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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 0E7786

EPA has received a pesticide petition (PP 0E7786) 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 D(+)-lactide-L(-)- lactide-meso-lactide poly mer (CAS Reg. No. 9051-89-2) under 40 CFR 180.920 when used as an inert ingredient (component of c ontrolled release agent) in honeybee hive

miticide formulations. EPA has determined that the petiti on contains data or information regarding the elements set fo rth 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 da ta 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 re sidue 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 iner t 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 th e honey and its toxicity is

“low” or “non toxic” in th e literature available. This mate rial is also a pproved 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 af ter 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 hi ve, 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 appr oved 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 a pplication as tolerance waiver requested