.....
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
-------
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
VIM. 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 Schiissel 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 4°C. 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 ishikariemis, 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.
-------
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
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.qc.ca/cps-spc/pest/part/consultations/ prd2010-23/prd2010-23-enq.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, IE, 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
181,600cfu/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
htty://www.regulations.sov (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 in 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 Disrupter
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 disrupters.
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.
-------
Typhula phacorrhiza Strain 94671 Page 9 of 17
Biopesticides Registration Action Document
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
http://www.regulations.gov (U.S. EPA 201 Ob).
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, IE, 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. 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
(http://www.epa.gov/PR Notices/pr2002-l.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.qc.ca/cps-spc/pest/part/consultations/ prd2010-23/prd2010-23-enq.php.
-------
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.sov/compliance/environmentaliustice/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
Biopesticides Registration Action Document
Page 13 of 17
TABLE 1. Physical and Chemical Properties for the Technical Grade of the Active Ingredient (TGAI), Typhula
phacorrhiza strain 94671 (40 CFR § 158.2120)"
OCSPP
Guideline
Number
830.6302
830.6303
830.6304
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7100
830.7200
830.7220
830.7300
830.7370
830.7550
830.7840
830.7950
Property
Color
Physical State
Odor
Stability
Oxidation/Reduction:
Chemical Incompatibility
Flammability
Explodability
Storage Stability
Miscibility
Corrosion Characteristics
Dielectric Breakdown Voltage
PH
Viscosity
Melting Range
Boiling Range
Density /Relative Density/Bulk
Density
Dissociation Constant in Water
Partition Coefficient
Water Solubility
Vapor Pressure
Description of Result
Beige.
Solid granule.
Odorless to faintly anise-like.
Expected to be stable at normal
temperatures and when exposed to
metals and metal ions. Not stable
at temperatures >30°C.
Not applicable, the product does
not contain oxidizing or reducing
agents.
Not applicable, the product is a
solid.
Not applicable, the product does
not contain explosive ingredients.
One-year study is ongoing.
Not applicable, the product is not
an emulsifiable liquid to be mixed
with petroleum solvents.
One-year study is ongoing.
Not required for MP.
6.8 (aqueous solution).
Not applicable, the product is a
solid.
Not applicable, the product is not
pure active ingredient.
Not applicable, the product is a
solid.
0.475 g/cm3
Not applicable, the product is not
pure active ingredient.
Not applicable, the product is not
pure active ingredient.
Not applicable, the product is not
pure active ingredient.
Not applicable, the product is not
pure active ingredient.
Methods
Visual observation
Visual observation
Olfactory inspection
Growth temperature analysis
pH meter
CIPAC MT-33
aData from MRID 478021 -01
-------
Typhula phacorrhiza Strain 94671
Biopesticides Registration Action Document
Page 14 of 17
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
870.1200
870.1300
870.2400
870.2500
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Acute Eye Irritation
Primary Dermal Irritation
Oral LD50>5000 mg/kg bw
(low acute oral toxicity)
Pathogenicty and infectivity
testing waived based on results
from 47802 106
Toxicity Category IV
Dermal LD50>5050 mg/kg bw
(low acute dermal toxicity)
Toxicity Category IV
Waived based on results from
47802106
Typhula phacorrhiza strain
94671 was minimally irritating
to the eye based on the
maximum mean irritation score
of 8, recorded one hour after
test material instillation.
Toxicity Category III
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
478021-02
478021-03
478021-04
478021-05
Tiers II and III
Not required for Typhula phacorrhiza strain 9467 1 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
Biopesticides Registration Action Document
Page 15 of 17
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
885.4050
885.4100
885.4150
885.4200
885.4240
885.4280
885.4300
885.4340
885.4380
Data Requirement
Avian Oral Toxicity
Avian Inhalation
Toxicity/Pathogenicity
Wild Mammal
Toxicity/Pathogenicity
Freshwater Fish
Toxicity/Pathogenicity
Freshwater
Invertebrate
Toxicity/Pathogenicity
Estuarine/Marine Fish
Testing
Estuarine/Marine
Invertebrate Testing
Nontarget Plant
Testing
Nontarget Insect
Testing
Honey Bee Testing
Results
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to birds is not expected.
Classification: Acceptable
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to birds is not expected.
Classification: Acceptable
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
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to freshwater fish is not
expected.
Classification: Acceptable
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to freshwater invertebrates is
not expected.
Classification: Acceptable
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to marine/estuarine fish and
invertebrates is not expected.
Classification: Acceptable
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
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to nontarget insects is not
expected.
Classification: Acceptable
Data waiver rationale is sufficient to determine that
toxicity/pathogenicity to honey bees is not expected.
Classification: Acceptable
MRID1
Number
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
478021-07
478021-08
Publications referenced in the data waiver rationale were contained in MRID 478021-09.
-------
Typhula phacorrhiza Strain 94671
Biopesticides Registration Action Document
Page 16 of 17
IX. APPENDIX B. MRID and Cited Literature Bibliography
A. Studies Submitted to Support the Typhula phacorrhiza strain 9461'I Pesticide
Products Registration
478021-00
478021-01
478021-02
478021-03
478021-04
478021-05
478021-06
478021-07
478021-08
478021-09
479221-00
479221-01
481369-00
481369-01
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.
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.
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.
Kuhn, J. (2009) Acute Dermal Toxicity Study in Rats (Nivalis): Final Report. Project
Number: 12373/08. Unpublished study prepared by Stillmeadow, Inc. 13 p.
Kuhn, J. (2009) Acute Eye Irritation Study in Rabbits (Nivalis): Final Report. Project
Number: 12374/08. Unpublished study prepared by Stillmeadow, Inc. 18 p.
Kuhn, J. (2009) Acute Dermal Irritation Study in Rabbits (Nivalis): Final Report.
Project Number: 12375/08. Unpublished study prepared by Stillmeadow, Inc. 13 p.
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.
Bjornson, H. (2009) Tier II Data Summaries for Nivalis Technical. Unpublished
study prepared by Agrum Advanced Technologies RP Inc. 96 p.
Bjornson, H. (2009) Tier I
study. 54 p.
Data Summaries for Nivalis Technical. Unpublished
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.
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.
Cascino, J. (2009) Supplemental Product Chemistry for Nivalis Technical.
Unpublished study prepared by Sylvan, Inc. 6 p.
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.
Cascino, J. (2010) Supplemental Product Chemistry for Nivalis Technical.
Unpublished study prepared by Agrium Advanced Technologies RP, Inc. 16 p.
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
13-Jul-
2009
19-Nov-
2009
19-Nov-
2009
30-Jun-
2010
30-Jun-
2010
-------
Typhula phacorrhiza Strain 94671
Biopesticides Registration Action Document
Page 17 of 17
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 Disrupter 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 Identi fi cati on Numb er
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
------- |