2 

### Macleaya Extract – Table of Contents

I. Introduction ............................................................................................................... ...........3

A. General Background ....................................................................................................4

II. Scientific Assessments .................................................................................................... ....4

A. Human Health Assessment..........................................................................................4

B. Environmental Assessment .........................................................................................5

C. Endangered Species Assessment .................................................................................5

D. Use and Usage Information .........................................................................................6

E. Endocrine Disruptor Screening Program ..................................................................6

III. Interim Registration Review Decision .............................................................................6

IV. Next Steps and Timeline ................................................................................................... 73 I. Introduction

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Interim Registration Review Decision for macleaya extract and it di scusses public comments received concerning the Proposed Interim Regist ration Review Decision . It is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and R odenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may (1) require new risk mitigation measures; (2) impose interim ri sk mitigation measures; (3) identify data or information required to complete the review ; and (4) include schedules for submitting the required data, conducting new risk assessments or revising preliminary assessments, and completing the registration review.

During the 60-day public comment period for the macleaya extr act Proposed Interim Registration Review Decision, which opened on July 23, 2014, and closed on September 22, 2014, the Agency received one comment. The comment was submitted by the Center for Biological Diversity (CBD) and CB D commented that it that agre ed with the Agency’s finding for this chemical case regarding endangered speci es. The public comment in its entirety is located in the docket, EPA-HQ-OPP-2011-0172.

Pursuant to 40 CFR Section 155.50, EPA forma lly initiated registration review for macleaya extract (case 7024). The following high lights significant events that have occurred during the registration revi ew of macleaya extract:

 March 30, 2011 – Publication of the Macleaya Extract Summary Document for a 60-day public comment period. The Summary Document included the preliminary work plan (PWP) and was accompanied by the scoping document and problem formulation.

 August 17, 2011 - Final Work Plan (FWP) for macleaya extract was signed -- two public comments were received during the 60-day comment period for the Macleaya Extract Summary Document . However, the comments did not a ffect the risk assessments to be performed, the anticipated data requirements, or the projected regist ration review timeline and thus, the FWP did not modify the Summary Document

.

 A Data Call-In (DCI) was issued in June 2012 requiring submission of certain toxicity studies. The required studies were subse quently waived by the Hazard and Science Policy Council (HASPOC) in 2013 based on th e Weight of Evidence (WOE) approach considering the following: 1) the limited exposure profile of macleaya extract; 2) there are no registered food uses of macleaya extr act at this time; 3) no exposure to macleaya extract is expected through dri nking water; 4) the use of an oral point of departure (POD) results in dermal margins of exposure (MOEs) that do not exceed the Agency’s level of concern (LOC) (MOEs >300 are below the Ag ency’s LOC) for highest occupational exposures (i.e., MOEs are greater than 3,600 and 440 for handlers and post-application workers, respectively); 5) the use of an oral POD results in inhalation MOEs that do not exceed the Agency’s level of concern for wo rkers (MOE greater than 13,000); and 6) the4 low vapor pressure and physical chemical pr operties of sanguinarine, a major component of macleaya extract.

 In June 2014, EPA completed a preliminary hum an health risk assessment for macleaya extract using available data and data from surrogate chemicals, sanguinaria extract and sanguinarine chloride. The Agency also completed a preliminary ecological risk assessment in 2014. No public comments were received concerni ng these assessments during a 60-day public comment period.

 June 26, 2014 – Proposed Interim Registration Review Decision for macleaya extract was signed -- one public comment was received during the 60-day comment period for the document. However, as discussed above, the comment did not affect the proposed

decision.

Additional information about m acleaya extract, including this Interim Registration

Review Decision can be found in EPA’s public dock et, EPA-HQ-OPP-2011-0172, accessed at www.regulations.gov

.

A. General Background

Macleaya extract is a plant extract of Macleaya cordata , and is registered for use only in enclosed commercial greenhouses, as an ornament al plant fungicide for the control of foliar fungal diseases. There are no regist ered food or feed uses of macleaya extract. The only end use formulation of macleaya extract is a soluble/concen trate liquid. It is a pplied as a foliar spray by backpack or high pressure sprayer and has no re sidential uses. Macleaya extract was first registered in 2002 and therefore wa s not subject to reregistration.

II. Scientific Assessments

A summary of the Agency’s human health risk assessment a nd ecological risk

assessment, Macleaya Extract: Preliminary Risk A ssessment for Registration Review (June 12, 2014) and Registration Review: Pr eliminary Ecological Risk Assessment and Endangered Species Effects Determination for Macleaya Extract (June 11, 2014) , is presented below. For the actual assessments, see the macleaya extrac t public docket (EPA-HQ-OPP-2011-0172) accessed

at www.regulations.gov

.

A. Human Health Assessment

Hazard Characterization
The toxicological database is considered ade quate for characterizing hazard and assessing risk from macleaya extract. A point of departure (POD) was identified for occupational exposure only.

Dietary Exposure Assessment
There are no registered food/feed uses and existing use patterns are not expected to contaminate surface or ground water; thus, a di etary exposure assessment was not conducted.5 Food Tolerances
There are no U.S. tolerances established for macleaya extract because macleaya extract is not registered for any food/feed uses.

Residential and O ccupational Exposure
Macleaya extract has no register ed residential uses; residentia l exposures are, therefore, not expected. The only end use fo rmulation of macleaya extract is a liquid concentrate and it is applied as a foliar spray by backpack or hi gh pressure sprayer in enclosed commercial greenhouses. Although exposure may occur during occupational handling and post-application activities, a screening level assessment based on maximum application rates and baseline attire 1

indicated no risk of concern vi a dermal and inhalation routes of exposure. Furthermore, the current label requires all handlers to wear personal protective e quipment (i.e., chemical-resistant gloves in addition to baseline attire ) and includes a restri cted entry interval of 12 hours, which is considered to be adequately protective. Theref ore, EPA concludes that risk from occupational exposure to macleaya extract should not be of concern. ( Macleaya Extract: Preliminary Risk Assessment for Registration Review, June 12, 2014)

B. Environmental Assessment

The Agency previously concluded in a 1999 review that the enclosed commercial greenhouse use for macleaya extract does not provide a feasible route of e xposure to non-target organisms, and therefore would not result in any significant exposure or risk to non-target organisms. As the use pattern has not change d since the previous review in 1999, the Agency concluded that a quantitative ecological ri sk assessment and a drinking water exposure assessment were not necessary for the registration review of macleaya extract.

C. Endangered Species Assessment

There is no reasonable expecta tion for registered use of m acleaya extract in enclosed commercial greenhouses to cause dir ect or indirect adverse effect s to threatened and endangered species. No adverse modification of critical habita t is expected from the use of macleaya extract. Based on the indoor-only use pattern for macleaya extract and the lack of a complete exposure pathway, EPA has made a “no effects” determ ination under the Endange red Species Act (ESA) for all listed species as well as a “no habitat modification” de termination for all designated critical habitats for the currently registered uses of macleaya extract. The Agency has therefore

concluded that consultation with the Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7(a)(2) is not requ ired. EPA anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the Registration Review process that would indicate such an assessment would be needed to inform the Agency’s decision. ( Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determ ination for Macleaya Extract, June 11,

2014 )

1 Baseline attire refers to a basic level of personal pr otective equipment worn during handling activities, and is defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and no respirator.6 D. Use and Usage Information

Use of macleaya extract was not reported in the National Agricultural Statistics Service (NASS) nursery and floriculture usage su rveys conducted in 2002, 2004, or 2007. In addition, usage was not reported in the 2006-2008 California Department of Pesticide Regulation pesticide usage reports. Macleaya extrac t was not reported in these surveys indicating that the usage of this chemical is likely to be low.

Macleaya extract can be used in or ganic production of greenhouse ornamentals 2 . There

are no known resistance concerns for th e macleaya extract end use product. Please see the BEAD Chemical Profile for Registration Review: Macleaya Extract in the registration review

docket for more details.

E. Endocrine Disruptor Screening Program

EPA has developed the Endocrine Disruptor Screening Program to determine whether certain substances (including pesticide active an d 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 Admi nistrator may designate.” Under FFDCA section 408(p), the Agency must screen all pesticide chemical s. Between October 2009 and November 2010, EPA

issued test orders/data call-ins for the first group of 67 chemicals and published a second list of chemicals proposed for order issuance in the fu ture. Macleaya extract was not among the group of 58 pesticide active ingredients on the initial li st nor is it proposed on the second list of

chemicals to be screened under the EDSP. Accord ingly, as part of registration review, EPA will issue future EDSP orders/data call-ins for regi stration review chemicals, including macleaya

extract. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future chemical lists proposed fo r screening, the test gui delines and the Tier 1 screening battery, plea se visit our website: http://www.epa.gov/endo/

.

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of macleaya extract. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

III. Interim Registrati on Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. Except for the EDSP component of the macleaya extract registration review case, the Agency has made the following Interim Registration Review Decision: (1) no additional data are required at this time; and (2) no changes to the affected registrations or their labeling are needed at this time. EPA has not identif ied any risks of concern

to human health. EPA has determined that us e of macleaya extract in commercial greenhouses should not result in any significan t exposure or risk to non-target organisms. As such, EPA

2 Copping, L.G. and Duke, S.O. 2007. Natural products that have been used commercially as crop protection agents. Pest Management Science 63:524-554.7 concludes “no effect” for listed sp ecies and no adverse modification of designated critical habitat for all currently registered uses of macleaya extract.

IV. Next Steps and Timeline

A final decision on the macleaya extract registration review case will occur after an EDSP FFDCA section 408(p) dete rmination has been made.

EPA created the following estimated timeline for the completion of the macleaya extract Interim Registration Review Decision.

Registration Review for Macleaya Extract – Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Commen t Period March 2011 – Completed Close Public Comment Period May 2011 – Completed Case Development Final Work Plan August 2011 – Completed Issue DCI June 2012 – Completed Open Public Comment Period for Draft Risk Assessments July 2014 – Completed Close Public Comment Period September 2014 – Completed Registration Review Decision Open Public Comment Period for Proposed Interim Registration Review Decision July 2014 – Completed

Close Public Comment Period September 2014 – Completed Interim Registration Review Decision and Begin PostDecision Follow-up 3 December 2014 – Completed

Total (years) 3.75

3 A final decision on the macleaya ex tract registration review case, in acco rdance with 40 CFR S ection155.158, will occur after an EDSP FFDCA section 408(p) determination has been made.