Exemptions from Requirements of Tolerances: Alkyl Amines Polyalkoxylates
This Rule document was issued by the Environmental Protection Agency (EPA)
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a Tolerance
Environmental Protection Agency (EPA).
This regulation amends the exemption from the requirement of a tolerance for residues alkyl amines polyalkoxylates under 40 CFR 180.920 and 40 CFR 180.930 to include the additional Chemical Abstract Service Registry Number (CAS Reg. No.) 1266162-49-5. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing requirement of a tolerance.
This regulation is effective October 10, 2012. Objections and requests for hearings must be received on or before December 10, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of theSUPPLEMENTARY INFORMATION).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-0949 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), EPA West 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.
For Further Information Contact
Elizabeth Fertich, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8560; email address: firstname.lastname@example.org.
I. General Information
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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2011-0949 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 December 10, 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 (excluding 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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0949, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In theFederal Registerof March 14, 2012 (77 FR 15012) (FRL-9335-9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 1E7931) by BASF Corporation, 100 Campus Drive; Florham Park, NJ 07932. The petition requested that 40 CFR 180.920 and 180.930 be amended by modifying an exemption from the requirement of a tolerance for residues of N,N-Bis-α-ethyl-ω-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8, 288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-5, 73246-96-5); herein referred to as alkyl amines polyalkoxylates. Specifically, the petition requested that the exemption also include the alkyl amines polyalkoxylate described by CAS Reg. No. 1266162-49-5. That notice referenced a summary of the petition prepared by BASF Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
In this petition, BASF Corporation claims that the chemical represented by CAS Reg. No. 1266162-49-5 (poly(oxy-1,2-ethandiyl), α,α'-[[(2-propylheptyl)imino]di-2,1-ethanediyl]bis[ω-hydroxy-) is covered by the published tolerance exemption for alkyl amines polyalkoxylates and that no further data or review is required to amend the existing tolerance exemption to include the additional CAS Reg. No.
III. Inert Ingredient Definition
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
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 ingredient 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 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 alkyl amine polyalkoxylates including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with alkyl amine polyalkoxylates follows.
The Agency agrees with the petitioner that CAS Reg. No. 1266162-49-5 is an alkyl amine polyalkoxylate similar to the other alkyl amine polyalkoxylates present in the exemption for N,N-Bis-α-ethyl-ω-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8, 288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8, 70955-14-5, 73246-96-5). In 2009, in establishing the exemption for the alkyl amine polyalkoxylates, EPA assessed the safety of the alkyl amine polyalkoxylates generally using worst case exposure assumptions. (74 FR 28616) (FRL-8418-6). EPA concluded that that assessment showed that exempting the alkyl amine polyalkoxylates from the requirement from a tolerance would be safe. Inclusion of chemical described by the CAS Reg. No. 1266162-49-5 in the risk assessment for the alkyl amine polyalkoxylates would in no way alter that prior risk assessment given the generic findings on toxicity and the worst case exposure assumptions used in that risk assessment. Accordingly, based on the findings in that earlier rule, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to alkyl amine polyalkoxylates, including the chemical described by the CAS Reg. No.1266162-49-5, under reasonably foreseeable circumstances. Therefore, the amendment of an exemption from tolerance under 40 CFR 180.920 and 180.930 for residues of alkyl amine polyalkoxylates to include the chemical described by the CAS Reg. No. 1266162-49-5 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.
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 United Nations 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 an MRL for alkyl amine polyalkoxylates.
Therefore, the exemption from the requirement of a tolerance under 40 CFR 180.920 and 180.930 for alkyl amine polyalkoxylates is amended to include CAS Reg. No. 1266162-49-5.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 28, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
Part 180 Amended
1. The authority citation for part 180 continues to read as follows:
21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended by revising the following inert ingredient to read as follows:
§ 180.920 Inert ingredients use pre-harvest; exemptions from the requirement of a tolerance.
* * * * *
3. In § 180.930, the table is amended by revising the following inert ingredient to read as follows:
§ 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance.
* * * * *
[FR Doc. 2012-24776 Filed 10-9-12; 8:45 am]
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Comment Period Closed
Dec 10 2012, at 11:59 PM ET
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Date Posted: Oct 10, 2012
RIN: Not Assigned
CFR: 40 CFR Part 180
Federal Register Number: 2012-24776
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