[Federal Register Volume 64, Number 39 (Monday, March 1, 1999)]
[Proposed Rules]
[Pages 10064-10073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4829]



[[Page 10063]]

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Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Chapter I



Approach to Reinventing Regulations of Storing Mixed Low-Level 
Radioactive Waste; Proposed Rule

  Federal Register / Vol. 64, No. 39, Monday, March 1, 1999 / Proposed 
Rules  

[[Page 10064]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I
[F-99-MLLP-FFFFF; FRL-6305-1]
RIN 2050-AE45


Approach to Reinventing Regulations on Storing Mixed Low-Level 
Radioactive Waste

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance notice of proposed rulemaking (ANPR).

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SUMMARY: This ANPR describes several options EPA is considering to make 
our regulations more flexible for generators of mixed low-level 
radioactive waste (MLLW) who are storing wastes that we and the Nuclear 
Regulatory Commission (NRC or Commission) oversee. In this ANPR, we are 
requesting: comments on options for storing mixed waste; other 
suggestions on providing regulatory flexibility to manage mixed waste; 
and from generators of MLLW, information about generating such wastes 
and your operating procedures and costs for storing, treating, and 
disposing of these wastes.

DATES: To make sure we consider your comments they must be received by 
April 15, 1999.

ADDRESSES: You can send an original and two copies of your comments 
referencing Docket Number F-99-MLLP-FFFFF to (1) if using regular US 
Postal Service mail: RCRA Docket Information Center, Office of Solid 
Waste (5305W), U.S. Environmental Protection Agency Headquarters (EPA, 
HQ), 401 M Street, SW., Washington, DC 20460, or (2) if using special 
delivery, such as overnight express service: RCRA Docket Information 
Center (RIC), Crystal Gateway One, 1235 Jefferson Davis Highway, First 
Floor, Arlington, VA 22202. To reduce paper, we are asking you to send 
one paper copy, and an electronic copy by diskette or Internet email. 
In this case, send your comments to the RCRA Information Center on 
labeled personal computer diskettes in ASCII (TEXT) format or a word 
processing format we can convert to ASCII (TEXT). Please include on the 
disk label the name, version, and edition of your word processing 
software as well as your name. Protect your diskette by putting it in a 
protective mailing envelope. To send a copy by Internet email, address 
it to: [email protected]. Make sure this copy is in ASCII 
format that doesn't use special characters on encryption. Cite the 
docket number F-99-MLLP-FFFFF in your electronic file.
    The RCRA Information Center is at Crystal Gateway One, 1235 
Jefferson Davis Highway, First Floor, Arlington Virginia. You may look 
at and copy supporting information for RCRA rules from 9 AM to 4 PM 
Monday through Friday, except for Federal holidays. But you must make 
an appointment to review docket materials by calling (703) 603-9230. 
You may copy up to 100 pages from any regulatory document at no cost. 
Additional copies cost $0.15 per page.

FOR FURTHER INFORMATION CONTACT: For general information, call the RCRA 
Hotline at 1-800-424-9346 or TDD 1-800-553-7672 (hearing impaired). 
Callers within the Washington Metropolitan Area must dial 703-412-9810 
or TDD 703-412-3323 (hearing impaired). The RCRA Hotline is open 
Monday-Friday, 9 a.m. to 6 p.m., Eastern Standard Time. For more 
information on specific aspects of this ANPR, telephone Nancy Hunt at 
(703) 308-8762, or Chris Rhyne at (703) 308-8658, or write them at the 
Office of Solid Waste (5303W), U.S. Environmental Protection Agency, 
401 M Street, SW, Washington, DC 20460.

SUPPLEMENTARY INFORMATION: The index and electronically obtainable 
supporting materials are available on the Internet. Follow these 
instructions to access the information electronically:

WWW: http://www.epa.gov/epaoswer/hazwaste/radio.
FTP: ftp.epa.gov
Login: anonymous
Password: your Internet address
Files are located in /pub/epasower

The official record for the action will be kept in the paper form. 
Accordingly, EPA will transfer all comments received electronically 
into paper form and place them in the official record which will also 
include all comments submitted directly in writing. The official record 
is the paper record maintained at the ADDRESSES at the beginning of 
this document.
    EPA responses to comments, whether the comments are written or 
electronic, will be placed in the official record, EPA will not 
immediately reply to commenters electronically other than to seek 
clarification of electronic comments that may be garbled in 
transmission or during conversion to paper form, as discussed above.

Outline

I. Why Are We Publishing Today's ANPR?
II. What Approaches Can Simplify Dual Regulation?
    A. Conditional Exemption for Storage
    1. Military Munitions Rule Precedent for Conditional Exemptions
    2. Court of Appeals Decision
    3. Rationale for Conditional Exemption
    4. Key Factors in Decision
    5. Possible Conditions
    6. What Facilities Might Be Eligible?
    7. Would DOE Mixed Waste Be Eligible for a Conditional 
Exemption?
    B. Conditional Exemption for Decal-in-Storage
    C. Can I Treat Waste During Storage?
III. Implementation
    A. Enforcement and Notification
    B. Future Amendments to NRC Regulations
    C. Request of Public Comment
IV. Information Needs
V. Facts and Historical Background
    A. What Is Mixed Waste?
    B. Where Is Mixed Waste Generated?
    C. Applicability of NRC Regulations
    D. EPA Receipt of Rulemaking Petition
    E. Policy of Lower Enforcement Priority for Mixed Waste
VI. What Regulatory Efforts Affecting Mixed Waste Are Underway at 
EPA?
    A. April 1997 Consent Decree and Mixed Waste Rulemaking 
Commitment
    B. Summary of Approach for Mixed Waste Disposal
    C. Hazardous Waste Identification Rulemaking (HWIR)
    D. Waste Management Proposal by EPA's Office of Radiation and 
Indoor Air (ORIA)
VII. Regulatory Assessment Requirements
    A. Executive Order (E.O.) 12866
    B. Executive Order (E.O.) 12875: Enhancing the Intergovernmental 
Partnership
    C. Executive Order (E.O.) 13084: Consultation and Coordination 
with Indian Tribal Governments
    D. Executive Order (E.O.) 13045: Children's Health Protection
    E. The Regulatory Flexibility Act (RFA) as Amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996
    F. Unfunded Mandates Reform Act
    G. National Technology Transfer and Advancement Act of 1995
    H. Paperwork Reduction Act
    I. Executive Order (E.O.) 12898: Environmental Justice.

I. Why Are We Publishing Today's ANPR?

    Today's ANPR introduces strategies we're considering to make 
regulations more flexible for commercial generators of Mixed Low-Level 
Radioactive Waste (MLLW), for storage and treatment of mixed waste. We 
are doing this in response to EPA's long-held view that the joint 
regulation of mixed waste under the Resource Conservation and Recovery 
Act and the Atomic Energy Act creates compliance difficulties and may 
be, at times, redundant. We are also responding to the regulated 
community's concerns regarding the inefficiencies of dual regulation of 
mixed waste, the perceived mismatch of

[[Page 10065]]

the two regulatory systems, and concern for radiation exposure of 
workers. This ANPR focuses on facilities regulated by the NRC or NRC 
Agreement States, and on strategies for reducing or eliminating the 
burden of dual regulation. These facilities include nuclear power 
plants, fuel cycle facilities, pharmaceutical companies, medical/
research laboratories, universities and academic institutions, and 
others.
    Our ANPR requests comments on ways for EPA to address the issue of 
dual regulation of mixed waste storage and treatment. We're also asking 
generators of MLLW to tell us the volumes and nature (waste codes, 
radionuclides present, and curie level) of mixed wastes you generate 
and your legacy \1\ wastes in storage.
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    \1\ Legacy MLLW is stored waste for which no treatment 
technology or disposal capacity is available.
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II. What Approaches Can Simplify Dual Regulation?

A. Conditional Exemption for Storage

    EPA is exploring options for providing regulatory flexibility in 
mixed waste management to the regulated community that generates, 
stores, and conducts on-site treatment of mixed low-level radioactive 
waste (MLLW) which is subject to NRC and EPA oversight. We are 
exploring an option modeled on the conditional exemption developed for 
non-chemical waste military munitions in the Military Munitions Rule 
(40 CFR part 266). (As discussed later in this ANPR, EPA is also 
developing approaches to address the disposal of mixed waste, but we 
are not soliciting comments on this issue in today's ANPR.)
1. Military Munitions Rule Precedent for Conditional Exemptions
    The Military Munitions Rule identifies when conventional and 
chemical military munitions become a hazardous waste subject to RCRA 
Subtitle C. In the case of the Military Munitions Rule, EPA developed a 
conditional exemption approach for providing regulatory flexibility to 
the military for storing and transporting non-chemical waste munitions. 
Under the conditional exemption, non-chemical waste military munitions 
that meet the definition of ``hazardous waste'' are not regulated under 
RCRA Subtitle C as a hazardous waste so long as the facilities storing 
or transporting these munitions meet all of the conditions for storing 
and transporting non-chemical waste munitions listed in the rule. (For 
a complete discussion of the Military Munitions Rule, see 62 FR 6621; 
February 12, 1997.)
2. Court of Appeals Decision
    The Court of Appeals upheld all aspects of the rule in Military 
Toxics Project v. EPA, 146 F. 3rd 948 (D.C. Cir. 1998). The court 
agreed that ``where a waste might pose a hazard only under limited 
management scenarios, and other regulatory programs already address 
such scenarios, EPA is not required to classify a waste as hazardous 
waste subject to regulation under Subtitle C.'' Id. at 958. The court 
agreed that ``Congress has not spoken directly to the issue of 
conditional exemption,'' and upheld as reasonable EPA's interpretation 
that Section 3001(a), which requires the Administrator to promulgate 
criteria for identifying and listing wastes that should be subject to 
Subtitle C requirements, allows the use of conditional exemptions. Id.
3. Rationale for Conditional Exemption
    In the munitions rule, EPA conditionally exempted munitions stored 
on site and transported off site to DOD or commercial facilities. 
However, off-site storage and treatment remained subject to RCRA. A 
comparable approach for commercial MLLW would be for EPA to provide a 
conditional exemption for commercial generators of MLLW who store mixed 
waste on site. EPA would base the approach on the NRC or the NRC 
Agreement State licensing process and regulatory requirements, and 
their adequacy in addressing risks from RCRA hazardous constituents. By 
a conditional exemption, EPA could eliminate redundant or dual 
requirements where: wastes are managed safely and mismanagement is 
unlikely; appropriate safeguards, recordkeeping, and monitoring are in 
place; and penalties or other consequences may be imposed if the 
governing regulatory framework is not followed.
4. Key Factors in Decision
    In studying a conditional exemption from RCRA regulation for 
commercial storage of MLLW, EPA will be evaluating certain key factors. 
First, EPA will evaluate whether NRC regulation of stored commercial 
low-level waste (LLW) adequately protects against possible risks from 
RCRA hazardous constituents in mixed waste. Although NRC regulation and 
oversight is designed primarily for radiation risks, NRC, the regulated 
industry, and others have argued that these standards largely duplicate 
RCRA requirements and thus will protect against chemical risks. In this 
rulemaking, EPA will review the licensing requirements and NRC 
standards for the management of LLW as compared to RCRA standards. EPA 
will also complete a study comparing NRC and EPA mixed waste storage 
requirements. This study will independently review the conclusions 
reached in studies by USWAG, the Electric Power Research Institute, and 
the Nuclear Management and Resources Council, Inc. (who represent 
members of the power generation industry) regarding applicable NRC 
standards. These parties concluded that the technical design and 
operating standards of the NRC meet or exceed RCRA standards in 
virtually all respects, though there were differences in certain 
procedural requirements.
    Second, as described below, EPA is reviewing documentation of 
incidents involving the management and on-site treatment of radioactive 
wastes at nuclear power facilities. The preliminary information 
suggests that these facilities generally have an excellent low-level 
waste management safety record. Thus, regulating mixed wastes stored at 
these facilities under RCRA Subtitle C may not provide additional 
protection to human health and the environment.
    If these key factors demonstrate that the NRC regulatory and 
licensing program will adequately control risks from hazardous 
constituents as well as radioactive material, we might rely on the 
safeguards of the NRC regulatory framework during MLLW storage via a 
conditional exemption. We are interested in your suggestions for other 
key factors needed to evaluate a conditional exemption.
EPA Study of NRC Nuclear Power Licenses
    EPA is studying the regulatory and licensing framework under which 
low-level waste (LLW), and therefore MLLW, is stored by waste 
generators. EPA is also looking into provisions in low-level waste 
generator licenses, in particular nuclear power plan licenses, 
concerning the on-site treatment of LLW prior to shipment off-site for 
disposal to assess whether these requirements are protective of human 
health and the environment. Though NRC requirements concerning the 
generation, storage, and treatment of LLW are more performance based 
(for example, no releases/leaks), rather than prescriptive as in RCRA 
(where types of drums and waste management are specified to prevent 
leaks), the protection from exposure to radioactive waste may serve as 
well to protect human health and the environment from exposure to 
hazardous wastes during storage. EPA

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will also be reviewing the licensing system of NRC and Agreement States 
for other generators of mixed waste (e.g., hospitals, pharmaceutical 
companies, and research laboratories).
EPA Compliance Review
    EPA is reviewing compliance records related to NRC radiation 
controls for nuclear power plants and other licensees, to determine if 
there are releases or mismanagement of LLW. If this review finds that 
these facilities are managing LLW safely (that is avoiding releases by 
complying with regulatory, licensing provisions and tie-down conditions 
\2\) such findings may support the protective nature of NRC's 
regulatory and licensing framework concerning the generation, storage, 
and treatment of LLW. This review will be available in the RCRA docket 
with the Federal Register publication of the proposed rulemaking 
planned for October 1999.
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    \2\ Tie-down conditions include guidance documents and policies 
concerning storage and treatment of LLW which become part of the 
license by reference.
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    For further information on applicable NRC regulations refer to 10 
CFR part 20 Subpart I. Information regarding NRC's regulations, or 
guidance documents may be obtained by either contacting the NRC Public 
Document Room, at 2120 L Street, NW, Lower Level, Washington, DC 20037 
(202-634-3273 or 800-397-4209, Monday through Friday, 8:30 am to 4:15 
pm) or by visiting NRC's Internet web page at http://www.nrc.gov.
5. Possible Conditions
    EPA would base any conditional exemption for commercial MLLW on a 
finding that mismanagement of the hazardous constituents in the waste 
would be improbable, given compliance with NRC standards. In connection 
with this finding, EPA might impose specific conditions under RCRA 
authority to insure protectiveness and enforceability of the exemption. 
This was the approach EPA took in the military munitions rule. Examples 
of possible conditions include:
    (1) The facility generating MLLW has a valid NRC or NRC Agreement 
State license.
    (2) The waste is stored in a tank, container, or containment 
building.
    (3) The facility stores its MLLW on-site in accordance with the NRC 
license requirements.
    (4) The facility is subject to periodic NRC or NRC Agreement State 
inspections.
    (5) Chemically incompatible wastes are not stored near each other.
    (6) The facility notifies EPA of any storage unit for which it 
claims a conditional exemption (discussed later in this ANPR).
    (7) The owner/operator reports any violation of the conditions for 
the exemption (discussed later in this ANPR).
    If a facility met these conditions under a conditional exemption 
approach, the wastes it generated would be exempt from RCRA hazardous 
waste requirements, such as RCRA permitting and technical storage 
standards. However, if the facility (or waste it generated) fell out of 
compliance with one of the exemption conditions, its waste would be 
regulated as hazardous. (This approach is discussed more fully later in 
the ANPR.)
    The basic conditions for an exemption would presumably apply to all 
options for regulatory flexibility covered in this ANPR. In other 
words, the basic conditions would apply to the conditional exemption 
for stored mixed waste described in section II.A., the approach for 
decay-in-storage contained in section II.B., and on-site treatment 
during storage discussed in section II.C. EPA seeks comments on these 
or other possible conditions. Commenters are encouraged to address the 
appropriateness of these conditions, and other conditions that might be 
appropriate. Commenters should also provide their views on whether 
conditions are needed at this level of specificity, given adequate NRC 
controls.
6. What Facilities Might Be Eligible?
    EPA's focus in preparing this ANPR has been on commercial MLLW 
generated by the nuclear power industry, based upon the April 1997 
consent decree (described under section VI.A.). EPA, however, 
encourages comment on whether a conditional exemption or similar 
approach should apply to all generators of mixed waste or be limited to 
specific industries, such as nuclear power plants. EPA recognizes that 
NRC exerts greater direct regulatory control over nuclear power plants 
than other sources. For example, NRC has a Radiation Safety Officer and 
on-site Resident Inspector at each operating nuclear power plant. 
However, it may be appropriate for a conditional exemption to include 
all mixed low-level waste generators because similar safeguards may be 
imposed by their NRC or NRC Agreement State licenses. In addition, the 
decay-in-storage option responds to specific problems encountered by 
facilities that use short-lived radionuclides and store this waste on-
site. (See II.B. below.)
    EPA seeks comment on whether a conditional exemption or other 
relief should apply to commercial mixed wastes stored at facilities 
that provide storage services to mixed waste generators with whom they 
contract and by whom they are paid. Also, should an exemption apply to 
mixed waste generated at RCRA mixed waste treatment facilities due to 
maintenance operations or residues from treatment?
    In summary, we encourage comment on whether a conditional exemption 
or similar approach should apply to: (1) the nuclear power industry 
storing waste on site, (2) other MLLW generators such as hospitals, 
laboratories, or pharmaceutical companies, (3) off-site facilities 
storing commercial mixed waste, and (4) mixed wastes generated during 
treatment or maintenance activities at RCRA TSDFs permitted to treat or 
dispose of mixed waste. Later in this ANPR, EPA solicits comments on 
extending RCRA relief to treatment of mixed waste.
7. Would DOE Mixed Waste Be Eligible for a Conditional Exemption?
    Today's ANPR addresses only commercial mixed waste regulated by NRC 
or NRC Agreement states. It does not cover DOE-managed mixed wastes. 
EPA has limited the ANPR in this way because it responds to a 1997 
Consent Decree (discussed later), in which EPA promised to consider 
relief for facilities managing commercial low-level mixed wastes. DOE 
wastes lie outside the scope of this decree.

B. Conditional Exemption for Decay-in-Storage

    The previous section of this ANPR discussed the possibility of a 
RCRA conditional exemption for mixed wastes stored at generator sites 
under NRC controls, including medical, research and other facilities. 
Another approach for these facilities might be based on NRC's decay-in-
storage requirements.
    NRC generally allows research, medical and other facilities to 
store low-level wastes containing radionuclides with half-lives of less 
than 65 days until 10 half-lives have elapsed and the radiation emitted 
from the unshielded surface of the waste (as measured with an 
appropriate survey instrument) is indistinguishable from background 
levels. This process is known as decay-in-storage. Once the specified 
decay has occurred, the waste may then be disposed of as non-
radioactive waste after ensuring that all radioactive material labels 
are rendered unrecognizable (see 10 CFR 35.92). Radioactive waste may 
also be decayed

[[Page 10067]]

in storage under certain circumstances in accordance with 10 CFR 
20.2001.
Reduced Worker Exposure to Radiation
    Decay-in-storage for LLW has a limited storage time frame based on 
the radionuclides (and half-lives) specified in the facility's NRC 
license. A RCRA exemption for mixed wastes undergoing decay-in-storage 
would address a major concern of mixed waste generators regarding 
overlapping RCRA and AEA requirements for radionuclides of relatively 
short duration. Such management of LLW reduces or eliminate worker 
exposures to radionuclides in keeping with NRC's ALARA (as low as 
reasonably achievable) goal for worker radiation exposures. EPA, at the 
request of several universities and medical facilities, is looking into 
decay-in-storage as a way of reducing risk and regulatory inefficiency 
in the management of MLLW.
Matching License Requirements for Storing Waste with Short Half-Lives
    Under current RCRA requirements, persons generating hazardous waste 
must obtain a RCRA permit if they store wastes on site for more than 90 
days. The flexibility EPA is considering may include RCRA requirements 
governing time in storage and the necessity of having a RCRA storage 
permit for certain generators. The generators include universities, 
hospitals, laboratories, and research operations who use short-lived 
radionuclides and generate MLLW that is subject to NRC and EPA 
oversight. We may allow these generators to store MLLW on-site in 
accordance with their NRC licenses, and without a RCRA storage permit, 
for the purpose of decay-in-storage where this practice is approved for 
LLW under the facility's NRC or Agreement State license. Such 
flexibility would allow storage of relative short-lived radionuclides 
during a decay period currently allowable under NRC regulations (see 10 
CFR 35.92 and 10 CFR 20.2001) without a RCRA storage permit.
How Long Might an Exemption Be Valid During Stored Decay?
    EPA might allow an exemption for decay-in-storage to be valid as 
long as the mixed waste: (1) remains on-site and (2) is subject to NRC 
regulation. EPA notes that, under a decay-in-storage conditional 
exemption, a MLLW is no longer subject to NRC licensing requirements 
when the radioactive portion of the waste has decayed to the level 
described in the NRC or NRC Agreement State license. At that point the 
waste no longer needs to be managed as a radioactive waste under the 
provisions of the license, and would be subject to the applicable 
provisions of Subtitle C of RCRA. Once the waste is subject only to the 
RCRA regulations (because the decayed waste still exhibits a RCRA 
hazardous waste characteristic, or is a listed hazardous waste), then 
shipment off-site for treatment, if needed, and disposal at a Subtitle 
C facility would be required. Under this exemption, RCRA time lines and 
other requirements (found at 40 CFR part 262) would begin when decay 
requirements in the NRC or Agreement State license are met. We seek 
general comment on this idea and on how to assure that waste is treated 
and/or disposed within the time frames required by RCRA following 
decay.

C. Can I Treat Waste During Storage?

    EPA also is considering exempting the on-site treatment of MLLW 
from Subtitle C regulation under the conditions listed above. An 
additional condition might be that the waste is treated on-site and is 
physically/chemically treated in a tank, container, or containment 
building in accordance with the generator's NRC license requirements. 
The logic behind this approach would be, in part, that EPA's 
regulations governing storage and treatment in tanks, containers, and 
containment buildings are generally the same. Thus, if NRC controls 
were sufficient for storage, it's likely they would also be sufficient 
for treatment. On the other hand, more specific control might be 
appropriate for some forms of treatment, such as thermal treatment, 
because of concerns for air emissions and the specificity of RCRA 
requirements in this area.
    We request comment on treatment of mixed waste under a conditional 
exemption, and while the mixed waste is subject to the specific NRC 
licensing requirements for the management of LLW. EPA requests comment 
on the degree to which NRC regulation of the treatment of LLW will 
protect against risks from hazardous waste treatment, and the added 
necessity of RCRA Subtitle C regulation for treatment of MLLW.

III. Implementation

A. Enforcement and Notification

    The NRC has in place a ``General Statement of Policy and Procedure 
for NRC Enforcement Actions'' (NUREG-1600) which states the 
Commission's policy regarding enforcement. This policy provides 
significant consequences for violating NRC or license requirements and 
takes into consideration the specific circumstances of a particular 
case. If a nuclear power plant is found to have violated the NRC 
license, or tie-down conditions of the license, the license (and 
responsible person) may be subject to substantial civil and criminal 
penalties. Based on these provisions, licensed facilities have 
incentives to manage stored waste safely.
    If we adopt a conditional exemption approach for mixed waste as we 
did in the Munitions Rule, we might adopt a similar enforcement 
approach. In this case, we would consider non-compliant facilities to 
be subject to RCRA Subtitle C from the time of non-compliance. 
Utilities or other mixed waste generators that claimed the conditional 
exemption, but failed to store and/or treat the MLLW in compliance with 
the provisions of the exemption, would no longer be exempt from the 
applicable provisions of RCRA. The facility could then be subject to 
enforcement action (or citizen suit) for violations of RCRA storage or 
treatment requirements. Alternatively, EPA might consider a less 
detailed approach, which didn't tie the conditional exemption to 
compliance with NRC standards. Instead, the exemption might be 
restricted to commercial MLLW regulated by NRC or Agreement States, and 
managed under basic conditions (e.g., managed in tanks or containers). 
In this case, releases or storage in non-tanks or containers would be 
enforceable under RCRA, but EPA would rely on NRC and the Agreement 
State for direct enforcement of the licenses. This approach would 
significantly simplify implementation, but would provide less direct 
EPA enforcement. EPA might choose an approach along these lines if it 
is convinced that NRC oversight of the low-level radioactive waste is 
sufficient to ensure against mismanagement of hazardous constituents in 
mixed wastes, without independent EPA oversight.
    We are seeking comment on both of these approaches as well as 
alternative implementation and enforcement approaches.
Reporting Requirement
    To determine if a unit used to store MLLW is in compliance with the 
terms of the exemption, we are considering including a reporting 
requirement as a condition of the exemption. If we were to adopt an 
approach comparable to that in the Military Munitions Rule, we might 
require the owner or operator to provide oral notice to EPA within 24 
hours of the time when he or she becomes aware of a failure to meet a 
condition of the NRC license as it relates

[[Page 10068]]

to the on-site storage and/or treatment of MLLW that may endanger human 
health or the environment with respect to the hazardous components of 
the waste. The owner/operator would provide a written notice of any 
failure to meet a condition for the exemption within 5 days of such 
failure. The owner/operator would be required to provide a written 
report to NRC, with a copy to EPA, pursuant to the reporting 
requirements outlined in 10 CFR part 20 Subpart M. As in the munitions 
rule, we could allow the owner or operator to request in writing that 
EPA reestablish the conditional exemption once the facility's waste 
management practices return to compliance with all conditions of the 
exemption. Under the munitions rule, reinstatement is automatic if EPA 
does not respond negatively. EPA requests comment on this approach, 
including whether reinstatement should be automatic.
    If EPA takes a broad approach to a conditional exemption, as 
described in II-A, reporting requirements as well as notification 
requirements discussed below might be simplified.
Notification of Conditional Exemption for a Unit
    Finally, to enable us to know which wastes and which storage units 
are subject to oversight under a conditional exemption, we are 
considering requiring the owner or operator to notify us within the 
first 90 days when a storage and/or treatment unit is used to store or 
treat MLLW and a conditional exemption is claimed for that unit. (See 
list of conditions under II.A.5.) This notification is similar to the 
provisions of the munitions rule (see 40 CFR 266.205).

B. Future Amendments to NRC Regulations

    NRC has extensive experience regulating radiation safety hazards, 
which directly affect not only the public but also workers stationed at 
every nuclear power facility. EPA is working closely with NRC in 
developing the approaches discussed in today's ANPR. EPA recognizes 
that NRC license requirements or regulations may change over time. EPA 
will continue to coordinate with NRC to implement these approaches, and 
NRC can notify EPA as changes to the storage and treatment requirements 
are considered, so that the EPA can make any modifications to the 
conditional exemption necessary to ensure the continued protection of 
human health and the environment. We are interested in your views on 
what impacts future amendments to NRC regulations may have on any 
conditional exemption EPA may propose.

C. Request for Public Comment

    We are requesting public comments regarding the suitability of the 
above approaches for providing regulatory flexibility under RCRA to the 
nuclear power industry and other facilities which generate, store, and/
or treat MLLW on site in accordance with their NRC licenses. We are 
also seeking comment regarding the ramifications of the options on (1) 
the protection of human health and the environment and (2) the degree 
to which the options are useful to the regulated community. EPA also 
requests comment on alternative ideas regarding managing mixed waste 
under RCRA.

IV. Information Needs

    In preparation for conducting the technical analyses and associated 
regulatory analyses (such as the required analyses of economic costs 
and benefits and of impacts on small businesses and government 
entities) for the upcoming mixed waste management rule, we are 
requesting data from NRC Agreement States and licensed commercial mixed 
waste generators other than nuclear power plants. We are interested in 
obtaining data on mixed waste generation and management practices for 
the following:
     Industrial--manufacturing facilities (both small quantity 
and large quantity generators);
     Industrial--research and development facilities;
     Industrial sealed source users;
     Other industrial facilities;
     Academic institutions (both large and small quantity 
generators);
     Medical facilities (colleges and hospitals);
     Medical research facilities;
     Federal research and development facilities (other than 
DOE, which has been providing data as a part of the rulemaking effort); 
and
     Other non-defense, non-nuclear power plant facilities.
    We are requesting data from facilities other than nuclear power 
plants, in order to address gaps in the available data. However, EPA 
also encourages nuclear power plants to provide data and comments that 
will inform the regulatory process.
    We have been reviewing information on the generation and management 
of MLLW in the commercial sector under current regulations using two 
primary sources of data on commercial generation and management 
practices. The first is a database developed by the Edison Electric 
Institute from a survey of nuclear power plants in 1997. The second is 
a database developed for the National Profile on Commercially Generated 
Low-Level Radioactive Mixed Waste (NUREG/CR 5938), a survey of 
commercial generators jointly sponsored by NRC and EPA that was 
published in December 1992. Both of these data sources contain valuable 
information concerning the generation and management of MLLW. They are 
available in the docket.
    To supplement currently available data, we are requesting 
generators of mixed waste to provide the following types of 
information:
     MLLW Generation and Management: The Agency requests 
information for individual waste types or categories of waste on 
current MLLW generation rates and storage, treatment, and disposal 
practices that can be used to update the data from the 1992 National 
Profile. Data on types of mixed waste generated, RCRA codes, hazardous 
constituents and concentrations, storage and treatment techniques, and 
disposal practices associated with individual waste streams or waste 
categories would be particularly useful, as would data on waste volumes 
at the point of generation and after treatment.
     MLLW Cost Data: The agency requests information on the 
costs associated with the management of MLLW, including storage costs; 
costs of sampling and analysis for compliance with RCRA requirements, 
including the universal treatment standards (UTS); pre-treatment and 
treatment costs (by method); packaging and transport costs; disposal 
costs; and reporting and recordkeeping costs. Because under an RCRA 
exemption, generators could manage MLLW in the same manner as LLW, the 
Agency seeks data on LLW management costs as well.
     Impacts of Exemption: The Agency requests comments and/or 
data on the potential effects of RCRA exemptions for MLLW (e.g., 
impacts on future waste management capacity, waste management 
practices, and waste minimization) that are important to parties 
potentially affected by the mixed waste rule.
    We request that you indicate the units of reference for all data 
(including time). We would appreciate the reporting of liquid volume in 
gallons; the mass of solids in kilograms; the radioactivity of 
individual radioisotopes in millicuries; the concentration of RCRA 
hazardous constituents in milligrams/kilogram (for solids) and 
milligrams/liter (for liquids); and the concentration of radionuclides 
in picocuries/gram (for solids) and picocuries/liter (for liquids).

[[Page 10069]]

    Lastly, we request information on the effect of a conditional 
exemption for commercial MLLW generators who qualify as ``small 
entities'' (i.e., businesses, governments, or organizations) for 
purposes of the Regulatory Flexibility and Small Business Regulatory 
Enforcement Fairness Acts. The Small Business Administration's 
definition of small business, which varies by Standard Industrial 
Classification code, can be found at 13 CFR 121.201 or on the Internet 
(http://www.sbaonline.sba.gov/gopher/Financial-Assistance/Size-
Standards). A small government is defined as a government of a city, 
county, town, school district, or special district with a population of 
less than 50,000. A small organization is defined as any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field. Generators of MLLW are encouraged to comment on 
potential impacts specific to small entities that may result from 
increased RCRA flexibility for MLLW management.

V. Facts and Historical Background

A. What Is Mixed Waste?

    Mixed waste is radioactive hazardous waste. In 1976, the Resource 
Conservation and Recovery Act (RCRA) authorized EPA to regulate 
hazardous waste from ``cradle to grave.'' This includes the 
minimization, generation, transportation, treatment, storage, and 
disposal of hazardous waste. The definition of solid waste in the RCRA 
legislation specifically excludes source, special nuclear, or byproduct 
material as defined by the Atomic Energy Act of 1954, as amended. In 
the 1984 Hazardous Solid Waste Amendments to RCRA (HSWA), Congress 
established land disposal restrictions (LDR) for hazardous waste and 
directed EPA to establish treatment standards for hazardous waste. 
Hazardous waste was prohibited from land disposal unless treated to EPA 
established standards. In 1986, EPA published a notice clarifying RCRA 
jurisdiction for mixed waste and indicated that States must include 
mixed waste in RCRA base authorization (51 FR 24504; July 3, 1986). EPA 
also published a notice (53 FR 37045; September 23, 1988) clarifying 
that existing facilities that treat, store or dispose of mixed waste 
had to obtain interim status pursuant to Subtitle C of RCRA and that 
generators of mixed waste were to notify EPA. Congress provided further 
clarification of mixed waste in the Federal Facilities Compliance 
Act.\3\ Information on mixed waste can be found at the website address: 
http://www.epa.gov/radiation/mixed-waste.
---------------------------------------------------------------------------

    \3\ The Federal Facilities Compliance Act (FFCA) of 1992, 
defined mixed waste as a waste that contains both hazardous waste 
subject to the requirements of the RCRA and source, special nuclear, 
or byproduct material subject to the requirements of the Atomic 
Energy Act of 1954, as amended. In addition, the FFCA required that 
for each facility at which DOE generates or stores mixed waste DOE 
was to develop a plan for developing treatment capacities and 
technologies to treat all of the facility's mixed wastes. Such plan 
had to be submitted to and approved by the State or EPA regulator, 
and incorporated into an order issued by the regulator requiring 
compliance with the approved plan.
---------------------------------------------------------------------------

    Mixed waste is regulated under multiple authorities: by RCRA, as 
implemented by EPA or authorized states for the hazardous waste 
components; and by the Atomic Energy Act of 1954, as amended (AEA), for 
radiological components as implemented by either the Department of 
Energy \4\ (for radioactive waste generated by DOE), or the Nuclear 
Regulatory Commission (NRC) or its Agreement States (for all other 
mixed waste).
---------------------------------------------------------------------------

    \4\ The Department of Energy (DOE) referred to in this ANPR 
includes DOE facilities and facilities operated by the Naval Nuclear 
Propulsion Program (NNPP), which is a joint program of DOE and the 
Department of the Navy.
---------------------------------------------------------------------------

    Commercial mixed waste generators, particularly nuclear power 
plants, have raised the concern that AEA and RCRA requirements for 
mixed waste overlap, and compliance with both is overly burdensome. The 
nuclear power industry has provided information which supports their 
view that radioactive waste disposal facilities designed and licensed 
according to the AEA offer human health and environmental protection 
similar to that required by RCRA.

B. Where Is Mixed Waste Generated?

    Mixed low-level radioactive waste (MLLW) is generated in all 50 
states and the District of Columbia at nuclear power plants, fuel cycle 
facilities, pharmaceutical companies, medical and research 
laboratories, universities and academic institutions, and other 
facilities. Wastes that are both radioactive and hazardous are 
generated as a result of a number of processes such as medical 
diagnostic testing and research, pharmaceutical and biotechnology 
development, and generation of nuclear power. The National Profile 
indicated approximately 3,950 m\3\ of MLLW was generated in the U.S. in 
1990. Of this amount, approximately 2,840 m\3\ (nearly 72%) was liquid 
scintillation counting fluid. Organic solvents, chlorofluorocarbons, 
waste oil, and aqueous corrosives, made up 17%, toxic metals made up 
3%, and ``other'' waste made up 8%.
    The Edison Electric Institute, based on a 1997 survey of nuclear 
power plants, reports that the volume of MLLW currently being generated 
by the nuclear utility industry has been substantially reduced from 
1990 levels due to waste minimization practices being followed by the 
generators. Legacy MLLW has also been reduced due to limited treatment 
technology development. Based on the Mixed Waste Treatment Study 
prepared for the Electric Power Research Institute (December 1995), EPA 
understands that for nuclear utilities there are still a few mixed 
wastes for which treatment technologies or disposal facilities may not 
be commercially available. Wastes, such as freon still bottoms, lead 
paint chips and sludge, are being indefinitely stored due to the lack 
of treatment and disposal facilities. A limited number of EPA site 
visits to hospitals and universities in 1998 found a small number of 
mixed wastes that could not be treated with technologies that are 
commercially available at this time. In addition, industry groups such 
as the American Chemical Society, and the International Isotope 
Society, have discussed with EPA representatives on several occasions 
their continued difficulty finding suitable treatment and/or disposal 
for some of the mixed wastes they generate despite considerable efforts 
to minimize waste generation in general and mixed waste generation in 
particular. They also cite very high costs for the treatment and 
disposal which is available. (See also the discussion of our policy of 
lowered enforcement priority for mixed waste later in this ANPR.)

C. Applicability of NRC Regulations

    NRC's mission, under the Atomic Energy Act of 1954, as amended 
(AEA), is to regulate the Nation's civilian use of byproduct, source, 
and special nuclear materials to ensure adequate protection of public 
health and safety, to promote the common defense and security, and to 
protect the environment. The NRC's scope of responsibility includes 
regulation of commercial nuclear power plants; research, test, and 
training reactors; fuel cycle facilities; medical, academic, and 
industrial uses of nuclear materials; and the transport (along with the 
Department of Transportation), storage, and disposal of nuclear 
materials and wastes. NRC is authorized by the AEA to issue licenses to 
commercial users of source, special nuclear and byproduct radioactive

[[Page 10070]]

materials and to regulate federal facilities other than DOE and Naval 
Nuclear Propulsion Program facilities.
    Thirty states have signed agreements with NRC enabling the various 
Agreement States to regulate source, byproduct, and small quantities of 
special nuclear material within their boundaries. Facilities located in 
agreement States are subject to regulatory requirements for radioactive 
material that are authorized by state law. This applies to all source, 
special nuclear, and byproduct material except that from utilization 
facilities and fuel cycle facilities, which are subject to NRC's 
requirements, and DOE facilities, which are subject to DOE Orders. 
While Agreement States are required to adopt programs that are adequate 
to protect public health and safety and compatible with the NRC 
program, Agreement States may also adopt some requirements that are 
more stringent than the comparable Federal NRC requirements. NRC 
conducts periodic reviews of Agreement State programs to assure that 
those programs remain adequate to protect public health and safety and 
compatible with NRC's program. NRC retains authority over production 
and utilization facilities and other activities in Agreement States 
specified by section 274(c) of the AEA.
    A large portion of the radioactive mixed waste generated by medical 
and biomedical research institutions contains radionuclides with 
relatively short half-lives. These short-lived radionuclides are 
especially prevalent in the combustible dry wastes, and aqueous wastes 
generated by medical and academic institutions. Currently NRC generally 
allows medical facilities to store for decay. For example, generators 
may store waste containing radionuclides with half-lives of less than 
65 days until the radiation emitted from the unshielded surface of the 
waste, as measured with an appropriate survey instrument, meets the 
decay levels described in their NRC license (typically 10 half-lives of 
decay and radioactivity levels indistinguishable from background 
levels). The waste may then be disposed as a non-radioactive waste 
after ensuring that all radioactive material labels are rendered 
unrecognizable (10 CFR 35.92). Radioactive waste may also be stored for 
decay under certain other circumstances in accordance with 10 CFR 
20.2001. Such management can reduce worker exposure and potential risks 
to the public during transportation of the waste.
    Generators of mixed waste are subject to both RCRA and AEA 
requirements. Generators of mixed waste must obtain a license from NRC 
or an NRC Agreement State for possession and use of radioactive 
materials, and may need a RCRA permit depending on the time waste is 
stored and the volume of waste generated. Some of the mixed waste 
generated by private entities and government-for example, wastes with 
radionuclide concentrations exceeding the acceptance criteria of 
commercial sector treatment and disposal facilities-is (and has been) 
stored on-site indefinitely.

D. EPA Receipt of Rulemaking Petition

    Because there is limited treatment technology and disposal capacity 
for some mixed waste, NRC licensees who generate mixed waste may be 
forced to store some of their mixed waste on site. On-site storage of 
mixed waste can subject the NRC licensees to RCRA permit requirements 
for storage facilities. In response to this, the Utility Solid Waste 
Activities Group (USWAG), a national organization of power companies, 
petitioned the U.S. EPA on January 13, 1992. USWAG requested that EPA 
``(1) amend 40 CFR 261.5 to establish a separate mixed waste small 
quality generator exemption for Nuclear Regulatory Commission (`NRC') 
licensees, and to make such rule immediately effective as an interim 
final rule, and (2) amend 40 CFR 262.34 to allow NRC licensees to 
accumulate such waste on-site in qualified tanks or containers until 
such time as adequate, fully licensed and permitted off-site treatment, 
storage or disposal capacity becomes available; to clarify that such 
on-site storage, which is compelled by the current lack of licensed 
treatment or disposal capacity, is legitimate storage under the land 
disposal restriction (`LDR') storage prohibition at 40 CFR 268.50; and 
to make such rule immediately effective as an interim final rule.'' 
While the approach in the petition differs from the approach in this 
ANPR, EPA seeks comment on the USWAG approach described above.
    The Edison Electric Institute also approached EPA requesting relief 
from permit requirements for the storage of mixed wastes. The nuclear 
power industry maintains that NRC management requirements for the 
radioactive component of their mixed waste streams provide complete 
protection for human health and the environment. NRC requirements for 
radioactive waste storage areas include security, frequent monitoring, 
primary containment, secondary containment for liquids, and cover for 
protection from the elements. EPA is studying NRC requirements for low-
level radioactive waste storage to determine whether the mixed waste 
storage under NRC (or Agreement State) regulations, license provisions, 
and guidance may be as protective of human health and the environment 
as the RCRA requirements for storage of hazardous waste.

E. Policy of Lower Enforcement Priority for Mixed Waste

    EPA LDR treatment standards exist for the hazardous components of 
most mixed wastes. However, adequate treatment technology or disposal 
capacity does not exist for some mixed waste streams, necessitating 
storage in violation of land disposal restrictions. Recognizing this 
difficulty, EPA issued a policy on the lower priority of enforcement of 
the storage prohibition contained in section 3004(j) of RCRA (see 56 FR 
42730; August 29, 1991). Section 3004(j) prohibits storage of a land 
disposal restricted waste (including mixed waste) except for the 
purposes of the accumulation of such quantities of hazardous waste as 
are necessary to facilitate proper recovery, treatment, or disposal. 
Because treatment technology or disposal capacity was still unavailable 
for some mixed wastes, EPA extended this policy on October 31, 1998. 
The policy stated that violators who were faced with an impossibility 
of complying with the RCRA regulations and were storing their wastes in 
an environmentally responsible manner would be a low enforcement 
priority for EPA. The extension of the policy was published in the 
Federal Register on November 6, 1998. (63 FR 59989)
    The policy affects only mixed wastes that are prohibited from land 
disposal under the RCRA Land Disposal Restrictions and for which there 
are no available options for treatment or disposal. For mixed waste 
generators who are storing mixed wastes in an environmentally 
responsible manner, as described in the policy, and where no viable 
treatment technology or disposal capacity exists, or becomes available 
during this extension, we consider violations of RCRA section 3004(j) 
involving relatively small volumes of waste to be a low priority among 
our potential civil enforcement actions. An enforcement activity 
arising from violations of section 3004(j) as these facilities will 
generally focus on determining whether these generators are managing 
their mixed wastes in an environmentally responsible manner, and 
whether they are storing wastes for which treatment technology is 
commercially available. EPA recently extended the policy of lowered 
enforcement priority to April 30, 2001.

[[Page 10071]]

VI. What Regulatory Efforts Affecting Mixed Waste Are Underway at 
EPA?

    We recognize that mixed waste storage and disposal may be 
significantly affected by other EPA rulemakings, especially the 
Hazardous Waste Identification Rule (HWIR). These activities will be 
closely monitored for impacts to a mixed waste storage and disposal 
rulemaking, for areas of overlapping analysis, and for opportunities to 
coordinate.

A. April 1997 Consent Decree and Mixed Waste Rulemaking Commitment

    Commercial nuclear power plants through their trade organizations 
(i.e., the Edison Electric Institute, the Utility Solid Waste Activity 
Group, and the Nuclear Energy Institute) were parties to the settlement 
discussions regarding the deadline for the final Hazardous Waste 
Identification Rule (HWIR) Rulemaking, ETC v. Browner, CIV, No. 94-2119 
(D.D.C.), During negotiations, they expressed their interest in 
regulatory flexibility to allow the disposal of mixed waste in 
commercial low-level radioactive waste disposal sites. There 
discussions resulted in a final consent decree which requires EPA to 
publish a proposed rule that requests comment on an exemption from 
hazardous waste disposal regulation for mixed wastes from nuclear power 
plants. The proposal must also request comment on other regulatory 
relief for these wastes, if EPA finds that any other relief would be 
appropriate. EPA is also committed to make ``best efforts'' to describe 
the exemptions in enough detail to allow it to promulgate a final rule. 
The decree requires EPA to issue the proposal by October 31, 1999.
    EPA made several commitments to the litigants in a ``sidebar'' 
letter which was not submitted to the Court. EPA committed to issue a 
final rule addressing relief for mixed wastes from nuclear power plants 
by April 30, 2001. EPA also agreed to recommend in writing to EPA 
Regions and RCRA authorized States that ``they suspend the call-in or 
processing of final RCRA Part B permits at power plants subject to 
regulation under the AEA by NRC or NRC Agreement States where the only 
reason for a Part B permit is the on-site storage of mixed waste...'' 
Such a letter to States and Regions was signed on May 21, 1997. In the 
letter EPA's Office of Solid Waste (OSW) recommended the temporary 
suspension of call-in and processing of RCRA Part B applications, and 
the issuance of RCRA permits for facilities that have interim status 
only for the purpose of on-site storage of commercial and mixed wastes. 
This permit suspension applies where the facility is not otherwise 
subject to RCRA permitting requirements. OSW did not recommend any 
suspension for facilities where Regions or States find a particular 
environmental concern that merits the call-in issuance of such a 
permit.
    EPA also committed in the side-bar letter to examining potential 
regulatory change related to the disposal of mixed waste in radioactive 
waste disposal facilities subject to NRC regulation. (A summary of 
disposal issues follows.) EPA is considering regulatory flexibility by 
examining opportunities related to mixed waste permitting and storage. 
In today's ANPR we are seeking comment from interested parties on mixed 
waste storage options. The October 1999 Proposed Rulemaking on mixed 
waste will address disposal and storage issues.

B. Summary or Approach for Mixed Waste Disposal

    We are considering a regulatory exemption from the RCRA hazardous 
waste disposal requirements for low-level radioactive mixed wastes 
containing low concentrations of RCRA hazardous constituents which may 
be disposed at low-level radioactive waste disposal facilities. We will 
determine whether the disposal of mixed waste in facilities designed to 
address radiological hazards under the AEA and regulated by NRC will 
provide adequate protection of human health and the environment from 
chemical hazards. We may propose that these mixed wastes would not be 
regulated as hazardous waste if disposed at radioactive waste disposal 
facilities subject to NRC or NRC Agreement State requirements. We are 
formulating the scope and form of such a proposal.

C. Hazardous Waste Identification Rulemaking (HWIR)

    The goal of HWIR is to develop a set of chemical concentration 
levels (``exit levels'') below which a list waste would no longer be 
regulated as a hazardous waste. In addition to the proposed exit 
levels, the HWIR reproposal will seek comment on a variety of 
implementation requirements, including testing, notification, record 
keeping and reporting and public participation.
    RCRA's hazardous waste program sometimes regulates comparatively 
low risk waste at the same stringent standards as higher risk waste. 
This system leaves companies little incentive to detoxify there list 
hazardous wastes, since the wastes continue to be regulated as 
hazardous, unless formally delisted. WHIR relies on an innovative risk 
assessment to identify the levels of hazardous chemicals in waste that 
can be safely disposed in a non-hazardous unit. HWIR will propose exit 
levels which allow waste management based on the risks posed by the 
waste. Thus the HWIR proposed focuses resources on risk reduction and 
encourages pollution prevention and development of treatment 
technologies. HWIR is scheduled to be proposed by October 31, 1999 and 
finalized by April 30, 2001.

D. Waste Management Proposal by EPA's Office of Radiation and Indoor 
Air (ORIA)

    Under the AEA, EPA has authority to establish generally applicable 
radiation standards. ORIA is developing a proposal under the AEA that 
would apply to disposal of mixed wastes with very low concentrations of 
radionuclides in RCRA Subtitle C hazardous waste landfills. Under this 
approach, EPA would establish maximum concentration limits for 
radionuclides in mixed waste allowed for disposal in such facilities. 
Radionuclides would continue to be regulated under the AEA; EPA would 
seek to have the Nuclear Regulatory Commission regulate mixed waste in 
RCRA facilities through a simplified license based on the requirements 
for low-level radioactive waste disposal facilities in 10 CFR part 61. 
RCRA disposal facilities that wish to accept mixed waste under this 
rule would need to obtain such a license from the NRC. This proposed 
rulemaking is planned for publication in the Federal Register in 1999.

VII. Regulatory Assessment Requirements

A. Executive Order (E.O.) 12866

    Under Executive Order 12866, [58 FR 51735 (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

[[Page 10072]]

legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    While this advance notice of proposed rulemaking establishes no 
regulatory requirements it could ultimately result in a rule that would 
satisfy one or more of the above criteria. Therefore, this action is a 
``significant regulatory action'' under the terms of Executive Order 
(E.O.) 12866. As such, this action was submitted to OMB for review. 
Changes made in response to OMB suggestions or recommendations will be 
documented in the public record.
    Under the terms of E.O. 12866, EPA is to prepare for any 
significant regulatory action an assessment of its potential costs and 
benefits. If that action satisfies the first of the criteria listed 
above, this assessment must include, to the extent feasible, a 
quantification of these costs and benefits, the underlying analyses 
supporting such quantification, and an assessment of the costs and 
benefits of reasonably feasible alternatives to the planned regulation. 
Because the purpose of this ANPR is to initiate a structured national 
debate on a broad set of issues rather than to proposed specific 
regulatory changes, it is not feasible to quantify the costs and 
benefits or any resulting regulations at this time. The Agency is 
aware, however, that his ANPR could lead to regulatory action for which 
the preparation of a quantitative assessment of costs and benefits 
would be appropriate. The Agency is thus requesting comment on the 
costs and benefits of any of the possible regulatory changes discussed 
in this ANPR, as well as on appropriate methodologies for assessing 
them. The Agency would be interested in hearing from States and Tribes. 
Members of the public and the regulated community are also encouraged 
to submit any data they may have on the costs and benefits of 
activities described in this ANPR.

B. Executive Order (E.O.) 12875: Enhancing the Intergovernmental 
Partnership

    Under Executive Order 12875, EPA may not issue a regulation that is 
not required by statute and that creates a mandate upon a State, local 
or tribal government, unless the Federal government provides the funds 
necessary to pay the direct compliance costs incurred by those 
governments. If EPA complies by consulting, Executive Order 12875 
requires EPA to provide to the Office of Management and Budget a 
description of the extent of EPA's prior consultation with 
representatives of affected State, local and tribal governments, the 
nature of their concerns, copies of any written communications from the 
governments, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 12875 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of State, local and tribal governments ``to provide 
meaningful and timely input in the development of regulatory proposals 
containing significant unfunded mandates.'' Today's ANPR does not 
create a mandate on State, local or tribal governments. This ANPR does 
not impose any enforceable duties on these entities. It solicits 
comments on potential approaches to regulatory flexibility. 
Accordingly, the requirements of section 1(a) of Executive Order 12875 
do not apply to this ANPR.

C. Executive Order (E.O.) 13084: Consultation with Indian Tribal 
Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments. If EPA complies by 
consulting, Executive Order 13084 requires EPA to provide to the Office 
of Management and Budget, in a separately identified section of the 
preamble to the rule, a description of the extent of EPA's prior 
consultation with representatives of affected tribal governments, a 
summary of the nature of their concerns, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 13084 
requires EPA to develop an effective process permitting elected and 
other representatives of Indian tribal governments ``to provide 
meaningful and timely input in the development of regulatory policies 
on matters that significantly or uniquely affect their communities.'' 
Today's ANPR does not significantly or uniquely affect the communities 
of Indian tribal governments because it does not impose any enforceable 
duties on these entities. This ANPR solicits voluntary comments on 
potential approaches to regulatory flexibility. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this ANPR.

D. Executive Order (E.O.) 13045: Children's Health Protection

    Executive Order 13045 applies to any rule that EPA determines is 
(1) ``economically significant'' as defined under Executive Order 
12866, and (2) concerns an environmental health or safety risk 
addressed by the rule has a disproportionate 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.
    E.O. 13045 applies to notices of proposed and final rulemakings, 
therefore, it does not apply to this advance notice of proposed 
rulemaking. Should this advance notice of proposed rulemaking result in 
a rulemaking proposal, the Agency will evaluate the proposal to 
determine if E.O. 13045 applies.

E. The Regulatory Flexibility Act (RFA) as Amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996

    Under the RFA, (5 U.S.C. 601 et seq.), as amended by SBREFA, 
whenever an agency is required to publish a notice of rulemaking for 
any proposed or final rule, it must prepare and make available for 
public comment a regulatory flexibility analysis (RFA) that describes 
the effect of the regulatory action on small entities. However, no 
regulatory flexibility analysis is required if the head of an Agency 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities.
    SBREFA amended the RFA to require Federal agencies to provide a 
statement of the factual bases for certifying that a rule will not have 
a significant economic impact on a substantial number of small 
entities. However, since this requirement applies to proposed rules 
only, and as this Document is an ANPR, these requirements do not apply.

F. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 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

[[Page 10073]]

result in expenditures to State, local, and tribal governments, in the 
aggregate, or the private sector, of $100 million or more in any one 
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 cost-effective 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 that 
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. Today's ANPR contains no Federal mandates (under the 
regulatory provisions of Title II of UMRA) for State, local, or tribal 
governments or the private sector. The ANPR also imposes no enforceable 
duty on any State, local or tribal governments or the private sector.

G. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA''), Pub.L. 104-113, section 12(d) (15 U.S.C. 272 
note) 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., material specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
ANPR does not involve technical standards. Therefore, EPA is not 
considering the use of any voluntary consensus standards.

H. Paperwork Reduction Act

    Under the implementing regulations for the Paperwork Reduction Act, 
an agency is required to certify that any agency-sponsored collection 
of information from the public is necessary for the proper performance 
of its functions, has practical utility, is not unnecessarily 
duplicative of information otherwise reasonably accessible to the 
agency, and reduces to the extent practicable and appropriate the 
burden on those required to provide the information (5 CFR 1320.9). Any 
proposed collection of information must be submitted, along with this 
certification, to the Office of Management and Budget for approval 
before it goes into effect.
    Some of the approaches for regulatory flexibility discussed in the 
ANPR could entail new reporting and recordkeeping requirements for 
States and Tribes and/or members of the regulated public if such change 
is proposed. EPA is interested in comments on any and all aspects of 
potential paperwork requirements, and in particular on how they should 
be structured to fulfill the requirements that they have practical 
utility, are not unnecessarily duplicative of other available 
information, and are the least burdensome necessary to ensure that the 
storage and treatment of mixed waste is safely managed.

I. Executive Order 12898: Environmental Justice

    Under Executive Order 12898, ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations,'' as well as through EPA's April 1995, ``Environmental 
Justice Strategy, OSWER Environmental Justice Task Force Action Agenda 
Report,'' and National Environmental Justice Advisory Council, EPA has 
undertaken to incorporate environmental justice into its policies and 
programs. EPA is committed to addressing environmental justice 
concerns, and is assuming a leadership role in environmental justice 
initiatives to enhance environmental quality for all residents of the 
United States. The Agency's goals are to ensure that no segment of the 
population, regardless of race, color, national origin, or income, 
bears disproportionately high and adverse human health and 
environmental effects as a result of EPA's policies, programs, and 
activities, and all people live in clean and sustainable communities. 
To address this goal, EPA considered the impacts of this final rule on 
low-income populations and minority populations and concluded that this 
ANPR will have no impact whatsoever on low-income or minority 
populations because it only solicits voluntary comments on potential 
approaches to regulatory flexibility.

    Dated: February 22, 1999.
Carol M. Browner,
Administrator, Environmental Protection Agency.
[FR Doc. 99-4829 Filed 2-26-99; 8:45 am]
BILLING CODE 6560-50-M