2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review of propazine. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the propazine registration review docket (EPA-HQ-OPP-2013-0250). Propazine is a triazine herb icide registered for use to control broadleaf and grass weeds. It is regi stered for use on grain so rghum and containerized ornamental plants grown in greenhouses. Propazine is a triazine he rbicide 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 three major chlo ro metabolites: desethyl-s-atrazine (DEA), desisopropyl-s-atrazine (DIA), a nd diaminochlorotriazine (DACT). 1

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. Changes in scienc e, public policy, and pesticide us e practices occur over time. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard. The public phase of registration review begins wh en the initial docket is opened for each case. Information on this program is provided on the Agency’s website. 2

The FWP begins with any updates since the PWP wa s issued. Next is a summary of comments received during the public comm ent period for the PWP, and a summary of the Agency’s responses to those comments. This section is followed by registration review planned data needs, risk assessments expected to be conducte d, and the projected registration review timeline for propazine. Lastly, there is a discussion of next steps.

UPDATES SINCE TH E PWP WAS ISSUED

The case number for propazine was inaccurately lis ted as # 7278 in the PWP. The FWP reflects the correct case number for propazine, which is # 230.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on th e Propazine Preliminary Work Plan which opened on June 26, 2013 and closed on August 26, 2013, the Agency received two sets of public comments. The comments were submitted by the technical registrant for propazine, Albaugh, Inc., and the FIFRA Endangered Species Task For ce (FESTF). They do not address the timeline or planned registration review risk assessments, but did include one comment on the data requirements identified in the PWP. The comment s were not substantive in nature and did not result in a change to the planned data requirement s, registration review timeline, or planned risk

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

. 2 http://www.epa.gov/oppsrrd1/registration_review/3 assessments. In the PWP, EPA also solicited co mments on the specific topics of environmental justice, water quality concerns, a nd trade irritants, but no comments or information were received

on those issues.

This section summarizes and addres ses all public comments received.

Comments submitted by FE STF in EPA-HQ-OPP-2013-0250-0009.

Comment : The technical registrant, as identified on the fact sheet included in the PWP, is Albaugh, Inc., which is a FESTF member and is entitled to rely on FESTF data.

Response : EPA thanks FESTF for the comment and w ill consider these data during registration

review.

Comments submitted by Morris Gaskin, Registration Manager, Albaugh Inc. in EPA-HQOPP-2013-0250-0010.

Comment : The Agency listed Guideline 850.2300 for Av ian Reproduction as a data gap because a study submitted in 2009 under MRID # 48036201 is deficient and classified as supplemental. Because Albaugh did not receive the Agency's data eva luation record (DER) for that study until August 22, 2013, there was not sufficient time to evaluate the deficiencies noted in the DER. Albaugh will consult with perfor ming laboratory to determine if the original study can be amended to upgrade the supplemental status.

Response : At this time, Guideline 850.2300 (Avian Re production) is required in support of registration review. EPA will review the propose d submission when it is received; if this study is upgraded, the guideline will be fulfilled.

Comment : The ornamental plants grown in gree nhouses use noted in the PWP was a placeholder use registered by Griffin Corp. in the 1990's while they pursued the Section 3 registration for sorghum. There is no act ual use of propazine on ornamentals grown in greenhouses. Albaugh intends to amend its techni cal and end use labels to delete the use.

Response : EPA will review the label amendment request when submitted. The registrant should also submit a written request to voluntarily cancel this use, which EPA will publish in the Federal Register for comment before finalizi ng. If the use on ornamental plants grown in greenhouses is cancelled prior to developmen t of the human health and ecological risk assessments for propazine, it will not be included in the risk assessments.

Comment : Propazine 4L (EPA Reg. No. 42750-148) is a restricted use pesticide (RUP).

Response : The PWP incorrectly indi cated in Table 3, Propazine Use and Usage Information, that propazine is not a restricted use pesticide. Propazine’s on e registered end use product (EPA Reg. No. 42750-148) is restricted use due to ground and surface water concerns.4 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for propazine based on the Registration Review: Problem Formulation for Envir onmental 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 . The planned data needs have not changed from wh at was included in the PWP.

Table 1: Planned Data Needs for the Propazine Registration Review

Guideline

Number 1 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

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; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of propazine. For human health, EPA will conduct revised dietary, residential, and o ccupational, and cumulative risk assessments during registration review. If t oxicological endpoints or points of departure are revised based on the results of literature reviewed during registra tion review, they will be considered in the new assessments, as well as any changes to the sta ndard operating procedures or default exposure assumptions.

Table 2 below summarizes the planned registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Docume nt, and the planned assessments have not changed from what was included in the PWP.

Table 2: Planned 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.5 Table 2: Planned Risk Assessments for the Propazine Registration Review

Type of Risk Assessment Conduct? Notes Ecological and Environmental Fate

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 will be conducted to include any updates to toxicological endpoints, dietary exposure estimates, and changes to assessment SOPs. Drinking water Y EPA plans to upda te the drinking water assessment for propazine during registration review. Occupational Handlers (mixers, loaders, applicators) Y In registration review, an up-to-date quantitative occupational risk assessment will be conducted 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. Cumulative Y An assessment of the triazine cumulative group is planned 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 plans to update the residue definition for the tolerance expression for propazi ne 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 3 be low. The projected timeline has not changed since the PWP.6 Table 3: Registration Review for Propazin e – Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2013 – June Table 3: Registration Review for Propazin e – Projected Registration Review Timeline

Activities Estimated Date Close Public Comment 2013 – August

Case Development

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

Assessments 1 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

1 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.

NEXT STEPS

As noted previously, the Agency plans to requir e two ecological effects studies for propazine through a Data Call-In Notice, expected to be issued by September 2014.