3 TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 12

III. Summary of Data Gaps 19

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. Registration Review – Preliminary Problem Formulation for the Environmental Fate and Ecological Risk, Drinking Water, and Endange red Species Assessments for Benfluralin

. December 12, 2011.

2. Benfluralin. Registration R eview Scoping Document for Human Health Assessments. December 12, 2011.

3. Benfluralin: Review of Human Incidents . August 10, 2011.

4. BEAD Chemical Profile for Registration Review: Benfluralin (084301) . May 19, 2011.

5. Benfluralin (084301) Screening Level Usage Analysis (SLUA) . January 20, 2011.

6. PRD Appendix A: Food/Feed & Non-Food/Non- Feed Uses Consider ed in Registration Review Work Planning

. Benfluralin (084301) . February 18, 2011.

Supporting documents for the registration review of benfluralin are lo cated in docket EPA-HQOPP-2011-0931 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN

Introduction

The Food Quality Protection Act (F QPA) of 1996 mandated a regist ration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. The 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 knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of benfluralin.

Benfluralin is a dinitroaniline herbicide registered for use to control certain grasses and smallseeded broadleaf weed species as a pre-emergence treatment. It is registered for use in many agricultural and non-agricu ltural use sites including residentia l areas. Agricultural use sites include lettuce, alfalfa, clover, birdsfoot tr efoil, nonbearing fruit and nut trees, nonbearing berries, and non-bearing vineyards. Non-agricu ltural use sites include turf, golf courses (including greens, tees, and fairways), orna mentals, Christmas tree plantations, fence rows/hedgerows, and rights of way (including in dustrial sites, utility substations, highway guardrails, sign posts, delineators, an d irrigation systems). Benfluralin has been registered in the U.S. since 1970, and the Reregistration Eligibility Decision (RED) for benfluralin was completed
in 2004.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting comprehe nsive human health and ecological risk assessments, including an endangered species risk assessment, for all uses of benfluralin. The5 Agency anticipates needing data for use in c onducting these assessments. Below is a summary
of the issues relevant to the re gistration review of benfluralin a nd a list of the anticipated data requirements.

Ecological Risk:

• The most recent ecological risk assessment was conducted in support of the 2004
benfluralin RED.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for benfluralin. Th e ecological risk asse ssment planned during registration review will allow the Agency to determine whether benfluralin’s use has “no effect” or “may affect” federally listed threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s use “may affect” a listed species or its designate d critical habitat, the Agency will consult
with the U.S. Fish and Wildlife Service (USFWS) and/or Nationa l Marine Fisheries Service (NMFS) (the Serv ices), as appropriate.

• On January 19, 2011, the Center for Biologi cal Diversity and the Pesticide Action
Network North America filed a lawsuit in th e United States District Court for the Northern District of California, against th e Environmental Protection Agency (EPA) for allegedly failing to undergo consultation with the United States Fish and Wildlife Service
and the National Marine Fisheries Service re garding the effects of over 350 pesticides, including benfluralin, on over 200 endangered and threat ened species throughout the United States (Center for Biological Dive rsity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.)

.

• Data gaps exist in the environmental fate and ecological toxicity database for benfluralin. The Agency anticipates needing the followi ng data for use in conducting a complete ecological risk assessment, including an e ndangered species assessment, for benfluralin:

Environmental Fate

o Non-Guideline – Laboratory Volatility (Special Study)

Ecological Effects

o GLN 850.1300 – Aquatic Invertebrate Life-Cycle (Freshwater)

o GLN 850.2100 – Avian Acute Oral Toxi city Test (Passerine species)

o Non-Guideline – Whole Sediment Chronic Invertebrates, Freshwater and Marine (Special Study)6 • The Agency seeks additional information for use in conducting a refined, complete ecological risk assessment, including an e ndangered species assessm ent for benfluralin. For further details, see the “Guida nce for Commenters” section below.

• Please refer to the Registration Review – Preliminary Problem Formulation for the Environmental Fate and Ecological Risk , Drinking Water, and Endangered Species Assessments for Benfluralin . December 12, 2011, located in docket EPA-HQ-OPP-2011- 0931 at www.regulations.gov, for a more detailed di scussion of the anticipated ecological
risk assessment and data needs.

Human Health Risk:

• The most recent human health risk assessm ent was conducted in 2003 in support of the
benfluralin RED.

• During registration review, the endpoints, doses , and safety factors used in the most
recent human health risk assessments will be revisited based on current policy as well as to incorporate any new data received and determined to be adequate.

• The Agency anticipates conducting an update d drinking water exposure risk assessment during registration review.

• An acute dietary assessment may be conducted if new toxicity data are received by the Agency that indicate the need for an acu te dietary risk assessment. The Agency anticipates conducting new chronic dietary exposure and risk assessments during registration review to inco rporate current consumption information, updated residue values, and percent crop trea ted information, while directly incorporating drinking water
values into the assessment.

• The Agency anticipates conducting a new residential exposure assessment during registration review based on revisions to th e Agency’s Residential Standard Operating
Procedures. Revised residential handler a nd postapplication assessments may also be needed if toxicological endpoi nts change or other new data are identified by the Agency which impact exposure estimates.

• During registration review, the Agency an ticipates conducting new short-term and chronic aggregate risk assessments to incorporate drinking water.

• The Agency anticipates conducting updated oc cupational handler e xposure assessments based on revisions to the Agency’s scenario-s pecific surrogate handler exposure data. Revised occupational handler and postapplica tion assessments may also be needed if7 toxicological endpoints change or other ne w data are received by the Agency which impact exposure estimates.

• The tolerance expression fo r benfluralin in 40 CFR §180.208(a) will be reviewed during registration review to ensure that it appropr iately covers the metabolites and degradates of benfluralin and that it sp ecifies the residues to be measured in each commodity.

• The Agency will modify tolerance levels as needed, and work to harmonize tolerances/maximum residue limits (MRL), wh ere possible, in key export markets during registration review.

• As part of reregistration, all benfluralin labels were require d to specify a 12-month plant back interval for crops that may be rotate d and to make it clear that rotational crop restrictions apply to all areas of the U.S. At this time, it doe s not appear that this change has been made on the benfluralin labels. EPA will work with the companies to update the benfluralin labels as appropriate.

• The toxicity and residue chemistry databases for benfluralin are complete except for the following studies, which the Agency anticip ates requiring for use in conducting an updated human health risk assessment:

o GLN 870.6200 – Acute and S ubchronic Neurotoxicity

o GLN 870.7800 – Immunotoxicity

• Please refer to Benfluralin. Registration Review Scoping Document for Human Health

Assessments. December 12, 2011, available in docket EPA-HQ-OPP-2011-0931 at www.regulations.gov, for a detailed discussion of the anticipat ed human health risk
assessment and data needs.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its reregistration decision for benfluralin, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing8 hazard database. However, as required by FFDCA section 408(p), benfluralin is subject to the endocrine screening part of the Endocrine Disruptor Screenin g Program (EDSP).

EPA has developed the EDSP to determine whet her 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 estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required
determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pesticide active ingredients and 9 inert ingredients. Benfluralin
was included on that list and has been issued an order to conduct the Ti er 1 testing. Once all required Tier 1 and Tier 2 data ha ve been received and reviewed, the endpoints and safety factors used for risk assessment purposes will be exam ined and a new risk assessment performed if necessary. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidel ines and the Tier 1 scr eening battery, please visit
our website: http://www.epa.gov/endo/

.9 Timeline

The projected timeline for the completion of the be nfluralin registration review is presented in
Table 1.

Table 1. Projected Benfluralin Registration Review Timeline Activity Estimated Date Opening the Docket Open Docket and Open Public Comment Period 2011 – December Close Public Comment Period 2012 – February Case Development Develop Final Work Plan (FWP) 2012 – May Issue Data Call-In (DCI) 2013 – Jan. – March

Data Submission 2015 – Jan. – March Open Public Comment Period for Draft Risk Assessments 2016 – July – Sept.

Close Public Comment Period 2016 – Oct. – Dec. Registration Review Decision Develop Proposed Registration Revi ew Decision and Open Public
Comment Period 2017 – Jan. – March

Close Public Comment Period 2017 – April – June Issue Registration Review Decision a nd Begin Post-Decision Follow-up 2017 Total (years) 6

Guidance for Commenters

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will carefully consider all commen ts, as well as any additional information or data provided in a timely manner, prior to issuing a final work plan for the benfluralin case.

Trade Irritants

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Environmental Justice

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation,10 and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to benflura lin compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure, compared to the general population.

Water Quality

Benfluralin is not identified as a cause of impairment for an y water bodies listed as impaired under section 303(d) of the Clean Water Act 1 . In addition, no Tota l Maximum Daily Loads (TMDLs) have been developed for benfluralin 2 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 3 . 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: In clusion of Impaired Water Body and
Other Water Quality Data in OPP’s Registratio n Review Risk Assessment and Management

Process 4 in order to ensure they can be used quant itatively or qualitativel y in pesticide risk

assessments.

Other Information

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining risk assessments, includ ing any species-specific ecological effects determinations, for benfluralin. The Agency is interested in receiving the following information:

1. Confirmation on the following label information

a. sites of application
b. formulations

c. application methods and equipment
d. maximum application rates

e. frequency of application, applicati on intervals, and maximum number of applications per season and per year
f. geographic limitations on use

2. Use or potential use distribution ( e.g ., acreage and geographical distribution of relevant uses/use sites)

3. Use history

4. Median and 90 th percentile reported use rates (lbs active ingredient(ai)/acre, lbs ai/1000 sq. ft.) from usage data – national, state and county

1 http://iaspub.epa.gov/tmdl_waters10/attains _nation_cy.cause_detail_30 3d?p_cause_group_id=885

2 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail ?p_pollutant_group_id=885&p_ pollutant_group_name=PESTIC IDES

3 http://www.epa.gov/owow/tmdl/

4 http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm11 5. Application timing (date of firs t application and application intervals) by use – national, state, and county

6. Sub-county use site location data

7. Directly acquired county-level usage data (not derived from state level data)

a. maximum reported use rate (lbs a i/acre) from usage data – county
b. median and 90 th percentile number of applications – county

c. total pounds per year – county
d. the year the pesticide was last us ed in the county/sub-county area

e. the years in which the pesticide was applied in the county/sub-county area

8. Typical application interval (days)

9. State or local use restrictions

10. Ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or beneficial insect mortalit ies) not already reported to the Agency

11. Monitoring data

Next Steps

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration
review of benfluralin.12 II. FACT SHEET

Background Information

• Registration Review Case Number: 2030

• Pesticide Chemical (PC) Code: 084301

• Chemical Abstracts Serv ice (CAS) Number: 1861-40-1

• Benfluralin has been regist ered in the U.S. since 1970.

• The benfluralin RED was completed in 2004.

• The technical registrants for benfluralin are Dintec Agrichemicals and Dow AgroSciences, LLC.

• There are 41 Section 3 registrations for benf luralin, including two technical products.

• All U.S. tolerances for benflura lin are 0.05 ppm [40 CFR §180. 208(a)].

• Pesticide Re-evaluation Divisi on (PRD) Contact: Cathryn Britton ( britton.cathryn@epa.gov )

• Registration Division (RD) Contact: Tracy White ( white.tracy@epa.gov )

Use and Usage Information

For additional details, please refer to BEAD Chemical Profile for Registration Review: Benfluralin (084301) , dated May 19, 2011; Benfluralin (084301) Screening Level Usage Analysis (SLUA) , dated January 20, 2011; and PRD Appendix A: Food/Feed & Non-Food/NonFeed Uses Considered in Re gistration Review Work Planning

- Benfluralin (084301) , dated February 18, 2011; located in docket EPA-HQ-OPP-2011-0931 at www.regulations.gov.

• Benfluralin is a dinitroaniline herbicide registered for use as a pre-emergence treatment to control certain grasses and small-s eeded broadleaf weed species.

• Agricultural use sites include lettuce, alfalfa, clover, birdsfoot tref oil, nonbearing fruit and nut trees, nonbearing berries, and vineyards.13 • Non-agricultural use sites include turf, golf courses (including greens, tees, and fairways), ornamentals, Christmas tree planta tions, fence rows/hedgerows, and rights of way (including industrial sites, utility s ubstations, highway guardrails, sign posts, delineators, and irrigation systems).

• Benfluralin is registered for residential uses on residential turf and ornamental plants.

• Target weeds include Johnson grass seedli ngs, chickweed, lambs quarters, purslane knotweed, clover, pigweed, plantain, crabgrass, foxtail, goose grass, Poa annua , barnyard grass, and fescue.

• Benfluralin formulation types include gr anules and water dispersible granules.

• Benfluralin may be applied as a band treatm ent, broadcast treatment, soil incorporated treatment, and as a spray with groun d or sprinkler irrigation systems.

• Equipment used to apply benfluralin incl ude groundboom, push spreader, belly grinder, shaker can, low pressure hand wand, tractor dr awn spreader, pump-feed and gravity-feed backpack sprayer, handgun sprayer, and bucket and spoon.

• Agricultural usage of benfluralin is mainly on lettuce. According to screening level estimates of the agricultural usage of benfluralin in the U.S. from 2000 to 2008, the average annual usage was approximately 60,000 pounds of active ingredient and an average of 15 percent of the lettuce crop treated.

• Non-agricultural usage of be nfluralin is mainly on lawns, by consumers and Lawn Care Operators (LCO), and on golf courses. The annual usage of benfluralin by consumers was approximately 1.8 million pounds of active ingredient (lbs a.i.) in 2000, decreasing to approximately 700,000 lbs a. i. in 2007. The annual usage of benfluralin by LCOs was approximately 171,000 lbs a.i. in 1999, decreasing to 35,000 lbs a.i. in 2006.

• Overall, the majority of the total annual usage of benfluralin is on commercial and
residential turf.

Recent and Pending Actions

• There are no recent or pending actions for benfluralin.14 Ecological Risk Assessment Status

The following are key findings from the most rece nt ecological risk assessments regarding the environmental fate, ecological effects and ri sks of benfluralin. Please refer to the Registration Review – Preliminary Problem Formulation for the Environmental Fate and Ecological Risk, Drinking Water, and Endangered Species Assessments for Benfluralin, dated December 12, 2011, located in docket EPA-HQ-OPP-2011-0931 at www.regulations.gov, for a detailed
discussion.

• The most recent ecological risk assessment was conducted in support of the 2004
benfluralin RED.

• In that assessment, the Agency concluded that acute risks from the use of benfluralin to non-endangered and endangered species of bi rds and mammals are below the Agency’s level of concern (LOC). The Agency also c oncluded that there are risks of concern to freshwater fish and invertebrates; however, there was uncertainty in the potential for
acute risks to freshwater fish and invertebrates due to variability in test concentrations as
well as tests conducted above the solubility limit of the compound.

• The Agency concluded that there are chroni c risks of concern for reproductive effects
from the use of benfluralin to birds and mamm als. The Agency also concluded that there is potential for reproductive e ffects in birds that consume fish containing benfluralin residues. In addition, the Agency conclude d that there are risks of concern for reproductive effects to freshwater and estuarine fish and invertebrates.

• The Agency concluded that there is uncertain ty in the potential fo r risk to non-target aquatic and terrestrial plants due to use of benfluralin technical grade active ingredient (TGAI) instead of a formulated, typical end- use product (TEP) in th e available studies.

Human Health Risk Assessment Status

The following are key findings from the human hea lth risk assessments conducted for benfluralin registered uses. Please refer to Benfluralin. Registration Review Scoping Document for Human Health Assessments, dated December 12, 2011, located in docket EPA-HQ-OPP-2011-0931 at www.regulations .gov, for a detailed discussion.

• The most recent human health risk assessm ent was conducted in 2003 in support of the
benfluralin RED.15 Hazard Characterization:

• In long-term toxicity studies in rats, mice, and dogs, the target organs for benfluralin were the liver and the kidneys.

• The HED Cancer Assessment Review Committee (CARC) classified benfluralin as

“ Suggestive Evidence of Carcinogenicity, but Not Sufficient to A ssess Human Potential .” There was no mutagenicity concern for benf luralin based on the available data.

Summary of Risks:

Dietary

• An acute dietary assessment was not conducte d because an appropriate endpoint was not
available.

• The Agency also concluded that unrefined chronic non-cancer diet ary (food and drinking water) risk estimates for benfluralin are be low the Agency’s LOC for the general U.S. population and all popu lation subgroups.

Residential

• The Agency concluded that residential handl er non-cancer risk estimates are below the Agency’s LOC for inhalation risk. Only ha ndler inhalation risks were assessed because systemic toxicity was not observed in a derm al toxicity study, up to a dose level of 1,000 mg/kg/day.

• The Agency also concluded th at residential postapplication non-cancer risk estimates are below the Agency’s LOC for all scenarios assessed. The Agency assessed a number of non-dietary ingestion scenarios for childre n, including hand-to-mouth on a treated lawn, object-to-mouth on a treated lawn, soil ingestio n, and episodic granular ingestion. In addition, the Agency assessed a combined non- dietary ingestion scenario for children, and concluded that the combined risk estimates remain below the Agency’s LOC.

Aggregate

• The Agency concluded that short-term aggreg ate risk estimates, from the combination of residential exposures from turf and chroni c dietary exposures, are below the Agency’s LOC for the general U.S. populat ion and all population subgroups.16 • The Agency also concluded that chronic aggr egate risk estimates are equivalent to the chronic dietary risk estimates for benflura lin and are below the Agency’s LOC for the general U.S. population and all population subgroups

• Drinking water was not direc tly incorporated into these dietary and aggregate

assessments.

Occupational

• Occupational handler exposures were esti mated using exposure data from several sources, including the surrogate data avai lable in the Pesticide Handlers Exposure Database (PHED) and data available from th e Outdoor Residential Exposure Task Force (ORETF). Only occupational handler inhalation risks were assessed because systemic toxicity was not observed in a dermal t oxicity study, up to a dose level of 1,000 mg/kg/day. Occupational handl er dermal risks were not assessed. The Agency concluded that non-cancer occupational handler inhalation risk estim ates are below the Agency’s LOC for all scenarios, with some level of risk mitigation.

• The Agency determined that there was the potential for occupational postapplication exposures to individuals ente ring fields treated with benf luralin. However, since no dermal endpoint was identified for systemic toxicity, an occupa tional postapplication exposure risk assessment was not conducted.

• Past benfluralin 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 exposures. Many such studies , involving exposure to many different pesticides, comprise generic pe sticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Outdoor Residential Exposure Task Force (ORETF)
Database. EPA has reviewed all the studi es supporting these multi-pesticide generic exposure databases, and has found no clear a nd convincing evidence that the conduct of any of them was either fundamentally unethic al or significantly defi cient relative to the ethical standards prevailing at the time th e research was conducted. All applicable requirements of EPA’s Rule for the Protecti on of Human Subjects ( 40 CFR Part 26) have been satisfied, and there is no regulatory barrier to conti nued reliance on these studies.

Cumulative

• The Agency has not determined whether be nfluralin shares a common mechanism of toxicity with other chemical substances. If, in the future, EPA obtains new data suggesting that benfluralin sh ares a common mechanism of to xicity with other chemical substances, the Agency will revisit the need for a cumulative risk assessment.17 Incidents

Ecological Incidents:

• The Agency reviewed the Ecological Incide nt Information System (EIIS), which is maintained by the EPA Office of Pesticide Programs (OPP), and the Avian Monitoring System (AIMS), which is maintained by the American Bird Conservancy, for ecological incident reports associated with the use of benfluralin in the U.S. The Agency also queried EFED’s Aggregate Incident Reports (A IR). There were a total of six incidents
identified with benfluralin. There were various levels of certainty that the incidents were caused by benfluralin.

• In the benfluralin registration review risk assessment, the Agency anticipates further evaluating the reported incidents to determine if they represent current use patterns for
benfluralin.

Human Health Incidents:

• The Agency reviewed the OPP Incident Data System (IDS) for human health pesticide
incident data associated with the use of benfluralin in th e U.S. to identify potential patterns on the frequency of health effects a ttributed to benfluralin exposure. In the Aggregate IDS summaries, from Januar y 1, 2006 to June 13, 2011, there are five incidents involving benfluralin. In the Ma in IDS, from January 1, 2006 to June 13, 2011, there are no cases reported for the single chemi cal only in the database , and there are four
incidents that involved more than one chem ical. Overall, there are few incidents involving benfluralin reported to IDS, and all are classified as moderate severity.

• Based on the low frequency and low severity of incident cases repor ted in the OPP IDS, there does not appear to be a concern at this time that would warrant further investigation
of benfluralin human health incidents in the preliminary risk assessment phase of registration review. However, the Agency an ticipates continuing to monitor the incident information and including additi onal analysis in the registrati on review risk assessment if a concern is triggered.

Tolerances and International Harmonization

• U.S. tolerances for benflurali n are established for residues of benfluralin in or on the raw agricultural commodities listed in 40 CFR §180. 208(a).

• During registration review, if any internationa l MRLs have been established, the Agency anticipates harmonizing the U.S. tolerances with the MRLs when the data warrant
harmonization.18 Data Call-Ins

• A DCI was issued in 2006 following the co mpletion of the 2004 Benfluralin RED.

• The following data remain outstanding:

o GLN 850.1010 – Acute Toxicity Fr eshwater Invertebrates Study

o GLN 850.1025 – Oyster Acute Toxic ity Test (Shell Deposition)

o GLN 850.1075 – Fish Acute Toxicity Test (Bluegill, Rainbow Trout)

o GLN 850.1500 – Fish Life Cycle

o GLN 850.2300 – Avian Reproduction Test (Bobwhite Quail)

o GLN 850.4100 – Seedling Emergence Terrestri al Plant Toxicity Test, Tier II

o GLN 850.4200 – Vegetative Vigor Terrestri al Plant Toxicity Test, Tier II

o GLN 850.5400 – Aquatic Plant Growth Ti er II Study (Non-Vascular Aquatic Plant)

o GLN 870.3465 – 90-day Inhalation Study (28-day duration acceptable)

o GLN 870.4200 – Mouse Carcinogenicity Study

o GLN 860.1200 – Directions for use (modify labels to specify 12 month plant back interval)

Labels

• Active Section 3 labels for benfluralin can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.19 III. SUMMARY OF DATA GAPS

A summary of the anticipated data needs for the benfluralin registration review is presented in
Table 2.

Table 2. Summary of Anticipated Data Needs for Benfluralin

Guideline Number Anticipated Data Requirement Test
Material Estimated
Timeframe

(Measured

in Months
from DCI Receipt)

Non-Guideline Laboratory Volatility (Special Study) TGAI 12

850.1300 Aquatic Invertebrate Life-Cycle (Freshwater) TGAI 12

850.2100 Avian Acute Oral Toxicity Test (Passerine species) TGAI 12

Non-Guideline Whole Sediment Chronic Invertebrates, Freshwater and Marine (Special Study) TGAI 12

870.6200 Neurotoxicity Screening Battery (Acute Neurotoxicity and Subchronic Neurotoxicity) TGAI 24

870.7800 Immunotoxicity TGAI 12