1 Docket Number EPA-HQ-OPP-2011-0931 www.regulations.gov



## Benfluralin

Final Work Plan Registration Review

May 20123 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 re gistration review timeline. The work plan also addresses public comments received concerning the Preliminary Work Plan in

the Summary Document , which was posted in the benflurali n registration review docket (EPAHQ-OPP-2011-0931), and any othe r comments concerning the in itial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and da ta or information the Agency believes are needed to make a registration review decision.

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. Changes in science, public policy, and pesticide use practi ces will occur over time. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practi ces change, all registered pes ticides continue to meet the statutory standard. The public pha se 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-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.

Comments Received on Preliminary Work Plan

The comment period for the benfluralin registrati on 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 Ta sk Force (FESTF), the Physicians Committee for Responsible Medicine (PCRM), and techni cal 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-da y Inhalation study (OPPTS 870.3465) and the Oncogenicity-mouse study (870.4200b), both of whic h were unsatisfied requirements of the4 2006 Benfluralin DCI. The Neurotoxicity batt ery (acute and subc hronic) (OPPTS 870.6200) requirement was also removed. The comments recei ved 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 Dock et for Benfluralin” dated May 15, 2012, the Agency memo “Benfluralin: Summary of Hazard and Science Policy Council (HASPOC) Meeting of April 26, 2012: Reco mmendations on the need for inhalation, neurotoxicity battery (acute a nd 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 fo r inhalation, neurotoxicity batte ry (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 Fa te and Ecological Problem Formulation

Comment 1: PCRM Passerine data may be available to fu lfill 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 OE CD Acute Avian Oral Sequential Dose Study Guideline (TG223) and has determined that TG 223 performed generally as well as EPA OPPTS Guideline 850.2100 regarding information on the LD 50 value, slope, and observation of sublethal effects. A study conducted using TG 223 may be classified as ‘accepta ble’ if it is scientifically valid, conducted using the ‘LD 50 – slope test’ or ‘limit dose test ’ guidelines, and meets certain

other criteria. Studies that devi ate from these criteria may be classified as ‘acceptable’ or ‘supplemental’ if they are considered adequate fo r 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 de viates from the criteria.

Comment 2: DAS The study by Hicks for Oyster Acut e Toxicity (GLN 850.1025) has been previously classified as "supplemental" primarily on the grounds that a sp ecific 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 scientifi cally sound but does not satisfy the guideline requirement for an acute estuarine mollu sk toxicity study because a definitive endpoint (the IC 50 ) could not be calculated from the study. Other deviations from study guidelines

contributed to the lack of suffici ent data to assess risk to th ese organisms, including a much5 shorter acclimation period (2 days) than the OCSPP recommenda tions of 12-15 days. Also, the TOC of the dilution water was not reported, and th e study author reported that each treatment

tank received more diluted con centrate shellfish diet during exposure than OCSPP guidelines suggest. EPA believes that a we ll designed flow-through study woul d reduce the fluctuations of

dissolved benfluralin to be within the OCSPP guidelines. Th is 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-Vascul ar 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 termin ation, 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 techni cal due to factors including re ported 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 wa s 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 eff ects observed, the test was only conducted for 72

hours instead of the recommended 96-120 hours. Al so, 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 n eeded to estimate the risk to aquatic plants from benfluralin exposur e and reduce uncertainties associated with the current risk assessment for plants, which form the basis of many habita ts and significantly

contribute to overall environmenta l quality. The data will also be used to determine whether affects to Federally-listed thre atened and endangered species are likely under the Endangered Species Act.

Comment 4: DAS DAS agrees to provide the Fish Acute T oxicity Test with th e bluegill sunfish (GLN 850.1075), the Aquatic Inve rtebrate Life Cycle study (F reshwater) (GLN 850.1300), and the Avian Acute Oral Toxicity Test (Passeri ne Species) (GLN 850.2100). DAS also agrees to provide the passeri ne study protocol for this guideline. DAS will be submitting a study by Memmert, U. (2003, Study ID: 842140) for the W hole Sediment chronic Invertebrates, Freshwater and Marine study re quirement (40 CFR Part 158 (U SEPA, 2007a)), and a recent study by Knoch and Heim for the Laboratory Vo latility 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.6 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) requi rement and the Acute Toxicity Freshwater Invertebrate (GLN 850.1010) requi rement. 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 toge ther with data from the "core" Early Life Stage study by Cocke (1990) are considered sufficient to provi de realistic and mean ingful data for the

evaluation of the chronic effects on fish resu lting from exposure to a substance of low persistence in the aquatic e nvironment. To satisfy the Seedling Emergence Terrestrial Plant Toxicity Test, Tier II (GLN 850.4100) and Vegetative Vigor Terrestrial Plant T oxicity 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 He rtl 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 th e 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 e xposure. 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 subs equent rebuttal to the Agency decision regarding that study by Huds on (2010) was submitted to the EPA on August 24,

2010 and the EPA evalua tion 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 determ ined 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 inte rpret, thus the guideli ne requirement remains

unfulfilled.

Comment 7: DAS DAS disagrees that no data are availabl e for the Aerobic Aquatic Metabolism Half-life (20 o C) because an aquatic degradation st udy is available (Knoch and Heim, 2002)

which shows that Benfluralin eith er rapidly volatilizes or dissipa tes 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.7 Comments Related to the Human Health Risk Scoping Document

Comment 8: PCRM With respect to the Acute and Subc hronic Neurotoxicity (870.6200) data requirements, we encourage this test requireme nt be reconsidered. In the past both EPA and European Food Safety Authority (EFSA) have c hosen 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 neurotox icity battery be rec onsidered. 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 ingredie nt and the exposure assessments (including worker exposure), the potential for human exposure is id entified to be very low.

EPA Response 8: Based on a weight of evidence (WOE) a pproach considering all the available hazard and exposure information for benflura lin, the Hazard and Science Policy Council (HASPOC) concludes that the acu te/subchronic oral neurotoxicit y studies in the rat are not required for benfluralin at this time.

Comment 9: PCRM In 2011, CropLife America (CLA) submi tted a retrospectiv e analysis of immunotoxicity studies that indicated such studies do not provide additional information for risk assessment purposes. The Agency is also conducting its own retrospe ctive analysis, and should complete the review before calling for addi tional immunotoxicity studies.

DAS DAS recommends the need for the immunot oxicity study be reconsidered. Based on the available toxicity data from the repeat dos e studies, benf1uralin does not appear to present any immunotoxicity hazard. In addition, an indu stry effort in cooperation with US EPA is currently underway to evaluate the impact of this data requi rement on the risk assessment.

EPA Response 9: The Agency acknowledges that the s ubmission 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 retros pective analysis suggest that immunotoxicity studies have not yet provided lower PoDs than are selected from othe r 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 registra tion review chemicals.

Comment 10: DAS A 28-day inhalation study is unnecessa ry 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 re quired the reduction of application rates to a maximum single rate of 2 lb a.i./A as opposed to th e rates of 3, 4 and 6 lbs a.i./A used for many of the risk assessment calculations.8 EPA Response 10: The HASPOC concludes, based on a WO E approach, that a repeated dose inhalation toxicity study is not re quired at this time. However, additional characte rization of the use pattern, and potential for intermediate-t erm inhalation exposure is suggested. The intermediate-term inhalation exposure assessment that was performed in 2003 is considered a highly conservative estimate of actual occupatio nal inhalation exposure. It is likely that agricultural workers are e xposed to benfluralin for a series of short-term exposures, rather than continuously over 6 months.

Comment 11: DAS DAS strongly disagrees th at the mouse oncogenicity requirement is not satisfied, and made extensive comments supporti ng the position that the conduct of a new study is unlikely to provide any valuable new in formation on carcinogenic potential and is not

warranted.

EPA Response 11: Based on a WOE approach, considering a ll the available h azard and exposure information for benfluralin, the HASPOC conclude s that the carcinogenicity study in the male mouse is not required for be nfluralin 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/ Fe ncerows/ Hedgerows, Industrial Construction Areas (Outdoor), and use patterns such as fo r 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 a nd endangered species, while Dintec Agrichemicals is not a member and ther efore 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 analys is of benfluralin use and endangered species locations, and fulfill the requirements indica ted 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.9 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. The 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 GLN 835.1410 – Laboratory Volatility

Ecological Effects

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

o GLN 850.2100 – Avian Acute Oral Toxi city Test (Passerine species)10 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 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 if toxicological endpoints change or other ne w data are received by the Agency which impact exposure estimates.11  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, this change has not been made to all benfluralin labels and EPA is working w ith 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 anticip ates 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 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 existing 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).12 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/

.

Timeline

The projected timeline for completion of the benflu ralin 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) 613 Next Steps

The Agency plans to conduct a human health ri sk assessment and comprehensive ecological risk assessment, including an endangere d species risk assessment, for be nfluralin. 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 re gistrants in February 2006 to address data gaps identified in the 2004 RED. These da ta, along with the an ticipated registration review data requirements that are required, su bmitted, 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 mari ne 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