Source: https://www.federalregister.gov/articles/2012/08/01/2012-18506/2-methyl-13-propanediol-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2016-02-12 12:05:51
Document Index: 462631472

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

Dates: This regulation is effective August 1, 2012. Objections and requests for hearings must be received on or before October 1, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
-45498 (4 pages)
EPA-HQ-OPP-2012-0031
FRL-9352-6
Document Number: 2012-18506
Shorter URL: https://federalregister.gov/a/2012-18506 Related Topics
Petition #1E7946; 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) for an exemption under 40 CFR 180.940
Memorandum for Petition # 1E7946; 2-Methyl-1,3-Propanediol...
Petition#1E7946; Notice of Filing for 2-methyl-1,3-propanediol...
This regulation establishes an exemption from the requirement of a tolerance for residues of 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) when used as an inert ingredient component of food contact sanitizing solutions applied to all food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. Lyondell Chemical Company 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 2-methyl-1,3-propanediol.
This regulation is effective August 1, 2012. Objections and requests for hearings must be received on or before October 1, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0031, is available either electronically through http://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, 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.
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-2012-0031 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 October 1, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0031, by one of the following methods:
http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 1E7946) by Lyondell Chemical Company, 1221 McKinney Street, Houston, Texas 77010. The petition requested that 40 CFR 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) when used as a component of food contact sanitizing solutions applied to all food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. That notice referenced a summary of the petition prepared by Lyondell Chemical Company, 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 2-methyl-1,3-propanediol including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with 2-methyl-1,3-propanediol 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 2-methyl-1,3-propanediol 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 the final rule published in the Federal Register of August 20, 2010 (75 FR 51388) (FRL-8838-3).
There was no hazard identified in repeat dose toxicity and reproductive/developmental studies with 2-methyl-1,3-propanediol at the limit dose of 1,000 milligram/kilogram/day (mg/kg/day) to either parental animals or their offspring. Thus, due to its low potential hazard and lack of a hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate for 2-methyl-1,3-propanediol.
2-Methyl-1,3-propanediol was not mutagenic in an in vitro chromosome aberration test, bacterial gene mutation test, and mammalian cell gene mutation assay and based on the available information, it is not anticipated to be carcinogenic. Specific information on the studies received and the nature of the adverse effects caused by 2-methyl-1,3-propanediol are discussed in the final rule published in the Federal Register of August 20, 2010 (75 FR 51388) and can be found at http://www.regulations.gov in the document “Decision Document for Petition Number 2E6484; 2-methyl-1,3-propanediol [CAS Reg No. 2163-42-0], requesting the establishment of an inert ingredient exemption from the requirement of a tolerance” in docket ID number EPA-HQ-OPP-2002-0185.
No hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term residential assessments (via all exposure routes), therefore, acute and chronic dietary and short-, intermediate-, and long-term residential exposure assessments were not performed.
EPA has not found 2-methyl-1,3-propanediol to share a common mechanism of toxicity with any other substances, and 2-methyl-1,3-propanediol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-methyl-1,3-propanediol 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.
The toxicity database for 2-methyl-1,3-propanediol is adequate for FQPA assessment and the potential exposure is adequately characterized given the low toxicity of the chemical. No hazard was identified and there is no residual uncertainty regarding prenatal and/or postnatal toxicity. No acute or subchronic neurotoxicity studies are available, but there were no clinical signs of neurotoxicity or any systemic toxicity observed in the available database at doses up to 1,000 mg/kg/day. No developmental or reproductive effects were seen in the available studies at doses up to and including 1,000 mg/kg/day.
Based on this information, there is no concern, at this time, for increased sensitivity to infants and children to 2-methyl-1,3-propanediol when used as a component of food contact sanitizing solutions applied to all food contact surfaces and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children.
Given the lack of concern for hazard posed by 2-methyl-1,3-propanediol, EPA concludes that there are no dietary or aggregate dietary/non-dietary risks of concern as a result of exposure to 2-methyl-1,3-propnaediol in food and water or from residential exposure. Residues of concern are not anticipated for dietary exposure (food and drinking water) or for residential exposure from the use of 2-methyl-1,3-propanediol as an inert ingredient in pesticide products. As discussed in this unit, EPA expects aggregate exposure to 2-methyl-1,3-propanediol to pose no appreciable dietary risk given that the data show a lack of any systemic toxicity or adverse developmental/reproductive effects at doses up to 1,000 mg/kg/day.
Taking into consideration all available information on 2-methyl-1,3-propanediol, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to 2-methyl-1,3-propanediol under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.940(a) for residues of 2-methyl-1,3-propanediol when used as a component of food contact sanitizing solutions applied to all food contact surface in public eating places, dairy-processing equipment, and food-processing equipment and utensils, is safe under FFDCA section 408.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for residues of 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) when used as a component of food contact sanitizing solutions applied to all food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils.
G. Jeffery Herndon,
2.In § 180.940(a), the table is amended by adding alphabetically the following inert ingredient after the entry for “Magnesium oxide” to read as follows: § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food contact surface sanitizing solutions).
[FR Doc. 2012-18506 Filed 7-31-12; 8:45 am]