### 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 addedto 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 ofthe following combinations: Titanium dioxide on mica; iron oxide on mica; titanium dioxide and iron oxide on mica. Mica usedto 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 inthis subpart as safe and suitable foruse in coloradditive mixtures for coloring ingested drugs.

(b)Specifications.Mica-based pearlescent pigments shall conform to the following specifications and shallbe 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), notmore than 4 parts per million (ppm). (2) Arsenic (asAs), not morethan 3 ppm. (3) Mercury (as Hg), not more than 1 ppm.

(c) Usesandrestrictions. Mica-based pearlescent pigments may be safely used
to color ingested drugs in amounts up to 3 percent, by weight, ofthe final drug product. The maximum amount ofiron oxide to be used in producing said pigments is not to exceed 55 percent, by weight, in the finished pigment. (d)Labeling.The label ofthe color additive and ofany mixture prepared therefrom intended solely orin part for coloring purposes shall conform to the requirements of§ 70.25 ofthis chapter. (e)Exemptionfrom certification. Certification ofthis color additive is not necessary for the protection ofthe public health, andtherefore batches thereofare exempt from the certification requirements of section 721(c) ofthe Federal Food,Drug, and Cosmetic Act.

Dated: July 13, 2005. Jeffrey Shuren, AssistantCommissioner forPolicy. [FRDoc. 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 ofState 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 ofchanges
to its hazardous waste program under the.Resource Conservation and Recovery Act (RCRA). OnMay 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. EPAhas decided that these revisions to the Idaho hazardous waste management program 4atisfy all ofthe requirements necessary to qualify for final authorization and is authorizing these revisions to Idaho's authorized hazardous waste management program intoday'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. onJuly 22, 2005.
FOR FURTHER INFORMATION CONTACT: Jeff Hunt, Mail Stop AWT-122, U.S. EPA Region 10, Office ofAir, Waste, and Toxics, 1200 SixthAvenue, Seattle, Washington 98101, phone (206) 553- 0256. E-mail: hunt.jeff@epa.gov.
SUPPLEMENTARY INFORMATION:
A. Why Are Revisions to State ProgramsNecessary?
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 ofthe 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 orregulatory authority is modified orwhen certain other changes occur. Most commonly, States mustchange theirprograms because ofchanges to EPA's regulations in title 40 ofthe Code ofFederal 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). EPAalso granted authorization for revisions to Idaho's program effective on June 5, 1992 (57 FR 11580, April 6, 1992), on August 10, 1992 (57FR 24757, June 11, 1992), on June 11, 1995 (60FR 18549, April 12, 1995), onJanuary 19, 1999 (63 FR 56086, October 21, 1998), onJuly 1, 2002 (67FR 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 ofchanges to the State program. OnMay 16, 2005, EPA published a proposed rule announcing its intent to grant Idaho final authorization forrevisions to Idaho's hazardous waste program andprovided

a period oftime for the receipt of public comments. The proposed rule can be found at 70FR 25798.

B. WhatWere 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 onbehalf ofthe Environmental Defense Institute and a second letter was dated June 14, 2005, from Mr. Chuck Broscious onbehalf of the Environmental Defense Institute, Keep Yellowstone Nuclear Free, and David B. McCoy, collectively the
commenters.

The comment letters focused on issues originally raised inpetitions submitted to EPA onAugust 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
atthe same INL facility. Inresponse to this aspect ofthe commenters' letter EPA observes that defense activities related to nuclear production and propulsion programs will generally not meet the definition ofsolid 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 intheir 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 ofpetitioners' 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 andthe documentation is currently available to the public under the Freedom of Information Act.

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On February 6, 2003, the EPA Office ofInspector 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 ofthe current commenters, as part ofan 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 inreaching 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 notexist to

commence withdrawal proceedings, the OIG did identify areas ofconcern 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 ofthese 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 ofthese quarterly reports were sent to the commenters and the OIG as part of aJuly 26, 2004, letter from then Regional Administrator, L. John Jani. Hardcopies ofall the quarterly reports were made directly available to the public aspart ofthe authorization docket forthe proposed authorization with repositories in Seattle, Washington and the University ofIdaho 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 inthe authorization docket available to the public through the Region 10 Library in Seattle, Washington, as well as through the Freedom ofInformation Act process. Inresponse to arequest by Mr. Chuck Broscious, EPA made ahardcopy version ofthe docket available to the public at the University ofIdaho Library inMoscow, Idaho. Furthermore, in response to a request from the Shoshone Bannock Tribe, and Mr. Chuck Broscious, EPA electronically scanned thb State ofIdaho's authorization application and made this document available on the Region 10 Web site at: http://yosemite.epa.gov/R10/OWCM. NSF/ed6c817875102d2d8825650

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### 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 onJune 3 and 14, 2005, allegingthat EPA and the Idaho Department ofEnvironmental Quality have not sufficiently responded to the issues raised by the February 5, 2004, OIG Evaluationreport. Therefore, EPA has determined that these comments do not constitute basis for continued delay

or denial ofIdaho's application for program revision.

C. WhatDecisions Have We Made in This Rule?

EPA has made afinal determination that Idaho's revisions to the Idaho authorized hazardous waste program meet all ofthe 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 ofIdaho to operate its hazardous waste program as described inthe revision authorization application. Idaho's authorized program will be responsible for carrying outthe aspects ofthe RCRAprogram described inits revised program application, subject to the limitations ofRCRA, including the Hazardous and Solid Waste Amendments of 1984 (HSWA). NewFederal requirements and prohibitions imposedby Federal regulations that EPA promulgates under the authority ofHSWA are implemented by EPA and take effect in Stateswith authorized programs before such programs are authorized forthe requirements. Thus, EPA will implement those HSWA requirements and prohibitions in Idaho, including issuing permits orportions ofpermits, until the State is authorized to do so.
D. What Will Bethe Effect ofToday's Action?

The effect oftoday's action is that a facility inIdaho 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 orderto comply with RCRA. Idaho has enforcement responsibilities under its State hazardous waste program forviolations of its currently authorized program and willhave enforcement responsibilities for the revisions which are the subject ofthis 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 orreports; -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

ofwhether 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 RulesAre 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 ofJuly 1, 2003,.as incorporated by reference inIDAPA .58.01.05.(002)-(016) and 58.01.05.997, including previously unauthorized portions ofthe Post Closure Rule promulgated on October 22, 1998 (63 FR 56710).

F. Who Handles Permits AfterThis Authorization Takes Effect?

Idaho will issue permits for all the. provisions forwhich it is authorized and will administer the permits it 

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issues. All permits orportions of permits issued by EPA prior to final authorization ofthis revision will continue to be administered by EPA untilthe effective date ofthe issuance, re-issuance aftermodification, or denial ofa State RCRA permit oruntil the permit otherwise expires or is revoked, and until EPA takes action on its permit

or portion ofpermit. HSWA provisions for which the State is not authorized will continue in effect under the EPAissued permit orportion ofpermit.EPA will continue to issue permits or portions ofpermits for HSWA requirements for which Idaho is notyet authorized.
G. What IsCodification and IsEPA Codifying Idaho'sHazardousWaste Programas Authorized inThis Rule?

Codification is the process ofplacing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code ofFederal Regulations. EPA does this by referencing the authorized State's authorized rules in 40 CFR part 272. EPA is reserving the amendment of40 CFR part 272, subpart F for codification of Idaho's program at alater 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 ofthis authorization, "Indian Country," as defined in 18 U.S.C. 1151. This includes: (1)All lands within the exteriorboundaries ofIndian reservations within or abutting the State of Idaho; (2) Any land held intrust 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 Order12866

UnderExecutive 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 ofthe Executive Order. The Order defines "significant regulatory action" as one that is likely to result in arule that may: (1)Have an annual effect on the economy of$100 million ormore, or adversely affect in

amaterial way, the economy, a sector of the economy, productivity, competition,- jobs, the environment, public health or safety, or State, local or tribal governments orcommunities; (2) create

a serious inconsistency orotherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, orloan
programs, or the rights and obligations ofrecipients thereof; or (4)raise novel legal or policy issues arising out oflegal mandates, the President's priorities, or the principles set forth in theExecutive Order. It has been determined that this final rule is not a "significant regulatory action" under the terms ofExecutive Order 12866 and is therefore not subject
to OMB review.

2. Paperwork ReductionAct
The Paperwork Reduction Act, 44 U.S.C. 3501, etseq., is intended to minimize the reporting and recordkeeping burden on the regulated community, as well as to minimize the
cost ofFederal information collection and dissemination. In general, the Act requires that information requests and recordkeeping requirements affecting
ten ormore non-Federal respondents be approved by OPM. Since this finalrule does not establish or modify any information orrecordkeeping requirements for the regulated community, it is not subject to the provisions ofthe Paperwork Reduction Act.

3.RegulatoryFlexibility

The Regulatory Flexibility Act (RFA),

as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), 5U.S.C. 601 etseq., generally requires federal agencies to prepare a regulatory flexibility analysis ofany rule subject to notice and 'commentrulemaking requirements under the Administrative Procedure Act

or any other statute unless the agency certifies thatthe rule will nothave a significant economic impact on a substantial number ofsmall entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For
purposes ofassessing 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 ofa city, county, town, school district or special district with a population ofless 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 willnot have a significant impact on small entities because the final rule will only have the effect ofauthorizing preexisting requirements under State law. After considering the economic impacts oftoday's rule, I certify that this action will not have a significant economic impact on a substantial number of small entities.

4. UnfundedMandatesReformAct

Title II ofthe 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 ofthe UMRA, EPA generally mustprepare awritten 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 inany year. Before promulgating

an EPA rule for which awritten
statement is needed, section 205 ofthe UMRA generally requires EPA to identify and consider a reasonable number ofregulatory alternatives and adopt the least costly, most costeffective orleast burdensome alternative that achieves the objectives ofthe rule. The provisions ofsection 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the leastcostly, most cost-effective

or least burdensome alternative ifthe Administrator publishes with the final rule an explanation why the alternative

was not adopted. Before EPA establishes anyregulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 ofthe UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials ofaffected small governments to have meaningful and timely input in the development ofEPA 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 ofTitle II ofthe UMRA) for State, local ortribal govemments orthe private sector. It imposes no new enforceable duty on any State, local or tribal governments orthe private sector. Similarly, EPA has also determined that thisrule contains no regulatory 

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requirements that might significantly or uniquely affect small government entities. Thus, the requirements of section 203 ofthe UMRA do notapply
to thisrule.

5.Executive Order13132:Federalism

Executive Order 13132, entitled "Federalism" (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure "meaningful and timely inputby 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 onthe States, on the relationship between the national government and the States, oron the distribution of
power andresponsibilities among various levels ofgovernment."

This rule does nothave federalism implications. It willnot have substantial direct effects 'on the States, on the relationship between the national government and the States, or on the distribution ofpower and responsibilities among various levels of government, as specified in Executive Order 13132. Thisrule addresses the authorization ofpre-existing State rules. Thus, Executive Order 13132 does not apply to this rule.
6.Executive Order13175:Consultation andCoordinationWith 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 Order13045:Protectionof ChildrenFromEnvironmentalHealth andSafety 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 riskthat EPA has reason to believe may have a dispropbrtionate effect on .children. Ifthe regulatory action meets both criteria, the Agency
must evaluate the environmental health

or safety effects ofthe 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 nothave reason to believe the environmental health or safety risks addressed by this action present a disproportionate riskto children.

8. Executive Order13211: Actions That Significantly Affect EnergySupply, Distribution, or Use
This rule is not subjectto 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. NationalTechnologyTransferand AdvancementAct

Section 12(d) ofthe National Technology Transfer andAdvancement 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, testmethods, sampling procedures, and business practices) that are developed oradopted by voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through the OMB, explanations whenthe 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 ofany voluntary consensus standards.

10.Executive Order12898:Federal Actions ToAddressEnvironmental JusticeinMinorityPopulations andLow Income Populations

To the greatest extent practicable and permitted by law, and consistent with the principles set forth inthe 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 ofits programs, policies, and activities onminoritypopulations 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 ReviewAct
The Congressional Review Act, 5 U.S.C. 801 etseq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before arule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy ofthe rule,to each House ofthe Congress and to the Comptroller General ofthe United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House ofRepresentatives, and the Comptroller General ofthe United States prior to publication ofthe rule in the Federal Register. A majorrule cannot take effect until 60 days after it is published in the Federal Register. This action is nota "major rule" as defined by5. U.S.C. 804(2). This rule willbe effective on the date the rule is published in the Federal Register.

Listof Subjects in40 CFR Part271

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 underthe authority ofsections 2002(a), 3006 and 7004(b) ofthe SolidWaste Disposal Actas amended 42 U.S.C. 6912(a), 6926, 6974(b).

Dated: July 14, 2005. MichellePirzadeh, ActingRegional Administrator, Region 10. [FRDoc. 05-14545 Filed 7-21-05; 8:45 am]

BILLING CODE 6560-50-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers forMedicare & Medicaid Services

45 CFR Part 146
[CMS-4094-F3]

RIN 0938-AN22

Amendment tothe Interim Final Regulation for Mental Health Parity

AGENCY: Centers forMedicare & Medicaid Services (CMS), DHHS. 

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