Potassium Hypochlorite; Exemption From the Requirement of a Tolerance, 11340-11344 [2011-4534]

Download as PDF 11340 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations converted into a nursing home; clarifies the provisions for multiple and separate occupancy for nursing homes; enhances door locking provisions based on clinical need or specialized security measures; recognizes the use of aerosolbased alcohol hand rub dispensers; and clarifies latching provisions for certain doors that open into/onto corridors. In the proposed rule, we noted that we were not aware of any significant changes from the 2006 edition to the 2009 edition. The commenter acknowledged that the differences between the two editions are insignificant. Because none of the applicable updates to the 2009 edition of NFPA 101 require costly or significant changes to the facilities governed by this rule, we make no changes based on this comment. This final rule amends § 51.200 as proposed without changes, and incorporates by reference NFPA 101, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule will have no such effect on state, local, and tribal governments, or on the private sector. WReier-Aviles on DSKGBLS3C1PROD with RULES Paperwork Reduction Act of 1995 This document contains no new collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a ‘‘significant regulatory action,’’ requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal VerDate Mar<15>2010 15:24 Mar 01, 2011 Jkt 223001 governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. VA has examined the economic, interagency, budgetary, legal, and policy implications of this final rule and has concluded that it does not constitute a significant regulatory action under the Executive Order. Regulatory Flexibility Act The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601–612. This rulemaking will affect veterans and State Homes. The State Homes that will be subject to this rulemaking are state government entities under the control of state governments. All State Homes are owned, operated and managed by state governments except for a small number that are operated by entities under contract with state governments. These contractors are not small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.026, Veterans State Adult Day Health Care. Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on February 8, 2011, for publication. List of Subjects in 38 CFR Part 51 Administrative practice and procedure, Claims, Day care, Dental health, Government contracts, Grant programs—health, Grant programs— veterans, Health care, Health facilities, Health professions, Health records, Incorporation by reference, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans. Dated: February 23, 2011. Robert C. McFetridge, Director, Regulations Policy and Management, Department of Veterans Affairs. For the reasons stated above, VA amends 38 CFR part 51 as follows: PART 51—PER DIEM FOR NURSING HOME CARE OF VETERANS IN STATE HOMES 1. The authority citation for part 51 continues to read as follows: ■ Authority: 38 U.S.C. 101, 501, 1710, 1741– 1743, 1745. 2. Amend § 51.200, by removing the phrase ‘‘NFPA 101, Life Safety Code (2006 edition)’’ each place it appears and adding, in its place, ‘‘NFPA 101, Life Safety Code (2009 edition)’’. ■ [FR Doc. 2011–4430 Filed 3–1–11; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0996; FRL–8859–5] Potassium Hypochlorite; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes the exemption from the requirement of a tolerance for residues of Potassium hypochlorite. Enviro Tech Chemical Services, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting that Potassium hypochlorite in end-use products be eligible for the exemption from the requirement of a tolerance. SUMMARY: E:\FR\FM\02MRR1.SGM 02MRR1 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations This regulation is effective March 2, 2011. Objections and requests for hearings must be received on or before May 2, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION. DATES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2009–0996. 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: Wanda Henson, Antimicrobials Division (7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–6345; e-mail address: henson.wanda@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information WReier-Aviles on DSKGBLS3C1PROD with RULES A. Does this action apply to me? You may be potentially affected by this action if you are a dairy cattle milk producer, food manufacturer, or beverage manufacturer. Potentially affected entities may include, but are not limited to: • Dairy Cattle Milk Production (NAICS code 11212). • Food manufacturing (NAICS code 311). • Beverage Manufacturing (NAICS code 31212). 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 VerDate Mar<15>2010 15:24 Mar 01, 2011 Jkt 223001 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:// www.gpoaccess.gov/ecfr. 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–2009–0996 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 May 2, 2011. 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–2009–0996, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 11341 Docket Facility telephone number is (703) 305–5805. II. Summary of Petitioned-For Exemption In the Federal Register of Wednesday, January 12, 2011 (76 FR 2110) (FRL– 8860–9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 0F7767) by Enviro Tech Chemical Services, Inc, Modesto, CA 95358. The petition requested that 40 CFR part 180 be amended to establish an exemption from the requirement of a tolerance for potassium hypochlorite in or on apple; artichoke; asparagus; brussel sprouts; carrot; cauliflower; celery; cherry; cabbage; lettuce; fruits, citrus; cucumber; onion, green; melon; peach; nectarine; plum; pear; pepper, bell; potato; radish; fruit, stone; and tomato. That notice referenced a summary of the petition prepared by Enviro Tech Chemical Services, Inc., the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. III. 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 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 in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which 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 . * * *’’ Consistent with section 408(c)(2)(A) of FFDCA, and the factors specified in section 408(c)(2)(B) of FFDCA, EPA has reviewed the available scientific data and other relevant information in E:\FR\FM\02MRR1.SGM 02MRR1 11342 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations WReier-Aviles on DSKGBLS3C1PROD with RULES support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for Potassium hypochlorite, including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with potassium hypochlorite follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by potassium hypochlorite is available in the docket, https:// www.regulations.gov. The Agency conducted an in-depth review of the similarities between potassium hypochlorite and the existing registered active ingredients, sodium hypochlorite and calcium hypochlorite. Based upon this review, the Agency determined that the data available to support the registrations of these active ingredients are also applicable to potassium hypochlorite. No additional generic or product-specific acute, chronic or subchronic toxicological studies were required to be submitted in support of this application. All toxicology data were bridged from studies on sodium and calcium hypochlorite based on their chemical similarity. Potassium hypochlorite is corrosive and can cause severe damage to the eyes and skin. Potassium hypochlorite has been assigned a Toxicity Category I, indicating the highest degree of toxicity for these acute effects. In the presence of oxygen, however, these compounds react easily with organic matter and convert readily into potassium chloride due to their simple chemical nature and structure. Exemptions from the requirement of a tolerance have been established for sodium and calcium hypochlorite used both as food contact surface sanitizers (40 CFR 180.940) and as antimicrobials used on raw agricultural commodities (40 CFR 180.1054 and 180.1235). Widely used in disinfecting water supplies for nearly a century, the hypochlorite class of chemicals has proven safe and practical to use provided that necessary precautions are taken by the user to prevent the eye and skin irritation VerDate Mar<15>2010 15:24 Mar 01, 2011 Jkt 223001 which are inherent to all strong oxidizing agents. All documents related to this case can be found at https:// www.regulations.gov in the document ‘‘Antimicrobial Pesticide Products; Registration Applications’’ page 16110 in docket ID number EPA–HQ–OPP– 2009–0996. B. Toxicological Points of Departure/ Levels of Concern for Potassium Hypochlorite Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/ pesticides/factsheets/riskassess.htm. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to potassium hypochlorite, EPA considered exposure under the petitioned-for exemption. EPA assessed dietary exposures from potassium hypochlorite in food as follows: Residues of potassium hypochlorite may remain on certain food crops as a result of their disinfectant uses. However, these residues pose no dietary risks of concern to human health based on data bridged from sodium hypochlorite. Therefore, a dietary risk assessment for potential exposures to residues in food is unwarranted. 2. Dietary exposure from drinking water. Residues of potassium hypochlorite that may remain in drinking water as a result of the use of this chemical are not expected to pose PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 dietary risks of concern to human health based on data bridged from sodium hypochlorite. 3. Non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Potassium hypochlorite is currently registered for the following residential non-dietary sites: Swimming pools, spa and hot tubs, hard, non-porous and porous surfaces, and laundry. Although residential exposure to mixer/loader/applicators is likely from the proposed uses of potassium hypochlorite, a quantitative risk assessment is not required because adverse systemic effects attributable to the dermal and inhalation routes of exposure to potassium hypochlorite are not expected based on toxicity data bridged from sodium hypochlorite. Label precautionary statements and the requirement that applicators wear certain personal protective equipment (goggles or face shield and rubber gloves) are sufficient to protect users from the localized, irritation effects of exposure to potassium hypochlorite. In addition, the label states that users of swimming pools may not enter treated water until the residual chlorine is measured to be between 1 ppm and 3 ppm in order to prevent acute irritation effects. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/ trac/science/trac6a05.pdf. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found potassium hypochlorite to share a common mechanism of toxicity with any other substances, and potassium hypochlorite does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that Potassium hypochlorite 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 E:\FR\FM\02MRR1.SGM 02MRR1 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations chemical, see EPA’s Web site at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children Because potassium hypochlorite was of very low systemic toxicity, EPA did not use a safety factor analysis for assessing risk. For similar reasons, the additional safety factor for the protection of infants and children is not necessary. E. Aggregate Risks and Determination of Safety Based on the toxicity profile and exposure scenarios for potassium hypochlorite, EPA believes that the risks from dietary exposures to this pesticide would be minimal and without consequence to human health. Although residential use of potassium hypochlorite poses potential risks for acute eye and skin injury, it is not appropriate to aggregate the exposure related to these surface irritation effects with systemic exposure from dietary ingestion. In any event, the Agency believes that these acute risks will be sufficiently mitigated by precautionary labeling requiring protection of eyes and skin while using this pesticide. Based on the toxicological and exposure data discussed in this preamble, EPA concludes that potassium hypochlorite will not pose a risk under reasonably foreseeable circumstances. Accordingly, EPA finds that there is a reasonable certainty of no harm will result to the general population, or to infants and children, from aggregate exposure to potassium hypochlorite residues. IV. Other Considerations WReier-Aviles on DSKGBLS3C1PROD with RULES A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/ World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade VerDate Mar<15>2010 15:24 Mar 01, 2011 Jkt 223001 agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for potassium hypochlorite. V. Conclusion Therefore, an exemption is established for residues of potassium hypochlorite. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 11343 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), Pub. L. 104–113, section 12(d) (15 U.S.C. 272 note). VII. 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, Potassium hypochlorite. Dated: February 23, 2011. Joan Harrigan Farrelly, Director, Antimicrobials 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 180.1300 is added to subpart D to read as follows: ■ § 180.1300 Potassium hypochlorite; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues E:\FR\FM\02MRR1.SGM 02MRR1 11344 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations of potassium hypochlorite in or on all commodities. SUPPLEMENTARY INFORMATION: I. General Information [FR Doc. 2011–4534 Filed 3–1–11; 8:45 am] A. Does this action apply to me? BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0823; FRL–8864–9] Difenoconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of difenoconazole in or on mango and wax jambu. Syngenta Crop Protection, Incorporated requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 2, 2011. Objections and requests for hearings must be received on or before May 2, 2011, 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–2009–0823. 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: Tony Kish, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 308– 9443; e-mail address: kish.tony@epa.gov. WReier-Aviles on DSKGBLS3C1PROD with RULES SUMMARY: VerDate Mar<15>2010 15:24 Mar 01, 2011 Jkt 223001 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). • 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://www.gpoaccess.gov/ecfr. 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–2009–0823 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 May 2, 2011. 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 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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–2009–0823, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Summary of Petitioned-For Tolerances In the Federal Register of January 6, 2010 (75 FR 864) (FRL–8801–5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7573) by Syngenta Crop Protection, Inc., P. O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.475 be amended by establishing tolerances for residues of the fungicide, difenoconazole, [1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H–1,2,4-triazole], in or on mango at 0.09 parts per million(ppm) and waxapple at 1.5 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised the proposed tolerance for mango, fruit from 0.09 ppm to 0.07 ppm to reflect the Agency’s recommended tolerance level. Additionally, EPA corrected commodity definitions from ‘‘mango, fruit’’ to ‘‘mango’’ and ‘‘waxapple’’ to ‘‘wax jambu’’ to reflect prescribed terminology. The reasons for these changes are explained in Unit IV.D. E:\FR\FM\02MRR1.SGM 02MRR1

Agencies

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11340-11344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4534]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0996; FRL-8859-5]


Potassium Hypochlorite; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes the exemption from the requirement 
of a tolerance for residues of Potassium hypochlorite. Enviro Tech 
Chemical Services, Inc. submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting that Potassium 
hypochlorite in end-use products be eligible for the exemption from the 
requirement of a tolerance.

[[Page 11341]]


DATES: This regulation is effective March 2, 2011. Objections and 
requests for hearings must be received on or before May 2, 2011, 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-2009-0996. 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: Wanda Henson, Antimicrobials Division 
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6345; e-mail 
address: henson.wanda@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 a dairy 
cattle milk producer, food manufacturer, or beverage manufacturer. 
Potentially affected entities may include, but are not limited to:
     Dairy Cattle Milk Production (NAICS code 11212).
     Food manufacturing (NAICS code 311).
     Beverage Manufacturing (NAICS code 31212).
    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://www.gpoaccess.gov/ecfr.

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-2009-0996 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 
May 2, 2011. 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-2009-0996, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Exemption

    In the Federal Register of Wednesday, January 12, 2011 (76 FR 2110) 
(FRL-8860-9), EPA issued a notice pursuant to section 408(d)(3) of 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 0F7767) by Enviro Tech Chemical Services, Inc, 
Modesto, CA 95358. The petition requested that 40 CFR part 180 be 
amended to establish an exemption from the requirement of a tolerance 
for potassium hypochlorite in or on apple; artichoke; asparagus; 
brussel sprouts; carrot; cauliflower; celery; cherry; cabbage; lettuce; 
fruits, citrus; cucumber; onion, green; melon; peach; nectarine; plum; 
pear; pepper, bell; potato; radish; fruit, stone; and tomato. That 
notice referenced a summary of the petition prepared by Enviro Tech 
Chemical Services, Inc., the registrant, which is available in the 
docket, https://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. 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 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 in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which 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 . * 
* *''
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in section 408(c)(2)(B) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in

[[Page 11342]]

support of this action. EPA has sufficient data to assess the hazards 
of and to make a determination on aggregate exposure for Potassium 
hypochlorite, including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with potassium hypochlorite follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by potassium hypochlorite is available in 
the docket, https://www.regulations.gov.
    The Agency conducted an in-depth review of the similarities between 
potassium hypochlorite and the existing registered active ingredients, 
sodium hypochlorite and calcium hypochlorite. Based upon this review, 
the Agency determined that the data available to support the 
registrations of these active ingredients are also applicable to 
potassium hypochlorite. No additional generic or product-specific 
acute, chronic or subchronic toxicological studies were required to be 
submitted in support of this application. All toxicology data were 
bridged from studies on sodium and calcium hypochlorite based on their 
chemical similarity.
    Potassium hypochlorite is corrosive and can cause severe damage to 
the eyes and skin. Potassium hypochlorite has been assigned a Toxicity 
Category I, indicating the highest degree of toxicity for these acute 
effects. In the presence of oxygen, however, these compounds react 
easily with organic matter and convert readily into potassium chloride 
due to their simple chemical nature and structure. Exemptions from the 
requirement of a tolerance have been established for sodium and calcium 
hypochlorite used both as food contact surface sanitizers (40 CFR 
180.940) and as antimicrobials used on raw agricultural commodities (40 
CFR 180.1054 and 180.1235). Widely used in disinfecting water supplies 
for nearly a century, the hypochlorite class of chemicals has proven 
safe and practical to use provided that necessary precautions are taken 
by the user to prevent the eye and skin irritation which are inherent 
to all strong oxidizing agents. All documents related to this case can 
be found at https://www.regulations.gov in the document ``Antimicrobial 
Pesticide Products; Registration Applications'' page 16110 in docket ID 
number EPA-HQ-OPP-2009-0996.

B. Toxicological Points of Departure/Levels of Concern for Potassium 
Hypochlorite

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect in a lifetime. For more information on the general 
principles EPA uses in risk characterization and a complete description 
of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to potassium hypochlorite, EPA considered exposure under the 
petitioned-for exemption. EPA assessed dietary exposures from potassium 
hypochlorite in food as follows:
    Residues of potassium hypochlorite may remain on certain food crops 
as a result of their disinfectant uses. However, these residues pose no 
dietary risks of concern to human health based on data bridged from 
sodium hypochlorite. Therefore, a dietary risk assessment for potential 
exposures to residues in food is unwarranted.
    2. Dietary exposure from drinking water. Residues of potassium 
hypochlorite that may remain in drinking water as a result of the use 
of this chemical are not expected to pose dietary risks of concern to 
human health based on data bridged from sodium hypochlorite.
    3. Non-dietary exposure. The term ``residential exposure'' is used 
in this document to refer to non-occupational, non-dietary exposure 
(e.g., textiles (clothing and diapers), carpets, swimming pools, and 
hard surface disinfection on walls, floors, tables). Potassium 
hypochlorite is currently registered for the following residential non-
dietary sites: Swimming pools, spa and hot tubs, hard, non-porous and 
porous surfaces, and laundry.
    Although residential exposure to mixer/loader/applicators is likely 
from the proposed uses of potassium hypochlorite, a quantitative risk 
assessment is not required because adverse systemic effects 
attributable to the dermal and inhalation routes of exposure to 
potassium hypochlorite are not expected based on toxicity data bridged 
from sodium hypochlorite.
    Label precautionary statements and the requirement that applicators 
wear certain personal protective equipment (goggles or face shield and 
rubber gloves) are sufficient to protect users from the localized, 
irritation effects of exposure to potassium hypochlorite. In addition, 
the label states that users of swimming pools may not enter treated 
water until the residual chlorine is measured to be between 1 ppm and 3 
ppm in order to prevent acute irritation effects.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found potassium hypochlorite to share a common 
mechanism of toxicity with any other substances, and potassium 
hypochlorite does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that Potassium hypochlorite 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

[[Page 11343]]

chemical, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Because potassium hypochlorite was of very low systemic toxicity, 
EPA did not use a safety factor analysis for assessing risk. For 
similar reasons, the additional safety factor for the protection of 
infants and children is not necessary.

 E. Aggregate Risks and Determination of Safety

    Based on the toxicity profile and exposure scenarios for potassium 
hypochlorite, EPA believes that the risks from dietary exposures to 
this pesticide would be minimal and without consequence to human 
health. Although residential use of potassium hypochlorite poses 
potential risks for acute eye and skin injury, it is not appropriate to 
aggregate the exposure related to these surface irritation effects with 
systemic exposure from dietary ingestion. In any event, the Agency 
believes that these acute risks will be sufficiently mitigated by 
precautionary labeling requiring protection of eyes and skin while 
using this pesticide.
    Based on the toxicological and exposure data discussed in this 
preamble, EPA concludes that potassium hypochlorite will not pose a 
risk under reasonably foreseeable circumstances. Accordingly, EPA finds 
that there is a reasonable certainty of no harm will result to the 
general population, or to infants and children, from aggregate exposure 
to potassium hypochlorite residues.

IV. 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 U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for potassium hypochlorite.

V. Conclusion

    Therefore, an exemption is established for residues of potassium 
hypochlorite.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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), Pub. L. 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. 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, Potassium hypochlorite.

    Dated: February 23, 2011.
Joan Harrigan Farrelly,
Director, Antimicrobials 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 180.1300 is added to subpart D to read as follows:


Sec.  [emsp14]180.1300  Potassium hypochlorite; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues

[[Page 11344]]

of potassium hypochlorite in or on all commodities.

[FR Doc. 2011-4534 Filed 3-1-11; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.