EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

Interregional Research No. 4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201

- W, Princeton, NJ 08540

PP# 6E8464

EPA has received a pesticide petition (PP# 6E8464) from Interregional Res earch Project Number 4 (IR

- 4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing , pursuant to section 408(d) of the Feder al Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. 627 by :

1) establis hing a tolerance for residues of the fungicide fluopicolide [2,6

- dichloro

- N

- [[3

- chloro

5

- (trifluoromethyl)

- 2

- pyridinyl]methyl]benzamide], including its metabolites and degradates , in or on the raw agricultural commodities: basil, dried leaves at 200 parts per million ( ppm ) ; b asil,
fresh leaves at 3 0 ppm; b ean, succulent at 0.9 ppm; citrus, dried pulp at 0.048 ppm; citrus, oil at 1.94 ppm; h op, dried cones at 15 ppm; fruit, citrus, group10

- 10 at 0.02 ppm; f ruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F at 2.0 ppm ; and vegetable, fruiting, group 8

- 10 at 1.60 ppm ; and

2) remov ing established tolerances for residues of the fungicide fluopicolide [2,6

- dichloro

- N

- [[3

- chloro

- 5

- (trifluoromethyl)

- 2

- pyridinyl]methyl]benzamide], including its metabolites and degradates, in or on raw agricultural commodity grape at 2.0 ppm and v egetable, fruiting, group

8 at 1.60 ppm.

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 grantin g of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism

. The metabolism of fluopicolide in crop plants has been reported previously and is adequately understood for the purpose of gr a nting the proposed tolerances.

2. Analytical method. Practical analytical methods for detecting and measuring levels of fluopicolide and its metabolites have been developed and validated in/on all appropriate plant
and animal matrices.

3. Magnitude of residues

. Re sidue data which adequately support the proposed tolerances in the proposed crops have been submitted.

B. Toxicological Profile

The toxicological profile and toxicological endpoints for fluopicolide supporting this petition for2

tolerance s was published in the Federal Register on January 30, 2008 (Volume 73, Number 20)

, May 28, 2008 (Volume 73 Number 103) and March 5, 2014 (Volume 79 , Number 43 ) for
rotational corn

. The toxicology database for fluopicolide is complete. The chronic reference dose (cRfD) of 0.2 mg/kg/day was calculated from the NOAEL of the rabbit developmental toxicity study and an uncertainty factor of 100X. Because fluopicolide is not acutely toxic or carcinogenic, no acute or cancer exposure assessment was perfor med.

The fluopicolide metabolite 2,6

- dichlorobenzamide (BAM) was not assessed as the new use pattern does not add significantly to the BAM dietary exposure.

C. Aggregate Exposure

1. Dietary exposure.

i. Food. Chronic d ietary exposure (food) assessments were conducted by EPA Health Effects Division (HED) to evaluate the potential risk due to chronic dietary exposure of the U.S. population and various subgroups to tolerance level residues of fluopicolide in/on crops for which there are existing tolerances. Details can be found in “Fluopicolide. Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Tolerances on Rotational Corn.”, 4/8/2013. Proposed tolerance

- level residues, default processing values and 100% percent crop treated were used for the Tier I assessment using

DEEM

- FCID Version 3.16. Residues of food or water from uses in the current petition were not included in the analysis as they would have a negligible contribution to the dietary burden.

ii. Drinking water. Surface (drinking) water concentrations were calculated by
the Envi ronmental Fate and Effects Division (EFED) using PRZM version 3.21/EXAMS version
2.98. Details can be found in: “ Tier II Drinking Water Exposure Assessment for Fluopicolide and its Major Degradate, 2, 6

- Dichlorobenzamide (BAM) for Use on Potatoes, Carrots , Sugar Beets and Brassica (Cole) Leafy Vegetables” 6/20/ 20 10

. The modeled chronic (non

- cancer) exposure concentration of fluopicolide in surface water was estimated to be 0.02414 ppm.

2. Non

- dietary exposure

. There is no potential for non

- dietary re sidential exposure from uses in the current petition. However, previously registered uses (turf, gardens and golf courses) do present the potential for non

- dietary exposures. These scenarios have been assessed by EPA previously. Details can be found in “Fluopicolide. Human Health Risk Assessment for the New Section 3 Tolerances on Rotational Corn”, 5/8/2013.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency con sider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity”. EPA does not have, at this time, available data to determine whether fluopicolide has a

c ommon mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, EPA has not assumed that fluopicolide has a common mechanism of toxicity with other substances.3

E. Safety Determination

FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to ten

- fold, for added protection for infants and children in the case of threshold effects, unless EPA determines that a different margin of safet y will be safe for infants and children. The toxicological database for evaluating prenatal and postnatal toxicity for fluopicolide is complete with respect to current data requirements, and there are no special prenatal or postnatal toxicity
concerns for infants and children. EPA has concluded that reliable data support reduction of the FQPA Safety Factor for protection of infants and children to 1X.

1. U.S. population

. Based on a highly conservative assessment of currently registered

uses , t he chr onic dietary exposure estimates result in estimated exposures to the US population of 7.6% of the chronic population adjusted dose (cPAD) Chronic aggregate exposure s below
100% of the cPAD are generally considered to represent a reasonable certainty of no harm to exposed populations

. Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub

- populations) by including the incremental additional exposure resulting from the proposed uses of fluopicoli de.

2. Infants and children

. Based on currently registered uses, total chronic aggregate exposure to fluopicolide is conservatively estimated to be 12% of the cPAD for children aged 1

- 2 years (the most highly exposed subpopulation). Chronic aggregate e xposure below 100% of the cPAD is generally considered to represent a reasonable certainty of no harm to exposed populations

. When dietary exposures are aggregated with non

- dietary exposures from treated turf and gardens, the overall MOE’s do not exceed t he level of concern. Aggregate MOEs greater than 100 indicate a reasonable certainty of no harm to exposed populations. Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub

- populations) by i ncluding the incremental additional exposure resulting from the proposed uses of fluopicolide.

F. International Tolerances

Crop MRL (ppm)

EU Korea Turkey

Basil 9

- 9 Citrus Crop Group

- 0.7

- Hops 0.7 0.1 0.02