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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:

NOD Apiary Products USA, Inc.

PP 0E7780

EPA has received a pesticide petition ([PP 0E7780) from NOD Apiary Products USA Inc., 8345 NW 66 th Street #8418, Miami, FL 33166, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosme tic 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), polym er with 1,4-butanediol, adiptic acid, hexamethylene diisocyanate and further react ed with no more than 1% by weight of polyhydric alcohol, (CAS Re g.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 c ontains data or in formation 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 emerge nce, 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

, LD 50 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 exposur e as this inert is on the inside of the laminated paper wrap and is not contacted by persons applying the product. No toxic effects exp ected in this application.

2. Genotoxicty

. No data available. Approved fo r food contact uses by the FDA (FCN No 907). Handling limited to applic ation and removal of products in honeybee hive. No direct exposure as this inert is on the inside of th e 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 explan ation. 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 hi ve 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 appl ication as tolerance waiver requested