Document ID: EPA-HQ-OPP-2021-0656-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-10-21T04:00Z

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

EPA Registration Division contact: Kerry Leifer, Branch Chief Inert Assessment Branch (IAB) 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:

Spring Regulatory Sciences on behalf of BASF Corporation. IN-11530

 EPA has received a pesticide petition (IN-11530) from Spring Regulatory Sciences on behalf of BASF Corporation, 100 Park Avenue, Florham Park, New Jersey 07932 (EPA Co. No 33753) 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 the exemption from the requirement of a tolerance for
for α-alkyl (minimum C6 linear or branched, saturated and or unsaturated)-ω-hydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of di- and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium and zinc salts of the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles and α-alkyl(C6-C15)-ω-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2-4 moles in or on the raw agricultural commodity growing crops under 40 CFR 180.910 and 930. For ease of reading, the alkyl alcohol alkoxylate phosphate and sulfate derivatives are referred to throughout this document as AAAPDs and AAASDs respectively, and collectively as AAAPSDs.

 This petition proposes the addition of CAS number 157627-92-4, Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts.
 
 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.

 Residue Chemistry

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

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

 Magnitude of residues. BASF Corporation is petitioning the agency to amend an existing exemption from the requirement of a tolerance. Therefore, information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.

    Toxicological Profile

 Acute toxicity. The AAASD and AAAPD surfactants are not acutely toxic by the oral and dermal routes of exposure under normal use conditions. Concentrated materials are generally moderate to severe eye and skin irritants and may be skin sensitizers.

 Genotoxicty. There is no evidence of mutagenicity in the mouse lymphoma L5178 TK +/- gene mutation study.

 Reproductive	and	developmental	toxicity.	In a rat developmental toxicity study conducted with the AAASD surfactant, no maternal or developmental toxicity was observed at 700 mg/kg/day. In an OECD 416 reproduction and fertility effects study conducted with the AAASD surfactant, the only significant effects observed were liver effects characterized by dose-related decrease in absolute and relative liver weight and an increased incidence in the number of animals with "minimal" hepatocyte necrosis in males. There were no treatment-related effects on reproductive parameters or the offspring.
 
 In an OECD 422 study conducted with the AAAPD surfactant CAS RN 78330-24-2, parental toxicity was observed based on lesions in the forestomach and thymus atrophy in females. Developmental toxicity observed was based on increased number of stillborn pups and pups dying and clinical observations (coldness to the touch, discolored heads, and a lack of nesting behavior); however, reproductive toxicity was not observed.
 
 In the second OECD 422 study conducted with the AAAPD surfactant CAS RN 68130-47-2, parental toxicity was observed based on clinical signs (rales and excessive salivation), reduced body weight, and lesions in the forestomach. Reproductive, developmental, and offspring toxicity were not observed at any dose level.
  
 In general, surfactants are surface-active materials that can damage the structural integrity of cellular membranes at high dose levels. Thus, surfactants are often corrosive and irritating in concentrated solutions. It is possible that some of the observed toxicity seen in the repeated studies, such as irritation of forestomach or decreased body weight gain, can be attributed to the corrosive and irritating nature of these surfactants.
       
 Subchronic toxicity. Following subchronic exposure to rats, gastrointestinal irritation (increased incidences of hyperplasia, submucosal edema, and ulceration) was observed, but no specific target organ toxicity or neurotoxicity was seen. No effects were detected in a functional observational battery (FOB) or motor activity assessment.

 Chronic toxicity. In an OECD 416 reproduction and fertility effects study conducted with the AAASD surfactant, the only significant effects observed were liver effects characterized by dose-related decrease in absolute and relative liver weight and an increased incidence in the number of animals with "minimal" hepatocyte necrosis in males. There were no treatment-related effects on reproductive parameters or the offspring.
       
 Endocrine disruption. EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).
 
 When additional appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, the AAAPD and AAASD surfactants may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption.
 
    Aggregate Exposure

 Dietary exposure. In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

 i. Food. In conducting the acute and chronic dietary exposure assessments, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data was submitted for AAAPSDs.  In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredients. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides.
 
 ii. Drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for AAAPSDs, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessment. These values were directly entered into the dietary exposure model.
 
 2. Non-dietary exposure. The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). AAAPSDs are used as inert ingredients in pesticide products that are registered for specific uses that could result in indoor residential exposures and may have uses as inert ingredients in pesticide products that may result in outdoor residential exposures.
 
 A screening level residential exposure and risk assessment was completed for products containing AAAPSDs as inert ingredients. In this assessment, representative 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 (applicator) inhalation and dermal exposure for use scenarios with high exposure potential (i.e., exposure scenarios with high-end unit exposure values) to serve as a screening assessment for all potential residential pesticides containing AAAPSDs. Similarly, residential postapplication dermal and oral exposure assessments were also performed utilizing high-end exposure scenarios.
 
    Cumulative Effects

BASF Corporation has not found a common mechanism of toxicity finding and the AAAPSDs not appear to produce a toxic metabolite produced by other substances. For the purposes of this requested tolerance action the AAAPSDs do not have a common mechanism of toxicity with other substances.

    Safety Determination

 U.S. population. Based on these risk assessments, BASF Corporation concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the AAAPSDs.

 Infants and children. Based on these risk assessments, BASF Corporation concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the lower weight AAAPSDs.

    International Tolerances

BASF Corporation is not aware of any country requiring a tolerance for the AAAPSDs nor have any CODEX Maximum Residue Levels been established for any food crops at this time.