Source: https://www.federalregister.gov/documents/2010/08/20/2010-20581/2-methyl-13-propanediol-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2016-10-28 16:03:12
Document Index: 764051953

Matched Legal Cases: ['art 180', 'ART 180', 'art 180', 'art 180', 'art2', '§\u2009180', 'art3', '§\u2009180']

51388-51392
II. Petition for Exemption III. Inert Ingredient Definition
E. Aggregate Risks and Determination of Safety V. Other Considerations
A. Analytical Enforcement Methodology B. International Residue Limits
List of Subjects in 40 CFR Part 180 PART 180—[AMENDED]
https://www.federalregister.gov/d/2010-20581
SUMMARY: 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 in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, and when used as an inert ingredient solvent and/or surfactant in pesticide formulations applied to animals (used for food). 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.
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2002-0185. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Keri Grinstead, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; e-mail address: grinstead.keri@epa.gov.
You may access a frequently updated electronic version of 40 CFR part 180 Start Printed Page 51389through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/​ecfr. C. How Can I File an Objection or Hearing Request?
II. Petition for Exemption In the Federal Register of August 28, 2002 (67 FR 55243) (FRL-7194-6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 2E6484) by Lyondell Chemical Company, 1221 McKinney Street, Suite 1600, Houston, TX 77253-2583. The petition requested that 40 CFR part 180 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) in or on all raw agricultural commodities. 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. III. Inert Ingredient Definition
Consistent with section 408(c)(2)(A) of FFDCA, 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. A. Toxicological Profile
Acute toxicity studies of 2-methyl-1,3-propanediol in the rat indicate that this compound is practically non-toxic (EPA Toxicity Category IV) by the oral and inhalation exposure routes. The oral LD50 is greater than 5,000 milligrams/kilogram (mg/kg) and the inhalation LC50 is greater than 5,100 mg/m3. It is slightly toxic by the dermal exposure route (EPA Toxicity Category III) with an acute dermal LD50 in rabbits of greater than 2,000 mg/kg. Acute irritation studies in rabbits indicate that 2-methyl-1,3-propanediol is not irritating to the skin and eyes. Based on the results of a dermal sensitization study in guinea pigs, 2-methyl-1,3-propanediol was determined to have mild sensitizing potential. Start Printed Page 51390
Repeat oral exposure produced no toxicity at doses up to and including 1,000 mg/kg/day. No neurotoxicity studies are available; however, no clinical signs of neurotoxicity or any systemic toxicity were observed in any of the available studies. 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. No developmental, reproductive, or teratogenic effects were seen in the available studies at doses up to and including 1,000 mg/kg/day (highest dose tested). No carcinogenicity studies are available for 2-methyl-1,3-propanediol and it has not been evaluated by the International Agency for Research on Cancer (IARC). Based on available studies, there is no evidence of genotoxic activity. There is no evidence of systemic toxicity at doses up to and including 1,000 mg/kg/day in the available toxicity studies, such as 14-day oral gavage study in rats, 90-day oral gavage study in rats, developmental toxicity studies in rats and rabbits and 2-generation reproduction study in rats. In addition, a qualitative structure activity relationship database, DEREK Version 11, identified no structural alerts suggestive of carcinogenicity. Based on the weight of the evidence, the Agency has determined that 2-methyl-1,3-propanediol 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 as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 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. B. Toxicological Points of Departure/Levels of Concern
There was no hazard identified in repeat dose toxicity and reproductive/developmental studies at the limit dose of 1,000 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. 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.
No hazard was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term residential assessments, and therefore no aggregate risk assessments were performed. 1. Dietary exposure from food and feed uses and drinking water. Since an endpoint for risk assessment was not identified, an exposure assessment for 2-methyl-1,3-propanediol was not conducted. The primary route of exposure to 2-methyl-1,3-propanediol from its use as an inert ingredient in pesticide products would most likely be through consumption of food to which pesticide products containing it have been applied, and possibly through drinking water (from runoff). 2. From 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). Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for 2-methyl-1,3-propanediol was not conducted. Residential (dermal and inhalation) exposures from home garden uses are possible. 3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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 pesticide's residues and “other substances that have a common mechanism of toxicity.”
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 website 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/Start Printed Page 51391day. No developmental, reproductive, or teratogenic 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 an inert ingredient in pesticide formulations for pre-harvest and post-harvest uses, as well as, for application to animals, 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.
E. Aggregate Risks and Determination of Safety 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-propanediol 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 above, 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 at doses up to 1,000 mg/kg/day and a lack of any apparent developmental effects.
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 reasonably foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 and 180.930 for residues of 2-methyl-1,3-propanediol when used as an inert ingredient in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and to animals (used for food), is safe under FFDCA section 408. V. Other Considerations
A. Analytical Enforcement Methodology 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.
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
Start Printed Page 51392
Start Amendment Part2. In § 180.910, the table is amended by adding alphabetically the following inert ingredient to read as follows:End Amendment Part
Inert ingredientsLimitsUses* * * * * * *2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0)Solvent, surfactant* * * * * * *
Start Amendment Part3. In § 180.930, the table is amended by adding alphabetically the following inert ingredient to read as follows:End Amendment Part