Registration Review Problem Formulation for Dichlobenil , dated April 26, 2012

.

2. Dichlobenil. Human Health Assessment Scoping Document in Support of Registration

Review

, dated May 16, 2012

.

3. BEAD Chemical Profile for Registration Review: Dichlobenil , dated February 6, 2012

.

4. Dichlobenil: Review of Human Incidents , dated February 14, 2012

.

5. Dichlobenil. Recommendation for the residue of concern in drinking water , dated March
14, 2012.

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

in the docket EPA

- HQ

- OPP

- 2012

- 0395 at http://www.regulations.gov

.3 OVERVIEW :

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

- HQ

- OPP

- 2012

- 0395 )

. This case includes the following

active ingredients : dichlobenil

. Dichlobenil is a pre

- emergent herbicide registered for use to control grasses and broadleaf weeds in a variety of agricultural and non

- agricultural use sites. Dichlobenil acts by inhibiting cell wall synthesis. This Preliminar y Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about dichlobenil

, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the re view , and providing an anticipated timeline for completing dichlobenil ’s review

.

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

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

environmental non

- profit or interest groups; pesticide manufacturers; agri cultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The PWP begins by listing the anticipated data needs for dichlobenil

. Next, it discusses the statutory and regulatory autho rity for R egistration R eview. Then the document provides

dichlobenil ’s chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix to this

document inclu des identification and discussion of some areas that are considered generally in

R egistration R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS :

The table below summarizes anticipated data needs for dichlobenil . For additional discussion of the anticipated data needs, see the EFED Reg i stration Review Problem Formulation for

Dichlobenil , dated April 26, 2012 and Dichlobenil. Human Health Assessment Scoping Document in Support of Registration Review

, dated May 16 , 2012

.

Anticipated Data Needs for Dichlobenil ’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.1230 Leaching and Adsorption/Desorption 1 BZZ 2 ; BAM 3 12

835. 4 100 Aerobic Soil Metabolism T GAI 24

835.4300 Aerobic Aquatic Metabolism 1 BAM 24

835.6200 Aquatic F ield D issipation 4 TGAI ; BAM 12

850.1075 Fish Acute Toxicity Test (Freshwater) BZZ 12

850.1350 Mysid Chronic Toxicity Test TGAI 12

850.1400 Fish Early Life

- Stage Toxicity Test (Freshwater) TGAI 12

850. 2100 Avian Acute Oral Toxicity Test (Passerine) TGAI 12

850. 2300 Avian Reproduction Test TGAI 24

850. 4150 Terrestrial Plant Toxicity: Tier II Vegetative Vigor TGAI 12

850.4400 Aquatic Plant Growth: Tier II Vascular Plants BZZ 12

8 6 0.1 340 Independent Laboratory Validation for the

A nalytical M ethod for enforcement of tolerances ( ruminant commodities ) TGAI; BAM 12

Special Study Evaluation of Olfactory Toxicity TGAI; BAM 24

870.7800 Immunotoxicity TGAI 12
The study listed below w as previously required through a generic data call

- in (GDCI

- 0 27401

- 16334 ),

issued in March 1987, and is still outstanding . Th is study is listed in this document as background; it

will NOT be included in the anticipated R egistration R eview DCI as it is already required through the

earlier DCI

.

8 6 0. 1520 Processing Study for Grape TEP; BAM Past Due
TGAI = technical grade active ingredient; TEP = typical end

- use product

1 A study for BAM has been submitted and is undergoing review. A new study may be needed depending on the

outcome of the review.

2 A dichlobenil aquatic degradate 4

- chloro

- 2(3H) benzoxazolone (BZZ).

3 The common metabolite/degradate of dichlobenil and the fungicide fluopicolide, 2,6

- dichlorobenzamide (BAM).

4 Only the analytical detection method is needed. An acceptable method (MRID 45321801) has been received and reviewed by the Agency. However, an independent laboratory validation of the method is expected to be needed before this requirement can be considered satisfied.5 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 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 sure that, as the ability

t o 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 pract ices 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 opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. After reviewing an d 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 dichlobenil

.

D ICHLOBENIL CHEMICAL FACTS :

PC code 027401

Case Number 0263

CAS Number 1194

- 65

- 6

Year first registered 1964 Pesticide Type Herbicide

Chemical class Benzonitrile

R eregistration Eligibility Decision (R E D) October 1998

Cumulative group None

40 CFR Citation Tolerances for dichlobenil are established in 40 CFR § 180.231

. Dual

- use Conventional pesticidal uses only.

Pesticide Re

- evaluation Division, Chemical Review Manager Eric Miederhoff; miederhoff.eric@epa.gov ; (703) 347

- 8028

Registration Division

, Product Manager Kable Davis ; davis.kable@epa.go v ; (703) 306

- 0415

5 http://www.epa.gov/oppsrrd1/registration_review/6 USE AND USAGE INFORMATION :

Please see the BEAD Chemical Profile for Registration Review: Dichlobenil , dated February 6,

2012 in the registration review docket for more details

.

Summary of Use Dichlobenil is a pre

- eme rgent herbicide registered to control grasses and broadleaf weeds in a variety of agricultural and non

agricultural use sites. Dichlobenil acts by inhibiting cell wall synthesis.

Use Sites Agricultural use sites include: apples, grapes, cherries, caneberries, blueberries, pears, plant nurseries, shelterbelts, nut trees, and other crops such as filberts, huckleberries, laurel, rhubarb, and

strawberries.

Non

- a gricultural use sites include: In and around ornamental plantings, drain lines, drains, irrigation supply systems, sewage system, waste water systems, sewer lines, cesspools, storm sewers,

non

- crop areas, military installations, buildings, roadways, rights

of

- way, roadsides, rail yards, industrial sites, asphalt paving, parking lots, walks, dri veways, parking areas, pre

- paving treatment, sidewalks, paved areas, fencerows, and vinyl swimming pool liners. Summary of Usage Limited data are available for dichlobenil’s use on specific crops. The Agency estimates that annual agricultural usage avera ged 5,000 pounds of active ingredient (A.I.) treating an average of 2,000 acres for the years 2001

- 2010.

Non

- agricultural usage of dichlobenil appears to be greater than agricultural usage. M ajor non

- agricultural uses include turf ( 2006

national use data ; 9,881 pounds ) , rights of way (data for CA only ; 9,500 pounds) , sewage systems ( 2008

- 2010 data for CA only ; 8,400 pounds), and nurseries/greenhouses ( 2006 national use data; 4,024 pounds)

. Formulation Type(s) Dichlobenil is formulated as microencapsula ted, wettable powder, granular, water soluble packages, and soluble concentrate

. Application Method(s) Products can be applied by aerosol can s , handheld sprayers, foggers, and mechanical sprayers. Technical Registrant (s) Chemtura Corporation and PBI Gordon Corporation No. of Registrations 19 Section 3 products 6 and 1 Section 24(c) product

Restricted Use No

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

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).7 **•** C ertain dichlobenil labels are unclear with respect to the parameters for residential applications to recreational areas : In the absence of clear label information, EPA expects

to approximate these pa rameters in order to conduct a quantitative residential risk

assessment for dichl o benil . The Agency will work with registrants to clarify the

dichlobenil product labels

.

**•** Dichlobenil labels are required to have language restricting dichlobenil use in confined or

enclosed areas. Certain dichlobenil labels need to be amended to include these restrictions. The Agency will work with registrants to amend the relevant dichlobenil product labels appropriately.

**•** C onfirmation 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 ; geographic limitations on use

.

**•** U se distribution ( e.g. , acre age and geographical distribution of relevant use sites )

.

**•** M edian and 90 th percentile reported use rates (lbs ai/ 1000 sq ft ) from usage data

– national, state, and county

.

**•** 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 local use restrictions

.

**•** F oreign technical registrants not listed above who supply technical dichlobenil to the U

. S

. market

.

RECENT ACTIONS :

There are no recent actions for dichlobenil.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW :

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

2008 for a n amendment to registration to add new uses

. T he mos t recent ecological and environmental fate risk assessment was completed in 2008 f or the same purpos e . Findings and

conclusions from these risk assessments are summarized in the EFED Registration Review Problem Formulation for Dichlobenil , dated April 26, 2012 and Dichlobenil. Human Health Assessment Scoping Document in Support of Registration Review

, dated May 16, 2012

.

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

dichlobenil

. The Agency has limited data on the dichlobenil aquatic degradate 4

- chloro

- 2(3H) benzoxazolone (BZZ) and expect s to require ecotoxicity and environmental fate studies to determine the toxicity of BZZ to aquatic organisms. If BZZ is found to have equal or greater toxicity to these organisms than dichlobenil, it will be considered explicitly in the ecological risk

assessment.8 Additionally, t he Agency is expects to requ ire data on the ecotoxicity and environmental fate properties of the common metabolite/degradate of dichlobenil and the fungicide fluopicolide,
2,6

- dichlorobenzamide (BAM). These data will be used in assessing BAM in the anticipated ecological risk assess ment. The registration review docket for fluopicolide is scheduled to open in early 2013.

For human health, EPA anticipates the need to conduct revised dietary, residential

, and occupational risk assessment s during registration review

. BZZ has been identified as a major degradate of dichlobenil in water and should be considered as a residue of concern in drinking water. Therefore, the Agency plans to conduct an updated drinking water assessment to account for the combined exposure from parent dichlo benil and BZZ (using a total toxic residue approach)

. Further, the major metabolite of dichlobenil, BAM, will also be considered, but will be evaluated separately because: (1) its toxicity profile is unlike dichlobenil’s, and (2) to

consider residues resu lting from uses of both dichlobenil and fluopicolide. U pdated aggregate dietary assessment s for dichlobenil and BAM may be needed if the updated drinking water

assessment s result in higher estimated drinking water concentrations (EDWCs)

.

I f toxicologi cal endpoints, points of departure and/or FQPA safety factors are revised (for dichlobenil and/or BAM) based on the data that are anticipated to be required for registration review, they will be considered in the new assessments . In addition, any signific ant changes to

the standard operating p rocedures or default exposure assumptions will be considered

.

The table below summarizes the anticipated registration review risk assessments based on the

E FED Problem Formulation, HED Scoping Document and the Dichlobenil. Recommendation for the Residue of Concern in Drinking Water , dated March 14, 2012

.

Anticipated Risk Assessments for Dichlobenil’s Registration Review

Type of Risk Assessment Incl ude? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Yes

Human Health Dietary

Food Yes

Drinking water Yes

Occupational

Handlers (mixers, loaders, applicators) Yes

Post

- application Yes9 Anticipated Risk Assessments for Dichlobenil’s Registration Review

Type of Risk Assessment Include? Notes

Residential

Handlers Yes

Post

- application No Residential post

- application exposure to dichlobenil is not anticipated. However, label clarification of

dichlobenil use in recreational areas is needed.

Incidental oral No Residential post

- application exposure to dichlobenil is not anticipated. However, label clarification of

dichlobenil use in recreational areas is needed. Companion animal No Not registered for pet uses.

Recreational No Residential post

- application exposure to dichlobenil is not anticipated. However, label clarification of

dichlobenil use in recreational areas is needed.

Other Aggregate Yes E valuates the combined risk from dietary and residential exposures.

Cumulative No Dichlobenil, BZZ, and BAM are not assumed to have a common mechanism of toxicity with other substances.

Tolerances Yes The tolerances for dichlobenil will be modified during registration review.

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 dichlobenil’s registration

review

.

Registration Review for Dichlobenil

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and Public Comment Period 2012

– June

Close Public Comment 2012

– August Case Development

Final Work Plan 2012

– November

Issue DCI 2013

– July

– Sept.

Data Submission 2015

– July

– Sept.10 Registration Review for Dichlobenil

– Projected Registration Review Timeline

Activities Estimated Date Open Public Comment Period for Draft Risk Assessments 2017

– Jan.

– March

Close Public Comment Period 2017

– April

– June Registration Review Decision Open Public Comment Period for Proposed Registration Review

D ecision 2017

– July

– Sept.

Close Public C omment P eriod 2017

– Oct.

– Dec. Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 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 dichlobenil

.11 

### Appendix

– Additional Areas Considered in Dichlobenil ’s 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.

Water Quality:

Dichlobenil is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 7

. In addition, n o Total Maximum Daily Load s (TMDL) have been developed for dichlobenil 8 . More information on impaired water bodies and

TMDLs can be found at the Agency’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.

Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Pro cess 11 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, c olor, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the

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

8 http://iaspub.ep a.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

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

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

11 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12 p opulation who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to dichlobenil 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.

ENDANGERED SPECIES :

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

conducted for dichlobenil

. The ecological risk assessment planned during registrat ion review will allow the Agency to determine whether dichlobenil ’s use has “no effect” or “may 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 hab itat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network

North America filed a lawsuit 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 Fi sheries Service regarding the effects of over 350 pesticides, including dichlobenil , on over 200 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 D ISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments o f 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, est rus 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 di fferent taxonomic groups. As part of its most recent registration decision for dichlobenil

, 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), dichlobenil is subject to the endocrine screening part of the Endocri ne Disruptor 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

che mical 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 o f the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 213 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and

establish a dose

- response relationsh ip between the dose and the E, A, or T effect.

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

- ins for the first group of 67 chemicals,

which contains 58 pesticide active ingredients and 9 inert ingredients. Dichlobenil was included on that list and has been issued an order to conduct the Tier 1 testing. Once all required Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety fa ctors used for risk assessment purposes will be examined and a new risk assessment performed if necessary. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website 12

.

HUMAN STUDIES :

Occupationa l and Residentia l

Past dichlobenil 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 gen eric pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database , and the Outdoor Residential Exposure Task Force (ORETF) Database

. EPA has reviewed all the studies supporting t hese 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 resea rch 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

.

12 http://www.epa.gov/endo/