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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Rules and Regulations
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inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408c2A, and the factors specified in FFDCA section 408c2B, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to sodium lauroyl sarcosinate, including exposure resulting from the exemption established by this action. EPAs assessment of exposures and risks associated with sodium lauroyl sarcosinate follows.
A. Toxicological Profile EPA has evaluated the available toxicity data and considered their 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. Specific information on the studies received and the nature of the adverse effects caused by sodium lauroyl sarcosinate as well as the no-observed-adverse-effect-level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies are discussed in this unit.
Sodium lauroyl sarcosinate is metabolized to the fatty acid lauric acid and the amino acid sarcosine, both of which are found naturally in food.
Sodium lauroyl sarcosinate has low acute oral toxicity, and results on a surrogate chemical showed low dermal toxicity. Two acute inhalation studies in rats showed varying LC50 values lethal concentration for 50% of the animals, with one study reporting the LC50 to be between 0.050.5 mg/L and the other indicating a LC50 of 1 to 5 mg/L. These studies indicate that sodium lauroyl sarcosinate is potentially toxic if inhaled. However, inhalation exposure to sodium lauroyl sarcosinate is not likely because it is unlikely that sodium lauroyl sarcosinate will volatilize based on its physical/chemical properties e.g.
vapor pressure and Henrys Law Constant. Sodium lauroyl sarcosinate
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caused minimal eye irritation, did not cause skin irritation, and was not a skin sensitizer.
Repeat dose oral toxicity testing in rats include a 90-day, 6-month, and 2year study. In addition, a developmental toxicity test was conducted. High repeated exposures to sodium lauroyl sarcosinate in the diet resulted in minor irritation to the stomach in studies up to 2 years. This effect was not seen as an adverse effect of treatment and therefore, the NOAEL for the 6-month and 2-year studies were 1,000 mg/kg/
day, the highest dose tested. When the test substance was administered by gavage, the effects were more severe and include, in addition to increasing thickness in the stomach wall, a yellow discoloration of non-glandular gastric mucosa, more severe squamous cell hyperplasia, hyperkeratosis/
parakeratosis, inflammation and edema of the non-glandular gastric mucosa.
Systemic effects of sodium lauroyl sarcosinate have not been observed in animal studies.
Sodium lauroyl sarcosine tested negative for genotoxic effects in various studies. Similarly, there was no evidence of carcinogenicity or neuropathological changes or effects reported in any of the studies. The agency does not believe sodium lauroyl sarcosine is carcinogenic or neurotoxic.
B. Toxicological Points of Departure/
Levels of Concern The local effects seen in the stomach in the 90-day and developmental studies are the result of gavage dosing and are not relevant for end point selection for the purposes of assessing this chemical as an inert ingredient in pesticide formulations. Therefore, no toxicological significant endpoint of concern for sodium lauroyl sarcosinate has been identified in the database.
C. Exposure Assessment 1. Dietary exposure from food, feed uses, and drinking water. In evaluating dietary exposure to sodium lauroyl sarcosinate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. Sodium lauroyl sarcosinate is currently exempt from the requirement of a tolerance under 40 CFR 180.1207 for use as an inert ingredient surfactant at levels not to exceed 10% in pesticide formulations containing glyphosate. Dietary exposure to sodium lauroyl sarcosinate may occur from eating foods treated with pesticide formulations containing this inert ingredient, from eating foods that come in contact with surfaces treated with pesticide formulations containing the inert ingredient, and drinking water
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containing runoff from soils containing the treated crops. In addition, sodium lauroyl sarcosinate is used as an additive in food packaging. However, no toxicological endpoint of concern was identified for sodium lauroyl sarcosinate and therefore, a quantitative assessment of dietary exposure is not necessary.
2. Non-dietary exposure. The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure e.g., textiles clothing and diapers, carpets, swimming pools, and hard surface disinfection on walls, floors, tables.
Residential exposure to sodium lauroyl sarcosinate may occur based on its use as an inert ingredient in pesticide formulations registered for residential uses. Additional non-dietary exposure may occur from use of sodium lauroyl sarcosinate in household products and cosmetics. However, no toxicological endpoint of concern was identified for sodium lauroyl sarcosinate and therefore a quantitative residential exposure assessment for sodium lauroyl sarcosinate was not conducted.
3. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv of FFDCA
requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
EPA has not found sodium lauroyl sarcosinate to share a common mechanism of toxicity with any other substances, and sodium lauroyl sarcosinate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has assumed that sodium lauroyl sarcosinate does not have a common mechanism of toxicity with other substances. For information regarding EPAs efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPAs website at http
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children Section 408b2C of the FFDCA
requires EPA to retain an additional tenfold margin of safety in the case of threshold effects to ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. As noted in Unit IV.B., there is no indication of threshold
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