2

I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of acibenzolar

- S

- methyl (hereafter, ref erred to as acibenzolar) . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the acibenzolar registration review docket (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 suppressio n of downy mildew, black rot, white rust, bacterial leaf spot 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.

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 F IFRA standard for registration. Changes in science, public policy, and pesticide use practices occur over time. 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 statutory standard. The public phase of registration review begins when the initial docket is opened for each case.
Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any update s since the PWP was issued. Next is a summary of substantive

comments received during the public comment period for the PWP concerning anticipated data
needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration
review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for acibenzolar

. Lastly, there is a discussion of next st eps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on acibenzolar since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Acibenzolar Preliminary Work Plan , which opened on December 20, 2013 and closed on February 18, 2014 , the Agency received six unique public comments. Comments were submitted from non

- governmental organizations, universities, and the acibenzolar registrant, Syngenta . The comments do not address the timeline
described in the PWP, but they do address the planned ecological risk assessment and data requirements. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns , and trade irritants, but no comments or informat ion were received
on those issues.

1 http://www.epa.gov/oppsrrd1/registration_review/3

This section does not capture every comment made about the PWP nor all of the Agency’s

responses. Summarized below are public comments that are of a broad regulatory nature. None of the comments resulted in changes to the anticipated registration review data needs, risk assessments, or timeline. Public comments and EPA responses in their entirety are located in the docket, EPA

- HQ

- OPP

- 2013

- 0755 . Summarized public comments and Agency responses related
to the anticipated ecological risk assessment or data needs are in the Response to Public Comments on the Acibenzolar

- S

- methyl Registration Review Problem Formulation

.

Comment submitted by the University of Hawai‘i in EPA

- HQ

- OPP

- 2013

- 0755

- 0011

.

1. Comment: Acibenzolar is important for golf course turf maintenance in Hawai‘ i, particularly for dollar spot control.

Comment submitted by Syngenta Crop Protection, LLC in EPA

- HQ

- OPP

- 2013

- 0755

- 0012

.

2

. Comment: Corrected label information and additional use information was provided

.

Comment submitted by Washington State University Tri

- Cities in EPA

- HQ

- OPP

- 2013

- 0755

- 0013.

3. Comment: I

nformation about the potential importance of acibenzolar in Integrated Pest Management (IPM) programs was provided for cra nberry, and for lettuce, pepper, spinach, and tomato when used in conjunction with fungicides.

Comment submitted by the FIFRA Endangered Species Task Force (FESTF) in EPA

- HQ

OPP

- 2013

- 0755

- 0014

.

4

. Comment: FESTF noted that registrants that are not currently members must offer to pay or develop their own data

. However, Syngenta is a member of FESTF.

Comment submitted by the Arizona Pest Management Center in EPA

- HQ

- OPP

- 2013

- 0755

- 0015

.

5

. Comment: A cibenz olar is an effective product against downy mildew. In Arizona, it is primarily used in spinach, but is also being used in chili.

Response to comments 1

- 5 : The Agency appreciates the information provided and will take it into consideration during the registration review of acibenzolar.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for acibenzolar based on the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Acibenzolar

- S

- methyl;4

Acibenzolar

- S

- methyl: Human Health Risk Scoping Document in Support of Registration Review; and Response to Public Comments on the Acibenzolar

- S

- methyl Registration Review
Problem Formulation

. The planned data needs have not changed from what was included in the
PWP. However, the guideline number for the larval honeybee acute oral toxicity study was listed incorrectly in the PWP as 850.3020 and the estimated timeframe was listed in the PWP as
1 2 months. The FWP has been corrected to reflect the correct information.

Table 1: Anticipated Data Needs for the Acibenzolar Registration Review

Guideline
Number 2 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

Non

GDLN Larval honeybee acute oral toxicity TGAI 24

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 3

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

2 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

3 The studies listed in this section were prev iously submitted 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

.5

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of acibenzolar

. For human health, EPA may conduct revised dietar y, residential, and occupational risk assessments during registration review. If toxicological endpoints or points of departure are revised, they will be considered in any updated assessments, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

Table 2 below summarizes the planned registration review risk assessments based on the EFED
Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.6

Table 2 : Planned 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 cha nges to the estimated drinking water concentrations (EDWCs) may also necessitate changes to the dietary assessment

. Occupational Handlers (mixers, loaders, 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 N
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

.7

TIMELINE

EPA has create d the following estimated timeline for the completion of the acibenzolar registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Acibenzolar

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period December 2013

– Completed
Close Public Comment February 2014

– Completed Case Development
Final Work Plan May 2014

– Completed

Issue DCI 2014 July

– Sept.
Data Submission 2016 July

– Sept.

60

- day Public Comment Period for Draft Risk Assessments 4 2018 Jan.

- March 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

4 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 60 calendar day public comment period generally for draft risk assessments.

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate and ecological
effe ct s studies for acibenzolar through a D ata C all

- I n Notice , expected to be issued in September
2014

.

4 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.