Source: https://www.federalregister.gov/documents/2016/01/22/2016-01154/propanoic-acid-2-methyl--monoester-with-224-trimethyl-13-pentanediol-exemption-from-the-requirement
Timestamp: 2017-10-20 02:11:50
Document Index: 57229432

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 2', '§\u2009180']

Federal Register :: Propanoic acid, 2-methyl-, monoester With 2,2,4-trimethyl-1,3-pentanediol; Exemption From the Requirement of a Tolerance
Propanoic acid, 2-methyl-, monoester With 2,2,4-trimethyl-1,3-pentanediol; Exemption From the Requirement of a Tolerance
A Rule by the Environmental Protection Agency on 01/22/2016
This regulation is effective January 22, 2016. Objections and requests for hearings must be received on or before March 22, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
3723-3726 (4 pages)
EPA-HQ-OPP-2015-0373
FRL-9941-17
Dow AgroSciences Notice Of Filing Pesticide Petition# IN-10786...
https://www.federalregister.gov/d/2016-01154 https://www.federalregister.gov/d/2016-01154
This regulation establishes an exemption from the requirement of a tolerance for residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol when used as an inert ingredient (solvent, co-solvent) in pesticide formulations applied to growing crops or raw agricultural commodities under the EPA's regulations. Dow AgroSciences submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0373, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/​cgi-bin/​text-Start Printed Page 3724idx?​&​c=​ecfr&​tpl=​/​ecfrbrowse/​Title40/​40tab_​02.tpl.
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0373 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 22, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0373, by one of the following methods:
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10786) by Dow AgroSciences, 9330 Zionville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS Reg. No. 25265-77-4) when used as an inert ingredient as a solvent or co-solvent in pesticide formulations applied to growing crops or raw agricultural commodities after harvest. That document referenced a summary of the petition prepared by Dow AgroSciences, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol follows.
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 propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol has low acute toxicity with oral lethal dose (LD)50 values >3,200 milligram/kilogram (mg/kg), dermal LD50 values >14,000 Start Printed Page 3725mg/kg, and inhalation lethal concentration (LC)50 values >3.55 mg/liter (L) in rats, rabbits, and guinea pigs. In a 15-day oral gavage study in rats, the NOAEL was >1,000 mg/kg/day. In a combined repeat dose toxicity and developmental and reproductive toxicity screening test in rats, no reproductive or developmental toxicity was observed at doses up to 1,000 mg/kg body weight (bw)/day, the highest dose tested.
No chronic toxicity studies were available; however, the lack of systemic toxicity in two shorter repeat dose studies at the limit dose of 1,000 mg/kg bw/day indicates that chronic toxicity is not a concern.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol was negative genotoxicity in the Ames assay and in vivo micronucleus assay.
No cancer study is available for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol, however based on the lack of genotoxicity, no adverse effects seen in subchronic toxicity studies, and structure-activity relationship models (QSAR) modeling that did not indicate any triggers for carcinogenicity, propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is not expected to be carcinogenic.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is a mixture of the 1-substituted (−65%) and the 3-substituted (−35%) monoisobutyrate isomers of 2,2,4-trimethyl-l,3-pentanediol. The half-life of the 1-substituted isomer in human and rat blood is between 15 to 22 minutes. No specific information is available on toxicity of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol metabolites. However, propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is rapidly metabolized in rat blood, and toxicity of parent propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol in rats was not observed at doses up to 1,000 mg/kg/day, so metabolite toxicity is anticipated to be low.
Since there is no indication of toxicity at the limit dose, a toxicological endpoint of concern for risk assessment purposes was not identified. Since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation exposure, a quantitative risk assessment for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is not necessary.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol in food as follows:
Dietary exposure can occur from eating foods containing residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol. Because no hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), a quantitative dietary exposure risk assessment was not conducted.
2. Dietary exposure from drinking water. Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol residues may be found in drinking water. However, since an endpoint of concern was not identified for the dietary assessment (food and drinking water), a quantitative dietary exposure risk assessment was not conducted.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is used as an inert ingredient in pesticide products that could result in short- and intermediate-term residential exposure. However, based on the lack of toxicity, a quantitative exposure assessment from residential exposures was not performed.
EPA has not found propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol to share a common mechanism of toxicity with any other substances, and propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/​pesticides/​cumulative.
Based on an assessment of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and has determined that a qualitative assessment is appropriate. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.Start Printed Page 3726
Based on the lack of any toxicological endpoints of concern, EPA 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 propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol residues.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS Reg. No. 25265-77-4) when used as an inert ingredient (solvent or co-solvent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.
2. In § 180.910, add alphabetically the entry “Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol” to the table to read as follows:
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS Reg. No. 25265-77-4) Solvent, co-solvent.
[FR Doc. 2016-01154 Filed 1-21-16; 8:45 am]