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Docket Number EPA-HQ-OPP-2011-0706

www.regulations.gov

Tralkoxydim

Summary Document

Registration Review: Initial Docket

September 2011

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TABLE OF CONTENTS

 

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 12

III. Summary 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 Species, 

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 19, 2011.

3. Tralkoxydim: Review of Human Incidents. May 17, 2011.

4. BEAD Chemical Profile for Registration Review: Tralkoxydim (121000). September 26, 

2011.

5. Tralkoxydim California Department of Pesticide Regulation Usage Data. January 4, 

2010.

6. Tralkoxydim (121000) Screening Level Usage Analysis (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.

Supporting documents for the registration review of tralkoxydim are located in docket EPA-HQOPP-2011-0706 at www.regulations.gov. 
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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 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 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 registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. 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 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 registration review of tralkoxydim.

Tralkoxydim is a systemic, postemergence herbicide registered for agricultural use to selectively 

control certain annual grass weeds in wheat, barley, and triticale. Target weeds include wild 

oats, green foxtail, yellow foxtail, annual ryegrass (Italian), and Persian darnel. There are

currently no residential uses. Tralkoxydim was first registered in the U.S. in 1998; therefore, it 

was not subject to the reregistration requirements of FIFRA.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting comprehensive human health and ecological risk 

assessments, including an endangered species risk assessment, for all uses of tralkoxydim. The 

Agency anticipates needing data for use in conducting these assessments. Below is a summary 

of the issues relevant to the registration review of tralkoxydim and a list of the anticipated data 

requirements. 
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Ecological Risk:

• 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.

• 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 submitted and 

determined to be adequate.

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination 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 designated critical habitats. When an assessment concludes that a 

pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency 

will consult with the U.S. Fish and Wildlife Service (USFWS) and/or National Marine 

Fisheries Service (NMFS) (the Services), as appropriate.

• 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

conducting a complete ecological risk assessment, including an endangered species 

assessment, for tralkoxydim and its degradates:

Environmental Fate

o Guideline Number 835.4300 – Aerobic Aquatic Metabolism with Compounds 8 and 

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Ecological Toxicity

o Guideline Number 850.1400 – Fish Early 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 conducting a refined, complete ecological risk 

assessment, including an endangered species assessment for tralkoxydim. For further 

details, see the “Guidance for Commenters” section below.

• 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, located in docket 
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EPA-HQ-OPP-2011-0706 at www.regulations.gov, for a more detailed discussion of the 

anticipated ecological risk assessment and data needs.

Human Health Risk:

• The most recent human health risk 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, 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 updated dietary (food and water), 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 registration 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 volatilization) 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, the Agency anticipates conducting both an occupational 

handler exposure risk assessment and an occupational postapplication exposure risk 

assessment based 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.
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• The toxicity database for tralkoxydim is complete except for the following studies, which 

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

assessment:

Toxicology Data

o Guideline Number 870.6200 – Acute and Subchronic Neurotoxicity

o Guideline Number 870.7800 – Immunotoxicity

• Please refer to Tralkoxydim. Human Health Assessment Scoping Document in Support of 

Registration Review ̧ dated September 19, 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 carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its 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), tralkoxydim 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 or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

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

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 
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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. Accordingly, 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 chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

Timeline

 

The projected timeline for the completion of the tralkoxydim registration review is presented in 

Table 1.

Table 1. Projected Tralkoxydim Registration Review Timeline

Activity Estimated Date

Opening the Docket

Open Docket and Open Public Comment Period 2011 – September

Close Public Comment Period 2011 – November

Case Development

Develop Final Work Plan (FWP) 2012 – February

Issue Data Call-In (DCI) 2012 – Oct. – Dec.

Data Submission 2014 – Oct. – Dec.

Develop Preliminary Risk Assessments and Open Public Comment

Period

2016 – 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 2017

Total (years) 6
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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 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 regarding 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 enforcement 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 Quality

Tralkoxydim is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act1

. In addition, no Total Maximum Daily Loads 

(TMDLs) have been developed for tralkoxydim2

. More information on impaired water bodies 

and TMDLs can be found at the Agency’s website3

. The Agency invites submission of water 

quality data 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 Process4 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=PESTICIDES 3 http://www.epa.gov/owow/tmdl/ 4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
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Other Information

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 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, application intervals, and maximum number of 

applications 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 90th percentile reported use rates (lbs active ingredient(ai)/acre, lbs ai/1000

sq. ft.) from usage data – national, state and county

5. Application timing (date of first application and application intervals) by use – national, 

state, and county

6. Sub-county use site location data

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

a. maximum reported use rate (lbs ai/acre) from usage data – county

b. median and 90th 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. Typical application interval (days)

9. State or local use restrictions

10. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian, 

mammalian mortalities, and bee or 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 received in a timely manner and then issue a Final Work Plan for the registration 

review of tralkoxydim.
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FACT SHEET

Background Information

• Registration Review Case Number: 7237

• Pesticide Chemical (PC) Code: 121000

• Chemical Abstracts Service (CAS) Number: 87820-88-0

• Tralkoxydim was first registered in the U.S. in 1998.

• Tralkoxydim was not subject to reregistration; therefore, there is no Reregistration 

Eligibility Decision (RED) for tralkoxydim.

• The technical registrant for tralkoxydim is Syngenta Crop Protection, LLC.

• There are four Section 3 registrations for tralkoxydim, including one technical product 

and three end-use products (EUP). 

• U.S. tolerances for tralkoxydim range from 0.02 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 and Usage Information

For additional details, please refer to BEAD Chemical Profile for Registration Review: 

Tralkoxydim (121000), dated September 26, 2011; Tralkoxydim California Department of 

Pesticide Regulation Usage Data, dated January 4, 2010; Tralkoxydim (121000) Screening Level 

Usage Analysis (SLUA), dated December 17, 2010; and PRD Appendix A: Food/Feed & NonFood/Non-Feed Uses Considered in Registration Review Work Planning. Tralkoxydim

(121000), dated January 14, 2011; located in docket EPA-HQ-OPP-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 target weeds include wild oats, green foxtail, yellow foxtail, annual ryegrass 

(Italian), and Persian darnel.
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• Tralkoxydim EUP formulation types include water dispersible granules (two products:

one 40% dry granular and one 80% dry granular) and one soluble concentrate product.

• Tralkoxydim application methods include application by ground and aerial equipment. 

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

use sites.

• Agricultural usage of tralkoxydim is mainly on barley and wheat. According to screening 

level estimates of the agricultural usage of tralkoxydim in the U.S. from 2000 to 2008, 

the 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 treated.

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 effects 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, located 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 information, acute risks from the use of tralkoxydim to 

birds, mammals, 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; 

however, 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 information, chronic risks from the use of tralkoxydim

to birds, aquatic invertebrates, and fish were below the Agency’s LOC. The chronic 
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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 LOC 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 findings 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 19, 2011, located in docket 

EPA-HQ-OPP-2011-0706 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 Tralkoxydim 

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 target 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 tralkoxydim 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 (food and drinking water) risk estimates for 

tralkoxydim were below the Agency’s LOC for the general U.S. population and all 

population subgroups.
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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 below 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 Handlers 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 inhalation 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 their dermal and 

inhalation exposures. 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) Database. 

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 the 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 data 
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suggesting that tralkoxydim shares a common mechanism of toxicity with other chemical 

substances, the Agency will revisit the need for a cumulative risk assessment.

Incidents

Ecological Incidents:

• The Agency reviewed the Ecological Incident Information System (EIIS), which is 

maintained by the EPA Office of Pesticide Programs (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). 

• The 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 the 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 database were caused 

by tralkoxydim, but all incidents were ascribed to two tralkoxydim products, Achieve SC 

Herbicide (Registration Number 100-1130) or Achieve 40DG Herbicide (Registration 

Number 100-1105). The AIMS reported no bird incidents for tralkoxydim.

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. The 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 severity outcomes from January 1, 2006 to March 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.
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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 Maximum Residue Limits (MRLs) for tralkoxydim is included in the

Tralkoxydim. Human Health Assessment Scoping Document in Support of Registration 

Review ̧ dated September 19, 2011, available in docket EPA-HQ-OPP-2011-0706 at 

www.regulations.gov. Currently, there 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-Ins

• 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.
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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 

Material

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