2 

### Prometon Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessment s for Registration Review 7

Timeline 9

Next Steps 9

Appendix

– Additional Areas Considered in Prometon’s Registration Re view 10

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. Registration Review Problem Formulation for Prometon

. Sternberg, Wente

. February 26,

2013

.

2. Prometon Human Health Assessment Scoping Document in Support of Registration

Review

. Irwin, Britton, Donovan. March 15, 2013.

3. BEAD Chemical Profile for Registration Review: Prometon (080804)

. Phillips, Alsadek,

Faulkner

. October 10, 2012.

4. Prometon: Review of Human Incidents

. Recore, Evans. November 20, 2012.

5. Prometon Focus Meeting Summary. Keller. November 7, 2012

These and other supporting documents for the prometon registration review case may be found in

the docket EPA

- HQ

- OPP

- 2013

- 0068 at http://www.regulations.gov

.3 OVERVIEW

The docket for prometon is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2013

- 0068 )

. Prometon is a non

- selective

“bare

- ground” herbicide registered for pre

- and post

- emergen t applications to manage annual and perennial grasses and broadleaf weeds in parking lots, roadsides and under pavement. There are no registered agricultural uses, and the majority of prometon use is associated with weed control along fencerows and building perimeters, with smaller usage on industrial sites, rights

- of

- way areas, and residential areas

. This Preliminary Wor k Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about prometon

, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review , an d providing an anticipated timeline for completing prometon’s review

.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about prometon and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on prometon

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision

making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in th e PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholders could include:

environmental non

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, instit utional, residential, and other users of pesticides; or the public at large.

The Prometon Reregistration Eligibility Decision (RED) specified that all residential use of prometon was to be cancelled. On January 2 , 2013 a notice of receipt of requests for

amendments to terminate uses for certain pesticide registrations was published in the F ederal

R egister [EPA

- HQ

- OPP

- 2012

- 0548; FRL

- 9372

- 3]; this included a notice of request to cancel all residential uses for prome ton. Should no request to withdraw the canc ellation of all residential

use of prometon be received, the cancellation would become effective July 1, 2013 and would void the need for a residential and aggregate risk assessment during registration review. The Preliminary Work Plan begins by listing the anticipated data needs for prometon

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides prometon’s chemical facts, use and usage information, recen t actions, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in

R egistration R eview along with some add itional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for prometon . For additional discussion of the anticipated data needs, see the Registration Review Problem Formulation for Prometon and

Prometon Human Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for Prometon’s Registration Review 1

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835. 4300 Aerobic Aquatic Metabolism T GAI 24

835. 4400 Anaerobic Aquatic Metabolis m TGAI 24

850.1075 Fish Acute Toxicity, fathead minnow 2 TGAI 12

850.1400 Fish Early Life Stage Toxicity Test, rainbow trout 2 TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.44 00 Aquatic plant toxicity test u sing Lemna spp. TGAI 12

850.450 0 Algal t oxicity TGAI 12

850.4550 Cyanobacteria t oxicity TGAI 12

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation for soil

, sediment, and water TGAI 12

870.3465 90

- day inhalation toxicity 3 TGAI 24

TGAI = tec hnical grade active ingredient

As part of the Problem Formulation for Prometon

, the Agency considers Guideline 850.1350, Aquatic invertebrate life cycle (salt water) a low value study. Given that prometon is slightly toxic to aquatic animals on an acute basis, and there is no evidence to indicate that

estuarine/marine animals are su bstantially more sensitive to prometon than freshwater animals, fulfilling this data requirement would seem to have a low potential to add value to the Regist ration Review risk assessment. At this time, t he A gency does not anticipate requiring this study for this registration review as the acute to chronic ratio extrapolation from the daphnid study is expected to be used.

Additionally, the Agency also considers Guideline 850.1400

– Fish Early Life Stage Toxicity Test (on Esturine/Marine Species) a low va lue study. Given that prometon is slightly toxic to

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Not ice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 E ither an acute toxicity test with fathead minnow using GDLN 850.1075 or a chronic test with rainbow trout

, GDLN 850.1400, is anticipated to be required. These data would be used by the Agency to generate an acute to chronic ratio (ACR) for evaluating risk to estuarine/marine fish species from chronic exposure to prometon.

3 For the inhalation toxicity study, a test of 28 days duration should be sufficient to satisfy this anticipated data requirement.5 aquatic animals on an acute basis, and there is no evidence to indicate that estuarine/marine animals are substantially more sensitive to prometon than freshwater animals, fulfilling this data requiremen t has a low potential to add value to the Registration Review risk assessment. In the absence of this data, toxicity to estuarine/marine fish from c hronic exposure to prometon may be characterized using toxicity data for freshwater fi sh exposed to prometo n or toxicity data for estuarine/marine fish exposed to other triazines.

STATUTORY AND REGULATORY AUTHORITY

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 envi ronment 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 4

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicid e, 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 regulations governing registration review begin at 40 CFR 155.40

. 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 and what additi onal 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 a F inal W ork P lan (FWP) and anticipated schedule for the registration review of prometon

.

Table 2 provides a summary of the current regulatory status of (chemical)

.

Table 2: PROMETON CHEMICAL FACTS

PC code 080804

Case Number 2545

CAS Number 1610

- 18

- 0

Year first registered 1959 Pesticide Type herbicide

Chemical class triazine

R eregistration Eligibility Decision (R E D) March 2008

4 http://www.epa.gov/oppsrrd1/registration_review/6 Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable as prometon is not a part of a cumulative group.

40 CFR Citation There are no established tolerances for prometon because there are no registered food or feed uses for prometon

. Dual

- use Conventional pesticidal uses only.

Non

- pesticidal uses No non

- pes ticidal uses of prometon.

Pesticide Re

- evaluation Division, Chemical Review Manager Steven Snyderman, snyderman.steven@epa.gov , 703

- 347

- 0249

Registration Division

, Product Manager Kable Davis, davis.kable@epa.gov , 703

- 347

- 0249

USE AND USAGE INFORMATION Table 3 summarizes the use and usage information for (chemical). Please see the BEAD Chemical Profile for Registration Review: Prometon (080804) in the re gistration review docket

for more details

.

Table 3: USE AND USAGE INFORMATION

Summary of Use Non

- selective triazine herbicide registered for use to control broadleaf and grass weeds when applications are made prior to weed emergence or postemergence to the weed ; however, woody brush or tree weeds are not controlled unless prometon is applied in

a mix of oil such as diesel fuel.

Use Sites Use sites are typically those that require total vegetation control resulting in bare ground for between one and two years following a single application. Not currently registered for agricultural use.

Non

- Agricultural use site s include domestic dwellings (outdoor), commercial/industrial areas, drainage ditch banks, farm buildings (indoor/outdoor), ornamental turf, re sidential areas, uncultivated areas, airports/landing fields, fencerows/hedgerows, right s

- of

- way, paths/patios, paved areas (private roads/sidewalks), recreational areas, and utility poles. Summary of Usage The majority of prometon use is associated with weed control along fencerows and building perimeters, with smaller usage on other industrial sites (i.e., pump stations, tanks, pipelines, pipe storage areas), rights

- of

- way areas (i.e., airports, railroads, and medians),

and residential areas. Based on usage information provided by the registrant for the 2008 RED , total annual sales of prometon are approximately 550,00 0

– 600,000 pounds of a.i.: approximately 60% is applied to building perimeters or fencerows; 30% is applied to industrial sites; and <10% is applied to rights

- of

- way areas. Formulation Type(s) Granules, peletted/tabulated, wettable powder, emulsifiable,7 flowable soluble concentrate, and solution ready

- to

- use. Application Method(s) Boom sprayers, handheld nozzle or wand sprayers, knapsack sprayers, and granular spreaders. Technical Registrant (s) Makhteshim

- Agan of North America

, Inc. No. of Registrations 21 Section 3 products 5

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

• Information such as pounds active ingredient applied, application methods, application rates for risk drivers, and application timing on: domestic dwellings (outdoor), commercial/industrial areas, drainage ditch banks, farm buildings (indoor/outdoor), ornamental turf, residential areas, uncultivated non

- agricultural areas, airports/landing fields, fencerows/hedgerows, non

- agricultural right s

- of

- way, paths/pati os, paved areas (private roads/sidewalks), and recreational areas, could assist assessment of the importance of prometon.

• C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum appli cation rates ; frequency of application, application intervals, and maximum number of applications per year ; and geographic limitations on use

.

• U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

• M edian and 90 th percentile r eported use rates (lbs ai/ A ) from usage data

– national, state, and county

• A pplication timing (date of first application and application intervals)

– national, state, and county

• Usage/use information for non

- agricultural uses

• S tate or local use restrictions

• F oreign technical registrants not listed above who supply technical prometon to the US

market

RECENT ACTIONS

On January 2 nd , 2013 a notice of receipt of requests for amendments to terminate uses for certain pesticide registrations was published in the Federal Register [EPA

- HQ

- OPP

- 2012

- 0548; FRL

9372

- 3]; this included a notice of request to cancel all residential uses for prometon. Should no requests to withdraw the cancellation of all residential uses of prometon then the cancellations would become effective July 1, 2013 and would void the need for a residential and aggregate risk assessment during registration review.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for p rometon was completed in

2008 in preparation for the Reregistration Eligibility Decision. T he most recent ecological and

5 Sec tion 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).8 environmental fate risk assessment was completed for the same purpose . Findings and

conclusions from these risk assessments are summa rized in the Registration Review Problem Formulation for Prometon and Prometon Human Health Assessment Scoping Document in Support of Registration Review

.

During registration review, t he Agency anticipates the need to conduct a comprehensive ecological ri sk assessment, including an endangered species assessment, for all uses of

prometon

. For human health, EPA anticipates the need to conduct revised drinking water and

residential risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating

p rocedures or default exposure assumptions

.

Tab le 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

Table 4: Anticipated Risk Assessments for Prometon’s Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Y Prometon degradates GS

- 11526 and GS

- 14626 have been determined to be approximately as toxic as the parent prometon to aquatic organisms; therefore these degradates, along with the parent, will be considered stressors of concern for the ecological risk assessment

Incidents Will check for updates For a discussion of prometon’s reported ecological

inc idents, see page 1 7 of the Problem Formulation.

Human Health Dietary

Food N Prometon is not currently registered for use on food

or feed

. Drinking water Y Occupational Handlers (mixers, loaders, applicators) N There are currently no significant changes identified which would require an update of the occupational exposure risk assessment since the 2008 RED. Post

- application N

Residential

Handlers Y Should remaining residential uses be cancelled

, a residential handler assessment would no longer be

necessary.

Post

- application N Due to the nature of its use, significant dermal exposure from recently treated areas is not anticipated.9 Other Aggregate N E valuates the combined risk from dietary and residential exposures. An aggregate assessment may be required should the cancellation of all residential uses of prometon not be finalized

. Cumulative N Although prometon is a triazine chemical, it is specifically a methoxy triazine and not included in the

triazine cumulativ e assessment

. Tolerances N Tolerances are not established for prometon since it is

not registered for use on food or feed at this time.

Incidents Will check for updates For a discussion of prometon’s reported human incidents, see page 6 of the Scoping Document.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring data (see Appendix for further details)

.

TIMELINE

EPA has created the following estimated timeline for the completion of prometon’s registration

review in Table 5 below

.

Table 5: Registration Review for Prometon

– Projected Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2013

- March

Close Public Comment 2013

- May

Case Development

Final Work Plan 2013

- August

Issue DCI 2014

– April

- June

Data Submission 2016

– April

- June

6 0

- day Public Comment Period for Draft Risk Assessments 2017

– Oct.

– Dec. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 2018

– April

- June

Registration Review Decision and Begin Post

- Decision Follow

- up 2019 Total (years) 6

NEXT STEPS

After the 6 0

- 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 prometon

.10 

### Appendix

– Additional Areas Considered in Prometon’s Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould be of particular use.

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. The Agency

will work to harmonize tolerances and international maximum r esidue limits (MRL s ) and may modify tolerance levels to do so, when possible

. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export market s, providing as much specificity as possible regarding

the nature of the concern. Because prometon is not registered for food/feed uses in the U.S., it

has no U.S. tolerances ; therefore, the Agency does not anticipate any trade irritant issues for it.

W

ater Quality:

Prometon is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 6

. In addition, n o Total Maximum Daily Load s (TMDL) have been developed for prometon 7 . More information on impaired water bodies and TMDLs

can be found at the Agency’s website 8

. 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

Process 9 in order to ensure they can be used quantitatively or qualitatively in pesticide risk

assessments.

Envi ronmental 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, r egulations, 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, unusual ly high exposure to prometon 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.

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

7 http://iaspub.ep a.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

8 http://www.epa.gov/owow/tmdl/

9 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm11 ENDANGERED SPECIES :

A risk assessment that suppor ts a complete endangered species determination has not been

conducted for prometon

. The ecological risk assessment planned during registration review will allow the Agency to determine whether prometon’s use has “no effect” or “may affect” federally

liste d 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 and/or National Marine Fisheries Service (the Services), as appropriate.

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, neurotoxici ty, 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 maturati on, 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 reregistration decision for prometon

, 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), prometon 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 t o 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 scre ening 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 ho rmonal 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 subs tance, 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 th e first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Prometon is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registrat ion review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screening assays for prometon. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the

test g uidelines and the Tier 1 screening battery, please visit our website 10

.

10 http://www.epa.gov/endo/12 HUMAN STUDIES :

Occupationa l and Residentia l

Past prometon 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 exposure. Many such studies, involving exposure to many different pesticides, comprise gen eric pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), 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 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. A ll applicable requirements of EP A’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued

reliance on these studies

.