BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Typhula phacorrhiza

Strain 94671

PC Code: 036604

U.S. Environmental Protection Agency

Office of Chemical Safety and Pollution Prevention

Biopesticides and Pollution Prevention Division

Version # 5

September 2010
Typhula phacorrhiza Strain 94671 Page 2 of 17

Biopesticides Registration Action Document

TABLE OF CONTENTS

I. BACKGROUND........................................................................ ................. 5

II. ACTIVE INGREDIENT OVERVIEW........................................................................ 6

III. REGULATORY BACKGROUND ............................................................................ 6

A. APPLICATIONS FOR PESTICIDE REGISTRATION .............................................. 6

B. NORTH AMERICAN FREE TRADE AGREEMENT JOINT REVIEW ...................... 6

C. FOOD CLEARANCES/TOLERANCES.........................................................6

IV. RISK ASSESSMENT............................................................................................. 7

A. ACTIVE INGREDIENT CHARACTERIZATION ....................................................... 7

B. HUMAN HEALTH ASSESSMENT........................................................................... 8

1. TOXICITY ................................................................................................................ 8

2. EFFECTS ON THE ENDOCRINE SYSTEM ............................................................ 8

3. RISK CHARACTERIZATION........................................................................9

C. ENVIRONMENTAL ASSESSMENT..............................................................9

1. NONTARGET ORGANISM TOXICOLOGY............................................................. 9

2. ENVIRONMENTAL FATE AND GROUND WATER DATA...................................... 9

3. ECOLOGICAL EXPOSURE AND RISK CHARACTERIZATION............................. 9

4. THREATENED AND ENDANGERED SPECIES ASSESSMENT.......................10

D. PRODUCT PERFORMANCE DATA (EFFICACY)................................................. 10
Typhula phacorrhiza Strain 94671 Page 3 of 17

Biopesticides Registration Action Document

V. RISK MANAGEMENT DECISION ......................................................................... 11

VI. ENVIRONMENTAL JUSTICE....................................................................11

VII. TERMS OF THE REGISTRATION(S).................................................................... 11

VIII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART V)........ 12

IX. APPENDIX B. MRID AND CITED LITERATURE BIBLIOGRAPHY...................... 16

A. STUDIES SUBMITTED TO SUPPORT THE TYPHULA PHACORRHIZA STRAIN 

94671 PESTICIDE PRODUCTS REGISTRATION ....................................................... 16

B. ENVIRONMENTAL PROTECTION AGENCY RISK ASSESSMENT

MEMORANDA..............................................................................................17

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS.....................................17
Typhula phacorrhiza Strain 94671 Page 4 of 17

Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Chemical Safety and Pollution Prevention

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch (MPB)

Science Reviews

John L. Kough, Ph.D., Senior Scientist Product Characterization and Human

Stuart Schüssel Health Assessment

Shannon Borges M.S. Environmental Effects Assessment

Zigfridas Vaituzis, Ph.D., Senior Scientist

 Regulations

Denise Greenway Regulatory Action Leader

Sheryl K. Reilly, Ph.D. Chief, Microbial Pesticides Branch
Typhula phacorrhiza Strain 94671 Page 5 of 17

Biopesticides Registration Action Document

I. BACKGROUND

Typhula phacorrhiza is a fungus widely reported from northern temperate zones, thriving in cold 

temperatures and living on dead organic matter. While it is related to other Typhula species that 

are known plant pathogens, it has been shown to be a distinct species. Typhula phacorrhiza is 

often found in corn (Zea mays L.) residues and other organic debris following at least 80 days of 

snow cover, but has also been collected from dead leaves of other plants. Typhula phacorrhiza

strain 94671 was originally isolated from overwintered corn husks and stubble in a field near 

Acton, Ontario (Canada). Cold weather and abundant moisture create optimum conditions for 

growth and reproduction, and Typhula phacorrhiza strain 94671 grows optimally at 4oC. The 

Typhula phacorrhiza strain 94671 end-use product is for non-food use. As a pesticide active 

ingredient, it is a competitor intended to prevent development of grey and pink snow molds of 

golf course turf grasses caused by Typhula incarnata or Typhula ishikariensis, and 

Microdochium (Fusarium) nivale, respectively. The product is to be applied to golf course turf 

in the fall, before snowfall, in regions where continuous snow cover persists for 90 days or more.

Typhula phacorrhiza requires the same environmental cues of high moisture and near-freezing 

temperatures as do the plant pathogenic Typhula incarnate and Typhula ishikariensis, but is a 

superior competitor for resources and tolerates a wider range of conditions. Microdochium nivale

frequently occurs with plant pathogenic Typhula species and while it doesn’t require snow cover 

and has a higher optimum growth temperature, under the application conditions for the microbial 

pest control agent, Typhula phacorrhiza would be expected to out-compete it, as well.

On October 1, 2009, the Environmental Protection Agency (EPA or the Agency) announced a 

new policy to provide a more meaningful opportunity for the public to participate in major 

registration decisions before they occur. According to this new policy, the Agency intends to 

provide a public comment period prior to making a registration decision for, at minimum, the 

following types of applications: new active ingredients; first food uses; first outdoor uses; first 

residential uses; and any registration decisions for which the Agency believes there may be 

substantial public interest.

Consistent with the new policy of making registration actions more transparent, Typhula 

phacorrhiza strain 94671 is subject to a 30-day comment period as a “new active ingredient” 

whose registration would result in a “first outdoor use.” While a final decision on registration is 

contingent upon review and consideration of public comments, the Agency presently believes 

that, based upon the preliminary risk assessment and information submitted in support of 

registration of Typhula phacorrhiza strain 94671, it is in the best interest of the public and the

environment to issue the registration for Typhula phacorrhiza strain 94671. The basis for this 

preliminary decision can be found in the risk assessment for Typhula phacorrhiza strain 94671, 

which is characterized throughout this Biopesticides Registration Action Document (BRAD) and 

the associated reference documents written by Agency scientists. 
Typhula phacorrhiza Strain 94671 Page 6 of 17

Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Typhula phacorrhiza strain 94671

Culture Deposit: University of Alberta Microfungus Collection and Herbarium

(Accession Number UAMH 10959)

Trade & Other Names: Nivalis Technical

OPP Chemical Code: 036604

Type of Pesticide: Microbial Pesticide/Biofungicide

III. REGULATORY BACKGROUND

A. Applications for Pesticide Registration

On March 10, 2010, EPA published a Notice of Receipt in the Federal Register (75 FR 11175), 

announcing that Technology Sciences Group Incorporated, 712 Fifth Street, Suite A, Davis, CA 

95616 (on behalf of the applicant, Agrium Advanced Technologies RP Incorporated) submitted 

applications to register two pesticide products (a technical product and one end-use product) 

containing a new active ingredient not included in any currently registered pesticide products. 

No comments were received following this publication.

B. North American Free Trade Agreement Joint Review

Typhula phacorrhiza strain 94671 was the subject of a North American Free Trade Agreement 

joint registration review conducted by the Environmental Protection Agency Office of Pesticide 

Programs and the Health Canada Pest Management Regulatory Agency (PMRA). The PMRA 

“Proposed Registration Decision,” a consultation document recommending full registration of 

Typhula phacorrhiza strain 94671, is the current subject of a 45-day public comment period. See 

http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/index-eng.php. 

C. Food Clearances/Tolerances 

No tolerance or exemption from the requirement of a tolerance is associated with or required for

this regulatory action as only non-food uses are currently proposed for Typhula phacorrhiza 

strain 94671. Accordingly, this action is outside the scope of the Food Quality Protection Act 

(FQPA). There are no CODEX maximum residue levels established for Typhula phacorrhiza 

strain 94671.
Typhula phacorrhiza Strain 94671 Page 7 of 17

Biopesticides Registration Action Document

IV. RISK ASSESSMENT

On October 26, 2007, the Agency issued a Final Rule in the Federal Register on the data 

requirements to support registration of microbial pesticides and updated the definition for 

microbial pesticides (72 FR 61002). The rule became effective on December 26, 2007. The data 

and information evaluated for this BRAD were considered in light of these requirements.

The classifications that are found for each data submission are assigned by Agency science 

reviewers and are an indication of the usefulness of the information contained in the documents 

for risk assessment. A rating of “ACCEPTABLE” indicates the study is scientifically sound and 

is useful for risk assessment. A “SUPPLEMENTAL” rating indicates the data provide some 

information that can be useful for risk assessment. The studies may have certain aspects 

determined not to be scientifically acceptable (“SUPPLEMENTAL: UPGRADABLE”). If a 

study is rated as “SUPPLEMENTAL: UPGRADABLE,” the Agency always provides an 

indication of what is lacking or what can be provided to change the rating to “ACCEPTABLE.” 

If there is simply a “SUPPLEMENTAL” rating, the reviewer will often state that the study is not 

required by the current 40 Code of Federal Regulations (CFR) part 158. Both “ACCEPTABLE” 

and “SUPPLEMENTAL” studies may be used in the risk assessment process, as appropriate. An 

“UNACCEPTABLE” rating indicates that new data need to be submitted.

For the acute toxicity data requirements, toxicity categories are assigned based on the 

hazard(s) identified from studies and/or other information submitted to the Agency in support of 

a pesticide registration. The active ingredient or particular product is classified into Toxicity

Category I, II, III, or IV, where Toxicity Category I indicates the highest toxicity and Toxicity

Category IV indicates the lowest toxicity. 

A. Active Ingredient Characterization

Nivalis Technical is a manufacturing-use product to be incorporated into an end-use product. The 

active ingredient is 4.00% weight/weight Typhula phacorrhiza strain 94671 (minimum of 

181,600 cfu/lb).

All product analysis data requirements for registration of Typhula phacorrhiza strain 94671 have 

been satisfied.

Refer to Table 1 in Appendix A for a brief summary of these data requirements. 

 

Additionally, the comprehensive Agency risk assessments that evaluate these data are available 

as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0090 at 

http://www.regulations.gov (U.S. EPA 2010a and U.S. EPA 2010c). 
Typhula phacorrhiza Strain 94671 Page 8 of 17

Biopesticides Registration Action Document

B. Human Health Assessment

1. Toxicity

All toxicology data requirements for Typhula phacorrhiza strain 94671 have been satisfied.

Acceptable Tier I mammalian toxicology data/information support the registration of Typhula 

phacorrhiza strain 94671. The infectivity/pathogenicity endpoint was not addressed by a study

following the suggested guidelines, but rather with a pilot study and data indicating the inability

of the fungal active ingredient to grow at mammalian body temperatures. Furthermore, Tier II 

and Tier III studies were not required for Typhula phacorrhiza strain 94671 based on the lack of 

acute toxicity/pathogenicity in the Tier I studies.

Refer to Table 2 in Appendix A for a brief summary of these data requirements. 

Additionally, the comprehensive Agency risk assessments that evaluate these data are available 

as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0090 at 

http://www.regulations.gov (U.S. EPA 2010a.). 

2. Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a 

“naturally occurring estrogen, or other such endocrine effects as the Administrator may

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group 

of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. This 

list of chemicals was selected based on the potential for human exposure through pathways such 

as food and water, residential activity, and certain post-application agricultural scenarios. This 

list should not be construed as a list of known or likely endocrine disruptors.

Typhula phacorrhiza strain 94671 is not among the group of 58 pesticide active ingredients on 

the initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must 

screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test 

orders/data call-ins for all pesticide active ingredients. 

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

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.
Typhula phacorrhiza Strain 94671 Page 9 of 17

Biopesticides Registration Action Document

3. Risk Characterization

The Agency considered human exposure to Typhula phacorrhiza strain 94671 in light of the 

relevant safety factors in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A 

determination has been made that no unreasonable adverse effects to the U.S. population in 

general, and to infants and children in particular, will result from the use of Typhula phacorrhiza

strain 94671 when label instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT

1. Nontarget Organism Toxicology 

All nontarget toxicology data requirements for Typhula phacorrhiza strain 94671 have been 

satisfied. 

Adequate Tier I nontarget organism data/information are available to support registration of

Typhula phacorrhiza strain 94671. 

Refer to Table 3 in Appendix A for a brief summary of these data requirements.

Additionally, the comprehensive Agency risk assessments that evaluate these data are available 

as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0090 at 

http://www.regulations.gov (U.S. EPA 2010b). 

2. Environmental Fate and Ground Water Data 

As the information provided is sufficient to both satisfy the Tier I nontarget organism data 

requirements and for nontarget organism risk assessment for Typhula phacorrhiza strain 94671, 

further testing at higher tier levels (i.e., Tiers II, III, and IV) is not required.

3. Ecological Exposure and Risk Characterization

The Agency has performed an environmental risk assessment based on the data, literature 

citations, and data waiver rationale provided by the registrant, and has determined that the 

proposed use of Typhula phacorrhiza strain 94671 does not pose risk to nontarget organisms. 

Typhula phacorrhiza is a saprotrophic snow mold that is an obligate psychrophile (i.e., it requires 

low temperatures for growth and reproduction and lives on dead organic matter). It is abundant

within its range and is widely distributed in areas with persistent snow cover. Typhula 

phacorrhiza is recognized as a species distinct from the target Typhula species that are 

recognized plant pathogens. It is not known to produce toxins or other chemicals as a means of 

competing with other fungi. Exposure of nontarget organisms to actively growing Typhula 

phacorrhiza strain 94671 is also expected to be limited due to the conditions it requires for 

growth. 
Typhula phacorrhiza Strain 94671 Page 10 of 17

Biopesticides Registration Action Document

The registrant has submitted data waiver rationale to satisfy data requirements for nontarget 

organism risk assessment with the active ingredient (TGAI). Review of the rationale and data 

submitted to support the registration of Typhula phacorrhiza strain 94671 was completed jointly

with Health Canada’s PMRA. Submitted data, data waiver rationale, and a search by EPA of 

several literature databases provides sufficient information to determine that 

toxicity/pathogenicity to wild mammals, avian wildlife, freshwater and marine/estuarine 

vertebrates and invertebrates, honey bees, nontarget insects, and terrestrial and aquatic plants is 

not expected from the proposed label uses. As a result, a “No Effect” determination is also made 

for direct and indirect effects to listed species and their designated critical habitats resulting from 

the proposed use of Typhula phacorrhiza strain 94671, as labeled.

The information provided is sufficient to both satisfy the Tier I nontarget organism data 

requirements and for nontarget organism risk assessment for the active ingredient. Further

testing at higher tier levels is not required.

4. Threatened and Endangered Species Assessment 

EPA has determined that adverse effects will not occur to nontarget organisms as a result of the 

proposed labeled applications of Typhula phacorrhiza strain 94671. Additionally, Typhula 

phacorrhiza is a saprotrophic fungus that competes specifically with other snow mold fungi, and 

reduction or loss of these fungi will not affect habitat or other resources required by threatened 

and endangered species.

Since the Agency has determined that no effects are anticipated for any nontarget species 

exposed to Typhula phacorrhiza strain 94671 as a result of the proposed labeled applications, 

effects to federally-listed threatened and endangered species and their designated critical habitats 

are also not expected. Therefore, a “No Effect” determination is made for direct and indirect 

effects to listed species and their designated critical habitats resulting from the registered uses of

Typhula phacorrhiza strain 94671, as labeled.

D. PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all 

pesticide products. Customarily, the Agency requires efficacy data to be submitted for review 

only in connection with the registration of products directly pertaining to the mitigation of 

disease bearing human health organisms and certain designated quarantine pests, i.e., ticks, 

mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc. For a list of 

organisms considered by the Agency as “public health pests,” please refer to Pesticide 

Registration Notice 2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf). 

Efficacy data were neither required nor reviewed by EPA in association with the U.S. pesticide 

registration applications for Typhula phacorrhiza strain 94671. 
Typhula phacorrhiza Strain 94671 Page 11 of 17

Biopesticides Registration Action Document

V. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is 

determined that (A) its composition is such as to warrant the proposed claims for it; (B) its 

labeling and other materials required to be submitted comply with the requirements of FIFRA; 

(C) it will perform its intended function without unreasonable adverse effects on the 

environment; and (D) when used in accordance with widespread and commonly recognized 

practice it will not generally cause unreasonable adverse effects on the environment. 

The four criteria of the eligibility determination for pesticidal active ingredients are satisfied by

the science assessments supporting products containing Typhula phacorrhiza strain 94671. Such 

products are not expected to cause unreasonable adverse effects, and are likely to provide 

protection as claimed when used according to label instructions. Therefore, Typhula phacorrhiza

strain 94671 is eligible for registration for the labeled uses. 

VI. 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. At this time 

EPA does not believe that use of pesticide products containing Typhula phacorrhiza strain 94671 

will cause harm or a disproportionate impact on at-risk communities.

For additional information regarding environmental justice issues, please visit EPA’s website at:

http://www.epa.gov/compliance/environmentaljustice/index.html.

VII. TERMS OF THE REGISTRATION(S)

Storage stability and corrosion characteristics (OCSPP Guideline numbers 830.6317 and 

830.6320, respectively) testing is currently underway and the study results are required to be 

submitted for EPA review upon completion. 
Typhula phacorrhiza Strain 94671 Page 12 of 17

Biopesticides Registration Action Document

VIII. APPENDIX A. Data Requirements (40 CFR Part 158-Subpart V)

*NOTE: MRID numbers listed in the following tables are representative of supporting data for 

the original registration of the product containing this active ingredient. Subsequent to this 

registration, there may be additional MRIDs that support registration of other products containing 

this active ingredient. 
Typhula phacorrhiza Strain 94671 Page 13 of 17

Biopesticides Registration Action Document

TABLE 1. Physical and Chemical Properties for the Technical Grade of the Active Ingredient (TGAI), Typhula 

phacorrhiza strain 94671 (40 CFR § 158.2120)a

OCSPP 

Guideline 

Number

Property Description of Result Methods

830.6302 Color Beige. Visual observation

830.6303 Physical State Solid granule. Visual observation

830.6304 Odor Odorless to faintly anise-like. Olfactory inspection

830.6313 Stability Expected to be stable at normal 

temperatures and when exposed to 

metals and metal ions. Not stable 

at temperatures >30°C.

Growth temperature analysis

830.6314 Oxidation/Reduction:

Chemical Incompatibility

Not applicable, the product does

not contain oxidizing or reducing 

agents.

830.6315 Flammability Not applicable, the product is a 

solid.

830.6316 Explodability Not applicable, the product does 

not contain explosive ingredients.

830.6317 Storage Stability One-year study is ongoing.

830.6319

Miscibility

Not applicable, the product is not 

an emulsifiable liquid to be mixed 

with petroleum solvents.

830.6320 Corrosion Characteristics One-year study is ongoing.

830.6321 Dielectric Breakdown Voltage Not required for MP.

830.7000 pH 6.8 (aqueous solution). pH meter

830.7100 Viscosity Not applicable, the product is a 

solid.

830.7200 Melting Range Not applicable, the product is not 

pure active ingredient.

830.7220 Boiling Range Not applicable, the product is a 

solid.

830.7300 Density/Relative Density/Bulk

Density 0.475 g/cm3 CIPAC MT-33

830.7370 Dissociation Constant in Water Not applicable, the product is not 

pure active ingredient.

830.7550 Partition Coefficient Not applicable, the product is not 

pure active ingredient.

830.7840 Water Solubility Not applicable, the product is not 

pure active ingredient.

830.7950 Vapor Pressure Not applicable, the product is not 

pure active ingredient.

aData from MRID 478021-01
Typhula phacorrhiza Strain 94671 Page 14 of 17

Biopesticides Registration Action Document

TABLE 2. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Typhula 

phacorrhiza strain 94671 (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data Requirement Results MRID Number

Tier I

870.1100 Acute Oral Toxicity

Oral LD50>5000 mg/kg bw

(low acute oral toxicity)

Pathogenicty and infectivity 

testing waived based on results 

from 47802106

Toxicity Category IV

478021-02

870.1200 Acute Dermal Toxicity

Dermal LD50>5050 mg/kg bw

(low acute dermal toxicity)

Toxicity Category IV

478021-03

870.1300 Acute Inhalation Toxicity

Waived based on results from 

47802106

870.2400 Acute Eye Irritation

Typhula phacorrhiza strain 

94671was minimally irritating 

to the eye based on the 

maximum mean irritation score 

of 8, recorded one hour after 

test material instillation.

Toxicity Category III

478021-04

870.2500 Primary Dermal Irritation

Typhula phacorrhiza strain 

94671 was non- to slightlyirritating to the skin, based on 

the maximum individual 

irritation and maximum 

irritation scores of 1 and 0.67, 

respectively at the one hour 

observation point; and the 

maximum average score of 

zero over the 24, 48 and 72 

hour observation points.

Toxicity Category IV

478021-05

Tiers II and III

Not required for Typhula phacorrhiza strain 94671 based on the lack of acute toxicity/pathogenicity in the Tier I 

studies.

Additional Studies

885.3200

Pilot Study in Preparation 

for Intraperitoneal 

Toxicity Study

This fungus could not be 

recovered after dose 

administration and has been 

shown to be unable to grow at 

mammalian body temperatures.

Typhula phacorrhiza was not 

toxic or pathogenic as tested in 

this pilot study.

478021-06
Typhula phacorrhiza Strain 94671 Page 15 of 17

Biopesticides Registration Action Document

TABLE 3. Nontarget Organism Data Requirements for the Technical Grade of the Active Ingredient (TGAI),

Typhula phacorrhiza strain 94671 (40 CFR § 158.2150)

OCSPP 

Guideline 

Number

Data Requirement Results MRID1

Number

885.4050 Avian Oral Toxicity Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to birds is not expected.

Classification: Acceptable

478021-07

478021-08

885.4100 Avian Inhalation 

Toxicity/Pathogenicity

Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to birds is not expected.

Classification: Acceptable

478021-07

478021-08

885.4150 Wild Mammal 

Toxicity/Pathogenicity

An acute oral toxicity test with albino rats indicates 

no adverse effects at 5000 mg/kg-bw. Data waiver 

rationale also support the conclusion that adverse 

effects to wild mammals are not expected.

Classification: Acceptable

478021-07

478021-08

885.4200 Freshwater Fish 

Toxicity/Pathogenicity

Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to freshwater fish is not 

expected.

Classification: Acceptable

478021-07

478021-08

885.4240 Freshwater 

Invertebrate 

Toxicity/Pathogenicity

Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to freshwater invertebrates is 

not expected.

Classification: Acceptable

478021-07

478021-08

885.4280 Estuarine/Marine Fish 

Testing

Estuarine/Marine 

Invertebrate Testing

Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to marine/estuarine fish and 

invertebrates is not expected.

Classification: Acceptable

478021-07

478021-08

885.4300 Nontarget Plant 

Testing

Plant pathogenicity data show no evidence of adverse 

effects on two monocotyledonous plant species and 

three dicotyledonous plant species. Classification:

Supplemental; Additional data waiver rationale 

supports the conclusion that adverse effects to 

nontarget plants are not expected.

Classification: Acceptable data waiver rationale

478021-07

478021-08

885.4340 Nontarget Insect 

Testing

Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to nontarget insects is not 

expected.

Classification: Acceptable

478021-07

478021-08

885.4380 Honey Bee Testing Data waiver rationale is sufficient to determine that 

toxicity/pathogenicity to honey bees is not expected.

Classification: Acceptable

478021-07

478021-08

1

Publications referenced in the data waiver rationale were contained in MRID 478021-09. 
Typhula phacorrhiza Strain 94671 Page 16 of 17

Biopesticides Registration Action Document

IX. APPENDIX B. MRID and Cited Literature Bibliography

 A. Studies Submitted to Support the Typhula phacorrhiza strain 94671 Pesticide

 Products Registration

478021-00

Agrium Advanced Technologies RP, Inc. (2009) Submission of Product Chemistry

and Toxicity Data in Support of the Application for Registration of Nivalis 

Technical. Transmittal of 9 Studies. 

13-Jul2009

478021-01

Cascino, J. (2009) Product Chemistry for Nivalis Technical. Project Number: 7277, 

3504, SOP/TP/101. Unpublished study prepared by Sylvan Inc. and Microbac 

Laboratories, Inc. 121 p.

13-Jul2009

478021-02 Kuhn, J. (2009) Acute Oral Toxicity Study (UDP) in Rats (Nivalis): Final Report. 

Project Number: 12372/08. Unpublished study prepared by Stillmeadow, Inc. 11 p.

13-Jul2009

478021-03 Kuhn, J. (2009) Acute Dermal Toxicity Study in Rats (Nivalis): Final Report. Project

Number: 12373/08. Unpublished study prepared by Stillmeadow, Inc. 13 p.

13-Jul2009

478021-04 Kuhn, J. (2009) Acute Eye Irritation Study in Rabbits (Nivalis): Final Report. Project

Number: 12374/08. Unpublished study prepared by Stillmeadow, Inc. 18 p.

13-Jul2009

478021-05 Kuhn, J. (2009) Acute Dermal Irritation Study in Rabbits (Nivalis): Final Report. 

Project Number: 12375/08. Unpublished study prepared by Stillmeadow, Inc. 13 p.

13-Jul2009

478021-06

Monds, K. (2009) Typhula phacorrhiza: Pilot Study in Preparation for IP Toxicity

Study (Rat): Final Report. Project Number: 12378/08. Unpublished study prepared 

by Stillmeadow, Inc. 18 p.

13-Jul2009

478021-07 Bjornson, H. (2009) Tier II Data Summaries for Nivalis Technical. Unpublished 

study prepared by Agrum Advanced Technologies RP Inc. 96 p.

13-Jul2009

478021-08 Bjornson, H. (2009) Tier III Data Summaries for Nivalis Technical. Unpublished 

study. 54 p.

13-Jul2009

478021-09

Roberts, A. (2009) Reference Data Volume for Tier II & III Data Summaries for 

Nivalis Technical. Unpublished study prepared by Agrium Advanced Technologies 

RP Inc. 199 p.

13-Jul2009

479221-00

Agrium Advanced Technologies RP, Inc. (2009) Submission of Product Chemistry

Data in Support of the Application for Registration of Nivalis Technical. Transmittal 

of 1 Study.

19-Nov2009

479221-01 Cascino, J. (2009) Supplemental Product Chemistry for Nivalis Technical. 

Unpublished study prepared by Sylvan, Inc. 6 p.

19-Nov2009

481369-00

Agrium Advanced Technologies RP, Inc. (2010) Submission of Product Chemistry

Data in Support of the Applications for Registration of Nivalis Technical and 

Nivalis. Transmittal of 1 Study.

30-Jun2010

481369-01 Cascino, J. (2010) Supplemental Product Chemistry for Nivalis Technical. 

Unpublished study prepared by Agrium Advanced Technologies RP, Inc. 16 p.

30-Jun2010
Typhula phacorrhiza Strain 94671 Page 17 of 17

Biopesticides Registration Action Document

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2010a. Review of Typhula phacorrhiza the active ingredient in the end-product 

Nivalis for control of snow mold in turfgrass from Agrium Advanced Technologies. 

Memorandum from J. L. Kough to D. Greenway dated May 18, 2010.

U.S. EPA. 2010b. Environmental Risk Assessment for the of FIFRA Section 3 registration of 

Typhula phacorrhiza strain 94671 (EPA File Symbol. Nos. 84888-R and 84888-E) for 

control of snow mold disease in turf; MRIDs 478021-07, 478021-08 and 478021-09. 

Memorandum from S. Borges and Z. Vaituzis to D. Greenway dated June 2, 2010.

U.S. EPA. 2010c. Review of Supplemental Information Provided by Agrium Advanced 

Technologies RP, Inc. and Sylvan, Inc. on the Nivalis Product Based on Typhula 

phacorrhiza isolate 94671. Memorandum from J. L. Kough to D. Greenway dated July

23, 2010.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

cfu colony-forming units

cfu/lb colony-forming units per pound

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EP end-use product

EPA 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

mg/kg bw milligram per kilogram of body weight

MRID No. Master Record Identification Number

OCSPP Office of Chemical Safety and Pollution Prevention; formerly, Office of Pesticides 

 and Toxic Substances (OPPTS)

OPP Office of Pesticide Programs

PMRA Pest Management Regulatory Agency (of Health Canada)

TGAI technical grade of the active ingredient