82 FR 14327 - Alabama: Final Authorization of State Hazardous Waste Management Program Revisions
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 52 (March 20, 2017)
Federal Register Volume 82, Issue 52 (March 20, 2017)
| Page Range | 14327-14332 | |
| FR Document | 2017-05464 |
[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)] [Rules and Regulations] [Pages 14327-14332] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05464] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R04-RCRA-2016-0497; FRL-9959-14-Region 4] Alabama: Final Authorization of State Hazardous Waste Management Program Revisions AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: Alabama has applied to the United States Environmental Protection Agency (EPA) for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this direct final rule. In the ``Proposed Rules'' section of today's Federal Register, EPA is also publishing a separate document that serves as the proposal to authorize these changes. EPA believes this action is not controversial and does not expect comments that oppose it. Unless EPA receives written comments that oppose this authorization during the comment period, the decision to authorize Alabama's changes to its hazardous waste program will take effect. If EPA receives comments that oppose this action, EPA will publish a document in the Federal Register withdrawing today's direct final rule before it takes effect, and the separate document published in today's ``Proposed Rules'' section of this Federal Register will serve as the proposal to authorize the changes. DATES: This final authorization will become effective on May 19, 2017 unless EPA receives adverse written comment by April 19, 2017. If EPA receives such comment, EPA will publish a timely withdrawal of this direct final rule in the Federal Register and inform the public that this authorization will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04- RCRA-2016-0497, by one of the following methods:Federal eRulemaking Portal: www.regulations.gov. Follow the on-line instructions for submitting comments. Email: baker.audrey@epa.gov. Fax: (404) 562-9964 (prior to faxing, please notify the EPA contact listed below). Mail: Send written comments to Audrey Baker, RCRA Programs and Materials Management Section, Materials and Waste Management Branch, Resource Conservation and Restoration Division, U.S. Environmental Protection Agency, Atlanta Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Hand Delivery or Courier: Deliver your comments to Audrey Baker, RCRA Programs and Materials Management Section, Materials and Waste Management Branch, Resource Conservation and Restoration Division, U.S. Environmental Protection Agency, Atlanta Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Regional Office's normal hours of operation, and special [[Page 14328]] arrangements should be made for deliveries of boxed information. Instructions: EPA must receive your comments by April 19, 2017. Direct your comments to Docket ID No. EPA-R04-RCRA-2016-0497. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or email. The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made publicly available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. (For additional information about EPA's public docket, visit the EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm). Docket: All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at www.regulations.gov, or in hard copy. You may view and copy Alabama's applications and associated publicly available materials from 8:00 a.m. to 4:00 p.m. at the following locations: EPA Region 4, Resource Conservation and Restoration Division, Atlanta Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960; telephone number: (404) 562-8483; and the Alabama Department of Environmental Management, 1400 Coliseum Boulevard, Montgomery, Alabama 36110-2059; telephone number: (334) 271- 7700. Interested persons wanting to examine these documents should make an appointment with the office at least a week in advance. FOR FURTHER INFORMATION CONTACT: Audrey Baker, RCRA Programs and Materials Management Section, Materials and Waste Management Branch, Resource Conservation and Restoration Division, U.S. Environmental Protection Agency, Atlanta Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960; telephone number: (404) 562-8483; fax number: (404) 562-9964; email address: baker.audrey@epa.gov. SUPPLEMENTARY INFORMATION: A. Why are revisions to state programs necessary? States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279. New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized States at the same time that they take effect in unauthorized States. Thus, EPA will implement those requirements and prohibitions in Alabama, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so. B. What decisions has EPA made in this rule? On July 20, 2015 and August 15, 2016, Alabama submitted final complete program revision applications seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between July 1, 2006 through June 30, 2008, and July 1, 2011 through June 30, 2014 (also known as RCRA Clusters XVII through XVIII, and XXII through XXIII). EPA concludes that Alabama's applications to revise its authorized program meet all of the statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA grants Alabama final authorization to operate its hazardous waste program with the changes described in the authorization applications, and as outlined below in Section G of this document. Alabama has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program applications, subject to the limitations of HSWA, as discussed above. C. What is the effect of this authorization decision? The effect of this decision is that the changes described in Alabama's authorization applications will become part of the authorized State hazardous waste program, and will therefore be federally enforceable. Alabama will continue to have primary enforcement authority and responsibility for its State hazardous waste program. EPA retains its authorities under RCRA sections 3007, 3008, 3013, and 7003, including its authority to: Conduct inspections, and require monitoring, tests, analyses, or reports; Enforce RCRA requirements, including authorized State program requirements, and suspend or revoke permits; and Take enforcement actions regardless of whether the State has taken its own actions. This action does not impose additional requirements on the regulated community because the regulations for which Alabama is being authorized by today's action are already effective and enforceable requirements under State law, and are not changed by today's action. D. Why wasn't there a proposed rule before today's rule? Along with this direct final rule, EPA is publishing a separate document in the ``Proposed Rules'' section of today's Federal Register that serves as the proposal to authorize these State program changes. EPA did not publish a proposed rule before today because EPA views this as a routine program change and does not expect comments that oppose this approval. EPA is providing an opportunity for public comment now, as described in Section E of this document. [[Page 14329]] E. What happens if EPA receives comments that oppose this action? If EPA receives comments that oppose this authorization, EPA will withdraw today's direct final rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the State program changes on the proposed rule mentioned in the previous section, after considering all comments received during the comment period, and will address all such comments in a later final rule. You may not have another opportunity to comment on these State program changes. If you want to comment on this authorization, you must do so at this time. If EPA receives comments that oppose only the authorization of a particular change to the State hazardous waste program, EPA will withdraw that part of today's direct final rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn. F. What has Alabama previously been authorized for? Alabama initially received final authorization on December 8, 1987, effective December 22, 1987 (52 FR 46466), to implement a hazardous waste management program. EPA granted authorization for changes to Alabama's program on the following dates: November 29, 1991, effective January 28, 1992 (56 FR 60926); May 13, 1992, effective July 12, 1992 (57 FR 20422); October 21, 1992, effective December 21, 1992 (57 FR 47996); March 17, 1993, effective May 17, 1993 (58 FR 20422); September 24, 1993, effective November 23, 1993 (58 FR 49932); February 1, 1994, effective April 4, 1994 (59 FR 4594); November 14, 1994, effective January 13, 1995 (59 FR 56407); August 14, 1995, effective October 13, 1995 (60 FR 41818); February 14, 1996, effective April 15, 1996 (61 FR 5718); April 25, 1996, effective June 24, 1996 (61 FR 5718); November 21, 1997, effective February 10, 1998 (62 FR 62262); December 20, 2000, effective February 20, 2001 (65 FR 79769); March 15, 2005, effective May 16, 2005 (70 FR 12593); June 2, 2005, effective August 1, 2005 (70 FR 32247); September 13, 2006, effective November 13, 2006 (71 FR 53989); and April 2, 2008, effective June 2, 2008 (73 FR 17924). G. What changes is EPA authorizing with this action? On July 20, 2015 and August 15, 2016, Alabama submitted final complete program revision applications seeking authorization of its changes in accordance with 40 CFR 271.21. EPA now makes an immediate final decision, subject to receipt of written comments that oppose this action, that Alabama's hazardous waste program revisions are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all of the requirements necessary to qualify for final authorization. Therefore, EPA grants Alabama final authorization for the following program changes: ---------------------------------------------------------------------------------------------------------------- Description of Federal requirement Federal Register date and page Analogous state authority \1\ ---------------------------------------------------------------------------------------------------------------- Checklist 214, Corrections to 71 FR 40254 7/14/06................ 335-14-1-.02(117)(b); -02(167); -.02(178); Errors in the Code of Federal -.02(180); -.02(196); -.02(205); - Regulations. .02(266); -.02(273); 335-14-1-.03(2)(a)1.; -.03(2)(d)1.(ii); - .03(20)(a); -.03(21); 335-14-2-.01(2)(c)1.(i); -.01(3)(a)2.(i); .01(4)(a)20.(v); -.01(4)(b)6.(i)(II); - .01(4)(b)6.(ii); -.01(4)(b)6.(ii)(IV)- (V); -.01(4)(b)9.; -.01(4)(e)2.(vi); - .01(4)(e)3.(i); -.01(6)(a)2.(ii)-(iv); - .01(6)(c)2.; 335-14-2-.03(2)(a)3.; -.03(2)(a)3.(i)- (ii); -.03(2)(a)3.(ii)(I)-(IV); - .03(2)(a)4.; -.03(2)(a)4.(i); - .03(2)(a)4.(i)(I)-(IV); - .03(2)(a)4.(i)(IV) Notes 1-4; -.03(5)(b); 335-14-2-.04(2)(a)/Table; -.04(3)(a)/Table ``K107'' and ``K069'' entries; - .04(4)(e); -.04(4)(e)/Comment; -.04(4)(e)/ Table; -.04(4)(f); -.04(4)(f)/Table; 335-14-2 Appendices VII-VIII; 335-14-3-.03(5)(a)1.(iv); 335-14-3-.05(4)(b); -.05(7)(b); - .05(9)(a)1.; 335-14-3-.07(1); 335-14-3-.09(3)(a)1.(ii); -.09(4)(b)1.(i); -.09(4)(b)2.(i); -.09(5)(e); -.09(8)(a); .09(8)(a)5.; 335-14-5-.01(1)(g)2.; -.01(4); 335-14-5-.02(4)(b)7.(iii)(II); -.02(8)(b); -.02(9)(b)2.(iii); 335-14-5-.06(8)(a)1.; -.06(8)(a)1.(i); - .06(8)(i)5.; -.06(9)(a)2.; - .06(9)(g)4.(i); -.06(10)(h)2.; - .06(12)(d); 335-14-5-.07(2)(c); -.07(3)(b)8.; -.07(6)- (7); -.07(9)(c); -.07(10)(b)1.(ii); 335-14-5-.08(1)(c); -.08(3)(b)2.; - .08(4)(b)7.; -.08(4)(b)8.; -.08(4)(e)5.; .08(6)(a)3.(i); -.08(6)(d)6.; - .08(6)(f)11.; -.08(8)(h)1.; -.08(12)(b); .08(12)(f); -.08(12)(g) Letter From Chief Financial Officer; -.08(12)(h)2. Guarantee For Liability Coverage; - .08(12)(h)2. Recitals, Item 13(a) Certification of Valid Claim; - .08(12)(h)2. Recitals, Item 14; - .08(12)(i) Hazardous Waste Facility Liability Endorsement, Item 2(e); - .08(12)(j) Hazardous Waste Facility Certificate of Liability Insurance, Item 2(d); -.08(12)(k) Irrevocable Standby Letter of Credit; -.08(12)(k) Certificate of Valid Claim; -.08(12)(l); -.08(12)(l) Certification of Valid Claim; -.08(12)(m) Trust Agreement, Section 8(c); - .08(12)(n)1. Standby Trust Agreement, Sections 3(c)(1), 3(e)(3), 12, and 16; 335-14-5-.09(6)(b)1.; 335-14-5-.10(4)(c)4. Note; -.10(4)(d)4.; - .10(4)(e)2.(ii)-(iii); -.10(4)(e)2.(v)(I)- (II); -.10(4)(e)3.(i)-(ii); - .10(4)(g)1.(iii)-(iv); - .10(4)(g)2.(i)(I); [[Page 14330]] 335-14-5-.11(2)(c)1.(i)(II); - .11(2)(c)2.(ii); -.11(2)(e)1.; - .11(2)(e)2.(i)(II)-(III); -.11(4)(b)1.; - .11(7)(a)2.; 335-14-5-.12(2)(a)2.(i)((I); -.12(3)(a)- (b); -.12(10)(b); 335-14-5-.13(11)(c)7.; -.13(11)(d); - .13(14)(a); 335-14-5-.14(2)(b)2.; -.14(3)(a); - .14(3)(b); -.14(5)(b)1.; -.14(15)(f)2.; - .14(18)(a); 335-14-5-.15(5)(b); 335-14-5-.19(3)(e)4.(iii); - .19(3)(e)4.(iv)(VI); - .19(3)(e)6.(iii)(V); -.19(4)(e); - .19(5)(a); -.19(6)(e)6.; 335-14-5-.23(4)(a)1.; -.23(4)(a)4.(i); - .23(4)(a)5.; -.23(4)(b); -.23(4)(m)2.; - .23(4)(m)3.; 335-14-5-.24(1); -.24(2)(a); - .24(2)(b)11.; -.24(2)(c)4.; 335-14-5-.27(1); -.27(4)-(6); 335-14-5-.28(1); -.28(9); -.28(15); 335-14-5-.29(1); -.29(11); 335-14-5-.30(2)(b)3.(iii); -.30(2)(c)3.; - .30(2)(c)3.(i); -.30(2)(d); -.30(3)(a); 335-14-5-Appendix I/Table 1 and Table 2(d); 335-14-6-.01(1)(c)4.; -.01(1)(c)6.; 335-14-6-.02(3)(a)1.; -.02(5)(b)1.; - .02(7)(b); -.02(10)(c)2.; 335-14-6-.04(7)(b); 335-14-6-.06(1)(d); 335-14-6-.07(1)(b)4.; -.07(2)(c); - .07(3)(b)5.; -.07(3)(d)4.(iii)-(iv); - .07(4)(b); -.07(4)(e)4.; -.07(8)(b); - .07(10)(b)1.(ii); 335-14-6-.08(1)(b); -.08(1)(b)2.; - .08(3)(a); -.08(6)(e)11.; - .08(8)(a)1.(i); -.08(8)(b)1.(i)-(ii); 335-14-6-.09(5); 335-14-6-.10(4)(e)2.(v)(I)-(II); - .10(4)(i)2.; -.10(5)(b)1.; -.10(5)(b)2.; 335-14-6-.10(8)(b); -.10(12)(c); 335-14-6-.11(2)(d)2.(i)(I)-(II); - .11(5)(b)1.; -.11(9)(a)2.(iii)(IV); - .11(9)(b)2.; -.11(10)(b)2.; - .11(10)(b)3.; 335-14-6-.12(6)(b); -.12(10)(b)1.; 335-14-6-.13(11)(a)4.; -.13(12)(a)1.; 335-14-6-.14(2)(a); -.14(2)(d); - .14(3)(b); -.14(4)(b)1.; -.14(13)(a)1.; - .14(15)(f)1.(ii); -.14(15)(g)2.; - .14(17); -.14(17)(c)-(d); 335-14-6-.17(6)(a)1.(i); 335-14-6-.23(2)(c); -.23(4)(a)4.(i); - .23(4)(b); -.23(6)(b); 335-14-6-.27(4); -.27(6); 335-14-6-.28(14); 335-14-6-.29(1); -.29(6); -.29(8); - .29(11); 335-14-6-.30(1)(d); -.30(2)(b)3.(i)(II); - .30(2)(b)3.(iii); -.30(2)(c)3.; - .30(2)(d); 335-14-6-Appendix I/Tables 1 and 2; 335-14-6-Appendix V/Table; 335-14-6-Appendix VI; 335-14-7-.06(1)(a); 335-14-7-.07(1)(a)/Table; 335-14-7-.08(1); -.08(3)-(4); -.08(7); - .08(10); 335-14-7-.14 heading; 335-14-7-Appendices III-VII, IX, and XIII; 335-14-8-.01(1)(a)2.; -.01(1)(b); - .01(1)(c)1.; -.01(1)(c)3.(i); 335-14-8-.02(1)(j)1.; -.02(2)(d)1.; - .02(2)(d)2.; -.02(4)(k)7.; -.02(5)(a); - .02(5)(b)11.(ii); -.02(5)(b)19.(iii); - .02(5)(b)21.; -.02(8)(f); -.02(9)(b); - .02(9)(g); -.02(11)(i)2.; -.02(17)(c)15.; 335-14-8-.03(4)(b); 335-14-8-.04(2)(c); -.04(3)(b)2.(ii)(I)- (II); 335-14-8-.07(1)(a); -.07(3)(b)2.; 335-14-9-.01(2); -.01(4); -.01(6)-(7); 335-14-9-.02(5); 335-14-9-.04(1); -.04(3); -.04(5)-(6); - .04(8)-(9); 335-14-9-.05(1); 335-14-9-Appendix VIII; 335-14-11-.02(4)(b); -.02(5)(a); 335-14-11-.03(5)(a); 335-14-17-.02(1)(b)2.; -.02(2); -.02(2)/ Table 1; 335-14-17-.05(5)(c)3.(i); -.05(5)(c)5.; - .05(6)(a); -.05(6)(c)2.; -.05(7)(a); 335-14-17-.06(3)(a)-(b); -.06(3)(b)1.(ii); -.06(3)(b)6.(ii)-(iii); -.06(6)(a); - .06(6)(a)2.(i)(II); -.06(7)(a)2.; - .06(8)(a)2.(iii); -.06(10); 335-14-17-.07(4)(b)3.; -.07(5)(e); and 335-14-17-.08(1)(b)1. [[Page 14331]] Checklist 215, Cathode Ray 71 FR 42928, 7/28/06............... 335-14-1-.02(28)-(31); Tubes Rule. 335-14-2-.01(4)(a)22.(i)-(iv); 335-14-2-.04(9); and 335-14-2-.05(1)-(3). Checklist 218, F019 Exemption 73 FR 31756, 6/4/08................ 335-14-1-.02(1)(a)(158); for Wastewater Treatment 335-14-2-.04(2)(b)4.; -.04(2)(b)4.(i); and Sludges from Auto -.04(2)(a)/Table. Manufacturing Zinc Phosphating Processes. Checklist 228, Hazardous Waste 77 FR 22229........................ 335-14-2-.04(3)(a) entry for K107; and Technical Corrections and 4/13/12............................ 335-14-7-.03(1)(b). Clarifications Rule. Checklist 229, Conditional 78 FR 46448........................ 335-14-1-.02(1)(a)177.; -.02(1)(a)248.; - Exclusions for Solvent 7/31/13............................ .02(1)(a)312.; Contaminated Wipes. 335-14-2-.01(4)(a)26.; -.01(4)(a)26.(i)- (v); -.01(4)(a)26.(v)(I)-(IV); - .01(4)(a)26.(vi); -.01(4)(b)(18); - .01(4)(b)(18)(i)-(v); - .01(4)(b)(18)(v)(I)-(IV); - .01(4)(b)(18)(vi); and - .01(4)(b)(18)(vi)(I)-(II). ---------------------------------------------------------------------------------------------------------------- \1\ The Alabama provisions are from the Alabama Hazardous Waste Management Rules 335-14-1, effective May 27, 2008 (Checklists 214 and 215); March 31, 2009 (Checklist 218); March 26, 2013 (Checklist 228); and March 31, 2015 (Checklist 229). H. Where are the revised State rules different from the Federal rules? We consider the following State requirements to be more stringent than the Federal requirements: Rules 335-14-2-.01(4)(a)26.(v)(IV) and 335-14-2-.01(4)(b)(18)(v)(IV) (from RCRA Cluster XXIII, Checklist 229) because, in addition to the three types of records required by the federal regulation, the State requires generators to maintain in their onsite records, documentation that verifies that ``no free liquids'' were present in the container prior to shipment. The Federal requirements found at 40 CFR 261.4(a)(26)(v) and 261.4(b)(18)(v) do not include this record keeping requirement. These requirements are part of Alabama's authorized program and are federally enforceable. EPA cannot delegate the Federal requirements at 40 CFR 261.39(a)(5), 261.40, and 261.41 contained in the Cathode Ray Tubes Rule set forth in 71 FR 42928 (July 28, 2006). Although Alabama has adopted these requirements at Rules 335-14-2-.05(1)(a)5., 335-14- 2-.05(2), and 335-14-2-.05(3), EPA will continue to implement those requirements. I. Who handles permits after the authorization takes effect? Alabama will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which EPA issued prior to the effective date of this authorization until they expire or are terminated. EPA will not issue any more permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Alabama is not authorized. J. How does today's action affect Indian Country (18 U.S.C. 1151) in Alabama? Alabama is not authorized to carry out its hazardous waste program in Indian Country within the State, which includes the Poarch Band of Creek Indians. EPA will continue to implement and administer the RCRA program in these lands. K. What is codification and is EPA codifying Alabama's hazardous waste program as authorized in this rule? Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by referencing the authorized State rules in 40 CFR part 272. EPA is not codifying the authorization of Alabama's changes at this time. However, EPA reserves the amendment of 40 CFR part 272, subpart B, for the authorization of Alabama's program changes at a later date. L. Administrative Requirements The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. Under RCRA section 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the [[Page 14332]] requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the ``Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document 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 in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This action will be effective May 19, 2017, unless objections to this authorization are received. List of Subjects in 40 CFR Part 271 Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements. Authority: This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912(a), 6926, and 6974(b). Dated: March 9, 2017. V. Anne Heard, Acting Regional Administrator, Region 4. [FR Doc. 2017-05464 Filed 3-17-17; 8:45 am] BILLING CODE 6560-50-P
![14332 Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Rules and Regulations
requirements of section 12(d) of the DEPARTMENT OF HEALTH AND Please do not submit confidential
National Technology Transfer and HUMAN SERVICES commercial information or personal
Advancement Act of 1995 (15 U.S.C. identifying information that you do not
272 note) do not apply. As required by 42 CFR Part 10 want in the public domain.
section 3 of Executive Order 12988 (61 RIN 0906–AA89 FOR FURTHER INFORMATION CONTACT:
FR 4729, February 7, 1996), in issuing
CAPT Krista Pedley, Director, OPA,
this rule, EPA has taken the necessary 340B Drug Pricing Program Ceiling
HSB, HRSA, 5600 Fishers Lane, Mail
steps to eliminate drafting errors and Price and Manufacturer Civil Monetary
Stop 08W05A, Rockville, MD 20857, or
ambiguity, minimize potential litigation, Penalties Regulation
by telephone at 301–594–4353.
and provide a clear legal standard for
AGENCY: Health Resources and Services
affected conduct. EPA has complied SUPPLEMENTARY INFORMATION:
Administration, HHS.
with Executive Order 12630 (53 FR
8859, March 15, 1988) by examining the ACTION: Interim final rule; further delay I. Background
takings implications of the rule in of effective date with comment.
In September 2010, HHS published an
accordance with the ‘‘Attorney SUMMARY: The Health Resources and advanced notice of proposed
General’s Supplemental Guidelines for Services Administration (HRSA) rulemaking (ANPRM) in the Federal
the Evaluation of Risk and Avoidance of administers section 340B of the Public Register, ‘‘340B Drug Pricing Program
Unanticipated Takings’’ issued under Health Service Act (PHSA), which is Manufacturer Civil Monetary Penalties’’
the executive order. This rule does not referred to as the ‘‘340B Drug Pricing (75 FR 57230, (September 20, 2010)).
impose an information collection Program’’ or the ‘‘340B Program.’’ The HHS subsequently published a notice of
burden under the provisions of the January 5, 2017 final rule sets forth the proposed rulemaking (NPRM) in June
Paperwork Reduction Act of 1995, 44 calculation of the ceiling price and 2015 to implement civil monetary
U.S.C. 3501 et seq. application of civil monetary penalties, penalties (CMPs) for manufacturers who
The Congressional Review Act, 5 and applies to all drug manufacturers knowingly and intentionally charge a
U.S.C. 801 et seq., as added by the Small that are required to make their drugs covered entity more than the ceiling
Business Regulatory Enforcement available to covered entities under the price for a covered outpatient drug; to
Fairness Act of 1996, generally provides 340B Program. This interim final rule provide clarity on the requirement that
that before a rule may take effect, the delays the effective date of the final rule manufacturers calculate the 340B
agency promulgating the rule must published in the Federal Register (82 ceiling price on a quarterly basis; and to
submit a rule report, which includes a FR 1210, (January 5, 2017)) to May 22, establish the requirement that a
copy of the rule, to each House of the 2017. Commenters are also invited to manufacturer charge a $.01 (penny
Congress and to the Comptroller General provide their views on whether a longer pricing policy) for drugs when the
of the United States. EPA will submit a delay of the effective date to October 1, calculation equals zero (80 FR 34583,
report containing this document and 2017, would be more appropriate. (June 17, 2015)). The public comment
other required information to the U.S. DATES: As of March 20, 2017, the period closed in August 2015, and
Senate, the U.S. House of effective date of the final rule published HRSA received approximately 35
Representatives, and the Comptroller in the Federal Register (82 FR 1210, comments. After review of the initial
General of the United States prior to January 5, 2017) is further delayed to comments, HHS reopened the comment
publication in the Federal Register. A May 22, 2017. Comments on the delay period (81 FR 22960, (April 19, 2016))
major rule cannot take effect until 60 of the effective date to May 22, 2017, as to invite additional comment on specific
days after it is published in the Federal well as comments on alternatively areas of the NPRM: 340B ceiling price
Register. This action is not a ‘‘major delaying the effective date further to calculations that result in a ceiling price
rule’’ as defined by 5 U.S.C. 804(2). This October 1, 2017, must be submitted on that equals zero (penny pricing); the
action will be effective May 19, 2017, or before April 19, 2017. methodology that manufacturers utilize
unless objections to this authorization ADDRESSES: You may submit comments, when estimating the ceiling price for a
are received. identified by the Regulatory Information new covered outpatient drug; and the
Number (RIN) 0906–AA89, by any of the definition of the ‘‘knowing and
List of Subjects in 40 CFR Part 271 following methods. Please submit your intentional’’ standard to be applied
Environmental protection, comments in only one of these ways to when assessing a CMP on manufacturers
Administrative practice and procedure, minimize the receipt of duplicate who overcharge a covered entity. The
Confidential business information, submissions. The first is the preferred comment period closed May 19, 2016,
Hazardous waste, Hazardous waste method. and HHS received approximately 70
transportation, Indian lands, • Federal eRulemaking Portal: http:// additional comments.
Intergovernmental relations, Penalties, www.regulations.gov. Follow
instructions for submitting comments. On January 5, 2017, HHS published a
Reporting and recordkeeping final rule in the Federal Register (82 FR
requirements. This is the preferred method for the
submission of comments. 1210, (January 5, 2017)) and comments
Authority: This action is issued under • Email: 340BCMPNPRM@hrsa.gov. from both the NPRM and the reopening
the authority of sections 2002(a), 3006, Include 0906–AA89 in the subject line notice were considered in the
and 7004(b) of the Solid Waste Disposal of the message. development of the final rule. The
Act, as amended, 42 U.S.C. 6912(a), • Mail: Office of Pharmacy Affairs provisions of that rule were to be
6926, and 6974(b). effective March 6, 2017; however, HHS
nlaroche on DSK30NT082PROD with RULES
(OPA), Healthcare Systems Bureau
(HSB), Health Resources and Services issued a subsequent final rule (82 FR
Dated: March 9, 2017.
Administration (HRSA), 5600 Fishers 12508, (March 6, 2017)) delaying the
V. Anne Heard, effective date to March 21, 2017, in
Lane, Mail Stop 08W05A, Rockville, MD
Acting Regional Administrator, Region 4. 20857. accordance with a January 20, 2017,
[FR Doc. 2017–05464 Filed 3–17–17; 8:45 am] All submitted comments will be memorandum from the Assistant to the
BILLING CODE 6560–50–P available to the public in their entirety. President and Chief of Staff, entitled
VerDate Sep<11>2014 15:08 Mar 17, 2017 Jkt 241001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\20MRR1.SGM 20MRR1](https://thefederalregister.org/doc/82_FR_14379/page/6.svg)
Document Created: 2017-03-18 01:10:45
Document Modified: 2017-03-18 01:10:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This final authorization will become effective on May 19, 2017 unless EPA receives adverse written comment by April 19, 2017. If EPA receives such comment, EPA will publish a timely withdrawal of this direct final rule in the Federal Register and inform the public that this authorization will not take effect. | |
| Contact | Audrey Baker, RCRA Programs and Materials Management Section, Materials and Waste Management Branch, Resource Conservation and Restoration Division, U.S. Environmental Protection Agency, Atlanta Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960; telephone number: (404) 562-8483; fax | |
| FR Citation | 82 FR 14327 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Confidential Business Information; Hazardous Waste; Hazardous Waste Transportation; Indian Lands; Intergovernmental Relations; Penalties and Reporting and Recordkeeping Requirements |
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