Federal Register/Vbl. 70, No. 140/Friday, July 22, 2005/Rules and Regulations

PART 73-LISTING OF COLOR

ADDITIVES EXEMPT FROM

CERTIFICATION

E 1. The authority citation for 21 CFR

part 73 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343,

348, 351,352,355,361,362,371,379e.

0 2. Section 73.1128 is added to subpart

B to read as follows:

§73.1128 Mica-based pearlescent

pigments.

(a) Identity. (1) The color additive is

formed by depositing titanium and/or

iron salts onto mica, followed by

heating to produce one of the following

combinations: Titanium dioxide on

mica; iron oxide on mica; titanium

dioxide and iron oxide on mica. Mica

used to manufacture the color additive

shall conform in identity to the

requirements of § 73.1496(a)(1).

(2)-Color additive mixtures for drug

use made with mica-based pearlescent

pigments may contain only those

diluents listed in this subpart as safe

and suitable for use in color additive

mixtures for coloring ingested drugs.

(b) Specifications. Mica-based

pearlescent pigments shall conform to

the following specifications and shall be

free from impurities other than those

named to the extent that such other

impurities may be avoided by good

manufacturing practice:

(1) Lead (as Pb), not more than 4 parts

per million (ppm).

(2) Arsenic (as As), not more than 3

ppm.

(3) Mercury (as Hg), not more than 1

ppm.

(c) Uses and restrictions. Mica-based

pearlescent pigments may be safely used

to color ingested drugs in amounts up

to 3 percent, by weight, of the final drug

product. The maximum amount of iron

oxide to be used in producing said

pigments is not to exceed 55 percent, by

weight, in the finished pigment.

(d) Labeling. The label of the color

additive and of any mixture prepared

therefrom intended solely or in part for

coloring purposes shall conform to the

requirements of § 70.25 of this chapter.

(e) Exemption from certification.

Certification of this color additive is not

necessary for the protection of the

public health, and therefore batches

thereof are exempt from the certification

requirements of section 721(c) of the

Federal Food, Drug, and Cosmetic Act.

Dated: July 13, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05-14457 Filed 7-21-05; 8:45 am]

BILUNG CODE 4160-01-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 271

[FRL-7942-9]

Idaho: Final Authorization of State

Hazardous Waste Management

Program Revision

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: Idaho 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). On May 16, 2005,

EPA published a proposed rule to

authorize the changes and opened a

public comment period. The comment

period closed on June 15, 2005. EPA has

decided that these revisions to the Idaho

hazardous waste management program

4atisfy all of the requirements necessary

to qualify for final authorization and is

authorizing these revisions to Idaho's

authorized hazardous waste

management program in today's final

rule.

DATES: Final authorization for the

revisions to the hazardous waste

program in Idaho shall be effective at 1

p.m. E.S.T. on July 22, 2005.

FOR FURTHER INFORMATION CONTACT: Jeff

Hunt, Mail Stop AWT-122, U.S. EPA

Region 10, Office of Air, Waste, and

Toxics, 1200 Sixth Avenue, Seattle,

Washington 98101, phone (206) 553-

0256. E-mail: hunt.jeff@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 and consistent with

the Federal program. States are required

to have enforcement authority which is

adequate to enforce compliance with the

requirements of the hazardous waste

program. UnderRCRA Section 3009,

States are not allowed to impose any

requirements which are less stringent

than the Federal program. 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 title 40 of the Code of Federal

Regulations (CFR) parts 124, 260

through 266, 268, 270, 273 and 279.

Idaho's hazardous waste management

program received final authorization

effective on April 9, 1990 (55 FR 11015,

March 29, 1990). EPA also granted

authorization for revisions to Idaho's

program effective on June 5, 1992 (57 FR

11580, April 6, 1992), on August 10,

1992 (57 FR 24757, June 11, 1992), on

June 11, 1995 (60 FR 18549, April 12,

1995), on January 19, 1999 (63 FR

56086, October 21, 1998), on July 1,

2002 (67 FR 44069, July 1, 2002), aid

on March 10, 2004 (69 FR 11322).

Today's final rule addresses a

program revision application that Idaho

submitted to EPA in September 2004, in

accordance with 40 CFR 271.21, seeking

authorization of changes to the State

program. On May 16, 2005, EPA

published a proposed rule announcing

its intent to grant Idaho final

authorization for revisions to Idaho's

hazardous waste program and provided

a period of time for the receipt of public

comments. The proposed rule can be

found at 70 FR 25798.

B. What Were the Comments to EPA's

Proposed Rule?

EPA received two letters during the

public comment period. One letter was

dated June 3, 2005, from Mr. Chuck

Broscious on behalf of the

Environmental Defense Institute and a

second letter was dated June 14, 2005,

from Mr. Chuck Broscious on behalf of

the Environmental Defense Institute,

Keep Yellowstone Nuclear Free, and

David B. McCoy, collectively the

commenters.

The comment letters focused on

issues originally raised in petitions

submitted to EPA on August 8, 2000,

and September 13, 2001, and on

numerous follow up letters and

correspondence related to those

petitions. The petitions themselves

centered on issues related to specific

units located at the Idaho National

Laboratory (INL) in Idaho Falls, Idaho.

The comment letters also raised a

concern about nuclear defense activities

at the same INL facility. In response to

this aspect of the commenters' letter

EPA observes that defense activities

related to nuclear production and

propulsion programs will generally not

meet the definition of solid waste under

the RCRA regulations and may be

regulated by other federal authorities.

With respect to mixed waste, Idaho's

hazardous waste program is authorized

for mixed waste.

In the September 13, 2001, petition

which commenters refer to in their

current comments, the commenters as petitioners sought EPA's withdrawal of

Idaho's authorization to implement the

hazardous waste program under RCRA

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because of petitioners' concerns with

hazardous waste issues at the INL

facility. EPA in response to that

withdrawal petition request conducted

an informal investigation and

determined that sufficient evidence did

not exist to initiate formal -withdrawal

proceedings. The investigation findings

were issued on March 20, 2002, with a

follow up response on June 20, 2002.

The supporting documentation was

provided to the commenters and the

documentation is currently available to

the public under the Freedom of

Information Act. -

On February 6, 2003, the EPA Office

of Inspector General (OIG) requested

that Region 10 conduct a second

investigation to answer a series of

follow up questions related to the

September 13, 2001, petition. EPA

Region 10 conducted a second

investigation and issued its findings on

April 10, 2003. The investigation results

were provided to Mr. David McCoy, one

of the current commenters, as part of an

October 13, 2004, Freedom of,

Information Act response. On February

5, 2004, after conducting independent

field work, the OIG issued a final

evaluation report which concluded,

"Region 10 generally relied on

appropriate regulatory requirements and

standards in reaching its conclusion that

evidence did not exist to commence

proceedings to withdraw the State of

Idaho's authority to run its RCRA

Hazardous Waste program."

While the evaluation report

concluded that evidence did not exist to

commence withdrawal proceedings, the

OIG did identify areas of concern for'

further Regional and State follow up. As

detailed in the Evaluation Report, the

OIG and EPA Region 10 agreed to

specific follow up actions. To document

resolution of these action Items, EPA

Region 10 submitted quarterly progress

reports to the Region 10 OIG Audit

Liaison on January 13, 2004, April 16,

2004, July 15, 2004, October 12, 2004,

February 9, 2005, and April 8, 2005.

These reports doculnent the steps taken

by EPA and the Idaho Department of

Environmental Quality to meet the

specific actions recommended by the

OIG. The first three of these quarterly

reports were sent to the commenters and

the OIG as part of a July 26, 2004, letter

from then Regional Administrator, L.

John Jani. Hardcopies of all the

quarterly reports were made directly

available to the public as part of the

authorization docket for the proposed

authorization with repositories in

Seattle, Washington and the University

of Idaho in Moscow. These quarterly

reports are also currently available to

the public under the Freedom of

Information Act.

While the Region will continue its

ongoing obligation to conduct state

oversight, EPA considers the follow up

to the September 13, 2001, withdrawal

petitioA and the February 5, 2004, OIG

Evaluation Report complete. The

information documenting EPA's follow

up to the February 5, 2004, OIG

Evaluation Report was contained in the

authorization docket available to the

public through the Region 10 Library in

Seattle, Washington, as well as through

the Freedom of Information Act process.

In response to a request by Mr. Chuck

Broscious, EPA made a hardcopy

version of the docket available to the

public at the University of Idaho Library

in Moscow, Idaho. Furthermore, in

response to a request from the Shoshone

Bannock Tribe, and Mr. Chuck

Broscious, EPA electronically scanned

thb State of Idaho's authorization

application and made this document

available on the Region 10 Web site at:

http://yosemite.epa.gov/R10/OWCM.

NSF/ed6c817875102d2d8825650

-f00714a59/2b89088c6ed73517882570

140081e7f9?OpenDocument.

Based on the-follow up actions that

were taken in response to the OIG

Evaluation Report, EPA disagrees with

comments submitted on June 3 and 14,

2005, alleging that EPA and the Idaho

Department of Environmental Quality

have not sufficiently responded to the

issues raised by the February 5, 2004,

OIG Evaluation report. Therefore, EPA

has determined that these comments do

not constitute basis for continued delay

or denial of Idaho's application for

program revision.

C. What Decisions Have We Made in

This Rule?

EPA has made a final determination

that Idaho's revisions to the Idaho

authorized hazardous waste program

meet all of the statutory and regulatory

requirements established by RCRA for

authorization. Therefore, EPA is

authorizing the revisions to the Idaho

hazardous waste program and

authorizing the State of Idaho to operate

its hazardous waste program as

described in the revision authorization

application. Idaho's authorized program

will be responsible for carrying out the

aspects of the RCRA program described

in its revised program application,

subject to the limitations of RCRA,

including 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 are implemented

by EPA and take effect in States with

authorized programs before such

programs are authorized for the

requirements. Thus, EPA will

implement those HSWA requirements

and prohibitions in Idaho, including

issuing permits or portions of permits,

until the State is authorized to do so.

D. What Will Be the Effect of Today's

Action?

The effect of today's action is that a

facility in Idaho subject to RCRA must

comply with the authorized State

program requirements and with any

applicable federally-issued requirement,

such as, for example, the federal HSWA

provisions for which the State is not

authorized, and RCRA requirements that

are not supplanted by authorized Stateissued requirements, in order to comply

with RCRA. Idaho has enforcement

responsibilities under its State

hazardous waste program for violations

of its currently authorized program and

will have enforcement responsibilities

for the revisions which are the subject

of this final rule. EPA continues to have

independent enforcement authority

under RCRA sections 3007, 3008, 3013,

and 7003, which include, among others,

authority to:

-Conduct inspections; require

monitoring, tests, analyses or reports;

-Enforce RCRA requirements,

including State program requirements

that are authorized by EPA and any

applicable Federally-issued statutes

and regulations; suspend, modify or

revoke permits; and

-Take enforcement actions regardless

of whether the State has taken its own

actions.

This final action approving these

revisions will not impose additional

requirements on the regulated

community because the regulations for

which Idaho's program is being

authorized are already effective under

State law.

E. What Rules Are We Authorizing

With Today's Action?

In September 2004, Idaho submitted a

complete program revision application,

seeking authorization for all delegable

federal hazardous waste regulations

codified as of July 1, 2003,.as

incorporated by reference in IDAPA

.58.01.05.(002)-(016) and 58.01.05.997,

including previously unauthorized

portions of the Post Closure Rule

promulgated on October 22, 1998 (63 FR

56710).

F. Who Handles Permits After This

Authorization Takes Effect?

Idaho will issue permits for all the.

provisions for which it is authorized

and will administer the permits it

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issues. All permits or portions of

permits issued by EPA prior to final

authorization of this revision will

continue to be administered by EPA

until the effective date of the issuance,

re-issuance after modification, or denial

of a State RCRA permit or until the

permit otherwise expires or is revoked,

and until EPA takes action on its permit

or portion of permit. HSWA provisions

for which the State is not authorized

will continue in effect under the EPAissued permit or portion of permit. EPA

will continue to issue permits or

portions of permits for HSWA

requirements for which Idaho is not yet

authorized.

G. What Is Codification and Is EPA

Codifying Idaho'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's

authorized rules in 40 CFR part 272.

EPA is reserving the amendment of 40

CFR part 272, subpart F for codification

of Idaho's program at a later date.

H. How Does Today's Action Affect

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

Idaho?

EPA's decision to authorize the Idaho

hazardous waste program does not

include any land that is, or becomes

after the date of this authorization,

"Indian Country," as defined in 18

U.S.C. 1151. This includes: (1) All lands

within the exterior boundaries of Indian

reservations within or abutting the State

of Idaho; (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, this action has no

effect on Indian country. EPA retains

jurisdiction over "Indian Country" as

defined in 18 U.S.C. 1151.

I. Statutory and Executive Order

Reviews

1. Executive Order 12866

Under Executive Order 12866 (58 FR

5"1735, October 4,1993), the Agency

must determine whether the regulatory

action is "significant", and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines "significant

regulatory action" as one that is likely

to result in a rule that may: (1) Have an

annual effect on the economy of $100

million or more, or adversely affect in

a material way, the economy, a sector of

the economy, productivity, competition,-

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities; (2) create

a serious inconsistency or otherwise

interfere with an action taken or

planned by another agency; (3)

materially alter the budgetary impact of

entitlements, grants, user fees, or loan

programs, or the rights and obligations

of recipients thereof; or (4) raise novel

legal or policy issues arising out of legal

mandates, the President's priorities, or

the principles set forth in the Executive

Order. It has been determined that this

final rule is not a "significant regulatory

action" under the terms of Executive

Order 12866 and is therefore not subject

to OMB review.

2. Paperwork Reduction Act

The Paperwork Reduction Act, 44

U.S.C. 3501, et seq., is intended to

minimize the reporting and

recordkeeping burden on the regulated

community, as well as to minimize the

cost of Federal information collection

and dissemination. In general, the Act

requires that information requests and

recordkeeping requirements affecting

ten or more non-Federal respondents be

approved by OPM. Since this final rule

does not establish or modify any

information or recordkeeping

requirements for the regulated

community, it is not subject to the

provisions of the Paperwork Reduction

Act.

3. Regulatory Flexibility

The Regulatory Flexibility Act (RFA),

as amended by the Small Business

Regulatory Enforcement Fairness Act

(SBREFA), 5 U.S.C. 601 et seq.,

generally requires federal agencies to

prepare a regulatory flexibility analysis

of any rule subject to notice and

'comment rulemaking requirements

under the Administrative Procedure Act

or any other statute unless the agency

certifies that the rule will not have a

significant economic impact on a

substantial number of small entities.

Small entities include small businesses,

small organizations, and small

governmental jurisdictions. For

purposes of assessing the impacts of

today's rule on small entities, small

entity is defined as: (1) A small

business, as codified in the Small

Business Size Regulations at 13 CFR

part 121; (2) a small governmental

jurisdiction that is a government of a

city, county, town, school district or

special district with a population of less

than 50,000; and (3) a small

organization that is any not-for-profit

enterprise which is independently

owned and operated and is not

dominant in its field. EPA has

determined that this action will not

have a significant impact on small

entities because the final rule will only

have the effect of authorizing preexisting requirements under State law.

After considering the economic impacts

of today's rule, I certify that this action

will not have a significant economic

impact on a substantial number of small

entities.

4. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act (UMRA) of 1995 (Pub. L.

104-4) establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local

and tribal governments and the private

sector. Under section 202 of the UMRA,

EPA generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with "Federal mandates" that may

result in expenditures to State, local and

tribal governments, in the aggregate, or

to the private sector, of $100 million or

more in any year. Before promulgating

an EPA rule for which a written

statement is needed, section 205 of the

UMRA generally requires EPA to

identify and consider a reasonable

number of regulatory alternatives and

adopt the least costly, most costeffective or least burdensome alternative

that achieves the objectives of the rule.

The provisions of section 205 do not

apply when they are inconsistent with

applicable law. Moreover, section 205

allows EPA to adopt an alternative other

than the least costly, most cost-effective

or least burdensome alternative if the

Administrator publishes with the final

rule an explanation why the alternative

was not adopted. Before EPA establishes

any regulatory requirements that may

significantly or uniquely affect small

governments, including tribal

governments, it must have developed

under section 203 of the UMRA a small

government agency plan. The plan must

provide for notifying potentially

affected small governments, enabling

officials of affected small governments

to have meaningful and timely input in

the development of EPA regulatory

proposals with significant Federal

intergovernmental mandates, and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

This rule contains no Federal

mandates (under the regulatory

provisions of Title II of the UMRA) for

State, local or tribal govemments or the

private sector. It imposes no new

enforceable duty on any State, local or

tribal governments or the private sector.

Similarly, EPA has also determined that

this rule contains no regulatory

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requirements that might significantly or uniquely affect small government

entities. Thus, the requirements of

section 203 of the UMRA do not apply

to this rule.

5. Executive Order 13132: Federalism

Executive Order 13132, entitled

"Federalism" (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure "meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications." "Policies that have

federalism implications" is defined in

the Executive Order to include

regulations that 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

various levels of government."

This rule does not have federalism

implications. It 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 various levels of

government, as specified in Executive

Order 13132. This rule addresses the

authorization of pre-existing State rules.

Thus, Executive Order 13132 does not

apply to this rule.

6. Executive Order 13175: Consultation

and Coordination With Indian Tribal

Governments

Executive Order 13175, entitled

"Consultation and Coordination with

Indian Tribal Governments" (65 FR

67249, November 9, 2000), requires EPA

to develop an accountable process to

ensure "meaningful and timely input by

tribal officials in the development of

regulatory policies that have tribal

implications." This rule does not have

tribal implications, as specified in

Executive Order 13175. Thus, Executive

Order 13175 does not apply to this rule.

7. Executive Order 13045: Protection of

Children From Environmental Health

and Safety Risks

Executive Order 13045 applies to any

rule that: (1) Is determined to be

"economically significant" as defined

under Executive Order 12866, and (2)

concerns an environmental health or

safety risk that EPA has reason to

believe may have a dispropbrtionate

effect on .children. If the regulatory

action meets both criteria, the Agency

must evaluate the environmental health

or safety effects of the planned rule on

children, and explain why the planned

regulation is preferable to other

potentially effective and reasonably

feasible alternatives considered by the

Agency. . This rule is not subject to Executive

Order 13045 because it is not

economically significant as defined in

Executive Order 12866 and because the

Agency 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, "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" as

defined under Executive Order 12866.

9. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 ("NTTAA"), Public Law

104-113, 12(d) (15 U.S.C. 272) directs

EPA to use voluntary consensus

standards in its regulatory activities

unless to do so would be inconsistent

with applicable law or otherwise

impractical. Voluntary consensus

standards are technical standards (e.g.,

materials specifications, test methods,

sampling procedures, and business

practices) that are developed or adopted

by voluntary consensus bodies. The

NTTAA directs EPA to provide

Congress, through the OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards. This

rule does not involve "technical

standards" as defined by the NTTAA.

Therefore, EPA is not considering the

use of any voluntary consensus

standards.

10. Executive Order 12898: Federal

Actions To Address Environmental

Justice in Minority Populations and Low

Income Populations

To the greatest extent practicable and

permitted by law, and consistent with

the principles set forth in the report on

the National Performance Review, each

Federal agency must make achieving

environmental justice part of its mission

by identifying and addressing, as

appropriate, disproportionately high

and adverse human health and

environmental effects of its programs,

policies, and activities on minoritypopulations and low-income

populations in the United States and its

territories and possessions, the District

of Columbia, the Commonwealth of

Puerto Rico, and the Commonwealth of

the Mariana Islands. Because this rule

addresses authorizing pre-existing State

rules and there are no anticipated

significant adverse human health or

environmental effects, the rule is not

subject to Executive Order 12898.

11. Congressional Review Act

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 rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule 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 rule

will be effective on the date the rule is

published in the Federal Register.

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: July 14, 2005.

Michelle Pirzadeh,

Acting Regional Administrator, Region 10.

[FR Doc. 05-14545 Filed 7-21-05; 8:45 am]

BILLING CODE 6560-50-P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Medicare & Medicaid

Services

45 CFR Part 146

[CMS-4094-F3]

RIN 0938-AN22

Amendment to the Interim Final

Regulation for Mental Health Parity

AGENCY: Centers for Medicare &

Medicaid Services (CMS), DHHS.

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