EPA REGISTRATION DIVISION CO MPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Kerry Leifer, 703-308-8811

INSTRUCTIONS: Please utilize this outline in p reparing the pesticide petition. In

cases where the outline element does not apply, please insert “NA-Remove” and

maintain the outline. Please do not chan ge 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.

TEMPLATE:

Novozymes North America Inc

#0E7697

EPA has received a pesticide petition (#0E7697) from Novozymes North America Inc., P.O. Box 576 77 Perry Chap el Church Road, Franklinton, NC 27525 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 Lipase, triacylglycerol (CAS # 9001-62-1) under 40 CFR § 180.950 when used as an inert ingredie nt in pesticide formulations as an aid in the removal of lipids when used in a non-food contact surface sanitizer. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of F DDCA; however, EPA has not fully evaluated the sufficiency

of the submitted data at this time or whethe r the data supports gran ting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism Not available

2. Analytical method. Not available

3. Magnitude of residues. Not available

B. Toxicological Profile

1. Acute toxicity. LD 50 >5 g/kg

2. Genotoxicty. Not genotoxic2

3. Reproductive and developmental toxicity. No adverse effects seen when lipase, triacylglycerol is 5% of the diet

4. Subchronic toxicity. No adverse effects seen at 10 g/kg for 2 weeks

5. Chronic toxicity. No adverse effects seen at 5 g/kg

6. Animal metabolism. Any residual protein will be metabolized as food

7. Metabolite toxicology

. Not available

8. Endocrine disruption

. Not available

C. Aggregate Exposure

1. Dietary exposure. Since this lipase is an enzyme found in almost all living organisms, and as a result is present in the ti ssue and cells of the food eaten, it leads to the conclusion that there is a reasonable certainty of no harm from exposure to the enzyme from food or drinking wat er nor from an aggregate exposure. Lipases have been evaluated by the FDA for use in food, as well as in published literature.

i. Food. Lipase, triacylglycerol is an enzyme present in almost all living organisms, and as a result is present in the ti ssue and cells of the food eaten, as well as being cleared for food use. Therefore, it leads to the conclusion that there is a reasonable certainty of no harm from exposu re to the enzyme from food exposure.

ii. Drinking water. Not available

2. Non-dietary exposure

. Given the protein nature of lipase, triacylglycerol, mainly that it grades readily in the en vironment due to endogenous proteases and microorganisms, it leads to the conclusion th at there is a reasonable certainty of no harm from exposure to the en zyme from non-dietary means.

D. Cumulative Effects

At this time there is no informatio n to indicate that any toxic effects produced by lipase, triacylglycerol would be cumulative with any other chemical. Given the enzyme is readily biodegraded in the environment, there is no expectation of increased risk due to cumulative exposure.

E. Safety Determination

1. U.S. population. Given the nature of lipase, triacylglycerol, the evaluation by the FDA for use in food, and the bi odegradable nature of proteins, adverse effects are not expected.3

2. Infants and children

. Given the nature of lipase, triacylglycerol, the evaluation by the FDA for use in food, and the biodegradable nature of proteins, adverse effects are not expected.

F. International Tolerances

There are no Codex maximum residue limits established for lipase, triacylglycerol for food handling/food proces sing facilities or post harvest treatment

of commodities at this time.