Document ID: EPA-HQ-OPP-2017-0722-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-03-06T05:00Z

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Biopesticides and Pollution Prevention Division contact: Mike Mendelsohn, Acting Branch Chief, 703-308-8715 

SUBMISSION: Email the completed template to: hollis.linda@epa.gov.

TEMPLATE:

Adjuvants Plus, Inc.

[7F8589]

	EPA has received a pesticide petition ([7F8589]) from Adjuvants Plus, Inc., 1755 Division Road N., Kingsville, ON N9Y 2Y8  requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for microbial pesticide  Clonostachys rosea strain ACM941 TGAI.

Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, Adjuvants Plus, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Adjuvants Plus, Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. Adjuvants Plus, Inc.  Petition Summary
   
   	[7F8589]

A. Product Name and Proposed Use Practices

	Clonostachys rosea strain ACM941 TGAI

The intended use of products that contain the active ingredient Clonostachys rosea strain ACM941 is as 1) a seed treatment in the control of soil and seed borne pathogens such as Pythophthora sp., Fusarium sp., Pythium sp., Rhizoctonia sp., Alternaria sp., Sclerotinia sp., by the suppression of spore production and 2)  as a spray, dip, drench or bee-vectored pest agent for the control of Botrytis cinerea ("Grey Mold"), Botrytis allii, (Neck Rot), Rhizopus sp., Alternaria sp. (Early Blight), Monilinia sp., (Brown Rot),Sclerotinia sp. (White Mold or Sclerotinia Berry Drop), Phomopsis canker, Fusicladium effusum (Pecan Scab), Venturia sp. (Apple Scab), Taphrina deformans (Leaf Curl), Colletotrichum sp. (Anthracnose), Cercospora sp. (Leaf Spot), Phoma sp. (Black Leg), Didymella sp. (Black Rot), Fusarium sp. (Fusarium Wilt) and other fungal pests by the suppression of spore production [and] [or] removal of disease organisms] in fruiting and flowering plants.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. 

Clonostachys rosea is ubiquitous in the environment and has been identified in tissue from a variety of terrestrial plants, aquatic plants and all types of soils (MRID No. 501757-01).  Information regarding the name, identity and composition has been submitted to EPA (MRID No. 501757-14). 

Clonostachys rosea is a beneficial endophyte that is used to control and prevent spore production of Botrytis sp. and other similar plant diseases in plant tissues and is used to enhance the plant's natural resistance (induced systemic resistance (ISR)).  Hyphae have been found to coil around, penetrate and grow inside the hyphae and conidia of Botrytis sp. (MRID No. 501757-01).

	2. Magnitude of residues at the time of harvest and method used to determine the residue.   N/A--Remove

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed.

An analytical method for residues is not applicable.  It is expected that, when used as proposed, Clonostachys rosea strain ACM941 would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

Studies to evaluate the safety to mammals were conducted on Clonostachys rosea strain ACM941 TGAI and are summarized herein  (see Table 1).  The studies performed include an acute oral toxicity/pathogenicity study in the rat, acute dermal toxicity study in the rat,  acute pulmonary toxicity study in the rat, acute eye irritation study in the rabbit, and acute dermal irritation study in the rabbit.

    Table 1. Summary of C. rosea strain ACM941 TGAI Mammalian Toxicity Data
                                     Test
                                    Species
                                  Dose Tested
                           Results (Date Completed)
                       Acute Oral Toxicity/Pathogenicity
                                      Rat
                                >5,000 mg/kg
                             Non-toxic Category IV
                                 May 31, 2016
                             Acute Dermal Toxicity
                                      Rat
                                >5,050 mg/kg
                             Non-toxic Category IV
                                 May 31, 2016
                    Acute Pulmonary Toxicity/Pathogenicity
                                      Rat
                             1.7 x 10[9] CFU/mL or
                            1.7 x10[8] CFU per rat
                     Non-toxic Category IV  July 20, 2016
                            Primary Eye Irritation
                                    Rabbit
                        100 mg undiluted test substance
                   Mildly irritating, Toxicity Category III
                                 May 31, 2016
                           Primary Dermal Irritation
                                    Rabbit
             500 mg test substance moistened with deionized water
                     Non-irritating, Toxicity Category IV
                                 May 31, 2016

The results of toxicity testing of the organism show there is no risk to human health from the active ingredient.  Clonostachys rosea strain ACM941 is not toxic, pathogenic, infective or irritating to animals.

Literature searches have demonstrated that there are no reports of ecological or human health hazards caused by Clonostachys rosea.  It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity.

As has been demonstrated, dietary exposure to Clonostachys rosea strain ACM941 meets the FQPA 1996 safety standard.  Studies submitted with this petition showed no evidence of toxicity, pathogenicity or infectivity when this strain was tested in laboratory animals.  It is important to note as well that the strains that Adjuvants Plus, Inc., seeks to register grow well at 25°C (77°F) but not at all at 37°C (98.6°F), the temperature of the human body. 

D. Aggregate Exposure

	1. Dietary exposure.

	i. Food. 

Dietary exposure from use of products containing Clonostachys rosea strain ACM941, as proposed, is minimal.  The intended use of products containing Clonostachys rosea strain ACM941  is to growing agricultural crops for the purposes of control of fungal plant diseases.

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain ACM941.  There are no reports of ecological or human health hazards cause by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

	ii. Drinking water. 

Similarly, exposure to humans from residues of Clonostachys rosea strain ACM941 in consumed drinking water would be unlikely.  Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure.  Clonostachys rosea is ubiquitous in the environment and has been identified in tissue from a variety of terrestrial plants, aquatic plants and all types of soils. (MRID No. 501757-01)  

The intended use of Clonostachys rosea strain ACM941 is application via seed treatment and foliar/drench applications.  Formulated end use products with this active ingredient are not expected to increase levels of the microbe above natural levels.  Additionally, the fungus would not tolerate the conditions water is subjected to in a drinking water facility (including: chlorination, pH adjustments, high temperatures and/or anaerobic conditions.)

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain ACM941.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

	2. Non-dietary exposure. 

The potential for non-dietary exposure to the U.S. general population, including infants and children, is unlikely as the proposed use sites are agricultural.  The intended use of products containing Clonostachys rosea strain ACM941 is to agricultural crops for the purposes of control of fungal plant diseases. Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels.  Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings. 

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain ACM941.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

E. Cumulative Effects

It is not expected that, when used as proposed, products containing Clonostachys rosea strain ACM941 would result in residues that are of toxicological concern.  The intended use of Clonostachys rosea strain ACM941 is to agricultural crops for the purpose of control of fungal plant diseases.  Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels. The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain ACM941.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

F. Safety Determination

	1. U.S. population. 

Acute toxicity studies have shown that Clonostachys rosea strain ACM941 is not toxic, pathogenic, or irritating to mammals.  The intended use of Clonostachys rosea strain ACM941 is to agricultural crops for the purposes of insect control.  Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels. The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain ACM941.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.  There is a reasonable certainty of no harm to the general population from exposure to this active ingredient.

	2. Infants and children. 

As mentioned above, it is not expected that, when used as proposed, Clonostachys rosea strain ACM941 would result in residues that are of toxicological concern.  There is a reasonable certainty of no harm for infants and children from exposure to Clonostachys rosea strain ACM941.

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Clonostachys rosea strain ACM941 functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances

US EPA Tolerance - 
There is no U.S. EPA tolerance or tolerance exemption for Clonostachys rosea strain ACM941.

I. International Tolerances

International - 
A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Clonostachys rosea strain ACM941.