95886 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Rules and Regulations

C. Regulatory Flexibility Act (RFA) I. National Technology Transfer and ENVIRONMENTAL PROTECTION Advancement Act (NTTAA) AGENCY This action is not subject to the RFA. This rulemaking does not involve The RFA applies only to rules subject to 40 CFR Part 180 notice-and-comment rulemaking technical standards. requirements under the APA, 5 U.S.C. [EPA–HQ–OPP–2016–0007 and EPA–HQ– J. Executive Order 12898: Federal OPP–2016–0008; FRL–9950–40] 553, or any other statute. This rule is not Actions To Address Environmental subject to notice-and-comment Justice in Minority Populations and Isobutyl Acetate and Isobutyric Acid; requirements because the agency has Low-Income Populations Exemption From the Requirement of a invoked the APA ‘‘good cause’’ The EPA believes that this action is Tolerance exemption under 5 U.S.C. 553(b). not subject to Executive Order 12898 (59 AGENCY: Environmental Protection FR 7629, February 16, 1994) because it D. Unfunded Mandates Reform Act Agency (EPA). (UMRA) does not establish an environmental health or safety standard. This good ACTION: Final rule. This action does not contain any cause final action simply extends the SUMMARY: This regulation establishes unfunded mandate of $100 million or date for the EPA to take action on a more as described in UMRA, 2 U.S.C. exemptions from the requirement of a petition and does not have any impact tolerance for residues of isobutyl acetate 1531–1538, and does not significantly or on human health or the environment. uniquely affect small governments. The (CAS Reg. No. 110–19–0) and isobutyric action imposes no enforceable duty on K. Congressional Review Act (CRA) acid (CAS Reg. No. 79–31–2) when used any state, local or tribal governments or This action is subject to the CRA, and as inert ingredients (solvent) in the private sector. the EPA will submit a rule report to pesticide formulations applied to each House of the Congress and to the growing crops and raw agricultural E. Executive Order 13132: Federalism Comptroller General of the United commodities after harvest. Technology States. The CRA allows the issuing Sciences Group Inc. on behalf of Jeneil This action does not have federalism Biosurfactant Company submitted a implications. It will not have substantial agency to make a rule effective sooner than otherwise provided by the CRA if petition to EPA under the Federal Food, direct effects on the states, on the Drug, and Cosmetic Act (FFDCA), relationship between the national the agency makes a good cause finding that notice-and-comment rulemaking requesting establishment of these government and the states, or on the exemptions from the requirement of a distribution of power and procedures are impracticable, unnecessary or contrary to the public tolerance. This regulation eliminates the responsibilities among the various need to establish maximum permissible levels of government. interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule levels for residues of isobutyl acetate F. Executive Order 13175: Consultation as discussed in Section II.B of this and isobutyric acid. and Coordination With Indian Tribal document, including the basis for that DATES: This regulation is effective Governments finding. December 29, 2016. Objections and requests for hearings must be received This action does not have tribal IV. Statutory Authority on or before February 27, 2017, and implications, as specified in Executive The statutory authority for this action must be filed in accordance with the Order 13175. This good cause final is provided by sections 110, 126 and instructions provided in 40 CFR part action simply extends the date for the 307 of the CAA as amended (42 U.S.C. 178 (see also Unit I.C. of the EPA to take action on a petition. Thus, 7410, 7426 and 7607). SUPPLEMENTARY INFORMATION). Executive Order 13175 does not apply V. Judicial Review ADDRESSES: The dockets for this action, to this rule. identified by docket identification (ID) Under section 307(b)(1) of the CAA, G. Executive Order 13045: Protection of numbers EPA–HQ–OPP–2016–0007 and judicial review of this final rule is Children From Environmental Health EPA–HQ–OPP–2016–0008, are available available only by the filing of a petition and Safety Risks at http://www.regulations.gov or at the for review in the U.S. Court of Appeals Office of Pesticide Programs Regulatory The EPA interprets Executive Order for the appropriate circuit by February Public Docket (OPP Docket) in the 13045 as applying only to those 27, 2017. Under section 307(b)(2) of the Environmental Protection Agency regulatory actions that concern CAA, the requirements that are the Docket Center (EPA/DC), West William environmental health or safety risks that subject of this final rule may not be Jefferson Clinton Bldg., Rm. 3334, 1301 the EPA has reason to believe may challenged later in civil or criminal Constitution Ave. NW., Washington, DC disproportionately affect children, per proceedings brought by us to enforce 20460–0001. The Public Reading Room the definition of ‘‘covered regulatory these requirements. is open from 8:30 a.m. to 4:30 p.m., action’’ in section 2–202 of the List of Subjects in 40 CFR Part 52 Monday through Friday, excluding legal Executive Order. This action is not holidays. The telephone number for the Environmental protection, subject to Executive Order 13045 Public Reading Room is (202) 566–1744, Administrative practices and because it does not concern an and the telephone number for the OPP procedures, Air pollution control, environmental health risk or safety risk. Docket is (703) 305–5805. Please review Electric utilities, Incorporation by the visitor instructions and additional H. Executive Order 13211: Actions That reference, Intergovernmental relations, information about the docket available Significantly Affect Energy Supply, Nitrogen oxides, Ozone. at http://www.epa.gov/dockets. Distribution or Use Dated: December 15, 2016. FOR FURTHER INFORMATION CONTACT: This action is not subject to Executive Gina McCarthy, Michael Goodis, Registration Division Order 13211, because it is not a Administrator. (7505P), Office of Pesticide Programs, significant regulatory action under [FR Doc. 2016–31256 Filed 12–28–16; 8:45 am] Environmental Protection Agency, 1200 Executive Order 12866. BILLING CODE 6560–50–P Pennsylvania Ave. NW., Washington,

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DC 20460–0001; main telephone objection or hearing request, identified polyoxyethylene polymers and fatty number: (703) 305–7090; email address: by docket ID number EPA–HQ–OPP– acids; carriers such as clay and [email protected]. 2016–0007 or EPA–HQ–OPP–2016– diatomaceous earth; thickeners such as SUPPLEMENTARY INFORMATION: 0008, by one of the following methods: carrageenan and modified cellulose; • Federal eRulemaking Portal: http:// wetting, spreading, and dispersing I. General Information www.regulations.gov. Follow the online agents; propellants in aerosol A. Does this action apply to me? instructions for submitting comments. dispensers; microencapsulating agents; Do not submit electronically any and emulsifiers. The term ‘‘inert’’ is not You may be potentially affected by information you consider to be CBI or intended to imply nontoxicity; the this action if you are an agricultural other information whose disclosure is ingredient may or may not be producer, food manufacturer, or restricted by statute. chemically active. Generally, EPA has • pesticide manufacturer. The following Mail: OPP Docket, Environmental exempted inert ingredients from the list of North American Industrial Protection Agency Docket Center (EPA/ requirement of a tolerance based on the Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. low toxicity of the individual inert not intended to be exhaustive, but rather NW., Washington, DC 20460–0001. ingredients. provides a guide to help readers • Hand Delivery: To make special determine whether this document arrangements for hand delivery or IV. Aggregate Risk Assessment and applies to them. Potentially affected delivery of boxed information, please Determination of Safety entities may include: follow the instructions at http:// Section 408(c)(2)(A)(i) of FFDCA • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html. allows EPA to establish an exemption • Animal production (NAICS code Additional instructions on from the requirement for a tolerance (the 112). commenting or visiting the docket, legal limit for a pesticide chemical • Food manufacturing (NAICS code along with more information about 311). residue in or on a food) only if EPA dockets generally, is available at http:// determines that the tolerance is ‘‘safe.’’ • Pesticide manufacturing (NAICS www.epa.gov/dockets. code 32532). Section 408(b)(2)(A)(ii) of FFDCA II. Petition for Exemption defines ‘‘safe’’ to mean that ‘‘there is a B. How can I get electronic access to In the Federal Register of April 25, reasonable certainty that no harm will other related information? 2016 (81 FR 24044) (FRL–9944–86), result from aggregate exposure to the You may access a frequently updated EPA issued a document pursuant to pesticide chemical residue, including electronic version of 40 CFR part 180 FFDCA section 408, 21 U.S.C. 346a, all anticipated dietary exposures and all through the Government Printing announcing the filing of a pesticide other exposures for which there is Office’s e-CFR site at http:// petition (IN–10846 for isobutyl acetate; reliable information.’’ This includes www.ecfr.gov/cgi-bin/text- IN–10852 for isobutyric acetate) by exposure through drinking water and in idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Technology Sciences Group Inc., (1150 residential settings, but does not include 40tab_02.tpl. 18th Street NW., Suite 1000, occupational exposure. Section Washington, DC 20036) on behalf of 408(b)(2)(C) of FFDCA requires EPA to C. How can I file an objection or hearing give special consideration to exposure request? Jeneil Biosurfactant Company (400 N. Dekora Woods Blvd. Saukville, WI of infants and children to the pesticide Under FFDCA section 408(g), 21 53080). The petition requested that 40 chemical residue in establishing a U.S.C. 346a, any person may file an CFR 180.910 be amended by tolerance and to ‘‘ensure that there is a objection to any aspect of this regulation establishing exemptions from the reasonable certainty that no harm will and may also request a hearing on those requirement of a tolerance for residues result to infants and children from objections. You must file your objection of isobutyl acetate (CAS Reg. No. 110– aggregate exposure to the pesticide or request a hearing on this regulation 19–0) and isobutyric acid (CAS Reg. No. chemical residue. . . .’’ in accordance with the instructions 79–31–2) when used as inert ingredients EPA establishes exemptions from the provided in 40 CFR part 178. To ensure (solvent) in pesticide formulations requirement of a tolerance only in those proper receipt by EPA, you must applied to growing crops and to raw cases where it can be clearly identify docket ID number EPA–HQ– agricultural commodities after harvest. demonstrated that the risks from OPP–2016–0007 or EPA–HQ–OPP– That document referenced the aggregate exposure to pesticide 2016–0008 in the subject line on the summaries of the petitions prepared by chemical residues under reasonably first page of your submission. All Technology Sciences Group Inc. on foreseeable circumstances will pose no objections and requests for a hearing behalf of Jeneil Biosurfactant Company, appreciable risks to human health. In must be in writing, and must be the petitioner, which is available in the order to determine the risks from received by the Hearing Clerk on or docket, http://www.regulations.gov. A aggregate exposure to pesticide inert before February 27, 2017. Addresses for comment was received on the notice of ingredients, the Agency considers the mail and hand delivery of objections filing concerning petition #IN–10846. toxicity of the inert in conjunction with and hearing requests are provided in 40 EPA’s response to this comment is possible exposure to residues of the CFR 178.25(b). discussed in Unit V.B. inert ingredient through food, drinking In addition to filing an objection or water, and through other exposures that hearing request with the Hearing Clerk III. Inert Ingredient Definition occur as a result of pesticide use in as described in 40 CFR part 178, please Inert ingredients are all ingredients residential settings. If EPA is able to submit a copy of the filing (excluding that are not active ingredients as defined determine that a finite tolerance is not any Confidential Business Information in 40 CFR 153.125 and include, but are necessary to ensure that there is a (CBI)) for inclusion in the public docket. not limited to, the following types of reasonable certainty that no harm will Information not marked confidential ingredients (except when they have a result from aggregate exposure to the pursuant to 40 CFR part 2 may be pesticidal efficacy of their own): inert ingredient, an exemption from the disclosed publicly by EPA without prior Solvents such as alcohols and requirement of a tolerance may be notice. Submit the non-CBI copy of your hydrocarbons; surfactants such as established.

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Consistent with FFDCA section equivalent to 6,000 mg/L) in rats. screening battery and acute toxicity 408(c)(2)(A), and the factors specified in Isobutanol is severely irritating to the studies, respectively. EPA concluded FFDCA section 408(c)(2)(B), EPA has eye and minimally to moderately that isobutyl acetate and isobutyric acid reviewed the available scientific data irritating to the skin in rabbits. are not expected to be neurotoxic. and other relevant information in Based on the subchronic data Immunotoxicity studies with support of this action. EPA has available, isobutanol is not toxic up to isobutyric acid and isobutanol are sufficient data to assess the hazards of the limit dose of 1,000 milligram/ available for review. Mouse cell- and to make a determination on kilogram/day (mg/kg/day). In a 90-day mediated immune response is not aggregate exposure for isobutyl acetate oral toxicity study via gavage in rats, modulated by isobutyric acid in a host- and isobutyric acid including exposure hypo-activity, ataxia and salivation were resistant assay using Listeria resulting from the exemption observed at 1,000 mg/kg/day of monocytogenes. Humoral immunity is established by this action. EPA’s isobutanol. In another 90-day oral unaffected in mice as measured by the assessment of exposures and risks toxicity study with isobutanol via antibody plaque-forming cell response associated with isobutyl acetate and drinking water in rats, no adverse effects to sheep erythrocytes. Also, a isobutyric acid follows. were observed at doses up to 16,000 lymphocyte mitogenesis test with ppm (approximately 1,450 mg/kg/day), A. Toxicological Profile isobutanol showed mitogenic activity is the highest dose tested (HDT). The not inhibited in stimulated B and T cells EPA has evaluated the available study conducted via drinking water in from mouse spleen. Therefore, isobutyl toxicity data and considered their rats is considered more relevant to acetate and isobutyric acid are not validity, completeness, and reliability as human exposure and therefore more expected to be immunotoxic. well as the relationship of the results of reflective of potential human toxicity. Metabolism studies are not available the studies to human risk. EPA has also In developmental toxicity studies considered available information with isobutanol via inhalation in rats for isobutyl acetate. Limited data are concerning the variability of the and rabbits, neither maternal nor available on isobutyric acid and sensitivities of major identifiable developmental toxicity is seen at doses isobutanol. A metabolism study with a subgroups of consumers, including up to 10,000 mg/m3 (approximately single dose of isobutyric acid via gavage infants and children. Specific 3,060 mg/kg/day), the HDT in both in rats showed that it is rapidly information on the studies received and studies and above the limit dose of metabolized and the majority eliminated the nature of the adverse effects caused 1,000 mg/kg/day. as expired CO2. Less than 1.0% of the by isobutyl acetate and isobutyric acid Similarly, no adverse effects are dose is found in feces and 3.21–4.61% as well as the no-observed-adverse- observed in a two-generation in urine. A metabolism study with effect-level (NOAEL) and the lowest- reproductive study with isobutanol via isobutanol via gavage in rabbits showed observed-adverse-effect-level (LOAEL) inhalation in rats at doses up to 2,500 that it is rapidly metabolized. 0.5% is from the toxicity studies are discussed ppm (approximately 2,326 mg/kg/day). excreted in the urine or exhaled air. in this unit. Carcinogenicity studies with isobutyl Identified metabolites are Only acute toxicity data are available acetate, isobutyric acid or isobutanol are isobutyraldehyde, isobutyric acid, and on isobutyric acid and no data are not available. However, a chronic isovaleric acid. There is no concern for available on isobutyl acetate. However, toxicity study in rats treated with the metabolites isobutyraldehyde and upon ingestion, isobutyl acetate is isobutantol in drinking water for 53–56 isovaleric acid as they will be rapidly and completely hydrolyzed to weeks did not show any evidence of conjungated and excreted. isobutanol and acetic acid. Isobutyric toxicity or tumors at doses as high as B. Toxicological Points of Departure/ acid is a metabolic product of 200 mg/kg/day. In addition, no toxicity Levels of Concern isobutanol. is observed in other studies at doses Isobutanol is metabolized by alcohol below 1,450 mg/kg/day with isobutanol. The available toxicity studies indicate dehydrogenase to form isobutyric acid Moreover, mutagenicity studies are that isobutanol has very low toxicity. via conversion to isobutyraldehyde. negative with isobutanol and isobutyric The lowest NOAEL (316 mg/kg/day) in Therefore, toxicity data on isobutanol acid. An Ames test, unscheduled DNA the database occurred in a 90-day oral are considered suitable to assess synthesis and mouse lymphoma assay toxicity study with isobutanol via repeated exposure to isobutyl acetate are negative when tested with isobutyric gavage in rats. Hypo-activity, ataxia and and isobutyric acid. Since acetic acid is acid. The Ames test, mouse lymphoma, salivation were seen at 1,000 mg/kg/day. currently exempted from tolerance Comet and micronucleus assays are In a second study conducted for 90 days under 40 CFR 180.910 without negative when tested with isobutanol. with isobutanol via drinking water in limitation, this risk assessment focuses Therefore, isobutyl acetate and rats, the aforementioned effects weren’t on toxicity data available on isobutanol. isobutyric acid are not expected to be seen at doses as high 1,450 mg/kg/day. The acute oral and dermal toxicities carcinogenic. The drinking water study in rats are low for isobutyric acid. Isobutyric A neurotoxicity screening battery represents a more realistic route for acid has an acute oral lethal dose (LD50) with isobutanol via the inhalation route human exposure to isobutyric acid and ≥ 2,230 milligram/kilogram (mg/kg) in of exposure in rats was available for isobutyl acetate, and is considered more rats and rabbits. The acute dermal LD50 review. Also, neurotoxicity endpoints reflective of potential toxicity. = 475 mg/kg in rabbits. The acute were evaluated in an acute toxicity Therefore, since no signs of toxicity inhalation LC50 > 9.59 milligram/liter study in rats with isobutanol via the were observed at doses up to the limit (mg/L) in rats. It is corrosive to the eye inhalation route of exposure. No adverse dose in oral and inhalation toxicity and skin in rabbits. Isobutyric acid is effects were observed in the functional studies, an endpoint of concern for risk not a dermal sensitizer in rabbits. observational battery, motor activity, assessment purposes was not identified. Isobutanol has an acute oral LD50 ≥ schedule control operant behavior or Since no endpoint of concern was 2,830 mg/kg in rats. The acute dermal neuropathology at doses up to 1,500 identified for the acute and chronic acute LD50 ≥ 2,000 mg/kg in rabbits. The ppm (approximately 1,408 mg/kg/day) dietary exposure assessment and short acute inhalation LC50 > 6,000 parts per and 2,500 ppm (approximately 2,326 and intermediate dermal and inhalation million (ppm) (approximately mg/kg/day) in rats in the neurotoxicity exposure, a quantitative risk assessment

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for isobutyric acid and isobutyl acetate safety for infants and children in the VI. Conclusions is not necessary. case of threshold effects to account for Therefore, exemptions from the prenatal and postnatal toxicity and the C. Exposure Assessment requirement of a tolerance are completeness of the database on toxicity established under 40 CFR 180.910 for 1. Dietary exposure from food and and exposure unless EPA determines residues of isobutyl acetate (CAS Reg. feed uses. In evaluating dietary based on reliable data that a different No. 110–19–0) and isobutyric acid (CAS exposure to isobutyl acetate and margin of safety will be safe for infants Reg. No. 79–31–2) when used as inert isobutyric acid, EPA considered and children. This additional margin of ingredients (solvent) in pesticide exposure under the proposed exemption safety is commonly referred to as the formulations applied to growing crops from the requirement of a tolerance. Food Quality Protection Act Safety and raw agricultural commodities after EPA assessed dietary exposures from Factor (FQPA SF). In applying this harvest. isobutyl acetate and isobutyric acid in provision, EPA either retains the default food as follows: value of 10X, or uses a different VII. Statutory and Executive Order Under this exemption from the additional safety factor when reliable Reviews requirement of a tolerance, residues of data available to EPA support the choice This action establishes tolerance isobutyl acetate and isobutyric acid may of a different factor. exemptions under FFDCA section be found on foods from crops that were As part of its qualitative assessment, 408(d) in response to a petition treated with pesticide formulations the Agency did not use safety factors for submitted to the Agency. The Office of containing isobutyl acetate and assessing risk, and no additional safety Management and Budget (OMB) has isobutyric acid. However, a quantitative factor is needed for assessing risk to exempted these types of actions from dietary exposure assessment was not infants and children. Based on an review under Executive Order 12866, conducted since a toxicological assessment of isobutyl acetate and entitled ‘‘Regulatory Planning and endpoint for risk assessment was not isobutyric acid, EPA has concluded that Review’’ (58 FR 51735, October 4, 1993). identified. there are no toxicological endpoints of 2. Dietary exposure from drinking Because this action has been exempted concern for the U.S. population, from review under Executive Order water. Since a hazard endpoint of including infants and children. concern was not identified for the acute 12866, this action is not subject to and chronic dietary assessment, a E. Aggregate Risks and Determination of Executive Order 13211, entitled quantitative dietary exposure risk Safety ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, assessment for drinking water was not Because no toxicological endpoints of conducted, although exposures may be Distribution, or Use’’ (66 FR 28355, May concern were identified, EPA concludes 22, 2001) or Executive Order 13045, expected from use on food crops. that aggregate exposure to residues of 3. From non-dietary exposure. The entitled ‘‘Protection of Children from isobutyl acetate and isobutyric acid will Environmental Health Risks and Safety term ‘‘residential exposure’’ is used in not pose a risk to the U.S. population, this document to refer to non- Risks’’ (62 FR 19885, April 23, 1997). including infants and children, and that This action does not contain any occupational, non-dietary exposure there is a reasonable certainty that no (e.g., textiles (clothing and diapers), information collections subject to OMB harm will result to the general approval under the Paperwork carpets, swimming pools, and hard population, or to infants and children surface disinfection on walls, floors, and Reduction Act (PRA) (44 U.S.C. 3501 et from aggregate exposure to isobutyl seq.), nor does it require any special tables). acetate and isobutyric acid residues. Isobutyl acetate and isobutyric acid considerations under Executive Order may be used in pesticide products and V. Other Considerations 12898, entitled ‘‘Federal Actions to Address Environmental Justice in non-pesticide products that may be used A. Analytical Enforcement Methodology in and around the home. Based on the Minority Populations and Low-Income discussion in Unit IV.B., a quantitative An analytical method is not required Populations’’ (59 FR 7629, February 16, residential exposure assessment for for enforcement purposes since the 1994). isobutyl acetate and isobutyric acid was Agency is establishing an exemption Since tolerances and exemptions that not conducted. from the requirement of a tolerance are established on the basis of a petition 4. Cumulative effects from substances without any numerical limitation. under FFDCA section 408(d), such as the exemptions in this final rule, do not with a common mechanism of toxicity. B. Response to Comments Section 408(b)(2)(D)(v) of FFDCA require the issuance of a proposed rule, requires that, when considering whether A comment was received from a the requirements of the Regulatory to establish, modify, or revoke a private citizen who was concerned Flexibility Act (RFA) (5 U.S.C. 601 et tolerance, the Agency consider about the safety and impact pesticides seq.), do not apply. ‘‘available information’’ concerning the on food on human health. The Agency This action directly regulates growers, cumulative effects of a particular understands the commenter’s concerns food processors, food handlers, and food pesticide’s residues and ‘‘other and recognizes that some individuals retailers, not States or tribes, nor does substances that have a common believe that no residue of pesticides this action alter the relationships or mechanism of toxicity.’’ should be allowed. However, under the distribution of power and Based on the available data, isobutyl existing legal framework provided by responsibilities established by Congress acetate and isobutyric acid do not have section 408 of the Federal Food, Drug in the preemption provisions of FFDCA a toxic mechanism; therefore, section and Cosmetic Act (FFDCA), EPA is section 408(n)(4). As such, the Agency 408(b)(2)(D)(v) does not apply. authorized to establish pesticide has determined that this action will not tolerances or exemptions where persons have a substantial direct effect on States D. Safety Factor for Infants and seeking such tolerances or exemptions or tribal governments, on the Children have demonstrated that the pesticide relationship between the national 1. In general. Section 408(b)(2)(C) of meets the safety standard imposed by government and the States or tribal FFDCA provides that EPA shall apply the statute, which EPA has determined governments, or on the distribution of an additional tenfold (10X) margin of here. power and responsibilities among the

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various levels of government or between Transfer and Advancement Act Dated: December 16, 2016. the Federal Government and Indian (NTTAA) (15 U.S.C. 272 note). Daniel J. Rosenblatt, tribes. Thus, the Agency has determined VIII. Congressional Review Act Acting Director, Registration Division, Office that Executive Order 13132, entitled of Pesticide Programs. ‘‘Federalism’’ (64 FR 43255, August 10, Pursuant to the Congressional Review 1999) and Executive Order 13175, Act (5 U.S.C. 801 et seq.), EPA will Therefore, 40 CFR chapter I is entitled ‘‘Consultation and Coordination submit a report containing this rule and amended as follows: with Indian Tribal Governments’’ (65 FR other required information to the U.S. 67249, November 9, 2000) do not apply Senate, the U.S. House of PART 180—[AMENDED] to this action. In addition, this action Representatives, and the Comptroller does not impose any enforceable duty or General of the United States prior to ■ 1. The authority citation for part 180 contain any unfunded mandate as publication of the rule in the Federal continues to read as follows: Register. This action is not a ‘‘major described under Title II of the Unfunded Authority: 21 U.S.C. 321(q), 346a and 371. Mandates Reform Act (UMRA) (2 U.S.C. rule’’ as defined by 5 U.S.C. 804(2). 1501 et seq.). List of Subjects in 40 CFR Part 180 ■ 2. In § 180.910, add alphabetically the inert ingredients to the table to read as This action does not involve any Environmental protection, follows: technical standards that would require Administrative practice and procedure, Agency consideration of voluntary Agricultural commodities, Pesticides § 180.910 Inert ingredients used pre- and consensus standards pursuant to section and pests, Reporting and recordkeeping post-harvest; exemptions from the 12(d) of the National Technology requirements. requirement of a tolerance.

Inert ingredients Limits Uses

******* Isobutyl Acetate (CAS Reg. No. 110–19–0) ...... Solvent. Isobutyric Acid (CAS Reg. No. 79–31–2) ...... Solvent.

*******

[FR Doc. 2016–31211 Filed 12–28–16; 8:45 am] ‘‘Medicare Program; Revisions to 2016. Accordingly, the corrections are BILLING CODE 6560–50–P Payment Policies under the Physician effective January 1, 2017. Fee Schedule and Other Revisions to II. Summary of Errors Part B for CY 2017; Medicare Advantage DEPARTMENT OF HEALTH AND Bid Pricing Data Release; Medicare A. Summary of Errors in the Preamble HUMAN SERVICES Advantage and Part D Medical Loss On page 80252, in our discussion of Ratio Data Release; Medicare Advantage certain primary care services, we made Centers for Medicare & Medicaid Provider Network Requirements; typographical errors and referenced the Services Expansion of Medicare Diabetes final HCPCS G-codes incorrectly. Prevention Program Model; Medicare On page 80268, we made a 42 CFR Parts 405, 410, 411, 414, 417, Shared Savings Program Requirements.’’ typographical error in the new locality 422, 423, 424, 425, and 460 DATES: This correcting document is number for Stockton-Lodi-CA. [CMS–1654–CN3] effective January 1, 2017. On page 80330, due to a drafting FOR FURTHER INFORMATION CONTACT: error, we inadvertently stated that we RIN 0938–AS81 Jessica Bruton (410) 786–5991. did not receive any comments on our Medicare Program; Revisions to SUPPLEMENTARY INFORMATION: proposals for the Electroencephalogram (EEG) family of codes, CPT Codes Payment Policies Under the Physician I. Background Fee Schedule and Other Revisions to 95812, 95813, and 95957. Part B for CY 2017; Medicare In FR Doc 2016–26668 (81 FR 80170 On page 80540, we inadvertently Advantage Bid Pricing Data Release; through 80562), the final rule entitled, included language in our discussion of Medicare Advantage and Part D ‘‘Medicare Program; Revisions to ICRs regarding payment to organizations Medical Loss Ratio Data Release; Payment Policies under the Physician that provide Medicare Diabetes Medicare Advantage Provider Network Fee Schedule and Other Revisions to Prevention Program Services. Requirements; Expansion of Medicare Part B for CY 2017; Medicare Advantage On page 80543, due to a drafting Diabetes Prevention Program Model; Bid Pricing Data Release; Medicare error, in our discussion of RVUs relative Medicare Shared Savings Program Advantage and Part D Medical Loss to 2016, we inadvertently used the Requirements; Corrections Ratio Data Release; Medicare Advantage result descriptors incorrectly. Provider Network Requirements; On page 80543, due to typographical AGENCY: Centers for Medicare & Expansion of Medicare Diabetes errors the title of Table 51 and the CY Medicaid Services (CMS), HHS. Prevention Program Model; Medicare 2017 RVU Budget Neutrality ACTION: Final rule; correction. Shared Savings Program Requirements’’ Adjustment are incorrect. there were a number of technical and SUMMARY: This document corrects typographical errors that are identified B. Summary and Correction of Errors in technical and typographical errors that and corrected in this correcting the Addenda on the CMS Web Site appeared in the final rule published in document. These corrections are Due to a data error, the incorrect CY the November 15, 2016 Federal Register effective as if they had been included in 2017 PE RVUs are included in (81 FR 80170). That rule is entitled, the document published November 15, Addendum B for HCPCS codes G0422

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