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 summarize 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 Endangered Species Assessments for Benfluralin. 

December 12, 2011. 

2. Benfluralin. Registration Review 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 Considered in Registration 

Review Work Planning. Benfluralin (084301). February 18, 2011. 

Supporting documents for the registration review of benfluralin are located in docket EPA-HQOPP-2011-0931 at www.regulations.gov. 
4 

I. PRELIMINARY WORK PLAN 

Introduction

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 registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at: http://www.epa.gov/oppsrrd1/registration_review/. 

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. 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 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 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-agricultural use sites including residential areas. Agricultural use sites 

include lettuce, alfalfa, clover, birdsfoot trefoil, nonbearing fruit and nut trees, nonbearing 

berries, and non-bearing vineyards. Non-agricultural use sites include turf, golf courses 

(including greens, tees, and fairways), ornamentals, Christmas tree plantations, fence 

rows/hedgerows, and rights of way (including industrial sites, utility substations, highway 

guardrails, sign posts, delineators, and 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 comprehensive human health and ecological risk 

assessments, including an endangered species risk assessment, for all uses of benfluralin. The 
5 

Agency anticipates needing data for use in conducting these assessments. Below is a summary 

of the issues relevant to the registration review of benfluralin and 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 assessment that supports a complete endangered 

species determination for benfluralin. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether benfluralin’s use has “no 

effect” or “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 (USFWS) and/or National Marine Fisheries 

Service (NMFS) (the Services), as appropriate. 

• On January 19, 2011, the Center for Biological Diversity and the Pesticide Action 

Network North America filed a lawsuit in the United States District Court for the 

Northern District of California, against the Environmental Protection Agency (EPA) for 

allegedly failing to undergo consultation with the United States Fish and Wildlife Service 

and the National Marine Fisheries Service regarding the effects of over 350 pesticides, 

including benfluralin, on over 200 endangered and threatened species throughout the 

United States (Center for Biological Diversity, 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 following data for use in conducting a complete 

ecological risk assessment, including an endangered 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 Toxicity 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 endangered species assessment for benfluralin. 

For further details, see the “Guidance 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 discussion of the anticipated ecological 

risk assessment and data needs.

Human Health Risk: 

• The most recent human health risk assessment 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 updated 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 acute dietary risk assessment. The Agency 

anticipates conducting new chronic dietary exposure and risk assessments during 

registration review to incorporate current consumption information, updated residue 

values, and percent crop treated 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 the Agency’s Residential Standard Operating 

Procedures. Revised residential handler and postapplication assessments may also be 

needed if toxicological endpoints change or other new data are identified by the Agency 

which impact exposure estimates. 

• During registration review, the Agency anticipates conducting new short-term and 

chronic aggregate risk assessments to incorporate drinking water. 

• The Agency anticipates conducting updated occupational handler exposure assessments 

based on revisions to the Agency’s scenario-specific surrogate handler exposure data. 

Revised occupational handler and postapplication assessments may also be needed if 
7 

toxicological endpoints change or other new data are received by the Agency which 

impact exposure estimates. 

• The tolerance expression for benfluralin in 40 CFR §180.208(a) will be reviewed during 

registration review to ensure that it appropriately covers the metabolites and degradates 

of benfluralin and that it specifies 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), where possible, in key export markets during 

registration review. 

• As part of reregistration, all benfluralin labels were required to specify a 12-month plant 

back interval for crops that may be rotated and to make it clear that rotational crop 

restrictions apply to all areas of the U.S. At this time, it does 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 anticipates requiring for use in conducting an 

updated human health risk assessment: 

o GLN 870.6200 – Acute and Subchronic 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 anticipated human health risk 

assessment and data needs. 

Endocrine Disruptor Screening Program

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

outcomes 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 endpoints 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 ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive 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 existing 
8 

hazard database. However, as required by FFDCA section 408(p), benfluralin 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 estrogen, 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 

chemical 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 the 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 pesticide active ingredients and 9 inert ingredients. Benfluralin 

was included on that list and has been issued an order to conduct the Tier 1 testing. Once all 

required Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety factors 

used for risk assessment purposes will be examined 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 guidelines and the Tier 1 screening battery, please visit 

our website: http://www.epa.gov/endo/. 
9 

Timeline

 

The projected timeline for the completion of the benfluralin 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 Review Decision and Open Public 

Comment Period 

 2017 – Jan. – March 

Close Public Comment Period 2017 – April – June 

Issue Registration Review Decision and 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 comments, 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 Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (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. 

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, 
10 

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 benfluralin 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. 

Water Quality 

Benfluralin is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act1. In addition, no Total Maximum Daily Loads 

(TMDLs) have been developed for benfluralin2

. More information on impaired water bodies and 

TMDLs can be found at the Agency’s website3

. 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: Inclusion of Impaired Water Body and 

Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management 

Process4 in order to ensure they can be used quantitatively or qualitatively in pesticide risk 

assessments. 

Other Information 

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining risk assessments, including 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, application 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 90th 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_303d?p_cause_group_id=885 2 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES 3 http://www.epa.gov/owow/tmdl/

4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
11 

5. Application timing (date of first 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 ai/acre) from usage data – county 

b. median and 90th percentile number of applications – county 

c. total pounds per year – county 

d. the year the pesticide was last used 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 damage and avian, fish, reptilian, amphibian, 

mammalian mortalities, and bee or beneficial insect mortalities) 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 issue 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 Service (CAS) Number: 1861-40-1 

• Benfluralin has been registered 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 benfluralin, including two technical products. 

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

• Pesticide Re-evaluation Division (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 Registration 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-seeded broadleaf weed species. 

• Agricultural use sites include lettuce, alfalfa, clover, birdsfoot trefoil, 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 plantations, fence rows/hedgerows, and rights of 

way (including industrial sites, utility substations, 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 seedlings, chickweed, lambs quarters, purslane 

knotweed, clover, pigweed, plantain, crabgrass, foxtail, goose grass, Poa annua, barnyard 

grass, and fescue. 

• Benfluralin formulation types include granules and water dispersible granules. 

• Benfluralin may be applied as a band treatment, broadcast treatment, soil incorporated 

treatment, and as a spray with ground or sprinkler irrigation systems. 

• Equipment used to apply benfluralin include groundboom, push spreader, belly grinder, 

shaker can, low pressure hand wand, tractor drawn 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 benfluralin 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 recent ecological risk assessments regarding the 

environmental fate, ecological effects and risks 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 birds and mammals are below the Agency’s 

level of concern (LOC). The Agency also concluded 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 chronic risks of concern for reproductive effects 

from the use of benfluralin to birds and mammals. The Agency also concluded that there 

is potential for reproductive effects in birds that consume fish containing benfluralin 

residues. In addition, the Agency concluded that there are risks of concern for 

reproductive effects to freshwater and estuarine fish and invertebrates. 

• The Agency concluded that there is uncertainty in the potential for 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 the available studies. 

Human Health Risk Assessment Status

The following are key findings from the human health 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 assessment 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 Assess Human Potential.” 

There was no mutagenicity concern for benfluralin based on the available data. 

Summary of Risks: 

Dietary

• An acute dietary assessment was not conducted because an appropriate endpoint was not 

available. 

 

• The Agency also concluded that unrefined chronic non-cancer dietary (food and drinking 

water) risk estimates for benfluralin are below the Agency’s LOC for the general U.S. 

population and all population subgroups.

Residential 

• The Agency concluded that residential handler non-cancer risk estimates are below the 

Agency’s LOC for inhalation risk. Only handler inhalation risks were assessed because 

systemic toxicity was not observed in a dermal toxicity study, up to a dose level of 1,000 

mg/kg/day. 

• The Agency also concluded that 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 children, including hand-to-mouth on a treated lawn, 

object-to-mouth on a treated lawn, soil ingestion, 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 aggregate risk estimates, from the combination of 

residential exposures from turf and chronic dietary exposures, are below the Agency’s 

LOC for the general U.S. population and all population subgroups. 
16 

• The Agency also concluded that chronic aggregate risk estimates are equivalent to the 

chronic dietary risk estimates for benfluralin and are below the Agency’s LOC for the 

general U.S. population and all population subgroups 

• Drinking water was not directly incorporated into these dietary and aggregate 

assessments. 

Occupational

• Occupational handler exposures were estimated using exposure data from several 

sources, including the surrogate data available in the Pesticide Handlers Exposure 

Database (PHED) and data available from the Outdoor Residential Exposure Task Force 

(ORETF). Only occupational handler inhalation risks were assessed because systemic 

toxicity was not observed in a dermal toxicity study, up to a dose level of 1,000 

mg/kg/day. Occupational handler dermal risks were not assessed. The Agency 

concluded that non-cancer occupational handler inhalation risk estimates 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 entering fields treated with benfluralin. However, since no 

dermal endpoint was identified for systemic toxicity, an occupational 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 pesticide exposure databases such as the Pesticide Handlers 

Exposure Database (PHED) and the Outdoor Residential Exposure Task Force (ORETF) 

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 for the Protection of Human Subjects (40 CFR Part 26) have 

been satisfied, and there is no regulatory barrier to continued reliance on these studies. 

Cumulative

• The Agency has not determined whether benfluralin shares a common mechanism of 

toxicity with other chemical substances. If, in the future, EPA obtains new data 

suggesting that benfluralin shares a common mechanism of toxicity with other chemical 

substances, the Agency will revisit the need for a cumulative risk assessment. 
17 

Incidents

Ecological Incidents: 

• The Agency reviewed the Ecological Incident 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 (AIR). 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 the U.S. to identify potential 

patterns on the frequency of health effects attributed to benfluralin exposure. In the 

Aggregate IDS summaries, from January 1, 2006 to June 13, 2011, there are five 

incidents involving benfluralin. In the Main IDS, from January 1, 2006 to June 13, 2011, 

there are no cases reported for the single chemical only in the database, and there are four 

incidents that involved more than one chemical. 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 reported 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 anticipates continuing to monitor the incident 

information and including additional analysis in the registration review risk assessment if 

a concern is triggered. 

Tolerances and International Harmonization

• U.S. tolerances for benfluralin 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 international 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 completion of the 2004 Benfluralin RED. 

• The following data remain outstanding: 

o GLN 850.1010 – Acute Toxicity Freshwater Invertebrates Study 

o GLN 850.1025 – Oyster Acute Toxicity 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 Terrestrial Plant Toxicity Test, Tier II 

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

o GLN 850.5400 – Aquatic Plant Growth Tier 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