Docket Number EPA-HQ-OPP-2010-0117 www.regulations.gov

Bentazon Summary Document Registration Review: Initial Docket

March 20103 TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 11

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

1. Registration Review – Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, a nd Drinking Water Assessments for Sodium Bentazon (PC Code 103901), February 5, 2010. 2. Bentazon. Human Health Assessment Scopi ng Document in Support of Registration

Review

, March 17, 2010.

3. Food/Feed & Non-Food/Non-Feed Uses Consid ered in Registration Re view Work Planning – Bentazon Sodium Salt (103901), July 20, 2009. 4. Screening Level Usage Analysis (SLUA) – Bentazon Sodium Salt 103901, August 20, 2009. 5. Bentazon Sodium Salt (103901) California DPR Usage Data, July 20, 2009. 6. Updated Review of Bentazon Incident Reports, November 24, 2009.

Additional supporting documents for the registration review of bentazon are located in docket EPAHQ-OPP-2010-0117 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Bentazon Sodium Salt

Introduction

The Food Quality Protection Act of 1996 manda ted a registration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA), based on sc ientific 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 reevaluate s pesticides to make sure that as change occurs, products in the marketplace can be used safely. Info rmation on this program is provided at: http://www.epa.gov/oppsrrd1/ registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes ar e needed to make a regist ration 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 s odium bentazon (bentazon).

Bentazon is a benzothiadiazole herbicide registered to contro l post-emergent broadleaf weeds and sedges in numerous agricultura l field crops, and around trees and vines in various fruit and nut crops. Bentazon is also registered for use to co ntrol weeds in residential and recreational lawns around ornamental plants. The Reregistration Eligibility Decision (RED) for bentazon was completed in September 1994 (available at http://www.epa.gov/oppsrrd1/REDs/0182.pdf ). In 2000, EPA reassessed tolerances of bentazon in complian ce with the Food Quality Protection Act (FQPA). (65 Fed. Reg. 12122, March 8, 2000).

In 2005, EPA received new use applications fo r bentazon for peaches and nectarines from Interregional Research Project N o. 4 (IR-4). A dietary risk asse ssment was completed in 2006 that evaluated the proposed new uses and updated drinking water exposure estimates for registered uses

of bentazon. This risk assessment showed that the existing uses of bentazon result in chronic dietary

risk estimates of concern for infants. Most of the dietary bentazon expos ure to infants is from drinking water. IR-4 subsequently withdrew th e new use requests. EPA plans to begin working with the registrant this year to address the ri sk concerns identified from existing uses. Below is a summary of the issues relevant to the registration re view of bentazon and the data the Agency plans to require.5 Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting a comprehens ive ecological risk a ssessment, including an endangered species risk assessment, for all uses of bentazon. The Agency also anticipates revising dietary, residential, aggregate, and occupational risk assessmen ts for all uses of bentazon.

Ecological Risk:

• The most recent ecological risk assessment was completed in 2005 to support the proposed

new use of bentazon to control weed s in peach and nectarine orchards.

• In a refined risk assessment for the 1994 RED, EPA concluded that registered uses of bentazon would “not likely advers ely affect” threatened and endangered mammals and birds. However, this assessment was not conducted pursu ant to current policie s. Accordingly, the Agency has not conducted a risk assessment th at supports a complete endangered species determination. The ecological risk assessment pl anned during registrati on review will allow the Agency to determine whether bent azon’s use has “no effect” or “may affect” federally listed threatened or e ndangered species (listed species) or their designated critical habitats. When an assessm ent concludes that a pesticide’s use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the

U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

• The Agency anticipates needing the following da ta in order to conduct a complete ecological risk assessment, including an endang ered species assessment for bentazon:

• GDLN 850.1300 – Aquatic Invertebrate Life Cycle (freshwater)

• GDLN 850.1400 – Fish Early Life-Stage (freshwater)

• GDLN 850.2100 – Avian Acute Or al Toxicity, Passerine

• GDLN 850.5400 – Aquatic Plant Gr owth (algal) (Tier II)

• GDLN 835.6100 (7) – Environmental Chemistry Methods – soil

• GDLN 835.6200 (7) – Environmental Chemistry Methods – sediment

Please refer to Registration Review – Preliminary Probl em Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drin king water Assessments for Sodium Bentazon (PC Code 103901) (February 5, 2010) for a more detailed discussion of the anticipated ecological

risk assessment and data needs for bentazon.

Human Health Risk:

• The most recent human health risk assessm ent for bentazon was completed in 2006 to support the proposed new use of bentazon to cont rol weeds in peach and nectarine orchards.6 • The bentazon toxicity database is not complete. EPA anticipates requiring the following guideline studies to reevaluate t oxicological endpoints for bentazon:

o GDLN 870.7800 – Immunotoxicity

o GDLN 870.6200 – Acute Neurotoxicity – Rat

o GDLN 870.6200 – 90-day Neurotoxocity – Rat

• The bentazon residue chemistry database is sufficient to support all current bentazon registrations.

• The Agency anticipates conducting a complete dietary risk assessment, which includes a refined drinking water assessment, in registra tion review to incorpor ate updated estimated drinking water concentrations , updated percent crop treated information, and potential changes to toxicological endpoi nts and safety factors.

• The Agency anticipates revising the bentazon residential risk assessment in registration review. A higher application ra te (application by commercial a pplicators only) is registered

for use on residential lawns and has not been assessed for post-application exposure. In addition, updated transfer coefficients are available for the post -application dermal assessment. Lastly, a golfer post-application a ssessment will need to be conducted as part of registration review.

• The Agency anticipates revisi ng the aggregate risk assessmen t in registration review to incorporate revised residential and dietary a ssessments as well as any new toxicological endpoints and safety factors.

• The Agency anticipates revising the occupationa l risk assessment in registration review to incorporate revised toxicological endpoints and several handler and post-application exposure scenarios that have not been previously assessed.

Please refer to Bentazon. Human Health Assessme nt Scoping Document in Support of Registration Review (March 17, 2010) available in the docket, for a detailed discussion of the anticipated human health risk asse ssment and data needs for bentazon.

Other Data Needs:

• GLDN 830.7050 UV/Visible Li ght Absorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Require ments) for registration of a pesticide (food and non-food uses). The Agency anticipates requ iring this study to obt ain basic information about the compound’s identity/composition and th e wavelengths at which the compound may be susceptible to photochemical degradation.7 Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain su bstances (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 effect s 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 a ny, 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 es tablish a quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued te st orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingr edients and 9 inert ingredients. This list of chemicals was selected based on the potential fo r human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios. This list should

not be construed as a list of know n or likely endocrine disruptors.

Bentazon is not among the group of 58 pesticide active ingredients on the initia l list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agen cy must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for all Registration Review cases, including those for which EPA has alr eady opened a Registration Review docket for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/.8 Timeline

The Agency has created the following estimated timeline for the completion of the bentazon registration review.

Registration Review for Bentazon– Pr ojected Registration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – March Close Public Comment 2010 – May Case Development Final Work Plan 2010 – August Issue DCI 2011 – April - June Data Submission 2013 – April - June Open Public Comment Period for Preliminary Risk Assessments 2014 – Oct. – Dec.

Close Public Comment Period 2015 – Jan. - March Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – April - June

Close Public Comment Period 2015 – July – Sept. Final Registration Review Decision a nd Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters

The public is invited to comment on EPA’s preliminary registration re view 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 issui ng a final work plan for the bentazon 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 re sulting 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 environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or ot her factors, may have atypical,9 unusually high exposure to bentazon compared to the general population. Pl ease comment if you are aware of any sub-populations that may have atypical, unusually hi gh exposure, compared to the general population. Water Quality:

Bentazon is not identified as a cau se of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Ac t, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=885

. In addition, no Total Maximum Daily Loads (TMDL) have been developed for bentazon, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_na tion.tmdl_pollutant_deta il?p_pollutant_group_id=88 5&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/

.

Possible chronic effects of long- term drinking water exposure prompted EPA's Office of Water to

establish a lifetime Health Adviso ry (HA) of 200 parts per billion (ppb). However, bentazon is not regulated under the Safe Drinking Water Act (SDWA); no Maximum Contaminant Level (MCL) has been established, and water supply systems are not required to sample or analyze for its residues.

The Agency invites submission of water quality data fo r 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 Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitati vely in pesticide risk assessments.

Additional Information:

Stakeholders are also specifically asked to provide information and da ta that will assist the Agency in refining risk assessments, including any species -specific ecological effects determinations. 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, a pplication intervals, and maxi mum number of applications per season and per year

f. geographic limitations on use

2. Use or potential use distribution ( e.g . geographical distributio n of relevant uses).

3. Use history.

4. Median and 90 th percentile reported use rates (lb/A, lb 1K sq.ft) from usage data – national, state and county.10 5. Application timing (date of firs t application and application intervals) by use – national, state, and county.

6. Usage/use information for non-agricultural uses.

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

a. maximum reported use rate (lb/A, lb 1K sq. ft) from usage data – county

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

c. total pounds per year – county

d. the year the pesticide was last us ed in the county/sub-county area

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

8. Typical application interval (days).

9. State or local use restrictions.

10. Ecological incidents specific to bentazon (non-ta rget plant damage and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or be neficial insect mort alities) not already reported to the Agency.

11. Monitoring data.

12. Bee toxicity data.

Next Steps: After the 60-day comment period closes, the Ag ency will consider and respond to any comments received in a Final Work Plan for bentazon, which will be issued in August 2010.11 II. FACT SHEET

Background Information:

• Bentazon registration review case number: 182

• Bentazon PC Code: 103901; CAS # 25057-89-0

• Bentazon was first registered in the United States in 1975 and was the subject of a 1994 Reregistration Eligibility Decision.

• Technical registrant: BASF Corporation.

• There are 15 FIFRA Section 3 active produc t registrations, including one technical registration.

• Pesticide Re-evaluation Divi sion Contact: Joy Schnackenbeck (schnackenbeck.joy@epa.gov)

• Registration Division Contact: Kathryn Montague (montague.kathryn@epa.gov)

Use and Usage Information: (For additional details, please refer to Food/Feed & Non-Food/NonFeed Uses Considered in Registration Review Work Planning – Bentazon (103901) , July 20, 2009, in the bentazon docket).

• Bentazon is a postemergent herbicide register ed for use to control broadleaf weeds and nutsedges on terrestrial food and feed crops, orna mental plants, residential lawns, and turf.

• Agricultural uses of bentazon include alfalf a, nuts, almonds, apples, avocados, berries, cherries, figs, flax, clover, dry beans, green beans, cabbage, melons, corn, cucumbers, peas, mint, onions, peanuts, potatoes, pumpkins, rice, sorghum, sod, soybeans, squash, sugar beets,

and tomatoes.

• The largest agricultural uses of bentazon are on dry beans and soybean s with an estimated usage of 600,000 and 400,000 pounds of activ e ingredient, respectively.

• Bentazon is formulated as a liquid and as a dry flowable water dispersible granule.

• Bentazon can be applied by airc raft, band sprayer, ground spraye r, hand held sprayer, high pressure sprayer, hose-end sprayer, b ackpack sprayer, and pump-up sprayer.

Ecological Risk Assessment Status

Please refer to Registration Review – Preliminary Probl em Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drin king water Assessments for Sodium Bentazon (PC Code 103901) (February 5, 2010) for a more detailed discussion of the anticipated ecological

risk assessment and data needs for bentazon. A summary follows:

• The primary environmental concerns identified in a 1993 screening level risk assessment for

the 1994 RED were risks of concern to terrestria l plants in uplands and semi-aquatic habitats

as well as chronic risk to bird s. However, the chronic risk concern for birds was based on a supplemental study, in which the ob served adverse effects were not statistically significant.

• In 1994, EPA did a refinement of the screening- level risk assessment that was conducted for the RED. The 1994 assessment used exposure fact ors and scenarios that were more realistic12 for actual bentazon use and potenti al exposures for endangered mamm al and bird species. In this refined assessment, EPA concluded that re gistered uses of bent azon would “not likely adversely affect” threatened and endangered mammals and birds.

• In 1997, new avian reproduction studies were completed and have been categorized as fully acceptable (MRID 44337801 and 44227402). Th ese studies found no sign ificant adverse effects at 800 ppm, the highes t level tested.

Human Health Risk Assessment Status

The following are key findings of the human he alth risk assessments conducted to support bentazon’s registered uses. Please refer to Bentazon. Human Health Assessment Scoping Document in Support of Registration Review (January 28, 2010) located in the docket for a detailed discussion

of the human health risk assessment status.

Hazard Characterization:

• Bentazon has low acute toxicity via the oral, inhalation and dermal routes of exposure. Bentazon is irritating to the eye, slightly irrita ting to the skin, and is also a skin sensitizer.

• Bentazon is classified as a group E carcinogen “evidence of non-carcinogenicity for

humans.” This classification is based on the l ack of evidence of carcinogenicity in mice and

rats in a 1992 car cinogenicity study.

• An FQPA 10x safety factor ha s been retained for assessing acute risk from dietary and residential exposure to females 13-49 years and for assessing chronic risk from dietary and residential exposure to all population subgroups. This decision was based on evidence of increased susceptibility following in utero exposure to bentazon in the prenatal developmental toxicity study in rats in the ab sence of maternal toxi city, and quantitative evidence of increased susceptibility following pre- and post- natal exposure to bentazon in the two-generation reproduction study in rats.

Dietary:

• In the 2006 dietary risk assessment conducte d for the general U.S. population and all population subgroups, risk from acute dietary exposure (food + water) to females 13-49 did not exceed the Agency’s level of concern (< 1% of the acute population adjusted dose (aPAD)). No acute dietary exposure asse ssment was performed for the general U.S. population (including infants and children) because no toxicological endpoint was applicable.

• However, the same 2006 dietary risk assessment did show chronic risk of concern to infants from registered bentazon uses (135% of th e chronic population adjusted dose (cPAD)). Dietary exposure from drinking water alone for infants exceeded the Agency’s level of concern (115% of the cPAD).

Residential and Recreational:13 Handlers:

• Residential handlers are likely to be exposed to bentazon residues via dermal and inhalation routes during mixing, loading, a nd application. EPA expects th e duration of these exposures to be short-term (1-30 days).

• In the most recent residential risk assessmen t completed in 1999, only short-term inhalation exposures were assessed because no short-term de rmal toxicity was seen in a 21-day dermal toxicity study on rabbits. These exposures did not result in risks of concern.

Post-application :

• There is a potential for short- and intermediate -term post-application exposure to adults and

toddlers from use of bentaz on on residential lawns.

• In the most recent residential risk assessm ent completed in 1999, only intermediate-term dermal exposure, and intermediate-term, non- dietary ingestion exposure for toddlers were assessed. These exposures did not result in risks of concern. S hort-term non-dietary ingestion exposure to toddlers was not asse ssed because no toxicological endpoint was applicable.

• However, this risk assessment did not incor porate residential post-a pplication exposure from the highest registered applic ation rate on turf, post applic ation exposure to golfers and updated transfer coefficients.

A ggregate:

• In the 2006 human health risk assessment, aggr egate short- and interm ediate-term risk did not exceed the Agency’s level of concern.

• Aggregate long-term risk for infants did exceed the Agency’s level of concern based on dietary exposures from drinking water.

Occupational:

• In the 1994 RED for bentazon, the following crops/us e sites were assessed: alfalfa, beans, corn, peanuts, peas, pepper, peppermint, rice, sorghum, soybeans, spearmint, and ornamental lawns and turf. Several occupational exposure assessments were also completed after the RED to evaluate new uses (flax, clover grown for seed and peas).

Handlers:

• Occupational handlers are likely to be expos ed to bentazon. Previous occupational assessments evaluating short- and intermediate -term exposure did not exceed the Agency’s

level of concern.

• However, several occupational handler scen arios have not been assessed previously.

Post-application :

• There is the potential for occupational post-a pplication exposure to bentazon. Previous occupational assessments evaluating post-appli cation exposure did not exceed the Agency’s

level of concern.

• However, several occupational pos t-application scenarios have not been assessed previously.14 Cumulative:

• EPA has not made a common mechanism of t oxicity finding for bentazon and any other substances, and bentazon does not appear to produce a toxic metabolite produced by other

substances.

Human Studies

Past bentazon risk assessments rely in part on data in generic databases from studies in which adult human subjects were intentionally exposed to a pe sticide to determine their dermal and inhalation exposure. Many such studies, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Non-dietary Exposure Data base and the Pesticide Handler Exposure Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and convi ncing evidence that any of them were either fundamentally unethical or signifi cantly deficient relativ e to standards of et hical research conduct prevailing when they were conducted. There is no regulatory barrier to c ontinued reliance on these studies, and all applicable require ments of EPA’s Rule for the Pr otection of Huma n Subjects of Research (40 CFR Part 26) have been satisfied.

Incidents

• In October 2009, a preliminary review of the Ecological Incident Information System (EIIS) Database identified only two incidents associated with bent azon. One incident was a bee kill

in which residues of bentazon and the insecticide dimethoate were detected in the dead bees. Dimethoate is much more toxic to bees; theref ore, the report classified this incident as “unlikely” for bentazon. The second incident in EIIS involved damage to a peanut crop from direct application of bentazon al ong with four other he rbicides. This inci dent was classified as “possible” for bentazon. In addition to the in cidents in EIIS, incident s were reported to the agency by registrants under FIFRA (6)(a)(2). There have been 39 aggregated minor plant

incidents associated with sodium salt of bent azon and one minor plant incident associated with bentazon. The registrants have reporte d no minor fish and wildlife incidents and no minor other nontarget incidents.

• On November 24, 2009, an updated review of bent azon human incident reports was prepared by consulting the OPP Incident Data System (IDS). In the United States, from 2002 to the present, two incidents were reported for th e single chemical, bentazon. The symptoms appear generic and are not confirmed to be re lated to exposure. Based on the low number and low severity of human incident cases, ther e does not appear to be a risk concern that warrants future investigation.

Tolerances and International Harmonization

U.S. tolerances for bentazon are listed under 40 CFR §180.355. The U.S., Mexico, Canadian, and Codex residue definitions for crops are harmonized. However, there are discrepancies between the15 U.S. and Codex residue definitions fo r livestock commodities. Additionally, t here are several

commodities for which the U.S. tolerances are not harmonized with other countries’ maximum residue limits (MRL). Specific limits which do not appear to be harm onized include: bean, succulent; corn, field, grain; corn, field, stover; flax, seed; pea, dry, seed; pea, succulent; rice, grain; sorghum, grain, grain; and milk.

Data Call-In Status

A Data Call-In was issued in 1994 pursuant to th e Bentazon RED. There is only one outstanding data requirement – a prospective ground water (PGW) study. In BASF’s 90-day DCI response, BASF submitted a waiver request and supporting water monitoring data for the PGW study. This data did not fulfill the PGW data requirement. However, this wavier request was never formally granted or denied. On January 5, 2010, BASF submitted a new waiver request for this study and new additional ground water monitoring information generated by various federal and state agencies. The Agency is currently reviewing this waiver request and will issue a response this spring.

Labels

Active Section 3 labels for bentazon can be obt ained from the Pesticide Product Label System (PPLS) website: http://oaspub.e pa.gov/pestlabl/ppls.home.