2 

### Furfural Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ...................... 3

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

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

ANTICIPATED R ISK ASSESSMENTS FOR REGISTRATION REVIEW

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

TIMELINE

................................ ................................ ................................ ................................ ........................ 9

NEXT STEPS

................................ ................................ ................................ ................................ .................... 9

Appendix

– Additional Areas Considered in the Furfural Registration Review

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

References:

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

1. Problem Formulation for Registration Review of Furfural

. J. Meléndez, G. Rothman, G. Sinclair, May 13, 2015

.

2. Furfural. Human Health Scoping Document in Support of Registration Review. K. O’Rourke, T. Morton, J. Kidwell

. May 20, 2015

.

3. Furfural: Tier I Review of Human Incidents . E. Evans and S. Recore. March 25, 2015

.

4. BEAD Chemical Profile (BCP) for Registration Review: Furfural (043301)

. C. Chen, D. Atwood, M.

Ranville. March 20, 2015

.

These and other supporting documents for the furfural registration review case may be found in the

docket EPA

- HQ

- OPP

- 2014

- 0765 at http://www.regulations.gov

.3 OVERVIEW

The docket for furfural is now open , initiating the first public comment period for this registration

review (docket number EPA

- HQ

- OPP

- 2014

- 0764 )

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

- home fung al pathogens. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows

about furfural , highlighting anticipated 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 furfural

.

The registration review process was designed to include a public participation component to solicit input from interested stakehol ders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about furfural and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on furfural

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that 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

information. Interested stakeholders could include: environmental non

- profit or interest groups; pesticide manufacturers; agri cultural 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 furfural

. Next, it discusses the statutory and r egulatory 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 furfural

. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in R egistration

R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for furfural . For additional discussion of the anticipated data needs, see the Problem Formulation for Registration Review of Furfural and Furfural. Human Health Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the F urfural Registration Review

Guideline

Number 1 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic Aquatic Metabolism 2 TGAI 24

Non

guideline Laboratory Investigation of Subsurface Degradation Study 2 TGAI 24

850.1035 Estuarine/Marine Acute Toxicity

- Shrimp TGAI 12

850.2100 Avian acute oral toxicity TGAI 12

850.2200 Avian sub

- acute dietary toxicity TGAI 12

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

The Problem Formulation for Registration Review of Furfural indicates the need for test data from

Guideline 835.4100 ( aerobic soil metabolism ) and Guideline 835.4200 ( anaerobic soil metabolism )

, but because these data originally were required as a condition of registration they will not be

include d in the DCI for registration review. Th e Agency is particularly interested in the development

of the transformation products furfuryl alcohol and 2

- furoic acid during the studies, since th os e data

will help reduce uncertainty in the environmental fate database

.

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 or 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 statutory 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

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

- HQ

- OPPT

- 2009

- 0154

- 0028

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

- furoic acid

.5 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 F IFRA 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

know n about the pesticide 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 develop a F inal W ork

P lan (FWP) and anticipated schedule for the registration review of furfural

.

CHEMICAL FACTS

Table 2 provid es a summary of the chemical facts for furfural

.

Table 2: Chemical Facts for F urfural

PC code 043301

Case Number 7050

CAS Number 98

- 01

- 1

Year first registered 2006 Pesticide Type Nematicide/Fungicide

Chemical class Heterocyclic aromatic aldehyde

R eregistration Eligibility Decision (R E D) Because it was registered after November 1984, furfural was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Because it was registered after November 1984, furfural was not subject to tolerance reassessment. Cumulative group Not applicable. Furfural has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation Furfural is not registered for any food uses and n o tolerances are

established for residues of furfural

. Dual

- use Furfural is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses.

Non

- pesticidal uses There are no identified non

- pesticidal uses of furfural.

Pesticid e Re

- evaluation Division, Chemical Review Manager Jolene Trujillo trujillo.jolene@epa.gov

303

- 312

- 6579 Registration Division

, Product Manager Hope Johnson Johnson.H ope@epa.gov

703

- 305

- 5410

3 http://www.epa.gov/oppsrrd1/registration_review/6 USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for f urfural

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Furfural (043301) in the registration review docket for more

details

.

Table 3: F urfural Use and Usage Information

Summary of Use Furfural is registered for use as a contact nematicide . It is also registered as a fungicide to control certain soil

- borne fungal pathogens.

Use Sites Sod/turf farm is the only registered agricultural site. The registered

non

- agricultural sites include ornamental turf (golf course and athletic fields), field grown plants and ornamentals (non

- bearing fruit trees and
vines, cut flower production, and production nurseries), and greenhouse orna mentals. Summary of Usage No q uantitative usage information is available for furfural at this time

. Formulation Type(s) Flowable concentrate Application Method(s) Products can be applied by ground boom sprayer, chemigation (drip and overhead), drench, or low pressure back pack sprayer

. Technical Registrant (s) Agriguard Company LLC No. of Registrations 2 Section 3 products 4

Restricted Use No

Guidance for Commente rs: Quantitative u sage information is not available to the Agency at this

time for any uses of furfural . Obtaining or confirming the following information may improve future assessments related to the use and importance of furfural.

• Total pounds active ingredient applied per year on a national or regional basis for each use

site

• Typical application rates and application (retreatment) intervals

• Percent crop/site treated

• Unique geographic areas of use with high intensity

• Ma x imum number of applications for greenhouse ornamental uses

• M ethods of application alternative to those listed above

• Target or niche pest species

• Efficacy information/product performance

• S tate or local use restrictions

• F oreign technical registrants not listed above who supply technical furfural to the US market

RECENT ACTIONS

There is a proposed new use for application to bare soil that is currently undergoing evaluation for registration.

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

( http://oaspub.epa.go v/pestlabl/ppls.home ).7 ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for furfural, completed on August 8, 2012, was conducte d for the use on athletic fields and outdoor ornamentals. The most recent ecological and environmental fate risk assessment was completed May 7, 2012 for new use on ornamentals and clarification on existing uses on turf. Findings and conclusions from the se risk

assessments are summarized in the Problem Formulation for Registration Review of Furfural and Furfural

. Human Health Scoping Document in Support of Registration Review.

During registration review, the Agency anticipates the need to conduct a compr ehensive ecological risk assessment, including an endangered species assessment, for all uses of furfural. For human health, EPA anticipates the need to conduct revised dietary, residential, and occupational risk assessments during registration review. T he cancer re

- classification will be considered in the new assessments for registration review, as well as any changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated registration review risk a ssessments based on the EFED Problem Formulation and HED Scoping Document.8 Table 4: Anticipated 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 degradate s . 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 N o Not needed for the currently registered uses of furfural. Drinking water Y es An u pdated 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 estim ated drinking water concentrations (EDWCs). The

assessments will use the newest version of DEEM and reflect updated consumption information. Occupational Handlers (m ixer s, loader s, applicators ) Y es 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 Y es An updated occupational post

- application risk assessments is likely to be nec essary given the cancer re

classification.

Residential

Handlers N o Furfural is not registered for residential uses.

Post

- application Y es 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 N o 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 aggre gate with

the dietary exposure.9 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 S ee 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 5 below

.

Table 5: Projected F urfural Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2015

- June

Close Public Comment 2015

- August Case Development

Final Work Plan 2015

- November

Issue DCI 2016 Jan.

- March

Data Submission 2018 Jan.

- March

60

- day Public Comment Period for Draft Risk

Assessments 5 2019

- July

- Sept.

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2020

- April

- June

Registration Review Decision and Begin Post

- Decision

Follow

- up 2021

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 furfural

.

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, t he Age ncy plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.10 

### Appendix

– Additional Areas Considered in the F urfural Registration Review

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 proc ess, 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 and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Because furfural is not registered for food/feed uses in the U.S., it has no U.S. tolerances ; therefore, the Agency does not anticipate any trade irritant issues for it.

Water Quality:

F urfural is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 6 In addition, no Total Maximum Daily Loads (TMDL) have been developed for furfural

. 7 More information on impaired water bodie s 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: Inclusio n of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management 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 race, 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 furfural compared to the general population. Please comment if you are aware of any sub

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

ENDANGERED SPECIES :

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

7 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pol lutant_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.htm11 A risk assessment that supports a complete endangered species determination has not been

conducted for furfural

. The ecological risk assessment planned during registration review will allow

t he Agency to determine whether use of furfural has “no effect” o r “may affect” federally listed threatened or endangered species (listed species) or their designated critical 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 appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse

outco mes 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 endpo ints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecologica l hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in differen t taxonomic groups. As part of its most recent registration decision for furfural

, 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), furfural 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 other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring est rogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemic al substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of t he 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 p esticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 10 and includes some pesticides scheduled for registration review and chemicals found in water

. Furfural was not on either list. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

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

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

11 http://www.epa.gov/endo/12 HUMAN STUDIES :

Occupational

Past furfural risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise gen eric pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases, and has found no clear and convincing 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. All applicable requirements of EPA’s Rule f or the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.