### Federal Register / Vol. 55, No. 58 / Monday, March 26, 1990 / Rules and Regulations

PART620-ADDITIONAL STANDARDS FOR BACTERIAL PRODUCTS

19. 

### The authority citation for21 CFR part 620continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 

### 701oftheFederal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 360, 371];

secs. 215, 351, 352, 353, 361 ofthe Public Health Service Act(42 U.S.C. 216, 262 263, 263a, 264).
§620.12 [Amended]



### 20. Section 620.12 U.S.Standard preparations is amended in the .introductory text paragraph byremoving 

### the words "Office ofBiologics Research and Review (HFN-890), Center for Drugs 

### and Biologics" and by adding, in their place, the words "Center forBiologics Evaluation and Research (HFB-210)".
§620.14 [Amended]



### 21. Section 620.14 General requirementsisamended in the introductory text ofparagraph (c) by 

### removing the words "Office of Biologics Research and Review [HFN-890), Center forDrugs and Biologics" and by adding, 

### in theirplace, the words "Center for Biologics Evaluation and Research 

### (HFB-1)".

PART660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

22. The authority citation for21 CFR part 660 continues to read as follows:

Authority: Secs. 201, 501, 502,503, 505,510, 

### 701 oftheFederal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355,360, 371);

secs. 215,351, 352, 353, 361 ofthe Public Health Service Act (42U.S.C. 216,262, 263, 263a, 264).


### §660.36 [Amended]



### 23. Section660.36 Samplesand protocolsis amended in theintroductory
text ofparagraph (a)by removing the words "Office ofBiologics Research and 

### Review Sample Custodian (ATTN: HFN-895)" and by adding, in theirplace, the words "Office ofBiological Product Review Sample Custodian (ATTN: HFB-- 215]".

§660.52 [Amended]



### 24. Section 660.52Reference preparations is amended byremoving the words "Center for Drugs and Biologics (HFN-890)" and by adding, in their place, the words "Center for 

### Biologics Evaluation and Research (HF3-22}".

PART 680-ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

25. Theauthority citation for 21 CFR part 680 continues to read as follows: Authority: Secs. 201, 501, 502, 503, 505, 510, 701 ofthe Federal Food, Drug,and Cosmetic Act (21 U.S.C. 321, 351, 352,353, 355, 360, 371); seps. 215,351, 352, 353, 361 of the Public Health Service Act (42U.S.C. 216,262, 263, 263a, 264).

26. Section 680.11 is amended by revising the section heading to read as follows:



### §680.11 Pretesting byCenter;, sample of each lot

Dated: March 19, 1990. Alan L.Hoeting, ActingAssociateCommissioner for Regulotory Affairs.

IFRDoc. 90-6753 Filed 3-23-90; 8:45 am]

BILLING CODE 4160-01-M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 271

[FRL-3749-1]

Idaho; Final and Interim Authorization of State Hazardous Waste Management Program

AGENCY: Environmental Protection Agency.
ACTION: Notice offinal determination on Idaho's application for final and interim authorization.

SUMMARY- Idaho has applied forfinal authorization ofits hazardous waste program under the Resource Conservation and Recovery Act (RCRA) including a request for interim authorization for the corrective action provisions ofthe Hazardous and Solid Waste Amendments of1984 (HSWA). The Environmental Protection Agency (EPA) has reviewed Idaho's application and made the determination that Idaho's hazardous waste program satisfies all of the requirements necessary to qualify for final and interim authorization. Thus, EPA is granting final and interim authorization toIdaho to operate its program, subject to the authority retained by EPA in accordance with the Hazardous and Solid Waste Amendments of 1984.
EFFECTIVE DATE: Final and interim authorization forIdaho shall be effective
at Ip.m. on April 9,1990.

FOR FURTHER INFORMATION CONTACr: Nina Kocourek, Waste Management Branch, HW-112, U.S. EPA,Region 10, 1200 Sixth Avenue, Seattle, Washington 98101, (206) 442-6502. SUPPLEMENTARY INFORMATION: A. Background

Section 3006 of the Resource Conservation and Recovery Act (RCRA) allows the Environmental Protection Agency [EPA) to authorize State hazardous waste programs tooperate in the State in lieu ofthe-Federal hazardous waste program. To qualify for final authorization, a State's program must (1) Be "equivalent" to the Federal
program, (2) be consistent with the Federal program and other State
programs, and (3) provide for adequate enforcement (section 3006(b) ofRCRA, 42 U.S.C. 6926(b)). States applying for authorization must demonstrate a program equivalent to the Federal
program in effect one year prior to the date the application is submitted.

Interim authorization is a temporary authorization which a State can request and which isgranted ifthe evidence submitted shows State requirements are at least substantially equivalent to the Federal program requirement. See section 3006(g)[2), 42 U.S.C. 6926(g)(2). All interim authorizations pursuant to section 3006(g)(2) expire on January 1, 1993. Responsibility for that portion of the program reverts to EPA on that date ifa State has not received final authorization for those provisions.

On July 7, 1988,Idaho submitted an official application for final authorization for those non-HSWA and HSWA requirements promulgated as of July 7, 1987. On November 17, 1989, the State requested interim authorization for the HSWA corrective action provisions ofsection 3004(u), promulgated as of July 7, 1987. The State has incorporated by reference all Federal Regulations in 40 CFR parts 124, 260-266, 268, and 270 thatwere promulgated and codified as ofJuly 1, 1987. (No changes were made
to the Federal RCRA program between July 1, 1987 and July 8,1987.)

The State's application included aspects ofthe Land Disposal restrictions Rule (LDR) "California List", (52 FR 25760), promulgated on July 8, 1987. However, at thistime these rules are not included in our final authorization decision. These rules will be addressed in a forthcoming program revision action which will give the public an opportunity to review and comment.

During EPA's review ofIdaho's application a question arose concerning the scope ofIdaho's regulatory exclusion for farmers. EPA excludes from all hazardous waste regulation "farmers" who dispose ofwaste pesticides from their own use, provided that the disposal meets specified standards. See 40 CFR 264.1(g)(4). Idaho's exclusion specifies that both I |1" I 1 I 

### 11015

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### 11016 Federal'Register 

### /. Vol. 55, No. 58 / Monday, March 26, 1990 / Rules and Regulations

'farmers" and "ranchers" are exempt. EPA solicited public'comment on this issue and received no comment. Thus, EPA has determined to interpret "farmers", as used in EPA'sRCRA regulatory.exclusion, to includeboth "farmers" and "ranchers" and to .approve this aspect ofIdaho's application. '! Further background onthe tentative decision togrant final and interim. authorization appears at54 FR 52800, dated December 22, 1989. Alongwith the tentative decision,EPA announced the availability of the application and other materials forpublic comment and scheduled a public hearing. EPA , cancelled the scheduled publichearing because there was no significant interest in such hearing expressed. The public comment period ended January .26,1990. * Six public comment letters were *received, three ofwhich expressed

concerns about aspects ofthe State's program and the other three'expressed clear support for authorization. Many of * the concerns and questions raised relate to issues not within the scope of

. decision criteria for authorization. The following are EPA's responses to commentor's concerns regarding various aspects ofthe State's program.

.1.Comment:Timing ofauthorization relative to impact oftheBevill mining exclusion rules (54FR 36592, dated September 1, 1989, effective March 1. 

### 1990 and 55 FR 2322, datedJanuary 23, 1990, effective July 23, 1990) upon

### Idaho's mining community.

Response:The Bevill mining exclusion rules cited above are non-HSWA provisions. Once a State receives * authorization, all non-HSWA provisions that the State does not have authorization forwillno longer be implemented by either EPA or the State. Only requirements imposed pursuant to the Hazardous and SolidWaste Amendments of1984 (HSWA)will remain in effect and be implemented by EPA, untilthe State seeks and is granted authorization for thoseprovisions (see 40 CFR 271.21).

:Therefore, the September 1, 1989 

### Bevill rule effective March 1,1990,will be in effect and implemented by EPA until the effective date ofIdaho's authorization. After Idaho's authorization these Bevill provisions and any other non-HSWA provisions promulgated after July7, 1987, willno longer be implemented nor applicable in the State until the State adopts comparable regulations Thus,during the period oftime between Idaho's authorization and when the State adopts the Bevill rules theregulated community will not be subject to the Bevill rules.' Any applicable State requirements in effect priorto authorization and/or adopted after authorization will remain in effect.

Once Idaho receives authorization the State will be required to revise their program to adoptequivalent standards regulating as hazardous waste nonBevill mineral processingwastes that exhibit hazardous characteristics by July 1,1991, ifonly regulatory changes *are necessary, orby July 1,1992, if

.statutorychanges are necessary. See 40 CFR 271.21(e).

2. 

### Comment: Concern was expressed that Idaho's authorized program encompasses Federal rules as ofJuly 1987, resulting in a regulatory gap between EPA's currentFederal program * and the State's authorized program.The commentor encouraged the State to keep its program updated in a more timely

manner.

Response:EPA acknowledges that an inevitable regulatory gapresults during the authorization process. The RCRA statute and implementing regulations (see 40 CFR 271.3(fl) specifically provide forthis. Statesare not required to include in their applications federal requirements in effect lessthan 12 months before submittal oftheir application. Idaho submitted their application on July7, 1988 which 

### encompassed and incorporated by reference all federal provisions through July 7, 1987.



### However, the annual cluster rule (see 40 CFR 271.21) sets forth regulatory 

### deadlines for a state to revise their program in order toretain authorization. This provision ensures that future program modifications and revisions will occur in atimely manner.

In order to retain authorization a state must revise their program to adopt new federal requirements by the cluster deadlines and procedures as specified in 40 CFR 271.21. 

### (See 51 FR 33712, 

### September 22, 1986 for a complete discussion ofall these procedures and deadlines.) Ithas been agreed that the Statewill initiate a regulatory update immediately after authorization and the state will submit a new application expeditiously. EPAalso expects the state will meetprogram revision deadlines in thefuture.

3.Comment:A commentor requested clarification ofexactly which federal regulations from RCRA and HSWA Idaho willbe authorized to implement.

Response:EPA acknowledges that the various references to July 1,1987and July 7, 1987 are confusing. The July 7, 

### 1987 date is relevant as authorization requires a state to have its program encompass all federal requirements in effect 12 months prior to the State's submission ofits-officialapplication. (See 40 CFR 271.3(f)): The July 1,1987 date relates to the last federal~rule. codified in the CFR for Which Idaho will

- receive authorization, as cited and. published June 10,1988,in title I chapter 5, Rules, Regulations and.Standards for Hazardous Waste, section 16.01.5002,. "Incorporation by Reference". Thus, for

ease ofreference, EPA cited Idaho as receiving authorization for the federal'
program codified as ofJuly 1, 1987,

EPAwill also codify in40 CFR part. 272 subpart N, Idaho's authorized

. • statutes and regulations which are part oftheir approyed program. This identification ofIdaho's statutes and regulations should substantially enhance the public's ability to discern the current status of the authorized state program and clarify the extent offederal enforcement authority.

4. Comment:Concerns were expressed about Idaho's ability to implement an effective program with respect to funding, recruiting and retaining a technically qualified workforce. These concerns were specifically expressed with respect to the Department ofEnergy (DOE) INEL facility; a concern was also expressed about the state's commitment to implement an aggressive enforcement
program at INEL.

Response:EPA recognizesthe challenges facing Idaho being a' relatively small state with a limited

resource base, with an exceptionally large, complex DOE facility among its regulated community. The major U.S. DOE facilities present enormous

resource challenges to any State or EPAregion in which they are located. EPA evaluated the state's capability to implement the RCRA program and has determined the State has adequate

resources and capability towarrant authorization.

A commentor objected to the concept ofU.S. DOE providing agencies with funds forregulatory oversight and argued that direct congressional funding for oversight is more appropriate. The issue offunding source has been determined to be not relevant to the authorization decision.

In a related comment, a commentor suggested that the state program include

an element forperiodic (e.g., semiannual) comment by the regulated community,on the adequacy ofstate program implementation. The
commentor noted such comments should be reviewed by EPA ifprogram . withdrawal proceedings were initiated, in accordance with RCRA Section 3006(e).

EPA has evaluated the state's capability and has determined that the

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### Federal Register / Vol. 55, No. 58 / Monday, March 26, 1990 / Rules and Regulations

state has adequate resources and capability to warrant authorization.

At any time, any member ofthe public; including the regulated community; may raise such concerns to EPA. In accordance with provisions in the State/EPA Memorandum of Agreement (MOA), EPA will consider such comments as part ofits on-going
assessment ofthe State's program. Other scheduled opportunities for public review ofthe state's program include the opportunity for comment on the annual State/EPA Agreement (which specifies annual priorities and activities for federal grant funding) and opportunity forcomment on subsequent state authorized program revisions. Due to interim authorization forthe HSWA corrective action provisions there will-, be another EPA authorization action to determine ifIdaho will receive final authorization, therefore giving the public another opportunity to comment on. Idaho's hazardous waste program.. Finally, any such comments that are related to an EPAprogram -evaluationin the context ofwithdrawal proceedings would be considered by EPA.

Thus, EPA concludes there are sufficient opportunities for the regulated community to bring concerns to EPA's attention without specifically creating a formal, periodic process envisioned by the commentor.

5. Comment:A commentor requested specific MOA provisions addressing State protection of "classified' information, as such information relates
to national security considerations.-

The issue ofprotection of"1classified" national security information/ documents will be addressed within the
context of the.State/EPA intergovernmental agreement with INEL (JAG), under Section 120(j)(1),(2) of
CERCLA.

6. Comment: One commentor raised questions'about the consistency and stringency ofthe Idaho program. This
commentor noted the state has a comprehensive site.licensing statute which is broader in scope than RCRA permitting requirements. Concern was expressed that this aspect ofthe state's
program is not consistent withEPA's. In addition, because.the state Hazardous Waste Management Act prohibits the
state from adopting provisions more stringent than RCRA, the commentor expressed concern that the state's regulations might be rendered more stringent ifEPA changes its regilations
to be less stringent.

Response:EPAhas reviewed'the siting requirements and does not believe they render the state program . inconsistent with the RCRA program pursuant to 40 CFR- 271.4. EPA is placing in the docket a memorandum which provides a more detailed rationale for this conclusion.

With respect to the state statutory provisions regarding adoption ofmore stringent regulations, the State explains in its application that the State is not precluded fromimplementing a requirement which is rendered more stringent because ofa change in the Federal regulations.

Concern was also expressed about the effect ofauthorization on the National Environmental Policy Act (NEPA) regulations and whether the State has similar requirements. EPA's decision on authorization has no effect on applicability ofNEPA, nor are there any authorization requirements for the State
to have NEPA-like processes.,
B. Decision

:.

'Afterreviewing the public comments I conclude that Idaho's application for final and interim authorization meets all ofthe statutory and regulatory requirements established byRCRA. Accordingly, Idaho isgranted final authorization forRCRA'base program and HSWA provisions promulgated as ofJuly 1, 1987 (except for HSWA corrective action), and interim authorization of HSWA corrective action provisions section 3004(u) to operate itshazardous waste program, subject to the limitations on its authority retained by EPA in accordance with the HSWA.

Under interim authorization for corrective action,'the State has responsibility to implement the' requirements and its provisions operate in'lieu of the Federal requirements as is the case with final authorization. The difference between interim authorization and final authorization is that interim authorization expires on January 1,1993, and responsibility for that portion ofthe EPAif the State has
not received final authorization by the expiration date.

The State hazardous waste program has statutes and regulations promulgated concerning routing of hazardous waste shipments that are broader in scope than the Fedeial'
program and will not be part of'the Idaho authorized program. However, these rules will remain in effect as State law.

Idaho now has the responsibility for permitting treatment, storage and disposal facilities Within its borders and carrying out the other'aspects of the RCRA'program. Idaho also has primary enforcement responsibility, although, EPAretains the7 right to conduct inspections under section 3007 ofRCRA 

### and to-take enforcement actions under sections 3008, 3013, and- 7003 ofRCRA. 

### Upon authorization, all previous EPA RCRA permits issued before the State

was authorized Will be administered by the State.

The State ofIdaho isnot being authorized to operate the RCRA program over any Indian lands; this authority will remain with EPA.

As stated above, Idaho's authority to operate a hazardous waste program under subtitle C ofRCRA is limited by HSWA. Prior to HSWA, a State with final authorization administered its hazardous waste program entirely in lieu ofthe EPA. The Federal requirements no longer apply in the authorizaed State, and EPA could not issue permits forany facilities the State

was authorized to permit. When new,
more stringent Federal requirements

were promulgated or enacted, the State

was obligated to enact equivalent authority within specified time frames. New Federal requirements did not take effect in an authorized State until the State adopted the requirements as State law.

In contrast, pursuant to 42 U.S.C. 6926(g), new requirements and prohibitions imposedby HSWA take effect in authorized States at the same time as they take effect in nonauthorized States. EPA is directed to carry out those requirements and prohibitions in authorized States, including the issuance offull orpartial permits, until the State is granted authorization to do so.While States must still adoptHSWA-related provisions as State law to retain final authorization, HSWA applies in authorized States in' the interim. As a result ofHSWA, there will be'a dual State/Federal regulatory program in Idaho. While this authorization does

cover certain HSWA provisions it does not cover those promulgated after July 7, 1987, e.g. HSWA Land Disposal Restrictions-First Third "California List", Second Third, or Third Third.To the extent the authorized State program is unaffected by HSWA, the State program will-operate in lieu ofthe Federal program. Where yet to be authorized HSWA requirements apply, EPA will administer and enforce these requirements in Idaho until the State receives authorization to do so. Among other things, thismay entail theissuance ofFederal RCRA permits concerning HSWA piovisions for whichthe State is not yet authorized. Once the State is authorized to implement a HSWA requirementor prohibiti6n, the State 11017

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### 11018 Federal Register / Vol. 55, No. 58 / Monday March 26, 1990 / Rules and Regulations

program in that area will operate in lieu ofthe Federal program. Until that time, the State will assist EPA's implementation of the HSWA under a Cooperative Agreement.

Any State.requirement that is more stringent than a HSWA provision remains in effect; thus, the universe of the more stringent provisions in the HSWA and the approved State program define the applicable subtitle C requirements in Idaho.

EPA has published a Federal Register notice that explains in detail the HSWA and its effect on authorized States. That notice was.published at 50FR 28702- 28755, July 15, 1985. Compliance WithExecutive Order 12291

TheOffice ofManagement and Budget has exempted thisrule from the requirements ofsection 3ofExecutive Order 12291.

Certification Underthe Regulatory Flexibility Act

Pursuant to the provisions of 5U.S.C. 605(b), Ihereby certify that this authorization willnot have a significant economic impact on a substantial number ofsmallentities. This authorization effectively suspends the applicability ofcertain Federal regulations in favor ofIdaho's program, thereby eliminating duplicative : requirements forhandlers ofhazardous waste in the State. It does not impose any new burdens on smallentiiies. This rule, therefore, does not requie a regulatory flexibility analysis.

List ofSubjects In40CFR Part 271

Administrative practice and procedure, Confidential business information, Hazardous materials' transportation, Hazardous waste, Indian lands, Intergovernmental relations,' Penalties, Reporting and'recordkeeping requirements, Water pollution control,' Water supply.
Authority

This notice is issued under the 

### authority ofsections 2002(a), 3Q06, and 7004(b) of the Solid Waste DisposalAct
as amended 42U.S.C. 6912(a), 6926, 6974(b).

Dated:March 8,1990. ThomasP.Dunne, ActingRegional Administ rtor. (FR Doc.90-.778 Filed 3-23-90 8:45 am]

BILLING CODE 6560--' 

### GENERAL SERVICES ADMINISTRATION

41 CFR Ch. 101

[FPMR Temp. Reg. A-34, Supp. 21


### Limiting Travel Advancesto Manage Cash More Effectively

AGENCY: Federal Supply Service, GSA.

ACTION: Temporary regulation.



### SUMMARY: FPMR Temp. Reg.A-34 implemented Office ofManagement and Budget (OMB) Bulletin 88-17, July 22, 1988, "Limiting Travel Advances to Manage CashMore Effectively." Because theprovisions ofthis regulation have beenpermanently codified in the Federal Travel Regulation (FTR) at41 CFR part 301-10, this regulation and supplement 1(55 FR 3740,February 5, 1990) thereto are removed fromthe Appendix at the end ofsubchapter A to title 41 ofthe Code ofFederal Regulations.

EFFECTIVE DATE: March 26, 

### 1990.

FOR FURTHER INFORMATION CONTACT:. 

### Larry Tucker,TravelManagement Division,Regulations Branch (FBTR), Washington, DC 20406, telephone FTS 557-1253 or commercial 703-557-1253.

SUPPLEMENTARY INFORMATION: The 

### General Services Administration has deteimined that thisrule is not a major rule forthe purposes ofExecutive Order 12291 ofFebruary 17, 1981, because it Is not likely to result in an annual effect on the economy of$100 million ormore; a majorincrease in costs to consumers or others; or significant adverse effects. The General Services Administration has based all administrative decisions underlying this rule on adequate information concerning the need forand consequences ofthis rule has determined that thepotential benefits to society from this rule outweigh the potential costs and has maximized the netbenefits; and has chosen the alternative approach involving the least. net cost to society.

By the Administrator's authority (5U.S.C. 5701-5709; EO 11609, July 22, 1971), the 

### Appendix atthe end of subchapter Ain41 

### 'CFR chapter 101 isamended byremoving FPMRTemp.Reg. A-34 andFPMRTemp. Reg. A-34, Supplement 1. Richard G. Austin, ActihgAdministratorof GeneralServices.

[FR Doc.90-6668 Filed 3-23-90 8:45 am]

BILUNG CODE 6820-24- 41 CFR Ch. 101
[FPMRTemp. Reg. A-32, Supp. 21

First Duty Station Allowances for Relocated Presidential Transition Team Personnel Subsequently Appointed to Government Service
AGENCY:.Federal Supply Service, GSA.
ACTION: Temporary regulation.

SUMMARY: FPMR Temporary Regulation A-32 implemented authority to pay first duty station relocation allowances to eligible members ofthe Presidential Transition Team who relocate prior to selection for, or appointment to, certain Federal Government positions.Because the provisions of this'regulation have been made permanent and incorporated in the Federal Travel Regulation (FTR) under41 CFR part 302-1, this regulation and supplement 1 (54 FR 47522, November 15, 1989) thereto are removed fromthe Appendix at'the end of subchapter A to title 41, Code ofFederal Regulations. EFFECTIVE DATE: March 26, 1990."

FOR FURTHER INFORMATION CONTACT:. Larry Tucker,'Travel Management Division. Regulations Branch (FBTR), Washington, DC 20406, telephone FTS 557-1253 or commercial 703-557-1253.
SUPPLEMENTARY INFORMATION: 

### The General Services Administration has determined that thisrule is not a major rule 'for'thepurposes ofExecutive Order 12291 ofFebruary 17, 1981, because It is
not likely to result in an annual effect on. the econorhy of$100 million ormore; a major increase in costs to consumers or others; or significant adverse effects. The General Services Administration has based all administrative decisions underlying thisrule on adequate information concerning the need for and
consequences of this'rule; has determined that the potential benefits to society from this rule outweigh the potential costs and has maximized the
netbenefits; and has chosen the alternative approach invo0lving the least
net cost to,society.

By theAdministrator's authority (5U.S.C. 5721--5734; 20 U.S.C. 905(a): and EO 11609, July 22, 1971);the Alpendix at the end of' subchapter A in41 CFR chapter 101 is amended by removingFPMR Temporary Regulation A-32 and FPMR Temporary Regulation A-32, Supplement.1. Richard G.Austin, ActingAdministlator of

General Services. [FR Doc. 90-4667.Filed 3-23-90;,8:45 am]
BILUNo CODE 6820-24-U

HeinOnline -- 55 Fed. Reg. 11018 1990