BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## Typhula phacorrhiza Strain 94671

PC Code: 036604

U.S. Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Biopesti cides and Pollution Prevention Division

Version # 5 September 2010Typhula phacorrhiza Strain 94671 Page 2 of 17

Biopesticides Registration Action Docum ent TABLE OF CONTENTS I. BACKGROUND.............................. .......................................... ................. 5 II. AC TIVE INGREDIENT OV ERVIEW ................................ ................................ ........ 6 III. REGULA

TORY BACKGROUN D ................................ ................................ ............ 6 A. AP PLICA

TION S FOR PESTICIDE REGI STRA TION ................................ .............. 6 B. NORTH A MERICA N FREE TRA DE AGREEMENT JOINT REVIEW ...................... 6 C. FOOD CLEA RA NCES/TOLERA NCES.................................... .....................6 IV. RISK ASSESSMENT ................................ ................................ ............................. 7 A. AC TIVE INGREDIENT CH ARAC TERIZA TION ................................ ....................... 7 B. HUMA N HEA LTH ASSESSM ENT ................................ ................................ ........... 8 1. TOXICITY ................................ ................................ ................................ ................ 8 2. EFFECTS ON THE ENDOC RINE SYSTEM ................................ ............................ 8 3. RISK CHA RACTE RIZA TION.................................... ........................... ... ......9 C. ENVIRONMENTA L ASSESS MENT................................................ ............ . .9 1. NONTA RGET ORGA NISM T OXICOLOGY ................................ ............................. 9 2. ENVIRONMENTA L FA TE A ND GROUND WA TER DA TA ................................ ...... 9 3. ECOLOGICA L EXPOSURE AN D RISK CHA RACTERIZAT ION ............................. 9 4. TH REA

TENED A N D ENDA NGERED SPEC IES ASSESSMENT...................... .10 D. PRODUCT PERFORMA NCE DA TA (EFFICACY) ................................ ................. 1 0Typhula phacorrhiza Strain 94671 Page 3 of 17

Biopesticides Registration Action Docum ent V. RISK MA NAGEMENT DECI SION ................................ ................................ ......... 11 VI. ENVIRONMENTA L JUSTICE ....................................................................11 VI I . TERMS OF THE REGISTRAT ION(S) ................................ ................................ .... 11 VII I . AP PENDIX A . DA TA REQ UIREMENTS (40 CFR PA RT 158 - SUBPA RT V) ........ 1 2 I X . AP PENDIX B. MRID A ND CITED LITERA TURE BIB LIOGRA PHY ...................... 1 6 A. STUDIES SUBMITTED TO SUPPORT THE TYPHULA PHACORRHIZA STRA IN 94671 PESTICIDE PROD UCTS REGISTRA TION ................................ ....................... 1 6 B. ENVIRONMENTA L PROTEC TION AG ENCY RISK ASSESSMENT MEMORA NDA ................................. ............................................. ... ... ..........17 X. GLOSSA RY OF ACRONYMS A ND A BBREVIA TIONS .................. ... ................17Typhula phacorrhiza Strain 94671 Page 4 of 17

Biopesticides Registration Action Docum ent

BIOPESTICIDES REGIST RA TION ACTION DOCUME NT TEA M Office of Chemical Safety and Pollution Prevention Biopesticides and Pollution Prevention Division Micr o bial Pesticides Branch ( M PB)

Science Reviews Jo hn L . Kough , Ph.D. , Senior Scientist Product Characterization and Human Stuart Schü ssel Health Assessment Shannon Borges M.S. Environmental Effects Assessment Zigfridas Vaituzis , Ph.D. , Senior Scientist

Regulations Denise Greenway Regulatory Action L eader Sheryl K. Reilly , Ph.D. Chief, Microbial Pesticides BranchTyphula phacorrhiza Strain 94671 Page 5 of 17

Biopesticides Registration Action Docum ent I. BACKGROUND Typhula phacorrhiza is a fungus widely reported from northern temperate zones, thriving in cold temperatures and livi ng 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. T yphula phacorrhiza is often found in corn (Zea mays L. ) residues and other organic debris following at le ast 80 days of snow cover, but has also been collected from dead leaves of other plants. Typhula phacorrhiza s train 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 T yphula phacorrhiza s train 94671 grows optimally at 4oC. The T yphula phacorrhiza s train 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 T yphula ishikariensis, and Microdochium (Fusarium) nivale , respectively . The product is to be applied to golf course turf in the fall, bef

ore snowfall, in regions where continuous snow cover persists for 90 days or more. Typhula phacorrhiza requires the same environmental cues of high mois ture and near - freezing temperatures as do the plant pathogenic T yphula incarnate and T

yphula ishikarien sis , but is a superior competitor for resources and tolerates a wider range of conditions . Microdochium nivale frequentl y occurs with plant pathogenic Typhula species an d while it doesn’t require snow cover and has a higher optimum growth temperature, unde r the application conditions for the microbial pest control agent, Typhula phacorrhiza would be expe c ted 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 meani ngful 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 ty

pes 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 regis tration actions more transparent, Typhula phacorrhiza s train 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 s train 94671 , it is in the best interest of the public and the environment to issue the registration for Typhula phacorrhiza s train 94671 . The basis for this preliminary

decision can be found in the risk assessment for Typhula phacorrhiza s train 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 Docum ent II. ACTIVE INGREDIENT OVERVIEW Biological Name: Typhula phacorrhiza s train 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 , 20 1 0 , EPA p ublished a Notice of Receipt in the Federal Register ( 7 5 FR 11175 ) , announcing that Technology Sciences Group Incorporated, 712 Fifth Street, Suite A, Davis, CA 95616 (on behalf of the ap plicant, Agrium Advanced Technologies RP Incorporated) submitted application s 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 s train 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 s train 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 . F ood Clearances/Tolerances No toleranc e 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 s train 94671. Accordingly , this action is outside the scope of the Food Quali ty Protection Act ( FQPA ) . There are no CODEX maximum residue levels established for Typhula phacorrhiza s train 94671.Typhula phacorrhiza Strain 94671 Page 7 of 17

Biopesticides Registration Action Docum ent IV. RISK ASSESSMENT On October 26, 2007, the Agency issued a Final Rule in the Federal Register on the data requirements to suppo rt 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 info rmation 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 th e 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”). I f 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 rati ng 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) p art 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 infor mation 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 Iindicates 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% w eight/w eight Typhula phacorrhiza s train 94671 (minimum of 181,600 c fu/lb). All product analysis data requirements for registration of Typhula phacorrhiza s train 94671 have been satisfied . Refer to Table 1 in Appendix A for a brief summary of these data requirements. Additionally , the comprehensive Agency risk as sessments that evaluate these data are available as “Supporting & Related Materials” within Docket Number EPA - HQ - OPP - 20 10 - 0090 at http://www.regulations.gov (U.S. EPA 2010 a and U.S. EPA 2010 c ).Typhula phacorrhiza Strain 94671 Page 8 of 17

Biopesticides Registration Action Docum ent B. Hum an Health Assessment 1 . Toxicity All toxicology

data requirements for Typhula phacorrhiza s train 94671 have been satisfied. Acceptable Tier I mammalian toxicology data / information support the registration of Typhula phacorrhiza s train 94671 . The infect ivity /pathogenicity

endpoint w as 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 T ier III studies were not required for Typhula phacorrhiza s train 94671 based on the lack of acute toxicity

/pathogenicity

in the Tier I

studies. Refer to Table 2 in Appendix A f or a brief summary

of these data requirements. Additionally , the comprehensi ve Agency risk assessments that evaluate these data are available as “Supporting & Related Materials” within Docket Number EPA - HQ - OPP - 20 10 - 0090 at http://www.regulations.gov (U.S. EPA 2010 a. ). 2. Effects on t he 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 batt ery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thy roid (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 caus ed 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 activ e 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 n ot be construed as a list of known or likely endocrine disruptors. Typhula phacorrhiza s train 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 scree n 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 tes t 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 Docum ent

3. Risk Characterization The Agency

considered human exposure to Typhula phacorrhiza s train 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 s train 94671 when label instructions are followed. C. ENVIRONMENTAL ASSESSMENT 1. Nontarget Organism Toxicology All nontarget toxicology

data requirements for Typhula phacorrhiza s train 94671 have been satisfied. Adequate Tier I nontarget organism data / information are available to support registration of Typhula phacorrhiza s train 94671
. Refer to Table 3 in Appendix A f or 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 - 20 10 - 009 0 at http://www.regulations.gov (U.S. EPA 2010b ). 2. Environmental Fate and Ground Water Data As the information provid ed is sufficient to both satisfy the Tier I nontarget organism data requirements and for nontarget organism risk asse ssment for Typhula phacorrhiza s train 94671 , f urther testing at higher tier levels (i.e., Tiers II, III, and IV) is not required . 3. Ecol ogical 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 phacorrh iza s train 94671 do es 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 chemi cals as a means of competing with other fungi. Exposure of nontarget organisms to actively growing Typhula phacorrhiza s train 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 Docum ent 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 T yphula phacorrhiza s train 94 67 1 was completed jointly with Health Can ada’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 an d 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 s train 94671, as labeled. T he information provided is sufficient to both satisfy the Tier I nontarget organism data requirements and for nontarget organism risk asse ssment for the acti ve ingredient. F urther 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 T yphula phacorrhiza s train 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 e ndangered species. Since the Agency

has determined that no effects are anticipated for any nontarget species exposed to Typhula phacorrhiza s train 94671 as a result of the proposed labeled applications, effects to federally- listed threatened and e ndangere d species and their designated critical habitats are also not expected. There fore, 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 ph acorrhiza s train 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, gy psy moths, Ja

panese 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 n either required nor reviewed by EPA in association with the U.S. pesticide registration applications for Typhula phacorrhiza s train 94671.Typhula phacorrhiza Strain 94671 Page 11 of 17

Biopesticides Registration Action Docum ent V. RISK MANAGEMENT D ECISION Section 3(c)(5) of FIFRA provides for the registration of n ew 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 funct ion 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 e ligibility determination for pesticidal a ctive i ngredients are satisfied by the science assessments supporting products containing Typhula phacorrhiza s train 94671 . Such products are not expected to cause unreasonable adverse effects, and are likely to provide pro tection as claimed when used according to label instructions. Therefore, Typhula phacorrhiza s train 94671 is eligible for registration for the labeled uses. VI. E NVIRONMENTAL J USTICE 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 s train 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 . V I I . TERMS OF THE REGISTRATION(S) Storage stability and corrosion characteristics ( OCSPP Guideline numbers 830.6317 and 830.6320 , respectively

) test ing 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 Docum ent VI I I . A PPENDIX A. Data Requirements (40 CFR Part 158 - Subpart V) *NOTE: MRID numbers listed in the following tables are representative of suppor ting 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 Docum ent TABLE 1 . Physica l and Chemical Properties for the Technical Grade of the Active Ingredient (TGAI), Typhula phacorrhiza s train 94671 (40 CFR § 158. 2120) a OCSPP Guideline Number Property Description of Result Methods 830.6302 Color Beige. Visual observation 830.630 3 Phy sical 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 Explodabili ty 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. 830.63 20 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 ap plicable, the product is not pure active ingredient. aData from MRID 478021 - 01Typhula phacorrhiza Strain 94671 Page 14 of 17

Biopesticides Registration Action Docum ent TABLE 2 . Toxicology Data Requirem ents for the Technical Grade of the Active Ingredient (TGAI), Typhula phacorrhiza s train 94671 (40 CFR § 158.2140) OCSPP Guideline Number D ata Requirem ent Results MRID Number Tier I

870.1100 Acute Oral Toxicity Oral LD 50 >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 LD 50 >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 s train 94671 wa s minimal ly 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 s train 94671 wa s non - to slightly irritating 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 po ints . Toxicity Category IV 478021 - 05

Tiers II and III Not required for Typhula phacorrhiza s train 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 wa s not toxic or pathogenic as tested in this pilot study. 478021 - 06Typhula phacorrhiza Strain 94671 Page 15 of 17

Biopesticides Registration Action Docum ent

T ABLE 3 . Nontarget OrganismData Requirem ents for the Technical Grade of the Active Ingredient (TGAI), Typhula phacorrhiza s train 94671 (40 CFR § 158.2 150) OCSPP Guideline Number Data Requirem ent Results MRID 1 Number 885.4050 Avian Oral Toxicity Data wa iver 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 toxici ty/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 f reshwater 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 expecte d. 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 mo nocotyledonous plant species and three di cotyledonous plant species. Classification: S upplem e ntal ; Additional data waiver rationale support s 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 suff icient 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 n ot 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 Docum ent IX. A PPENDIX B. MRID and Cited Literature Bibliography A. Studies Submitted to Support th e Typhula phacorrhiza s train 94671 Pesticide Product s 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. Transmitta l of 9 Studies. 13 - Jul 2009 478021 - 01 Cascino, J. (2009) Product Chemistry for Nivalis Technical. Project Number: 7277, 3504, SOP/TP/101. Unpublished study prepared by

Sy lvan Inc. and Microbac Laboratories, Inc. 121 p. 13 - Jul 2009 478021 - 02 Kuhn, J. (20 09) Acute Oral Toxicity Study (UDP) in Rats (Nivalis): Final Report. Project Number: 12372/08. Unpublished study prepared by

Stillm eadow, Inc. 11 p. 13 - Jul 2009 478021 - 03 Kuhn, J. (2009) Acute Dermal Toxicity Study in Rats (Nivalis): Final Report. Project Number: 12373/08. Unpublished study prepared by

Stillm eadow, Inc. 13 p. 13 - Jul 2009 478021 - 04 Kuhn, J. (2009) Acute Eye Irritation Study in Rabbits (Nivalis): Final Report. Project Number: 12374/08. Unpublished study prepared by

Stillm eadow, Inc. 18 p. 1 3 - Jul 2009 478021 - 05 Kuhn, J. (2009) Acute Dermal Irritation Study in Rabbits (Nivalis): Final Report. Project Number: 12375/08. Unpublished study prepared by

Stillm eadow, Inc. 13 p. 13 - Jul 2009 478021 - 06 Monds, K. (2009) Ty phula phacorrhiza: Pilot Study in Preparation for IP Toxicity

Study (Rat): Final Report. Project Number: 12378/08. Unpublished study prepared by Stillm eadow, Inc. 18 p. 13 - Jul 2009 478021 - 07 Bjornson, H. (2009) Tier II Data Summaries for Nivalis Technical. Unpublished

study prepared b y Agrum Advanced Technologies RP Inc. 96 p. 13 - Jul 2009 478021 - 08 Bjornson, H. (2009) Tier III Data Summaries for Nivalis Technical. Unpublished

study . 54 p. 13 - Jul 2009 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 - Jul 2009 479221 - 00 Agrium Advanced Technologies RP, Inc. (2009) Submission of Product Chemistry

Data in Support of the Application for Registration of Niva lis Technical. Transmittal of 1 Study
. 19 - Nov 2009 479221 - 01 Cascino, J. (2009) Supplemental Product Chemistry for Nivalis Technical. Unpublished study

prepared by

Sy lvan, Inc. 6 p. 19 - Nov 2009 481369 - 00 Agrium Advanced Technologies RP, Inc. (2010) Submi ssion of Product Chemistry

Data in Support of the Applications for Registration of Nivalis Technical and Nivalis. Transmittal of 1 Study
. 30 - Jun 2010 481369 - 01 Cascino, J. (2010) Supplemental Product Chemistry for Nivalis Technical. Unpublished study

prep ared by

Agrium Advanced Technologies RP, Inc. 16 p. 30 - Jun 2010Typhula phacorrhiza Strain 94671 Page 17 of 17

Biopesticides Registration Action Docum ent B. Environmental Protection Agency Risk Assessment Memoranda U.S. EPA. 20 10 a . 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. 20 10 b . Environmental Risk Assessment for the of FIFRA Section 3 registration of Typhula phacorrhiza s train 94671 (EPA File Sy mbol. No s. 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. 20 10 c . R eview 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 E nvironmental 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 I dentification 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 (o f Health Canada) TGAI t echnical grade of the active ingredient