Registration Review: Final Work Plan Chondrostereum purpureum EPA

‐ HQ

‐ OPP

‐ 2015

‐ 0051

2 

### REGISTRATION REVIEW OF CHONDROSTEREUM PURPUREUM : FINAL WORK PLAN

Case Name: Chondrostereum purpureum Case No : 6091 PC Code: 081308 Docket: EPA-HQ-OPP-2015-0051 Registrant: MycoLogic Inc.

INTRODUCTION

This is the U.S. Environmental Protection Agency’s (EPA) Final Work Plan (FWP) for the Registration Review of Chondrostereum purpureum . This FWP follows the Preliminary Work Plan (PWP) which was posted in the public docket (EPA-HQ-OPP-2015-0051) on March 30, 2015 (80 FR 16675). Products containing Chondrostereum purpureum isolate PFC 2139 are registered for use as a vegetation management product intended to inhi bit sprouting and regrowth in cut stumps of certain deciduous tree species in rights-of-way and forests.

EPA is implementing the Registration Review pr ogram 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. Changes in science, public policy, and pesticide use practices o ccur over time. 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 that statutory standard of no unreasonable adverse effects to human health or the environment. The public phase of Registration Review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/.

The FWP begins with any updates since the PWP was issued. Next, it provides a summary of substantive comments received, if any, during the public comment period for the PWP concerning anticipated data needs, expected risk assessments, or the estimated timeline identified in the PWP, and a summary of the EPA's responses to those comments. This section is followed by the anticipated data needs, risk assessments expected to be conduct ed, and the projected Registration Review timeline. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PRELIMINARY WORK PLAN WAS ISSUED

Since the PWP was issued in March 2015 (U.S. EPA 2015), there have been no changes to the registrations of pesticide products 1 containing Chondrostereum purpureum isolate PFC 2139 as an active ingredient.

1 There are two register ed products containing Chondrostereum purpureum isolate PFC 2139 as an active ingredient: EPA Reg. No 74200-01 and -02.Registration Review: Final Work Plan Chondrostereum purpureum EPA

‐ HQ

‐ OPP

‐ 2015

‐ 0051

3 SUMMARY OF COMMENTS AND EPA’S RESPONSES

During the 60-day public comment period on the Chondrostereum purpureum Preliminary Work Plan (docket opened on March 30, 2015 and closed on May 30, 2015), EPA received no public comments. In the PWP, EPA specifically solicite d comments on: environmental justice, water quality concerns, and trade irritants; no comments or info rmation were received concerning these issues.

PLANNED DATA NEEDS

EPA has identified one data gap for Chondrostereum purpureum isolate PFC 2139; details are provided in Table 1.

Table 1 Planned Data Need for Case 6091— Chondrostereum purpureum

Harmonized

Guideline Number Study Title Test Material a Estimated Timeframe (months from Receipt of DCI b )

830.6313 Stability to normal and elevated temperatures, metals, and metal ions TGAI 8 months

a TGAI=technical grade of the active ingredient. b DCI=Data Call-in

REGISTRATION REVIEW RISK ASSESSMENTS

In the Chondrostereum purpureum Preliminary Work Plan, EPA stated that it plans to conduct an ecological risk assessment to determine whether use of Chondrostereum purpureum isolate PFC 2139 will have “no effect” or “may affect” federally listed threatened or endangered species (listed species) and/or their designated critical habitat (see, U.S. EPA 2015, p.9).

In addition, EPA will determine, whether, pursuant to Section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), Chondrostereum purpureum isolate PFC 2139 qualifies for exemption from the Endocrine Disruptor Screening Program (EDSP). EPA believes Chondrostereum
purpureum isolate PFC 2139 is likely not an endocrine disruptor; as such, EPA may exempt it from EDSP. If it is exempted, then EPA will issue an order.Registration Review: Final Work Plan Chondrostereum purpureum EPA

‐ HQ

‐ OPP

‐ 2015

‐ 0051

4 TIMELINE

The projected timeline for the completion of the Registration Review for Chondrostereum
purpureum is provided in Table 2.

Table 2 Registration Review for Chondrostereum purpureum : Projected Registration Review Timeline

Activity Estimated Month and Year

Docket Opening Open Docket and 60-Day Public Comment Period for Chondrostereum purpureum March 30, 2015: Completed

Close Public Comment Period May 30, 2015: Completed

Case Development

Issue Final Work Plan a June 30, 2015: Completed

Issue Data Call-in July 2016

Data Submission March 2017

Open 30-Day Public Comment Period for Draft Risk Assessments August 2017

Close Public Comment Period September 1, 2017

Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review Decision December 30, 2017

Close Public Comment Period March 1, 2018

Registration Review Final Decision and Begin Postdecision Follow-up April 1, 2018

E STIMATED T OTAL (years): ≈ 3.0

a This schedule is subject to revision should unforeseen issues arise during the Registration Review process. If an issue arises (e.g., failure to acquire an EDSP exemption), an amended FWP may be issued at that time. That FWP will identify any newly anticipated data needs and set forth a new timeline.

NEXT STEPS

As noted previously, EPA will determine whether, pursuant to FFDCA Section 408(p)(4), Chondrostereum purpureum isolate PFC 2139 qualifies for exemption from EDSP; this determination will inform EPA’s final Registration Review decision. Additionally, EPA intends to conduct an ecological risk assessment that would support a complete endangered species determination.

REFERENCE

U.S. EPA. 2015. Preliminary Work Plan and Summary Document for Registration Review: Chondrostereum purpureum . U.S. Environmental Protection Agency Office of Pesticide Programs. September 23, 2014. 17 pp. Available through regulations.gov docket number EPA-HQ-OPP-2015-0051.