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## T ABLE OF 

## C ONTENTS

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

A. Over view .................................................................................................................. ........................................ 4

B. Statutory and R egulatory Au thority ........................................................................................ .......................... 5

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

1. Taxonomy .................................................................................................................. .................................. 5 2. Regulator y Hist ory ........................................................................................................ ............................... 6

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

4. Toleranc e Actions ......................................................................................................... ............................... 7

D. Anticipated Data N eeds and Risk A ssessments ............................................................................... ............... 7

1. Product Analysis : 40 CFR 158.2120 ........................................................................................ .................. 7 2. Toxicology: 40 CFR 158.2140 .............................................................................................. ...................... 8 3. Nontarget Organisms and Envir onmental Fate: 40 CFR 158.2 150 ........................................................... 9

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

F. Endocrine Effe cts ......................................................................................................... .................................. 10

G. Literatu re Review ......................................................................................................... .................................. 10

H. In cident s ................................................................................................................. ........................................ 10

I. Summary of Antici pated Data Needs ......................................................................................... ..................... 11

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

K. Guidance fo r Comment ers ................................................................................................... .......................... 12

1. Environment al Justice ..................................................................................................... .......................... 12

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

3. Trade I rritants ........................................................................................................... ................................. 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 Assessm ent Memoranda ......................................................... 15

C. Other Re ferences .......................................................................................................... ................................. 16

TABLES

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

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

Table 3 Human Health Toxicology Data Requi rements and How T hey Were Met ............................................ 8

Table 4 Ecological Toxicity Data Require ments 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 IngredientRegistration Review Preliminary Work Plan Chondrostereum purpureum
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## A CRONYMS AND 

## A BBREVIATIONS

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 LoadsRegistration Review Preliminary Work Plan Chondrostereum purpureum
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4 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 shar ing 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 s pecifically seeks comment s 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 co mmenters; explains the next steps EPA will take for this Registration Review; summarizes background info rmation 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 “SEAR CH for: Rules, Comments, Adjudications or Supporting Documents,” enter the docket identification number, which is indicated above).Registration Review Preliminary Work Plan Chondrostereum purpureum
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5 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 periodica lly 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 classifi cation is (NLM 2014):

Kingdom: Fungi Subkingdom: Dikarya Phylum: Basidiomycota

Class: Agaricomycetes

Subclass: Agaricomycetidae

Order: Agaricales Family: Schizophyllaceae

Genus: Chondrostereum Species: purpureumRegistration Review Preliminary Work Plan Chondrostereum purpureum
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6 Chondrostereum purpureum strain PFC2139 1 was isolated from a canker on a red alder ( Alnus rubra Bong) on Vancouver Island, British Colu mbia 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 Managem ent 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).

1 Note: 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.Registration Review Preliminary Work Plan Chondrostereum purpureum
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7 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 Certificat ion of limits Confidential Statement of Formula (CSF) (U.S. EPA 2001a) Confidential Statement

of Formula (U.S. EPA 2001b)Registration Review Preliminary Work Plan Chondrostereum purpureum
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8 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 vi a the oral route (Guideline 870.1100), and no observed pathogenicity in the acut e 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 t he oral and dermal routes (Guidelines 870.1100 and 870.1200, respectively), and no observ ed 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 2004dRegistration Review Preliminary Work Plan Chondrostereum purpureum
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9 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 aeros ol particulate) (40 CFR 158.2120(d)6); products are so lids 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 toxici ty Waived based on:

 Low Mammalian Toxicity: Human heal th 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 birds 2

.

 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 lis ted 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.

2 The normal body temperature of rats is about 37°C (98°F) and of birds, 39°C (101°F).Registration Review Preliminary Work Plan Chondrostereum purpureum
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10 F. Endocrine Effects

The Agency has developed the Endocrine Disrupto r 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 deter mines 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 fi ndings 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-o f-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.Registration Review Preliminary Work Plan Chondrostereum purpureum
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11 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 Plan a 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

E STIMATED T OTAL (years): ≈ 3.5

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.Registration Review Preliminary Work Plan Chondrostereum purpureum
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12 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 m anner, prior to issuing an FWP for this case.

1. Environmental Justice

EPA seeks to achieve environmental justice, t he 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, regulati ons, 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/lawsgui dance/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 Operati ng 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.Registration Review Preliminary Work Plan Chondrostereum purpureum
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13 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

Products a 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 Produc t Label System at: http://ias pub.epa.gov/apex/pesticides/f?p=PPL S: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 90 th

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 data14 III. BIBLIOGRAPHY

A. Studies Supporting Registration Review of Chondrostereum purpureum PFC 2139

MRID 454933-00 Mycologic, Inc. 2001. Submissi on 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 Samp les, Certification of Ingredient Limits, Analytical Methods for Certified Limits an d 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, 885.150 0, 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 In stitute. 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. Unp ublished 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. Tr ansmittal 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 Resear ch 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. Acut e Dermal Toxicity/Pathogenicity Study of Chondrostereum

purpureum in Rabbits: Lab Project Number: L08725SN4. Unpublished study prepared by IIT Research Institute. 25 p. {OPPT S 885.3100}. Study Completion Date: August 26, 1998.

MRID 455071-04 Harder, J. 2001. Acute Eye Irri tation 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. Unpublish ed 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-PFC 2139 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. Envir onmental 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. Submissi on of Toxicity Data in Support of the Amended Registration of CP-PFC2139 and Chontrol Pa ste. 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: Fi nal 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 Stat ement 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 Stat ement 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 J oel Gagliardi to Susanne Cerrelli. Chondrostereum purpureum in Chontrol; EPA Reg. No. 74200-E/R. U. S. Environmental Protec tion 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 Offi ce of Pesticide Programs. Biopesticides and Pollution Prevention Division. September 23, 2004.

U.S. EPA 2004b. Notice of Registration. CP-PFC 2139. U.S. Environmental Prot ection Agency Office of Pesticide Programs. EPA Reg. No 74200-1. September 23, 2004.

U.S. EPA 2004c. Notice of Registration. Chontrol Past e. 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 Protec tion 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 Pest icide Programs. Biopesticides and Pollution Prevention

Division. October 2004.

U.S. EPA. 2005. Data Evaluation Record. Acute Pu lmonary 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 Prot ection Agency Office of Pesticide Programs. EPA Reg. No 74200-1. June 20, 2006.

U.S. EPA 2006b. Notice of Registration. Chontrol Past e. U.S. Environmental Protection Agency Office of Pesticide Programs. EPA Reg. No 74200-2. June 20, 2006.

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

. CASE 6091; PC CODE 081308. U.S. Environmental Prot ection 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 Ap plication; 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. Myc oLogic 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. In formation 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 Chontrol TM 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

Chontrol TM 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).