Document ID: EPA-HQ-OPP-2010-0090-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-11-10T05:00Z

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

November 2010

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

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  

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

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 was the subject of 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 was contingent upon review and consideration of
public comments, no comments were received.  The Agency believes that,
based upon its assessment of the data 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.  

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 (  HYPERLINK
"http://edocket.access.gpo.gov/2008/pdf/E8-25515.pdf"  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
consultation document recommending full registration of Typhula
phacorrhiza strain 94671 was made available on September 10, 2010, for
public comment for a period of 45-days; the consultation period for that
announcement is now closed.  For the PMRA Proposed Registration
Decision, see
http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_prd2010-23/prd20
10-23-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.

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 ( 
HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-TOX/2007/October/Day-26/t20828.htm"  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   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  (U.S. EPA
2010a and U.S. EPA 2010c).  

	

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   HYPERLINK
"http://www.regulations.gov"  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/.

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   HYPERLINK
"http://www.regulations.gov"  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.  

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. The Agency retains the right to
require submission of efficacy data to support an application for
registration of a pesticide, but customarily only requires the data 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 (  HYPERLINK
"http://www.epa.gov/PR_Notices/pr2002-1.pdf" 
http://www.epa.gov/PR_Notices/pr2002-1.pdf ).  

Efficacy data were not submitted, or reviewed by EPA, in association
with the U.S. pesticide registration applications for Typhula
phacorrhiza strain 94671.  The PMRA received and reviewed efficacy data
in support of the Canadian registration application.  For PMRA’s
summary of these data, see the “Value Considerations” section of  

http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_prd2010-23/prd20
10-23-eng.php.

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

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

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 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 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

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

1Publications referenced in the data waiver rationale were contained in
MRID 478021-09. 

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-Jul-2009

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-Jul-2009

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-Jul-2009

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-Jul-2009

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-Jul-2009

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-Jul-2009

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-Jul-2009

478021-07	Bjornson, H. (2009) Tier II Data Summaries for Nivalis
Technical. Unpublished study prepared by 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
Nivalis Technical. Transmittal of 1 Study.	19-Nov-2009

479221-01	Cascino, J. (2009) Supplemental Product Chemistry for Nivalis
Technical. Unpublished study prepared by Sylvan, Inc. 6 p.	19-Nov-2009

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-Jun-2010

481369-01	Cascino, J. (2010) Supplemental Product Chemistry for Nivalis
Technical. Unpublished study prepared by Agrium Advanced Technologies
RP, Inc. 16 p.	30-Jun-2010

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

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