Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPP-2012-0279-0003
Timestamp: 2016-02-09 07:45:31
Document Index: 581569367

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

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Tolerance Exemptions: a-(p-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) This Rule document was issued by the Environmental Protection Agency (EPA)For related information, Open Docket Folder Show agency attachment(s) ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2012-0279; FRL-9365-3]
SummaryThis regulation amends an exemption from the requirement of a tolerance for residues of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene); when used as an inert ingredient in a pesticide chemical formulation. Stephan Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates theneed to establish a maximum permissible level for residues of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) on food or feed commodities.
AddressesThe docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0279, 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 ContactWilliam Cutchin, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-7099; email address: cutchin.william@epa.gov. Supplementary InformationI. General InformationA. 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: Crop production (NAICS code 111).
Pesticide manufacturing (NAICS code 32532).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. 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-2012-0279 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 31, 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-2012-0279, by one of the following methods.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.II. Background and Statutory FindingsIn theFederal Registerof July 25, 2012 (77 FR 43562) (FRL-9353-6), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 2E8000) filed by Stephan Company, 22 West Frontage Rd., Northfield Illinois 60093. The petition requested that 40 CFR 180.960 be amended by revising an exemption from the requirement of a tolerance for residues of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene); CAS No. 37251-69-7. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.
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 exemption is “safe.” Section 408(c)(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 use 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 an exemption from the requirement of 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 * * *” and specifies factors EPA is to consider in establishing an exemption.III. Risk Assessment and Statutory FindingsEPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown 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 FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this final rule and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
7. The polymer's number average MW of 1,889 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10 percent oligomeric material below MW 500 and less than 25 percent oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
Thus, α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in 40 CFR 723.250, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).IV. Aggregate ExposuresFor the purposes of assessing potential exposure under this exemption, EPA considered that α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) is 1,889 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.V. Cumulative Effects From Substances With a Common Mechanism of ToxicitySection 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 α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) to share a common mechanism of toxicity with any other substances, and α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) 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. VI. Additional Safety Factor for the Protection of Infants and ChildrenSection 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene), EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.VII. Determination of SafetyBased on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).VIII. Other ConsiderationsA. Existing Exemptions From a ToleranceThere is an existing tolerance for α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene); poly oxyethylene content 30 to 90 moles; molecular weight (in amu) averages 3,000 in 40 CFR 180.960.B. Analytical Enforcement MethodologyAn 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.C. International Residue LimitsIn 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 isdifferent 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 α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).IX. ConclusionAccordingly, EPA finds that exempting residues of α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) from the requirement of a tolerance will be safe.X. Statutory and Executive Order ReviewsThis final rule establishes an exemption from the requirement of 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 rules 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 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).
Although this action does not 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), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population.XI. Congressional Review ActPursuant 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).
2. In the table to § 180.960, revise the following polymer entry which appears immediately above the polymer entry which reads in part “Octadecanoic acid, 12-hydroxy-* * *”, with “CAS No. 58128-22-6,” to read as follows:
***** α-(ρ-Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene); poly oxyethylene content 30 to 90 moles; minimum number average molecular weight (in amu), 1,88937251-69-7
***** * * * * *[FR Doc. 2012-26521 Filed 10-30-12; 8:45 am]BILLING CODE 6560-50-P
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Dec 31 2012, at 11:59 PM ET ID: EPA-HQ-OPP-2012-0279-0003 Tracking Number: View original printed format: Document Information Date Posted: Oct 31, 2012RIN: Not AssignedCFR: 40 CFR Part 180Federal Register Number: 2012-26521 Show More Details Submitter Information Comments0 Comments Received* Docket Information This document is contained in EPA-HQ-OPP-2012-0279 Related Dockets: NoneRelated RINs: NoneRelated Documents: Pesticide Petitions Filed for Residues of Pesticide... Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!