Document ID: EPA-HQ-OPP-2015-0232-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-05-29T04:00Z

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

EPA Registration Division contact: Kerry Leifer 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:

Cytec Industries Inc.

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Cytec Industries Inc.,  5 Garret Mountain Plaza Woodland Park, NJ 07424 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 establish an exemption from the requirement of a tolerance for

	Poly(oxy-1,2-ethanediyl), α-(3-carboxy-1-oxosulfopropyl)- ω-hydroxy, alkyl ethers, disodium salts (CAS Reg. Nos. 68815-56-5, 68954-91-6,  1013906-64-3,  1024612-24-5) (referred to hereinafter as "Disodium Sulfosuccinate Polyethoxylates  or "DSP") under 40 CFR §180.910 when used as an inert ingredient (surfactant) not to exceed 10% in pesticide formulations applied pre- and post-harvest to all raw agricultural commodities.  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. [NA-Remove. No specific plant metabolism data is available, nor is it required for the establishment of a tolerance exemption.]

	2. Analytical method. [NA-Remove. 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.] 

	3. Magnitude of residues. [NA-Remove. Information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required for the establishment of a tolerance exemption.] 

B. Toxicological Profile

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.

	1. Acute toxicity.  The Disodium Sulfosuccinate Polyethoxylates are not acutely toxic by the oral and dermal routes of exposure under normal use conditions.  They are moderate-to- non-irritating to skin and eyes and are negative-to-weak sensitizers. 

	2. Genotoxicty. The Disodium Sulfosuccinate Polyethoxylates showed no evidence of mutagenicity or induction of chromosomal aberrations.

	3. Reproductive and developmental toxicity. No data are available regarding the reproductive and developmental toxicity of these compounds; however, no effects were noted on reproductive organs in the repeated dose studies.  In addition, the structures of compounds in this group do not indicate the potential to bind to estrogen receptors.  The lower molecular weight compounds would be expected to be absorbed and metabolized, thereby releasing the alcohol ethoxylate subunit.  The critical study in the review of the alkyl alcohol alkoxylates by EPA was a repeated dose study with a LOAEL of 470 mg/kg/day based on one maternal death, decreased body weight, body weight gain, and food consumption, increased clinical signs (ptosis and hypoactivity), and microscopic changes of the testes and epididymides (testicular atrophy, increased intraluminal exfoliated spermatogenic cells in epididymides, and dilated seminiferous tubules) in parental animals, decreased litter size, and increased post-implantation loss.  Therefore, it is possible that with sufficient exposure and hydrolysis of the ester bond, these endpoints could be part of the hazard profile due to possible metabolites.  However, it is noted that no effects were observed in the rat or dog repeated dose study which would indicate such findings, even when dosed at higher levels.  

	4. Subchronic toxicity. In subchronic feeding studies rats and dogs, decreases in body weight and feed efficiency were observed.  The NOAEL in rats was 1% (0.77 g/kg bw/day for males and 0.96 g/kg bw/day for females) and the NOAEL in dogs was 0.5% (0.140 g/kg bw/day).

	5. Chronic toxicity. There is no evidence that the Disodium Sulfosuccinate Polyethoxylates would be a concern for chronic toxicity based on the limited effects observed in the repeated dose studies.  In addition, no concern is noted for carcinogenicity based on the observation that the compounds lack structural alerts for genotoxicity via DNA reactivity (covalent binding) or non-genotoxic mechanisms.  The prediction that the compounds lack of structural alerts is supported by the data (negative findings in genotoxicity assays). In addition, read across to substructures evaluated by EPA does not indicate that the substructures of these compounds have been identified as a concern for genotoxicity or carcinogenicity.

	6. Animal metabolism. Data were not identified on the metabolism of the compounds; however, data regarding metabolism of similar substituted sulfosuccinate compounds indicates that they would be expected to be readily hydrolyzed by carboxylesterases resulting in the corresponding alcohol ethoxylates and the sulfosuccinic acid moiety.  The sulfosuccinic acid would be conjugated with glucuronic acid and/or excreted via the urine.  The alkyl alcohol alkoxylates are expected to be further metabolized through degradation of the ether linkage resulting in the corresponding alkyl alcohol and polyalkoxylate group which would undergo further oxidative degradation and/or excretion.

	7. Metabolite toxicology. Data on the expected hydrolysis products are common to other compound for which EPA has already reviewed.   No concern was noted by EPA regarding the toxicity of dioctyl sodium sulfosuccinate and sodium 1,4-dialkyl sulfosuccinates, which would also release sulfosuccinate upon hydrolysis.  Regarding the alkyl alcohol alkoxylates metabolites, EPA has set a cRfD of 1.68 mg/kg bw/day.

	8. Endocrine disruption. No data were identified addressing the endpoint of endocrine disruption.  As noted in the modeling of the compounds, they do not fit the rules for binding to the estrogen receptor (alpha).  In addition, data from the available repeated dose toxicity studies does not indicate a concern for this endpoint.  

C. Aggregate Exposure

	1. Dietary exposure. These exposures numbers are modeled after the EPA review of similar surfactants, the Alkyl Alcohol Alkoxylates (AAA), which have similar use patterns to those covered in this petition.  
Exposure (mg/kg/day)
100% Crop Treated, 10% Surfactant
cPAD 1.40 %cPAD
General U.S. Population
0.038302
2.7
Infants (< 1 year old)
0.079416
5.7
Children 1-2 years old
0.124801
8.9
Children 3-5 years old
0.092392
6.6
Children 6-12 years old
0.051062
3.6
Youth 13-19 years old
0.028824
2.1
Adults 20-49 years old
0.028880
2.1
Adults 50+ years old
0.030415
2.2
Females 13-49 years old
0.029078
2.1

	i. Food. The dietary exposure above is the result of modeling to represent residues on food with 100% crop treated.  This is a worst case scenario, since it is expected that a reasonable percent crop treated would be on the order of 1%.

	ii. Drinking water. In their review of similar surfactants, the Alkyl Alcohol Alkoxylates, EPA modeled expected drinking water concentrations and considered that the maximum concentration would be 100 parts per billion.  This result is included in the exposure estimates in the dietary exposure table.
 	2. Non-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). Because this petition is for use in pesticide formulations pre- and post-harvest to crops, the only expected exposure will be dietary.

D. Cumulative Effects

	We have not found a common mechanism of toxicity finding as to the Disodium Sulfosuccinate Polyethoxylates and any other substances. DSP may metabolize to Alkyl Alcohol Alkoxylates but with respect to this petition, the exposures to both materials are considered since there is an assumption that 100% of the crops are treated. 

E. Safety Determination

      1. U.S. population. Based on these risk assessments, 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 DSP.

	2. Infants and children. Based on these risk assessments 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 DSP.

F. International Tolerances

	Cytec Industries Inc. is not aware of any country requiring a tolerance for the petitioned substances nor have any CODEX Maximum Residue Levels been established for any food crops at this time.

4826-5641-7821, v.  2