Document ID: EPA-HQ-OPP-2018-0244-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-07-24T04:00Z

Notice of Filing:
EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

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: [insert name and telephone number with area code]
INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

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

TEMPLATE:

[Monsanto Company]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from [Monsanto Company, EPA Company Number 524], [1300 I St., NW., Suite 450 East, Washington DC 20005] 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 biochemical pesticide [LCO MOR116]. Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Monsanto Company] has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by [Monsanto Company] 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. [Monsanto Company] Petition Summary
   
   	[Insert petition number]

A. Product Name and Proposed Use Practices

	[Monsanto is seeking to establish a tolerance exemption in conjunction with registration applications for a manufacturing use product (MON 90510) and one end-use product containing the biochemical biopesticide active ingredient LCO MOR116.  Use as a seed treatment is proposed.]

B. Product Identity/Chemistry

      1. Identity of the pesticide and corresponding residues. [LCO MOR116 is a synthetically-derived member of the lipo-chitooligosaccharide (LCO) chemical class, that are signaling molecules involved in the initiation of plant-microbe endosymbioses in an estimated 70-80% of land plants.   LCO compounds are designated by an oligomeric backbone of three to six β-1,4-linked N-acetyl-D-glucosamine residues that may be N-acylated at the nonreducing-terminal residue by a fatty acid such as cis-vaccenic acid or other fatty acyl chains with 14 to 26 carbons and may have substitutions such as methylfucosyl or fucosyl at the reducing terminal residue. The chemical names and CAS numbers for LCO MOR116 are as follows: D-​Glucose, O-​6-​deoxy-​2-​O-​methyl-​α-​L-​galactopyranosyl-​(1-->6)​-​O-​[O-​2-​deoxy-​2-​[[(11Z)​-​1-​oxo-​11-​octadecen-​1-​yl]​amino]​-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​]​-​2-​(acetylamino)​-​2-​deoxy- ;CAS Registry Number: 163181-92-8 (Methylfucosyl form); 
      D-​Glucose, O-​2-​deoxy-​2-​[[(11Z)​-​1-​oxo-​11-​octadecen-​1-​yl]​amino]​-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​2-​(acetylamino)​-​2-​deoxy-​β-​D-​glucopyranosyl-​(1-->4)​-​O-​[6-​deoxy-​α-​L-​galactopyranosyl-​(1-->6)​]​-​2-​(acetylamino)​-​2-​deoxy- ; CAS Registry Number: 200068-90-2 (Fucosyl form)]
	2. Magnitude of residues at the time of harvest and method used to determine the residue. [The proposed uses are anticipated to result in negligible and undetectable levels of residue in agricultural commodities in association with our requested uses.   Dietary exposure to exogenously applied LCO MOR116 and its degradation products is likely to be very limited due to the proposed very low use rates that are equivalent to the levels of LCO already found in the agricultural environment.]

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. [Analytical methods that are normally utilized for detection of compounds in crop plants are incapable of quantifying the negligible levels of LCO MOR116 that are predicted to be present in raw or processed agricultural commodities.  Even in the unlikely event that dietary exposure does occur associated with the requested uses, the demonstrated favorable toxicological profile for LCO MOR116 does not present a potential for hazard to humans or the environment. ]

C. Mammalian Toxicological Profile

	[LCOs and degradation products have low potential for toxicity. There are numerous enzymes in both plants and animals that degrade chitin (e.g., a LCO degradate) and metabolize lipids such as cis-vaccenic acid. In fact, N-acetylglucosamine, cis-vaccenic acid and fucose are natural components of human tissues and available toxicological information provides further evidence that these breakdown products of LCOs have low potential for toxicity. As such, the history of safe use data for LCOs is supported by the available toxicological information that indicates both the parent molecule and its metabolites are molecules with low potential for toxicity.  Acute toxicology data and a review of the relevant literature demonstrate a favorable toxicological profile for LCOs, regardless of the route and duration of exposure associated with the requested uses. 

LCOs including LCO MOR116 have a low order of acute toxicity regardless of route of exposure (e.g., oral, dermal, or inhalation) and are not irritants or sensitizers.  Acute oral, dermal and inhalation studies conducted with a manufacturing use product containing LCO MOR116 did not result in effects even when tested at the limit dose. ]  

D. Aggregate Exposure

	1. Dietary exposure. [Biologically insignificant low dietary exposure to LCO MOR116 is anticipated due to the very low use rates that are equivalent to LCOs that occur in the agricultural environment; requested use patterns also present a very low potential for dietary exposure for all the proposed application types.]

	i. Food. [The proposed uses are anticipated to result in negligible and undetectable levels of residue in raw and processed agricultural commodities in association with our requested uses.   Dietary exposure to LCO MOR116 and its degradation products is predicted to be insignificant due to the proposed very low use rates that are equivalent to the levels of LCOs that occur in the agricultural environment and have a history of safe use and exposure.]

	ii. Drinking water. [Requested application rate of LCO MOR116 is 4 x10[-][6] g /A; this amount is within the range of the levels of LCO found in the environment.  Degradation of LCOs in plants and in the environment is predicted to occur rapidly due to the presence of enzymes in plants and the rhizosphere such as hydrolyases and chitinases and practical experience with the natural degradation of LCOs.  Levels of LCO MOR116 anticipated to occur in drinking water are negligible and not of concern.]

	2. Non-dietary exposure. [The proposed use pattern will limit the potential for occupational exposure, as well as the low application rate and active ingredient concentration of the end use product (2.66 x 10[-5]%).  Mammals are not known to have the receptors present in plants to have a biologically meaningful interaction with LCOs.  Finally, along with the long history of safe use and exposure to LCOs, the acute toxicity tests conducted with our manufacturing use product containing LCO MOR116 demonstrate the lowest hazard classification possible, regardless of the route of exposure.]

E. Cumulative Effects

	[LCO MOR116 does not show a potential for hazard in association with the proposed uses, does not share a mechanism of toxicity with other compounds, has a history of safe use and exposure after lifetime exposures, and long-term toxicity tests with potential degradation products demonstrate no cumulative effects after chronic exposure.]

F. Safety Determination

	1. U.S. population. [The available data and peer reviewed literature supports the conclusion that LCOs have a history of safe use/exposure (HOSU); members of this class of compounds are involved in plant-microbe symbiosis in an estimated 70-80% of land plants. Available toxicological information indicates that LCO MOR116, as well as the breakdown products of this biochemical biopesticide, have a low potential for toxicity.  Therefore, since LCOs exist in the environment and have a history of safe use, and worst-case predicted consumer exposure is extremely low, the proposed uses of the synthetically-derived LCO MOR116 as a seed treatment do not pose a hazard or a potential risk to any segment of the US population.]

	2. Infants and children. [Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or a tolerance exemption and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue."  The information provided in this petition and in the accompanying FIFRA section 3 registration submission demonstrates that the proposed uses of LCO MOR116 fully satisfy this standard.  This active ingredient and other members of the LCO class have a low potential for toxicity.]

G. Effects on the Immune and Endocrine Systems

	[LCOs like LCO MOR116 do not belong to a class of chemicals known for having adverse effects on the immune or endocrine system. No effects indicative of endocrine disruption have been observed in the literature and animals are not known to have receptors for LCOs that are found in plants, effectively leading to no biologically meaningful interaction of LCOs with receptors found in mammalian or non-target animals, including humans.]

H. Existing Tolerances

	[In the United States Code of Federal Regulations at 40 CFR § 180.910, a food use tolerance exemption for rhizobial inoculants in pesticide formulations has been issued.  These inoculants as a class, are generally capable of producing LCOs in situ. The concentration of the LCOs present in crops treated with rhizobia is roughly equivalent to the concentration in the agricultural environment to those anticipated from the proposed uses associated with this request for establishment of a tolerance exemption.  Therefore - somewhat indirectly - the tolerance exemption for rhizobial inoculants could be interpreted to include an exemption for rhizobially-produced LCOs.  In addition, a food use tolerance exemption for LCO SP104, which is structurally similar to LCO MOR116, has been established in the United States Code of Federal Regulations at 40 CFR § 180. Other than the indirect exemption for rhizobial inoculants and exemption for LCO SP104, there are no other tolerances or exemptions that have been granted for any other LCOs or LCO MOR116, as this is a new biochemical biopesticide active ingredient.]

I. International Tolerances

	[There are no Codex MRLs established for LCO MOR116 in food and feed items.]