Registration Review Preliminary Work Plan

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TABLE OF CONTENTS

I. PRELIMINARY WORK PLAN ................................................................................................................................ 4

A. Overview .......................................................................................................................................................... 4

B. Statutory and Regulatory Authority .................................................................................................................. 5

C. Background ...................................................................................................................................................... 5

1. Taxonomy .................................................................................................................................................... 5

2. Regulatory History ....................................................................................................................................... 6

3. Use Profile ................................................................................................................................................... 6

4. Tolerance Actions ........................................................................................................................................ 7

D. Anticipated Data Needs and Risk Assessments .............................................................................................. 7

1. Product Analysis: 40 CFR 158.2120 .......................................................................................................... 7

2. Toxicology: 40 CFR 158.2140 .................................................................................................................... 8

3. Nontarget Organisms and Environmental Fate: 40 CFR 158.2150 ........................................................... 9

E. Risk to Threatened and Endangered Species ................................................................................................. 9

F. Endocrine Effects ........................................................................................................................................... 10

G. Literature Review ........................................................................................................................................... 10

H. Incidents ......................................................................................................................................................... 10

I. Summary of Anticipated Data Needs .............................................................................................................. 11

J. Timeline........................................................................................................................................................... 11

K. Guidance for Commenters ............................................................................................................................. 12

1. Environmental Justice ............................................................................................................................... 12

2. Water Quality ............................................................................................................................................. 12

3. Trade Irritants ............................................................................................................................................ 12

4. Additional Information ................................................................................................................................ 13

L. Next Steps ...................................................................................................................................................... 13

II. FACT SUMMARY FOR CASE 6091 .................................................................................................................. 13

III. BIBLIOGRAPHY ................................................................................................................................................ 14

A. Studies Supporting Registration Review of Chondrostereum purpureum PFC 2139 .................................... 14

B. U.S. Environmental Protection Agency Risk Assessment Memoranda ......................................................... 15

C. Other References ........................................................................................................................................... 16

TABLES 

Table 1 Summary of Pesticide Products Containing Chondrostereum purpureum PFC 2139 .......................... 6

Table 2 Product Analysis Data Requirements and How They Are Met .............................................................. 7

Table 3 Human Health Toxicology Data Requirements and How They Were Met ............................................ 8

Table 4 Ecological Toxicity Data Requirements and How They Were Met ........................................................ 9

Table 5 Anticipated Product Analysis Data Need for Case 6091—Chondrostereum purpureum .................... 11

APPENDIX: Regulatory History Pertaining to the Registration of Products Containing 

Chondrostereum purpureum PFC 2139 as an Active Ingredient 
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ACRONYMS AND ABBREVIATIONS

ATTC American Type Culture Collection 

BRAD Biopesticides Registration Action Document 

CFR Code of Federal Regulations 

CSF Confidential Statement of Formula 

DCI Data Call-in 

EDSP Endocrine Disruptor Screening Program 

EPA U.S. Environmental Protection Agency, or the Agency 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

FWP Final Work Plan 

IDS Incident Data System 

MRID Master Record Identification Number 

MRL’s Maximum Residue Limits 

NA Not applicable 

NAFTA TWG North American Free Trade Agreement’s Technical Working Group 

OPP Office of Pesticide Programs 

PMRA Health Canada’s Pest Management Regulatory Agency 

PWP Preliminary Work Plan 

TMDL’s Total Maximum Daily Loads 

 
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I. PRELIMINARY WORK PLAN

 Registration Review Case 6091—Chondrostereum purpureum—originally included two active 

ingredients: Chondrostereum purpureum isolate PFC 2139 (PC Code 081308) and Chondrostereum 

purpureum strain HQ1 (PC Code 081309). Because all pesticide products containing Chondrostereum 

purpureum strain HQ1 as an active ingredient were cancelled on July 18, 2006, the Preliminary Work 

Plan (PWP) for Chondrostereum purpureum (Case 6091) only pertains to Chondrostereum purpureum

isolate PFC 2139 (PC Code 081308). 

Case Name: Chondrostereum purpureum

Case No: 6091 

PC Code: 081308 

Docket: EPA-HQ-OPP-2015-0051 

Registrant: MycoLogic Inc. 

A. Overview 

 The docket for Chondrostereum purpureum is now open, initiating the first public comment 

period for Registration Review Case 6091. This PWP document explains what the U.S. Environmental 

Protection Agency’s (EPA Office of Pesticide Programs (OPP) knows about Chondrostereum 

purpureum isolate PFC 2139, highlighting anticipated data and assessment needs, identifying types of 

information that would be especially useful to EPA in conducting the review, and providing an 

anticipated timeline for completing review of this active ingredient. 

 The Registration Review process was designed to include a public participation component to 

solicit input from interested stakeholders. By sharing this information in the docket, EPA intends to 

inform the public of what it knows about Chondrostereum purpureum isolate PFC 2139 and what types 

of new data or other information would be helpful for the Agency to receive as it moves toward a 

decision on this active ingredient. EPA encourages all interested stakeholders to review the PWP and 

to provide comments and additional information that will help EPA’s decision-making process for this 

microbial pesticide. In addition to general areas on which persons may wish to comment, there are 

some areas identified in the PWP about which EPA specifically seeks comments and information. 

Interested stakeholders could include the following: environmental nonprofit or interest groups; 

pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, 

and other users of pesticides; or the public at large. 

 The PWP begins by discussing the statutory and regulatory authority for Registration Review. 

Next, it provides background on Chondrostereum purpureum isolate PFC 2139 including a description 

of the modes of action; currently registered pesticide products; application rates and methods; use 

sites; and tolerance exemption information. Then, it lists the anticipated data needs and risk 

assessments and a projected Registration Review timeline for Chondrostereum purpureum isolate 

PFC 2139. Finally, the PWP describes guidance for commenters; explains the next steps EPA will take 

for this Registration Review; summarizes background information for this Registration Review; and lists 

supporting studies, risk assessment memoranda, and other documents. 

 Further information about this case, including background and supporting documents, is 

available at http://www.regulations.gov (under “SEARCH for: Rules, Comments, Adjudications or 

Supporting Documents,” enter the docket identification number, which is indicated above). 

 
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B. 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 States must generally be registered by EPA, based on 

scientific data showing that they will not cause unreasonable risks to human health or the environment 

when used as directed on the product labeling. 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 the statutory standard of no unreasonable 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 program, EPA periodically reevaluates pesticides to make sure that, 

as change occurs, products in the marketplace can continue to be used safely. Information on this 

program is provided on EPA’s website. 

 EPA is implementing the Registration Review program pursuant to Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 

15 years to determine whether it continues to meet the FIFRA standard for registration. The 

regulations governing Registration Review begin at 40 CFR 155.40. EPA 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 EPA’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 

docket during this initial comment period, EPA will develop a Final Work Plan (FWP) and anticipated 

schedule for the Registration Review of Chondrostereum purpureum. 

 C. Background

1. Taxonomy 

Chondrostereum purpureum was first described by Christiaan Hendrik Persoon in 1794 as 

Stereum purpureum Pers. (Persoon 1794). In 1959, it was reclassified as Chondrostereum purpureum

(Pouzar 1959). Chondrostereum purpureum’s taxonomic classification is (NLM 2014): 

Kingdom: Fungi 

Subkingdom: Dikarya 

Phylum: Basidiomycota 

Class: Agaricomycetes 

Subclass: Agaricomycetidae

Order: Agaricales 

Family: Schizophyllaceae 

Genus: Chondrostereum 

Species: purpureum

 
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Chondrostereum purpureum strain PFC21391 was isolated from a canker on a red alder 

(Alnus rubra Bong) on Vancouver Island, British Columbia in 1994. The canker developed as a 

result of inoculation in July 1993 with strain PFC2090, originally isolated from an apple tree 

(Malus spp.) in Saanicton, British Columbia in 1989. (Health Canada 2004) 

2. Regulatory History 

 Products containing Chondrostereum purpureum strain PFC 2139 as an active ingredient were 

reviewed jointly by Health Canada’s Pest Management Regulatory Agency (PMRA) and the Agency 

within the North American Free Trade Agreement’s Technical Working Group (NAFTA TWG) on 

Pesticides Joint Review Program. A summary of EPA’s decision is provided in the Biopesticides 

Registration Action Document (BRAD) for Chondrostereum purpureum strain PFC 2139 (U.S. EPA 

2004a). PMRA’s conclusions are discussed in Health Canada’s Registration Decision for 

Chondrostereum purpureum strain PFC2139 Cp-PFC2139 Control Paste (Health Canada 2007). 

3. Use Profile 

Registered Products. MycoLogic Inc. is the sole registrant for pesticide products containing 

Chondrostereum purpureum PFC 2139 as an active ingredient. The Agency registered the first 

products containing Chondrostereum purpureum PFC 2139 as an active ingredient in 2004. Current 

pesticide registrations are listed in Table 1; there is one manufacturing-use product and one end-use 

product. Appendix I provides a detailed regulatory history. 

Table 1 Summary of Pesticide Products Containing 

Chondrostereum purpureum PFC 2139 

EPA 

Reg. No Product Name Product Type % Active Ingredient First Registered 

74200-1 CP-PFC 2139 manufacturing-use 1.68 September 23, 2004 

(U.S. EPA 2004b) 

74200-2 ChontrolTM Paste end-use 0.67 September 23, 2004 

(U.S. EPA 2004c) 

Mode of Action. Chondrostereum purpureum is a naturally-occurring fungal plant pathogen. 

As a facultative saprophyte it can be pathogenic to stressed trees and shrubs, especially through 

wounds (Ramsfield 1996). The active ingredient Chondrostereum purpureum strain PFC 2139 invades 

its tree host through fresh-cut wounds and grows in the xylem and is a weak pathogen affecting only 

compromised trees (U.S. EPA 2004a). 

 Use Pattern. The end-use product ChontrolTM Paste is a vegetation management product 

intended to inhibit sprouting and regrowth in cut stumps of certain deciduous tree species in 

rights-of-way and forests (U.S. EPA 2004a). 

 

 

1Note: The Canadian researchers and Health Canada’s Pest Management Regulatory Agency refer to the strain 

as PFC2139 (i.e., without a space between ‘PFC’ and ‘2139’); the Agency uses a space (i.e., PFC 2139). 

When referring to a particular Canadian document such as their Registration Decision (Health Canada 

2007), the Canadian convention (i.e., no space) is maintained throughout this document. 
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 Application Method and Rates of End-Use Product. According to the end-use product label 

(EPA Reg. No 74200-2), ChontrolTM Paste is a ready-to-use product that is supplied in a one-liter 

squeeze bottle. Users of this product are directed to apply “the paste on the entire surface of cut area. 

Entire contents in the bottle must be used on the same day after opening.” 

4. Tolerance Actions 

 The use of ChontrolTM Paste is limited to non-food uses; therefore, there have been no 

tolerance actions pertaining to Chondrostereum purpureum PFC 2139 as an active ingredient in a 

pesticide product. 

D. Anticipated Data Needs and Risk Assessments

 Provided below are tables identifying the current data requirements for microbial pesticides as 

set forth in 40 CFR part 158, subpart V; they are arrayed by scientific discipline: Table 2—Product 

Analysis, Table 3—Human Health Toxicology, and Table 4—Ecotoxicity. Each table lists the respective 

data requirements and shows how the requirement has been met (or not met). The term “Guideline” 

refers to the Agency test guidelines for microbial pesticides; these can be found under the 700 Series 

at: http://nepis.epa.gov/EPA/html/pubnumindex.html. 

1. Product Analysis: 40 CFR 158.2120 

 The Agency has identified one Product Analysis data gap—Stability to normal and elevated 

temperatures, metals, and metal ion (Guideline 830.6313)—which is an anticipated data need for this 

Registration Review. All other data requirements have been fulfilled. 

Table 2 Product Analysis Data Requirements and How They Are Met 

Guideline Data 

Requirement

How the Requirement Is Met (MRID; Review)

CP-PFC 2139 

EPA Reg. No 74200-1 

ChontrolTM Paste 

EPA Reg. No 74200-2 

Product Chemistry and Composition

885.1100 Product identity 454933-02, 459038-01; 

U.S. EPA 2003 

885.1200 Manufacturing process 454933-02, 459038-01; 

U.S. EPA 2003 

885.1250 Deposition of a sample in a nationally 

recognized culture collection. 

454933-02; Deposited at the American Tissue Type Culture 

Collection (ATTC); www.atcc.org/Products/All/60854.aspx. 

885.1300 Discussion of formation of 

unintentional ingredients 

454933-02, 459038-01; 

U.S. EPA 2003 

Analysis and Certified Limits

885.1400 Analysis of samples 454933-02, 459038-01; 

U.S. EPA 2003 

885.1500 Certification of limits 

Confidential Statement 

of Formula (CSF) 

(U.S. EPA 2001a) 

Confidential Statement 

of Formula 

(U.S. EPA 2001b) 
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Guideline Data 

Requirement

How the Requirement Is Met (MRID; Review)

CP-PFC 2139 

EPA Reg. No 74200-1 

ChontrolTM Paste 

EPA Reg. No 74200-2 

Physical and Chemical Characteristics

830.6302 Color 454933-02; 

U.S. EPA 2003 

454933-02; 

U.S. EPA 2003 

830.6303 Physical state 454933-02; 

U.S. EPA 2003 

454933-02; 

U.S. EPA 2003 

830.6304 Odor 454933-02; 

U.S. EPA 2003 

454933-02; 

U.S. EPA 2003 

830.6313 Stability to normal and elevated 

temperatures, metals, and metal ions Data Gap Data Gap 

830.6317 Storage stability 459038-01; 

U.S. EPA 2003 

459038-01; 

U.S. EPA 2003 

830.6319 Miscibility 

NA: Miscibility is only required for emulsifiable 

liquid forms of microbial pesticides 

(40 CFR 158.2120(d)3); these products are solids. 

830.6320 Corrosion characteristics 454933-02 454933-02 

830.7000 pH 459038-01; 

U.S. EPA 2003 

459038-01; 

U.S. EPA 2003 

830.7100 Viscosity NA: Viscosity is only required for liquid forms of microbial 

pesticides (40 CFR 158.2120(d)5); these products are solids.

30.7300 Density 454933-02; U.S. EPA 2003 

459038-01; U.S. EPA 2003 

454933-02; U.S. EPA 2003 

459038-01; U.S. EPA 2003 

2. Toxicology: 40 CFR 158.2140 

Table 3 Human Health Toxicology Data Requirements and How They Were Met 

Guideline Data 

Requirement 

How the Requirement Is Met (MRID; Review) 

CP-PFC 2139 

EPA Reg. No 74200-1 

ChontrolTM Paste 

EPA Reg. No 74200-2 

885.3050 Acute oral toxicity/ 

pathogenicity 

Waived based on: low acute toxicity via the oral route (Guideline 870.1100), 

and no observed pathogenicity in the acute pulmonary toxicity/pathogenicity 

study (Guideline 885.3150). U.S. EPA 2003, U.S. EPA 2004d 

885.3150 

Acute pulmonary 

 toxicity/ 

pathogenicity 

455071-01, -02; 460183-02, 467024-01; 

U.S. EPA 2003, U.S. EPA 2004d, U.S. EPA 2005 

885.3200 

Acute injection 

 toxicity/ 

pathogenicity (i.v.) 

Waived based on: low acute toxicity via the oral and dermal routes (Guidelines 870.1100 

and 870.1200, respectively), and no observed pathogenicity in the acute pulmonary 

toxicity/pathogenicity study (Guideline 885.3150). U.S. EPA 2003, U.S. EPA 2004d 

885.3400 Hypersensitivity 

incidents 

Registrant reported (MRID 454933-04) that no such incidents have occurred 

for any of their products containing Chondrostereum purpureum PFC 2139. The 

Agency informed the registrant that hypersensitivity incidents must be reported to 

 EPA (under FIFRA section 6(a)2) should they occur. (U.S. EPA 2003)

885.3500 Cell culture NA: Cell culture is only required for a for virus (40 CFR 158.2140(d)4); 

Chondrostereum purpureum PFC 2139 is a fungus. 

870.1100 Acute oral 

toxicity 

454933-03; 460183-02 

U.S. EPA 2003, U.S. EPA 2004d 

According to 40 CFR 158.2140(5), this data requirement 

can be waived “when the applicant can demonstrate 

that the combination of inert ingredients is not likely to 

pose any significant human health risks.” This 

 condition has been met. U.S. EPA 2004d 
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Guideline Data 

Requirement 

How the Requirement Is Met (MRID; Review) 

CP-PFC 2139 

EPA Reg. No 74200-1 

ChontrolTM Paste 

EPA Reg. No 74200-2 

870.1200 Acute dermal 

toxicity 

455071-03; 

U.S. EPA 2003 

455071-03, 460183-02; 

U.S. EPA 2003, U.S. EPA 2004d 

870.1300 Acute inhalation 

toxicity 

NA: Required when the product consists of, or under conditions of use would result in, an 

 inhalable material (e.g., gas, volatile substances, or aerosol particulate) 

(40 CFR 158.2120(d)6); products are solids and are not expected to be inhalable. 

870.2400 Acute eye irritation 455071-04; 

U.S. EPA 2003, U.S. EPA 2004d 

455071-04, 460183-02; 

U.S. EPA 2003, U.S. EPA 2004d 

870.2500 Primary dermal 

irritation 

455071-03; 

U.S. EPA 2003, U.S. EPA 2004d 

455071-03, 460183-02; 

U.S. EPA 2003, U.S. EPA 2004d 

3. Nontarget Organisms and Environmental Fate: 40 CFR 158.2150 

Table 4 Ecological Toxicity Data Requirements and How They Were Met 

Guideline Data Requirement How the Requirement Is Met (MRID; Review) 

885.4050 Avian oral toxicity Waived based on: 

 Low Mammalian Toxicity: Human health toxicity testing showed 

that Chondrostereum purpureum PFC 2139 is not toxic via the oral 

route; via the pulmonary route, it showed no signs of it being 

pathogenic or infective. 

 Growth Temperature: Chondrostereum purpureum does not grow 

at temperatures greater than 35°C (95°F); thus, it is unlikely to be a 

pathogen of mammals or birds2

. 

 Findings in the Published Literature: An extensive literature search 

found no reports of direct adverse effects resulting from 

Chondrostereum purpureum exposure to birds, wild mammals, fish, 

arthropods, non-arthropod invertebrates, or aquatic plants. 

 This fungus is Ubiquitous in the Forest Ecosystem so nontarget 

organisms are naturally exposed to Chondrostereum purpureum. 

 The End-Use Product Formulation is a paste, which is expected to 

minimize exposure to nontarget plants. U.S. EPA 2004a 

885.4100 Avian inhalation toxicity/pathogenicity 

885.4150 Wild mammal toxicity/pathogenicity 

885.4200 Freshwater fish toxicity/pathogenicity 

885.4240 Freshwater invertebrate toxicity/ 

pathogenicity 

885.4280 

Estuarine/Marine fish testing 

Estuarine and marine invertebrate testing

885.4300 Nontarget plant testing 

885.4340 Nontarget insect testing 

885.4380 Honey bee testing 

E. Risk to Threatened and Endangered Species

 The Agency has not prepared a risk assessment that supports a complete endangered species 

determination for Chondrostereum purpureum isolate PFC 2139. During Registration Review, EPA 

plans on conducting 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. When an assessment 

concludes that a pesticide’s use “may affect” a listed species and/or its designated critical habitat, EPA 

will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the 

Services), as appropriate. 

 

 

2The normal body temperature of rats is about 37°C (98°F) and of birds, 39°C (101°F). 
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F. Endocrine Effects 

 The Agency has developed the Endocrine Disruptor Screening Program (EDSP) to determine 

whether 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 other such 

endocrine effects as the Administrator may designate.” Under the Federal Food, Drug, and Cosmetic 

Act (FFDCA) section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 

and November 2010, EPA issued test orders/data call-ins (DCI’s) for the first group of 67 chemicals (58 

pesticide active ingredients and nine inert ingredients) and published a second list of chemicals 

proposed for order issuance in the future. 

Chondrostereum purpureum isolate PFC 2139 is not among the group of 58 pesticide active 

ingredients on the initial list nor is it proposed on the second list of chemicals to be screened under the 

EDSP. EPA believes that Chondrostereum purpureum isolate PFC 2139, the active ingredient in this 

Registration Review case, likely would not produce any effect in humans similar to an effect produced 

by a naturally occurring estrogenic substance. As such, pursuant to Section 408(p)(4), EPA will 

determine in the future whether it can exempt Chondrostereum purpureum isolate PFC 2139, from the 

requirements of section 408(p) of EDSP. If EPA determines to exempt this substance from the EDSP, 

then it will issue an order. 

 For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future chemical lists proposed for screening, the test guidelines and the Tier 1 screening 

battery, please visit our website: http://www.epa.gov/endo/. In the interim, the Agency is making no 

human health or environmental safety findings associated with EDSP screening of Chondrostereum 

purpureum isolate PFC 2139 (Case 6091). Before completing this Registration Review, the Agency 

will make an EDSP FFDCA section 408(p) determination. 

G. Literature Review

 To see if any new information regarding Chondrostereum purpureum has been published in the 

open literature since 2014, EPA searched the National Library of Medicine’s PubMed database (NLM 

2015) using the terms provided below and, the period January 1, 2004 to February 12, 2015. EPA did 

not identify any new information. 

Search Terms: Chondrostereum; Chondrostereum purpureum; forest management cutting; forest 

management microbial; fungus forest; inhibit regrowth; inhibition regrowth; inhibition 

sprouting; inhibit sprouting; right-of-way; and vegetation management tree. 

H. Incidents 

 Based on a search conducted on March 4, 2015 (U.S. EPA 2015), pertaining to the period 

September 2004 to March 2015, no adverse human, domestic animal, or environmental incidents 

involving exposure to Chondrostereum purpureum isolate PFC 2139 as an active ingredient in a 

pesticide formulation have been reported to OPP’s Incident Data System. The Agency will consider 

any incident data or comments submitted to this docket in response to this PWP. 

 
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I. Summary of Anticipated Data Needs

The Agency expects to issue a DCI for the following product analysis data gap (Table 5): 

Table 5 Anticipated Product Analysis Data Need for 

Case 6091—Chondrostereum purpureum 

Guideline Requirement Timeframe (months 

from receipt of DCI)

830.6313 Stability to normal and elevated 

temperatures, metals, and metal ions 8 months 

J. Timeline

 The projected timeline for Case 6091 Chondrostereum purpureum isolate PFC 2139 is: 

Activities Estimated Month and Year 

Docket Opening 

Open Docket and 60-Day Public Comment 

Period for Chondrostereum purpureum April 2015 

Close Public Comment Period June 2015 

Case Development 

Issue Final Work Plana December 2015 

Issue Data Call-in December 2016 

Data Submission August 2017 

Open 30-Day Public Comment 

Period for Draft Risk Assessments January 2018 

Close Public Comment Period February 2018 

Registration Review Decision 

Open 60-Day Public Comment Period for 

Proposed Registration Review Decision June 2018 

Close Public Comment Period August 2018 

Registration Review Final Decision 

and Begin Postdecision Follow-up September 2018 

ESTIMATED TOTAL (years): ≈3.5 

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. 

 
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K. Guidance for Commenters

 The public is invited to comment on the PWP and rationale. The areas below highlight topics of 

special interest to EPA where comments, information submissions, or reference to sources of additional 

information could be of particular use. EPA will consider all comments, as well as any additional 

information or data provided in a timely manner, prior to issuing an FWP for this case. 

1. Environmental Justice 

 EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of 

all people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, EPA seeks information on any groups or segments of the population who, 

as a result of their location, cultural practices, or other factors, may have atypical, unusually high 

exposure to Chondrostereum purpureum isolate PFC 2139 compared to the general population. 

Please comment if you are aware of any subpopulations that may have atypical, unusually high 

exposure compared to the general population. 

 2. Water Quality 

Chondrostereum purpureum isolate PFC 2139 is not identified as a cause of impairment for any 

water bodies listed as impaired under section 303(d) of the Clean Water Act. In addition, EPA has not 

developed Total Maximum Daily Loads (TMDL’s) for Chondrostereum purpureum isolate PFC 2139. 

More information on impaired water bodies and TMDL’s can be found at EPA’s website: 

http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/. EPA invites submission of water quality data for 

this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the Office of Pesticide Programs’ Standard Operating Procedure: Inclusion of Impaired Water Body 

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

Process to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

 3. Trade Irritants 

 Through the Registration Review process, EPA intends to solicit information on trade irritants 

and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency will work to 

harmonize tolerance and international Maximum Residue Limits (MRL’s) 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 MRL’s or disparities between U.S. tolerances and MRL’s in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

 The use of pesticide products containing Chondrostereum purpureum PFC 2139 as an active 

ingredient is limited to non-food use sites. Because of this, the Agency has taken no tolerance actions 

pertaining to Chondrostereum purpureum PFC 2139. EPA does not anticipate that current use of this 

pesticide active ingredient will pose concerns as trade irritants. 
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 4. Additional Information 

 Stakeholders also are asked to provide information and data that will assist the Agency in 

refining the risk assessments. The Agency is interested in obtaining the following information on 

Chondrostereum purpureum PFC 2139: 

L. Next Steps

 After the 60-day comment period closes, EPA will review and respond to any comments 

received in a timely manner and then issue an FWP for Case 6091. 

II. FACT SUMMARY FOR CASE 6091 

Active Ingredient 

(PC Code) 

First 

Registered 

Registered 

Pesticide 

 Productsa

Publicly Available 

EPA Science and 

Regulatory Documents 

Additional Risk Assessment Needed? 

Product 

Chemistry 

Human 

Health Ecological 

Chondrostereum

purpureum 

PFC 2139 

(081308) 

September 

23, 2004 

Two (one 

manufacturing- and 

one end-use product) 

BRAD (U.S. EPA 2004a) 

Biopesticide Fact Sheet 

(U.S. EPA 2004e) 

NO NO YES 

a

Labels for these products can be found in the Pesticide Product Label System at: http://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1. 

 Confirmation on the following label information: 

 - Formulations 

 - Application sites 

 - Application methods and equipment 

 - Maximum application rates 

 - Frequency of application, application intervals, 

 and maximum number of applications 

 - Geographic limitations on use 

 Use or potential use distribution (e.g., acreage and 

geographical distribution of relevant use sites) 

 Median and 90th percentile reported use rates 

 (lbs active ingredient/1,000 square feet) from usage 

 data—national, state, and county 

 Application timing (date of first application and 

 application intervals)—national, state, and county 

 Usage/use information for nonagricultural uses 

 Typical application interval (days) 

 State or local use restrictions 

 Monitoring data 
14 

III. BIBLIOGRAPHY

A. Studies Supporting Registration Review of Chondrostereum purpureum PFC 2139 

MRID 454933-00 Mycologic, Inc. 2001. Submission of Product Chemistry, Efficacy, Toxicity, and 

Environmental Fate Data in Support of the Application for Registration of Chontrol. 

Transmittal of 4 Studies. Date: August 2, 2001. 

MRID 454933-01 Bastide, P. 2001. Chondrostereum purpureum Isolate PFC 2139 (Comprehensive Data 

Summaries): Lab Project Number: 94B. Unpublished study prepared by MycoLogic, 

Inc. 33 p. Study Completion Date: August 2, 2001. 

MRID 454933-02 Bastide, P. 2001. Chondrostereum purpureum Isolate PFC 2139 Product Identity and 

Disclosure of Ingredients, Manufacturing Process and Discussion on the Formation of 

Unintentional Ingredients, Analysis of Samples, Certification of Ingredient Limits, 

Analytical Methods for Certified Limits and Physical and Chemical Properties: Lab 

Project Number: 94B. Unpublished study prepared by MycoLogic, Inc. 714 p. {OPPTS 

885.1000, 885.1100, 885.1300, 885.1400, 885.1500, 885.1600}. Study Completion Date: 

August 2, 2001. 

MRID 454933-03 Harrington, K. 1999. Acute Toxicity/Limit Testing of Chondrostereum purpureum

Following Acute Oral Challenge in Rats: Lab Project Number: L08725 SN2. 

Unpublished study prepared by IIT Research Institute. 30 p. {OPPTS 870.1100}. Study 

Completion Date: April 1999. 

MRID 454933-04 Bastide, P. 2001. Chondrostereum purpureum Isolate PFC 2139 Hypersensitivity 

Incidents: Lab Project Number: 94B. Unpublished study prepared by Mycologic, Inc. 5 

p. {OPPTS 885.3400}. Study Completion Date: August 2, 2001. 

MRID 455071-00 Mycologic Inc. 2001. Submission of Toxicity and Efficacy Data in Support of the 

Application for Registration of Chontrol. Transmittal of 5 Studies. Date: August 2, 1991. 

MRID 455071-01 Gingras, B. 1998. Sensitivity of Detection of Chondrostereum purpureum for 

Toxicity/Pathogenicity Testing in Rats: Final Report: Lab Project Number: L08725 SN1. 

Unpublished study prepared by IIT Research Institute. 32 p. {OPPTS 885.001, 

885.3100, 885.3150}. Study Completion Date: October 1998. 

MRID 455071-02 Gingras, B. 1999. Toxicity/Pathogenicity Testing of Chondrostereum purpureum

Following Acute Intratracheal Challenge in Rats: Final Report: Lab Project Number: 

L08725 SN3. Unpublished study prepared by IIT Research Institute. 95 p. {OPPTS 

885.3150}. Study Completion Date: April 1999. 

MRID 455071-03 Findlay, J. 1998. Acute Dermal Toxicity/Pathogenicity Study of Chondrostereum 

purpureum in Rabbits: Lab Project Number: L08725SN4. Unpublished study prepared 

by IIT Research Institute. 25 p. {OPPTS 885.3100}. Study Completion Date: August 

26, 1998. 

MRID 455071-04 Harder, J. 2001. Acute Eye Irritation Study of the Technical Grade Formulation 

Containing Viable Mycelia of Chondrostereum purpeum in Rabbits: Lab Project Number: 

1367 SN1. Unpublished study prepared by IIT Research Institute. 25 p. {OPPTS 

870.2400}. Study Completion Date: February 2001. 

MRID 455071-05 Biehn, W. 2001. Chondrostereum purpeum Isolate PFC 2139 Product Performance 

Data: Lab Project Number: 94B. Unpublished study prepared by The University of 

Victoria. 477 p. Study Completion Date: September 24, 2001. 

MRID 460183-00 Mycologic Inc. 2003. Submission of Product Chemistry and Toxicity Data in Support of 

the Applications for Registration of CP-PFC2139 and Chontrol Paste. Transmittal of 3 

Studies. Date: April 3, 2003. 
15 

MRID 460183-01 de la Batiste, P. 2003. Chondostereum purpueum (sic) Isolate PCF 2139 

Comprehensive Data Summaries: Amendment #1 to MRID 45493301. Project Number: 

94B. Unpublished study prepared by Mycologic, Inc. 35 p. Study Completion Date: 

June 23, 2003. 

MRID 460183-02 de la Batiste, P. 2003. Toxicology and Pathology Studies: Amendment 1: (Chontrol). 

Project Number: 94B. Unpublished study prepared by Mycologic Inc. 20 p. Study 

Completion Date: March 27, 2003. 

MRID 460183-03 de la Batiste, P. 2003. Environmental Toxicology and Non-Target Studies: 

 (Cp-PFC2139). Project Number: 94B. Unpublished study prepared by Mycologic Inc. 

130 pp. Study Completion Date: March 27, 2003. 

MRID 467024-00 Mycologic, Inc. 2005. Submission of Toxicity Data in Support of the Amended 

Registration of CP-PFC2139 and Chontrol Paste. Transmittal of 1 Study. Date: 

November 25, 2005. 

MRID 467024-01 Mega, W. 2005. Toxicity/Pathogenicity Testing of Chondrostereum purpureum Following 

Acute Intratracheal Challenge in Rats: Final Report. Project Number: 2112/SN1, 0094B. 

Unpublished study prepared by IIT Research Institute. 40 p. Study Completion Date: 

November 2005. 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda and Other

U.S. EPA. 2001a. Confidential Statement of Formulation for EPA Reg. No 74200-1. Submitted to the 

U.S. Environmental Protection Agency Office of Pesticide Program Agency by Paul de la Bastide, Mycologic Inc. 

Signed by Mycologic on August 2, 2001. 

U.S. EPA. 2001b. Confidential Statement of Formulation for EPA Reg. No 74200-2. Submitted to the 

U.S. Environmental Protection Agency Office of Pesticide Program Agency by Paul de la Bastide, Mycologic Inc. 

Signed by Mycologic on August 2, 2001. 

U.S. EPA. 2003. Memorandum from Joel Gagliardi to Susanne Cerrelli. Chondrostereum purpureum in 

Chontrol; EPA Reg. No. 74200-E/R. U.S. Environmental Protection Agency Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. December 8, 2003. 28 pp. 

U.S. EPA 2004a. Biopesticide Registration Action Document: Chondrostereum purpureum strain PFC 2139 (PC 

code 081308). U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution 

Prevention Division. September 23, 2004. 

U.S. EPA 2004b. Notice of Registration. CP-PFC 2139. U.S. Environmental Protection Agency Office of 

Pesticide Programs. EPA Reg. No 74200-1. September 23, 2004. 

U.S. EPA 2004c. Notice of Registration. Chontrol Paste. U.S. Environmental Protection Agency Office of 

Pesticide Programs. EPA Reg. No 74200-2. September 23, 2004. 

U.S. EPA 2004d. Memorandum from Joel Gagliardi to Susanne Cerrelli. Chondrostereum purpureum in 

Chontrol; EPA Reg. No. 74200-E/R. U.S. Environmental Protection Agency Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. March 11, 2004. 

U.S. EPA 2004e. Biopesticide Fact Sheet: Chondrostereum purpureum strain PFC 2139. 

U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution Prevention 

Division. October 2004. 

U.S. EPA. 2005. Data Evaluation Record. Acute Pulmonary Toxicity/Pathogenicity – Rat. Review of MRID 

467024-01. John Kough. U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides 

and Pollution Prevention Division. January 25, 2005. 
16 

U.S. EPA 2006a. Notice of Registration. CP-PFC 2139. U.S. Environmental Protection Agency Office of 

Pesticide Programs. EPA Reg. No 74200-1. June 20, 2006. 

U.S. EPA 2006b. Notice of Registration. Chontrol Paste. U.S. Environmental Protection Agency Office of 

Pesticide Programs. EPA Reg. No 74200-2. June 20, 2006. 

U.S. EPA. 2015. Email from Robert Miller to Kathleen Martin. REG REVIEW: Chondrostereum purpureum. 

CASE 6091; PC CODE 081308. U.S. Environmental Protection Agency Office of Pesticide Programs. 

March 4, 2015 6:36 AM. 

C. Other References

Health Canada. 2004. Product Monograph Chondrostereum purpureum (PFC2139) Chontrol Paste. 

Health Canada. Pest Management Regulatory Agency. March 2004. 

Health Canada. 2007. Registration Decision: Chondrostereum purpureum strain PFC2139. Cp-PFC2139 

Chontrol Paste. Health Canada. Pest Management Regulatory Agency. RD2007-06. June 4, 2007. 

MycoLogic. 2001a. Letter from Paul de la Bastide, MycoLogic Inc. to Susanne Cerrelli, U.S. Environmental 

Protection Agency. Cp-PFC 2139 Manufacturing Use Product containing Chondrostereum purpureum isolate 

PFC 2139; Mycologic Registration Application; EPA Company No. 74200-R. MycoLogic Inc. University of 

Victoria, Canada. August 2, 2001. 

MycoLogic. 2001b. Letter from Paul de la Bastide, MycoLogic Inc. to Susanne Cerrelli, U.S. Environmental 

Protection Agency. ChontrolTM End Use Product containing Chondrostereum purpureum isolate PFC 2139; 

Mycologic Registration Application; EPA Company No. 74200-E. MycoLogic Inc. University of Victoria, Canada. 

August 2, 2001. 

NLM. 2014. Taxonomy Database. National Institutes of Health. U.S. National Library Medicine. National 

Center for Biotechnology Information. Information accessed on: September 16, 2014. 

http://www.ncbi.nlm.nih.gov/taxonomy 

NLM. 2015. PubMed. National Institutes of Health. U.S. National Library of Medicine. National Center for 

Biotechnology Information. Information accessed on: February 12, 2015. Persoon, CH. 1794. Neuer Versuch 

einer systematischen Eintheilung der Schwämme. Neues Magazin für die Botanik. 1:63-80. 

Pouzar, Z. 1959. New genera of higher fungi III. Ceská Mykologie. 13(1):10-19. 

Ramsfield, TD et al. 1996. Geographic variation of Chondrostereum purpureum detected by polymorphisms in 

the ribosomal DNA. Canadian Journal of Botany, 1996, 74(12): 1919-1929. 

U Victoria. 1997. Letter from William Hintz, MycoLogic Inc. to Susanne Cerrelli, U.S. Environmental Protection 

Agency. Chondrostereum purpureum Pre-registration •Meeting. University of Victoria Department of Biology. 

August 5, 1997. 
Appendix 

APPENDIX I

Regulatory History Pertaining to the Registration of Products

Containing Chondrostereum purpureum PFC 2139 as an Active Ingredient

In July 1997, EPA met with representatives of MycoLogic Inc. to discuss the data that would be required

to register a pesticide active ingredient that had never previously been registered (U Victoria 1997).  In 2004, the

Agency registered a manufacturing‐ and an end‐use product containing Chondrostereum purpureum PFC 2139 as

an active ingredient (U.S. EPA 2004b,c).  The end‐use product is registered for use to control certain hardwood

trees in rights‐of‐way and forests.

August 2001 MycoLogic Inc. submits applications to register two products containing

Chondrostereum purpureum strain PFC 2139 as an active ingredient (MycoLogic

2001a,b).

December 31, 2001

66 FR 67520

Notice of Receipt.  Publication of a notice in the Federal Register announcing the

receipt of MycoLogic’s application to register two pesticide products containing

Chondrostereum purpureum isolate PFC 2139, an active ingredient not included

in any previously registered products:

  ‐ EPA File Symbol 74200‐R:  CP‐PFC 2139 (manufacturing use product); and  

  ‐ EPA File Symbol 74200‐E:  ChontrolTM Paste (end‐use product).

September 23, 2004

EPA Reg. No 74200‐1

EPA Reg. No 74200‐2

EPA registers CP‐PFC 2139 (EPA Reg. No 74200‐1) and ChontrolTM Paste  

EPA Reg. No 74200‐2) with the condition that MycoLogic submit production

information by November 15, 2005. (U.S. EPA 2004b,c)

December 22, 2004

69 FR 76718

Notice.  Publication of a notice in the Federal Register announcing the Agency’s  

conditional approval of MycoLogic’s applications to register CP‐PFC 2139 and

ChontrolTM Paste, products that have not previously been registered.  

June 23, 2006

EPA Reg. No 74200‐1

EPA Reg. No 74200‐2

EPA changes the registration from conditional to unconditional (U.S. EPA 2006 a,b).