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:<IP_ADDRESS>.<IP_ADDRESS>&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:<IP_ADDRESS>.<IP_ADDRESS>&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:<IP_ADDRESS>.<IP_ADDRESS>&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

 PAGE


[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Proposed Rules]
[Pages 38332-38334]
[FR Doc No: 2011-16479]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0649; Directorate Identifier 2011-NM-076-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model MD-11 and MD-
11F Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD would require replacing the rub
strips of the tail fuel tank access door with new rub strips. This
proposed AD was prompted by a report that the rub strips of the tail
fuel tank access door were manufactured improperly. We are proposing
this AD to prevent inadequate electrical bonding between the rub strips
and the fuel access door, which can contribute to possible ignition of
flammable fuel vapor in the tail fuel tank as a result of a lightning
strike.

DATES: We must receive comments on this proposed AD by August 15, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Philip Kush, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-0649;
Directorate Identifier 2011-NM-076-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We received a report that the rub strips of the tail fuel tank
access door were manufactured improperly. These rub strips were
inadvertently anodized (electrically non-conductive) instead of
alodined (electrically conductive) as prescribed in design drawings.
Anodization of the rub strips may prevent adequate electrical bonding
between the rub strips and the doors. Inadequate electrical bonding can
contribute to possible ignition of flammable fuel vapor in the tail
fuel tank as a result of a lightning strike.

Relevant Service Information

    We reviewed Boeing Special Attention Service Bulletin MD11-55-027,
dated March 17, 2011. The service information describes procedures for
replacing the rub strips of the tail fuel tank access door with new rub
strips. Replacing anodized rub strips with alodined rub strips will
provide adequate electrical bonding between the rub strips and the fuel
access doors.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    We estimate that this proposed AD affects 120 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                        Labor cost            Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Replace rub strips................  32 work-hours x $85 per                $0           $2,720         $326,400
                                     hour = $2,720.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

The Boeing Company: Docket No. FAA-2011-0649; Directorate Identifier
2011-NM-076-AD.

Comments Due Date

    (a) We must receive comments by August 15, 2011.

Affected ADs

    (b) None.

Applicability

    (c) The Boeing Company Model MD-11 and MD-11F airplanes,
certificated in any category, as identified in Boeing Special
Attention Service Bulletin MD11-55-027, dated March 17, 2011.

Subject

    (d) Joint Aircraft System Component (JASC)/Air Transport
Association (ATA) of America Code 5510: Tail Fuel Tank Access Door.

Unsafe Condition

    (e) This AD was prompted by a report that the rub strips of the
tail fuel tank access door were manufactured improperly. We are
issuing this AD to prevent inadequate electrical bonding between the
rub strips and the fuel access door, which can contribute to
possible ignition of flammable fuel vapor in the tail fuel tank as a
result of a lightning strike.

Compliance

    (f) Comply with this AD within the compliance times specified,
unless already done.

Installation

    (g) Within 60 months after the effective date of this AD,
replace the rub strips of the tail fuel tank access door with new
rub strips, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin MD11-55-027, dated March
17, 2011.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), Transport Airplane Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO, send it to the attention of the person
identified in the Related Information section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

Related Information

    (i) For more information about this AD, contact Philip Kush,
Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles
ACO, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    (j) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington 98057. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 22, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-16479 Filed 6-29-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Page 28649]
[FR Doc No: 2020-10199]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4530-DR; Docket ID FEMA-2020-0001]

Oklahoma; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4530-DR), dated April 5, 2020, and
related determinations.

DATES: This amendment was issued May 4, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include Individual
Assistance limited to the Crisis Counseling Program for those areas
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of April 5, 2020.

    Individual Assistance limited to the Crisis Counseling Program
for all areas in the State of Oklahoma (already designated for
emergency protective measures [Category B] not authorized under
other Federal statutes, including direct Federal assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-10199 Filed 5-12-20; 8:45 am]
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[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51164-51166]
[DOCID:fr18au10-187]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2010-0108, Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
1990-1996 ALPINA Burkard Bovensiepen GmbH B12 2-Door Coupe Model
Passenger Cars Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition for decision that nonconforming
1990-1996 ALPINA Burkard Bovensiepen GmbH (ALPINA) B12 2-door coupe
model passenger cars are eligible for importation.

-----------------------------------------------------------------------

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
1990-1996 ALPINA B12 2-door coupe model passenger cars that were not
originally manufactured to comply with all applicable Federal Motor
Vehicle Safety Standards (FMVSS) are eligible for importation into the
United States because they have safety features that comply with, or
are capable of being altered to comply with, all such standards.

DATES: The closing date for comments on the petition is September 17,
2010.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:

     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How To Read Comments Submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov.
    Follow the online instructions for accessing the dockets. The
docket ID number and title of this notice are shown at the heading of
this document notice. Please note that even after the comment closing
date, we will continue to file relevant information in the Docket as it
becomes available. Further, some people may submit late comments.
Accordingly, we recommend that you periodically search the Docket for
new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS, and has no
substantially similar U.S.-certified counterpart, shall be refused
admission into the United States unless NHTSA has decided that the
motor vehicle has safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    101 Innovations, LLC, of Ferndale, Washington (101 Innovations)
(Registered Importer 07-350) has petitioned NHTSA to decide whether
nonconforming 1990-1996 ALPINA B12 2-door coupe model passenger cars
are eligible for importation into the United States. 101 Innovations
believes that these vehicles are capable of being modified to meet all
applicable FMVSS.
    In its petition, 101 Innovations described the 1990-1996 ALPINA B12
2-door coupe as a modified version of the 1991-1997 BMW 8-series (e31)
2-door coupe that was manufactured for sale in the United States and
certified by BMW as complying with all applicable FMVSS. The petitioner
noted, however, that these vehicles were altered by ALPINA and, as
altered, were assigned vehicle identification numbers (VINs) by ALPINA
that differ from those assigned to the base vehicles by BMW. In view of
these circumstances, the petitioner acknowledged that it could not base
its petition on the substantial similarity of the 1990-1996 ALPINA B12
2-door coupe to the U.S.-certified 1991-1997 BMW 8-series (e31) 2-door
coupe, but would instead need to establish import eligibility on the
basis that the vehicles have safety features that comply with, or are
capable of being modified to comply with, the FMVSS based on
destructive test data or such other evidence that NHTSA decides to be
adequate. The petitioner did note, however, that the 1990-1996 ALPINA
B12 2-door coupe utilizes the same components as the U.S.-certified
1991-1997 BMW 8-series (e31) 2-door coupe in virtually all of the
systems subject to the FMVSS.
    101 Innovations submitted information with its petition intended to
demonstrate that non-U.S. certified 1990-1996 ALPINA B12 2-door coupe
model passenger cars conform to many FMVSS and are capable of being
altered to comply with all other standards to which they were not
originally manufactured to conform.
    Specifically, the petitioner claims that non-U.S. certified 1990-
1996 ALPINA B12 2-door coupe model passenger cars, as originally
manufactured, conform to: Standard Nos. 102 Transmission Shift Lever
Sequence, Starter Interlock, and Transmission Braking Effect, 103
Windshield Defrosting and Defogging Systems, 104 Windshield Wiping and
Washing Systems, 105 Hydraulic Brake Systems, 106 Brake Hoses, 107
Reflecting Surfaces, 109 New Pneumatic Tires, 113 Hood Latch System,
116 Motor Vehicle Brake Fluids, 124 Accelerator Control Systems, 201
Occupant Protection in Interior Impact, 202 Head Restraints, 204
Steering Control Rearward Displacement, 205 Glazing Materials, 206 Door
Locks and Door Retention Components, 207 Seating Systems, 210 Seat Belt
Assembly Anchorages, 211 Wheel Nuts, Wheel Discs and Hub Caps, 212
Windshield Mounting, 214 Side Impact Protection, 216 Roof Crush
Resistance, 219 Windshield Zone Intrusion, 301 Fuel System Integrity,
and 302 Flammability of Interior Materials.
    In addition, the petitioner claims that the vehicles comply with
the Bumper Standard found in 49 CFR Part 581.
    The petitioner also contends that the vehicles are capable of being
altered to meet the following standards, in the manner indicated:
    Standard No. 101 Controls and Displays: Installation of U.S.-model
instrument cluster and U.S.-version software.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of U.S.-model: (a) Headlamps; (b) front and
rear side marker lamps; and (c) rear high mounted stop lamp and
associated wiring.
    Standard No. 110 Tire Selection and Rims: Installation on the
vehicle of a tire information placard.
    Standard No. 111 Rearview Mirrors: Installation of a U.S.-model
passenger side rearview mirror, or inscription of the required warning
statement on the face of that mirror.
    Standard No. 114 Theft Protection: Installation of U.S.-version
software and a U.S.-model ignition switch to meet the requirements of
this standard.

    Standard No. 115 Vehicle Identification: Installation of a vehicle
identification plate near the left windshield post to meet the
requirements of this standard.
    Standard No. 118 Power-Operated Window, Partition, and Roof Panel
Systems: Inspection of all vehicles and modification or deactivation of
any remote activation features that cause the system not to conform to
the standard.
    Standard No. 208 Occupant Crash Protection:
    (a) Installation of U.S.-model knee bolsters; and (b) inspection of
all vehicles and replacement of any non U.S.-model air bag system
components, including all warning systems, warning labels and
telltales, with U.S.-model components on vehicles not already so
equipped.
    Standard No. 209 Seat Belt Assemblies: Inspection of all vehicles
and replacement of any non U.S.-model seat belt components on vehicles
not already so equipped.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: August 12, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-20433 Filed 8-17-10; 8:45 am]
BILLING CODE 4910-59-P