EPA REGISTRATION DIVISION COMPANY 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 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.

TEMPLATE: 

 Novozymes North America Inc

#0E7697

 EPA has received a pesticide petition (#0E7697) from Novozymes North 

America Inc., P.O. Box 576 77 Perry Chapel 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 ingredient 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 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 available

 2. Analytical method. Not available

 3. Magnitude of residues. Not available

B. Toxicological Profile

 1. Acute toxicity. LD50>5 g/kg

 2. Genotoxicty. Not genotoxic
2

 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 tissue 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 water 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 tissue 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 exposure 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 environment due to endogenous proteases and 

microorganisms, it leads to the conclusion that there is a reasonable certainty of no 

harm from exposure to the enzyme from non-dietary means.

D. Cumulative Effects

 At this time there is no information 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 biodegradable 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 processing facilities or post harvest treatment 

of commodities at this time.