## Registration Decision for the New Active Ingredient

Trichoderma asperelloides strain JM41R (originally Trichoderma fertile strain JM41R)

Approved by:

Date:

### 1. Background

On October 10, 2012, the U.S. Environmental Protection Agency (EPA) received applications for registration that involve and a petition to establish a tolerance exemption for the new fungicide Trichoderma fertile strain JM41R from Becker Underwood, Inc. (now BASF Corporation (BASF ) )

. Subsequently, BASF provided additional data on the identity o f the active ingredient associated with the aforementioned pesticide products and tolerance exemption petition to the EPA

. After reviewing these data, the EPA concluded that the correct identity of the active ingredient was Trichoderma asperelloides strain JM41R and not Trichoderma fertile
strain JM41R.

Fungi of the genus Trichoderma are abundant in nature, especially i n soil and close to plant

roots. Since 1989, several Trichoderma species (e.g., Trichoderma polysporum and Trichoderma
viride ) have been us ed in pesticide products

— notably without reported incidents

— to control various fungal plant pathogens such as Pythium species, Phytophthora species, Heterobasidion

annosum , and Chondrostereum purpureum . In conjunction with the registration of some of these pesticide products, the EPA established the following tolerance exemptions: (1) Gliocladium

virens isolate GL

- 21 (now recognized as Trichoderma virens isolate GL

- 21) ( 40 CFR §
180.1100 ) ; (2) Trichoderma harzianum Rifai strain T

- 22 ( 40 CFR § 180.1102 ) ; (3) Trichoderma harzianum strain T

- 39 ( 40 CFR § 180.1201 ) ; (4) Trichoderma gamsii strain ICC 080 ( 40 CFR §
180.1293 ) ; (5) Trichoderma asperellum strain ICC 012 ( 40 CFR § 180.1294 ) ; (6) Trichoderma
hamatum isolate 382 ( 40 CFR § 180.1298 ) ; and (7) Trichoderma virens strain G

- 41 ( 40 CFR §
180.1310 )

. The EPA also completed registration review of certain Trichoderma speci es in September 2008 (search for “ EPA

- HQ

- OPP

- 2006

- 0245 ” at www.regulations.gov )

.

Regarding Trichoderma asperelloides strain JM41R, t his particular fungus colonizes root surfaces close to inoculated plants, parasitizing and competitively displacing invasive fungi (e.g., Rhizoctonia species and Fusarium species) and mineralizing insoluble phosphate to create a form of this substance that is available to plants. In light of Trichoderma asperelloides strain JM41R’s fungicida l capabilities, BASF proposed to register a manufac turing

- use pesticide product (MP)
and an end

- use pesticide product (EP). B oth pesticide products contain Trichoderma asperelloides strain JM41R as an active ingredient, and the EP is to be applied to soil and growing media in commercial greenhouses to mana ge soilborne diseases caused by organisms
such as Rhizoctonia species and Fusarium species.



### 2. Evaluation

In evaluating a pesticide registration application, the EPA assesses a wide variety of studies to determine the likelihood of adverse effects ( i.e., risk) from exposures associated with the proposed use of the product. Risk a ssessments are develop ed to evaluate how the compound

m ight affect a wide range of non target organisms

, including humans and terrestrial and aquatic
wildlife (plants and animals)

. Based on these assessments, the EPA evaluates and approves language for e ach pesticide label to ensure the directions for use and safety measures are appropriate to mitigate any potential risk. In this way, the pesticide’s label helps to communicate

essen tial limitations and mitigations that ar e necessary for public safety. In fact, the pesticide law

Page 2 of 7has a provision that indicates it is a violation to use a pesticide in a way that conflicts with the
label.



### 2.1 Assessment of Risk to Human Health

In order to assess a microbial pesticide’s risk to human health, t he EPA initially requires a wide range of studies , including Tier I acute toxicity/pathogenicity (oral, pulmonary, and injection) data, cell culture data, reports of hypersensitivity incidents, acute t oxicity (oral, dermal, and inhalation) data, and irritation ( dermal and eye) data. Tier II and III testing (e.g., subchronic toxicity/pathogenicity) is triggered only when there is indication, usually through lower tier testing, that a micr obial pesticide has unusual toxicological characteristics, such as infectivity or being suspected as or known to be a carcin ogen. For Trichoderma asperelloides strain JM41R,
the database of studies required to support the assessment of risk to human health is complete.

The toxicity tests (acute oral, dermal, and inhalation toxicity) and irritation tests (acute eye and primary dermal irritation) that address potential routes of exposure to the active ingredient are all classified in Toxicity Category III or IV and reveal little to no toxicity or irritation attributed to Trichoderma asperelloides strain JM41R. Moreover, during a typical toxicity/pathogenicity test done with microbial pesticides, Trichoderma asperelloides strain JM41R did not show any signs of toxicity, pathogenicity, or infectivity via the pulmonary route of exposure. The EPA waived acute oral toxicity/pathogenicity and acute injection toxicity/pathogenicity testing for this active ingre dient, based on BAS F ’s scientific rationale. The rationale cited to the results of other toxicological data done with Trichoderma asperelloides strain JM41R, a literature search that yielded no human pathogenicity concerns, and data describing a lack of active ingredient gro wth
at 35°C or above (normal human body temperature is 37°C)

. Regarding cell culture testing, in this case, the EPA did not require these data as Trichoderma asperelloides strain JM41R is a fungus and not a virus. Finally, BASF reported that, to date, no h ypersensitivity incidents have occurred during research, development, and testing of this fungus. In light of the adequacy of the toxicological data, scientific rationale, and literature provided by BASF and the absence of hypersensitivity incidents, the E PA did not require toxicological testing at higher tiers.

The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Trichoderma asperelloi des strain JM41R. The EPA does not expect dietary (food and drinking water) or other

non

- occupational risks from use of Trichoderma asperelloides strain JM41R as an active ingredient in the proposed pesticide products. Although exposure to Trichoderma aspe relloides strain JM41R through consume d food and drinking water is possible, the EPA anticipates these
typ es of exposures may be reduced because, among other things, applications of the EP will be made to soil and growing media within commercial greenhouses, and typical processing

proc edures (e.g., peeling and/or additions of sugar, salt, and other preservatives) could remove the microbe from commodities . Furthermore, since applications of Trichoderma asperelloides
strain JM41R are limited to comm ercial greenhouses, increased exposures of the active ingredient to the general population in residential settings are not expected. Should Trichoderma asperelloides strain JM41R be present in or on food, in drinking water

, or in residential settings

,

Page 3 of 7supp orting toxicological information indicates that human exposure to this fungus would not
result in adverse effects.

For more information on the human health risk assessment of Trichoderma asperelloides strain

JM41R , p lease see the supporting documents cont ained in the associated regulatory dockets (search for “EPA

- HQ

- OPP

- 2012

- 0962” and/or “EPA

- HQ

- OPP

- 2012

- 0963” at www.regulations.gov ).



### 2.2 Assessment of Ecological Risk

In order to assess a microbial pesticide’s risk to the environment, the EPA initially requires a wide range of studies, including Tier I testing done on the following nontarget organisms: birds (oral and inhalation), wild mammals, freshwater fish and inver tebrates, estuarine/marine fish and invertebrates, plants, insects, and honeybees. Higher tier testing (II, III, and IV) generally encompasses definitive hazard determinations and longer term greenhouse or field testing and is implemented only when unaccep table effects are seen at the Tier I screening level. For Trichoderma asperelloides strain JM41R, the database of studies required to support the
assessment of risk to the environment is complete.

Exposure of nontarget organisms to Trichoderma asperelloi des strain JM41R is expected to be minimal, based on the uses as labeled. Applications are to occur only in greenhouses, which will limit environmental exposure. The EP labeling does not specify that greenhouses in which it will be used must be enclosed; t herefore, greenhouses may be open on the sides at certain or at all times during the year. Some exposure to nontarget organisms that would enter the greenhouse may occur; however, applications are to be directed to soil or planting media in containers with in the greenhouse. Therefore, the potential for any significant exposure to any nontarget organisms is expected to be very limited.

Information on bee hazard was inconclusive based on a submitted study; however, exposure to
bees as a result of the labeled uses is expected to be very low. Applications are directed to media or soil within containers in greenhouses, so they are not made to foliage and will not result in exposure to bees intentionally introduced for pollination or incidentally visiting greenho uses. Native species of bees that live in soil are also unlikely to make use of the soil in the treated containers. Therefore, exposure to bees as a result of the proposed labeled uses are not expected.

A dverse effects that might result from exposure are also unlikely. Trichoderma asperelloides is widespread within soil and is saprotrophic on pl ant matter . Since it is associated with growth within the plant rhizosphere, its likely mode of action is stimulation of no rmal plant defenses and competition for r esources (a common mode of action for Trichoderma species ). Therefore, its effects are expected to be limited to plant disease

- causing microorganisms for which it is labeled.

Based on limited exposure and very low likelihood of adverse effects, risk to no ntarget organisms resulting from the labeled applications of Trichoderma asperelloides strain JM41R is expected to be minimal. In addition, since the EPA has determined that adverse effects to nontarget organism s are not expec ted as a result of the applications of Trichoderma asperelloides
strain JM41R , it also makes a “no effect” determination for direct and indirect effects to

Page 4 of 7endangered and threatened species and their habitats from the uses of Trichoderma asperelloides strain JM41R, as labeled.

For more information on the environmental risk assessment of Trichoderma asperelloides strain JM41R, p lease see the supporting documents contained in the associated regulatory docket (search for “EPA

- HQ

- OPP

- 2012

- 0962” at www.regulations.gov ).



### 3. Alternatives

The use of this microbial fungicide could possibly reduce a certain amount of conventional fungicide used for soil treatment in commercial greenhouses

. Growers may use Trichoderma asperelloides strain JM41R as an alternative to conventional fungicides (e.g., fenamidone) or in conjunction with other biopesticides in an integrated pest management program. Among other things, Trichoderma asperelloides strain JM41R will have an established exemption from the

requ irement of a tolerance ( no limitations) for all food commodities

, the EP has a 4

- hour
restricted

- entry interval, and the EP is not classified as a restricted

- use pesticide because of human toxicity or environmental concerns

.



### 4. Benefits and Public Comments

Biopesticides are pesticides derived from such natural materials as animals, plants, bacteria, and
certain minerals. Microbial pesticides, a class of biopesticides, consist of a microorganism (e.g., bacterium, fungus, virus, or protozoan) as the active ing redient and may have t he following
benefits :

• Usually are inherently less harmful than conventional pesticides

.

• Generally affect only the target pest and closely related organisms , in contrast to broad

spectrum conventional pesticides that may affect many different organisms (e.g., birds, insects, and mammals)

.

• Often effective in very small quantities and often decompose quickly, thereby resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides

.

• C an greatly decrease the use of convent ional pesticides while crop yields remain high, when used as a component of integrated pest management programs.

• Can offer another tool for pest management in areas where pesticide resistance, niche markets, environmental concerns, and organic preference limit the use of conventional pesticides.

Like other microbial pesticides, Trichoderma asperelloides strain JM41R align s with the potential benefits above as it exhibits little to no toxicity or irritation, is not pathog enic or infective, seems to be specific to soilborne plant pathogens, and could fill particular needs in unique markets.

Page 5 of 7Overall, the EPA has provided the public five separate opportunities to comment on the Trichoderma fertile / Trichoderma asperelloides s train JM41R registration and tolerance exemption actions.

In the Federal Register of January 16, 2013 ( 78 FR 3422 ), the EPA announ ced receipt of applications to register pesticide products containing a new active ingredient ( Trichoderma fertile strain JM41R) and opened a 30

- day public comment period. The EPA received n o comments on this publication. Subsequent to this publication and a fter reviewing additional product iden tity data from BASF , the EPA concluded that the correct identity of the active ingredient was Trichoderma asperelloides strain JM41R and not Trichoderma fertile strain JM41R. In order to give the public an opportunity to comment on this new information, th e EPA republished its receipt of these applications with an updated and accurate description in the Federal Register of January 21, 2015 ( 80 FR 2929 ). The EPA received no comment s on this publication.

In the Federal Register of February 21, 2014 ( 79 FR 9870 )

, the EPA announced that BASF proposed to establish an exemption from the requirement of a tolerance for residues of the fungicide Trichoderma fertile strain JM41R in or on all food commodities and opened a 30

- day comment period. The EPA received no comments on this publication. Subseq uent to this publication and after reviewing additional product identity data from BASF, the EPA concluded that the correct identity of the pesticide was Trichoderma asperelloides strain JM41R and not Trichoderma fertile strain JM41R. In order to give the public an opportunity to comment on this new information, the EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of January 28, 2015 ( 80 FR 4525 ) and placed a revise d petition from BASF into the docket. The EPA received no comments on this publication.

Because BASF’s pesticide product applications involve a new active ingredient, as well as thi s active ingredient’s first food uses, the EPA opened a 15

- day public comment period from April 10, 2015, to April 25, 2015. The EPA took this action in accordance with a policy, first implem ented in October 2009, designed to provide a more meaningful oppo rtunity for the public to participate in major registration actions. During this comment period, the EPA received no

comments.



### 5. Regulatory Decision

The Trichoderma asperelloides strain JM41R database is comprised of 11 studies that cover at
least 33 diff erent data requirements and, with the exception of storage stability and corrosion characteristics studies that will be required as terms of registration, is considered complete . The

propose d uses of Trichoderma asperelloides strain JM41R are well supported by this database.

In considering the assessed risk to human health and the environment, the EPA conclude s that Trichoderma asperelloides strain JM41R meet s the regulatory standard under the Federal Insecticide, Fungicide

, and Rodenticide Ac t (FIFRA). Therefore, the EPA is granting the unconditional registration of the Trichoderma asperelloides strain JM41R pesticide products
under FIFRA section 3(c)(5)

.

Page 6 of 7Two pesticide products will be registered. “ Trichoderma asperelloides strain JM41R Tec hnical ”
is a MP, while “ TRICHO PLUS TM Biofungicide” is an EP ; Trichoderma asperelloides strain
JM41R is the sole active ingredient in both pesticide products

. In order to manage soilborne diseases caused by organisms such as Pythium

, Rhizoctonia

, Fusarium

, Sclerotinia , and Phytophthora , the EP will be applied to soil and growing media used within commercial greenhouses. It can be applied as a coarse spray, by soil drench, or by common irrigation application systems at a rate of 0.8 ounce per 10,000 square fe et of soil or growing media.

The risk assessment s supporting this decision can be found in the associated regulatory dockets (search for “EPA

- HQ

- OPP

- 2012

- 0962” and/or “EPA

- HQ

- OPP

- 2012

- 0963” at www.regulations.go v ).

Page 7 of 7