## Dried Fermentation Solids and Solubles of **Myrothecium verrucaria Pr**  **eliminary Wo**  **rk Plan and Summary Document Registration Review: Initial Docket** 

September 201 3 Case 6051 PC Code 1 19204

**Appr oved by:** 

Robert McNally

, Director Biopesticides and Pollution Prevention Division **Date:**Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

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### T **ABLE** 

### O **F** 

### C **ONTENTS I.**  **PRELIMINAR**

**Y WORK PLAN**  ................................ ................................ ................................ ...... 4 A. Overview ................................ ................................ ................................ ................................ ..... 4 B. Statutory

and Regulatory Authority ................................ ................................ ............................ 5 C. Background and Regulatory Information ................................ ................................ ................... 5 D. Anticipated Data Needs and Risk Assessments ................................ ................................ .......... 7 E. Risk to Threatened and Endangered Species ................................ ................................ ............. 11 F. Endocrine Ef

fects ................................ ................................ ................................ ....................... 11 G. In cidents ................................ ................................ ................................ ................................ .... 12 H. Ti meline ................................ ................................ ................................ ................................ .... 12 J. Guidance for Commenters ................................ ................................ ................................ ........ 13 K. Next Steps ................................ ................................ ................................ ................................ . 15 **II. FA**  **CT SUMMA RY**  **FO R CASE 605**  **1** ................................ ................................ ............................ 15 **III. BIBLIOGRAPHY**  ................................ ................................ ................................ ........................... 16 A. Studies Supporting Registration Review of Dried fermentation solids and solubles of Mycrothecium verrucaria ................................ ................................ ................................ ......... 16 B . Environmental Protection Agency Risk Assessment Memoranda ................................ ............ 20 C . Other References ................................ ................................ ................................ ....................... 21Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

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### ACRONYMS **AND ABBREVIA**  **TIONS** BPPD EPA’s Biopesticides and Pollution Prevention Division C . F . R . Code of Federal Regulations cw t C entum weight or hundredweight . In this document, cwt refers to a 100 pound measure of seed. DNA Deoxyribonucleic a cid EDSP Endocrine Disruptor Screening Program EP End - use pesticide product EPA U.S. Environmental Protection Agency (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 gal Gallon HR H ypersensitive response IDS Incident Data System kD Kilodalton kg Kilogram lb Pound mg M illigram MRID No. Master Record Identification Number : EPA's system of recording and tracking studies submitted to the

Office of Pesticide Programs. MRL Maximum Residue Limit M. verrucaria Myrothecium verrucaria OPP EPA’s Office of Pesticide Programs oz Ounce PC Code Pesti cide chemical c ode: a six - digit num ber assigned by OPP to identify pesticide chemicals. PWP Preliminary Work Plan TGAI Technical grade of the active ingredient TMDL Total Maximum Daily Load U.S. United StatesDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

4 **I. PRELIMINAR** 

**Y WORK**  **PLAN A.**  **Overview** The docket for dried fermentation solids and solubles of Mycrothecium verrucaria, (referred to as M

. verrucaria in this document ; Registration Review C ase 605 1 ) is now open, initiating the first public comment period for this Registration Review case (docket number EP A HQ - OPP - 2013 - 0539 ) . The pesticide active ingredient i s a mixture of the killed fungus, M. verrucaria , and the liquid in which the fungus is grown. Products containing this active ingredient are registered for use to kill parasitic , microscopic nematodes that attack plants, usually through their roots. The active ingredient is specific to nematodes that parasitize plants, and it is not intended to harm other types of nematodes. Because the mixture may be toxic to aquatic organisms, the EPA limited its use to prevent contamination of water bodies. This Preliminary

W ork Plan (PWP) document explains what the Environmental Protection Agency ’s (EP

A) Office of Pesticide Programs knows about M. verrucaria , highlighting anticipated data and assessment needs, identifying types of information that would be especially

useful to EP

A in conducting the review , and providing an anticipated timeline for completing review of th is active ingredient. The Re gistration Review process was designed to include a public participation component to solicit input from interested stakeholders. B y sharing this information in the docket, EP

A intends to inform the public of what it knows about M . verrucaria and what ty

pes of new data or other information would be helpful for EP A to receive as it moves toward a decision on this active ingredient . EP A encourages all interested stakeholders to review the PWP and to provide comments and additional information that will help EP A ’s decision - making process for th is microbial pesticide. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP about which EP

A specificall y seeks comments and information. Interested st akeholders 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 be gins b y discussing the statutory and regulatory

authority for Registration Review. Next, it provides background on M. verrucaria including a description of the mode s 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 M. verrucaria. F inally , the PWP describes guidance for commenters , explains the next steps EP A 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

.r egulations.gov (under “ SEARCH for: Rules, Comments, Adjudications or Supporting Documents, ” enter the docket identification number, which is indicated above) .Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

5 **B .**  **Statutory and Regulatory Authority**  The Food Quality

Protection Act (FQP

A) of 1996 mandated a Registration Review program . All pesticides distributed or sold in the United States (U.S.) must generall y be registered b y EP

A , 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 ef

fects to human health or the environment . Changes in science, public policy , and pesticide use practices will occur over time. Through the Registration Review program, EP

A periodically

reevaluates pesticides to make sure that , as change occurs, products in the marketplace can continue to be used safely . Informatio n on this program is provided on EP A’ s website . 1 EP A 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. Th e regulations governing Registration Review begin at 40 C.F.R. § 155.40. EP A will consider benefits information and data as required b y FIFRA. The public phase of Registration Review begins when the initial docket is opened for each case. The docket is EP A ’s opportunity

to state what it knows about the pesticide and what additional risk anal ys es 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, EP A wil l develop a F inal W ork P lan (FWP) and anticipated schedule for the Registration Review of M. verrucaria. **C .**  **Backgr ound and Regulatory Information** 

**i. Summary**  **of the Active Ingr** **edient 2**  The pesticide active ingredient called “ dried fermentation solids and solubles of Myrothecium verrucaria ” (referred to as M . verrucaria in this document) is a mixture of substances that are in suspension and in solution when the fungus, M . verrucaria , is grown in the laboratory . To prepare the active ingredient as a dry powder, researchers remove water from the culture mix and kill the fungus b y exposing it to high temperatures. The pesticidal activity is not due to a singl y identifiable component; it requires the entire mixture. The exact mechanism of action is unknown . The active ingredient is formulated into products registered for use on food, fiber, and ornamental crops to control various parasitic nematodes. These nematodes are microscopic, w orm - like creatures that parasitize plants, usually through the roots, thereby reducing the quality and yield of the plants they infect. Because the active ingredient is specific to parasitic nematodes, it is not intended to a ff ect free - living nematodes that do not cause plant disease.

1 See http://www.epa.gov/oppsrrd1/registration_review/ . 2 Information in this section extracted from U.S. EPA (1999) and U.S. EPA (1996).Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

6 Products containing M. verrucaria are applied as a dry powder or a ground spray and incorporated into the upper 3 to 6 inches of soil. These products can be applied at any time in the plant’ s life cycle

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before planting, during planting, or after planting. Because the ecological risk assessment indicated moderate toxicity to rainbow trout and because no valid study is available with which to assess risks to aquatic invertebrates, the EP A concluded that the following environmental hazard statements are required on end - use product label s to mitigate ecological risks : “Do not appl y directl y to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water b y cleaning of equipment or disposal of equipment washwaters.” “The application methods allowed on the product label are to be limited to soil incorporation at a depth of 3 to 6 inches, chemigation by drip irrigation and soil surface spray application.” EP A plans to follow - up with the registrant to confirm that the necessary environmental hazards statements are present on the end - use product labels.

**ii. Dried fermentation solids and solubles of**  **Myrothecium verrucaria**  **Pr oducts**  In 1996, the EP

A registered the first pesticide product s containing M. verrucaria f or use as nemat acide s on food, fiber, and ornamental crops. The original registrant was Abbott Laborato ries of North Chicago, Illinois, and the original products were ABG - 9008 and ABG 9017. The EP

A registered the most recent product in 20 04 . The currentl y registered products are manufacturing use and end - use pesticide products registered for use to protect food , fiber, and ornamental crops from parasitic nematodes. Th e registrant of all currently registered products containing M

. verrucaria as an active ingredient is Valent Biosciences Corporation. S ee Ta ble 1 below for additional information about the currently registered products . **TABLE 1. Summary of Currently Registered Products containing**  **Dried fermentation solids and solubles of Myrothecium**  **verrucaria a**  **s an Active Ingredient**  **EPA Registration**  **Number Product Name** 

**(% Active Ingredient, Form** **ulation Type) Date**  **Registered C**  **om pany Name**  **Application Rates**  **Application**

**Methods Use Sites** 

73049 - 36 Ditera Technical Powder April 29, 2000 Valent Biosciences

Corporation N/A N/A For Manufacturing Use Only
73049 - 37 Ditera WP April 29, 2000 Valent Biosciences

Corporation 25 pounds per 100 acres Irrigation/

Chemigation Agricultural crops:

food and feed, ornamentals, cotton, tobacco and turf 73049 - 43 Ditera ES Biological

Nemati cide Emulsifiable Suspension April 29, 2000 Valent Biosciences

Corporation 10 gallons per 40 acres Irrigation/

Chemigation Agricultural crops:

food and feed, ornamentals, cotton, tobacco and turfDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

7 **TABLE 1. Summary of Currently Registered Products containing**  **Dried fermentation solids and solubles of Myrothecium**  **verrucaria a**  **s an Active Ingredient**  **EPA Registration**  **Number Product Name** 

**(% Active Ingredient, Form** **ulation Type) Date**  **Registered C**  **om pany Name**  **Application Rates**  **Application**

**Methods Use Sites** 

73049 - 60 Myrothecium verrucaria Slurry September

27, 2004 Valent Biosciences

Corporation N/A N/A For Manufacturing Use Only

73049 - 67 Ditera Biological

Nematicide March 4, 2003 Valent Biosciences

Corporation 0 .31 pounds per

1,000 square feet to 2.4 pounds per 1,000 square feet; Irrigation/

Chemigation Agricultural crops:

food and feed, ornamentals, cotton, tobacco and turf **iii. To**  **lerance Actions**  Given that many of the uses associated with the registered M. verrucaria pesticide products involve treating food or feed crops directly or indirectly by treatment of the media that such food and feed plantings are grown in, it is expected that M. verrucaria pesticide residues could be found in or on such food or feed . The a pplicant submitted a p etition for the establishment of an exemption from the requirement of a tolerance for the active ingredient . In light of available toxicity and exposure data, the EP A concluded in a 1994 review that there was a reasonable certainty that no harm w ould result to the U.S. population from aggregate exposure to residues of M. verrucaria . (U.S. EP A , 1994 ) . BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG - 99008 TGAI/EP; and the Applicability of a To lerance Exemption for this killed microbial, Myr othecium verrucaria. Memorandum from Cindy Schaf fer to Phillip Hutton, dated December 6, 1994.) Therefore, the EP A established a tolerance exemption for residues of th is active ingredient , and in 1996 the Agency reassessed this exemption from tolerance to ensure adequate protection for infants and children . The current tolerance exempti on for this ac tive ingredient is stated as follows: **40 CFR §**  **180.1163** Killed Myrothecium verrucaria is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as a pre - seed or pre - or post - plating soil treatment alone or mixed with water and the mixed suspension be applied through drip or border irrigation sy stems and the indicator mycotoxin levels do not exceed 15 ppm. Federal Register Citations : Notices of Filing ( 61 FR 11 315 , March 20 , 1996 ) ; Final Rule ( 6 1 FR 58332 , November 14 , 1996 ) **D .**  **Anticipated Data Needs and Risk**  **Assessment s**  Provided below are tables identifying the current data requirements for microbial pesticides as set forth in 40 C.F.R. part 158, subpart U . The y are arrayed b y scientific discipline (i.e., product chemistry

, toxicology

, and nontarget organisms and environmental fate) andDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

8 descriptions are included regarding how the data requirements have been fulfilled or where data gaps (anticipated data needs) have been identified. Presently , there are no data gaps for M. verrucaria , and the EP A has no anticipated data needs for this active ingredient. **Pr oduct**  **Chemistry (**  **40 C.F .R. § 158.**  **212 0**  **) TABLE 2. Summary of Product Chemistry Data for**  **Dried ferm entation solids and solubles of**  **Myrothecium verrucaria**  **Harm onized**  **G uideline**  **Number Data Requirement**  **Has Data Requirement**  **Been Addressed?**  **How? Source**  **MRID/ Accession Number or Other**  **Reference**
885.1100 Product Identity Yes ; Study U.S. EPA ( 1994 ) 4 3337001 43337002 43337003 885.1200 Manufacturing Process Yes ; Study U.S. EPA ( 1994 ) 43337001 43337002 43337003 885.1250 Deposition o f a Sample

in a Nationally Recognized Culture Collection Yes; EPA

Memorandum U.S. EPA ( 1995 ) EPA Memo dated October 10, 1995

885.1300 Discussion o f Formation

o f Unintentional Ingredients Yes ; Study U.S. EPA ( 1994 ) 4 3337001 43337002 43337003
885.1400 Analysis o f Samples Yes ; Study U.S. EPA ( 1995 ) 43776902 43337002 43337003 885.1500 Certification o f Limits Yes ; Study U.S. EPA (1996) 43776901

**TABLE 3 .**  **Summary of Physical and Chemical Characteristics for Dried fermentation solids and solubles of**  **Myrothecium verrucaria**  **Harm onized**  **Guideline Number Data**  **Requirement Has Data**  **Requirement Been**  **Addressed? How?**  **Source MRID**  **/ Accession Number or Other Reference**  830.6302 Color Yes; Study U.S. EPA (1994) 43337004Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

9 **TABLE 3 .**  **Summary of Physical and Chemical Characteristics for Dried fermentation solids and solubles of**  **Myrothecium verrucaria**  **Harm onized**  **Guideline Number Data**  **Requirement Has Data**  **Requirement Been**  **Addressed? How?**  **Source MRID**  **/ Accession Number or Other Reference**  830.6303 Phy sical State Yes; Study U.S. EPA (1994) 43337004 830.6304 Odor Yes; Study U.S. EPA (1994) 43337004 830.6317 Storage Stability Yes; Study U.S. EPA (1994) 43337004 830.6319 Not Applicable . Dried fermentation solids and solubles of Myrothecium verrucaria is a solid powder, not a liquid. 830.6320 Corrosion

Characteristics Yes; Study U.S. EPA (1996) 4 3776904 830.7000 pH Yes; Study U.S. EPA (1994) 43337004 830.7100 Viscosity Yes; Study U.S. EPA (1996) 43776903 830.7300 Denisty/relative

density/bulk density Yes; Study U.S. EPA (1994) 43337004 **To xicology**  **( 40 C.F** 

**.R. § 158. 2050**  **) TABLE**  **4 .**  **Summary of Toxicology Data for Dried ferm**  **entation solids and solubles of Myrothecium**  **verrucaria Harm**  **onized Guideline**  **Number Data Requirement**  **Has Data Requirement**  **Been Addressed? How?**  **Source MRID**  **/ Accession Number or Other Reference**  885.3050 Ac ute Oral Toxicity/

Pathogenicity Data not required for a killed microbial pesticide because the organism is killed and cannot infect the test animal. 885.3150 Ac ute Pulmonary

Toxicity/Pathogenicity Yes; Study U.S. EPA (1994) 43337010 885.3200 Ac ute In jection Toxicity/ Pathogenicity Intravenous Data not required for a killed microbial pesticide because the organism is killed and cannot infect the test animal. 885.3400 Hy

persensitivity Incidents Any future hypersensitivity incidents should be reported per OPPTS Guideline 885.3400. 885.3500 Cell Culture Not applicable. 870.1100 Ac ute Oral Toxicity Yes ; Study U.S. EPA ( 1994 ) 4 3337006 433370 0 7Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

10 **TABLE 4**  **. Summary of Toxicology Data for**  **Dried ferm entation solids and solubles of**  **Myrothecium verrucaria**  **Harm onized**  **Guideline Number**  **Data Requirement Has Data**  **Requirement Been Addressed?**  **How? Source**  **MRID / Accession Number or**  **Other Reference** 870.1200 Ac ute Dermal Toxicity Yes; Study U.S. EPA (1996) 43776906 870.1300 Ac ute Inhalation Toxicity Yes; Study U.S. EPA (1994) 43337009 870.2400 Ac ute Eye Irritation Yes; Study U.S. EPA (1994) 43337012 870.2500 Primary Dermal Irritation Yes; Study U.S. EPA (1994) 43337011 **Nontarget Organisms and Envir** **onment al**  **Fate (**  **40 C.F .R. §**  **158.2 060**  **) TABLE 5. Summary of Nontarget Organisms Data for Dried ferm**  **entation solids and solubles of Myrothecium**  **verrucaria Harm**  **onized Guideline**  **Number Data Requirement**  **Has Data Requirem ent**  **Been Addressed? How?**  **Source MRID/Accession**  **Number or Other Reference**  885.4050 Avian Oral Toxicity Yes; Study U.S. EPA (1995) 43337013 43337014 885.4100 Avian Inhalation

Toxicity/Pathogenicity The nature of the microbial pesticide does not indicate potential pathogenicity to birds. 1 885.4150 Wild Mammal Toxicity/

Pathogenicity Not applicable: No testing expected to be required. Results of the Tier 1 toxicity tests required by 40 CFR § 158.2140 (Table 4) are adequate and

appropriate for assessment of hazards. 2 885.4200 Freshwater Fish Toxicity/

Pathogenicity Yes; Study U.S. EPA (1995) 43337015 43689601 885.4240 Freshwater Invertebrate

Toxicity/ Pathogenicity A study with Daphnia magna wa s submitted, but determined to be invalid. A study with rainbow

trout ( Oncorhynhus mykiss ) indicated moderate toxicity. Additional aquatic d ata were not required because exposure in aquatic

environments is expected to be minimal. 1 885.4280 Estuarine And Marine

Invertebrate Testing 885.4300 Nontarget plant Testing Yes; Scientific Rationale U.S. EPA (1996) None 885.4340 Nontarget insect testing Yes; Scientific Rationale U.S. EPA (1996) None 885.4380 Honey bee testing Yes Scientific Rationale U.S. EPA (1996) None 1 U.S. EP A. 1995. Ecological Risk Assessment of Heat Inactivated Myr othecium verrucaria AT CC Strain 46474 Preparation of Plant Parasitic Nematode Control. Memorandum from Michael L. Mendelohn to Cindy Schaffer, dated October 10, 1995. 2 U.S. EP A. 1994. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG - 99008 TGA I/EP; and the Applicability of a T olerance Exemption for this killedDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

11 microbial, Myr

othecium verrucaria. Memorandum from Cindy Schaf fer to Phillip Hutton, dated December 6, 1994. **E .**  **Risk to Thr** **eatened and Endanger ed Species**  In 1996, EPA prepared a risk assessment to support a complete endangered species determination for M. verrucaria . This assessment concluded that the heat -killed preparation of the specific strain of M. verrucaria “poses practically no threat to endangered species when used according to label directions while providing a possible alternative to methyl bromide for plant parasitic nematode control” (U.S. EPA. 1996). This conclusion was based on the following conditions set forth in EPA’s 1995 ecological risk a ssessment , which indicated moderate toxicity to rainbow trout and uncertainty about toxicity to aquatic invertebrates: 1) batch -to -batch quality control procedures would be done to demonstrate lack of fungal growth after heat treatment and minimal mycotoxin concentrations (i.e., below a specific level), 2) standard environmental hazard statements prohibiting application to areas with surface water, and 3) application methods that are limited to soil incorporation to a depth of 3

– 6 inches, chemigation only by drip irrigation, and soil surface sprays. Condition 1 was set forth to eliminate the potential for pathogenic effects of M. verrucaria and confirm that steps in the manufacturing process to inactivate trichothecene mycotoxin s are successful. This condition was intended to prevent effects to all nontarget organisms, since M. verrucaria is known to produce these mycotoxins, which are not responsible for its pesticidal effects. EPA has confirmed that these quality control procedures are in place. Conditions 2 and 3 were set forth specifically to limit exposure to aquatic organisms because testing demonstrated toxicity of the a.i. to fish and was insufficient to eliminate concerns for aquatic invertebrates. (U.S. EPA 2005.) While there are no data gaps associated with this case, on further consideration during the registration review process, EPA has some uncertainty as to 1), whether the mitigation set forth in conditions 2 and 3 is sufficient to fully address the risks to aquatic species, particularly threatened and endangered species, and 2), whether language implementing this mitigation is present on currentlyapproved product labeling. During the Registration Review process, EPA will re - assess whether appropriate mitigation is in place to address risks to aquatic species. If not, EPA will identify the appropriate mitigation and work with the registrant to revise precautionary statements and directions for use on product labels to effectively limit exposure to aquatic sp ecies. If necessary, following EPA’s evaluation of the mitigation to address risks to aquatic species, EPA will plan to conduct an additional ecological risk assessment to reassess whether use of products containing M. verrucaria will have “no effect” or “ may affect” federally listed threatened or endangered species (listed species) and/or their designated critical habitats. If that assessment is necessary and concludes that a pesticide’ s use “may af fect” a listed species and/or its designated critical habi tat, EP A will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

**F .**  **Endocrine Effects** As required b y the Administrator under the Federal Food, Drug, and Cosmetic Act ( FFDCA) section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticidesDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

12 in order to determine whether certain substances (including pesticide activ e and other ingredients) may

have an effect in humans or wildlife similar to an effect produced by a “naturall y occurring estrogen, or other such endocrine effects as the Administrator may designate.” FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic al substance or other substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produce d by a naturally

occurring estrogenic substance. Between October 2009 and February 2010, the EPA issued test orders/data call - ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. M. verrucaria is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. A s part of this Preliminary Work Plan , the EPA believes that M . verrucaria , the active ingredient in this Registratio n Review case, likely would not produce any effect in humans similar to an effect produced b y a naturall y occurring estrogenic substance. As such, pursuant to Section 408(p)(4), the EPA will determine in the future whether it can exempt M. verrucaria from the requirements of the Section 408(p) EDSP. I f the EPA determine s to exempt th is substance from the EDSP, then the EPA will issue an order. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelin es and the Tier 1 screening battery , please visit our website at http://www.epa.gov/endo/ . **G .**  **Incidents** From 199 6 through May 201 3 , the Of fice of Pesticide Programs’Incident Data Sy stem (IDS) indicates that there ha s been one report of adverse ef fects to a human following exposure to a pesticide product containing M. verrucaria . The product was Ditera ES. Because this one report was classified as a minor human incident, the EP A does not have detailed information on the reported incident. From 1996 to May

2013, the Agency

did not receive any r eports of adverse ef fects to plants and wildlife following exposure to a pesticide product containing M. verrucaria . The EP A will consider any incident data or comments submitted in response to this Preliminary W ork Plan. **H .**  **Timeline** The projected timeline for case 60 1 5

— Dried fermentation solids and solubles of Myr othecium verrucaria

—Registration Review follows. **Activities Estimated Month/Y**  **ear Opening the Docket**  Open Docket and 60 - Day Public Comment Period for M. verrucaria September 201 3 Close Public Comment Period November 201 3Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

13 **Case Development** Is sue Final Wo rk Plan May 201 4 Is sue Data Call - in N/A Data Submission N/A Open 30 - Day

Public Comment Period for Draft Risk Assessments September 201 4 Close Public Comment Period October 201 4 **Registration Review Decision** Open 60 - Day Public Comment Period for Proposed Registration Review Decision March 201 5 Close Public Comment Period May 201 5 Final Decision July 201 5 *Estimated To tal (years) 1. 75 * This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan may be issued at that time. That Final Work Plan will identify any ne wly anticipated data needs and set forth a new timeline. **J .**  **Guidance for**

**Commenters** The public is invited to comment on EP A ’s Preliminary

W ork P lan and rationale. The areas below highlight topics of special interest to EP A where comments, information submissions, or reference to sources of additional information could be of particular use. EP A will consider all comments , as well as any additional information or data provided in a timely manner, prior to issuing a Final Wo rk P lan for this ca se.

**i. Envir** **onmental Justice** EP A 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 policie s. To help address potential environmental justice issues, EP A 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 M. verrucaria , compared to the general population. **Please comment if you ar e awar** **e of any subpopulations that may have atypical, unusually high exposur** **e compared to the general population.**

**ii. Wa**  **ter**

**Quality** M. verrucaria is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean W ater Act. 1 In addition, the EP A has not developed To tal Maximum Daily

Loads (TMDL s ) fo r M. verrucaria. More information on impaired water bodies and TMDL s c an be found at EP A ’s website. 2 **EP**

**A invites submission of water**  **quality data for**  **these pesticides.** To the extent possible, data should conform to the quality standards in 1 Based on information provided at http://www.epa.gov/owow/tmdl/ . 2 See http://www.epa.gov/owow/tmdl/ .Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

14 Appendix A of the Office of Pesticide Pr ogram’ s (OPP) Standar

d Operating Pr

ocedur e: Inclusion of Impair

ed W ater Body and Other W

ater Quality Data in OPP’ s Registration Review Risk Assessment and Management Pr ocess 1 to ensure they

can be used quantitatively or qualitatively

in pesticide risk assessments. **iii. Tr**  **ade Irritants** Through the Registration Review process, the EP A intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The EP A 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 ar** **e 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 EP A has exempted M. verrucaria from the requirement of a tolerance. Moreover, there are no known MRLs for M. verrucaria . Therefore, the EP A does not anticipate that current uses of this pesticide active ingredient will pose concerns as trade irritants . **Additional Information** Stakeholders also are asked to provide information and data that will assist the EP A in refining the risk assessments . The EP A is interested in obtaining the following information on D ried fermentation solids and solubles of Myrothecium verrucaria :  Confirmation on the following label information:

**-** Sites of application

- Formulations

- Application methods and equipment

- Maximum application rates

- Fr equency 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 use s  Ty pical application interval (days)  State or local use restrictions

1 This document can be found at http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm .Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

15  Monitoring data **K .**  **Next Steps** After the 60 - day

comment period closes, the EPA will review and respond to any comments received in a timely manner and then issue a F inal W ork P lan for case 605 1 . **II. FA**  **CT SUMMAR**  **Y FO**  **R CASE 60**  **5 1**  **TABLE 6**  **. Background Inform**  **ation for Dried fermentation solids and solubles of**  **Myrothecium verrucaria**  **Registration Review Active Ingredient**  **(PC Code) First** 

**Registered Currently Registered** 

**Pesticide Products**  **1 Publicly**  **Available EPA**  **Science and Regulatory**  **Documents Additional Risk**  **Assessment Needed?**  **(Yes or No**  **) Product**  **Chemistry Hum**  **an**

**Health Ecological**  Dried fermentation solids and solubles of Myrothecium verrucaria (PC Code 119204) 200 1 4 end -use products & 2 technical products BPPD Fact Sheet & 7 other Science Reviews posted o n the EPA Chemical Search website No No No 1 See Table 1 for additional information (e.g., use sites) on the currently registered products. Labels for these products can be found in the Pesticide Product Label System .Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

16 **II I**  **. BIBLIOGRAPHY**  **A. Studies Supporting Registration Review of**  **Dried fermentation solids and solubles of Myrothecium**  **verrucaria (PC Code**  **119204 )**  **MRID No. Study Description**  43337000 Abbott L aboratories (1994) Submission of product chemistry and toxicity

data in support of registration for ABG - 9008 Biological Nematicide. Transmittal of 17 studies. 43337001 Birkhold, D.; Schwartz, R.; Doremus, M. (1994) Product Chemistry of ABG - 9008 (AARC - 0255) TGAI/EP: L ab Project Number: 9008IP/D451. Unpublished study prepared b y Chemical and Agricultural Products Division of Abbott L ab. 191 p. 43337002 Mathieu, G. (1993) Characterization of Five Lots AARC - 0255 (ABG - 9008)

TGAI/EP: Lab Project Number: 58/743/62. Unpublished study prepared by Chemical and Agricultural Products Division of Abbott L ab. 27 p. 43337003 Chang, W. (1993) Characterization of Five Lots AARC - 0255 (ABG - 9008)

TGAI/EP: Lab Project Number: 77/2254/62. Unpublished study prepared by Chemical and Agricultural Products Division of Abbott L ab. 52 p. 43337004 Khare, S.; Rehberger, L. (1992) Phy sical and Chemical Properties Characterization

of ABG - 9008 (TGA I/EP): Lab Project Number: 58/732/62. Unpublished study prepared b y Chemical and Agricultural Products Division of Abbott L ab. 20 p. 43337005 Rehberger, L. (1994) Storage Stability and Corrosion Characteristics of ABG - 9008: Final Report: Lab Project Numb er: 910/202/93. Unpublished study prepared by Abbott Agricultural Research Center. 13 p. 43337006 Shults, S. (1992) Acute Oral Toxicity Study in Rats with ABG - 9008: Lab Project Number: 92/0016: 5152/92/0016/TX/001. Unpublished study prepared by

Ricerca, In c. 18 p. 43337007 Shults, S.; Brock, A.; L aveglia, J. (1993) Acute Oral Toxicity Study in Rats with ABG - 9008: Lab Project Number: 93/0207. Unpublished study prepared by

Ricerca, In c. 22 p. 43337008 Shults, S. (1992) Acute Dermal Toxicity Study in Albino Rabbits with ABG - 9008: Lab Project Number: 92/0017: 5152/92/0017/TX/001. Unpublished study prep ared by Ricerca, Inc. 22 p. 43337009 Holbert, M. (1992) Acute Inhalation Toxicity Study in Rats with ABG - 9008: L ab Project Number: 8903/92. Unpublished study prepared by

Ricerca, Inc. 20 p. 43337010 Allan, S. (1994) ABG - 9008: Acute Intratracheal Toxici ty Study to the Rat: Lab Project Number: 920293D/ABT/203/AC. Unpublished study prepared by Huntingdon Research Center Ltd. 25 p.Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

17 43337011 Shultz, S. (1992) Primary Dermal Irritation Study in Albino Rabbits with ABG 9008: L ab Project Number: 92/0019: 5152 /92/ 0019/TX/001. Unpublished study prepared b y Ricerca, Inc. 18 p. 43337012 Shultz, S. (1992) Primary Eye Irritation Study in Albino Rabbits with ABG - 9008: Lab Project Number: 92/0018: 5152/92/ 0018/TX/001 . Unpublished study prepared by Ricerca, Inc. 36 p. 43337013 Campbell, S. (1992) ABG - 9008: An Avian Oral Toxicity Study in the Mallard: Lab Project Number: 161 - 123. Unpublished study prepared by

Wildlife International, Ltd. 22 p. 43337014 Campbell, S. (1992) ABG - 9008: An Avian Oral Toxicity Study with the Bobwhite: Lab Project Number: 161 - 122. Unpublished study prepared by

Wildlife International, Ltd. 21 p. 43337015 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Toxicity of ABG - 9008 -NP to the

Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 142/AB. Unpublished study prepared by

T.R. Wilbury

L ab., Inc. 26 p. 43337016 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Toxicity of ABG - 9008 -NP to the

Rainbow Trout, Oncorhynchus mykiss in Dilution Water Containing 10 mg/L Humic Acid: Lab Project Number: 137/AB. Unpublished study prepared by

T.R. Wilbury L ab., Inc. 23 p. 43337017 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute Toxicity of ABG - 9008 to the

Daphnid, Daphnia magna: Lab Project Number: 87/AB. Unpublished study prepared b y T.R. Wilbury Lab., Inc. 13 p. 43689600 Abbott L abs (1995) Submission of Hazard to Aquatic Organisms Data in Support of

Application for Registration of ABG - 9008 Biological Nematicide Wettable and Technical Powders. Transmittal of 1 Study . 43689601 Ward, T.; Magazu, J.; Boeri, R. (1993) Acute T oxicity of ABG - 9008 to the Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 88 - AB. Unpublished study prepared by

T. R. Wilbury

L abs, Inc. 25 p. 43776900 Abbott L abs. (1995) Submission of product chemistry and toxicity

data in support of the applic ation for registration of ABG - 9017. Transmittal of 9 studies. 43776901 Sudershan, P.; Warrior, P. (1995) Product Chemistry of ABG - 9017: Lab Project Number: 9017/D91K. Unpublished study prepared by

Abbott Lab. 42 p. 43776902 Rojas, F.; Rehberger, L. (1 995) Anal ys is of Five Lots of ABG - 9017 End - use

Product: L ab Project Number: 04/2913/62. Unpublished study prepared by

Abbott Lab. 32 p. 43776903 Rojas, F. (1995) Phys ical and Chemical Properties of ABG - 9017 End - use Product:

Final Report: Lab Project Number: 04/2914/62. Unpublished study prepared byDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

18 Abbott L ab. 16 p. 43776904 Rehberger, L. (1995) Storage Stability and Corrosion Characteristics of ABG - 9017: Lab Project Number: 910/201/95. Unpublished study prepared by

Abbott Agricultural Research Center. 23 p. 43776905 Shults, S.; L aveglia, J. (1995) Acute Oral Toxicity (LD50) Study in Rats with ABG 9017: L ab Project Number: 95 - 0002: 6316 - 95 - 0002 - TX - 001. Unpublished study prepared b y Ricerca, Inc. 24 p. 43776906 Shults, S.; L aveglia, J. (1995) Acute Dermal Toxicity (LD50) Study

in Albino Rabbits with ABG - 9017: L ab Project Number: 95 - 0003: 6316 - 95 - 0003 - TX - 001. Unpublished study

prepared by

Ricerca , Inc. 31 p. 43776907 Holbert, M. (1995) Acute Inhalation Toxicity Study in Rats: ABG - 9017: Final Report: L ab Project Number: 1907/95. Unpublished study prepared by

Stillmeadow, In c. 37 p. 43776908 Shults, S.; L aveglia, J. (1995) Primary Dermal Irritation Study

in Albino Rabbits with ABG - 9017: Lab Project Number: 95 - 0005: 6316 - 95 - 0005 - TX - 001. Unpublished study

prepared by

Ricerca, Inc. 27 p. 43776909 Shults, S.; L aveglia, J. (1995) Primary Eye Irritation Study

in Albino Rabbits with ABG - 9017: Lab Project Number: 95 - 0004: 6316 - 95 - 0004 - TX - 001. Unpublished study prepared by

Ricerca, Inc. 40 p. 44168100 Abbott L abs. (1996) Submission of Product Chemistry Data in Support of the

Application for Registration of DiTera G Biological Nematicide Granules. Transmittal of 3 Studies. 44168101 Sudershan, P.; Nikolai, T.; Warrior, P. (1996) Product Chemistry of ABG - 9008G (Product Identity , Manufacturing Process and Impurities): Lab Project Number: 9008G - D91K. Unpublished study prepared by

Abbott L abs. 46 p. 44168102 Rojas, F.; Rehberger, L. (1996) Anal ys is of Five Lots of ABG - 9008G End - use

Product: L ab Project Number: 20 - 3271 - 62. Unpublished study prepared by

Abbo tt Labs. 7 p. 44168103 Rojas, F. (1996) Phys ical and Chemical Properties of ABG - 9008G End - use

Product: Final Report: Lab Project Number: 17 - 3211 - 62. Unpublished study prepared b y Abbott Labs. 10 p. 44294600 Abbott L abs (1997) Submission of Product Chem istry Data in Support of the Registration of DiTera Technical Powder. Transmittal of 1 Study . 44294601 Birkhold, D.; Schwartz, R.; Doremus, M.; et al. (1997) Product Chemistry of ABG 9008 (AARC - 0255) TGAI/EP: Supplement to MRID 43337001: Lab Project Number: 9008IP - D451. Unpublished study prepared by

Abbott Labs. 11 p. 45233000 Valent Biosciences (2000) Submission of Product Chemistry Data in Support of theDried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

19 Application for the Registration of Bacillus thuringiensis subsp. aizawai Slurry , Bacillus subsp. israelensis Slurry , Bacillus subsp. kurstaki Slurry , Bacillus subsp. tenebrionis Slurry

and Bacillus subs p. sphareicus Slurry and M yr othecium verrucaria Slurry . Transmittal of 2 Studies. 45233006 Rowell, R. (2000) Slurry Manufacturing Process for DiTera Products (M yr othecium verrucaria) at Abbott Laboratories: Lab Project Number: MVSLMAN - V28R. Unpublished s tudy

prepared by

Abbott Laboratories. 27 p. 45296300 Valent BioSciences Corporation (2000) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of DiTera DF Biological Nematicide. Transmittal of 4 Studies. 45296301 Rowell, R.; Rehberger, L.; Rushforth, V. (2000) Product Chemistry of ABG - 9022: Product I dentity , Manufacturing Process, and Formation of Unintentional In gredients: Lab Project Number: 111700. Unpublished study prepared b y Abbott Laboratories. 69 p . {OPPTS 880.1100, 880.1200, 880.1400} 45296302 Rehberger, L. (2000) Physical and Chemical Properties of ABG - 9022 End - USe

Product: Final Report: Lab Project Number: 48030 - 00 - 01. Unpublished study prepared b y Valent BioSciences Corporation. 10 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.7300, 830.7000} 45296303 Rehberger, L. (2000) Analysis and Certification of Limits of ABG - 9022 End Use

Product: Final Report: Lab Project Number: 48030 - 00 - 02. Unpublished study prepared b y Valent BioSciences Corporation. 19 p. {OPPTS 830.1700, 830.1750} 45296304 Puppal a, S.; Warrior, P. (2000) Acute Toxicology for ABG - 9022: Lab Project Number: 112000. Unpublished study prepared b y Valent BioSciences Corporation. 12 p. 45701600 Valent BioSciences Corporation (2002) Submission of Product Chemistry Data in Support of the Application for Registration of DiTera DF. Transmittal of 1 Study . 45701601 Rowell, R. (2002) Manufacturing Process for DiTera DF (M yrothecium verrucaria)

at Abbott L aboratories: Lab Project Number: 9002 MAN 4/23/02. Unpublished study prepared by

Abbott Laboratories. 282 p. {OPPTS 885.1200} 45709900 Valent BioSciences Corp. (2002) Submission of Product Chemistry Data in Support of the Application for Registration of M yrothecium verrucaria Slurry . Transmittal of 1 Study . 45709901 Rowell, R. (2002) Slurry Manufacturing Process for DiTera Products (M yr othecium verrucaria) at Abbott Laboratories: Lab Project Number: 90001 MAN 5/09/02. Unpublished study

prepared by

Abbott Laboratories. 282 p. {OPPTS 885.1200}Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

20 **B. Envir** **onmental Pr o**  **tection Agency Risk**  **Assessment Memoranda** U.S. EP A. 1994. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG - 99008 TGAI/EP; and the Applicability of a T olerance Exemption for this killed microbial, Myr

othecium verrucaria. Memorandum from Cindy Schaf fer to Phillip Hutton, dated December 6, 1994. U.S. EP A. 1995. Ecological Risk Assessment of Heat Inactivated Myr othecium verrucaria AT CC Strain 46474 Preparation of Plant Parasitic Nematode Control. Memorandum from Michael L. Mendelohn to Cindy Schaffer, dated October 10, 1995. U.S. EP A. 1996. Endangered Species No Effect Finding for ABG - 9008 with killed Myr othecium verrucaria AT CC Strain as an Active Ingredient for Plant Parasitic Nematode Control. Memorandum from Robert Rose to Cindy Schaffer, dated February 7, 1996. U.S. EP A. 1996 . Registration of New Biological Active Ingredient, Killed Myr othecium verrucaria and Pesticide Products ABG - 9008 and ABG - 9017, Containing the Active In gredient. Memoran dum from Janet L . Andersen to Daniel M. Barolo, dated February 29, 1996. U.S. EP A. 1997. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of DiT era G (killed solids and solubles of Myr othecium verrucaria ). Memorandum from Cindy Sc haffer to Philip Hutton, dated April 30, 1997. U.S. EP A. 2003. Review of Manufacturing Process for Ditera DF. Memorandum from Ibrahim S. Barsoum to Leonard Cole, dated March 3, 2003. U.S. EP A. 2004. BPPD Review of Data Submitted by V alent BioSciences Corporation for Registration and Review of Manufacturing Product Process to DiT era Products ( Myr othecium verrucaria ) at Abbott Laboratories. Memorandum from Carl Etsitty to Alan Rey nolds, dated September 22, 2004. Product Chemistry

Data and Acute To xicity (Primary Eye and Skin Irritation) Waiver Submitted by A graQuest for Registration of QST2802 T echnical which contains Bacillus pumilus QST2808. Memorandum from C. Etsitty , and J. Kough, Ph.D. to S. Cerrelli dated January 7, 2002 U.S. EP A.2004a. BPPD Review of Storage Stability and Corrosion Characteristic Data Submitted by

Th e Gustafson LLC, for GB34 Concentrate and T echnical, which contains Bacillus pumilus GB34 . Memorandum from C. Etsitty , and J. Kough, Ph.D. to A. Ball dated July

7, 2004. U.S. EP A. 2007. BPPD Review of QST2808 MUPand Sonata® ASO containing Bacillus pumilus strain QST 2808 . Memorandum from J. Gagliardi, Ph.D. and J. Kough, Ph.D. to S. Bacchus dated July

26. 2007.Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

21 C. **Other References**  U.S. EP A. 1999 . Killed Myr

othecium verrucaria : Fermentation Solids and Solubles (1 19204) Fact Sheet.