EPA REGISTRATION DIVISION CO MPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah, Branch Chief Inert Assessment Branch (IAB) 703-308-1846]

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:

[BASF Corporation 100 Campus Drive, Florham Park, NJ 07932]

[1E7931]

EPA has received a pesticide petition ([1E7931]) from BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932, 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.

To amend an exemption from the requirement of a tolerance for N,N -Bis- α -ethylω -hydroxypoly(oxy-1,2-ethanediyl) C8-C18saturat ed and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) conten t is 2–60 moles; herein refe rred to as ALKYL AMINES POLYALKOXYLATES; under 40 CFR 180.920 and 180.930 to include CAS. Reg. No. 1266162-49-5. EPA has determined that the pe tition 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.

BASF believes that the chemistry desc ribed by the CAS. Reg. No. 1266162-49-5 is described by the published tolerance exemption N,N -Bis- α -ethyl- ω -hydroxypoly(oxy1,2-ethanediyl) C8-C18saturated and uns aturated alkylamines; the poly(oxy-1,2- ethanediyl) content is 2–60 moles (74 FR 28616) and ther efore would fall under the published tolerance exempti on in 40 CFR 180.920 and 180.930. Since the current risk assessment was conducted on a range of chemis tries to support the published descriptor range of chemistries and EPA has determined that this range of chemistries would be acceptable under this risk assessment BASF believes this chemistry is supported by the

current risk assessment.2 2

A. Residue Chemistry

The regulation published in 2009 for al kyl amine polyalkoxylates (74 FR

28616 eliminates the need to establish a m aximum permissible le vel for residues of alkyl amine polyalkoxylates. Since this chemistry fits the description under the established tolerance exemption addition al residue studies are not required.]

2. Analytical method. [ An analytical method is not required for enforcement purposes since the Agency has established an exemption from the requirement of a tolerance without any numerical limitation. ]

3. Magnitude of residues. [BASF is petitioning the agency to amend an exemption from the requirement of a tol erance. Therefore information regarding the nature and magnitude of chemical residue s resulting from the use of this inert ingredient is not required.]

B. Toxicological Profile

1. Acute toxicity. [ Alkyl amine polyalkoxylates are not acutely toxic by the oral and dermal routes of exposure, or via inhalation under normal use conditions. Concentrated materials are generally corro sive, eye and skin irritants and may be

dermal sensitizers. There is no evidence that alkyl amine polyalkoxylates are neurotoxic, mutageni c, or clastogenic. ]

2. Genotoxicty. No significant mutagenicity was observed in either the initial assays or the subsequent confirmation assays.

3. Reproductive and developmental toxicity. Maternal toxicity NOAEL for alkyl amine po lyalkoxylates was established and the developmental toxicity NOAEL was also established and found to be acceptable. There was no increased suscepti bility to the offspring of rats following in utero exposure in two prenatal developmental toxi city studies. However, there is evidence of increased susceptibility in a rep roductive screening study in rats.

4. Subchronic toxicity. [ A 4-week oral dietary subchron ic toxicity study in rats using an amine, tallow alkyl, polyeth oxvlate, resulted in NOAEL of 2000 ppm (160 mg/kg/day) for females and 800 ppm (63.2 mg/kg/day) for males. A 90-day oral dietary subchronic toxicity study in rats using an amine, tallow alkyl, ethoxylate, resulted in a NOAEL of 500 ppm (33.0 mg/k g/day in males and 39.9 mg/kg/day in females).

A 90-day oral subchronic toxicity study in rats was conducted on an amine, C13-15- derivates alkyl, ethoxylate. The NOAEL was 15 mg/kg/day.3 3

Lastly, a 28-day rat oral toxicity study on an amine, tallow alkyl, ethoxylate propoxylate resulted in a NOAEL of 15 mg/kg/day]

5. Chronic toxicity. [There is no chronic toxi city data available for alkyl amine polyalkoxylates, but the Agency noted that the effects did not increase in severity over time (4 weeks to 13 weeks) in subchr onic studies. The Agency also used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts for potential carcinogenicity of both a representative alkyl amine polyalkoxylate, as well as a po ssible metabolite/degradate of alkyl amine polyalkoxylate that had been extensiv ely dealkylated, with the amine group intact. No structural alerts for carcinogenicity were identified in ei ther case. Alkyl amine polyalkoxylates are not expected to be carcinogenic. Therefore a cancer dietary exposure assessment is not nece ssary to assess cancer risk. ]

6. Animal metabolism. [The mammalian metabolism may be predicted based on either environmental bacterial degr adation or by analogy to documented studies.]

7. Metabolite toxicology

. [The animal metabolism of this chrmistry has not been investigated and metabolites have no t been identified. However, based on the plausible metabolic pathways, no metabolite s of toxicological concern are expected.]

8. Endocrine disruption

. [This class of chemistry does not belong to a class of chemicals known or suspected of having ad verse effects on the estrogen receptor or endocrine system.]

C. Aggregate Exposure

The Agency’s previous assessment for alkyl amine polyalkoxylates did not identify any concern for dietary (food and dr inking water) or for non-dietary exposure. BASF believes that the use of the requested CA S. Reg. No. under the current descriptor is not expected increase the exposure profile.

1. Dietary exposure. [ BASF believes the assumptions used to estimate dietary exposures lead to an extremely conservativ e assessment of dietary risk due to a series of compounded conservatisms. First, a ssuming that the level of residue for an inert ingredient is equal to the level of re sidue for the active ingredient will overstate

exposure .]

i. Food. [ In conducting the acute and chronic dietary exposure assessments, EPA used food consumption information fr om the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nation wide Continuing Surveys of Food Intake by Individuals (CSFII). As to resi due levels in food, no residue data were submitted for the alkyl amine polyalkoxyla tes. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the s ubject inert ingredients. Upper bound4 4

exposure estimates are based on the highes t tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. ]

ii. Drinking water. [ A screening level drinking water analysis, based on the Pesticide Root Zone Model/Exposure An alysis Modeling System (PRZM/EXAMS) was performed to calculate the estimated drinking water concentrations (EDWCs) of alkyl amine polyalkoxylat es. Modeling runs on four surrogate inert ingredients using a range of physical chemical propertie s that would bracket those of the alkyl amine polyalkoxylates were conducted. Mode led acute drinking water values ranged from 0.001 parts per billion (ppb) to 41 ppb. ]

2. Non-dietary exposure

. [ A screening level residential exposure and risk assessment was completed for products cont aining alkyl amine polyalkoxylates as inert ingredients. In this assessment, rep resentative scenarios, based on end-use product application methods and labeled application rates, were selected. For each of the use scenarios, the Agency assessed residential handler (appl icator) inhalation and dermal exposure for outdoor scenario s with high exposure potential (i.e., exposure scenarios with high end unit ex posure values) to serve as a screening assessment for all potentia l residential pesticides containing alkyl amine polyalkoxylates. Similarly, residential po stapplication dermal and oral exposure assessments were also performed utilizin g high end outdoor exposure scenarios. ]

D. Cumulative Effects [BASF has not found alkyl amine po lyalkoxylates to share a common mechanism of toxicity with any other substances, and alkyl amine polyalkoxylates do not appear to produ ce a toxic metabolite produced by other substances. For the purposes of this tolera nce action, therefore, BASF has assumed that alkyl amine polyalkoxylates do not h ave a common mechanism of toxicity with

other substances. ]

E. Safety Determination

1. U.S. population. [ Determination of safety. Base d on these risk assessments,

BASF concludes that there is a reasonable cert ainty that no harm will result to the general population ]

2. Infants and children

. [BASF has determined that reliable data show the safety of infants and children would be adequately protected. ]

F. International Tolerances

[BASF is not aware of any country requi ring a tolerance for alkyl amine polyalkoxylates nor have any CODEX Maxi mum Residue Levels been established for any food crops at this time. ]