


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

EPA Registration Division contact: PV Shah, 703-308-1846

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:

Ecolab, Inc.


[IN-10549]

	EPA has received a pesticide petition ([IN-10549]) from Ecolab, Inc., EPA Company Number 1677, 370 N. Wabasha Street, St. Paul, MN 55102, 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.

   2. to establish an exemption from the requirement of a tolerance for

	[9-Octadecenoic acid (9Z)-, sulfonated, oxidized (CAS No. 1315321-93-7) (when formed using the pre-reaction material 9-octadecenoic acid (9Z-) sulfonated, (CAS No. 68988-76-1)); 9-Octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts (CAS No. 1315321-94-8) (when formed using the pre-reaction material 9-octadecenoic acid (9Z-) sulfonated, potassium salt (CAS No. 68609-93-8)); and 9-Octadecenoic acid (9Z)-, sulfonated, oxidized, sodium salts, (CAS No. 1315321-95-9) (when formed using the pre-reaction material 9-octadecenoic acid (9Z-) sulfonated, sodium salt (CAS No. 68443-05-0)) (also referred to as peroxy sulfonated oleic acids (PSOA)) for use as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils in accordance with 40 CFR §180.940(a)] at [250] parts per million (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 granting of the petition. Additional data may be needed before EPA rules on the petition.


A. Residue Chemistry

	1. Plant metabolism. [Not applicable/Not required for the establishment of a tolerance exemption for inert ingredients.]

	2. Analytical method. [Not applicable/Not required for the establishment of a tolerance exemption for inert ingredients.]

	3. Magnitude of residues. [Not applicable/Not required for the establishment of a tolerance exemption for inert ingredients.]

B. Toxicological Profile

	1. Acute toxicity.  [Based on the physio-chemical nature and characteristics of the compound as an organic acid, PSOA is expected to be corrosive.  The results of an in vitro rat dermal irritation study indicate that PSOA is corrosive to the skin.  Due to the corrosive nature of PSOA, acute toxicity studies by the dermal and inhalation route, acute eye irritation, and skin sensitization studies were not conducted.  Due to the corrosive nature of PSOA and in the interest of animal welfare, the acute oral toxicity study in rats was only conducted up to 300 mg/kg PSOA.  No animals died at 300 mg/kg PSOA and the LD50 was reported as >300 mg/kg (EPA Toxicity Category II).]  

	2. Genotoxicity. [Three in vitro mutagenicity studies and one in vivo mutagenicity study were conducted with PSOA.  Two of the in vitro studies were negative for mutagenicity, while one was positive for inducing chromosome aberration in mammalian cells.  However, the in vivo micronucleus test with bone marrow cells of the rat demonstrated that PSOA is considered to be non-mutagenic in this assay.  This study is further supported by the expected mammalian metabolism, which indicates that mammalian species will be exposed to Sulfonated Oleic Acid (SOA), not PSOA internally.  Based on the EPA's Re-registration Eligibility Decision (RED) document for Oleic Acid Sulfonates and Related Compounds (US EPA, 2005), there are no concerns for mutagenicity for sulfonated oleic acid (SOA), sodium salt and therefore, no mutagenicity analysis was conducted for that compound.]

      3. Reproductive and developmental toxicity. [A rat developmental toxicity study (OECD Guideline 414) was conducted with PSOA.  Animals were dosed by oral gavage daily from Day 6 to Day 19 of gestation at dosages of 0 (vehicle control) 5, 15, or 50 mg/kg/day PSOA.  

No test substance-related mortality was reported.  No abnormalities or variations were attributable to treatment with PSOA and all findings were considered to be incidental and not toxicologically significant.  The parental no-observable adverse effect level (NOAEL) for systemic effects was 50 mg/kg/day, and the NOAEL for embryotoxic, fetotoxic, and developmental effects was also 50 mg/kg/day, the highest dose tested.]

	4. Subchronic toxicity. [A subchronic oral toxicity study was conducted with PSOA in which rats were administered PSOA at 0 (vehicle control), 5, 15 or 50 mg/kg/day by oral gavage for 28 days.  The study also included additional animals in order to determine the 14-day recovery after cessation of treatment with PSOA.  

There were no PSOA-related findings noted in any of the parameters assessed.  The mucous membranes of the esophagus and stomach tolerated PSOA up to a concentration of 5 mg/mL (0.5%) without any adverse effects.  With regard to the local mucous membrane compatibility, a no observed effect concentration (NOEC) of 0.5% can be derived.

In conclusion, administration of PSOA by once daily oral gavage for 28 days was well tolerated in rats at levels of 5, 15 and 50 mg/kg/day.  Based on these results, the no-observed adverse effect level (NOAEL) was 50 mg/kg/day.]

	5. Chronic toxicity. [No long term studies are available for PSOA.]

	6. Animal metabolism. [There are currently no available PSOA mammalian metabolism studies. However, given the proposed conditions of use in which PSOA would be exposed to heat and light during the process of sanitizing food contact surfaces and sanitizing/disinfecting dairy processing equipment and food processing equipment and utensil, it should be expected that PSOA, as expected of peroxy acids and hydrogen peroxide, would rapidly decompose to oleic acid sulfonates (SOA), water and oxygen.   

The Risk Assessment for EPA's RED document for Oleic Acid Sulfonates (US EPA, 2005) has stated the following:

"The oleic acid sulfonates are considered to be fatty acid derivatives.  Fatty acids are a group of compounds which are monocarboxylic acids attached to aliphatic carbon chains. Oleic acid (unsaturated C18) is one of the most common naturally occurring fatty acids.  Fatty acids are present in common fats and oils (such as corn oil, peanut oil, and butter) as triglycerides... Free fatty acids are then degraded to produce acetyl CoA (one acetyl CoA for each 2 carbons in the chain) which is used in the Citric Acid Cycle or for ketone body synthesis..."]

	7. Metabolite toxicology. [There are no metabolites of toxicological concern.] 

	8. Endocrine disruption. [There is currently no information to suggest that PSOA should have any endocrine mediated estrogen, androgen or thyroid effects. Further, PSOA does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system.]

C. Aggregate Exposure

1. Dietary exposure. 

	i. Food.  [A dietary risk assessment was conducted to evaluate the potential exposure and risk to humans from the use of PSOA as an inert ingredient in food-use antimicrobial formulations.  The proposed chronic Population Adjusted Dose (cPAD) for PSOA is 0.5 mg/kg/d based on the NOAEL of 50 mg/kg/d from the 28-day oral toxicity study and the rat developmental toxicity study.  The standard 10X uncertainty factors for inter- and intra-species extrapolation are applied to calculate the cPAD.

The results of the dietary risk assessment, which incorporated potential exposures from use of sanitizing solutions containing PSOA, demonstrated that the estimated exposures do not exceed 2.9% of the cPAD for all of the population groups.]

	ii. Drinking water.  [PSOA is unlikely to be present in the environment at any appreciable levels when used as a pesticide inert ingredient in indoor antimicrobial formulations.  Furthermore, based on the physical chemical characteristics of PSOA, it is anticipated to break down rapidly in the environment.  Any contribution to exposure from drinking water would be unlikely.]  

2. Non-dietary exposure. [There are no known current commercial or residential use products containing PSOA, therefore, it is not appropriate to perform an aggregate risk assessment for PSOA.]

D. Cumulative Effects [EPA has not made a common mechanism of toxicity finding for PSOA. Further, PSOA is not anticipated to have a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on the quantitative dietary risk assessment using the toxicological endpoint of 50 mg/kg, the total exposure estimates for adult males and females are below 1.0% of the cPAD.  These exposure estimates demonstrate that there is reasonable certainty of no harm to all population subgroups as a result of dietary exposure to PSOA when used according to the applications consistent with 40 CFR §180.940(a).]

	2. Infants and children. [The FFDCA Section 408 requires an additional tenfold margin of safety for the protection of infants and children in case of threshold effects to account for prenatal and postnatal toxicity, and an inadequate toxicity database.  Where an adequate and reliable database is available and there is a lack of evidence for increased susceptibility, the FQPA safety factor may be reduced or removed.  On the basis of the available data for PSOA, the assignment of a FQPA Safety Factor for PSOA is not warranted.  No developmental or maternal effects were demonstrated in the developmental toxicity study.

Based on the quantitative dietary risk assessment using the toxicological endpoint of 50 mg/kg, the total exposure estimate for the most sensitive population subgroup, children, is 2.9% of the cPAD.  This exposure estimate demonstrates that there is reasonable certainty of no harm to all population subgroups as a result of dietary exposure to PSOA when used according to the applications consistent with 40 CFR §180.940(a).]

F. International Tolerances
[Currently, there are no known international tolerances established for PSOA.] 
