Document ID: EPA-HQ-OPP-2010-0247-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-01-06T05:00Z

BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Trichoderma asperellum strain T34

Pesticide Chemical (PC) Code: 119209

	U.S. Environmental Protection Agency

	Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

October 14, 2011

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc299966913"  I.  	 EXECUTIVE
SUMMARY	  PAGEREF _Toc299966913 \h  4  

  HYPERLINK \l "_Toc299966914"  II.	 ACTIVE INGREDIENT OVERVIEW	 
PAGEREF _Toc299966914 \h  5  

  HYPERLINK \l "_Toc299966915"  III.	REGULATORY BACKGROUND	  PAGEREF
_Toc299966915 \h  5  

  HYPERLINK \l "_Toc299966916"  A.  Applications for Pesticide
Registration	  PAGEREF _Toc299966916 \h  5  

  HYPERLINK \l "_Toc299966917"  B.  Food Tolerance Exemption	  PAGEREF
_Toc299966917 \h  5  

  HYPERLINK \l "_Toc299966918"  IV.	RISK ASSESSMENT	  PAGEREF
_Toc299966918 \h  5  

  HYPERLINK \l "_Toc299966919"  A.  Product Analysis Assessment (40 CFR
§ 158.2120)	  PAGEREF _Toc299966919 \h  6  

  HYPERLINK \l "_Toc299966920"  B.  Human Health Assessment (40 CFR §
158.2140)	  PAGEREF _Toc299966920 \h  6  

  HYPERLINK \l "_Toc299966921"  C.  Environmental Assessment (40 CFR §
158.2150)	  PAGEREF _Toc299966921 \h  10  

  HYPERLINK \l "_Toc299966922"  V.  ENVIRONMENTAL JUSTICE	  PAGEREF
_Toc299966922 \h  12  

  HYPERLINK \l "_Toc299966923"  VI.	RISK MANAGEMENT DECISION	  PAGEREF
_Toc299966923 \h  13  

  HYPERLINK \l "_Toc299966924"  VII.  ACTIONS REQUIRED BY THE APPLICANT	
 PAGEREF _Toc299966924 \h  13  

  HYPERLINK \l "_Toc299966925"  A.  Final Printed Labeling	  PAGEREF
_Toc299966925 \h  13  

  HYPERLINK \l "_Toc299966926"  B.  Terms of Registration	  PAGEREF
_Toc299966926 \h  13  

  HYPERLINK \l "_Toc299966927"  C.  Reporting of Adverse Effects and
Hypersensitivity Incidents	  PAGEREF _Toc299966927 \h  14  

  HYPERLINK \l "_Toc299966928"  VIII.  GLOSSARY OF ACRONYMS AND
ABBREVIATIONS	  PAGEREF _Toc299966928 \h  15  

  HYPERLINK \l "_Toc299966929"  IX.  BIBLIOGRAPHY	  PAGEREF
_Toc299966929 \h  16  

  HYPERLINK \l "_Toc299966930"  A.  Studies Submitted to Support
Pesticide Product Registrations	  PAGEREF _Toc299966930 \h  16  

  HYPERLINK \l "_Toc299966931"  B.  Environmental Protection Agency Risk
Assessment Memoranda	  PAGEREF _Toc299966931 \h  20  

  HYPERLINK \l "_Toc299966932"  APPENDIX A.  MICROBIAL PESTICIDES DATA
REQUIREMENTS	  PAGEREF _Toc299966932 \h  21  

  HYPERLINK \l "_Toc299966933"  APPENDIX B.  PESTICIDE PRODUCT	  PAGEREF
_Toc299966933 \h  26  

 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs (OPP)

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

John L. Kough, Ph.D.					

Ibrahim S. Barsoum, Ph.D.

Shannon Borges

Zigfridas Vaituzis

Product Characterization and Human Health Assessment			   

Product Characterization and Human Health Assessment			   

Environmental Effects Assessment

Environmental Effects Assessment



Regulations

Sheryl K. Reilly, Ph.D.

Anna Gross	

Matthew Thompson							

Chief, Microbial Pesticides Branch

Regulatory Action Leader

Regulatory Action Leader

Michael Glikes                                                         
  Regulatory Action Leader		

I.	EXECUTIVE SUMMAR

Trichoderma asperellum strain T34 is a naturally occurring fungus that
increases plant defenses against Fusarium oxysporum, a pathogenic,
soil-born fungus of significant economic importance in the United
States. When Trichoderma asperellum strain T34 (“T34”), is
preventatively applied, it protects plants from this disease-causing
organism by initially colonizing the roots and building a physical
barrier against pathogens. T34 induces the synthesis of defense proteins
in the plant, which increases the plants’ resistance to infection by
Fusarium oxysporum. T34 also has the ability to parasitize and kill the
plant pathogen. Biocontrol Technologies, S.L. (“applicant”) has
proposed to register an end-use microbial pesticide product, T34
Biocontrol (EPA File Symbol 87301-R), containing T34 as the active
ingredient. The proposed product is intended for use in greenhouses to
control Fusarium oxysporum on nonfood crops, specifically, carnations. 

Environmental Protection Agency (“EPA” or “Agency”) scientists
have reviewed product analysis, toxicology, and nontarget organism data
(reference 40 Code of Federal Regulations (CFR) §§ 158.2120, 158.2140,
and 158.2150, respectively), and other information submitted by the
applicant to support the registration. The submitted data and
information fulfill the current data requirements and demonstrate that
the proposed greenhouse use of T34 will not generally cause unreasonable
adverse effects on the environment, in accordance with the requirements
for pesticide registration under Section 3(c)(5) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

On October 1, 2009, EPA 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 policy, EPA
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; or any other registration actions for
which EPA believes there may be significant public interest.

  

Consistent with the policy of making registration actions more
transparent, the proposed pesticide products containing T34 as a new
active ingredient were subject to a 30-day comment period. The docket
identification number, associated with these registration actions and
accessed through either  HYPERLINK "http://www.regulations.gov/" \l
"!docketDetail;dct=FR+PR+N+O+SR;rpp=10;po=0;D=EPA-HQ-OPP-2010-0247"
http://www.regulations.gov/  or   HYPERLINK
"http://www.epa.gov/pesticides/regulating/registration-status.html" 
http://www.epa.gov/pesticides/regulating/registration-status.html , is
EPA-HQ-OPP-2010-0247. The following documents were made available for
comment in EPA-HQ-OPP-2010-0058: (1) draft Trichoderma asperellum strain
T34  Biopesticides Registration Action Document (BRAD); (2)
environmental risk assessment for T34; and (3) draft product label for
the end-use product, T-34  Biocontrol (EPA File Symbol 87301-R). While a
final decision on registration is contingent upon review and
consideration of public comments, EPA presently believes that, based
upon the risk assessment and information submitted in support of T-34 
Biocontrol, it is in the best interest of the public and the environment
to issue these registrations. The basis for this decision can be found
in the risk assessment for T34, which is characterized throughout this
BRAD.  

II.	ACTIVE INGREDIENT OVERVIEW

Biological Name:  	Trichoderma asperellum strain T34

Product Name:	T-34 Biocontrol

Culture Deposit:			Spanish Collection of Type Cultures, University of
Valencia in Valencia, Spain under CECT No. 20417.

	OPP Chemical Code: 		119209

	Type of Pesticide:				Microbial Pesticide – Fungicide

See   HYPERLINK  \l "AppendixB"  Appendix B  for specific information
(e.g., use sites, application rates, methods of application, formulation
types, and target pests) regarding the registered pesticide products
containing this active ingredient.

III.	  REGULATORY BACKGROUND

A.  Applications for Pesticide Registration

On December 31, 2009, Wagner Regulatory Associates, Inc. (address: P.O.
Box 640, 7460 Lancaster Pike, Suite #9, Hockessin, DE 19707-0640) on
behalf of Biocontrol Technologies, S.L. (address: 08028 Barcelona,
Spain, C/ Baldiri Reixac, 15-21), submitted applications to register an
end-use product (EP) T34  BIOCONTROL (EPA Reg. No. 87301-R) containing a
new TGAI Trichoderma asperellum strain T34  (“T34”), under section
3(c)(5) of FIFRA. On November 24, 2010, EPA announced receipt of these
applications to register pesticide products containing a new active
ingredient (  HYPERLINK
"http://frwebgate3.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=7xpnyr/0
/2/0&WAISaction=retrieve"  75 Federal Register (FR) 71697 ) and opened a
30-day public comment period pursuant to the provisions of FIFRA section
3(c)(4). No comments were received following this publication. 

B.  	Food Tolerance Exemption

No tolerance or exemption from the requirement of a tolerance is
associated with or required for this regulatory action as only nonfood
uses are currently proposed for T34. Accordingly, this action is outside
the scope of the Food Quality Protection Act (FQPA). There are no CODEX
maximum residue levels established for T34.

 

IV. RISK ASSESSMENT

In the Federal Register of October 26, 2007, EPA issued a Final Rule on
the data requirements to support registration of microbial pesticides
and updated the definition for microbial pesticides (  HYPERLINK
"http://www.gpo.gov/fdsys/pkg/FR-2007-10-26/pdf/E7-20828.pdf"  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 for each data submission are assigned by EPA 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: UPGRADEABLE”). If a study is rated as
“SUPPLEMENTAL: UPGRADEABLE,” EPA 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 40 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
EPA 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.  Product Analysis Assessment (  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=811fcae4d744ab
69cd2eb526e52ded8c&rgn=div8&view=text&node=40:24.0.1.1.9.16.1.3&idno=40"
 40 CFR § 158.2120 )

All product analysis data requirements for T34, have been fulfilled.
Refer to Table 1 in   HYPERLINK  \l "AppendixA"  Appendix A  for a brief
summary of the data requirements, including both generic and
product-specific information. 

B.  Human Health Assessment (  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=4dd09a63ec0371
bebbf53dba75449b8d&rgn=div8&view=text&node=40:24.0.1.1.9.16.1.5&idno=40"
 40 CFR § 158.2140 )

1.  Toxicity

All toxicology data requirements for T34, have been fulfilled.
Acceptable Tier I mammalian toxicology data and information support
registration of the T34 pesticide products. Furthermore, Tier II and
Tier III studies were not required for T34, based on the lack of acute
toxicity/pathogenicity in the Tier I studies.

For a comprehensive summary of the generic toxicology data requirements
described in sections IV(B)(1)(a) and IV(B)(1)(b), as well as additional
product-specific data submitted to support the individual registrations,
refer to Table 3   HYPERLINK  \l "AppendixA"  Appendix A .

a. Acute Toxicity/Pathogenicity – Tier I

Acute Oral Toxicity/Pathogenicity (Office of Chemical Safety and
Pollution Prevention (OCSPP) Guideline 885.3050; Master Record
Identification Number (MRID No.) 48067401 and 48067403):  In an acute
oral toxicity study (MRID 48067401), groups of fasted, 8-12 week old
HsdRccHan:32 WIST rats (3/sex) were given a single oral dose of T34 
(Batch No. 5170708;11.71% T-334, 1.8 x 109/g), at a concentration of 0.1
g in 1.5 mL water per animal (~108 cfu/animal).The animals were observed
up to 21 days with interim sacrifices on Days 3, 7, and 14. Two
untreated males and 2 females were housed together with the treated
animals as shelf controls, and two untreated animals were housed
separately from the test groups as room controls. 

There were no treatment related clinical signs, necropsy findings, or
significant changes in body weight. The clearance of T34 from the feces
was established by day 19, and no viable counts were noted from any
organ of animals sacrificed on day 21. No viable counts were noted in
the organ samples of untreated shelf control animals.

Based on the results of this study, T34 does not appear to be infective
and/or pathogenic in HsdRccHan: 32 WIST rats, when dosed at 1.1 x 108
cfu/animal. Toxicity has been observed in the pancreas and adrenal
glands of treated animals at necropsy. This study satisfies the
requirement for an acute oral toxicity and pathogenicity study, and is
classified as ACCEPTABLE.

Acute Pulmonary Toxicity/Pathogenicity (OCSPP Guideline 885.3150; MRID
No. 47946906 and 48067404):  In an acute pulmonary toxicity and
pathogenicity study (MRID No.47946906), groups of 8-12 week old
HsdRccHan: 44 WIST rats (3 or 5/sex) received intratracheal treatment
with T34 (Batch No. 5170708; 11.71% T-334, 1.8 x 109/g). The animals
were observed for up to 21 days. Five males and five females served as
untreated controls.

Following instillation of 0.2 mL test substance, one male and one female
died immediately and one male and two females died approximately 10
minutes thereafter. Thereafter, the instillation volume was decreased to
0.1mL. One female was found dead 2.5 hours after test material
instillation but all other animals survived to scheduled sacrifice. No
clinical signs were observed in surviving animals. Body weight gain of
the treated animals was slightly lower than that in the control group.
Slight effects on lungs, pancreas, liver, thymus, adrenal glands, and/or
spleen in treated animals were noted at necropsy. No grossly observable
pathological changes were found in control animals. The test material
showed slight toxic effects but did not proliferate in the treated
animals following a single intratracheal instillation. Nevertheless, the
organism could be detected in selected tissue samples, particularly the
lung, until day 21 of the study. 

Based on these results, T34 appears to be slightly toxic but not
infective and/or pathogenic in rats. 

The dose the animals received may be less than that suggested by
guideline requirements. The study report states the test material (1.8 x
109 cfu/g) was diluted 1:10 (~1.8 x 108 cfu/mL) and the animals received
0.1 mL (~1.8 x 107 cfu/animal). This study satisfies the acute pulmonary
toxicity and pathogenicity guideline requirement and is classified as
ACCEPTABLE. 

Acute Injection Toxicity/Pathogenicity (Intravenous) – Rat (OCSPP
Guideline 885.3200; MRID No. 47946903 and 48067406): In an acute
intravenous injection toxicity and pathogenicity study (MRID No.
47946903), three male and three female young adult 8-12 week old
HsdRccHan:10 WIST rats were injected IP with T34 (Batch No.
5170708;11.71% T-334, 1.8 x 109/g), at a dose of 0.1 g/animal, at a dose
volume of a 1 mL suspension. The test material was suspended in water
prior to use. Two males and two females not treated served as controls.
Surviving animals were observed for up to 21 days.

All treated animals died or were euthanized within 19-52 hours of test
material injection. Before death, the animals had reduced spontaneous
activity, apathy, sunken flanks and ruffled fur. All control animals
survived, gained weight, and had no clinical symptoms during the study.
All decedents had an accumulation of fluid in the peritoneum and
stomach, brightened fringes of the liver, and slightly reddish and
swollen pancreas. The control animals had no gross pathological changes
at necropsy. 

The test for enumeration of the test organisms in tissues and feces of
treated animals were validated in MRID 48067406.

Based on the results of this study, T34 showed toxic characteristics in
rats following a single intrapertioneal injection administration of 0.1
g/animal; however, infectivity and pathogenicity were not addressed.
Oral and pulmonary studies have shown that the test organism does appear
infective or to be a pathogen. 

The Agency requested further testing of the spores vs. the filtrate to
elucidate the mortality and pancreatic toxicity observed in the acute
toxicity/pathogenicity studies. Specifically, further testing will
determine if the presence of the toxins is the cause of the observed
mortality and pancreatic toxicity in the treated animals. 

The applicant responded to the Agency request noting: The high mortality
observed in the rats from the study “Acute Injection
Toxicity/Pathogenicity with Biocontrol Technologies, S.L., T34” (dosed
at 1 x 108 cfu/rat) was not due to the production of toxins by T34, but
rather to the high concentration of spores injected intrapertioneally to
the rats. This conclusion is based on:

New GLP studies conducted to find the test dose that causes moderate but
non-lethal symptoms in rats, and a new acute toxicity/pathogenicity
study with T34 (MRID 48348306, 48348307).

No toxins have been detected in T34 compared with other Trichoderma
species that do produce toxins (MRID 48377002).

Hypersensitivity Incidents (OCSPP Guideline 885.3400; MRID No.
47945023): No hypersensitivity incidents, including immediate-type or
delayed-type reactions of humans and domestic animals that occurred
during research, development, or testing of T34, were reported by the
applicant. Any future hypersensitivity incidents must be reported per
OCSPP Guideline 885.3400.

Cell Culture (OCSPP Guideline 885.3500): This study is not required
because T34 is not a virus (refer to test note #4 of 40 CFR §
158.2140(d)).

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;

   Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

   Infectivity/Pathogenicity Analysis – Tier III

Tier II and Tier III studies were not required for T34, based on the
lack of acute toxicity/pathogenicity in the Tier I studies. 

	c. Endocrine Disruptors

 tc \l4 "e.	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
quantitative 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 9 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.

T34 is not among the group of 58 pesticide active ingredients on the
initial list to be screened under the EDSP. Under FFDCA section 408(p),
EPA must screen all pesticide chemicals. Accordingly, EPA anticipates
issuing future EDSP 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:   HYPERLINK
"http://www.epa.gov/endo/"  http://www.epa.gov/endo/ .

2.  Food Quality Protection Act (FQPA) Considerations

Although no tolerance or exemption from the requirement of a tolerance
is associated with or required for this regulatory action as only
nonfood uses are currently proposed for T34, the applicant submitted
waiver requests for Residue Chemistry Guidelines OCSPP 885.2100,
885.2200, 885.2250, 885.2500, 885.2550, and 885.2600.

The following points were made to support the waivers for Residue
Chemistry requirements: (1) the proposed use pattern for T34 Biocontrol
EP is limited to closed greenhouse systems on nonfood crops,
specifically, carnations; (2) T34 occurs naturally in soil. It can grow
only in soil, under specific conditions (high soil organic matter
content, humidity, and temperatures <35OC); (3) the T34 mode of action
is to protect roots by inducing the plant’s own enzyme production to
stimulate growth and biological control of plant disease; (4) T34 does
not produce any known toxins. No T2 toxin (trichodermin; harzianum A)
was found in a sample of 0.25 g of the EP that was sonicated, extracted
with ethyl acetate, and the supernatant evaluated by mass spectroscopy,
and (5) T34 is not hazardous to humans, based on acute oral, pulmonary,
and intravenous toxicity studies conducted in rats. Rats treated with
5.5 x 105 to 108 units/animal had color changes in unspecified organs,
but these effects were not sufficient to classify T34 as toxic. It was
determined that the provided rationale was adequate to justify a waiver
for the requested Residue Chemistry Guidelines.  

3.  Occupational Exposure and Risk Characterization

Handler exposure to T34 is not expected to pose any undue risk.
Regardless, appropriate personal protective equipment and precautionary
statements are required on pesticide product labels to mitigate any
potential risks to pesticide handlers due to prolonged or numerous
exposures. Handlers applying T34 end-use products in commercial and
agricultural settings must wear a long-sleeved shirt, long pants, and
shoes plus socks. Additional PPE, other than the standard described
above, may be required on a product-specific basis.

4.  Human Health Risk Characterization

The Agency considered human exposure to T34 in light of the standard for
registration in FIFRA and the relevant safety factors in FFDCA. A
determination has been made that T34 has no known potential to cause
adverse human health effects or to produce a mammalian toxin, and that
residues are not likely to be present in or on food when used in
accordance with EPA-approved labeling.

C.  Environmental Assessment (  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=4c71452205fbe0
fb6f950520c5476135&rgn=div8&view=text&node=40:24.0.1.1.9.16.1.6&idno=40"
 40 CFR § 158.2150 )

The data and data waiver rationale, submitted by the applicant to
support the pesticide products containing T34, are sufficient to fulfill
the Tier I nontarget organism data requirements and for risk assessment
purposes. Further testing of nontarget organisms at higher tier levels
(i.e., Tiers II, III, and IV) is not required for the current uses and
application methods. EPA has performed an environmental risk assessment
based on the data and data waiver rationale provided by the applicant
and has determined that the proposed use of T34 does not pose
significant risk to nontarget organisms when used according to label
directions. 

For a comprehensive summary of the generic data requirements described
in sections IV(C)(1), refer to Table 4 in   HYPERLINK  \l "AppendixA" 
Appendix A .

1.  Ecological Exposure and Risk Characterization  

		a. Terrestrial Animals and Plants

The proposed registration limits use to indoor environments within
greenhouses and the proposed maximum application use rates result in
concentrations that are not above measured concentrations of Trichoderma
spp. naturally occurring in soil. Therefore, exposure in the terrestrial
environment is expected to be negligible, if it occurs at all. 

The applicant submitted data waiver rationales to fulfill the
requirement of acute oral and avian inhalation toxicity/pathogenicity
studies. Data from an optimum growth temperature study was also
submitted, and showed that T34 does not grow at normal avian body
temperatures. Based on this information, exposure of birds to T34 is not
expected to result in adverse effects on birds and risk to birds
resulting from the proposed use of T34 is not anticipated.

Acute oral toxicity/pathogenicity testing indicated no significant
adverse effects to laboratory rats dosed at 1.1 x 108 cfu/animal after
21 days (MRID 48067401). There is no reason that tests on laboratory
mammals are not representative of the potential hazard to wild mammals
in this case; therefore, based on this information, adverse effects on
wild mammals are not expected from exposure to T34. Since the proposed
use is also expected to minimize exposure, risk to wild mammals
resulting from the proposed registration of T34 is not anticipated.

The applicant submitted information on the toxicity/pathogenicity data
for several insect species exposed to Trichoderma harzianum (the former
classification of some strains of Trichoderma asperellum) and
Trichoderma gamsii. While these data cannot be used directly to
determine the potential hazard of this particular strain of Trichoderma
asperellum, they do provide some evidence of the lack of effects of
Trichoderma spp. on insects. The Agency had previously expressed concern
over the potential hazard of Trichoderma harzianum, strain T39 (USEPA
2000), and several papers have shown adverse effects of this related
fungus on nontarget insects, particularly coleopteran species (Cardoza
et al., 2006; Jassim et al., 1990; Shakeri and Foster 2006). Nontarget
insect testing has not been performed for T34 because nontarget
insects’ exposure to this strain is not expected. Future expansion of
the uses of T34 may require nontarget insect toxicity/pathogenicity
testing.

As with other nontarget insects, the Agency had previously expressed
concerns for potential effects on honey bees for a related Trichoderma
spp., Trichoderma harzianum strain T39 (USEPA 2000); however, data were
subsequently submitted to show that adverse effects are not expected
from exposure to that strain. Trichoderma spp. are widely understood to
present no potential adverse effects to honey bees, which is supported
by data submitted by the applicant showing lack of effects of honey bees
and bumble bees (Bombus terrestris) following exposure to several
Trichoderma spp. Therefore, BPPD concluded that T34 will not pose risk
to honey bees as a result of the proposed labeled uses.

Studies on the toxicity/pathogenicity of T34 to terrestrial plants were
not required because Trichoderma asperellum, and other Trichoderma spp.,
are not taxonomically related to any known plant pathogens. Therefore,
adverse effects to plants are not expected as a result of the proposed
uses of T34.

		b. Aquatic Animals and Plants

The applicant presented extensive rationale to show that exposure of T34
in aquatic environments would be negligible, if it occurred at all, and
would have no effects on fish or aquatic invertebrates if this
biopesticide were to reach surface waters. Data from a study was
submitted to show that at four months after the last application of T34
to potted plants, leachate from the pots contains 102 cfu/mL of T34,
which is less than the amount of Trichoderma spp. found naturally in
soil. Therefore, spillage onto greenhouse soil and outdoor disposal of
treated potting material would not increase the amount of Trichoderma
spp. normally found in soil or in runoff. Incidents such as these are
expected to have negligible contribution to exposure. The applicant
presented additional data from public literature to show that if T34
were to reach surface waters, it would be unable to proliferate and
would be unlikely to survive. Based on the information provided,
exposure to aquatic environments is expected to be negligible and
adverse effects in these environments are not expected. Therefore, BPPD
concludes that the proposed use of T34 will not result in risk of
adverse effects to fish and aquatic invertebrates in freshwater and
marine environments. 

Studies on the toxicity/pathogenicity of T34 to aquatic plants were not
required because Trichoderma asperellum and other Trichoderma spp. are
not taxonomically related to any known plant pathogens and exposure in
these environments is not expected. Therefore, adverse effects to
aquatic plants are not expected as a result of the proposed uses of T34.

		c. Open Literature Information

Literature searches were performed to determine if other effects have
been reported that were not contained within the information provided by
the applicant. Both the Science Citation Index Expanded database
(1970-present) and the Environmental Information Search service
(1964-present) were searched using the terms “Trichoderma
asperellum,” “Trichoderma asperellum strain T34,” and
“asperellum strain T34.”  The Environmental Information Search
service includes the Agricola; Biosis Previews; CAB Abstracts; Energy,
Science, and Technology; General Science Abstracts; National Technical
Information Service; and Waternet databases. None of the records found
in any of the searches described here reported effects on any non-target
species. 

2.  Environmental Fate Data 

The information provided, for the current uses and application methods
is sufficient to satisfy the Tier I nontarget organism data
requirements, and for conducting a nontarget organism risk assessment
for T34, further testing at higher tier levels (i.e., Tiers II, III, and
IV) is not required.  

3.  Threatened and Endangered Species Assessment

Since EPA has determined that no effects are anticipated for any
nontarget species exposed to T34 as a result of the proposed labeled
applications, effects to threatened and endangered species and their
designated critical habitats also are not expected. Therefore, a “No
Effect” determination was made for direct and indirect effects to
listed species and their designated critical habitats resulting from the
registered uses of T34.

V.  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—with respect to the development, implementation, and
enforcement of environmental laws, regulations, and policies. Fair
treatment means that no group of people, including racial, ethnic, or
socioeconomic groups, should bear a disproportionate share of the
negative environmental consequences resulting from industrial,
municipal, and commercial operations or the execution of federal, state,
local, and tribal environmental programs and policies. Meaningful
involvement means that (1) potentially affected community residents have
an appropriate opportunity to participate in decisions about a proposed
activity that will affect their environment and/or health; (2) the
public’s contribution can influence the regulatory agency’s
decision; (3) the concerns of all participants involved will be
considered in the decision-making process; and (4) the decision-makers
seek out and facilitate the involvement of those potentially affected.
EPA has this goal for all communities and persons across the United
States. 

To help address potential environmental justice issues, EPA seeks
information on any groups or segments of the population who, as a result
their location, cultural practices, or other factors, may have atypical,
unusually high exposure to T34 compared to the general population.
During the comment period, the Agency solicited comments from the public
on any subpopulations that may have atypical, unusually high exposure
compared to the general population.

For additional information regarding environmental justice issues,
please visit EPA’s web site at   HYPERLINK
"http://www.epa.gov/compliance/environmentaljustice/index.html" 
http://www.epa.gov/compliance/environmentaljustice/index.html .

VI.	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 were satisfied by the science assessments supporting
products containing T34. 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, we have
concluded that T34 is eligible for registration for the labeled uses. 

VII. ACTIONS REQUIRED BY THE APPLICANT

A.  Final Printed Labeling

Before releasing pesticide products containing T34 for shipment, the
applicant will be required to provide appropriate final printed labeling
to EPA.

B. Terms of Registration

We propose the following as terms for the T34 Biocontrol registration:
the applicant must submit the following data upon completion:

Acute Injection Toxicity/Pathogenicity – Rat (OCSPP Guideline
885.3200): Due to the results of a previous IP toxicity study and the
high potential of toxicity of the product, a new toxicity/pathogenicity
study, using a lower concentration of the TGAI, was performed and has
been accepted by the Agency. Another IP injection study addressing
concern relating to culture filtrates and killed cultures is in process
and will be submitted to the UK and the EU. US EPA also expects to
receive this study upon completion.

C.  Reporting of Adverse Effects and Hypersensitivity Incidents

Notwithstanding the information stated in the previous sections, it
should be clearly understood that certain, specific data are required to
be reported to EPA as a requirement for maintaining the federal
registration for a pesticide product. A brief summary of these types of
data are described below.

Reports of all incidents of adverse effects to the environment must be
submitted to EPA under the provisions stated in FIFRA section 6(a)(2).
Additionally, all incidents of hypersensitivity (including both
suspected and confirmed incidents) must be reported to EPA under the
provisions of 40 CFR § 158.2140(d).

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD	Biopesticides and Pollution Prevention Division

BRAD	Biopesticides Registration Action Document

CFR	Code of Federal Regulations

cfu	Colony-forming unit(s)

cfu/kg	Colony-forming units per kilogram

cfu/mL	Colony-forming units per milliliter

cP	Centipoise

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

g/mL	Gram per milliliter

LC50	Median lethal concentration. A statistically derived concentration
of a substance that can be expected to cause death in 50% of test
animals. It is usually expressed as the weight of substance per weight
or volume of water, air, or feed (e.g., mg/L, mg/kg, or ppm).

LD50	Median lethal dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered by
the route indicated (oral, dermal, or inhalation). It is expressed as a
weight of 	substance per unit weight of animal (e.g., mg/kg).

mg/kg	Milligrams per kilogram

mg/L	Milligrams per liter

MP	Manufacturing-use product

MPCA	Microbial Pesticide Control Agent

MPCP	Microbial Pesticide Control Product

MRID No.	Master Record Identification Number

NIOSH	National Institute for Occupational Safety and Health

NRRL	Northern Regional Research Laboratory

OCSPP	Office of Chemical Safety and Pollution Prevention (formerly
OPPTS).

OPP	Office of Pesticide Programs

PC Code	Pesticide Chemical Code

PP	Pesticide Petition

PPE	Personal protective equipment

ppm	Parts per million

TGAI	Technical grade of the active ingredient

IX. BIBLIOGRAPHY

A.  Studies Submitted to Support the T34 Pesticide Product Registrations

47946901	Schropp P. 2007. Acute Dermal Irritation/Corrosion. Project No.
070961. Unpublished study prepared by Biocontrol Technologies, S.L., 22
pages.

47946902	Schropp P. 2007. Acute Oral Toxicity Acute Toxic Class Method.
Project No. 070963. Unpublished study prepared by Biocontrol
Technologies, S.L., 21 pages.

47946903	Schropp P. 2007. Acute Injection Toxicity/Pathogenicity.
Project No. 070966. Unpublished study prepared by Biocontrol
Technologies, S.L., 23 pages.

47946904	Schropp P. 2007. Test for Sensitization (Guinea Pig
Maximasation Test). Project No. 070965. Unpublished study prepared by
Biocontrol Technologies, S.L., 33 pages.

47946905	Schropp P. 2007. Acute Eye Irritation/Corrosion. Project No.
070962. Unpublished study prepared by Biocontrol Technologies, S.L., 26
pages.

47946906	Schropp P. 2007. Acute Pulmonary Toxicity/Pathogenicity.
Project No. 070969. Unpublished study prepared by Biocontrol
Technologies, S.L., 27 pages.

47946907	Schropp P. 2007. Acute Dermal Toxicity. Project No. 070964.
Unpublished study prepared by Biocontrol Technologies, S.L., 21 pages.

47946907	Schropp P. 2007. Acute Oral Toxicity/Pathogenicity. Project No.
070967. Unpublished study prepared by Biocontrol Technologies, S.L., 42
pages.

47946908	Lowe, C. 2007. Acute Inhalation Toxicity Study in Rats- Limit
Test. Unpublished study prepared by Biocontrol Technologies, S.L., 20
pages.

47946909	Biocontrol Technologies, S.L. 2009. Microbial Pesticides
Residue Data Requirements: Rationale and Request for Waivers of Certain
Data. Unpublished study prepared by Biocontrol Technologies, S.L., 10
pages.

47946911	Byrd, C. 2009. Product Chemistry Data Waivers. Unpublished
study prepared by Biocontrol Technologies, S.L., 4 pages.

47946912	Trillas, Dr. I. 2009. Molecular Classification. Unpublished
study prepared by Biocontrol Technologies, S.L., 9 pages.

47946913	Trillas, Dr. I. 2007. Morphological Classification of the
Biological Control Agent. Unpublished study prepared by Biocontrol
Technologies, S.L., 28 pages.

47946914	Trillas, Dr. I. 2008. Specific Detection. Unpublished study
prepared by Biocontrol Technologies, S.L., 25 pages.

47946915	Trillas, Dr. I. 2008. Specific PCR Fingerprinting. Unpublished
study prepared by Biocontrol Technologies, S.L., 17 pages.

47946916	Biocontrol Technologies, S.L. 2008. Identity. Unpublished study
prepared by Biocontrol Technologies, S.L., 28 pages.

47946917	Samuels, Dr. G, Segarra G. 2007. Document on the Classification
of Trichoderma asperellum. Unpublished study prepared by Biocontrol
Technologies, S.L., 8 pages.

47946918	Fytovita S. 2008. Manufacturing Process. Unpublished study
prepared by Biocontrol Technologies, S.L., 35 pages.

47946919	Biocontrol Technologies, S.L. 2008. Protocol to Monitor the
Levels of Contaminating Microorganisms in the Formulated Microbial Pest
Control Product. Unpublished study prepared by Biocontrol Technologies,
S.L., 4 pages.

47946920	Fytovita S. 2008. Method to Control Impurities, Study of
Contaminants in Broth, Study of Contaminants in Formulated Product,
Quality Control of Formulated Product. Unpublished study prepared by
Biocontrol Technologies, S.L., 16 pages.

47946921	Trillas, Dr. I. 2007. Identification of Contaminant
Microorganisms in the Active Substance and the Formulated Microbial Pest
Control Product. Unpublished study prepared by Biocontrol Technologies,
S.L., 6 pages.

47946923	Guerrero, M. 2007. Determination of the Active Components of
Different Batches of the Microbial Pest Control Agent. Unpublished study
prepared by Biocontrol Technologies, S.L., 5 pages.

47946924	Trillas, Dr. I. 2008. Storage Stability and Shelf Life of the
MPCP at 36oC, 37oC, 38oC, 39oC, 40oC, 45oC, and 50oC. Unpublished study
prepared by Biocontrol Technologies, S.L., 15 pages.

47946925	Trillas, Dr. I. 2008. Study of Storage Stability and Shelf Life
of MPCA from Different Batches at 4oC and 25oC. Unpublished study
prepared by Biocontrol Technologies, S.L., 16 pages.

47946926	Trillas, Dr. I. 2008. Study of Storage Stability and Shelf Life
of MPCP from Different Batches at 4oC and 25oC. Unpublished study
prepared by Biocontrol Technologies, S.L., 19 pages.

47946927	Cassals, Dr. I. 2007. Study of pH. Unpublished study prepared
by Biocontrol Technologies, S.L., 12 pages.

47964922	Guerrero, M. 2007. Determination of the Active Components of
Different Batches of the Microbial Pest Control Product. Unpublished
study prepared by Biocontrol Technologies, S.L., 6 pages.

48067402	Hoppner, Dr. C. 2007. Determination of the microbial count of a
powdery formulation of conidia. Project No. 071324. Unpublished study
prepared by Biocontrol Technologies, S.L., 35 pages. 

48067403	Hoppner, Dr. C. 2007. Determination of the microbial count.
Project No. 071405. Unpublished study prepared by Biocontrol
Technologies, S.L., 44 pages. 

48067404	Hoppner, Dr. C. 2007. Determination of the microbial count.
Project No. 071406. Unpublished study prepared by Biocontrol
Technologies, S.L., 39 pages. 

48067405	Hoppner, Dr. C. 2007. Determination of the microbial count of a
powdery formulation of conidia. Project No. 071325. Unpublished study
prepared by Biocontrol Technologies, S.L., 35 pages. 

48067406	Hoppner, Dr. C. 2007. Validation of the determination of the
microbial count in tissue- and feces samples. Project No. 071327.
Unpublished study prepared by Biocontrol Technologies, S.L., 37 pages. 

48348303	Biocontrol Technologies, S.L. 2011. Discussion of Formation of
Unintentional Ingredients, Microbiological Analysis Results. Unpublished
study prepared by Biocontrol Technologies, S.L., 5 pages.

48348304	Trillas, Dr. I. 2011. Study of Storage Stability and Shelf Life
of MPCP from Different Batches at 4oC and 25oC. Unpublished study
prepared by Biocontrol Technologies, S.L., 24 pages.

48348305	Trillas, Dr. I. 2011. Study of the Tap Density. Unpublished
study prepared by Biocontrol Technologies, S.L., 7 pages.

48348306	Allingham, Dr. P. 2010. Intrapertioneal Dose Range Finding
Study in Rats. Study No. 101684. Unpublished study prepared by
Biocontrol Technologies, S.L., 22 pages.

48348307	Allingham, Dr. P. 2010. Acute Injection Toxicity/Pathogenicity
Study. Unpublished study prepared by Biocontrol Technologies, S.L., 112
pages.

48377001	Biocontrol Technologies, S.L. 2011. Response to the US EPA
Deficiency Letter of 17th December 2010. Unpublished study prepared by
Biocontrol Technologies, S.L., 17 pages.

48377002	Biocontrol Technologies, S.L. 2011. Production of Trichotecene.
Unpublished study prepared by Biocontrol Technologies, S.L., 39 pages.

B.  Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2010a. Environmental Risk Assessment for a FIFRA Section 3
Registration for T34 for Control of Fungal Root Disease in Ornamental
and Carnation Plants in Greenhouse [EPA File No. 87301-R]; Decision #
425700, DP Barcode # 373656, Submission # 865549, Memorandum from S.
Borges and Z. Vaituzis to A. Gross, dated September 22, 2010.

U.S. EPA. 2010b. Review of Product Chemistry, Manufacturing Process,
Acute Toxicity Studies, and Waiver Requests for Residue Chemistry
Studies, for Section 3 registration of a New End Use Product, T34
BIOCONTROL (EPA Reg. No. 87301-R) containing a new TGAI Trichoderma
asperellum, strain T34, Memorandum from I. Barsoum and J. Kough to A.
Gross, dated November 23, 2010

U.S. EPA. 2011. Review of the Applicant’s Response to the Deficiencies
Found by the Agency in its Review of Product Chemistry, Manufacturing
Process, and Acute Toxicity Studies of the Product T-34 Biocontrol
containing the AI T34(EPA Reg. No. 87301-R), Memorandum from I. Barsoum
and J. Kough to A. Gross, dated June 16, 2011. 

APPENDIX A.  MICROBIAL PESTICIDES DATA REQUIREMENTS

(40 CFR PART 158 – SUBPART V)

TABLE 1.  Product Analysis Data Requirements for the Technical Grade of
the Active Ingredient (TGAI) T34 & End-Use Product (EP) T34 Biocontrol,
(EPA Reg. No. 87301-R) (40 CFR § 158.2120)

OCSPP Guideline Number 	Data Requirement	Results	MRID No.

TGAI/MPCA	EP/MPCP

	885.1100

	Product Identity	Not applicable.	Submitted data fulfill the requirement
for product identity.  T34 Biocontrol contains 12.00% active ingredient
T34, 88.00% other ingredients.   	479461127

885.1200

	Manufacturing Process	Submitted data fulfill the requirement for
manufacturing process.	479461127

Not applicable	Deposition of a Sample in a Nationally Recognized Culture
Collection	T34 is deposited in the Spanish Collection of Type Cultures,
University of Valencia in Valencia Spain (CECT No. 20417).	Not
applicable.	47946917

885.1300	Discussion of Formation of Unintentional Ingredients	Submitted
data fulfill the requirement for discussion of formation of
unintentional ingredients.	479461127

885.1400	Analysis of Samples	Submitted data fulfill the requirement for
analysis of samples.	479461127

885.1500	Certification of Limits	Not applicable.	Limits listed on the
confidential statement of formula are acceptable.	479461127

Additional Studies

830.1800	Enforcement Analytical Method	Not applicable.	Submitted data
fulfill the requirement for an enforcement analytical method.	479461127

TABLE 2.  Physical and Chemical Characteristics for the Technical Grade
of the Active Ingredient (TGAI) T34 & End-Use Product (EP) T34
Biocontrol, (EPA Reg. No. 87301-R) (40 CFR § 158.2120)

OCSPP Guideline Number 	Data Requirement	Results	

MRID No.

TGAI/MPCA	EP/MPCP

	830.6302

	Color	Colorless (transparent or translucent), green or brown.	Not
applicable.

	47946913

830.6303	Physical State	Solid (Colony)	Not applicable.	47946913

830.6304	Odor	Decaying wood or forest-like.	Not applicable.	47946913

830.6313	Stability to Normal and Elevated

Temperatures, Metals,

and Metal Ions	Viability was maintained for 14 days at 36-40OC, but
viability decreased at 45OC after 5 days, and all colonies died after 3
days at 50OC.  Stability to metals is not relevant as the product will
not be packaged in metal containers (waiver requested).	Not applicable.
47946911

47946924

47946925

47946926

830.6317	Storage Stability	Stable at 4OC for 2 years and at 25OC for <5
months.	47946925-26

483483-04

830.6319	Miscibility	Not applicable.	Not required because T34 Biocontrol
is not an emulsifiable liquid to be mixed with petroleum solvents (refer
to test note #10 of 40 CFR § 158.2120(d)).	Not applicable

830.6320	Corrosion  Characteristics	Not applicable.	Data Waiver Request;
EP has no oxidizing properties, inters are noncorrosive, and packaging
not exposed to metal, metal ions or humidity.	Not applicable

830.7000	pH	5.95 (1% suspension of TGAI in water)	Not applicable.
47946927

47946916

CSF

830.7100	Viscosity	Not applicable.	Data not required, the material is a
powder.	47946911

830.7300	Density/Relative Density/Bulk Density (Specific Gravity)
200-600kg/m3 at 20OC per the MSDS

CSF lists 200 kg/m3 at 20OC	Not applicable.	47946911

47946918

CSF

TABLE 3.  Toxicology Data Requirements for the Technical Grade of the
Active Ingredient (TGAI) T34 & End-Use Product (EP) T34 Biocontrol, (EPA
Reg. No. 87301-R) (40 CFR § 158.2140)

OCSPP Guideline Number	Data Requirement	Results	MRID No.

TGAI/MPCA	EP/MPCP

	Tier I

885.3050	Acute Oral Toxicity/Pathogenicity	T34 does not appear to be
toxic, infective, and/or pathogenic to rats when dosed at 1.1 x 108
cfu/animal

Classification: Acceptable	Not applicable	48067401

48067403

885.3150	Acute Pulmonary Toxicity/Pathogenicity	T34 appears to be
slightly toxic but not infective and/or pathogenic in rats when dosed at
1.1 x 108 cfu/animal Classification: Acceptable	Not applicable	47946906

48067404

885.3200	Acute Injection Toxicity/Pathogenicity (Intravenous)	T34 is
associated with mild to moderate signs of toxicity but no mortality when
dosed with 4.2 x 107 cfu/animal

Classification: Acceptable 	Not applicable	47946903

48067406

483483-07

885.3400	Hypersensitivity 

Incidents	No hypersensitivity incidents, including immediate-type or
delayed-type reactions of humans and domestic animals that occurred
during research, development, or testing of the TGAI/MP, were reported
by the applicant. Any future hypersensitivity incidents must be reported
per OCSPP Guideline 885.3400. 

	885.3500	Cell Culture	Not required because T34 is not a virus (refer to
test note #4 of 40 CFR § 158.2140(d)).	Not applicable	Not applicable 

870.1100	Acute Oral Toxicity	Not applicable	Oral LD50 female rats >
2,000 mg/kg bw.

Classification: Acceptable

TOXICITY CATEGORY III	47946902

870.1200	Acute Dermal Toxicity	Not applicable	Dermal LD50 combined (male
and female) rabbits > 2,000 mg/kg bw.

Classification: Acceptable

TOXICITY CATEGORY III	47946907

870.1300	Acute Inhalation Toxicity	Not applicable	Inhalation LC50
combined (male and female) rats > 2.03 mg/L.

Classification: Acceptable

TOXICITY CATEGORY IV	47946908

870.2400	Acute Eye Irritation	Not applicable	T34 was mildly irritating
to the eyes of rabbits.

Classification: Acceptable

TOXICITY CATEGORY III	47946905

870.2500	Primary Dermal Irritation	Not applicable	T34 was not to the
skin of rabbits.

Classification: Acceptable

TOXICITY CATEGORY IV 	47946901

Tiers II and III

Not required for T34, based on the lack of acute toxicity/pathogenicity
in the Tier I studies.

Additional Studies

870.2600

	Skin Sensitization

	T34 was a dermal sensitizer to guinea pigs.  Classification: Acceptable
	47946904

Not applicable	Production of Toxins	If any trichodermin is produced by
T34, the amounts are smaller compared to known producer strains and no
toxicity is expected.

Classification: Supplemental – Not a required study	48377002



TABLE 4.  Nontarget Organism Toxicity and Environmental Fate Data
Requirements for the Technical Grade of the Active Ingredient (TGAI) T34
& End-Use Product (EP) T34 Biocontrol, (EPA Reg. No. 87301-R) (40 CFR §
158.2150)

OCSPP Guideline Number	Data Requirement	Results	MRID No.

Tier I

885.4050

885.4200

885.4240

885.4280

885.4340

885.4380	Avian Oral toxicity/pathogenicity

Freshwater fish toxicity/pathogenicity

Freshwater invertebrate toxicity/pathogenicity

Estuarine/marine fish and invertebrate testing

Nontarget insect testing

Honey bee testing	Data waiver rationale provides sufficient information
to determine that toxicity/pathogenicity to avian wildlife, wild
mammals, freshwater and marine/estuarine fish and invertebrates,
nontarget insects and honey bees is not expected as a result of the
proposed label. Classification: Acceptable		47068102

885.4150	Wild Mammal Toxicity/Pathogenicity	Studies required by 40 CFR
§ 158.2140 are adequate and appropriate for assessment of hazards to
wild mammals. Acute oral toxicity/pathogenicity testing indicated no
significant adverse effects to laboratory rats dosed at 1.1 x 108
cfu/animal after 21 days. Classification: Acceptable for wild mammal
risk assessment	47945023

885.4100

885.4300	Avian Inhalation Toxicity/Pathogenicity

Nontarget plant testing	Not required- active ingredient is not related
to known avian or plant pathogens.	N/A

Tiers II, III, and IV

Not required for T34, based on the current uses and application methods.

APPENDIX B.  PESTICIDE PRODUCT

EPA File Symbol 	Registration Name	Percentage Active Ingredient
Formulation Type	Use Site(s)	Method(s) of Application	Application Rate
Target Pest

87301-R	T34 Biocontrol	12.00%	End Use- Powder	Greenhouse Carnations
Standard ground spray, root soak, or irrigation	Maximum of 10g/L
Fusarium oxysporum

Trichoderma asperellum, strain T34	Page   PAGE  26  of   NUMPAGES  26 

Biopesticides Registration Action Document

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