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INTRODUCTION

This is the Environmental 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 (EPAHQ-OPP-2014-0764). 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 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.

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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 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 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 PWP, 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 

or 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-HQ-OPP2014-0764. 

 1 http://www2.epa.gov/pesticide-reevaluation.
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Comments submitted by Center for Biological Diversity (CBD) in EPA-HQ-OPP-2014-0764-

0007.

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 the 

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 concerns 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 risks 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 December 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 comment 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 Recommendations 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 this 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 document 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 present 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-basednas-report.
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of species where the potential for effects exists once the scientific methods being developed by the 

agencies have 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 registration 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.
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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 Data Needs for the Furfural Registration Review

Guideline 

Number4 Study Title4

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4300 Aerobic Aquatic Metabolism5 TGAI 24

850.1035 Estuarine/Marine Acute Toxicity-Shrimp TGAI 12

NonguidelineLaboratory Investigation of Subsurface 

Degradation Study5 TGAI 24

Nonguideline Vegetative Vigor Vapor-Phase Toxicity Study TEP 12

NonguidelineLaboratory 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, the 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 assessments 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 assessments, as well as any changes to the

standard operating procedures 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.

 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-HQ-OPPT-2009-0154-0028 5 The study must track the transformation products furfuryl alcohol and 2-furoic acid.
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Table 2: Planned Risk Assessments for the Furfural 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 reclassification, and possible revisions of the estimated 

drinking water concentrations (EDWCs). The 

assessments will use the newest version of DEEM and 

reflect updated 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-application risk 

assessments is likely to be necessary given the cancer reclassification. 

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 uncertainty 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 effects that are not appropriate to aggregate with 

the dietary exposure. 
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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 are 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 Furfural – 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 January - March 2016

Data Submission January – March 2018

60-day Public Comment Period for Draft Risk Assessments6 July- 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 Data Call-In 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 pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.