


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: Linda Hollis, 703-308-8733

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

TEMPLATE:

Ag Chem Resources, LLC

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Ag Chem Resources, LLC, (10120 Dutch Iris Drive, Bakersfield, California 93311) 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 the biochemical pesticide Extract of Caesalpinia spinosa.
	
Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Ag Chem Resources, LLC has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Ag Chem Resources, LLC 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. Ag Chem Resources, LLC Petition Summary
   
   	[Insert petition number]

A. Product Name and Proposed Use Practices

Extract of Caesalpinia spinosa is a broad-spectrum biochemical nematicide. Proposed end use products containing this active ingredient will be applied directly to soil to achieve a concentration of approximately 1.5%  -  2% in a single application or 0.75%  -  1% over two applications that are generally separated by 10  -  15 days.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. Extract of Caesalpinia spinosa is a tannin-rich extract of Peruvian tara (Caesalpinia spinosa)

	2. Magnitude of residues at the time of harvest and method used to determine the residue. Based on the lack of toxicity demonstrated in the available toxicological data and given that an exemption from the requirement for establishing a tolerance for residues is being proposed, this section is not applicable.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. Based on the lack of toxicity demonstrated in the available toxicological data and given that an exemption from the requirement for establishing a tolerance for residues is being proposed, this section is not applicable

C. Mammalian Toxicological Profile

Acute toxicity. Extract of Caesalpinia spinosa has low acute oral, dermal, and inhalation toxicity.  It is not an eye or dermal irritant. Furthermore, Extract of Caesalpinia spinosa is not a dermal sensitizer. 

Repeated dose toxicity. Extract of Caesalpinia spinosa exhibited no evidence of adverse effects from a 90-day oral toxicity study and a prenatal developmental study at the highest dose tested, which exceeded the Guideline limit dose. 

Further, Extract of Caesalpinia spinosa does not present mutagenic, subchronic, developmental, or neurotoxic effects.

D. Aggregate Exposure

	1. Dietary exposure. 
      In examining aggregate exposure, the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). Repeated dose toxicity testing at oral doses that exceed the Guideline limit dose demonstrate no adverse effects and is considered sufficiently protective of multiple routes of exposure including, dietary exposure. Given the lack of human health concerns associated with exposure to Extract of Caesalpinia spinosa and the proposed exemption from the requirement of a tolerance, quantitative consideration of aggregate exposure is not appropriate. Therefore, this section is not applicable.

	i. Food. 
      Repeated dose toxicity testing at oral doses that exceed the Guideline limit dose demonstrate no adverse effects and is considered sufficiently protective of multiple routes of exposure including dietary (i.e. food, drinking water) exposure. Given the lack of human health concerns associated with exposure to Extract of Caesalpinia spinosa and the proposed exemption from the requirement of a tolerance, quantitative consideration of aggregate exposure is not appropriate. Therefore, this section is not applicable.

	ii. Drinking water. 
      Repeated dose toxicity testing at oral doses that exceed the Guideline limit dose demonstrate no adverse effects and is considered sufficiently protective of multiple routes of exposure including dietary (i.e. food, drinking water) exposure. Given the lack of human health concerns associated with exposure to Extract of Caesalpinia spinosa and the proposed exemption from the requirement of a tolerance, quantitative consideration of aggregate exposure is not appropriate. Therefore, this section is not applicable.

      2. Non-dietary exposure. Potential risks from inhalation and dermal exposures are considered negligible. Additionally, repeated dose toxicity testing at oral doses that exceed the Guideline limit dose demonstrate no adverse effects and is considered sufficiently protective of multiple routes of exposure including non-dietary exposure. Given the lack of human health concerns associated with exposure to Extract of Caesalpinia spinosa and the proposed exemption from the requirement of a tolerance, quantitative consideration of aggregate exposure is not appropriate. Therefore, this section is not applicable.

E. Cumulative Effects

A common mechanism of toxicity finding for Extract of Caesalpinia spinosa has not been established as there is no identifiable hazard from the toxicological database and the mode of action is considered non-toxic and specific to the target organism. For the purposes of this requested exemption from the requirement of a tolerance exemption, Extract of Caesalpinia spinosa does not have a common mechanism of toxicity with other substances. In addition, the overall lack of toxicity of Extract of Caesalpinia spinosa supports the perspective that all cumulative effects resulting from exposure would not be expected to pose any quantifiable risk.


F. Safety Determination

 U.S. population. 
         Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance if they can determine that the exemption is "safe" and there is reasonable certainty that no harm will come from the aggregate exposure of the pesticide chemical residue from all avenues of dietary exposure. Extract of Caesalpinia spinosa is a tannin-rich plant extract. Tannin occurs as a natural constituent of fruits and vegetables in the human diet. Additionally, the specific class of tannin in Extract of Caesalpinia spinosa (hydrolyzable gallotannin) has a long history of use as a direct food substance affirmed as Generally Recognized as Safe in 21 CFR §184.1097 as well as a direct human food additive in 21 CFR §173.310. Finally, based on the lack of any significant adverse systemic effects reported in the repeated dose toxicity studies on Extract of Caesalpinia spinosa despite being tested at orally administered doses that exceed the limit dose, a reasonable certainty of no harm has been adequately established. An exemption from the requirement of tolerance is being proposed based on a lack of adverse effects reported in available toxicological data on Extract of Caesalpinia spinosa.

	2. Infants and children. 

      FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (MOE) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless EPA determines that a different MOE will be safe for infants and children. Margins of exposure, which are often referred to as uncertainty (safety) factors, are incorporated into EPA risk assessments either directly, or through an MOE analysis, or by using uncertainty(safety) factors in calculating a dose level that poses no appreciable risk.
	
      Based on the lack of developmental effects reported in the prenatal developmental rat toxicity study with Extract of Caesalpinia spinosa, which included administration of oral doses that exceed the Guideline limit dose, there has been no demonstration of any increased qualitative or quantitative susceptibility of the young. Given that an exemption from the requirement of a tolerance is being proposed, this section is not directly applicable.

G. Effects on the Immune and Endocrine Systems

There is no evidence to indicate that Extract of Caesalpinia spinosa will adversely interact with the immune or endocrine systems.

H. Existing Tolerances

Extract of Caesalpinia spinosa is a tannin-rich plant extract, which is part of a class of compounds (tannin) that has been previously reviewed and approved by EPA for use as an inert ingredient. Tannin has been well-studied and robustly reviewed by EPA, including its known toxicological and human health effects, environmental fate properties, and expected exposure, to support its use in pesticides as an inert ingredient. EPA currently classifies tannin as exempt from the requirement of a tolerance for use as a dispersing agent in pesticide formulations applied to growing crops under 40 CFR §180.920.

I. International Tolerances

The Codex Alimentarius Commission (CODEX) has no established maximum residue levels (MRLs) for Extract of Caesalpinia spinosa.
