Docket Number: EPA

- HQ

- OPP

- 2010

- 0855

www.regulations.gov



## Cloransulam

- Methyl Summary Document Registration Review : Initial Docket

December 20 103 

### TABLE OF CONTENTS

Page

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 1 1

________________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's current position on cloransulam

- methyl based on the following documents:

1. Registration Rev iew : Problem Formulation for Environmental Fate, Ecological Risk

, Endangered Species, and Drinking Water Exposure Assessment s for Cloransulam

- Methyl ( PC Code 129116 )

. (DP Barcode: D 379667

, December 10, 2010 )

.

2. Cloransulam

- Methyl. Registration Review Sc oping Document for Human Health

Assessments (DP Barcode: D 378194

, November 4, 2010 )

.

3

. BEAD Chemical Profile for Registration Review: Cloransulam

- methyl (129116). (November 29, 2010)

4. Cloransulam: Review of Human Incidents (DP Barcode: D381109

, Augus t 24, 2010 )

These and other supporting documents for the cloransulam

- methyl registration review case may
be found in the docket EPA

- HQ

- OPP

- 2010

- 0 855 at www.regulations.gov.4



### I. Preliminary Work Plan

Introduction: The Food Quality Protection Act of 1996 (FQPA) 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 no t 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 register ed 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 A gency 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 r e gistration r eview 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. T he 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 an d 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 an d commit to a final work plan and schedule for the registration review of

cloransulam

- methyl

.

Cloransulam

- methyl is a triazolopyrimidine sulfonamide her b icide which is currently registered
for use solely on soybeans to control broad leaf weeds by way of plant enzyme inhibition

. T he re are seven end

- use registrations and one technical product containing cloransulam

- methyl

. Cloransulam

- methyl was first registered in 1997 and, therefore, was not subject to the reregistration requirements of FIFRA.

Antici pated Risk Assessment and Data Needs: During registration review t he Agency anticipates conducting comprehensive human health and ecological risk assessment s , including an endangered species assessment

, for cloransulam

methyl

.

Ecological Risk :

The most recent comprehensive cloransulam

- methyl ecological risk assessment

was conducted for the initial chemical assessment in 1997.

Environmental fate data on cloransulam

- methyl are anticipated to be needed to
better understand

, for example, its biotic degrada tion. Also, environmental e ffects
data are anticipated to be needed to complete the Agency’s understanding of the potential acute effects to freshwater invertebrates as well as chronic effects to5 freshwater and estuarine/marine fish and invertebrates for which no effects data is
available.

The Agency anticipates needing the following data in order to conduct a comprehensive ecological risk and endangered species assessment for
cloransulam

- methyl

.

o (GLN 835.4200) Anaerobic Soil Metabolism

o (GLN 835.43 00 ) Aerobic Soil Metabolism

o (GLN 835.4400 ) Anaerobic Aquatic Metabolism

o (GLN 835.6100 ) Freezer Storage Stability and Analytical
Method

- sediment (with Independent Laboratory Validation) for Residues

o (GLN 850.1010 ) Acute Freshwater Invertebr ate Toxicity Test

o ( GLN 850.1300 ) Freshwater Invertebrate Life Cycle Toxicity

Test

o (GLN 850.1400 ) Fish Early

- Life Stage Toxicity Test,
Freshwater

o (GLN 850.2100) Avian Acute Oral Toxicity (passerine species)

o (GLN 850.2300) Avian Reprod uction Test (Bobwhite quail)

o (GLN 835.4200) Anaerobic Soil Metabolism

o (GLN 850.4225 ) Terre strial Plant Seedling Emergence, Tier II

o (GLN 850.4250 ) Terrestrial Plant Vegetative Vigor, Tier II

o (GLN 850.4400 ) Aquatic Plant Growth Tier II Study (v ascular plants)

o (GLN 850.5400 ) Algal Toxicity Study, Tier II

The Agency has not c onducted a n ecological risk assessment that supports a complete endangered species determination for cloransulam

- methyl . The ecological risk assessment planned during registration review will allow the Agency to determine
whether the use of cloransulam

- methyl has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats.6

When an assessment concl udes 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 (FWS) and/or National Marine Fisheries Service (NMFS) (the Services), as appropriate.

Please refe r to the document: Registration Review: Preliminary Problem Formulation for
Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Cloransulam

- methyl

, a more detailed discussion of the anticipated ecological ri sk assessment and data needs available in the docket

.

Human Health Risk : A comprehensive human health risk assessment was conducted for the initial chemical

assessment in 1997.

The Agency anticipates requiring the following studies, in accordance with the revised

40 CFR

, Part 158 , to conduct a comprehensive human health risk assessment for the registration review of cloransulam

- methyl

.

o (GLN 870.6200) 90 day Neurotoxicity

- rat

o (GLN 870.7800) Immunotoxicity

Based upon the anticipated data, and change s to various science policy and assessment methodolog ies implemented since the completion of the previous human health risk

assessment for cloransulam

- methyl, t he Agency will examine the toxicological database as a whole including all points of departure a nd uncertainty factors during the registration
review of cloransulam

- methyl

.

A drinking water assessment will be conducted and incorporated into a revised dietary
risk assessment. The assessments will reflect current models and methodologies, as well

as any updated hazard information.

The tolerance expression in 40 CFR §180.514 will be revised during registration review to ensure that it appropriately covers the metabolites and degradates of cloransulam

methyl, and that it specifies the residues to be me asured for each commodity.

The Agency’s residue chemistry database for cloransulam

- methyl is complete and sufficient for risk assessment purposes

.

There are no residential uses associated with cloransulam

- methyl registrations

, therefore

, the anticip ated aggregate risk assessment will include only dietary exposure (food + drinking water)

.7

T he Agency anticipate s conducting an occupational handler and post

- application r isk assessment during the r e gistration r eview of cloransulam

- methyl to incorporate current assessment methodologies

.

Please refer to the document: Cloransulam

- Methyl. Registration Review Scoping Document for Human Health Assessments a more detailed discussion of the anticipated
human health risk assessment and data needs, available in the docket.

Other Data Needs: GLDN 830.7050 UV/Visible Light Absorption

– this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requirements) for registration of a pesticide (food and non

- food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s identity/composition and the wavelengths at which the compound may be susceptible to photochemical degradation.

Endocrine Disruptor Screening Program:

For all pesticides that result i n residues in foods, EPA reviews numerous studies that bear on a pesticide's potential endocrine effects. (71 FR at 43921). These include data on developmental toxicity, reproductive toxicity, subchronic toxicity, chronic toxicity, and cancer. Developmenta l studies evaluate several endpoints susceptible to endocrine influence including effects on maternal animal fertility and pregnancy rates and on pup viability and sex ratios in pups. (71 FR at 43921). As part of the 1997 registration, EPA reviewed these d ata and concluded that the most appropriate and conservative regulatory endpoint was based on increased levels of alkaline phosphatase in the liver . However, as required by FFDCA section 408(p), cloransulam

- methyl will be subject to endocrine screening part of the Endocrine Disruptor Screening Program (EDSP)

As required under FFDCA section 408(p), 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 b y the substance, and establish a dose

- response relationship between the dose and the E, A, or T effect.

EPA has announced that it would begin to expedite the required EDSP testing of pesticides by conducting the testing in parallel or as part of the OPP R egistration Review program. Recently, EPA published a list of candidate chemicals based, in part, on pesticides that were scheduled for8

Registration Review during fiscal years 2007 and 2008. C loransulam

- methyl was not on that list. But as part of the Re gistration Review of cloransulam

- methyl EPA will issue an EDSP test order/data call in to require that testing. Once all required Tier 1 and Tier 2 data have been received and reviewed, the points of departure and safety factors used for risk assessment

p urposes should be reexamined and a new risk assessment performed if necessary.

Timeline: EPA has created the following estimated timeline for the completion of the registration review of
cloransulam

- methyl

.

Registration Review for Cloransulam

- methyl

– Projected Registration Review Timeline

Activities Estimated Date Opening the docket
Open Public Comment Period for the Cloransulam

- methyl Docket 2010

– December

Close Public Comment Period 201 1

– February Case Development
Develop Final Work Pla n (FWP) 201 1

– May

Issue DCI 201 2

– Jan.

– Mar.

Data S ubmission 2014

– Jan.

– Mar.
Open Public Comment Period for Preliminary Risk Assessments 201 5

– Jul.

– Sept.

Close Public Comment Period 2015

– Oct.

– Dec.
Registration Review Decision
Op en Public Comment Period for Proposed Reg. Review D ecision 201 6

– – Jan.

– Mar.

Close Public C omment P eriod 2016

– Apr.

– June Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 201 6 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 fina l work plan for the cloransulam

- methyl 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 an d 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 natur e of the concern.9

Water Quality
Cloransulam

- methyl is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for cloransulam

methyl

, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p _pollutant_group_id =885&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and
TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality d ata 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 Process (see: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitatively i n pesticide risk assessments.

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,
and enf orcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on m any groups or segments of the population who, as a result of their location, cultural practices, or other f actors, may have atypical, unusually high exposure to cloransulam

- methyl , c ompared 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.

Other Information Stakeholders are also specifically asked to provide information and data that will assist the Agency in refining the risk assessment s , including any species

- specific ecological effects
determinations.

The Agency is interested in receiving th e following information:

1. use history

2. directly acquired county

- level usage data (not derived from state level data)

a. total pounds per year ( county level)
b. the year the pesticide was last used in the county/sub

- county area

c. the years in which the pesticide wa s applied in the county/sub

- county area
3. typical interval (days)

4. state or local use restrictions

5. ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian

, insect (e.g., honey bees) and mammalian mortalities) not already reported t o the Agency

. 6. monitoring data10

Next Steps:
After the 60

- day 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 cloransulam

- methyl registration review case

.11

II. F ACT SHEET

Background Information : The cloransulam

- methyl PC Code is 129116 and the CAS# is 147150

- 35

- 4

. The t echnical registrant is Dow Argosciences

, LLC.

Cloransulam

- methyl was f irst registered as a n end

- use product in 1997

. The September 19, 1997 fi nal rule (40 CFR 180.514 ) established a tolerance for
cloransulam

- methyl use on soybean (forage, hay and seed).

There are eight active section 3 product registrations for cloransulam

- methyl: one
technical product and seven end

- use products

. Cloransulam

- m ethyl belong s to the triazolopyrimidine sulfonamide class of herbicides

. The Pesticide Re

- evaluation Division Chemical Review Manager (CRM) is James
Parker: parker.james@epa.gov

. Product Manager (PM) is James To mpkins : tompkins.jim @epa.gov

.

Use & Usage Information:

Cloransulam

- methyl is a n herbicide registered for use on soybeans to control various
broad leaf weeds

. Cloransulam

- methyl is a pplied pre

- and /or post

- emergent to soybean (hull, seed and forage). En d

- u se products are formulated as a suspension concentrate, in water soluble packages, and as a wettable powder

.

Recent Actions: There are no pending or recent actions associated with cloransulam

- methyl.

Ecological Risk Assessment Status : Please refer to the document: Registration Review: Preliminary Problem Formulation for
Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Cloransulam

- methyl in the registration review docket for a detailed summary of
the key findings of the most recent environmental fate and effects assessment

. A summary
follows :

T he initial cloranaulam

- methyl ecological risk assessment identified risk s to non

- target terrestrial plants based on Risk Quotients (RQs) ranging from <1 to 12

.

T he Agency’s Level of Concern (LOC) was not exceeded for non

- target aquatic plants

,

nor f ederally threatened and endangered (listed) or non

- listed terrestrial or aquatic organisms

.

Risk to federally listed (i.e., threatened or endangered) or non

- list ed terrestrial, aquatic organisms, or beneficial insects was not identified at the time of the initial ecological
review in 1997.12

Human Health Risk Assessment Status:
Please refer to the document: Cloransulam

- Methyl. Registration Review Scoping Docume nt for
Human Health Assessments in the registration review docket for a detailed summary of the key findings of the most recent human health assessment . A summary follows:

Ha z ard Characterization : The most consistent toxicological effect of c loransulam

- m ethyl was in the liver

, indicated by increased levels of alkaline phosphatase and increased liver weight.

Cloransulam

- methyl is categorized as T oxicity C ategory III via the dermal and inhalation

routes

. I t is neither a skin irritant n or a skin sensitiz er and is moderately toxic (toxicity category III) based on oral and dermal toxicity studies, in addition to eye irritation
studies

.

Cloransulam

- methyl is classified as “not likely ” to be a carcinogen based on lack of carcinogenicity in rat and mice studi es.

Dietary (Food and Drinking Water ): An acute dietary assessment was not conducted because n o acute endpoint was identified in the toxicity data base

.

A screening level chronic dietary risk assessment (including a screening level drinking

water assess ment) indicated that dietary exposure is below the Agency’s level of concern (LOC)

.

Residential:

Cloransulam

- methyl registrations do not contain residential uses. Therefore, a residential
assessment was not conducted.

Aggregate :
For c loransulam

- methyl, neither residential exposure exists, nor does an acute dietary
scenario exist. Hence, the previous aggregate risk assessment consisted of [chronic] food plus drinking water exp osures only. T he results were below the Agency’s level of concern

.

Occupation al:

O ccupational handler (i.e., mixers , loaders and applicators) r isks were below the Agency’s

LOC.

Cumulative : The Agency does not currently hav e data to determine whether cloransulam

- methyl shares a

common m echanism of toxicity with other substances

. A s a result, the Agency has not made a common mechanism of toxicity finding for cloransulam

- methyl a n d any other substances

, and cloransulam

- methyl does not appear to produc e a toxic metabolite that is produced by
other substances which have tolerances in t he U.S. Therefore, EPA has not assumed that
cloransulam

- methyl has a common mechanism of toxicity with other substances.13

Agricultural Health Study : Cloransulam

- methyl is among several agricultural chemicals included in the Agricultural Health Study (AH S). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and Health (NIOSH). Designed as a large long

- term epidemiological study, the AHS collects and analyzes data on the health and work practices of nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease developed. The study focuses particul arly on farmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall health outcomes for people who differ in whether they have had exposure to various ch emicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they can show some statistical associations.
More information on the AHS can be found at: http://aghealth.nci.nih.go v

. EPA is monitoring the results of the AHS and will consider this study in the registration review
of cloransulam

- methyl as appropriate.

Past cloransulam

- methyl risk assessments rely in part on data from studies in which adult human subjects were int entionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database 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 evid ence 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. A ll applicable requirements of EPA’s Rule for the

Protection of Human S ubjects of Research (40 CFR Part 26) have been satisfied , and

t here is no regulatory barrier to continued reliance on these studies

.

Incident Reports : The Agency ’s Incident Database System (IDS) identified two low severity (minor, unknown or no effects) incidents associated with human incidents involving cloransulam

methyl . IDS also identified one moderate high severity cloransulam

- methyl incident. This incident involved an adult male who got cloransulam

- methyl on his hands and then
washed his hands 30 minutes later, which resulted in a full body rash on the following day.

Preliminary reviews of the Ecological Incident Information System (EIIS, version 2.1) and the Avian Incident Monitoring System (AIMS) identified several plant incidents
between 199 8 and 2005 , with affected areas ranging from 5 acres to 677.5 acres. No incidents involving birds were reported in the AIMS database for cloransulam

- methyl.14

Tolerances and International Harmonization : MRL’s for c loransulam

- methyl have been established for U.S . (0.02 ppm ), Mexico (0.02ppm), Canada (0.01 ppm ), and Japan (0.06ppm). No CODEX MRLs have been set
for cloransulam

- methyl. The Agency will work to harmonize tolerances/MRLs, where possible, during registration review

Data Call

- In Status: No pre vious data call

- in (DCI) was issued for cloransulam

- methyl.

Labels : Cloransulam

- methyl labels can be obtained from the Pesticide Label Sy s tem (PPLS)
website: http://oaspub.epa.gov/pestlabl/ppls.ho me

. A summary of cloransulam

- methyl labels is provided in the table below.



### Cloransulam

- methyl Products Registration

Number Product Name Active Ingredient

228

- 380 RIVERDALE 565 SELECTIVE
HERBICIDE 84%

279

- 3231 GAUNTLET 42%

279

- 3246 GAUNTLET 70 DF HE RBICIDE 7.9%

279

- 3247 GAUNTLET 70 WP HERBICIDE 7.9%

59639

- 131 GANGSTER HERBICIDE 84%

62719

- 274 CLORANSULAM

- METHYL
TECHNICAL 97.5%

62719

- 275 FIRSTRATE 84%

62719

- 299 FRONTROW 84%