i

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: 

NOD Apiary Products USA, Inc.

PP 0E7786

 EPA has received a pesticide petition (PP 0E7786) from NOD Apiary Products 

USA Inc., 8345 NW 66th Street #8418, Miami, FL 33166, 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.

(Options (pick one)

2. to establish an exemption from the requirement of a tolerance for D(+)-lactide-L(-)-

lactide-meso-lactide polymer (CAS Reg. No. 9051-89-2) under 40 CFR 180.920 when 

used as an inert ingredient (component of controlled release agent) in honeybee hive 

miticide formulations. 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. No plant metabolism data is available. This material is fully 

degradable, contained in the honeybee hive during use and composted after use. No 

contact with plants is expected.

 2. Analytical method. As there is no significant residue expected and as the 

petition is for a tolerance waiver, no analytical method is required.

 3. Magnitude of residues. The inert ingredient breaks down in two stages, 

hydrolysis followed by digestion by micro organisms. No significant residues are 

expected. 
2

B. Toxicological Profile

 1. Acute toxicity. Specific toxicity data unavailable. A literature search shows all 

MSDS’s and other documents classify this inert as “low” or “non-toxic”. As used in this 

application, a thin adhesive layer between two other inerts, “non-toxic” is appropriate. 

There is no direct exposure to this inert by persons handling the product and no contact 

with foodstuffs.

 2. Genotoxicty. See 1. for explanation. Non-toxic 

 3. Reproductive and developmental toxicity. See 1. for explanation. Non-toxic

 4. Subchronic toxicity. . See 1. for explanation. Non-toxic

 5. Chronic toxicity. . See 1. for explanation. Non-toxic 

 6. Animal metabolism. . See 1. for explanation. Non-toxic

 7. Metabolite toxicology. . See 1. for explanation. Non-toxic

 8. Endocrine disruption. . See 1. for explanation. Non-toxic

C. Aggregate Exposure

 1. Dietary exposure. None, Wrap does not contact the honey and its toxicity is 

“low” or “non toxic” in the literature available. This material is also approved for food 

contact under FDA FCN No. 178.

 i. Food. None, See note 1 for explanation

 ii. Drinking water. None, Insoluble in water. Contained within honeybee hive 

during use and fully biodegradable in compost after use. This material is also approved 

for food contact under FDA FCN No. 178.

 2. Non-dietary exposure. There is no direct exposure. The inert is sandwiched 

between two other inerts in a paper wrap and the product is only handled twice, once to 

place in and again to remove from the hive, after which it is fully biodegradable

D. Cumulative Effects

No data available, however, as listed as “low” or “non toxic” in the literature and 

as there is no direct contact during use or residues left after post use composting effects 

are unlikely. 
3

E. Safety Determination

 1. U.S. population. Safe. This inert has been approved for food use. (FDA FCN 

No 178). There is no direct contact in this application.

 2. Infants and children. Safe. This inert has been approved for food use. (FDA 

FCN No 178). There is no direct contact in this application.

F. International Tolerances

Not available, and not required in this application as tolerance waiver requested