2-methyl-1,3-propanediol; Exemption from the Requirement of a Tolerance
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.
Table of Contents Back to Top
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- I. General Information
- A. Does this Action Apply to Me?
- B. How Can I Get Electronic Access to Other Related Information?
- C. How Can I File an Objection or Hearing Request?
- II. Petition for Exemption
- III. Inert Ingredient Definition
- IV. Aggregate Risk Assessment and Determination of Safety
- A. Toxicological Profile
- B. Toxicological Points of Departure/Levels of Concern
- C. Exposure Assessment
- D. Safety Factor for Infants and Children
- E. Aggregate Risks and Determination of Safety
- V. Other Considerations
- A. Analytical Enforcement Methodology
- B. International Residue Limits
- VI. Conclusions
- VII. Statutory and Executive Order Reviews
- VIII. Congressional Review Act
- List of Subjects in 40 CFR Part 180
- PART 180—[AMENDED]
DATES: Back to Top
This regulation is effective August 20, 2010. Objections and requests for hearings must be received on or before October 19, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: Back to Top
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: Back to Top
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: firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: Back to Top
I. General Information Back to Top
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
- Crop production (NAICS code 111).
- Animal production (NAICS code 112).
- Food manufacturing (NAICS code 311).
- Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
C. How Can I File an Objection or Hearing Request?
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-2002-0185 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 19, 2010. 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-2002-0185, by one of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
- Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
- Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption Back to Top
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 Back to Top
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
IV. Aggregate Risk Assessment and Determination of Safety Back to Top
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
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
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.
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 LD 50 is greater than 5,000 milligrams/kilogram (mg/kg) and the inhalation LC 50 is greater than 5,100 mg/m 3. It is slightly toxic by the dermal exposure route (EPA Toxicity Category III) with an acute dermal LD 50 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.
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
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level - generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) - and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
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.
C. Exposure Assessment
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.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
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, 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 Back to Top
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.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for 2-methyl-1,3-propanediol.
VI. Conclusions Back to Top
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 and 40 CFR 180.930 for 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) when used as an inert ingredient in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and to animals (used for food).
VII. Statutory and Executive Order Reviews Back to Top
This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
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).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act Back to Top
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).
Dated: August 10, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180—[AMENDED] Back to Top
1.The authority citation for part 180 continues to read as follows:
2.In § 180.910, the table is amended by adding alphabetically the following inert ingredient to read as follows:
§ 180.910 Inert Ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.
* * * * *
|2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0)||Solvent, surfactant|
* * * * *
3.In § 180.930, the table is amended by adding alphabetically the following inert ingredient to read as follows:
§ 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance.
|2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0)||Solvent, surfactant|
[FR Doc. 2010-20581 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S