56708 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[FRL–9464–4] 

Ohio: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Ohio has applied to EPA for 

final authorization of the changes to its 

hazardous waste program under the 

Resource Conservation and Recovery 

Act (RCRA). EPA has reviewed Ohio’s 

application with regards to Federal 

requirements, and is proposing to 

authorize the State’s changes. 

DATES: Comments on this proposed rule 

must be received on or before October 

14, 2011. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

RCRA–2011–0530 by one of the 

following methods: 

http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

E-mail: westefer.gary@epa.gov. 

Mail: Gary Westefer, Ohio Regulatory 

Specialist, LR–8J, U.S. EPA, Region 5, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

Instructions: Direct your comments to 

Docket ID Number EPA–R05–RCRA– 

2011–0530. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

http://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 http:// 

www.regulations.gov or e-mail. The 

http://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 e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made 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 or 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 http:// 

www.epagov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some of the 

information is not publicly available, 

e.g., CBI or other information for which 

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 in http:// 

www.regulations.gov or in hard copy. 

You may view and copy Ohio’s 

application from 9 a.m. to 4 p.m. at the 

following addresses: U.S. EPA Region 5, 

LR–8J, 77 West Jackson Boulevard, 

Chicago, Illinois, contact: Gary Westefer 

(312) 886–7450; or Ohio Environmental 

Protection Agency, Lazarus Government 

Center, 50 West Town Street, Suite 700, 

Columbus, Ohio, contact: Kit Arthur 

(614) 644–2932. 

FOR FURTHER INFORMATION CONTACT: Gary 

Westefer, Ohio Regulatory Specialist, 

U.S. EPA Region 5, LR–8J, 77 West 

Jackson Boulevard, Chicago, Illinois 

60604, (312) 886–7450, e-mail 

westefer.gary@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 request 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 266, 268, 270, 273 and 279. 

B. What decisions have we made in this 

rule? 

We conclude that Ohio’s application 

to revise its authorized program meets 

all of the statutory and regulatory 

requirements established by RCRA. 

Therefore, we propose to grant Ohio 

final authorization to operate its 

hazardous waste program with the 

changes described in the authorization 

application. Ohio has responsibility for 

permitting treatment, storage, and 

disposal facilities (TSDFs) within its 

borders (except in Indian Country) and 

for carrying out the aspects of the RCRA 

program described in its revised 

program application, subject to the 

limitations of the Hazardous and Solid 

Waste Amendments of 1984 (HSWA). 

New Federal requirements and 

prohibitions imposed by Federal 

regulations that EPA promulgates under 

the authority of HSWA take effect in 

authorized States before they are 

authorized for the requirements. Thus, 

EPA will implement those requirements 

and prohibitions in Ohio, including 

issuing permits, until the State is 

granted authorization to do so. 

C. What is the effect of this 

authorization decision? 

The effect of this decision, once 

finalized, is that a facility in Ohio 

subject to RCRA would have to comply 

with the authorized State requirements 

instead of the equivalent Federal 

requirements in order to comply with 

RCRA. Ohio has enforcement 

responsibilities under its State 

hazardous waste program for RCRA 

violations, but EPA retains its authority 

under RCRA sections 3007, 3008, 3013, 

and 7003, which include, among others, 

authority to: 

1. Do inspections, and require 

monitoring, tests, analyses or reports; 

2. Enforce RCRA requirements and 

suspend or revoke permits; and 

3. Take enforcement actions 

regardless of whether the State has 

taken its own actions. 

This action will not impose additional 

requirements on the regulated 

community because the regulations for 

which Ohio is being authorized are 

already effective, and will not be 

changed by EPA’s final action. 

D. What happens if EPA receives 

adverse comments on this action? 

If EPA receives adverse comments on 

this authorization, we will address all 

public comments in a later Federal 

Register. You may not have another 

opportunity to comment. If you want to 

comment on this authorization, you 

must do so at this time. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules 56709 

E. What has Ohio previously been 

authorized for? 

Ohio initially received final 

authorization on June 28, 1989, effective 

June 30, 1989 (54 FR 27170) to 

implement the RCRA hazardous waste 

management program. We granted 

authorization for changes to their 

program on April 8, 1991, effective June 

7, 1991 (56 FR 14203) as corrected June 

19, 1991, effective August 19, 1991 (56 

FR 28088); July 27, 1995, effective 

September 25, 1995 (60 FR 38502); 

October 23, 1996, effective December 

23, 1996 (61 FR 54950); January 24, 

2003, effective January 24, 2003 (68 FR 

3429); January 20, 2006, effective 

January 20, 2006 (71 FR 3220), and 

October 29, 2007, effective October 29, 

2007 (72 FR 61063). 

F. What changes are we proposing with 

today’s action? 

On May 9, 2011, Ohio submitted a 

final complete program revision 

application, seeking authorization of 

their changes in accordance with 40 

CFR 271.21. We are now proposing to 

authorize, subject to receipt of written 

comments that oppose this action, 

Ohio’s hazardous waste program 

revision. We propose to grant Ohio final 

authorization for the following program 

changes: 

OHIO’S ANALOGS TO THE FEDERAL REQUIREMENTS

Description of Federal requirement 

(include checklist number, if relevant) 

Federal Register date and page 

(and/or RCRA statutory authority) Analogous State authority 

Amendments to Land Disposal Restrictions for First Third Scheduled 

Wastes; Checklist 50.1.

February 27, 1989, 54 FR 8264 ......... OAC 3745–59–41(A); Effective June 29, 1990. 

Changes to Part 124 Not Accounted for 

by Present Checklists; Checklist 70.

April 1, 1983, 48 FR 14146 ................

June 30, 1983, 48 FR 30113 

OAC 3745–50–21; Effective July 14, 1997, amended September 5, 2010. 

July 26, 1988, 53 FR 28118 ............... OAC 3745–50–40; Effective July 14, 1997, amended February 16, 2009. 

September 26, 1988, 53 FR 37396 ....

January 4, 1989, 54 FR 246 

50–39; 50–51; Effective July 14, 1997, amended September 

5, 2010. 

NESHAPS: Final Standards for Hazardous Air Pollutants for Hazardous 

Waste Combustors; Technical Corrections; Checklist 188.1.

May 14, 2001, 66 FR 24270 ............... OAC 3745–50–41; Effective February 16, 2009. 

NESHAPS: Interim Standards for Hazardous Air Pollutants for Hazardous 

Waste Combustors (Interim Standards 

Rule); Checklist 197.

February 13, 2002, 67 FR 6792 ......... OAC 3745–50–44; 3745–50–66; 3745–50–235; 3745–57–40; 

3745–266–100; Effective February 16, 2009. 

NESHAPS: Standards for Hazardous Air 

Pollutants for Hazardous Waste Combustors; Final Rule; Checklist 198.

February 14, 2002, 67 FR 6968 ......... OAC 3745–50–51; 3745–266–100; Effective December 7, 

2004. 

Hazardous Waste Management System; 

Definition of Solid Waste; Toxicity 

Characteristic; Checklist 199.

March 13, 2002, 67 FR 11251 ............ OAC 3745–51–02; 3745–51–04; 3745–51–24; Effective December 7, 2004. 

NESHAPS: Standards for Hazardous Air 

Pollutants for Hazardous Waste Combustors—Corrections; Checklist 202.

December 19, 2002, 67 FR 77687 ..... OAC 3745–50–44(C)(7); 3745–50–44(C)(9); 3745–50–62; 

3745–50–66; Effective February 16, 2009. 

Hazardous Waste Management System; 

Identification and Listing of Hazardous 

Waste; Recycled Used Oil Management Standards; Checklist 203.

July 30, 2003, 68 FR 44659 ............... OAC 3745–51–05; 3745–279–10; 3745–279–74; Effective 

February 16, 2009. 

Hazardous Waste—Nonwastewaters 

From Production of Dyes, Pigments, 

and Food, Drug and Cosmetic 

Colorants; Mass Loadings-Based Listing; Final Rule; Checklist 206.

February 24, 2005, 70 FR 9138 ......... OAC 3745–51–04; 3745–51–11; 3745–51–30; 3745–51–32; 

3745–270–20; 3745–270–40; Effective February 16, 2009. 

Hazardous Waste—Nonwastewaters 

From Production of Dyes, Pigments, 

and Food, Drug and Cosmetic 

Colorants; Mass Loadings-Based Listing; Correction; Checklist 206.1.

June 16, 2005, 70 FR 35032 .............. OAC 3745–51–32; Effective February 16, 2009. 

Hazardous Waste Management System, 

Modification of the Hazardous Waste 

Manifest System; Final Rule; Checklist 

207.

March 4, 2005, 70 FR 10776 .............. OAC 3745–50–10; 3745–51–07; 3745–52–20; 3745.52–21; 

3745–52–27; 3745–52–32; 3745–52–33; 3745–52–34; 

3745–52–45; 3745–52–60; 3745–53–20; 3745–53–21; 

3745–54–70; 3745–54–71; 3745–54–72; 3745–54–76; 

3745–65–70; 3745–65–71; 3745–65–72; 3745–65–76; Effective February 16, 2009. 

Hazardous Waste Management System, 

Modification of the Hazardous Waste 

Manifest System; Correction; Checklist 207.1.

June 16, 2005, 70 FR 35034 .............. OAC 3745–52–20; 3745–52–33; Effective February 16, 2009. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

56710 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules 

OHIO’S ANALOGS TO THE FEDERAL REQUIREMENTS—Continued 

Description of Federal requirement 

(include checklist number, if relevant) 

Federal Register date and page 

(and/or RCRA statutory authority) Analogous State authority 

Waste Management System; Testing 

and Monitoring Activities; Final Rule: 

Methods Innovation Rule and SW– 

846 Final Update IIIB; Checklist 208.

June 14, 2005, 70 FR 34538 .............. OAC 3745–50–11; 3745–50–44(C)(7); 3745–50–44(C)(9); 

3745–50–62; 3745–50–66; 3745–51–03; 3745–51–20; 

3745–51–21; 3745–51–22; 3745–51–35; 3745–51–38; 

3745–55–90; 3745–57–14; 3745–66–90; 3745–68–14; 

3745–266–100; 3745–266–102; 3745–266–103; 3745– 

266–106; 3745–266–112; 3745–270–40; 3745–270–48; 

3745–279–10; 3745–279–44; 3745–279–53; 3745–279– 

63; Effective February 16, 2009. 

Waste Management System; Testing 

and Monitoring Activities; Final Rule: 

Methods Innovation Rule and SW– 

846 Final Update IIIB; Correction; 

Checklist 208.1.

August 1, 2005, 70 FR 44150 ............ OAC 3745–54–98; Effective February 16, 2009. 

Revision of Wastewater Treatment Exemptions for Hazardous Waste Mixtures (‘‘Headworks Exemptions’’); 

Checklist 211.

October 4, 2005, 70 FR 57769 ........... OAC 3745–51–03; Effective February 16, 2009. 

National Emission Standards for Hazardous Air Pollutants: Final Standards 

for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I 

Final Replacement Standards and 

Phase II); Checklist 212.

October 12, 2005, 70 FR 59402 ......... OAC 3745–50–10; 3745–50–11; 3745–50–44(C)(7); 3745– 

50–44(C)(9, 10, 11); 3745–50–51; 3745–50–62; 3745–50– 

66; 3745–50–235; 3745–57–40; 3745–68–40; 3745–266– 

100; Effective February 16, 2009. 

Hazardous Waste and Used Oil; Corrections to Errors in the Code of Federal 

Regulations; Checklist 214.

July 14, 2006, 71 FR 40254 ............... OAC 3745–50–27; 3745–50–28; 3745–50–40; 3745–50–41; 

3745–50–42; 3745–50–43; 3745–50–44; 3745–50–45; 

3745–50–50; 3745–50–51; 3745–51–02; 3745–51–03; 

3745–51–04; 3745–51–06; 3745–51–11; 3745–51–21; 

3745–51–24; 3745–51–30; 3745–51–31; 3745–51–32; 

3745–51–33; 3745–51–38; 3745–52–34; 3745–52–53; 

3745–52–56; 3745–52–58; 3745–52–70; 3745–52–81; 

3745–52–82; 3745–52–83; 3745–52–84; 3745–52–87; 

3745–54–01; 3745–54–13; 3745–54–17; 3745–54–18; 

3745–54–73; 3745–54–97; 3745–54–98; 3745–54–99; 

3745–54–101; 3745–55–11; 3745–55–12; 3745–55–15; 

3745–55–16; 3745–55–18; 3745–55–19; 3745–55–40; 

3745–55–42; 3745–55–43; 3745–55–45; 3745–55–47; 

3745–55–51; 3745–55–75; 3745–55–93; 3745–56–21; 

3745–56–23; 3745–56–26; 3745–56–51; 3745–56–52; 

3745–56–59; 3745–56–80; 3745–56–83; 3745–57–03; 

3745–57–04; 3745–57–06; 3745–57–14; 3745–57–17; 

3745–57–44; 3745–57–72; 3745–57–73; 3745–57–74; 

3745–57–75; 3745–57–83; 3745–57–90; 3745–57–91; 

3745–205–101; 3745–65–01; 3745–65–12; 3745–65–14; 

3745–65–16; 3745–65–19; 3745–65–56; 3745–65–73; 

3745–65–90; 3745–66–10; 3745–66–12; 3745–66–13; 

3745–66–17; 3745–66–19; 3745–66–40; 3745–66–42; 

3745–66–45; 3745–66–47; 3745–66–74; 3745–66–93; 

3745–66–94; 3745–66–97; 3745–66–99; 3745–66–101; 

3745–67–21; 3745–67–24; 3745–67–28; 3745–67–29; 

3745–67–55; 3745–67–59; 3745–67–80; 3745–67–81; 

3745–68–02; 3745–68–03; 3745–68–05; 3745–68–12; 

3745–68–14; 3745–68–16; 3745–69–05; 3745–69–41; 

3745–69–43; 3745–69–45; 3745–256–100; 3745–256– 

101; 3745–266–70; 3745–266–80; 3745–266–100; 3745– 

266–102; 3745–266–103; 3745–266–106; 3745–266–107; 

3745–266–109; 3745–266–112; 3745–270–02; 3745–270– 

04; 3745–270–06; 3745–270–07; 3745–270–40; 3745– 

270–42; 3745–270–44; 3745–270–45; 3745–270–48; 

3745–270–49; 3745–270–50; 3745–273–09; 3745–273– 

13; 3745–273–14; 3745–273–34; 3745–279–01; 3745– 

279–10; 3745–279–11; 3745–279–43; 3745–279–44; 

3745–279–45; 3745–279–52; 3745–279–55; 3745–279– 

56; 3745–279–57; 3745–279–59; 3745–279–63; 3745– 

279–64; 3745–279–70; Effective February 16, 2009. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules 56711 

TABLE 2—EQUIVALENT STATE INITIATED CHANGES

Ohio amendment Description of change Sections affected and effective date 

Rule Review per 119.032 ... ............................................. OAC 3745–50–31; 3745–50–47; 3745–54–56; 3745–54–77 Effective May 13, 2007. 

Housekeeping Rules Set I .. ............................................. OAC 3745–50–10; 3745–50–11; 3745–50–40 3745–50–51; 3745–50–235; 3745– 

51–03; 3745–51–04; 3745–51–05; 3745–51–20; 3745–51–22; 3745–51–24; 

3745–51–30; 3745–51–35; 3745–51–38; 3745–52–10; 3745–52–21; 3745–52–27; 

3745–52–32; 3745–52–33; 3745–52–34; 3745–52–41; 3745–52–54; 3745–53–20; 

3745–53–21; 3745–54–18; 3745–54–71; 3745–54–72; 3745–54–98; 3745–55–47; 

3745–55–90; 3745–55–99; 3745–57–14; 3745–57–83; 3745–57–91; 3745–65–72; 

3745–66–41; 3745–66–90; 3745–67–73; 3745–68–14; 3745–68–40; 3745–256– 

100; 3745–266–80; 3745–266–103; 3745–266–106; 3745–270–01; 3745–270–40; 

3745–270–48; 3745–279–44; 3745–279–53; 3745–279–55; 3745–279–63 Effective February 16, 2009. 

G. Which revised State rules are 

different from the Federal rules? 

Ohio has excluded the non-delegable 

Federal requirements at 40 CFR 268.5, 

268.6, 268.42(b), 268.44, and 270.3. EPA 

will continue to implement those 

requirements. In this action, because 

Ohio has not received statutory 

authority for Subparts AA, BB and CC 

of 40 CFR part 264, they have not 

adopted the rules for the 40 CFR subpart 

BB portion in checklist 212 (located in 

the table above). This will be added at 

a later date. Checklist 214 in the above 

table appeared in the Federal Register 

on July 14, 2006 (71 FR 40254) as a 

Federal regulation that corrected 

numerous errors that had appeared in 

the Code of Federal Regulations over 

several years. Not all of the amendments 

in the July 14 Federal Register are 

reflected in this Ohio rules effective 

date or in the current Authorization 

Revision Application. Since the July 14 

Federal Register includes several 

hundred amendments, it was broken 

into several rule-makings in Ohio. This 

is the first of these rule-makings. 

Subsequent rule-makings will address 

the balance of the corrections. A number 

of these Federal corrections had already 

been made in the State rules, so not all 

the Federal changes made in the July 14 

FR resulted or will result in Ohio rule 

amendments attributable to the July 14 

FR. Ohio has corrected the errors in the 

sections cited in Checklist 214 above, 

additional corrections will be noted in 

future Federal Registers as State 

Initiated Changes to Checklist 214. 

H. Who handles permits after the 

authorization takes effect? 

Ohio 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 we issued 

prior to the effective date of this 

authorization until they expire or are 

terminated. We will not issue any more 

new 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 Ohio is not yet 

authorized. 

I. How does today’s action affect Indian 

Country (18 U.S.C. 1151) in Ohio? 

Ohio is not authorized to carry out its 

hazardous waste program in ‘‘Indian 

Country,’’ as defined in 18 U.S.C. 1151. 

Indian Country includes: 

1. All lands within the exterior 

boundaries of Indian Reservations 

within or abutting the State of Ohio; 

2. Any land held in trust by the U.S. 

for an Indian tribe; and 

3. Any other land, whether on or off 

an Indian reservation that qualifies as 

Indian Country. 

Therefore, EPA retains the authority 

to implement and administer the RCRA 

program in Indian Country. 

J. What is codification and is EPA 

codifying Ohio’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. We do this by 

referencing the authorized State rules in 

40 CFR part 272. Ohio’s rules, up to and 

including those revised June 7, 1991, as 

corrected August 19, 1991, have 

previously been codified through the 

incorporation-by-reference effective 

February 4, 1992 (57 FR 4162) . We 

reserve the amendment of 40 CFR part 

272, subpart KK for the codification of 

Ohio’s program changes until a later 

date. 

K. Statutory and Executive Order 

Reviews 

This proposed rule only authorizes 

hazardous waste requirements pursuant 

to RCRA 3006 and imposes no 

requirements other than those imposed 

by State law (see SUPPLEMENTARY

INFORMATION, Section A. Why are 

Revisions to State Programs Necessary?). 

Therefore this rule complies with 

applicable executive orders and 

statutory provisions as follows: 

1. Executive Order 18266: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulations 

and Regulatory Review 

The Office of Management and Budget 

has exempted this rule from its review 

under Executive Orders 12866 (58 FR 

51735, October 4, 1993) and Executive 

Order 13563 (76 FR 3821 January 21, 

2011). 

2. Paperwork Reduction Act 

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.). 

3. Regulatory Flexibility Act 

This rule authorizes State 

requirements for the purpose of RCRA 

3006 and imposes no additional 

requirements beyond those required by 

State law. Accordingly, I certify that this 

rule 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.). 

4. Unfunded Mandates Reform Act 

Because this rule approves preexisting 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). 

5. Executive Order 13132: Federalism 

Executive Order 13132 (64 FR 43255, 

August 10, 1999) does not apply to this 

rule because it will not have federalism 

implications (i.e., substantial direct 

effects on the States, on the relationship 

between the national government and 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

56712 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government). 

6. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175 (65 FR 67249, 

November 9, 2000) does not apply to 

this rule because it will not have tribal 

implications (i.e., substantial direct 

effects on one or more Indian tribes, or 

on the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes). 

7. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

This rule is not subject to Executive 

Order 13045 (62 FR 19885, April 23, 

1997), because it is not economically 

significant as defined in Executive 

Order 12866 and because the EPA does 

not have reason to believe the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. 

8. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not a significant 

regulatory action as defined in 

Executive Order 12866. 

9. National Technology Transfer 

Advancement Act 

EPA approves State programs as long 

as they meet criteria required by RCRA, 

so it would be inconsistent with 

applicable law for EPA, in its review of 

a State program, to require the use of 

any particular voluntary consensus 

standard in place of another standard 

that meets requirements of RCRA. Thus, 

the requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply to this rule. 

10. Executive Order 12988 

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. 

11. Executive Order 12630: Evaluation 

of Risk and Avoidance of Unanticipated 

Takings 

EPA has complied with Executive 

Order 12630 (53 FR 8859, March 18, 

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. 

12. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and Low 

Income Populations 

Because this rule proposes 

authorization of pre-existing State rules 

and imposes no additional requirements 

beyond those imposed by State law and 

there are no anticipated significant 

adverse human health or environmental 

effects, the rule is not subject to 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

13. Congressional Review Act 

EPA will submit a report containing 

this rule and other information required 

by the Congressional Review Act (5 

U.S.C. 801 et seq.) 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). 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous materials transportation, 

Hazardous waste, Indians—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, 6974(b). 

Dated: August 28, 2011. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2011–23553 Filed 9–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 493 

Office of the Secretary 

45 CFR Part 164 

[CMS–2319–P] 

RIN 0938–AQ38 

CLIA Program and HIPAA Privacy 

Rule; Patients’ Access to Test Reports 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS; Centers 

for Disease Control and Prevention 

(CDC), HHS; Office for Civil Rights 

(OCR), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

amend the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) regulations to specify that, upon 

a patient’s request, the laboratory may 

provide access to completed test reports 

that, using the laboratory’s 

authentication process, can be identified 

as belonging to that patient. Subject to 

conforming amendments, the proposed 

rule would retain the existing 

provisions that provide for release of 

test reports to authorized persons and, 

if applicable, the individuals (or their 

personal representative) responsible for 

using the test reports and, in the case of 

reference laboratories, the laboratory 

that initially requested the test. In 

addition, this proposed rule would also 

amend the Health Insurance Portability 

and Accountability Act of 1996 (HIPAA) 

Privacy Rule to provide individuals the 

right to receive their test reports directly 

from laboratories by removing the 

exceptions for CLIA-certified 

laboratories and CLIA-exempt 

laboratories from the provision that 

provides individuals with the right of 

access to their protected health 

information. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 14, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–2319–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

mstockstill on DSK4VPTVN1PROD with PROPOSALS