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Docket Number EPA-HQ-OPP-2011-0931 

www.regulations.gov

Benfluralin 

Final Work Plan 

Registration Review 

May 2012 

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Introduction

This is the Environmental Protection Agency’s (EPA’s) Final Work Plan for the registration 

review of benfluralin. This work plan includes the expected registration review timeline. The 

work plan also addresses public comments received concerning the Preliminary Work Plan in 

the Summary Document, which was posted in the benfluralin registration review docket (EPAHQ-OPP-2011-0931), and any other comments concerning the initial docket postings. The 

Summary Document provided information on what EPA knows about the pesticide and what 

additional risk analyses and data or information the Agency believes are needed to make a 

registration review decision. 

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 will 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 at: 

http://www.epa.gov/oppsrrd1/registration_review/. 

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. 

Comments Received on Preliminary Work Plan

The comment period for the benfluralin registration review docket was open for 60 days, from 

December 21, 2011 to February 21, 2012. During the comment period, the Agency received 

comments from the FIFRA Endangered Species Task Force (FESTF), the Physicians Committee 

for Responsible Medicine (PCRM), and technical registrant Dow AgroSciences (DAS). 

However, these comments do not alter the Agency’s work plan outlined in the Preliminary Work 

Plan. As a result of the comments received, the Agency removed several guideline studies from 

the data requirements, including the 28-day Inhalation study (OPPTS 870.3465) and the 

Oncogenicity-mouse study (870.4200b), both of which were unsatisfied requirements of the 
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2006 Benfluralin DCI. The Neurotoxicity battery (acute and subchronic) (OPPTS 870.6200) 

requirement was also removed. The comments received on data requirements for benfluralin, as 

well as the Agency’s responses, are summarized below. For more detailed and complete 

responses, please see the Agency memos “The Environmental Fate and Effects Division 

Response to Comments Posted to the Registration Review Docket for Benfluralin” dated May 

15, 2012, the Agency memo “Benfluralin: Summary of Hazard and Science Policy Council 

(HASPOC) Meeting of April 26, 2012: Recommendations on the need for inhalation, 

neurotoxicity battery (acute and subchronic) and carcinogenicity studies” dated May 8, 2012, and 

the Agency memo “Benfluralin: Response to comments on Registration Review docket (EPAHQ-OPP-2011-0931) on the need for inhalation, neurotoxicity battery (acute and subchronic), 

carcinogenicity, and immunotoxicity studies,” dated May 10, 2012, all of which are available in 

docket EPA-HQ-OPP-2011-0931. 

Summary of Comments and Agency Responses

Comments related to the Environmental Fate and Ecological Problem Formulation 

Comment 1: PCRM Passerine data may be available to fulfill the Avian Acute Oral Toxicity 

requirement, and if this is not sufficient, we recommend using the Organization for Economic Co 

-operation and Development (OECD) Test Guideline 223, Avian Acute Oral Toxicity Test as the 

protocol in the interest of reducing the numbers of animals used.

EPA Response 1: EPA will consider the available toxicity data for benfluralin and passerines. 

EPA has completed its evaluation of the OECD Acute Avian Oral Sequential Dose Study 

Guideline (TG223) and has determined that TG223 performed generally as well as EPA OPPTS 

Guideline 850.2100 regarding information on the LD50 value, slope, and observation of sublethal 

effects. A study conducted using TG223 may be classified as ‘acceptable’ if it is scientifically 

valid, conducted using the ‘LD50 – slope test’ or ‘limit dose test’ guidelines, and meets certain 

other criteria. Studies that deviate from these criteria may be classified as ‘acceptable’ or 

‘supplemental’ if they are considered adequate for use in risk assessment or ‘invalid’ if they are 

not scientifically sound; however, consultation with EPA will need to confirm the classification 

for any TG223 study that deviates from the criteria. 

Comment 2: DAS The study by Hicks for Oyster Acute Toxicity (GLN 850.1025) has been 

previously classified as "supplemental" primarily on the grounds that a specific endpoint has not 

been identified, but DAS believes that a repeat study is unlikely to provide any useful additional 

information. 

EPA Response 2: This study (MRID 47269801) is scientifically sound but does not satisfy the 

guideline requirement for an acute estuarine mollusk toxicity study because a definitive endpoint 

(the IC50) could not be calculated from the study. Other deviations from study guidelines 

contributed to the lack of sufficient data to assess risk to these organisms, including a much 
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shorter acclimation period (2 days) than the OCSPP recommendations of 12-15 days. Also, the 

TOC of the dilution water was not reported, and the study author reported that each treatment 

tank received more diluted concentrate shellfish diet during exposure than OCSPP guidelines 

suggest. EPA believes that a well designed flow-through study would reduce the fluctuations of 

dissolved benfluralin to be within the OCSPP guidelines. This study (GLN 850.1025) is still 

needed. 

Comment 3: DAS DAS commented that it is unnecessary to repeat the Aquatic Plant Growth 

Tier II study (Non-Vascular Aquatic Plants) (GLN 850.5400). The studies by Hancock et al. on 

Navicula and Skeletonema submitted for this requirement have been previously classified as 

supplemental due to measured concentrations below the LOQ, but treatment groups in both 

studies were above the LOQ except at study termination, as would be expected for benfluralin. 

Further, an equivalent study on Anahaenaflos-aquae, conducted by Hertl et al. (MRID 

47055203) was submitted to EPA on February 12, 2007 and the EPA evaluation is still pending. 

EPA Response 3: In both Hancock et al (2007a) and (2007b), there was less than a 24-hr 

exposure to the benfluralin technical due to factors including reported measured concentrations 

at the 24, 48, 72 and 96 hr times below the LOQ. The study by Hertl et al. (MRID 47055203) 

was determined to be scientifically unsound and was classified as Invalid. Concentrations of the 

test solutions were not measured, no clear dose-dependent response was observed, and although 

there were no compound-related phytotoxic effects observed, the test was only conducted for 72 

hours instead of the recommended 96-120 hours. Also, measurements of the dissolved test 

chemical were not provided, and the emulsifier included likely interferes with the chemical 

properties of benfluralin. This data requirement (GLN 850.5400) is still needed to estimate the 

risk to aquatic plants from benfluralin exposure and reduce uncertainties associated with the 

current risk assessment for plants, which form the basis of many habitats and significantly 

contribute to overall environmental quality. The data will also be used to determine whether 

affects to Federally-listed threatened and endangered species are likely under the Endangered 

Species Act. 

Comment 4: DAS DAS agrees to provide the Fish Acute Toxicity Test with the bluegill sunfish 

(GLN 850.1075), the Aquatic Invertebrate Life Cycle study (Freshwater) (GLN 850.1300), and 

the Avian Acute Oral Toxicity Test (Passerine Species) (GLN 850.2100). DAS also agrees to 

provide the passerine study protocol for this guideline. DAS will be submitting a study by 

Memmert, U. (2003, Study ID: 842140) for the Whole Sediment chronic Invertebrates, 

Freshwater and Marine study requirement (40 CFR Part 158 (USEPA, 2007a)), and a recent 

study by Knoch and Heim for the Laboratory Volatility data requirement (GLN 835.1410).

EPA Response 4: EPA looks forward to the receipt of these studies and will consider their 

adequacy for use in the risk assessment and the fulfillment of the guideline requirements, and 

also looks forward to the receipt of the passerine study protocol. 
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Comment 5: DAS DAS has previously submitted several studies to address requirements that the 

Agency has identified as remaining data gaps. EPA evaluation for these studies is still pending. 

Two studies by Hertl et al. (2003) were submitted on February 12, 2007 to address the rainbow 

trout Fish Acute Toxicity (GLN 850.1075) requirement and the Acute Toxicity Freshwater 

Invertebrate (GLN 850.1010) requirement. For the Fish Life Cycle (GLN 850.1500) requirement 

DAS submitted a study on October 28, 2011 by Marino et al. (2011). Although not a full lifecycle study, its findings taken together with data from the "core" Early Life Stage study by 

Cocke (1990) are considered sufficient to provide realistic and meaningful data for the 

evaluation of the chronic effects on fish resulting from exposure to a substance of low 

persistence in the aquatic environment. To satisfy the Seedling Emergence Terrestrial Plant 

Toxicity Test, Tier II (GLN 850.4100) and Vegetative Vigor Terrestrial Plant Toxicity Test, Tier 

II (GLN 850.4200) data requirements, a study by Rockliff was submitted on November 21, 2011. 

EPA Response 5: The Hertl et al. (2003; MRID 47055202) and Hertl et al (2003; MRID 

47055201) studies were determined to be invalid because the measurements of the dissolved 

chemical were not provided, and the exposure of the organisms to the test chemical could not be 

determined. The data requirements (GLN 850.1010 and GLN 850.1075) are still needed to 

evaluate the risk of this exposure. EPA is still reviewing DAS’s other submissions and will 

follow up on the need for any additional data when the reviews are completed. 

Comment 6: DAS DAS disagrees with the inclusion of the Avian Reproduction Test (Bobwhite 

Quail) (GLN 850.2300) in the data gap summary. A study by Frey et al. (2008) was submitted on 

February 11, 2008 to the Agency to satisfy this data requirement. A subsequent rebuttal to the 

Agency decision regarding that study by Hudson (2010) was submitted to the EPA on August 24, 

2010 and the EPA evaluation is still pending.

EPA Response 6: EPA has reviewed the Hudson (2010; MRID 48204501) rebuttal to the 

classification of Frey et al. (2008) (MRID 47346601), which was determined to be scientifically 

unsound because the control mortality was 12.5% during the study, while no more than 10% is 

acceptable. The amount and type of mortalities indicate high levels of stress on the test 

organisms and make the results difficult to interpret, thus the guideline requirement remains 

unfulfilled. 

Comment 7: DAS DAS disagrees that no data are available for the Aerobic Aquatic Metabolism 

Half-life (20o

C) because an aquatic degradation study is available (Knoch and Heim, 2002) 

which shows that Benfluralin either rapidly volatilizes or dissipates into the sediment layer. 

EPA Response 7: EPA has an aerobic aquatic metabolism study by Knoch and Heim (MRID 

46355301) that is currently under review and will be considered for use in the risk assessment. 
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Comments Related to the Human Health Risk Scoping Document

Comment 8: PCRM With respect to the Acute and Subchronic Neurotoxicity (870.6200) data 

requirements, we encourage this test requirement be reconsidered. In the past both EPA and 

European Food Safety Authority (EFSA) have chosen not to require neurotoxicity studies 

because they would not provide any additional data that would support the risk assessment. 

 DAS DAS recommends the need for the neurotoxicity battery be reconsidered. Based on 

the available toxicity data, benfluralin does not appear to present any neurotoxicity hazard. In 

addition, upon review of the use pattern of this active ingredient and the exposure assessments 

(including worker exposure), the potential for human exposure is identified to be very low. 

EPA Response 8: Based on a weight of evidence (WOE) approach considering all the available 

hazard and exposure information for benfluralin, the Hazard and Science Policy Council 

(HASPOC) concludes that the acute/subchronic oral neurotoxicity studies in the rat are not 

required for benfluralin at this time. 

Comment 9: PCRM In 2011, CropLife America (CLA) submitted a retrospective analysis of 

immunotoxicity studies that indicated such studies do not provide additional information for risk 

assessment purposes. The Agency is also conducting its own retrospective analysis, and should 

complete the review before calling for additional immunotoxicity studies. 

 DAS DAS recommends the need for the immunotoxicity study be reconsidered. Based on

the available toxicity data from the repeat dose studies, benf1uralin does not appear to present

any immunotoxicity hazard. In addition, an industry effort in cooperation with US EPA is 

currently underway to evaluate the impact of this data requirement on the risk assessment. 

EPA Response 9: The Agency acknowledges that the submission of CLA’s retrospective 

analysis on immunotoxicity studies is currently under review. In addition, EPA is conducting an 

independent retrospective analysis of more than 150 immunotoxicity studies submitted to 

Agency. Preliminary findings of EPA’s retrospective analysis suggest that immunotoxicity 

studies have not yet provided lower PoDs than are selected from other guideline experimental 

toxicology studies and thus, so far, immunotoxicity studies would not have impacted the 

Agency’s risk assessments. The EPA retrospective analysis is anticipated to be completed in 

2012. In the interim, EPA recommends that the immunotoxicity continue to be required for 

registration and registration review chemicals.

Comment 10: DAS A 28-day inhalation study is unnecessary based on the risk assessment 

conducted by EPA for benfluralin in the Benfluralin RED. Calculated MOEs for this time frame 

were all well in excess of 1000, indicating that short-term inhalation exposures should not 

represent a source of concern for workers. Also the Benfluralin RED required the reduction of 

application rates to a maximum single rate of 2 lb a.i./A as opposed to the rates of 3, 4 and 6 lbs 

a.i./A used for many of the risk assessment calculations. 
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EPA Response 10: The HASPOC concludes, based on a WOE approach, that a repeated dose 

inhalation toxicity study is not required at this time. However, additional characterization of the 

use pattern, and potential for intermediate-term inhalation exposure is suggested. The 

intermediate-term inhalation exposure assessment that was performed in 2003 is considered a 

highly conservative estimate of actual occupational inhalation exposure. It is likely that 

agricultural workers are exposed to benfluralin for a series of short-term exposures, rather than 

continuously over 6 months. 

Comment 11: DAS DAS strongly disagrees that the mouse oncogenicity requirement is not 

satisfied, and made extensive comments supporting the position that the conduct of a new study 

is unlikely to provide any valuable new information on carcinogenic potential and is not 

warranted. 

EPA Response 11: Based on a WOE approach, considering all the available hazard and exposure 

information for benfluralin, the HASPOC concludes that the carcinogenicity study in the male 

mouse is not required for benfluralin at this time. 

Other comments related to the risk assessments or required data 

Comment 12: DAS Comments submitted by DAS concerned the methods of Benfluralin 

application, which do not include ground or sprinkler irrigation systems or aerial application. 

Comments also addressed the maximum use rates for Christmas Tree Plantations, Non 

Agricultural Rights of Way/Industrial sites/ Fencerows/ Hedgerows, Industrial Construction 

Areas (Outdoor), and use patterns such as for Ornamental Sod Farm (Turf) identified by the 

Agency in the Problem Formulation, which have yet to be updated as required by the 2004 RED 

by certain registrants. 

EPA Response 12: EPA appreciates the information provided by DAS. The risk assessment will 

be based on currently registered uses and active labels at the time of the assessment. EPA is 

working with the registrants to update their labels according to the 2004 RED. 

Comment 13: FESTF FESTF commented that DAS is a current member of FESTF is thus 

entitled to rely on FESTF data on federally-listed threatened and endangered species, while 

Dintec Agrichemicals is not a member and therefore must offer to pay to rely on FESTFsubmitted data. FESTF also indicated the data that they have previously submitted to the Agency 

are the best available for the proximity analysis of benfluralin use and endangered species 

locations, and fulfill the requirements indicated in Pesticide Registration Notice 2000-2. 

EPA Response 13: EPA thanks FESTF for its comment and will consider all appropriate 

information as we conduct the registration review assessment and make our registration review 

decision. 
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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 

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 GLN 835.1410 – Laboratory Volatility 

Ecological Effects

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

o GLN 850.2100 – Avian Acute Oral Toxicity Test (Passerine species) 
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o Non-Guideline – Whole Sediment Chronic Invertebrates, Freshwater and Marine 

(Special Study) 

 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 

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

impact exposure estimates. 
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 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, this change has not been made to 

all benfluralin labels and EPA is working with the companies to update the benfluralin 

labels to specify the appropriate plantback interval. 

 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 870.7800 – 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 

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). 
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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/. 

Timeline

 

The projected timeline for completion of the benfluralin registration review is presented below. 

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 
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Next Steps

The Agency plans to conduct a human health risk assessment and comprehensive ecological risk 

assessment, including an endangered species risk assessment, for benfluralin. Drafts of the risk 

assessments are scheduled to be available for public comment in 2016. 

Summary of Data Needs for the Registration Review of Benfluralin

Data Call-Ins

 A DCI was issued to benfluralin technical registrants in February 2006 to address data 

gaps identified in the 2004 RED. These data, along with the anticipated registration 

review data requirements that are required, submitted, and determined to be adequate will 

be used in conducting the forthcoming human health and ecological risk assessments for 

the registration review of benfluralin. The following data for GDCI-084301-24018 are 

outstanding: 

o GLN 850.1010 Acute Toxicity Freshwater Invertebrates 

o GLN 850.1025 Oyster Acute Toxicity 

o GLN 850.1075 Freshwater and marine fish acute toxicity 

o GLN 850.2300 Avian Reproduction 

o GLN 850.5400 Algal toxicity, Tier II 

Table 2. Summary of Anticipated Data Needs for Benfluralin

Guideline Number Anticipated Data Requirement Test Material 

 Estimated 

Timeframe 

(Measured in 

Months from 

DCI Receipt) 

835.1410 Laboratory Volatility TGAI 12 

850.1300 Aquatic Invertebrate Life-Cycle (Freshwater) TGAI 12 

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

Non Guideline 

(ORD Study Method EPA 600/R-099-064) Chronic 

Freshwater Sediment Testing 2 Flowthrough: (Hyallela 

azteca) 

TGAI 24 

Non Guideline 

(ORD Study Method: EPA 600/R-099-064) Chronic 

Freshwater Sediment Testing 2 Flowthrough: 

(Chironomus dilutus or C. tentans)

TGAI 24 

Non Guideline 

(ORD Study Method: EPA 600/R-099-020) Chronic 

Estuarine/Marine Sediment Testing 2 Flowthrough: 

(Leptocheirus plumulosus) 

TGAI 24 

870.7800 Immunotoxicity TGAI 12