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

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

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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 EPAHQ-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).

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

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B. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review 

program. All pesticides distributed or sold in the United States (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.

1

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 Ingredient2

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.

 

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

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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 ABG9017. 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
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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

73049-60 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 
Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

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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
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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

830.6303 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
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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

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) 4333701543689601

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

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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 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 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 
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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
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 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.1In 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.2 EPA 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

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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 Process

1

to 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 90th percentile reported use rates (lbs active ingredient/1,000 square feet) 

from usage data – national, state, and county

 Application timing (date of first application and application intervals) – national, state, 

and county

 Usage/use information for nonagricultural uses

 Typical application interval (days)

 State or local use restrictions

 

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

16

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. 
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 ABG9008: 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
Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

18

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 ABG9017: 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 ABG9008 (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 
Dried 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 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} 
Dried fermentation solids and solubles of Myrothecium verrucaria (Case 6051) www.regulations.gov

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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® 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

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C. Other References

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

Fact Sheet.