[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate and Phosphate Esters; Exemption From the Requirement of a Tolerance, 27126-27130 [2012-10933]

Download as PDF 27126 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM) * * * * * 700 Special Standards * * * * * 707 Periodicals * * 6.0 Qualification Categories 6.1 General Publications * * * * * * * * 6.1.2 Circulation Standards General publications must meet these circulation standards: * * * * * [Revise the first sentence in f as follows:] f. At least 50% of a publication’s distribution must be to persons who have paid above a nominal price. (For explanation of how electronic copies may be included, see 6.5.) * * * * * * * * * * * sroberts on DSK5SPTVN1PROD with RULES [FR Doc. 2012–11107 Filed 5–8–12; 8:45 am] * 6.4.2 Circulation Standards Requester publications must meet these circulation standards: * * * * * [Revise item b as follows:] b. Subscription copies of the publications that are paid for or promised to be paid for, including those at or below a nominal price, may be included in the determination of whether the 50% request requirement is met. (For explanation of how electronic copies may be included, see 6.5.) * * * * * [Renumber current 6.5 through 6.6 as new 6.6 through 6.7 and add new 6.5 as follows:] 6.5 Electronic Copies Copies of Periodicals publications distributed through email or by accessing a password protected Web site may be counted toward an approved or pending general or requester publication’s eligibility for Periodicals prices. The following conditions additionally apply: a. Electronic copies that may be counted toward a publication’s eligibility for Periodicals prices: 1. Must be paid at a price above nominal rate for publications approved in the General category; or 2. Must be requested in writing or by electronic correspondence for publications approved in the Requester category. VerDate Mar<15>2010 Stanley F. Mires, Attorney, Legal Policy and Legislative Advice. BILLING CODE 7710–12–P 6.4 Requester Publications * b. Electronic copies of a Periodicals publication for which access is offered free in conjunction with printed copies of the same issues may not be counted when determining total circulation for the publication. c. At least 40% of the total circulation of each issue must consist of printed copies distributed to paying subscribers or requesters, as applicable. Up to 10% of the distributed copies used to qualify or remain eligible for Periodicals prices may be copies that are paid or requested to be sent electronically. d. If less than 60% of a Periodicals publication’s total circulation consists of printed copies distributed to paying subscribers or requesters, as applicable, annual Postal eligibility audits must be conducted by a certified audit bureau. * * * * * We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes. 15:36 May 08, 2012 Jkt 226001 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2011–0526; FRL–9340–2] α-(p-Nonylphenol)-whydroxypoly(oxyethylene) Sulfate and Phosphate Esters; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of a-(pnonylphenol)-whydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts when used as inert ingredients at levels not to exceed 7% in pesticide formulations applied to growing crops, raw agricultural commodities after harvest and animals. The Joint Inerts Task Force, (JITF) Cluster Support Team Number (CST) 9 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting SUMMARY: PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts. DATES: This regulation is effective May 9, 2012. Objections and requests for hearings must be received on or before July 9, 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). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2011–0526. All documents in the docket are listed in the docket index available at https://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 https://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: Kerry Leifer, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 308–8811; email address: leifer.kerry@epa.gov. ADDRESSES: SUPPLEMENTARY INFORMATION 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. Potentially E:\FR\FM\09MYR1.SGM 09MYR1 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 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. sroberts on DSK5SPTVN1PROD with RULES 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 https://ecfr. gpoaccess.gov/cgi/t/text/text-idx?&c= ecfr&tpl=/ecfrbrowse/Title40/40tab_ 02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ 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–2011–0526 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 July 9, 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 VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2011–0526, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online 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. Background In the Federal Register of August 26, 2011 (76 FR 53372) (FRL–8884–9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 1E7860) by Joint Inerts Task Force, Cluster Support Team 9, c/o CropLife America, 1156 15th St. NW., Suite 400, Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts when used as inert ingredients at levels not to exceed 7% in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and to animals. That notice referenced a summary of the petition prepared by JITF, CST 9, the petitioner, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. Previously, in the Federal Register of May 17, 2010 (75 FR 27434) (FRL–8826– 3), EPA established a time-limited tolerance exemption for a-(pnonylphenol)-whydroxypoly(oxyethylene) mixture of dihydrogen phosphate and PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 27127 monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts (herein referred to in this document as nonylphenol ethoxylate phosphate and sulfate derivatives or NPEPSDs) with an expiration date of May 17, 2012. The 2year time limitation was established for two purposes: 1. To provide time for the development and submission of confirmatory toxicity data to address equivocal results in the available genotoxicity studies conducted on NPEPSDs (as described in Unit IV of the May 17, 2010 final rule); and 2. To provide additional time, should the initial testing not confirm EPA’s conclusion regarding the lack of a cancer concern, for registrants to attain EPA approval of registration amendments for reformulation of their pesticide products to remove NPEPSDs and to replace existing products with reformulated products. In establishing the time-limited tolerance exemption for NPEPSDs, EPA stated that if the submitted data confirmed its conclusion regarding a lack of cancer concern, the Agency intended to remove the expiration date from the tolerance exemption prior to expiration of the exemption. 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 E:\FR\FM\09MYR1.SGM 09MYR1 sroberts on DSK5SPTVN1PROD with RULES 27128 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 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 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 NPEPSDs including exposure resulting from the exemption established by this action. In the Federal Register of May 17, 2010, EPA issued a final rule establishing an exemption from the requirement of a tolerance for residues of NPEPSDs when used as an inert ingredient at levels not to exceed 7% in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910 with an expiration date of May 17, 2012. EPA has determined that VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 establishing an exemption from the requirement of a tolerance for residues of NPEPSDs when used as an inert ingredient at levels not to exceed 7% in pesticide formulations applied to growing crops and raw agricultural commodities after harvest will not significantly change the risk assessments the Agency relied on to support the May 17, 2010, tolerance action, as explained in this unit. As part of the Agency’s conduct of the risk assessment in support of the May 17, 2010, tolerance action, it was determined that there were no acute, chronic, short- or intermediate term aggregate risks of concern. With regards to aggregate cancer risk, the assessment concluded that based on a weight of the evidence consideration of the available data, the Agency believed that cancer risks would be negligible. However, due to the equivocal findings in the mutagenicity data base, the Agency asked for confirmatory data. Specifically, EPA recommended that supporters of the NPEPSD tolerance exemption perform the following studies for confirmatory purposes: A new Ames assay (OCSPP Harmonized Guideline 870.5100— Bacterial reverse mutation test) and a mouse lymphoma assay (OCSPP Harmonized Guideline 870.5300—in vitro Mammalian cell gene mutation test). A bone marrow assay (OCSPP Harmonized Guideline 870.5395— Mammalian erythrocyte micronucleus test). Since in vivo mutagenicity studies such as the bone marrow assay are generally regarded as more definitive than in vitro studies, and a negative result in the bone marrow test may outweigh whatever results are found in the Ames test and mouse lymphoma assay, supporters of the NPEPSD tolerance exemption were given the option of conducting the mammalian erythrocyte micronucleus test in lieu of the two in vitro mutagenicity studies. If those data did not confirm EPA’s cancer conclusion, then EPA would need 2year cancer bioassays in the mouse and rat (OCSPP Harmonized Guideline 870.4200—Carcinogenicity (mouse) and OCSPP Harmonized Guideline 870.4300—Combined Chronic Toxicity/ Carcinogenicity (rat)) to make a safety finding in support of the tolerance exemption. In response to the May 17, 2010, final rule, the JITF, CST 9 conducted an in vivo Mouse Bone Marrow Erythrocyte Micronucleus Test Following Oral Administration (OCSPP Harmonized Test Guideline 870.5395) of two representative test compounds, PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 poly(oxy-1,2-ethanediyl)-a-(pnonylphenyl)-w-hydroxy-, branched, phosphates (CAS Reg. No. 68412–53–3) and poly(oxy-1,2-ethanediyl)-a-sulfo-w(nonylphenoxy), sodium salt (CAS Reg. No. 9014–90–8). These data were submitted to the Agency on November 12, 2010 (MRID 48293401 and 48293402). The data were evaluated by EPA and it was determined that the test substances did not induce numerical or structural chromosomal damage, providing further confirmation that NPEPSDs are not of concern for aggregate cancer risk. Further details of this evaluation can be found at https:// www.regulations.gov in the document ‘‘Nonylphenol Ethoxylates and Their Phosphate and Sulfate Derivatives (JITF CST 9 Inert Ingredients)-Review of Confirmatory Mutagencity Toxicity Data’’ in docket ID number EPA–HQ– OPP–2011–0526. Refer to the May 17, 2010, Federal Register document, available at https:// www.regulations.gov, for a detailed discussion of the aggregate risk assessment and determination of safety. Therefore, based on this information and the findings in the final rule published in the Federal Register of May 17, 2010, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to NPEPSD residues. 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 E:\FR\FM\09MYR1.SGM 09MYR1 27129 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for NPEPSDs. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established for residues of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts when used as an inert ingredient at levels not to exceed 7% in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910 and in pesticide formulations applied to animals under 40 CFR 180.930. 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) (Pub, L. 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 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 26, 2012. G. Jeffery Herndon, Acting 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: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.910 is amended by revising the following entries in the table of inert ingredients to read as follows: ■ § 180.910 Inert ingredients used pre and post-harvest; exemptions from the requirement of a tolerance. * * * * * sroberts on DSK5SPTVN1PROD with RULES Inert ingredients Limits * * * * a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4– 14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412– 53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7, 37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1). * * Not to exceed 7% of pesticide formulation. * Surfactants, related adjuvants of surfactants. * * * * a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014– 90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8. * * Not to exceed 7% of pesticide formulation. * Surfactants, related adjuvants of surfactants. VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\09MYR1.SGM Uses 09MYR1 27130 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations Inert ingredients * * Limits * 3. Section 180.930 is amended by revising the following entries in the * * * * § 180.930 Inert ingredients applied to animas; exemptions from the requirement of a tolerance. table of inert ingredients to read as follows: ■ Uses * * * * * Inert ingredients Limits * * * * a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4– 14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412– 53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7, 37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1). a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014– 90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8. * * Not to exceed 7% of pesticide formulation. * Surfactants, related adjuvants of surfactants. Not to exceed 7% of pesticide formulation. Surfactants, related adjuvants of surfactants. * * * [FR Doc. 2012–10933 Filed 5–8–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–0261; FRL–9339–6] Ametoctradin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of ametoctradin in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 9, 2012. Objections and requests for hearings must be received on or before July 9, 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). SUMMARY: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0261. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose sroberts on DSK5SPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 * * 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 https://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: Shaunta Hill, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8961; email address: hill.shaunta@epa.gov. SUPPLEMENTARY INFORMATION: 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. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). PO 00000 Frm 00018 Fmt 4700 Uses Sfmt 4700 * * • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide 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? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at https://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 E:\FR\FM\09MYR1.SGM 09MYR1

Agencies

[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Rules and Regulations]
[Pages 27126-27130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10933]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0526; FRL-9340-2]


[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate 
and Phosphate Esters; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, potassium, sodium, and zinc salts of the phosphate esters 
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate, 
ammonium, calcium, magnesium, potassium, sodium, and zinc salts when 
used as inert ingredients at levels not to exceed 7% in pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest and animals. The Joint Inerts Task Force, (JITF) Cluster 
Support Team Number (CST) 9 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 [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) 
mixture of dihydrogen phosphate and monohydrogen phosphate esters and 
the corresponding ammonium, calcium, magnesium, potassium, sodium, and 
zinc salts of the phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts.

DATES: This regulation is effective May 9, 2012. Objections and 
requests for hearings must be received on or before July 9, 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).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0526. All documents in the 
docket are listed in the docket index available at https://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 https://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: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; email address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION

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. 
Potentially

[[Page 27127]]

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?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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-2011-0526 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 
July 9, 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-2011-0526, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online 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. Background

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7860) by Joint 
Inerts Task Force, Cluster Support Team 9, c/o CropLife America, 1156 
15th St. NW., Suite 400, Washington, DC 20005. The petition requested 
that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an 
exemption from the requirement of a tolerance for residues of [alpha]-
(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) mixture of dihydrogen 
phosphate and monohydrogen phosphate esters and the corresponding 
ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the 
phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts when used as inert ingredients at 
levels not to exceed 7% in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest and to animals. 
That notice referenced a summary of the petition prepared by JITF, CST 
9, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Previously, in the Federal Register of May 17, 2010 (75 FR 27434) 
(FRL-8826-3), EPA established a time-limited tolerance exemption for 
[alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) mixture of 
dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc 
salts of the phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts (herein referred to in this document 
as nonylphenol ethoxylate phosphate and sulfate derivatives or NPEPSDs) 
with an expiration date of May 17, 2012. The 2-year time limitation was 
established for two purposes:
    1. To provide time for the development and submission of 
confirmatory toxicity data to address equivocal results in the 
available genotoxicity studies conducted on NPEPSDs (as described in 
Unit IV of the May 17, 2010 final rule); and
    2. To provide additional time, should the initial testing not 
confirm EPA's conclusion regarding the lack of a cancer concern, for 
registrants to attain EPA approval of registration amendments for 
reformulation of their pesticide products to remove NPEPSDs and to 
replace existing products with reformulated products.
    In establishing the time-limited tolerance exemption for NPEPSDs, 
EPA stated that if the submitted data confirmed its conclusion 
regarding a lack of cancer concern, the Agency intended to remove the 
expiration date from the tolerance exemption prior to expiration of the 
exemption.

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

[[Page 27128]]

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 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 NPEPSDs including exposure 
resulting from the exemption established by this action.
    In the Federal Register of May 17, 2010, EPA issued a final rule 
establishing an exemption from the requirement of a tolerance for 
residues of NPEPSDs when used as an inert ingredient at levels not to 
exceed 7% in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest under 40 CFR 180.910 with an 
expiration date of May 17, 2012. EPA has determined that establishing 
an exemption from the requirement of a tolerance for residues of 
NPEPSDs when used as an inert ingredient at levels not to exceed 7% in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest will not significantly change the risk 
assessments the Agency relied on to support the May 17, 2010, tolerance 
action, as explained in this unit.
    As part of the Agency's conduct of the risk assessment in support 
of the May 17, 2010, tolerance action, it was determined that there 
were no acute, chronic, short- or intermediate term aggregate risks of 
concern. With regards to aggregate cancer risk, the assessment 
concluded that based on a weight of the evidence consideration of the 
available data, the Agency believed that cancer risks would be 
negligible. However, due to the equivocal findings in the mutagenicity 
data base, the Agency asked for confirmatory data. Specifically, EPA 
recommended that supporters of the NPEPSD tolerance exemption perform 
the following studies for confirmatory purposes:
    A new Ames assay (OCSPP Harmonized Guideline 870.5100--Bacterial 
reverse mutation test) and a mouse lymphoma assay (OCSPP Harmonized 
Guideline 870.5300--in vitro Mammalian cell gene mutation test).
    A bone marrow assay (OCSPP Harmonized Guideline 870.5395--Mammalian 
erythrocyte micronucleus test).
    Since in vivo mutagenicity studies such as the bone marrow assay 
are generally regarded as more definitive than in vitro studies, and a 
negative result in the bone marrow test may outweigh whatever results 
are found in the Ames test and mouse lymphoma assay, supporters of the 
NPEPSD tolerance exemption were given the option of conducting the 
mammalian erythrocyte micronucleus test in lieu of the two in vitro 
mutagenicity studies. If those data did not confirm EPA's cancer 
conclusion, then EPA would need 2-year cancer bioassays in the mouse 
and rat (OCSPP Harmonized Guideline 870.4200--Carcinogenicity (mouse) 
and OCSPP Harmonized Guideline 870.4300--Combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety finding in support of the 
tolerance exemption.
    In response to the May 17, 2010, final rule, the JITF, CST 9 
conducted an in vivo Mouse Bone Marrow Erythrocyte Micronucleus Test 
Following Oral Administration (OCSPP Harmonized Test Guideline 
870.5395) of two representative test compounds, poly(oxy-1,2-
ethanediyl)-[alpha]-(p-nonylphenyl)-[omega]-hydroxy-, branched, 
phosphates (CAS Reg. No. 68412-53-3) and poly(oxy-1,2-ethanediyl)-
[alpha]-sulfo-[omega]-(nonylphenoxy), sodium salt (CAS Reg. No. 9014-
90-8). These data were submitted to the Agency on November 12, 2010 
(MRID 48293401 and 48293402).
    The data were evaluated by EPA and it was determined that the test 
substances did not induce numerical or structural chromosomal damage, 
providing further confirmation that NPEPSDs are not of concern for 
aggregate cancer risk. Further details of this evaluation can be found 
at https://www.regulations.gov in the document ``Nonylphenol Ethoxylates 
and Their Phosphate and Sulfate Derivatives (JITF CST 9 Inert 
Ingredients)-Review of Confirmatory Mutagencity Toxicity Data'' in 
docket ID number EPA-HQ-OPP-2011-0526.
    Refer to the May 17, 2010, Federal Register document, available at 
https://www.regulations.gov, for a detailed discussion of the aggregate 
risk assessment and determination of safety.
    Therefore, based on this information and the findings in the final 
rule published in the Federal Register of May 17, 2010, EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children from aggregate exposure 
to NPEPSD residues.

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

[[Page 27129]]

EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for NPEPSDs.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, potassium, sodium, and zinc salts of the phosphate esters 
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate, 
ammonium, calcium, magnesium, potassium, sodium, and zinc salts when 
used as an inert ingredient at levels not to exceed 7% in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest under 40 CFR 180.910 and in pesticide formulations 
applied to animals under 40 CFR 180.930.

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) (Pub, L. 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

    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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 26, 2012.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.910 is amended by revising the following entries in the 
table of inert ingredients to read as follows:


Sec.  180.910  Inert ingredients used pre and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-(p-Nonylphenol)-[omega]-   Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene) mixture   of pesticide        related
 of dihydrogen phosphate and        formulation.        adjuvants of
 monohydrogen phosphate esters                          surfactants.
 and the corresponding ammonium,
 calcium, magnesium, potassium,
 sodium, and zinc salts of the
 phosphate esters; the nonyl
 group is a propylene trimer
 isomer and the poly(oxyethylene)
 content averages 4-14 or 30
 moles (CAS Reg. Nos. 51811-79-1,
 59139-23-0, 67922-57-0, 68412-53-
 3, 68553-97-9, 68954-84-7, 99821-
 14-4, 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7, 68584-
 47-4, 52503-15-8, 68458-49-1).
 
                              * * * * * * *
[alpha]-(p-Nonylphenol)-[omega]-   Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)           of pesticide        related
 sulfate, ammonium, calcium,        formulation.        adjuvants of
 magnesium, potassium, sodium,                          surfactants.
 and zinc salts the nonyl group
 is propylene trimer isomer and
 the poly(oxyethylene) content
 averages 4 moles (CAS Reg. Nos.
 9014-90-8, 9051-57-4, 9081-17-8,
 68649-55-8, 68891-33-8.
 

[[Page 27130]]

 
                              * * * * * * *
------------------------------------------------------------------------


0
3. Section 180.930 is amended by revising the following entries in the 
table of inert ingredients to read as follows:


Sec.  180.930  Inert ingredients applied to animas; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-(p-Nonylphenol)-[omega]-   Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene) mixture   of pesticide        related
 of dihydrogen phosphate and        formulation.        adjuvants of
 monohydrogen phosphate esters                          surfactants.
 and the corresponding ammonium,
 calcium, magnesium, potassium,
 sodium, and zinc salts of the
 phosphate esters; the nonyl
 group is a propylene trimer
 isomer and the poly(oxyethylene)
 content averages 4-14 or 30
 moles (CAS Reg. Nos. 51811-79-1,
 59139-23-0, 67922-57-0, 68412-53-
 3, 68553-97-9, 68954-84-7, 99821-
 14-4, 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7, 68584-
 47-4, 52503-15-8, 68458-49-1).
[alpha]-(p-Nonylphenol)-[omega]-   Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)           of pesticide        related
 sulfate, ammonium, calcium,        formulation.        adjuvants of
 magnesium, potassium, sodium,                          surfactants.
 and zinc salts the nonyl group
 is propylene trimer isomer and
 the poly(oxyethylene) content
 averages 4 moles (CAS Reg. Nos.
 9014-90-8, 9051-57-4, 9081-17-8,
 68649-55-8, 68891-33-8.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2012-10933 Filed 5-8-12; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.