Document ID: EPA-HQ-OPP-2019-0572-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-02-04T05:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: Kerry Leifer, Branch Chief (Acting), Chemistry/Inerts/Toxicology Branch, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-001; telephone number:  703-308-8811; email address:  leifer.kerry@epa.gov

BASF Corporation

EPA has received a pesticide petition, IN-11282, from BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709, proposing, 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 Bacillus thuringiensis strain EX 297512 whole broth, under 40 CFR 180.920 for seed treatment use only when used as an inert ingredient (carrier, diluent) in pesticide formulations without limitation.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry
	1.  Plant metabolism:  Not Applicable 
	2.  Analytical method:  Not Applicable
	3.  Magnitude of residues:  Not Applicable

B. Toxicological Profile

For the purposes of assessing potential exposure under this exemption, Bacillus thuringiensis strain EX 297512 whole broth is considered low risk.  The bioinformatics report (MRID # 50738908) confirms the absence beta­exotoxin I and beta-exotoxin II.  In addition, the acute toxicology studies and the human safety assessment report (MRID#50738907) indicated no concerns for toxicity with the preparation or the strain.  The summary report (MRID# 50738909 and references therein) supports the claim of low risk and an exemption from tolerance.

C. Aggregate Exposures

For the purposes of assessing potential exposure under this exemption, Bacillus thuringiensis strain EX 297512 whole broth could be present in all raw and processed agricultural commodities and drinking water and that non-occupational non-dietary exposure are not of concern. Therefore, an exemption from the requirement of a tolerance is justified.

D. Cumulative Effects

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, "available information" concerning the cumulative effects of a particular chemical's residues and "other substances that have a common mechanism of toxicity'', must be considered. Bacillus thuringiensis strain EX 297512 whole broth is not expected to contribute to any cumulative effects.

E. Determination of Safety

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the low toxicity of Bt EX297512 and Bt strains more generally, especially the Bt israelensis strain from which Bt EX297512 is derived, and minimal anticipated exposures, additional tenfold safety factor is not necessary.

Based on established safety profile of Bt EX297512 and similar strains referenced in the summary report (MRID# 50738909 and references therein), there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure.

F. International Tolerances

There are no CODEX maximum residue limits established for Bt EX297512 in or on crops or commodities at this time.

G. Other Considerations

Endocrine Disruptors:  There is no available data nor evidence to suggest that Bt EX297512 is an endocrine disruptor.