Docket Number EPA-HQ-OPP-2014-0199 

wwv.r.regul ations.gov 

Boscalid Final Work Plan 

Registration Review 

Case Number 7039 

June 2015 

Approved by: ~,(Lh~p ~:JD 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: 
INTRODUCTION 

This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of boscalid. This work plan addresses public comments received 

concerning the Pre liminary Work Plan (PWP), which was posted in the bosca lid registration 

review docket (EPA-HQ-OPP-2014-0199). Boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-

c hloro[ I, 1'-biphenyl)-2-yl), is a carboxamide fungicide registered for the control of several 

economically important diseases, including gray mold on several crops, white mold on potato 

and beans, and lettuce drop. It is registered on numerous agricultural and orchard crops, and as a 

seed treatment. It is also registered for use on golf course turf, gardens, residential fruit and nut 

trees, ornamentals, including shrubs and bushes, and on tomato plants meant to be transplanted 

into home gardens. 

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 detern1ine whether it continues to meet the FTFRA 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. 

Information on this program is provided on the Agency's website. 1 

The FWP begins with any updates 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 time line identified in the PWP, and a 

summary of the Agency's responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected 

registration review timeline for boscalid. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on boscalid since the PWP (November 20 14). 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period on the boscalid PWP, which opened 

on December 19, 2014 and closed on February 17, 20 15, the Agency received public comments 

from six stakeholders. Comments were submitted by the Northwest Horticultural Council, 

FIFRA Endangered Species Task Force, BASF Corporation, National Alfalfa and Forage 

Alliance, Center for Biological Diversity, and Almond Board of California. The comments do 

not address the time li nc described in the PWP, but they do address the pl anned ecological and 

human health risk assessments and data requirements. Consideration of these comments did not 

result in any changes to the data the Agency anticipates requiring for the boscalid registration 

review. The Agency will however consider waiver requests submitted in response to the DCI. 

In the PWP, EPA also solicited comments on the specific topics of environmental justice, water 

1 hllp://www.cpa.gov/oppsrrd 1/rcgistrat ion_rcvicw/ 

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quality concerns, and trade irritants, but no comments or information were received on those 

ISSUeS. 

Summari zed below are signifi cant public comments that do not result in changes to the 

anticipated registration review data needs, risk assessments, or timeli ne. They are of a broader 

regulatory nature. Public comments in their entirety are located in the docket, EPA-HQ-OPP20 14-0199. 

Comments submitted by Northwest Horticultural Council in EPA-HQ-OPP-2014-0199-

0015 

I. Comment: The Northwest Horticultural Council commented on the importance of boscalid 

in the deciduous tree fruit indust1y in the Northwest and also provided information on usage and 

resistance development. 

Response: The Agency thanks the Northwest Horticultural Council for its comment and will 

take this infonnation into consideration. 

Comments submitted by FIFRA Endangered Species Task Force (FESTF) in EPA-HQOPP-2014-0199-001 .1 

2. Comment: FESTF submilled a comment informing the Agency that the technical registrant 

ofboscalid is a member of the FESTF (or a company having met its data compensation 

obligations) and is entitled to rely on FESTF data. 

Response: The Agency thanks FESTF for its comment and looks forward to reviewing the 

FESTF data in the context of the endangered species assessment for boscalid. 

Comments submitted by BASF Corporation in EPA-HQ-OPP-2014-0199-0012 

3. Comment: BASF Corporation indicated that it intends to request waiversfor some of the 

data EPA plans to call-in for the registration review ofboscalid. BASF also suggests alternative 

approaches to developing some of the data the Agency has indicated it imends to require. 

Response: EPA will consider the waiver requests when BASF responds to the boscalid 

registration review DCI and provides a detailed justification for each data requirement the 

company wishes to have waived. Likewise, EPA will take the alternative proposal for 

developing certain data into consideration at that time. 

Comments submitted by National Alfalfa and Forage Alliance in EJ> A-HQ-OPP-2014-0199-

0013 

4. Commenr: The National Alfalfa and Forage Alliance commented on the importance of 

boscalid in managing white mold and spring black stem and leaf spot in alfalfa seed and hay 

product ion areas. 

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Response: EPA thanks the National Alfalfa and Forage Alliance for its comment and will 

take this information into consideration. 

Comments submitted by the Center for Biological Diversity (CBD) in EPA-HQ-OPP-2014-

0199-0010 

5. Comment: The CBD commentsfocus on the EPA 's duty under the Endangered Species Act 

(ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries 

Service (the Servkes) on the registration revie·w of boscalid. Habitat data, including life histo1y 

and spatial distribution, are provided for several listed species. 

Response: EPA plans to address many of the concerns raised by CBD as part of the 

implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations of the April 2013 National Academy of Sciences (NAS) report, available 

at http://www.nap.edu/catalog.php?record_id= 18344. EPA will address concerns specific to 

boscalid in connection with the development of its registration review decision for boscalid. 

The NAS report outlines recommendations on specific scientific and technical issues related 

to the development of pesticide risk assessments that EPA and the Services must conduct in 

connection with their obligations under the ESA and FIFRA. At this time, EPA has not fu lly 

developed its risk assessment process for listed species. In November 2013, the EPA, along 

with the Services and the U.S. Department of Agriculture, released a summary of their joint 

Interim Approaches for assessing risks to listed species from pesticides (see the white paper 

"Interim Approaches for National-Level Pesticide Endangered Species Act Assessments 

Based on the Recommendations of the National Academy of Sciences April 2013 Report," 

available at http://www.epa.gov/espp/20 13/nas.html). The Interim Approaches were 

developed by the Agencies in response to the NAS recommendations, and reflect a common 

approach to risk assessment shared by the Agencies as a way of addressing scientific 

differences between the EPA and the Services. 

The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 20 13. In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee and State-FIFRA Issues Research 

and Evaluation Group meetings, allowing additional opportunities for stakeholders to 

comment. As part of a phased, iterative process for further development of the Interim 

Approaches, the Agencies will also consider public comments on the Interim Approaches in 

the context of upcoming registration review decisions. 

Comments submitted by Almond Board of California in EPA-HQ-OPP-2014-0199-0014 

6. Comment: The Almond Board of California addressed the importance ofboscalid in almond 

production and the need for continued stakeholder involvement in the registration review 

process. 

Response: The Agency thanks the Almond Board of California for its comment and will 

take this information into consideration. 

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PLANNED DATA NEEDS 

Table I below summarizes the planned data needs for boscalid based on the Registration Review: 

Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and 

Human Health Drinking Water Exposure Assessments for Boscalid; and Boscalid. Human Health 

Assessment Scoping Document in Support of Registration Review. The planned data needs have 

not changed from what was included in the PWP. 

Table 1: Planned Data Needs for the Boscalid Registration Review 

Estimated 

Guideline Study Title1 

Timeframe 

Number• Test Material (Months from 

receipt of DC I) 

Planned Data Needs for Boscalid 

835.4100 Aerobic soil metabolism TGAI 24 

835.4400 Anaerobic aquatic metabolism TGAI 24 

Acute toxicity freshwater invertebrates -

850.1010 daphnids (with boscalid alone and representati ve TGAI, TEP2 24 

end-use products) 

850. 1035 Acute toxicity estuarine and marine organisms TGAI 12 

(mysid) 

850.1350 Aquatic invertebrate life cycle (sa ltwater) TGAI 12 

850.1400 Fish early-life (estuarine/marine) TGAI 12 

850.1500 Fish life cyc le (freshwater) TGJ\1 24 

850.4150 Vegetative vigor (cabbage only) TEP 12 

Environmental Chemistry Methods and 

850.6 100 Independent Laboratory validation for water, TGA I 12 

sediment, and soil for analysis ofboscalid 

Non- Chronic sediment toxicity with Chironomus 

GDLN dilutus, Hyalella azteca, and Leptocheirus TGAI 24 

plumulosus 

870.3465 90-Day inhalation TGA I 24 

fGAI = techmcal grade acuvc mgredrcrll. TEP = typrcal end-usc product 

1 On June 27.2012. EPA announced certain revisions in harmonized guideline series 850- Ecological EITccls Tests - including renumbering and 

other designations or changes for some guideline studies. Sec "Final Test Guide lines; OCSPP 850 Series: Notice of Availability" 77 FR 

38282. June 27, 2012. hllp://1\ 11 rc~ulations.gov #ldocu cn tD~taii I'A· II O-OPPT 2009-0 154-0028 

2 Testing with the TEPs is needed for the boscalid products thai arc formulated with other active ingredients. i.e .• boscalid+pyrac lostrobin. 

boscalid+pyraclostrobin+lamhda cyhalothrin, and boscalid+chlorothalonil. 

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RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent aggregate risk assessment was completed by BED on September 30, 2014 

(0416695). The most recent dietary assessment that was included in that aggregate risk 

assessment was completed on July 16, 2014 (042 1151). Residential and occupational handler 

and post-application risk assessments were conducted around the same time. The most recent 

ecological and environmental fate risk assessment was completed in 2003 (USEPA, 2003, 

0278387). Findings and conclusions from these risk assessments are summarized in 

Regisrrarion Review: Preliminmy Problem Formularionfor Environmental Fare, Ecological 

Risk, Endangered Species, and Human Heal1h Drinking Water Exposure Assessments for 

Boscalid and Boscalicl. Human Health Assessment Scoping Documenl in Supporr of Regis/ration 

Review, which can be found in the docket for registration review. 

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of boscalid. The Agency intends to 

consider the need for bystander drift and volatilization human health risk assessments. In 

addition, if toxicological endpoints or points of departure are revised based on the data that are 

required for registration review, they will be considered in the new assessments, as well as any 

changes to the standard operating procedures or default exposure assumptions. 

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Table 2 below summarizes the planned registration review risk assessments. The planned 

assessments have not changed from what was included in the PWP. 

Ta ble 2: Planned Risk Assessments for the Boscalid Registt·ation Review 

Type of Risk Assessment Conduct? Notes 

E cological and Environmental Fate 

Comprehensive ecological y The Agency will conduct a comprehensive ecological 

(species to be assessed risk assessment for the parent boscalid, including an 

include terrestrial and aquatic endangered species assessment. 

organisms), including 

endangered species 

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

updates boscalid, see page 21 of the Problem Formulation. 

Human Health ~ 

Dietary 

Food N 

Drinking water N 

Occupational 

llandlers (mixers, loaders, N 

applicators) 

Post-application N 

Residential 

Handlers N 

Post-application y During registration revievv, the Agency intends to 

consider the need for bystander drift and volatili zation 

risk assessments. 

Other 

Aggregate N Evaluates the combined risk from dietary and 

residential exposures. 

Cumulative N 

Tolerances N 

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

updates boscalid, see pages 11 - 12 of the Seeping Document 

and the Boscalid: Tier I Review of Human Incidents 

report. 

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TIMELINE 

EPA has created the following estimated timeline for the completion of the boscalid registration 

review in Table 3 below. The projected timeline has not changed since the PWP. 

Table 3: Registration Review for Boscalid -Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period December 2014 -

Completed 

Close Public Comment February 20 15 -

Completed 

Case Development 

Final Work Plan June 2015-

Completed 

Issue DCI July - September 

2015 

Data Submission July - September 

2017 

60-day Public Comment Period for Draft Risk Assessments2 January- March 

20 19 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review October - December 

Decision 2019 

Registration Review Decision and Begin Post-Decision Follow-up 2020 

Total (years) 6 

NEXT STEPS 

As noted previously, the Agency plans to require several environmental fate, ecological effects, 

and human health studies for boscalid through a Data Call-In Notice, expected to be issued in 

July - September 20 15. 

2 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; sec 40 CFR Pan 155.5J(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public 

comment period generally for draft risk assessments. 

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