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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 0E7780 

 EPA has received a pesticide petition ([PP 0E7780) 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 1,4-benzene 

dicarboxylic acid, (or dimethyl ester), polymer with 1,4-butanediol, adiptic acid, 

hexamethylene diisocyanate and further reacted with no more than 1% by weight of 

polyhydric alcohol, (CAS Reg.No 55231-08-8) 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. US studies not available. This inert is classified under the 

European standard, OECD 208 (seedling emergence, seedling growth) as “No effects at 

the highest concentration”. The inert is also certified as fully biodegradable so no plant 

related issues are expected

 2. Analytical method. Based on 1, and as this is a tolerance exemption petition, no 

test method is required.
2

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

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

expected. 

B. Toxicological Profile

 1. Acute toxicity. Oral, Rat, LD50 OECD >4000mg/kg. No toxic effects reported. 

Approved for food contact uses by the FDA (FCN No 907). Handling limited to 

application and removal of products in honeybee hive. No direct exposure as this inert is 

on the inside of the laminated paper wrap and is not contacted by persons applying the 

product. No toxic effects expected in this application. 

 2. Genotoxicty. No data available. Approved for food contact uses by the FDA 

(FCN No 907). Handling limited to application and removal of products in honeybee 

hive. No direct exposure as this inert is on the inside of the laminated paper wrap and is 

not contacted by persons applying the product. No toxic effects expected in this 

application

 3. Reproductive and developmental toxicity. See 2. for explanation. Non-toxic

 4. Subchronic toxicity. See 2. for explanation. Non-toxic

 5. Chronic toxicity. See 2. for explanation. Non-toxic 

 6. Animal metabolism. See 2. for explanation. Non-toxic

 7. Metabolite toxicology. See 2. for explanation. Non-toxic

 8. Endocrine disruption. See 2. for explanation. Non-toxic

C. Aggregate Exposure

 1. Dietary exposure. None, Wrap does not contact the honey. This material is also 

approved for food contact under FDA FCN No. 907

 i. Food. None, Wrap does not contact the honey. This material is also approved 

for food contact under FDA FCN No. 907

 ii. Drinking water. None. Wrap remains in the hive during use and inert is 

insoluble in water.

 2. Non-dietary exposure. There is no direct exposure. The product containing the 

inert is handled twice, once to place in a beehive and once to remove it. 
3

D. Cumulative Effects No data available, however, inert is listed as “non toxic” in the 

literature and as there is no direct contact during use or residues left after post use 

composting, effects are unlikely. Approved for food contact by FDA (FCN No 907) 

E. Safety Determination

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

No 907). There is no direct contact in this application

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

FCN No 907). There is no direct contact in this application

F. International Tolerances

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