Document ID: EPA-HQ-OPP-2013-0539-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-09-25T04:00Z

Dried Fermentation Solids and Solubles of 
                           Myrothecium verrucaria  

                                       
                  Preliminary Work Plan and Summary Document
                                       
                      Registration Review: Initial Docket
                                       
                                September 2013
                                        
                                       
                                   Case 6051
                                       
                                       
                                PC Code 119204
                                       
                                       
                                       
                                         
                                                                               
                                                
                                                Approved by:

													
                                                
                                                Robert McNally, Director 
                                                Biopesticides and 
                                                Pollution Prevention Division
                                                                               
								Date:
													
				

                               Table Of Contents

I.	PRELIMINARY 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 Effects	11
G.	Incidents	12
H.	Timeline	12
J.	Guidance for Commenters	13
K.	Next Steps	15
II.	FACT SUMMARY FOR CASE 6051	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	21

                          ACRONYMS AND ABBREVIATIONS

BPPD
EPA's Biopesticides and Pollution Prevention Division
C.F.R.
Code of Federal Regulations
cwt
Centum weight or hundredweight. In this document, cwt refers to a 100 pound measure of seed.
DNA
Deoxyribonucleic acid
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
Hypersensitive response
IDS
Incident Data System 
kD
Kilodalton
kg
Kilogram
lb
Pound
mg
Milligram
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 
Pesticide chemical code: a six-digit number 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 States
                                       
                                       

I.	PRELIMINARY 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 Case 6051) is now open, initiating the first public comment period for this Registration Review case (docket number EPA-HQ-OPP-2013-0539). The pesticide active ingredient is 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 Work Plan (PWP) document explains what the Environmental Protection Agency's (EPA) Office of Pesticide Programs knows about M. verrucaria, highlighting anticipated data and assessment needs, identifying types of information that would be especially useful to EPA in conducting the review, and providing an anticipated timeline for completing review of this active ingredient.

      The Registration Review process was designed to include a public participation component to solicit input from interested stakeholders. By sharing this information in the docket, EPA intends to inform the public of what it knows about M. verrucaria and what types of new data or other information would be helpful for EPA to receive as it moves toward a decision on this active ingredient. EPA encourages all interested stakeholders to review the PWP and to provide comments and additional information that will help EPA's decision-making process for this microbial pesticide. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP about which EPA specifically seeks comments and information. Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large. 

      The PWP begins by discussing the statutory and regulatory authority for Registration Review. Next, it provides background on M. verrucaria 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 M. verrucaria. Finally, the PWP describes guidance for commenters, explains the next steps EPA will take for this Registration Review, summarizes background information for this Registration Review, and lists supporting studies, risk assessment memoranda, and other documents.  

      Further information about this case including background and supporting documents is available at http://www.regulations.gov (under "SEARCH for: Rules, Comments, Adjudications or Supporting Documents," enter the docket identification number, which is indicated above). 
        

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 (U.S.) must generally be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on the product labeling. The Registration Review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the Registration Review program, EPA periodically reevaluates pesticides to make sure that, as change occurs, products in the marketplace can continue to be used safely. Information on this program is provided on EPA's website. 
	
      EPA is implementing the Registration Review program pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing Registration Review begin at 40 C.F.R. § 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 M. verrucaria.

C.	Background and Regulatory Information	

         i. Summary of the Active Ingredient

	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 by exposing it to high temperatures. The pesticidal activity is not due to a singly 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, worm-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 affect free-living nematodes that do not cause plant disease.
 
	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 -- 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 EPA concluded that the following environmental hazard statements are required on end-use product labels to mitigate ecological risks:
      
      "Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water by 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."

	EPA 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 Products

      In 1996, the EPA registered the first pesticide products containing M. verrucaria for use as nematacides on food, fiber, and ornamental crops. The original registrant was Abbott Laboratories of North Chicago, Illinois, and the original products were ABG-9008 and ABG-9017. The EPA registered the most recent product in 2004. The currently registered products are manufacturing use and end-use pesticide products registered for use to protect food, fiber, and ornamental crops from parasitic nematodes. The registrant of all currently registered products containing M. verrucaria as an active ingredient is Valent Biosciences Corporation. See Table 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 as an Active Ingredient
                            EPA Registration Number
                                       
                                 Product Name
                    (% Active Ingredient, Formulation Type)
                               Date Registered 
                                 Company 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 Nematicide Emulsifiable Suspension
                                April 29, 2000
                        Valent Biosciences Corporation
                                       
                            10 gallons per 40 acres
                            Irrigation/ Chemigation
                             Agricultural crops: 
             food and feed, ornamentals, cotton, tobacco and turf
                                   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.	Tolerance 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 applicant submitted a petition 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 EPA concluded in a 1994 review that there was a reasonable certainty that no harm would result to the U.S. population from aggregate exposure to residues of M. verrucaria.  (U.S. EPA, 1994). BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG-99008 TGAI/EP; and the Applicability of a Tolerance Exemption for this killed microbial, Myrothecium verrucaria. Memorandum from Cindy Schaffer to Phillip Hutton, dated December 6, 1994.) Therefore, the EPA established a tolerance exemption for residues of this active ingredient, and in 1996 the Agency reassessed this exemption from tolerance to ensure adequate protection for infants and children. The current tolerance exemption for this active 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 systems and the indicator mycotoxin levels do not exceed 15 ppm. 

Federal Register Citations:  Notices of Filing (61 FR 11315, March 20, 1996); Final Rule (61 FR 58332, November 14, 1996)
                                       
                                       
	D.		Anticipated Data Needs and Risk Assessments

	Provided below are tables identifying the current data requirements for microbial pesticides as set forth in 40 C.F.R. part 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, toxicology, and nontarget organisms and environmental fate) and 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 EPA has no anticipated data needs for this active ingredient.
                                       
                   Product Chemistry (40 C.F.R. § 158.2120)
TABLE 2.  Summary of Product Chemistry Data for Dried fermentation solids and solubles of Myrothecium verrucaria
                          Harmonized Guideline 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)
                                   43337001
                                   43337002
                                   43337003
                                       
                                   885.1200
                             Manufacturing Process
                                  Yes;  Study
                                U.S. EPA (1994)
                                       
                                   43337001
                                   43337002
                                   43337003
                                       
                                   885.1250
     Deposition of a Sample in a Nationally Recognized Culture Collection
                              Yes; EPA Memorandum
                                U.S. EPA (1995)
                                       
                        EPA Memo dated October 10, 1995
                                       
                                   885.1300
             Discussion of Formation of Unintentional Ingredients
                                  Yes; Study
                                U.S. EPA (1994)
                                       
                                   43337001
                                   43337002
                                   43337003
                                       
                                       
                                   885.1400
                              Analysis of Samples
                                  Yes; Study
                                U.S. EPA (1995)
                                   43776902
                                   43337002
                                   43337003
                                   885.1500
                            Certification of 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
                          Harmonized 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)
                                   43337004
                                   830.6303
                                Physical 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)
                                   43776904
                                   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

Toxicology (40 C.F.R. § 158.2050)
TABLE 4.  Summary of Toxicology Data for Dried fermentation solids and solubles of Myrothecium verrucaria
                         Harmonized Guideline Number 
                               Data Requirement
                   Has Data Requirement Been Addressed? How?
                                    Source
                   MRID/ Accession Number or Other Reference
                                   885.3050
                      Acute Oral Toxicity/ Pathogenicity
Data not required for a killed microbial pesticide because the organism is killed and cannot infect the test animal.
                                   885.3150
                    Acute Pulmonary Toxicity/Pathogenicity
                                  Yes; Study
                                U.S. EPA (1994)
                                   43337010
                                   885.3200
                    Acute Injection Toxicity/ Pathogenicity
                                  Intravenous
Data not required for a killed microbial pesticide because the organism is killed and cannot infect the test animal. 
                                   885.3400
                          Hypersensitivity Incidents
                                       
Any future hypersensitivity incidents should be reported per OPPTS Guideline 885.3400.

                                   885.3500
                                 Cell Culture
                                Not applicable.
                                     870.1100
                              Acute Oral Toxicity
                                  Yes;  Study
                                U.S. EPA (1994)
                                       
                                   43337006
                                   43337007
                                   870.1200
                             Acute Dermal Toxicity
                                  Yes; Study
                                U.S. EPA (1996)
                                   43776906
                                   870.1300
                           Acute Inhalation Toxicity
                                  Yes; Study
                                U.S. EPA (1994)
                                   43337009
                                   870.2400
                                       
                             Acute Eye Irritation

                                  Yes; Study
                                U.S. EPA (1994)
                                   43337012
                                   870.2500
                           Primary Dermal Irritation
                                  Yes;  Study
                                U.S. EPA (1994)
                                   43337011
               
               Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060)

TABLE 5.  Summary of Nontarget Organisms Data for Dried fermentation solids and solubles of Myrothecium verrucaria
                         Harmonized Guideline Number 
                               Data Requirement
                   Has Data Requirement 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 was submitted, but determined to be invalid. A study with rainbow trout (Oncorhynhus mykiss) indicated moderate toxicity.  Additional aquatic data 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. EPA. 1995. Ecological Risk Assessment of Heat Inactivated Myrothecium verrucaria ATCC Strain 46474 Preparation of Plant Parasitic Nematode Control. Memorandum from Michael L. Mendelohn to Cindy Schaffer, dated October 10, 1995.
[2] U.S. EPA. 1994. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG-99008 TGAI/EP; and the Applicability of a Tolerance Exemption for this killed microbial, Myrothecium verrucaria. Memorandum from Cindy Schaffer to Phillip Hutton, dated December 6, 1994.
	
E.              Risk to Threatened and Endangered 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 assessment, 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 mycotoxins 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 currently-approved 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 species.
      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 affect" a listed species and/or its designated critical habitat, EPA will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.
      	F.	Endocrine Effects
      As required by 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 pesticides in order 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." 
      FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biological 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 produced 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.	
      As part of this Preliminary Work Plan, the EPA believes that M. verrucaria, 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), the EPA will determine in the future whether it can exempt M. verrucaria from the requirements of the Section 408(p) EDSP. If the EPA determines to exempt this 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 guidelines and the Tier 1 screening battery, please visit our website at http://www.epa.gov/endo/.

G.	Incidents

      From 1996 through May 2013, the Office of Pesticide Programs' Incident Data System (IDS) indicates that there has been one report of adverse effects 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 EPA does not have detailed information on the reported incident.
      
        From 1996 to May 2013, the Agency did not receive any reports of adverse effects to plants and wildlife following exposure to a pesticide product containing M. verrucaria. The EPA will consider any incident data or comments submitted in response to this Preliminary Work Plan. 
      H.	Timeline

The projected timeline for case 6015 --   Dried fermentation solids and solubles of Myrothecium verrucaria  -- Registration Review follows. 
                                  Activities
                             Estimated Month/Year
  Opening the Docket
  Open Docket and 60-Day Public Comment Period for M. verrucaria
                                September 2013
  Close Public Comment Period 
                                 November 2013
  Case Development
  Issue Final Work Plan 
                                   May 2014
  Issue Data Call-in
                                     N/A 
  Data Submission
                                     N/A 
  Open 30-Day Public Comment Period for Draft Risk Assessments
                                September 2014
  Close Public Comment Period
                                 October 2014
  Registration Review Decision
  Open 60-Day Public Comment Period for Proposed Registration Review  
  Decision 
                                  March 2015
  Close Public Comment Period 
                                   May 2015
  Final Decision 
                                   July 2015
                           *Estimated Total (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 newly anticipated data needs and set forth a new timeline. 
      J.	Guidance for Commenters
	
      The public is invited to comment on EPA's Preliminary Work Plan and rationale. The areas below highlight topics of special interest to EPA where comments, information submissions, or reference to sources of additional information could be of particular use. EPA will consider all comments, as well as any additional information or data provided in a timely manner, prior to issuing a Final Work Plan for this case.

	i.		Environmental Justice	

      EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to M. verrucaria, 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.

	ii.		Water 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 Water Act. In addition, the EPA has not developed Total Maximum Daily Loads (TMDLs) for M. verrucaria. More information on impaired water bodies and TMDLs can be found at EPA's website. EPA invites submission of water quality data for these pesticides. To the extent possible, data should conform to the quality standards in Appendix A of the Office of Pesticide Program's (OPP) Standard Operating Procedure:  Inclusion of Impaired Water Body and Other Water Quality Data in OPP's Registration Review Risk Assessment and Management Processto ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

	iii. 	Trade Irritants
      Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs) 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 MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern. 
	The EPA has exempted M. verrucaria from the requirement of a tolerance. Moreover, there are no known MRLs for M. verrucaria. Therefore, the EPA 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 EPA in refining the risk assessments. The EPA is interested in obtaining the following information on Dried fermentation solids and solubles of Myrothecium verrucaria:  
       Confirmation on the following label information:
            - Sites of application
            - Formulations
            - 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 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 Final Work Plan for case 6051.

II.	FACT SUMMARY FOR CASE 6051

TABLE 6.  Background Information for Dried fermentation solids and solubles of Myrothecium verrucaria 
                             Registration Review 
                              Active Ingredient 
                                  (PC Code) 
                               First Registered
                   Currently Registered Pesticide Products1
            Publicly Available EPA Science and Regulatory Documents
                Additional Risk Assessment Needed? (Yes or No)
                                       
                                       
                                       
                                       
                               Product Chemistry
                                 Human Health
                                  Ecological
Dried fermentation solids and solubles of Myrothecium verrucaria (PC Code 119204)
                                       
                                     2001
                              4 end-use products
                                     &
                             2 technical products
                                BPPD Fact Sheet
   & 7 other Science Reviews  posted on 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.

III.	BIBLIOGRAPHY
A. Studies Supporting Registration Review of Dried fermentation solids and solubles of Myrothecium verrucaria (PC Code 119204)
MRID No.					Study Description
43337000
Abbott Laboratories (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: Lab Project Number: 9008IP/D451. Unpublished study prepared by Chemical and Agricultural Products Division of Abbott Lab. 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 Lab. 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 Lab. 52 p. 
43337004
Khare, S.; Rehberger, L. (1992) Physical and Chemical Properties Characterization of ABG-9008 (TGAI/EP): Lab Project Number: 58/732/62. Unpublished study prepared by Chemical and Agricultural Products Division of Abbott Lab. 20 p. 
43337005
Rehberger, L. (1994) Storage Stability and Corrosion Characteristics of ABG-9008: Final Report: Lab Project Number: 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, Inc. 18 p. 
43337007
Shults, S.; Brock, A.; Laveglia, J. (1993) Acute Oral Toxicity Study in Rats with ABG-9008: Lab Project Number: 93/0207. Unpublished study prepared by Ricerca, Inc. 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 prepared by Ricerca, Inc. 22 p. 
43337009
Holbert, M. (1992) Acute Inhalation Toxicity Study in Rats with ABG-9008: Lab Project Number: 8903/92. Unpublished study prepared by Ricerca, Inc. 20 p. 
43337010
Allan, S. (1994) ABG-9008: Acute Intratracheal Toxicity Study to the Rat: Lab Project Number: 920293D/ABT/203/AC. Unpublished study prepared by Huntingdon Research Center Ltd. 25 p. 
43337011
Shultz, S. (1992) Primary Dermal Irritation Study in Albino Rabbits with ABG-9008: Lab Project Number: 92/0019: 5152/92/ 0019/TX/001. Unpublished study prepared by 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 Lab., 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 Lab., 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 by T.R. Wilbury Lab., Inc. 13 p. 
43689600
Abbott Labs (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 Toxicity of ABG-9008 to the Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 88-AB. Unpublished study prepared by T. R. Wilbury Labs, Inc. 25 p. 
43776900
Abbott Labs. (1995) Submission of product chemistry and toxicity data in support of the application 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. (1995) Analysis of Five Lots of ABG- 9017 End-use Product: Lab Project Number: 04/2913/62. Unpublished study prepared by Abbott Lab. 32 p. 
43776903
Rojas, F. (1995) Physical and Chemical Properties of ABG-9017 End-use Product: Final Report: Lab Project Number: 04/2914/62. Unpublished study prepared by Abbott Lab. 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.; Laveglia, J. (1995) Acute Oral Toxicity (LD50) Study in Rats with ABG-9017: Lab Project Number: 95-0002: 6316-95-0002-TX-001. Unpublished study prepared by Ricerca, Inc. 24 p. 
43776906
Shults, S.; Laveglia, J. (1995) Acute Dermal Toxicity (LD50) Study in Albino Rabbits with ABG-9017: Lab 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: Lab Project Number: 1907/95. Unpublished study prepared by Stillmeadow, Inc. 37 p. 
43776908
Shults, S.; Laveglia, 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.; Laveglia, 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 Labs. (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 Labs. 46 p. 
44168102
Rojas, F.; Rehberger, L. (1996) Analysis of Five Lots of ABG-9008G End-use Product: Lab Project Number: 20-3271-62. Unpublished study prepared by Abbott Labs. 7 p. 
44168103
Rojas, F. (1996) Physical and Chemical Properties of ABG-9008G End-use Product: Final Report: Lab Project Number: 17-3211-62. Unpublished study prepared by Abbott Labs. 10 p. 
44294600
Abbott Labs (1997) Submission of Product Chemistry 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 the Application for the Registration of Bacillus thuringiensis subsp. aizawai Slurry, Bacillus subsp. israelensis Slurry, Bacillus subsp. kurstaki Slurry, Bacillus subsp. tenebrionis Slurry and Bacillus subsp. sphareicus Slurry and Myrothecium verrucaria Slurry. Transmittal of 2 Studies. 
45233006
Rowell, R. (2000) Slurry Manufacturing Process for DiTera Products (Myrothecium verrucaria) at Abbott Laboratories: Lab Project Number: MVSLMAN-V28R. Unpublished study 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 Identity, Manufacturing Process, and Formation of Unintentional Ingredients: Lab Project Number: 111700. Unpublished study prepared by 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 by 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 by Valent BioSciences Corporation. 19 p. {OPPTS 830.1700, 830.1750} 
45296304
Puppala, S.; Warrior, P. (2000) Acute Toxicology for ABG-9022: Lab Project Number: 112000. Unpublished study prepared by 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 (Myrothecium verrucaria) at Abbott Laboratories: 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 Myrothecium verrucaria Slurry. Transmittal of 1 Study. 
45709901
Rowell, R. (2002) Slurry Manufacturing Process for DiTera Products (Myrothecium verrucaria) at Abbott Laboratories: Lab Project Number: 90001 MAN 5/09/02. Unpublished study prepared by Abbott Laboratories. 282 p. {OPPTS 885.1200} 

B. Environmental Protection Agency Risk Assessment Memoranda
U.S. EPA. 1994. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of ABG-99008 TGAI/EP; and the Applicability of a Tolerance Exemption for this killed microbial, Myrothecium verrucaria. Memorandum from Cindy Schaffer to Phillip Hutton, dated December 6, 1994.

U.S. EPA. 1995. Ecological Risk Assessment of Heat Inactivated Myrothecium verrucaria ATCC Strain 46474 Preparation of Plant Parasitic Nematode Control. Memorandum from Michael L. Mendelohn to Cindy Schaffer, dated October 10, 1995.

U.S. EPA. 1996. Endangered Species No Effect Finding for ABG-9008 with killed Myrothecium verrucaria ATCC Strain as an Active Ingredient for Plant Parasitic Nematode Control. Memorandum from Robert Rose to Cindy Schaffer, dated February 7, 1996.

U.S. EPA. 1996. Registration of New Biological Active Ingredient, Killed Myrothecium verrucaria and Pesticide Products ABG-9008 and ABG-9017, Containing the Active Ingredient. Memorandum from Janet L. Andersen to Daniel M. Barolo, dated February 29, 1996.

U.S. EPA. 1997. BPPD Review of Data Submitted by Abbott Laboratories for the Registration of DiTera G (killed solids and solubles of Myrothecium verrucaria). Memorandum from Cindy Schaffer to Philip Hutton, dated April 30, 1997.

U.S. EPA. 2003. Review of Manufacturing Process for Ditera DF. Memorandum from Ibrahim S. Barsoum to Leonard Cole, dated March 3, 2003.

U.S. EPA. 2004. BPPD Review of Data Submitted by Valent BioSciences Corporation for Registration and Review of Manufacturing Product Process to DiTera Products (Myrothecium verrucaria) at Abbott Laboratories. Memorandum from Carl Etsitty to Alan Reynolds, dated September 22, 2004.

Product Chemistry Data and Acute Toxicity (Primary Eye and Skin Irritation) Waiver Submitted by AgraQuest for Registration of QST 2802 Technical which contains Bacillus pumilus QST 2808.  Memorandum from C. Etsitty, and J. Kough, Ph.D. to S. Cerrelli dated January 7, 2002

U.S. EPA.2004a. BPPD Review of Storage Stability and Corrosion Characteristic Data Submitted by The Gustafson LLC, for GB34 Concentrate and Technical, which contains Bacillus pumilus GB34.  Memorandum from C. Etsitty, and J. Kough, Ph.D. to A. Ball dated July 7, 2004.

U.S. EPA. 2007.  BPPD Review of QST 2808 MUP and Sonata[(R)] 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.

               C. Other References

U.S. EPA. 1999. Killed Myrothecium verrucaria: Fermentation Solids and Solubles (119204) Fact Sheet.