1 Docket Number EPA

- HQ

- OPP

- 2011

- 0706 www.regulations.gov



## Tralkoxydim Summary Document Registration Review: Initial Docket September 20113 TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 1 2

III. Su mmary of Data Gaps 18

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

1. Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Spe cies, and Drinking Water Exposure Assessments in Support of Registration Review of Tralkoxydim

. September 13 , 2011.

2. Tralkoxydim . Human Health Assessment Scoping Document in Support of Registration Review

. September 1 9 , 2011.

3. Tralkoxydim : Review of Hum an Incidents

. May 17 , 2011.

4. BEAD Chemical Profile for Registration Review: Tralkoxydim (121000) . September 2 6

, 2011.

5. Tralkoxydim California Department of Pesticide Regulation Usage Data

. January 4,

2010

.

6. Tralkoxydim (121000) Screening Level Usage Ana lysis (SLUA)

. December 17 , 2010.

7. PRD Appendix A: Food/Feed & Non

- Food/Non

- Feed Uses Considered in Registration Review Work Planning

. Tralkoxydim (121000)

. January 14, 2011

.

S upporting documents for the registration review of tralkoxydim are located in docket EPA

- HQ

OPP

- 2011

- 0706 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration rev iew program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the

environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safel y. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

The Agency is implementing the registration review program pursuant to Section 3(g) of the

Fe deral Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The Agency will consider benefits information and data as re quired 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 i t believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop and commit to a final work plan and

schedule for the regis tration review of tralkoxydim

.

Tralkoxydim is a sys temic, postemergence herbicide registered for agricultural use to select ively

control certain annual grass weeds in wheat

, barley

, and triticale

. Target weeds include wild oats, green foxtail, yellow fox tail, annual ryegrass (Italian), and Persian darnel. There are currently no residential uses. Tralkoxydim was first registered in the U.S. in 19 9 8 ; therefore, it was not subject to the reregistration requirements of FIFRA.

Anticipated Risk Assessment a nd Data Needs

The Agency anticipates conducting comprehensive human health and ecological risk

assessment s , including an endangered species risk assessment, for all uses of tralkoxydim

. The Agency anticipates needing data for use in conduct ing these asse ssments. Below is a summary of the issues relevant to the registration review of tralkoxydim and a list of the anticipated data requirements.5 Ecological Risk:

**•** The most re cent ecological risk assessment was a Section 3 review conducted in 1998 in

suppo rt of new uses of tralkoxydim on wheat and barley

.

**•** The Agency anticipates conducting an updated environmental fate and ecological risk

assessment for tralkoxydim , including an endangered species assessment, during registration review. The new assessment will incorporate the most up

- to

- date modeling methodologies, updated toxicological endpoints, and any new data submitte d and determined to be adequate

.

**•** The Agency has not conducted a risk assessment that supports a complete endangered species determinatio n for tralkoxydim

. The ecological risk assessment planned during registration review will allow the Agency to determine whether tralkoxydim ’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their d esignated 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 ( US FWS) and/or National Marine

Fisheries Ser vice (NMFS) (the Services), as appropriate.

**•** Data gaps exist in the environmental fate and ecological toxicity database for tralkoxydim

and two of its degradates

. The Agency anticipates needing the following data for use in

conduct ing a complete ecologica l risk assessment, including an endangered species assessment, for tralkoxydim and its degradates :

Environmental Fate

o Guideline Number 835.43 00

– Aerobic Aquatic Metabolism with Compounds 8 and

17

Ecological Toxicity

o Guideline Number 850.1400

– Fish Earl y Life

- stage Toxicity Test (freshwater) with tralkoxydim TGAI

**•** The Agency seeks additional information, particularly information on the use and usage of tralkoxydim on triticale

, for use in conduct ing a refined, complete ecological risk assessment, includi ng an endangered species assessment for tralkoxydim . For further details, s ee the “Guidance for Commenters” section below.

**•** Please refer to the Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposur e Assessments in Support of Registration Review of Tralkoxydim , dated September 13 , 2011

, located in docket6 EPA

- HQ

- OPP

- 2011

- 0706 at www. regulations.gov, for a more detailed discussion of the anticipated ecological risk assessment and data needs.

Human H ealth Risk:

**•** The most recent human health risk assessments were conducted in the 1999 Health Effects Division Risk Characterization Document for the First Food Use of Tralkoxydim in/on Wheat and Barley

.

**•** During registration review, the endpoints, doses, an d safety factors used in the most

recent human health risk assessment s 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 updated dietary (food and wat er) , aggregate, and occupational exposure risk assessments to include any changes in toxicological endpoints, doses, and procedures for risk assessment.

**•** The Agency also anticipates conducting an updated drinking water exposure risk assessment during reg istration review.

**•** Currently, there are no registered residential uses for tralkoxydim or uses that would result in residential exposure. However, residential bystander inhalation exposures resulting from off

- site transport (e.g., spray drift or volatiliz ation) may occur as a result of applications of tralkoxydim . The Agency is in the process of examining its policies

and refining the methods used to complete residential exposure assessments

. Therefore, the potential need for a bystander inhalation risk assessment for tralkoxydim will be examined during registration review.

**•** During registration review, th e Agency anticipates conducting both an occupational

handler exposure risk assessment and an occupational postapplication exposure risk

assessment base d on updated doses, endpoints, and procedures for risk assessment

.

**•** The tolerance expression for tralkoxydim in 40 CFR § 180.548 will be reviewed during registration review to ensure that it appropriately covers the metabolites and degradates

of tralkoxydim 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.7 **•** The toxicity database for tralkoxydim is complete except for the following studies, which

the Agency anticipates requiring for use in conduct ing an updated human health risk

assessment:

Toxicology Data

o Guideline Number 870.6200

– Acute and Subchronic Neurotox icity

o Guideline Number 870.7800

– Immunotoxicity

**•** Please refer to Tralkoxydim . Human Health Assessmen t Scoping Document in Support of Registration Review  ̧ dated September 1 9 , 2011

, available in docket EPA

- HQ

- OPP

- 2011

- 0706 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 carcinoge nicity, 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 cyclic ity, 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

ta xonomic groups. As part of its most recent registration decision, 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), tr alkoxydim is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans o r 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

intera ct 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 effe cts 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 order s/data call

- ins for the first group of 678 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Tralkoxydim is not among the group of 58 pesticide active ingredients on the initial list to be screened under

the EDSP. Accordin gly, as part of registration review, EPA will issue future EDSP orders/data

call

- ins, requiring the submission of EDSP screening assays for tralkoxydim

. For further

information on the status of the EDSP, the policies and procedures, the list of 67 chemica ls, 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 the completion of the tralkoxydim registration review is presented in

Table 1.

Table 1. Projected Tralkoxydim Registration Review Timeline Activity Estimated Date Opening the D ocket Open Docket and Open Public Comment Period 201 1

– September

Close Public Comment Period 2011

– November Case Development

De velop Final Work Plan (FWP) 2012

– February

Issue Data Call

- In (DCI) 201 2

– Oct.

– Dec.

Data Submission 2014

– Oct.

– Dec

. Develop Preliminary Risk Assessments and Open Public Comment

Period 201 6

– April

– June

Close Public Comment Period 2016

– July

– Sept. Registration Review Decision Develop Proposed Registration Review Decision and Open Public

Comment Period 2016

– Oct.

– Dec

.

Close Public Comment Period 2017

– Jan.

– March

Issue Registration Review Decision and Begin Post

- Decision Follow

- up 20 1 7 Total (years) 69 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, prio r to is suing a final work plan for the tralkoxydim case

.

Trade Irritants

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution . Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regard ing the nature of the concern.

Environmental Justice

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation,

and e nforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to tralkoxydim compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure, compared to the general population.

Water Quali ty

Tralkoxydim is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 1

. In addition, n o Total Maximum Daily Load s (TMDL s ) have been developed for tralkoxydim 2 . More information on i mpaired water bodies

and TMDLs can be found at the Agency’s website 3

. The Agency invites submission of water quality data for th is 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 4 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

1 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

2 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PEST ICIDES

3 http://ww w.epa.gov/owow/tmdl/

4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm10 Other Inform ation

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

- specific ecological effects

determinations

, for tralkoxydim . The Agency is interested in receiv ing the following

information:

1. Confirmation on the following label information

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates

e. frequency of application, application intervals, and maximum number of application s per season and per year

f. geographic limitations on use

2. Use or potential use distribution ( e.g

. , acreage and geographical distribution of relevant uses/use sites)

3. Use history

4. Median and 90 th percentile reported use rates (lb s a ctive ingredient(ai) /acre , lb s ai/ 1 000

sq. ft

. ) from usage da ta

– national, state and county

5. Application timing (date of first application and application intervals) by us e

– national, state, and county

6. Sub

- county use site location data

7. Directly acquired county

- level usage data (not d erived from state level data)

a. maximum reported use rate (lbs ai/acre) 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 used in the county/sub

- county area

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

- county area
8. Typi cal application interval (days)

9. State or local use restriction s 10. Ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian, mammalian mortalities, and bee o r beneficial insect mortalities) not already reported to the Agency

11. Monitoring data

12. Data on the use and usage of tralkoxydim on triticale.

Next Steps

After the 60

- day public comment period closes, the Agency will review and respond to any

comments receiv ed in a timely manner and then issue a Final Work Plan for the registration

review of tralkoxydim

.11 FACT SHEET

Background Information

**•** Registration Review Case Number: 7237

**•** Pesticide Chemical (PC) Code: 12 1000

**•** Chemical Abstracts Service (CAS) Number : 87 820

- 88

- 0

**•** Tralkoxydim was firs t registered in the U.S. in 19 9 8

.

**•** Tralkoxydim was not subject to reregistration; therefore, there is no Reregistration Eligibility Decision (RED) for tralkoxydim

.

**•** T he technical registrant for tralkoxydim is Syngenta Crop Pro tection, LLC

.

**•** T here are four Section 3 registrations for tralkoxydim , including one technical product

and three end

- use products (EUP)

.

**•** U.S. tolerances for tralkoxydim range from 0.0 2 ppm to 0.05 ppm [ 40 CFR §180.548 ].

**•** Pesticide Re

- evaluation Division (PRD) Contact: Katherine St. Clair ( stclair.katherine@epa.gov )

**•** Registration Division (RD) Contact : Kable ( Bo ) Davis ( davis.kable@epa.gov )

Use a nd Usage Information

For additional details, please refer to BEAD Chemical Profile for Registration Review: Tralkoxydim (121000) , dated September 2 6 , 2011; Tralkoxydim California Department of Pesticide Regulation Usage Data , dated January 4, 2010 ; Tralko xydim (121000) Screening Level Usage Analysis (SLUA) , dated December 17, 2010 ; and PRD Appendix A: Food/Feed & Non

Food/Non

- Feed Uses Considered in Registration Review Work Planning

. Tralkoxydim (121000)

, dated January 14, 2011 ; located in docket EPA

- HQ

- O PP

- 2011

- 0706 at

www. regulations.gov.

**•** Tralkoxydim is a systemic, postemergence herbicide registered for agricultural use to selectively control certain annual grass weeds in wheat

, barley , and triticale.

**•** Specific t arget weeds include wild oats, green fo xtail, yellow foxtail, annual ryegrass (Italian), and Persian darnel.12 **•** Tralkoxydim EUP formulation types include water dispersible granules ( two products:

one 40% dry granul ar and one 80% dry granular ) and one soluble concentrate product

.

**•** Tralkoxydim a p plication methods include application by ground an d aerial equipment

. Tralkoxydim is applied directly to actively growing weeds in the registered agricultural

use sites

.

**•** A gricult ural usage of tralkoxydim is mainly on barley and wheat. According to scre ening

level es timates of the agricultural usage of tralkoxydim in the U.S. from 2000 to 2008

, t he largest use is on barley , with an average annual usage of approximately 50 ,000 pounds of active ingredient and an average of 5 percent of the barley crop trea ted

.

Recent and Pending Actions

**•** There are no recent or pending actions for tralkoxydim.

Ecological Risk Assessment Status

The following are key findings from the most recent ecological risk assessments regarding the environmental fate, ecological effec ts and risks of tralkoxydim . Please refer to the Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of Registration Review of Tralkoxydim , dated September

13 , 2011

, locat ed in docket EPA

- HQ

- OPP

- 2011

- 0706 at www. regulations.gov , for a detailed

discussion.

**•** The most recent ecological risk assessment was a Section 3 review conducted in 1998 in support of new uses of tralkoxydim on wheat and barley. Other previous ecological risk

assessments include several experimental use assessments in 1995, and Section 18 emergency exemption assessments in 1996 and 1998.

Ecological Effects:

**•** Based on toxicity data and other in formation, acute risks from the use of tralkoxydim to birds, ma mmals, aquatic plants, freshwater invertebrates, and freshwater fish were below the Agency’s level of concern (LOC) . The acute toxicity of tralkoxydim to saltwater

invertebrates and saltwater fish could not be directly assessed, due to lack of data;

howev er, risk was not assumed since freshwater fish were used as a surrogate and the

acute LOC was not exceeded.

**•** Based on toxicity data and other in formation

, chronic risks from the use of tralkoxydim to birds, aquatic invertebrates, and fish were below the Ag ency’s LOC

. The chronic13 toxicity of tralkoxydim to both freshwater and saltwater fish and saltwater invertebrates could not be directly assessed, due to lack of data; however, risk was not assumed since daphnids were used as a surrogate and the chronic LO C was not exceeded.

**•** There were acute risks of concern to listed and non

- listed species of non

- target terrestrial plants exposed to drift from aerial application from the use of tralkoxydim

.

Human Health Risk Assessment Status

The following are key find ings from the human health risk assessments conducted for tralkoxydim registered uses. Please refer to Tralkoxydim . Human Health Assessment Scoping Document in Support of Registration Review  ̧ dated September 1 9 , 2011 , located in docket

EPA

- HQ

- OPP

- 2011

- 0 706 at www.regulations.gov

, for a detailed discussion of the human health

risk assessment status.

**•** The most recent human health risk assessments were conducted in the 1999 Health

Effects Division Risk Characterization Document for the First Food Use of Tra lkoxydim in/on Wheat and Barley

.

Hazard Characterization:

**•** In subchronic and chronic toxicity studies in rats, dogs, and hamsters, the common target organ of tralkoxydim was the liver. In chronic toxicity studies in dogs and rats, the blood

was also a ta rget organ system. In chronic toxicity studies in dogs, the adrenals and thyroid were also target organs. In chronic toxicity studies in rats, the testes and eyes were also adversely affected.

**•** The HED Cancer Assessment Review Committee (CARC) classified t ralkoxydim as

“ Suggestive Evidence of Carcinogenicity, but Not Sufficient to Assess Human Potential

. ”

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

Summary of Risks:

Dietary

**•** Acute and chronic non

- cancer dietary (fo od and drinking water ) risk estimates for tralkoxydim were below the Agency’s LOC for the general U.S. population and all population subgroups

.14 Residential

**•** Tralkoxydim is not registered for use in residential settings ; therefore, potential

residential risk was not assessed

.

Aggregate

**•** Since a residential risk assessment was not conducted for tralkoxydim, acute and chronic aggregate risk assessments included only dietary (food and drinking water ) risk estimates. Acute and chronic aggregate risks were b elow the Agency’s LOC

.

Occupational

**•** Since chemical

- specific data were not available to assess potential tralkoxydim exposure to pesticide handlers, estimates were based upon surrogate study data available in the

Pesticide Handler s Exposure Database (PHED ).

**•** An occupational handler risk assessment was conducted for the registered uses of tralkoxydim. Since handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than postapplication exposure, it was assumed that the

handler inh alation exposure estimates were protective of most occupational postapplication inhalation exposure scenarios. The exposure levels from this assessment were adequate to cover the most highly exposed occupational pesticide handlers for all currently registered use patterns, and resulted in risk estimates below the Agency’s LOC.

**•** Past tralkoxydim risk assessments rely

, in part

, on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine thei r dermal and inhalation exposure s . Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Dat abase. EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to t he ethical standards prevailing at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

Cumulative

**•** The Agency has not determined whether tralkoxydim shares a common mechanism of toxicity with other chemical substances. If, in the future, EPA obtains new data15 suggesting that tralkoxydim shares a common mechanism of toxicity with ot her chemical substances, the Agency will revisit the need for a cumulative risk assessment.

Incidents

Ecological Incidents :

**•** T he Agency reviewed the Ecological Incident Information System (EIIS), which is maintained by the EPA Office of Pesticide Program s (OPP) , and the Avian Monitoring System (AIMS), which is maintained by the American Bird Conservancy, for ecological incident reports associated with the use of tralkoxydim in the U.S. The Agency also queried EFED’s Aggregate Incident Reports (AIR).

**•** T he EIIS included a total of three reports of ecological incidents in 1999, 2004, and 2005 which involved effects to terrestrial plants. For one of the incidents, the certainty that it was caused by tralkoxydim was classified as probable, and for two of th e incidents the certainty was classified as possible. The AIR database reported a total of 406 minor plants incidents between April 1, 1999 and September 30, 2000. No information was available on the degree of likelihood that the incidents in the AIR dat abase were caused by tralkoxydim, but all incidents were a scribed to two tralkoxydim products, A c h ieve SC Herbicide (Registration Number 100

- 1130) or Achieve 40 D G Herbicide (Registration

Number 100

- 1105) . The AIMS reported no bird incidents for tralkoxydi m.

Human Health Incidents:

**•** The Agency reviewed the OPP Incident Data System (IDS) for human health pesticide

incident data associated with the use of tralkoxydim in the U.S. to identify potential patterns on the frequency of health effects attributed to tralkoxydim exposure. T he IDS aggregate summaries from January 1, 2006 to March 23, 2011 include three minor cases reported for tralkoxydim

. There were no incidents reported to the Main IDS resulting in higher severi ty outcomes from January 1, 2006 to Ma rch 23 , 2011.

**•** Based on the low frequency and low severity of incident cases reported in the OPP IDS, there does not appear to be a concern at this time that would warrant further investigation

of tralkoxydim human health incidents in the preliminary risk assessment phase of registration review. However, the Agency anticipates continuing to monitor the incident information and including additional analysis in the registration review risk assessment if a concern is triggered.16 Tolerances and International Harmonization

**•** U.S. tolerances for tralkoxydim are established for residues of tralkoxydim in or on the raw agricultural commodities listed in 40 CFR §180.548

.

**•** A table listing the differences between U.S. tolerances and Canadian, Mexican, and

CODEX Maximu m Residue Limits (MRL s ) for tralkoxydim is included in the Tralkoxydim . Human Health Assessment Scoping Document in Support of Registration

Review

 ̧ dated September 1 9 , 2011 , available in docket EPA

- HQ

- OPP

- 2011

- 0706 at www.regulations.gov. Currently, ther e are no harmonization issues with Canada, CODEX, or Mexico. During registration review, if any Codex MRLs have been established, the Agency anticipates harmonizing the U.S. tolerances with the Codex

MRLs when the data warrant harmonization.

Data Call

- In s

**•** No DCIs have been issued for tralkoxydim

.

Labels

**•** Active Section 3 labels for tralkoxydim can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls .home

.17 II. SUMMARY OF DATA GAPS

A summary of the anticipated data needs for the tralkoxydim registration review is presented in

Table 2.

Table 2. Summary of Anticipated Data Needs for Tralkoxydim

Guideline Number Anticipated Data Requirement Test

Materia l Estimated

Timeframe

(Measured

in Months

from DCI Receipt)

835.4300 Aerobic Aquatic Metabolism Compounds

8 and 17 24

850.1400 Fish Early Life

- stage Toxicity Test (freshwater) TGAI 12

870.6200 Neurotoxicity Screening Battery ( Acute Neurotoxicity and Subchronic Neurotoxcity) TGAI 24

870.7800 Immunotoxicity TGAI 12