2 

### Acibenzolar S

- methyl Preliminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

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

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

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

TIMELINE

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

NEXT STEPS

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

Appendix

– Additional Areas Considered in the Acibenzolar

- S

- methyl Registration Review 12

References:

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

1. Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the Registration Review of
Acibenzolar

- S

- methyl. Lowit, M. and Wente, S. December 5, 2013.

2. Acibenzolar

- S

- methyl: Human Health Risk Scoping Document in S upport of Registration

Review

. Morton, T., Miller, J.S., and Khasawinah, A. October 23, 2013.

3. Acibenzolar : Tier I Review of Human Incidents

. Recore, S. and E. Evans. August 20,

2013

.

4. BEAD Chemical Profile (BCP) for Registration Review: Acibenzolar

- S

- methyl (061402 )

. Chen, C., Alsadek, J., and Ranville, M. August 12, 2013.

5. Acibenzolar (061402) Screening Level Usage Analysis (SLUA). December 6, 2012.3 6. Acibenzolar

- S

- methyl EFED Label Data Report

. July 11, 2013.

7. Acibenzolar

- S

- methyl HED Master Label Report

. July 11, 2013.

These and other supporting documents for the acibenzolar

- S

- methyl registration review case may be found in the docket EPA

- HQ

- OPP

- 2013

- 0755 at http://www.regulations.gov

.4 OVERVIEW

The docket for acibenzolar

- S

- methyl (hereafter, referred to as acibenzolar) is now open

, initiating the first public comment period for this registration review (docket number EPA

- HQ

OPP

- 2013

- 0755 )

. Acibenzolar is registered for use to protect plant s against invading pathogen s by induc ing a natural defense reaction that enhances the plants ability to ward off disease. It is registered for use on a number of leafy and fruiting v egetables crops and tobacco for the control or suppression of downy mildew, black rot, white rust, bacterial leaf sp ot and speck, and blue

mold. Acibenzolar is also registered for use in commercial seed treatment operations for protection against certain early season seed and seed

- borne nematodes in cotton and sunflower.

It is also used on sod farms, golf courses, professional and collegiate athletic fields, and lawns around commercial and industrial buildings to control turf diseases. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about acibenzolar

, highlighting an ticipated 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 acibenzolar

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

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information t hat 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 informa tion. Interested stakeholders could include:

environmental non

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

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

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

. Finally, the Appendix

to this document includes identification and discussion of some areas that are considered generally in R egistration R eview along with som e additional chemical case

- specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for acibenzolar . For additional discussion of the anticipated data needs, see the Registration Review: Preliminary Problem Formulat ion for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Acibenzolar

- S

- methyl and Acibenzolar

- S

- methyl: Human Health Risk Scoping

Document in S upport of Registration Review

.

Table 1: Anticipated Data Needs for the Acibenzolar Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Acibenzolar

850.4100 Seedling emergence (Tier II) ; wheat and tomato TEP 12

850.4400 Aquatic plant growth toxicity (Tier II) TGAI 12

850.3020 Larval honeybee acute oral toxicity TGAI 12

850.6100 Environmental chemistry methods and associated independent laboratory v alidation s for water TGAI 12

Anticipated Data Needs for the CGA

- 210007 Degradate

850. 2300 Avian reproduction test (bobwhite quail) CGA

- 210007 24

850.6100 Environmental chemistry methods and associated independent laboratory v alidation s for water CGA

- 210007 12

Outstanding Data Requirements from Conditional Registration 2

850.6100 Environmental chemistry methods and associated independent laboratory v alidation s for soil CGA

- 210007 In review

850.5400 Aquatic plant growth (freshwater diatom, saltwater diatom, cyanobacteria ) TGAI In review

850.2100 Avian acute oral toxicity (passerine) TGAI In review
TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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 studies listed in this section were previo usly required as conditions of registration in April 2013 and are still

outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required as conditions of registration

.6 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 o r 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 evolves and as policies and practices change, all registered pesticides continue to

meet the statutor y 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

. 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 pest icide 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 d evelop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of acibenzolar.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for acibenzolar

.

Table 2: Chemical Facts for Acibenzolar

PC code 061402

Case Number 7031

CAS Number 135158

- 54

- 2

Year first registered 2000 Pesticide Type Host p lant resistance activator

Chemical class B enzothiadiazole

R eregistration Eligibility Decision (R E D) Acibenzolar was not subject to reregistration since it was registered

after 1984.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

.

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

.

3 http://www.epa.gov/oppsrr d1/registration_review/7 Table 2: Chemical Facts for Acibenzolar

40 CFR Citation Tolerances for acibenzolar are established in §180.561(a)

. Dual

- use Acibenzolar is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticide uses.
Non

- pesticidal uses There are no identified non

- pesticidal uses of acibenzolar.

Pesticide Re

- evaluation Division, Chemical Review Manager Dana L. Friedman, friedman.dana@epa.gov , 703

- 347

- 8827

Registration Division

, Product Manager Tony Kish, kish.tony@epa.gov , 703

- 308

- 9443

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for acibenzolar

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Acibenzolar

- S

- methyl ( 061402 ) in the registration

review docket for more details

.

Table 3 : Acibenzolar Use and Usage Information

Summary of Use Acibenzolar

- S

- methyl belongs to the benzo

- thiadiazole (BTH) chemical group of fungicides which controls or suppresses diseases by inducing the host plant's natural defense responses , and has no direct activity on pathogens.

It is registered for use to con trol or suppress plant diseases such as downy mildew on lettuce, spinach, cucurbits, and cole crops; bacterial diseases caused by Xanthomonas spp. or Pseudomonas syringae on tomatoes, peppers, and cucurbits; blue mold on tobacco; and black root rot, Fusari um wilt, and early season plant

parasitic nematodes on cotton and turf

. Use Sites Agricultural Use Sites Registered for use on brassica vegetables , cotton, cucurbits, fruiting vegetables, leafy vegetables , onion, peppers, chili peppers, low growing berry 13

- 07G , spinach, sunflower, tobacco and tomato.

Non

- agricultural Use Sites Registered for use on commercial/industrial lawns, golf course turf, ornamental lawns and turf, and ornamental sod farm (turf). Summary of Usage Available data shows that from 2000

- 2011, the annual total agricultural usage averaged approximately 1,000 pounds a.i. to treat approximately 48,000 acres for an average application rate of 0.02 lbs. a.i. per acre. This time frame shows an increase in usage from 2000

- 2005, and a decreas e thereafter through 2011. For the more recent

2007

- 2011 timeframe, usage averaged approximately 1,000 pounds active ingredient (a.i.) annually on 53,000 treated acres with an overall application rate of 0.02 lbs. a.i

. per acre. Formulation Type(s) Formu lated as water dispersible granules and flowable concentrates.8 Table 3 : Acibenzolar Use and Usage Information

Application Method(s) Products may be applied as a band treatment, broadcast, chemigation, directed spray, foliar treatment, seed treatment, or soil/media treatment using ground or aerial app lication equipment

. Technical Registrant (s) Syngenta Crop Protection LLC No. of Registrations 4 Section 3 products 4

, 8 Section 24(c) products

Restricted Use No

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

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

.

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

.

• M edian and 90 th percentile reported use rates (lb s 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

- agricultural uses , including pounds a.i. applied, average application rate, regional application, time of application, and number of applications per

year

.

• Typical application interval (days)

.

• S tate or local use restrictions

.

• F oreign technical registrants not li sted above who supply technical acibenzolar to the US

market

.

RECENT ACTIONS

New uses on turf and cotton were added in August 2010

, the low growing berry subgroup was added in April 2012, and the sunflower seed treatment was added in January 2013. An Experimental Use Permit (EUP) was granted in June 2012 for apple, grapefruit, and pear . The EUP approval period and time

- limited tolerances will expire in December 2015.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent human health risk assessment for acibenzolar was completed in April 2012 for a proposed Experimental Use Permit on apples, pears, and grapefruit, as well as for all of the other currently registered uses of acibenzolar

. T he most recent ecological and environmental fate risk assessment was completed June 2012 for the registration of the sunflower seed treatment use

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

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).9 Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Ass essments in Support of the Registration Review of Acibenzolar

- S

- methyl. and

Acibenzolar

- S

- methyl: Human Health Risk Scoping Document in S upport 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

acibenzolar

. For human health, EPA does not anti cipate the need to conduct revised dietary,

residential

, and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure 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 well as any changes to

the standard operating p rocedures or def ault 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 Acibenzolar 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 Acibenzolar

- S

- methyl and the major degradate of

concern, CGA

- 210007

, will be considered the stressors of concern in the ecological risk assessment.

Incidents Will check for updates For a discussion of reported ecological incidents for acibenzolar, see page 15 of the Problem Formulation.

Human Health Dietary

Food N Updated dietary exposure assessments may be conducted if there are any significant changes to the toxicological points

- of

- departure (PODs) or Food Quality Protection Act (FQPA) and other uncertainty factors (UFs).

Drinking water N If any significant changes to the estimated drinking water concentrations (EDWCs) may also necessitate changes to the dietary assessme nt

. Occupational Handlers (m ixer s, loader s, applicators ) N The occupational handler assessment may need to be updated to reflect the most recent occupational handler surrogate exposure data or any significant change in exposure assessment methodology, toxicological PODs, or UFs.

Post

- application N

Residential

Handlers N10 Post

- application Y A quantitative exposure/risk assessment for direct residential application may be necessary during registration review to incorporate any changes to the Agency’s policies regarding off

- site transport.

Other Aggregate Y Emerging policies related to pesticide drift and volatilization assessments may warrant changes to the existing aggregate risk assessment

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

. Tolerances N The current tolerance expression as listed in the 40 CFR§180.561 (a) has been updated to reflect current policy.

Incidents Will check for updates For a discussion of reported human incidents for acibenzolar, see page 6 of the Scoping Document and

the Acibenzolar : Tier I Review of 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 acibenzolar registration review in Table 5 below

.

Table 5: Projected Acibenzolar Registration Review Timeline

Activities Estimated Dat e Opening the Docket
Open Docket and 60

- day Public Comment Period 2013

– December

Close Public Comment 2014

– February
Case Development

Final Work Plan 2014

– May

Issue DCI 2014 July

– Sept.

Data Submission 2016 July

– Sept.

60

- day Public Comment Period for Draft Risk

Assessments 5 2018 Jan.

- March

5 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, the Agency plans to provide a 6 0 calendar day public comment period generally for draft risk assessments.11 Registration Review Decision

60

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

– Sept.

Registration Review Decision and Begin Post

- Decision

Follow

- up 2019

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 acibenzolar

.12 

### Appendix

– Additional Areas Considered in the Acibenzolar Registration

Rev iew

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 resulting from lack of MRLs or disparities between U.S.

tolerances a nd MRLs in key export markets, providing as much specificity as possible regarding

the nature of the concern.

Water Quality:

Acibenzolar is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clea n Water Act

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

. 7 More information on impaired water bodies and

TMDLs can be found at the Agency’s website

. 8 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 Managemen t Process 9 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 ra ce, color, 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 population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to acibenzolar compared to the general population. Please comment if you are aware of any sub

- populations that may have aty pical, unusually high exposure compared to the general population.

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

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

group_name=PESTICIDES

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

9 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm13 ENDANGERED SPECIES :

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

conducted for acibenzolar

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of acibenzolar has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critica l 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 a ppropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include 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 histopathol ogy, 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 rep roductive effects in different taxonomic groups. As part of its most recent registration decision for acibenzolar

, 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), acibenzolar is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide

active and o ther 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 statutor ily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screenin g 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 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. A second list of chemicals identified for EDSP screening was published on June 14, 2 013 10 and includes some pesticides scheduled for registration r eview and chemicals found in water

. For further

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

- HQ

- OPPT

- 2009

- 047 7

- 0074 for the final second list of

chemicals.14 information on the status of the EDSP, the policies and procedures, the list s of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 11

HUMAN STUDIES :

Occupationa l and Residentia l

Past acibenzolar risk assessments rely in part on data from studies in which adult human subjects

w ere intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database , 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 convinc ing 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

.

.

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