2 

### Propazine Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Propazine Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessments for Registration Review 8

Timeline 10

Next Steps 10

Appendix – Additional Areas Considered in the Propazine Registration Review 11

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Registration Review: Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Propazine

. B. Kiernan. May 8,

2013.

2. Atrazine, Propazine, and Simazine. Human He alth Risk Scoping Document in Support of Registration Review . W. Donovan. June 4, 2013

3. Atrazine, Propazine, and Simazine: Review of Human Incident Reports . S. Recore. January 22, 2013.

4. BEAD Chemical Profile for Registration Review: Propazine. B. Phillips. December 5,

2012.

5. Propazine Screening Level Usage Analysis: Propazine . June 15, 2012

6. PRD Label Data Report: Food/Feed & N on-Food/Non-Feed Uses Considered in Registration Review Work Planning . July 5, 2012.3 These and other supporting documents for the pr opazine registration re view case may be found in the docket EPA-HQ-OPP-2013-0250 at http://www.regulations.gov

.4 OVERVIEW

The docket for propazine is now open, initiati ng the first public comment period for this registration review (docket number EPA-HQ-OPP-2013-0250). Propazine is a triazine herbicide registered for use to control broadleaf and grass weeds. It is registered for use on grain so rghum

and containerized ornamental plants grown in greenhouses. Propazine is a triazine herbicide and part of the triazine common mechanism group based on a common toxicity end-point and known mechanism of toxicity. The other members of the triazine comm on mechanism group are atrazine, simazine, and the thre e major chloro metabolites (DEA, DIA, and DACT for short). 1
This Preliminary Work Plan (PWP) document expl ains what EPA's Office of Pesticide Programs knows about propazine, highlighting anticipated data and assessment needs, identifying the types of information that would be especially usef ul to the Agency in conducting the review, and providing an anticipated timeline for comple ting the registration review for propazine.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows ab out propazine and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on propazine. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional inform ation that will help the Agency’s decisionmaking process for propazine. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholde rs could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for propazine. Next, it discusses the statutory and regul atory authority for Registration Review. Then the document provides propazine facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration review timeline for propazine. Finally, the Appendix to

this document includes identification and discussion of some areas that ar e considered generally in Registration Review along with some a dditional propazine case-specific information.

1 There are other triazine pesticides, such as ametryn, prometryn, and prometon, but they are excluded from the

triazine common mechanism group because they do not share the same toxicity profile. For additional information, see the triazine cumulative risk assessment at http://www.regulations.gov /#!docketDetail;D=EPAHQ-OPP-2005-0481

.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipa ted data needs for propazine. For additional discussion of the anticipated data needs, see the Registration Review: Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Propazine

and Atrazine, Propazine , and Simazine. Human Health Risk Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the Propazine Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.2100 Acute avian toxicity (passerine species) TGAI 12
850.2300 Avian reproduction TGAI 24
TGAI = technical grade active ingredient;

2 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; Notice of Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-00286 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 3

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. 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 docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of propazine.

PROPAZINE FACTS

Table 2 provides a summary of the chemical facts for propazine.

Table 2: Chemical Facts for Propazine

PC code 080808

Case Number 7278

CAS Number 139-40-2 Year first registered 1989 Pesticide Type Herbicide Propazine class Triazine Reregistration Eligibility Decision (RED) Because it was registered after November 1984, propazine was not subject to reregistration

Tolerance Reassessment Eligibility Decision (TRED) April 2006

3 http://www.epa.gov/oppsrrd1/registration_review/7 Table 2: Chemical Facts for Propazine

Cumulative group Triazine. Propazi ne is a triazine herbicide and part of the triazine common mechanism group based on a common toxicity end-point and known mechanism of toxicity. The other members of the triazine common mechanism group ar e atrazine, simazine, and the three major chloro metabolites (DEA, DIA, and DACT for short).

The most recent cumulative risk assessment for the triazine common mechanism group was completed March 28, 2006 . 40 CFR Citation Tolerances for propazine are established in 40 CFR Part 180.243. Dual-use Propazine is registered for c onventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identi fied non-pesticidal uses of propazine

Pesticide Re-evaluation Division, Propazine Review Manager Molly Clayton clayton.molly@epa.gov

703-603-0522 Registration Division, Product Manager Kable Bo Davis davis.kable@epa.gov

703-306-0415

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage info rmation for propazine. Please see the BEAD Chemical Profile for Regi stration Review: Propazin in the registration re view docket for more

details.

Table 3: Propazine Use and Usage Information

Summary of Use Propazine is a triazine herbicide registered for use to control broadleaf and grass weeds. It is registered for use on so rghum and containerized ornamental plants grown in greenhouses. Use Sites There are only two registered uses for simazine: Agricultural: Sorghum (fo rage, grain, stover) Non-Agricultural: Greenhouses on ornamental plants grown in

containers. Summary of Usage During the 2007-2011 t ime f ram e, use of propazine on gra in sorghum averaged approximately 74,000 pounds annually and was applied on average to 96,000 acres. No information on the containerized ornamental usage is available. Formulation Type(s) Propazin e is formulated as a flowable concentrate

. Application Method(s) Pr oducts can be applied via aeria l and ground spray applications, using flat fan-type nozzles for uniform broadcast applications and band treatments. Propazine is also applied through

flood or drench nozzles in greenhouse applications. Technical Registrant(s) Albaugh, Inc.8 Table 3: Propazine Use and Usage Information

No. of Registrations 1 Section 3 registration 4

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Information on typical propazine use in the non-agricultural sector , including but not limited to, application timing, application rate, application me thod, and application frequency. Confirmation of the following labe l information for all uses: sites of application; formulations; application me thods and equipment; maximum application rates; frequency of appli cation, application intervals, and maximum number of applications per season; and geographic limitations on use.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

 Usage/use information for non-agricultural uses.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply tech nical propazine to the US

market.

PENDING ACTIONS

The Agency is currently evaluating a toleran ce petition for simazine (2F8006, 77 FR 50686) to establish crop group tolerances for stone fruit, pome fruit, citrus fruit, and tree nuts; to remove

individual tolerances which w ould be replaced by the new crop groups; and for several other related actions. EPA is in the pr ocess of reviewing this request which will likely necessitate an updated assessment for the triazine cumulative group.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health ri sk assessment for propazine was completed in 2005 for the new sorghum use request for propa zine. The most recent ecological and environmental fate risk assessment was completed in March 2006 for the same purpose. Findings and conclusions from these ri sk assessments are summarized in the Registration Review: Problem Formulation for Envir onmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Propazine and Atrazine, Propazine, and Propazine: Human Health Ri sk Scoping Document in Suppo rt of Registration Review.

4 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).9 During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an enda ngered species assessment, for all uses of propazine. For human health, EPA anticipates th e need to conduct revised dietary, residential, and occupational, and cumulative risk assessments during registration revi ew. If toxicological endpoints or points of departure ar e revised based on the data that are anticipated to be required,

or based on the results of literature reviewed dur ing registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk Assessments for the Propazine Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The parent propazine will be considered the stressor of concern because it is expe cted to be protective for any non-target organisms that may be exposed to the parent and any of its degradates.

Incidents Will check for updates For a discussion of reporte d ecological incidents for propazine, see page 15 of the Problem Formulation.

Human Health Dietary Food Y During registration review, an updated dietary assessment may be conducted to include any updates to toxicological endpoints, dietary exposure estimates, and changes to assessment SOPs. Drinking water Y EPA anticipates updating the drinking water assessment for propazine dur ing registration review. Occupational Handlers (mixers, loaders, applicators) Y In registration review, an up-to-date quantitative occupational risk assessme nt may be required to account for current registered application rates, unit exposures, transfer coeffici ents (TCs), and toxicity endpoints and safety factors. Post-application Y

Residential Handlers N There are no registered residential uses of propazine. Post-application N

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. Since there are no registered residential uses of propazine , its aggregate assessment consists of the dietary exposure assessment only.10 Cumulative Y An assessment of the triazine cumulative group is expected as part of registration review.

Tolerances Y Tolerances ar e established under 40 CFR §180.243 for residues of propazine in/on sorghum commodities. EPA anticipates updating the residue definition for the tolerance expression for propazine to be in accordance with current policy on tolerance

definitions.

Incidents Will check for updates For a discussion of reported human incidents for propazine, see page 12 of the Scoping Document and

the Atrazine, Propazine, and Propazine: Review of Human Incident Reports.

TIMELINE

EPA has created the following estimated ti meline for the completion of the propazine registration review in Table 5 below.

Table 5: Projected Propazine Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2013 – June Close Public Comment 2013 – August Case Development

Final Work Plan 2013 – November Issue DCI 2014 July - September Data Submission 2016 July - September 60-day Public Comment Period for Draft Risk

Assessments 5 2018 January – March

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2018 October – December

Registration Review Decisi on and Begin Post-Decision Follow-up 2019

Total (years) 6

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 i ssue a Final Work Plan for the registration review of propazine.

5 The regulations governing Registration Review require the Agency to provide a public comment period of at least

30 calendar days for draft risk assessments; see 40 CFR Pa rt 155.53(c). The Agency pl ans to provide a 60 calendar day public comment period for draft risk assessm ents as a general standard of practice.11 

### Appendix – Additional Areas Considere d in the Propazine Registration

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) 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 markets, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Propazine is not identifie d as a cause of impairment for any wa ter bodies listed as impaired under section 303(d) of the Clean Water Act. 6 In addition, no Total Maximum Daily Loads (TMDL) have been developed for propazine. 7 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 8 The Agency invites submissi on of water quality data for this pesticide. To the extent possible, data shoul d conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: In clusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registratio n Review Risk Assessment and Management

Process 9 in order to ensure they can be used quant itatively or qualitativel y in pesticide risk

assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to propazi ne 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.epa.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.htm12 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for propazine. The ecolo gical risk assessment planned dur ing registration review will allow the Agency to determine whether use of propazine has “no effect” or “may affect” federally listed threatened or endangered specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Se rvices), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to propazines. Collectiv ely, these studies include acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most re cent registration de cision for propazine, EPA reviewed these data and selected the most sensitive endpoint s for relevant risk assessment scenarios from the existing hazard database. However, as re quired by FFDCA section 408(p), propazine is subject to the endocrine screeni ng part of the Endocrine Disrup tor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a propazine substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. Propazine is not among the group of 58 pesticide active ingredient s on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for propazine. For further information13 on the status of the EDSP, the policies and procedur es, the list of 67 chemi cals, future lists, the test guidelines and the Tier 1 scr eening battery, please visit our website. 10

HUMAN STUDIES:

Past propazine risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to de termine their dermal and inhalation exposure. Many such studies, involving exposur e to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Databa se. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databa ses, 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 prevai ling at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on

these studies.

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