Registration Review:  Final Work Plan

Chondrostereum purpureum

EPA‐HQ‐OPP‐2015‐0051

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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 inhibit sprouting and regrowth in cut stumps of 

certain deciduous tree species in rights-of-way and forests. 

 EPA is implementing the Registration Review 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 the FIFRA standard for registration. Changes in 

science, public policy, and pesticide use practices occur 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 conducted, 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 products1 containing Chondrostereum purpureum isolate PFC 2139 as an 

active ingredient. 

 

 

1There are two registered 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

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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 solicited comments on: environmental justice, water quality 

concerns, and trade irritants; no comments or information 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 

Materiala

Estimated Timeframe 

(months from Receipt of DCIb)

830.6313 

Stability to normal and 

elevated temperatures,

metals, and metal ions 

TGAI 8 months 

aTGAI=technical grade of the active ingredient. bDCI=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

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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 Plana 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 

ESTIMATED TOTAL (years): ≈3.0

aThis 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.