Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 70761 

Executive Order 13175 Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule also does not have 

tribal implications because it will not 

have a substantial direct effect on one or 

more Indian tribes, 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, 

as specified by Executive Order 13175 

(65 FR 67249, November 9, 2000). 

Executive Order 13132 Federalism 

This proposed action also does not 

have federalism implications because it 

does 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). 

Redesignation is an action that merely 

affects the status of a geographical area, 

does not impose any new requirements 

on sources, or allows a state to avoid 

adopting or implementing other 

requirements, and does not alter the 

relationship or the distribution of power 

and responsibilities established in the 

Clean Air Act. 

Executive Order 13045 Protection of 

Children From Environmental Health 

and Safety Risks 

This proposed rule also is not subject 

to Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant. 

National Technology Transfer 

Advancement Act 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. In this context, in the 

absence of a prior existing requirement 

for the state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Clean Air Act. Redesignation is an 

action that affects the status of a 

geographical area but does not impose 

any new requirements on sources. 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. 

Paperwork Reduction Act 

This proposed 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.). 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Nitrogen oxides, Ozone, 

Volatile organic compounds. 

40 CFR Part 81 

Air pollution control, Environmental 

protection, National parks, Wilderness 

areas. 

Dated: November 15, 2005. 

Bharat Mathur, 

Acting Regional Administrator, Region 5. 

[FR Doc. 05–23221 Filed 11–22–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[FRL–8001–4] 

Michigan: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Michigan has applied to the 

EPA for final authorization of the 

changes to its hazardous waste 

management 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 proposing to authorize the state’s 

changes through this proposed final 

action. 

DATES: Written comments must be 

received on or before December 23, 

2005. 

ADDRESSES: Send written comments to 

Ms. Judy Feigler, Michigan Regulatory 

Specialist, U.S. Environmental 

Protection Agency, Waste, Pesticides 

and Toxics Division (DM–7J), 77 W. 

Jackson Blvd., Chicago, Illinois 60604, 

phone number: (312) 886–4179. We 

must receive your comments by 

December 23, 2005. You can view and 

copy Michigan’s application from 9 a.m. 

to 4 p.m. at the following addresses: 

Waste Management Division, Michigan 

Department of Environmental Quality, 

Constitution Hall—Atrium North, 

Lansing, Michigan (mailing address P.O. 

Box 30241, Lansing, Michigan 48909), 

contact Ronda Blayer (517) 353–9548; 

and EPA Region 5, contact Judy Feigler 

at the following address. 

FOR FURTHER INFORMATION CONTACT: Judy 

Feigler, Michigan Regulatory Specialist, 

U.S. EPA, DM–7J, 77 W. Jackson Blvd., 

Chicago, IL 60604, (312) 886–4179. 

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 266, 268, 270, 273 and 279. 

B. What Decisions Have We Made in 

This Rule? 

We conclude that Michigan’s 

application to revise its authorized 

program meets all of the statutory and 

regulatory requirements established by 

RCRA. Therefore, we propose to grant 

Michigan final authorization to operate 

its hazardous waste management 

program with the changes described in 

the authorization application. Michigan 

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 

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 Michigan, including 

issuing permits, until the State is 

granted authorization to do so. 

C. What Is the Effect of Today’s 

Authorization Decision? 

This decision means that a facility in 

Michigan subject to RCRA will now 

have to comply with the authorized 

state requirements (listed in section F of 

70762 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 

this notice) instead of the equivalent 

federal requirements in order to comply 

with RCRA. Michigan has enforcement 

responsibilities under its state 

hazardous waste management program 

for violations of such program, but EPA 

retains its authority under RCRA 

sections 3007, 3008, 3013, and 7003, 

which include, among others, the 

authority to: 

• Do inspections, and require 

monitoring, tests, analyses or reports; 

• Enforce RCRA 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 Michigan is being 

authorized by today’s action are already 

effective, and are not changed by today’s 

action. 

D. What Happens if EPA Receives 

Comments That Oppose This Action? 

If EPA receives comments that oppose 

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. 

E. What Has Michigan Previously Been 

Authorized for? 

Michigan initially received final 

authorization on October 16, 1986, 

effective October 30, 1986 (51 FR 

36804–36805) to implement the RCRA 

hazardous waste management program. 

We granted authorization for changes to 

Michigan’s program on November 24, 

1989, effective January 23, 1990 (54 FR 

48608); on January 24, 1991, effective 

June 24, 1991 (56 FR 18517); on October 

1, 1993, effective November 30, 1993 (58 

FR 51244); on January 13, 1995, 

effective January 13, 1995 (60 FR 3095); 

on February 8, 1996, effective April 8, 

1996 (61 FR 4742); on November 14, 

1997, effective November 14, 1997 (62 

FR 61775); on March 2, 1999, effective 

June 1, 1999 (64 FR 10111); and on July 

31, 2002, effective July 31, 2002 (67 FR 

49617). 

F. What Changes Are We Authorizing 

With Today’s Action? 

On September 7, 2005, Michigan 

submitted a complete program revision 

application seeking authorization of its 

changes in accordance with 40 CFR 

271.21. We now make a final decision, 

subject to receipt of written comments 

that oppose this action, that Michigan’s 

hazardous waste management program 

revision satisfies all requirements 

necessary to qualify for final 

authorization. Therefore, we propose to 

grant Michigan final authorization for 

the following program changes: 

PROGRAM REVISIONS BASED ON FEDERAL RCRA CHANGES

Description of federal requirement Checklist No., 

if relevant 

Federal Register date and page (and/ 

or RCRA statutory authority) Analogous state authority 

HSWA Codification Rule; Household 

Waste (Resource Recovery Facilities).

17C ........................ July 15, 1985, 50 FR 28702 ................ R 299.9204(2)(a) and (2)(a)(i)–(ii). 

Corrective Action Management Units 

and Temporary Units.

121 ......................... February 16, 1993, 58 FR 8658 .......... R 299.9102(s) and (cc), R 299.9103(r), 

R 299.9105(c)(vii), R 299.9105(t), R 

299.9107(j), R 299.9311, R 

299.9413, R 299.9519(9), R 

299.9601(1), (2)(k) and (l) and 

(3)(a), R 299.9627, R 299.9629(3)(a) 

and (b), R 299.9635(3), R 299.9636, 

and R 299.11003(1)(u). 

Waste Water Treatment Sludges from 

Metal Finishing Industry; 180-day Accumulation Time.

184 ......................... March 8, 2000, 65 FR 12378 ............... R 299.9306(1)(d) and (7)–(10). 

Organobromine Production Waste and 

Petroleum Refining Process Waste: 

Technical Correction.

187 ......................... June 8, 2000, 65 FR 36365 ................. R 299.9220 and R 299.11003(1)(u). 

NESHAPS: Final Standards for Hazardous Air Pollutants for Hazardous 

Waste Combusters.

188, 188.1, 188.2 .. July 10, 2000, 65 FR 42292; May 14, 

2001, 66 FR 24270; July 3, 2001, 66 

FR 35087.

R 299.9230(2) and (3); R 

299.9519(5)(j)(v); R 299.9623(2), 

(3)(b) and (11); and R 

299.11003(1)(n). 

Chlorinated Aliphatics Production 

Wastes; Land Disposal Restrictions 

for Newly Identified Wastes; and 

CERCLA Hazardous Substance Designation and Reportable Quantities.

189 ......................... November 8, 2000, 65 FR 67068 ........ R 299.9222, R 299.9311, R 299.9413, 

R 299.9627, and R 299.11003(1)(j) 

and (u). 

Deferral of Phase IV Standards for 

PCBs as a Constituent Subject to 

Treatment in Soil.

190 ......................... December 26, 2000, 65 FR 81373 ...... R 299.9311, R 299.9413, R 299.9627, 

and R 299.11003(1)(u). 

Storage, Treatment, Transportation and 

Disposal of Mixed Wastes.

191 ......................... May 16, 2001, 66 FR 27218 ................ R 299.9101(q), R 299.9102(d) and (z), 

R 299.9103(d) and (k), R 299.9104, 

R 299.9105(b), (j), (k), (v), (w), (z) 

and (aa), R 299.9203, R 

299.9822(2)–(14), R 299.9823(2)–(4) 

and (6)–(12). 

Mixture and Derived-From Rule Revisions.192A ...................... May 16, 2001, 66 FR 27266 ................ R 299.9203(1)(c), (3), (7) and (8). 

Land Disposal Restrictions Correction .. 192B ...................... May 16, 2001, 66 FR 27266 ................ R 299.9311, R 299.9413, R 299.9627, 

and R 299.11003(1)(u). 

Change of EPA Mailing Address; Additional Technical Amendments and 

Corrections.

193 ......................... June 28, 2001, 66 FR 34374 ............... R 299.11005(2). 

Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 70763 

PROGRAM REVISIONS BASED ON FEDERAL RCRA CHANGES—Continued 

Description of federal requirement Checklist No., 

if relevant 

Federal Register date and page (and/ 

or RCRA statutory authority) Analogous state authority 

Correction to the Hazardous Waste 

Identification Rule (HWIR): Revisions 

to the Mixture and Derived-From 

Rules.

194 ......................... October 3, 2001, 66 FR 50332 ............ R 299.9203(1)(c) and (7)(c). 

Inorganic Chemical Manufacturing 

Wastes Information and Listing.

195, 195.1 .............. November 20, 2001, 66 FR 58258; 

April 9, 2002, 67 FR 17119.

R 299.9204(2)(o), R 299.9222, R 

299.9311, R 299.9413, R 299.9627, 

and R 299.11003(1)(j) and (u). 

CAMU Amendments .............................. 196 ......................... January 22, 2002, 67 FR 2962 ............ R 299.9102(s) and (t), R 299.9107(j), 

R 299.9635, R 299.9638, and R 

299.9639. 

Hazardous Air Pollutant Standards for 

Combusters: Interim Standards.

197 ......................... February 13, 2002, 67 FR 6792 .......... R 299.9504(4), (15) and (20), R 

299.9508(1)(b), R 299.9601(2)(i) and 

(7), R 299.9623, R 299.9640, R 

299.9808(4), (7) and (9), R 

299.11003(1)(v). 

Hazardous Air Pollutant Standards for 

Combusters; Corrections.

198 ......................... February 14, 2002, 67 FR 6968 .......... R 299.9519(5)(j)(v), R 299.9808(2), 

(3), (4), (7) and (9); and R 

299.11003(1)(r). 

Vacatur of Mineral Processing Spent 

Materials Being Reclaimed as Solid 

Wastes and TCLP Use with MGP 

Waste.

199 ......................... March 13, 2002, 67 FR 11251 ............. R 299.9202(1)(b)(iii), R 299.9204(1)(v), 

and R 299.9212(4). 

Zinc Fertilizers Made From Recycled 

Hazardous Secondary Materials.

200 ......................... July 24, 2002, 67 FR 48393 ................ R 299.9204(1)(x) and (y), R 299.9311, 

R 299.9413, R 299.9627, R 

299.9801(3) and (5), and R 

299.11003(1)(u). 

Land Disposal Restrictions: National 

Treatment Variance to Designate 

New Treatment Subcategories for 

Radioactively Contaminated Cadmium-, Mercury-, and Silver-Containing Batteries.

201 ......................... October 7, 2002, 67 FR 48393 ............ R 299.9311, R 299.9413, R 299.9627, 

and R 299.11003(1)(u). 

NESHAP: Standards for Hazardous Air 

Pollutants for Hazardous Waste 

Combusters: Corrections.

202 ......................... December 19, 2002, 67 FR 77687 ...... R 299.9504(4) and (15) and R 

299.9508(1)(b), R 299.9623(8), and 

R 299.9808(7) and (9). 

Recycled Used Oil Management Standards.203 ......................... July 30, 2003, 68 FR 44659 ................ R 299.9205(8), R 299.9809 (1)(e) and 

(2)(p), and R 299.9815(1)(b) and 

(3)(f). 

STATE-INITIATED MODIFICATIONS

State requirement Effective date Federal analog 

MAC R 299.9205(4) .................................................................. October 15, 1996 .................... 40 CFR 261.5 and 262.34. 

MAC R 299.9206(3) .................................................................. September 11, 2000 ............... 40 CFR 261.6(a)(3). 

MAC R 299.9206(3)(g) .............................................................. September 11, 2000 ............... 40 CFR 261.6(1)(2). 

MAC R 299.9207(3) .................................................................. June 21, 1994 ......................... 40 CFR 261.7(b)(1)(i). 

MAC R 299.9212(1), (2), and (3) .............................................. October 15, 1996 .................... 40 CFR 261.21, 261.22, and 261.23. 

MAC R 299.9215(3) .................................................................. April 20, 1988 .......................... 40 CFR 261.21(c). 

MAC R 299.9303(4) .................................................................. September 22, 1998 ............... 40 CFR 262.12(b) and 270.11. 

MAC R 299.9304(2)(h) and (4)(c) ............................................. October 15, 1996 .................... 40 CFR 262.20. 

MAC R 299.9304(6) .................................................................. October 15, 1996 .................... None. 

MAC R 299.9306(1)(e) and (f) .................................................. October 15, 1996 .................... 40 CFR 262.34(a)(1). 

MAC R 299.9307(5)–(7) ............................................................ September 22, 1998 ............... 40 CFR 262.40(c). 

MAC R 299.9401 ....................................................................... October 15, 1996 .................... 40 CFR 263.10. 

MAC R 299.9404 ....................................................................... October 15, 1996 .................... 40 CFR 263.12. 

MAC R 299.9410(1) and (3) ..................................................... October 15, 1996 .................... 40 CFR 263.30 and 263.31. 

MAC R 299.9503(1)(i) and (k) and (5) ...................................... October 15, 1996 .................... 40 CFR 262.34. 

MAC R 299.9508(1)(f) ............................................................... October 15, 1996 .................... 40 CFR 270.14(b)(17). 

MAC R 299.9514(1) and (2)(c) ................................................. September 22, 1998 ............... 40 CFR 124.12. 

MAC R 299.9516(3) .................................................................. October 15, 1996 .................... 40 CFR 270.50. 

MAC R 299.9611(4) .................................................................. October 15, 1996 .................... None. 

MAC R 299.9629(3)(a)(ii) and (iii) and (3)(b)(ii) and (iii) .......... September 11, 2000 ............... 40 CFR 264.90(a) and 264.101(b). 

MAC R 299.9633 ....................................................................... October 15, 1996 .................... 40 CFR 260.10, definition of ‘‘treatment’’. 

MAC R 299.9701(2) (removal) and (3) renumbered as (2) ...... September 11, 2000 ............... 40 CFR 264.140(a) and (c). 

MAC R 299.9713(6) and (7) ..................................................... October 15, 1996 .................... 40 CFR 264.101(b). 

MAC R 299.11004(4) ................................................................ September 11, 2000 ............... 40 CFR part 263. 

MAC R 299.11007(2) ................................................................ September 11, 2000 ............... None. 

MAC R 299.11008(2) ................................................................ September 11, 2000 ............... None. 

70764 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 

G. Where Are the Revised State Rules 

Different from the Federal Rules? 

Michigan hazardous waste 

management regulations are more 

stringent than the corresponding federal 

regulations in a number of different 

areas. The more stringent provisions are 

being recognized as a part of the 

federally-authorized program and are 

federally enforceable. More stringent 

provisions in the state’s authorization 

application include, but are not limited 

to, the following: 

1. At MAC R 299.9203(7)(a) and (c), 

Michigan’s exclusion differs from the 

corresponding Federal counterpart at 40 

CFR 261.3(g)(2)(i) in that the exclusion 

only applies to mixtures generated as a 

result of a cleanup conducted at the 

individual site of generation pursuant to 

parts 31, 111, 201, or 213 of Michigan’s 

Act 451 (1994 PA 451, MCL 324.101, 

known as the natural resources and 

environmental protection act), or 

CERCLA. 

2. At R 299.9306(7)(d)(i) and (ii) and 

(g), Michigan’s rules contain 

containment, inspection, recordkeeping 

and emergency requirements that are 

not found in the Federal counterpart at 

40 CFR 262.34(g)(4)(i)(A) and (B) and 

(g)(4)(v), respectively. 

3. At R 299.9307(7)(d)(i)(C), Michigan 

does not allow containment buildings, 

as does 40 CFR 262.34(g)(4)(i)(C). 

4. At R 299.9639(5)(e), Michigan does 

not allow permits as a shield as does the 

Federal counterpart at 40 CFR 

§ 264.555(e)(5). 

We consider the following state 

requirements to be beyond the scope of 

the Federal program, though this list 

may not be exhaustive: 

At R 299.9104 and R 299.9203, 

Michigan regulates more hazardous 

wastes than the Federal counterpart at 

40 CFR 266.210. The hazardous wastes 

that are regulated by Michigan but not 

by EPA are broader-in-scope 

requirements. 

Broader-in-scope requirements are not 

part of the authorized program and EPA 

cannot enforce them. Although you 

must comply with these requirements in 

accordance with state law, they are not 

RCRA requirements. 

H. Who Handles Permits After the 

Authorization Takes Effect? 

Michigan 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 Michigan is not 

yet authorized. 

I. How Does Today’s Action Affect 

Indian Country (18 U.S.C. 1151) in 

Michigan? 

Michigan is not authorized to carry 

out its hazardous waste program in 

Indian country within the state, as 

defined in 18 U.S.C. 1151. This 

includes: 

1. All lands within the exterior 

boundaries of Indian reservations 

within the State of Michigan; 

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. 

EPA will continue to implement and 

administer the RCRA program in Indian 

country. It is EPA’s long-standing 

position that the term ‘‘Indian lands’’

used in past Michigan hazardous waste 

approvals is synonymous with the term 

‘‘Indian country.’’ Washington Dep’t of 

Ecology v. U.S. EPA, 752 F.2d 1465, 

1467, n.1 (9th Cir. 1985). See 40 CFR 

144.3 and 258.2. 

J. What Is Codification and Is EPA 

Codifying Michigan’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. Michigan’s rules, up to 

and including those revised October 19, 

1991, have previously been codified 

through incorporation-by-reference 

effective April 24, 1989 (54 FR 7421, 

February 21, 1989); as amended 

effective March 31, 1992 (57 FR 3724, 

January 31, 1992). We reserve the 

amendment of 40 CFR part 272, subpart 

X, for the codification of Michigan’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 does not impose 

requirements other than those already 

imposed by state law (see 

SUPPLEMENTARY INFORMATION, Section A. 

Why Are Revisions to State Programs 

Necessary?; and Section C. What Is the 

Effect of Today’s Authorization 

Decision?). Therefore, this rule complies 

with applicable executive orders and 

statutory provisions as follows: 

1. Executive Order 18266: Regulatory 

Planning Review 

The Office of Management and Budget 

has exempted this rule from its review 

under Executive Order 12866 (58 FR 

51735, October 4, 1993). 

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 

After considering the economic 

impacts of today’s rule on small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.), I certify that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

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 19, 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 

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 and it is not based on 

environmental health or safety risks. 

Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Proposed Rules 70765 

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 met 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 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. 

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, 6974(b). 

Dated: November 9, 2005. 

Margaret M. Guerriero, 

Acting Regional Administrator, Region 5. 

[FR Doc. 05–23213 Filed 11–22–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

42 CFR Part 121 

RIN 0906AA62 

Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This notice sets forth the 

Secretary’s proposal to include 

intestines within the definition of 

organs covered by the rules governing 

the operation of the Organ Procurement 

and Transplantation Network. The 

Secretary further proposes a 

corresponding change to the definition 

of human organs covered by section 301 

of the National Organ Transplant Act, as 

amended. 

DATES: To be considered, comments on 

this proposed rule must be submitted by 

January 23, 2006. Subject to 

consideration of the comments 

submitted, the Department intends to 

publish final regulations. 

ADDRESSES: You may submit comments, 

identified by RIN 0906AA62, by any of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.hrsa.gov/. Follow the instructions 

for submitting comments on the Agency 

Web site. 

• E-mail: jburdick@hrsa.gov. Include 

RIN 0906AA62 in the subject line of the 

message. 

• Fax: 301–594–6095. 

• Mail: Jim Burdick, M.D., Director, 

Division of Transplantation, Healthcare 

Systems Bureau, Health Resources and 

Services Administration (HRSA), 5600 

Fishers Lane, Room 12C–06, Rockville, 

Maryland 20857. 

• Hand Delivery/Courier: Jim 

Burdick, M.D., Director, Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Room 12C–06, Rockville, 

Maryland 20857. 

Instructions: All submissions received 

must include the agency name and 

Regulatory Information Number (RIN) 

for this rulemaking. All comments 

received will be posted without change 

to http://www.hrsa.gov/, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to the Division 

of Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Room 12C–06, Rockville, 

Maryland 20857 weekdays (Federal 

holidays excepted) between the hours of 

8:30 a.m. and 5 p.m. To schedule an 

appointment to view public comments, 

phone (301) 443–7757. 

FOR FURTHER INFORMATION CONTACT: Jim 

Burdick, M.D. at the above address; 

telephone number (301) 443–7577. 

SUPPLEMENTARY INFORMATION: 

Adding Intestines to the Definition of 

Organs Covered by the Rules Governing 

the Operation of the Organ 

Procurement and Transplantation 

Network (OPTN) 

Based upon a review of intestinal 

transplants, the Secretary believes that 

intestines should now be included 

within the definition of organs covered 

by the rules governing the operation of 

the OPTN (42 CFR part 121) (hereinafter 

the final rule). This notice sets forth the 

history of intestinal transplants, the 

factors that have persuaded the 

Department of the advisability of 

including intestines within the ambit of 

the regulations governing the operation 

of the OPTN, and the anticipated 

consequences of this proposal. 

The first successful intestinal 

transplant was performed in 1989. 

Intestinal transplantation may be 

considered for patients with irreversible 

intestinal failure due to surgery, trauma, 

or acquired or congenital disease who 

cannot be managed through the 

intravenous delivery of nutrients, also 

referred to as total parenteral nutrition 

(TPN). Although intestinal transplants 

have been performed for years, 

considerable morbidity and mortality 

have limited widespread clinical use. 

Complications are frequent and include 

acute and chronic rejection, 

lymphoproliferative disease, and serious 

infections such as cytomegalovirus 

disease. For patients who received 

intestinal transplants in the United 

States from January 2000 through June 

2002, one-year graft and patient survival 

rates were 67 percent and 81 percent 

respectively for adults, and 58 percent 

and 65 percent respectively for pediatric 

recipients. Despite the shortcomings, 

the number of candidates for intestinal 

transplants and the number of intestinal