2 INTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of furfural . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the furfural registration review docket (EPA

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- 0764 ). Furfural is primarily a nematicide that has contact activity, as well as a fungicide that can be used against soil

- borne fungal pathogens

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. 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 p olicies 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 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 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 furfural

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on furfural since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the furfural Preliminary Work Plan , which opened on June 24, 2015 and closed on August 24, 2015 the Agency received one public comment . The

comment was submitted by the Center for Biological Diversity (CBD) . The comments do not

address the timeline described in the P WP, but they do address the planned ecological and human health risk assessments 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

o r information were received on those issues.

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

responses. Summarized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are located in the docket, EPA

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1 http://www2.epa.gov/pesticide

- reevaluation

.3 Comments submitted by Center for Biological Dive rsity (CBD) in EPA

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Comment : CBD’s comments focus on the EPA’s independent duty under the Endangered Species Act (ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on th e registration review of furfural.

Response : EPA has reviewed the comments from CBD on the registration review docket opening

for furfural and 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. EPA will address c oncerns specific to furfural in connection with the development of its final registration review decision for furfural

. In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing ris ks to endangered and threatened (listed) species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (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 NAS report 2 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.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15,

2013. In addition, the EPA presented the joint Interim Approaches at the D ecember 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April and October 2014, allowing additional opportunities for stakeholders to c omment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments

Based on the R ecommendations of the National Academy of Sciences April 2013 Report” 3 , dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting th is Final Work Plan for furfural does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem

formulation doc ument for furfural , EPA described the screening

- level risk assessment to determine the potential effects of furfural on all taxa of non

- target wildlife and plants, which will assume that listed species and their designated critical habitats may be presen t in the vicinity of the application of

furfural

. This screening

- level assessment will allow EPA to focus its future evaluations on the types

2 http://www.nap.edu/catalog.php?record_id=18344

3 http://www2.epa.gov/endangered

- species/interim

- approaches

- pesticide

- endangered

- species

- act

- assessments

- based

nas

- report

.4 of species where the potential for effects exists once the scientific methods being developed by the agencies ha ve been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

- level risk assessment for the registration review of furfural will describe the level of ESA analysis completed for this particular registr ation review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for furfural as part of completing this registration review.5 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for furfural based on the Problem Formulation for Registration Review of Furfural and Furfural. Human Health Scoping Document in Support of Registration

Review

. The planned data needs have changed from what was included in the PWP

. The guideline studies 850.2100 avian acute oral toxicity and 850.2200 avian sub

- acute dietary toxicity were erroneously included in the PWP and have now been removed.

Table 1: Planned D ata Needs for the F urfural Registration Review

Guideline

Number 4 Study Title 4 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic Aquatic Metabolism 5 TGAI 24

850.1035 Estuarine/Marine Acute Toxicity

- Shrimp TGAI 12

Non

guideline Laboratory Investigation of Subsurface Degradation Study 5 TGAI 24

Non

guideline Vegetative Vigor Vapor

- Phase Toxicity Study TEP 12

Non

guideline Laboratory Investigation acute vapor phase toxicity study with the honey bee TGAI 24

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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 furfural

. For human health, EPA will

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 required for registration review

, they will be considered in the new assessment s , as well as any changes to the standard operating procedures or default exposure assumpti ons.

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

.

4 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 Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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5 The study must track the transformation products f urfuryl alcohol and 2

- furoic acid

.6 Table 2: Planned Risk Assessments for the F urfural Registration Review

Type of Risk Assessment Conduct ? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Yes The stressors of concern are furfural and furfural’s major degradates. A total toxic residues (TTR) approach will be used for the ecological risk assessment.

Incidents Will check for updates See page 18 of the Problem Formulation. The Agency’s databases do not show any reported ecological incidents

for furfural.

Human Health Dietary

Food No Not needed for the currently registered uses of furfural. Drinking water Yes An updated drinking water risk assessment will be

necessary to reflect changes to the acute dietary endpoint and point of departure (POD), the cancer re

classification, and possible revisions of the estimated drinking water concentrations (EDWCs). The

assessments will use the newest version of DEEM and reflect up dated consumption information. Occupational Handlers (mixers, loaders, applicators) Yes Although no occupational risks of concern were identified in previous risk assessments, updated occupational exposure and risk assessments are likely to be necessary given the cancer re

- classification.

Post

- application Yes An updated occupational post

- a pplication risk assessments is likely to be necessary given the cancer re

classification.

Residential

Handlers No Furfural is not registered for residential uses.

Post

- application Yes Although no residential risks of concern were identified

in previous risk assessments, updated residential bystander risk estimates resulting from off

- site transport (i.e., volatilization) associated with occupational applications are likely to be necessary given the cancer

re

- classification and any changes to unce rtainty factors.

Other Aggregate No While a common effect has been identified in oral and dermal toxicity studies, post

- application dermal exposure to furfural residues is expected to be negligible. The inhalation endpoint is based on portal of entry eff ects that are not appropriate to aggregate with the dietary exposure.7 Cumulative No EPA has not made a common mechanism of toxicity finding as to furfural and any other substances and furfural does not appear to produce a toxic metabolite produced by other substances.

Tolerances No Furfural is not registered for food uses in the U.S. and

no tolerances have been established. There are no Codex Alimentarius Commission (Codex) or Canadian maximum residue limits (MRLs) for furfural. As a result, there a re no harmonization issues at the present

time.

Incidents Will check for updates See page 9 of the Scoping Document and Furfural: Tier I Review of Human Incidents. The Agency’s databases do not show any reported human incidents for furfural.

TIMELINE

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

review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for F urfural

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period June 2015

– Completed

Close Public Comment August 2015

– Completed Case Development

Final Work Plan November 2015

– Completed
Issue DCI Jan uary

- March 2016

Data Submission Jan uary

– March 2018

6 0

- day Public Comment Period for Draft Risk Assessments 6 J uly

- September 2019 Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision April

- June 2020

Registration Review Decision and Begin Post

- Decision Follow

- up 2021 Total (years) 6

NEXT STEPS

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

studies for furfural through a D ata C all

- I n Notice , expected to be issued in January

- March of 2016.

6 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 pesti cides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.