[Federal Register Volume 67, Number 154 (Friday, August 9, 2002)]
[Proposed Rules]
[Pages 51930-51946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19796]
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Part II
Environmental Protection Agency
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40 CFR Part 194
Criteria for the Certification and Recertification of the Waster
Isolation Pilot Plant's Compliance With the Disposal Regulations;
Alternative Provisions; Proposed Rule
Federal Register / Vol. 67, No. 154 / Friday, August 9, 2002 /
Proposed Rules
[[Page 51930]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 194
[FRL-7255-4]
RIN 2060-AJ07
Criteria for the Certification and Recertification of the Waste
Isolation Pilot Plant's Compliance with the Disposal Regulations;
Alternative Provisions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (``EPA,'' or ``the
Agency'' or ``we'') is proposing to revise the ``Criteria for the
Certification and Recertification of the Waste Isolation Pilot Plant's
Compliance with the Disposal Regulations,'' which are used to determine
whether the Department of Energy's Waste Isolation Pilot Plant
(``WIPP'') will comply with EPA's ``Environmental Radiation Protection
Standards for Management and Disposal of Spent Nuclear Fuel, High-Level
and Transuranic Radioactive Wastes.'' The following proposed revisions
are included in today's action: addition of a mechanism to address
minor changes to the provisions of the Compliance Criteria; changes to
the approval process for waste characterization programs at Department
of Energy transuranic sites; changes to allow for the submission of
copies of compliance applications and reference materials in
alternative format; and replacement of the term ``process knowledge''
with ``acceptable knowledge.'' The proposed changes do not lessen the
requirements for complying with the Compliance Criteria. Moreover,
these changes will have no effect on the technical approach that EPA
employs when conducting independent inspections of the waste
characterization capabilities at DOE waste generator sites. EPA is
conducting this proposed action in accordance with the procedures for
substituting alternative provisions of the Compliance Criteria. Today's
notice marks the beginning of a 120-day public comment period on this
proposed action.
DATES: EPA requests comments on all aspects of these proposed
revisions. If you wish to submit comments on this proposal, you must do
so by December 9, 2002.
ADDRESSES: Send your comments to: Air Docket, Room M-1500, U.S.
Environmental Protection Agency, 401 M Street, SW., Mail Code 6102,
Washington, DC 20460, Attention Docket ID No. OAR-2002-0005. Comments
may be submitted electronically, by mail, by facsimile, or through hand
delivery/courier. Follow the detailed instructions as provided in
Section B of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Agnes Ortiz; telephone number: (202)
564-9310; postal address: Radiation Protection Division, Mail Code
6608J, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC, 20460.
SUPPLEMENTARY INFORMATION:
General Information
A. How Can I Get Copies of This Document and Other Related Information?
EPA has established an official public docket for this action under
Docket ID No. OAR-2002-0005. The official public docket consists of the
documents specifically referenced in this action, any public comments
received, and other information related to this action. Although a part
of the official docket, the public docket does not include Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. The official public docket is the collection of
materials that is available for public viewing at: Air Docket, Room M-
1500, U.S. Environmental Protection Agency, 401 M Street, SW., Mail
Code 6102, Washington, DC 20460. This Docket Facility is open from
8:30am-5 pm, Monday through Friday, excluding legal holidays. The Air
Docket telephone number is 202-260-7548.
You may access this Federal Register document electronically
through the EPA Internet under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Section B under General Information.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
For additional information about EPA's electronic public docket
visit EPA Dockets online or see 67 FR 38102, May 31, 2002.
B. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, by facsimile, or
through hand delivery/courier. To ensure proper receipt by EPA,
identify the appropriate docket identification number in the subject
line on the first page of your comment. Please ensure that your
comments are submitted
[[Page 51931]]
within the specified comment period. Comments received after the close
of the comment period will be marked ``late.'' EPA is not required to
consider these late comments. However, late comments may be considered
if time permits. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in
Section C under General Information. Do not use EPA Dockets or e-mail
to submit CBI or information protected by statute.
1. Electronically
If you submit an electronic comment as prescribed below, EPA
recommends that you include your name, mailing address, and an e-mail
address or other contact information in the body of your comment. Also
include this contact information on the outside of any disk or CD ROM
you submit, and in any cover letter accompanying the disk or CD ROM.
This ensures that you can be identified as the submitter of the comment
and allows EPA to contact you in case EPA cannot read your comment due
to technical difficulties or needs further information on the substance
of your comment. EPA's policy is that EPA will not edit your comment,
and any identifying or contact information provided in the body of a
comment will be included as part of the comment that is placed in the
official public docket, and made available in EPA's electronic public
docket. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.
Your use of EPA's electronic public docket to submit comments to
EPA electronically is EPA's preferred method for receiving comments. Go
directly to EPA Dockets at http://www.epa.gov/edocket, and follow the
online instructions for submitting comments. To access EPA's electronic
public docket from the EPA Internet home page, select ``Information
Sources,'' ``Dockets,'' and ``EPA Dockets.'' Once in the system, select
``search,'' and then key in Docket ID No. OAR-2002-0005. The system is
an ``anonymous access'' system, which means EPA will not know your
identity, e-mail address, or other contact information unless you
provide it in the body of your comment.
Comments may be sent by electronic mail (e-mail) to [email protected] Attention Docket ID No. OAR-2002-0005. In contrast to
EPA's electronic public docket, EPA's e-mail system is not an
``anonymous access'' system. If you send an e-mail comment directly to
the Docket without going through EPA's electronic public docket, EPA's
e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
You may submit comments on a disk or CD ROM that you mail to the
mailing address identified in Section A under General Information.
These electronic submissions will be accepted in WordPerfect or ASCII
file format. Avoid the use of special characters and any form of
encryption.
2. By Mail
Send your comments to: Air Docket, Room M-1500, U.S. Environmental
Protection Agency, 401 M Street, SW., Mail Code 6102, Washington, DC
20460, Attention Docket ID No. OAR-2002-0005.
3. By Hand Delivery or Courier
Deliver your comments to: Air Docket, Room M-1500, U.S.
Environmental Protection Agency, 401 M Street, SW., Mail Code 6102,
Washington, DC 20460, Attention Docket ID No. OAR-2002-0005. Such
deliveries are only accepted during the Docket's normal hours of
operation as identified in Section A under General Information.
4. By Facsimile
Fax your comments to: (202) 260-4400, Attention Docket ID. No. OAR-
2002-0005.
C. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the FOR FURTHER INFORMATION CONTACT section.
D. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
identification number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.
Abbreviations Used in This Document
AK--Acceptable knowledge
Am--Americium
APA--Administrative Procedure Act
ASME--American Society of Mechanical Engineers
BID--Background information document
CAR--Corrective Action Required
CARD--Compliance Application Review Document
CBFO--Carlsbad Field Office
CCA--Compliance Certification Application
CFR--Code of Federal Regulations
CH--Contact handled
Cs--Cesium
DOE--Department of Energy
EEG--Environmental Evaluation Group
EPA--Environmental Protection Agency
INEEL--Idaho National Energy and Engineering Laboratory
LANL--Los Alamos National Laboratory
NDA--Nondestructive Assay
NPRM--Notice of Proposed Rulemaking
NTS--Nevada Test Site
NQA--Nuclear Quality Assurance
ORNL--Oak Ridge National Laboratory
PK--Process knowledge
Pu--Plutonium
QA--Quality assurance
QAPP--Quality Assurance Project Plan
QAPjP--Quality Assurance Project Plan
RC--Radiochemistry
RCRA--Resource Conservation Recovery Act
RFETS--Rocky Flats Environmental Technology Site
RTR--Real-time radiography
SRS--Savannah River Site
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Sr--Strontium
TRU--Transuranic
U--Uranium
VE--Visual inspection
WAC--Waste Acceptance Criteria
WAP--Waste Acceptance plan
WC--Waste characterization
WIPP--Waste Isolation Pilot Plant
WIPP LWA--WIPP Land Withdrawal Act
WWIS--WIPP Waste Information System
Table of Contents
I. What Is WIPP?
II. What Is the Purpose of Today's Proposed Action?
III. How Is EPA Revising the Process for Establishing Alternative
Provisions in Sec. 194.6?
A. What Are the Current Requirements in Sec. 194.6?
B. What Changes Are Proposed for Sec. 194.6?
C. How Has EPA Addressed the Alternative Provision Analysis
Required by Sec. 194.6?
IV. How Is EPA Revising the Approval Process for Waste Shipment from
Waste Generator Sites for Disposal at WIPP in Sec. 194.8(b)?
A. What Are the Current Requirements in Sec. 194.8(b)?
B. What Are the Proposed Changes to Sec. 194.8(b)?
C. How Has EPA Addressed the Alternative Provision Analysis
Required by Sec. 194.6?
V. How Is EPA Revising the Submission of Compliance Applications and
Reference Materials Requirements in Secs. 194.12 and 194.13?
A. What Are the Current Requirements in Secs. 194.12 and 194.13?
B. What Are the Proposed Changes to Secs. 194.12 and 194.13?
C. How Has EPA Addressed the Alternative Provision Analysis
Required by Sec. 194.6?
VI. How Is EPA Revising the Waste Characterization Requirements in
Sec. 194.24(c)(3)?
A. What Are the Current Waste Characterization Requirements in
Sec. 194.24(c)(3)?
B. What Are the Proposed Changes to Sec. 194.24(c)(3)?
C. How Has EPA Addressed the Alternative Provision Analysis
Required by Sec. 194.6?
VII. Administrative Reuquirments
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Unfunded Mandates Reform Act
E. Executive Order 12898
F. National Technology Transfer & Advancement Act of 1995
G. Executive Order 13045: Children's Health Protection
H. Executive Order 13132: Federalism
I. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
J. Executive Order 13211: Energy Effects
I. What Is WIPP?
The Waste Isolation Pilot Plant (``WIPP'') is a disposal system for
transuranic radioactive waste. Developed by the Department of Energy
(``DOE'' or ``the Department''), the WIPP is located near Carlsbad in
southeastern New Mexico. Transuranic (TRU) radioactive wastes are
emplaced 2,150 feet underground in an ancient layer of salt that will
eventually ``creep'' and encapsulate the waste containers. The WIPP has
a total capacity of 6.2 million cubic feet of TRU waste.
Development and construction of the WIPP was authorized under
Section 213 of the Department of Energy National Security and Military
Applications of Nuclear Energy Authorization Act of 1980 (Public Law
No. 96-164, 93 U.S. Stat. 1259, 1265). WIPP was authorized as a defense
activity of the Department of Energy to demonstrate the safe disposal
of radioactive wastes resulting from the defense activities and
programs of the United States. Pursuant to Section 7 of the WIPP Land
Withdrawal Act (Public Law No. 102-579, as amended by Public Law No.
104-201) (WIPP LWA), disposal operations at WIPP are limited to a total
volume of 6.2 million cubic feet of transuranic radioactive waste.
Section 2(18) of the WIPP LWA defines TRU waste as waste containing
more than 100 nanocuries of alpha-emitting transuranic isotopes per
gram of waste, with half-lives greater than 20 years. This definition
excludes high-level radioactive waste, waste determined by DOE with the
concurrence of EPA to not need such isolation, or waste that the
Nuclear Regulatory Commission has approved for disposal on a case-by-
case basis, consistent with NRC regulations.
Most TRU waste proposed for disposal at WIPP consists of items that
have become contaminated as a result of activities associated with the
production of nuclear weapons (or with the cleanup of nuclear weapons
production facilities), such as, rags, equipment, tools, protective
gear, and sludges. Some TRU waste is contaminated with hazardous wastes
regulated under the Resource Conservation and Recovery Act (42 U.S.C.
6901-6992k)(RCRA). The waste proposed for disposal at WIPP is currently
stored at Federal facilities across the United States, including
locations in Colorado, Idaho, New Mexico, Nevada, Ohio, South Carolina,
Tennessee, and Washington.
Section 8(c) of the WIPP LWA required EPA to promulgate criteria,
pursuant to Section 4 of the Administrative Procedure Act (APA), for
EPA's certification of the WIPP's compliance with the radioactive waste
disposal regulations at 40 CFR Part 191. On February 9, 1996, EPA
published the final ``Criteria for the Certification and Re-
Certification of the Waste Isolation Pilot Plant's Compliance With the
40 CFR Part 191 Disposal Regulations' (61 FR 5224) (Compliance
Criteria). Section 8(d) of the WIPP LWA set forth specific procedures
governing the certification of the WIPP. Section 8(d)(1) required DOE
to submit a complete compliance application by October 31, 1996.
Section 8(d)(1) also provided that EPA had the authority to request any
additional information necessary for the Agency's determination of
compliance. Section 8(d)(2) required that EPA complete its
certification decision within one year of receipt of the DOE's
application. (EPA clarified at Sec. 194.11 of the Compliance Criteria
that, consistent with legislative intent, EPA's certification decision
would be due within one year of receipt of a complete compliance
application.) EPA determined DOE's compliance application to be
complete on May 22, 1997 (62 FR 27996).
EPA determined on May 18, 1998, that DOE had demonstrated that the
WIPP will comply with EPA's radioactive waste disposal regulations at
Subparts B and C of 40 CFR part 191. EPA's certification determination
permitted the WIPP to begin accepting transuranic waste for disposal,
provided that other applicable environmental regulations were met and
once a 30-day statutory waiting period had elapsed. EPA based its
decision on a thorough review of all the information submitted by DOE,
independent technical analyses, and all significant public comments
submitted during a nominal 120-day comment period. EPA's certification,
however, was subject to four specific conditions. Thus, EPA amended the
WIPP compliance criteria at 40 CFR part 194 to include an appendix
setting forth the four conditions on the certification of compliance.
These conditions related to (1) design of the panel closure system
(which is intended over the long term to block brine flow between waste
panels in the WIPP); (2) and (3) activities conducted at waste
generator sites that produce the transuranic waste proposed for
disposal in the WIPP (specifically with respect to quality assurance
and waste characterization); and (4) passive institutional controls.
Subsequent to the initial certification, EPA continues to have an
oversight role at the WIPP. First, Section 9 of the WIPP LWA requires
that DOE submit biennial documentation of continued compliance with
specified laws, regulations, and permit requirements. Second,
Sec. 194.4 of the Compliance Criteria requires that DOE submit periodic
reports on any activities or conditions at the WIPP that differ
significantly from the information contained in the most recent
compliance application. EPA may also, at any time, request additional
information from DOE regarding the
[[Page 51933]]
WIPP to determine if regulatory action is required concerning the
certification. Third, Section 8(f) of the WIPP LWA requires at least
five years after the initial certification and every five years
thereafter, that DOE submit to EPA and the State of New Mexico
documentation of continued compliance with the Part 191 radioactive
waste disposal regulations. In accordance with Sec. 194.64 of the
Compliance Criteria, documentation of continued compliance will be made
available in EPA's dockets, and the public will be provided at least a
30-day period during which to submit comments. EPA's decision on
recertification will be announced in the Federal Register.
II. What Is the Purpose of Today's Proposed Action?
EPA proposes to revise certain provisions of the Compliance
Criteria at 40 CFR part 194. Specifically, EPA is proposing to (1)
revise the process for establishing ``alternative provisions'' in
Sec. 194.6; (2) revise the approval process in Sec. 194.8 for waste
characterization processes at TRU waste generator sites for disposal at
WIPP; (3) revise the requirements in Secs. 194.12 and 194.13 for
submission of compliance applications and reference materials; and (4)
change the term ``process knowledge'' to ``acceptable knowledge'' in
Sec. 194.24(c)(3). The proposed revisions are intended to ensure that
40 CFR Part 194 remains comprehensive, appropriate, and based upon
current knowledge and information. The Agency solicits comments on this
proposal.
Section 194.6 of the Compliance Criteria imposes specific
requirements for substitution of ``alternative provisions'' of the
Criteria. Such alternative provisions must be promulgated pursuant to
Section 4 of the APA. Also, in proposing the alternative provisions EPA
must describe how the proposed changes comport with the radioactive
waste disposal regulations at 40 CFR part 191, the reasons why the
existing provisions appear inappropriate, and the costs, risks, and
benefits of compliance with the new provisions. Finally, EPA must
provide for a public comment period of 120 days and hearings in New
Mexico, and fully consider the public comments that are received.
Today's Notice of Proposed Rulemaking (NPRM) is organized so that, for
each of the proposed revisions, the preamble addresses the following
topics: A. What are the current requirements?; B. What are the proposed
changes?; and C. How has EPA addressed the Alternative Provision
Analysis required by Sec. 194.6?
III. How Is EPA Revising the Process for Establishing Alternative
Provisions in Sec. 194.6?
A. What Are the Current Requirements in Sec. 194.6?
Section 194.6 establishes procedures applicable to substitution of
alternative provisions of the Compliance Criteria. As discussed above,
such substitutions require notice and comment rulemaking, pursuant to
Section 4 of the APA. In addition, Sec. 194.6 stipulates that EPA's
NPRM address specific aspects of the proposed substitution, include a
public comment period of at least 120 days, and public hearings in New
Mexico.
B. What Changes Are Proposed for Sec. 194.6?
EPA is proposing to revise Sec. 194.6 to add a rulemaking process
for substituting ``minor alternative provisions'' of the Compliance
Criteria. The process for substituting ``minor alternative provisions''
would include: (1) Rulemaking pursuant to Section 4 of the APA; (2)
publication of the proposed changes in the Federal Register, together
with information describing how the changes conform with the disposal
regulations, the reasons why the changes are needed, and the benefits
of compliance with the minor changes; (3) a public comment period of at
least 30 days; and (4) publication in the Federal Register of the final
notice after public comments received have been fully considered. EPA
is also proposing to add the following definition of ``minor
alternative provision'' to Sec. 194.2: ``minor alternative provision
means an alternative provision to the Compliance Criteria that
clarifies a regulatory provision, or does not substantively alter the
existing regulatory requirement.''
C. How Has EPA Addressed the Alternative Provision Analysis Required by
Sec. 194.6?
The Agency wants to have the ability to make insignificant changes
to the Compliance Criteria in an expedited time frame to facilitate
WIPP's continued compliance with our regulations. The provisions for
substituting minor alternative provisions could, for example, be used
to modify the Compliance Criteria to change regulatory terminology to
more clearly express the Agency's intended meaning or to clarify
expectations. Substitution of ``minor alternative provisions'' would
not in any way substantively modify the Compliance Criteria
requirements.
1. Why Do the Existing Provisions in Sec. 194.6 Appear Inappropriate?
In certain specific contexts, discussed below, EPA considers the
existing provisions to be inappropriate because they are unnecessarily
stringent. When Sec. 194.6 was promulgated, EPA was beginning the
process of formal regulation of the WIPP. EPA had not yet even received
the DOE's compliance certification application. EPA now has engaged in
close regulatory oversight of the WIPP for over six years. EPA has
engaged in post-certification oversight of the WIPP for almost four
years. During that time, EPA has gained substantial experience and
insight into this regulatory process. While Sec. 194.6, as originally
drafted, was intended to address all changes to the Compliance
Criteria, EPA now realizes that there may be modifications to the
Compliance Criteria that, while useful, are not sufficiently
significant to require the stringent procedures currently set forth in
Sec. 194.6. EPA's oversight experience indicates that minor revisions
to the Compliance Criteria requirements may improve implementation and
consistency in regulatory compliance.
EPA believes that today's proposal includes several examples of
minor revisions that would be appropriately addressed by a less
stringent process than currently available under Sec. 194.6. For
example, EPA is proposing to replace the term ``process knowledge'' in
Sec. 194.24(c)(3) with the term ``acceptable knowledge'' (see section
VI of the preamble). This minor revision is intended to acknowledge
that ``acceptable knowledge'' is the term EPA has used consistently
since the WIPP was certified. EPA is also proposing to permit DOE to
submit fewer printed recertification compliance applications than
currently required in the Compliance Criteria. These proposed revisions
do not substantively alter the intent or the approach to verifying
compliance with the waste characterization requirements in any way, but
improve the clarity of and more clearly reflect the intent of the
Compliance Criteria. Such minor revisions should not require a 120-day
public comment period, nor necessitate a public hearing.
We propose that a 30-day comment period is sufficient for the
public to provide the Agency with relevant input on such minor
revisions of the Compliance Criteria. In addition to the publication of
the NPRM in the Federal Register, EPA intends to announce the proposal
on the Agency's website and place all relevant supporting materials in
the Agency's public docket. For all
[[Page 51934]]
substitutions of alternative provisions that are not minor alternative
provisions, as defined in this document (for example, the addition,
deletion, or significant revision of a requirement), EPA will continue
to comply with the current requirements of Sec. 194.6.
EPA defines a ``minor alternative provision'' as an alternative
provision that ``clarifies a regulatory provision, or does not
substantively alter the existing regulatory requirement.'' Thus,
revisions that do not alter the intent or the approach to verifying
compliance of an existing regulatory requirement are considered to
constitute minor alternative provisions. For example, today's proposed
revisions to Secs. 194.2, 194.12, 194.13, and 194.24(c)(3) are examples
of minor changes. The proposed revisions to Secs. 194.6 and 194.8(b),
however, are examples of non-minor alternative provisions.
2. How Do the Proposed Changes in Sec. 194.6 Comport with 40 CFR part
191?
The proposed changes for Sec. 194.6 comport fully with the
radioactive waste disposal regulations at 40 CFR part 191. The WIPP
must comply with EPA's radioactive waste disposal regulations located
at Subparts B and C of 40 CFR part 191. These regulations limit the
amount of radioactive materials that may escape from a disposal
facility, and are intended to protect individuals and ground water
resources from dangerous levels of radioactive contamination. The
Compliance Criteria implement and interpret the general disposal
regulations specifically for the WIPP, and constitute the basis on
which EPA's certification decision was made. Section 194.6 was included
in the Compliance Criteria to ensure that any amendments to the
Criteria would be effected through the same rigorous rulemaking
procedure under which the original Criteria were promulgated. The
proposed amendment to Sec. 194.6 would not substantively alter the
scope of those requirements. The Compliance Criteria would continue to
include the current process established in Sec. 194.6 to revise 40 CFR
part 194. The principle difference between the existing and proposed
new provisions is the addition of a revision process for minor changes.
This new revision process would not substantively affect the Compliance
Criteria's implementation of 40 CFR part 191.
3. What Are the Costs, Risks, and Benefits of Compliance with the New
Provisions in Sec. 194.6 ?
As part of our implementation efforts for the 1998 certification
decision, we will continue to develop revisions to the Compliance
Criteria, as we deem necessary, based on lessons learned from our
oversight experience. This is our first revision to the Compliance
Criteria since the initial certification decision in 1998.
There will be no increased costs for EPA as a result of the
proposed revision. Rather, EPA believes that it is reasonable to expect
significant savings over the period of active regulation of the WIPP.
The proposed revision will shorten rulemakings where appropriate and
eliminate a requirement for public hearings in instances where the
impact of changes would be small and public interest may reasonably be
expected to be low. Moreover, EPA does not expect DOE to incur
additional costs, since the implementation of Sec. 194.6 is solely
EPA's responsibility.
EPA does not anticipate any increased risks related to the
implementation of the proposed revision. Rather, we anticipate that
EPA's regulatory activities will become more efficient, and that EPA
will be able to implement necessary minor revisions to the Compliance
Criteria that are designed to improve implementation and consistency in
regulatory compliance.
The benefits of the proposed revision to Sec. 194.6 are several.
First, the Agency, would be able to make minor revisions to the
Compliance Criteria in a timely fashion. Making these types of
revisions in a shorter timeframe will enhance compliance with 40 CFR
part 194. Second, the public will continue to have an opportunity to
review and comment on proposed minor revisions. Third, the Agency will
continue to hold public hearings in New Mexico for major revisions to
the Compliance Criteria. Fourth, DOE will be able to implement minor
revisions faster, therefore, this proposed revision will contribute to
safer and more cost effective disposal of radioactive wastes.
IV. How Is EPA Revising the Approval Process for Waste Shipment
From Waste Generator Sites for Disposal at WIPP in Sec. 194.8(b)?
A. What Are the Current Requirements in Sec. 194.8(b)?
Section 194.8(b) describes the process by which EPA reviews and
approves WIPP-related waste characterization activities \1\ at DOE
transuranic waste sites. At present, for each waste stream or group of
waste streams \2\ other than those approved in our final certification
decision, DOE must provide information on how a waste site uses process
knowledge \3\ to characterize those streams (Sec. 194.8(b)(1)(i)). The
DOE also must implement a system of controls \4\ that confirms that the
total quantity of important waste components \5\ in the WIPP does not
exceed limits established by the final Certification Decision
(Sec. 194.8(b)(1)(ii)). In order to show EPA that the system of
controls is effective, DOE must demonstrate each TRU waste site's
measurement techniques and control methods, and must demonstrate that
data about waste components are properly transferred from the waste
sites to the WIPP Waste Information System (WWIS).\6\
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\1\ The term ``waste characterization,'' as we use it with
regard to the WIPP repository and the numerous waste generator
sites, encompasses a wide array of activities, all of which serve to
determine what is inside any given container of transuranic waste
and to control that container until DOE places it in the WIPP for
disposal. Stated generally, the Compliance Criteria for waste
characterization in Sec. 194.24 require DOE to: Determine which
waste components (such as ferrous metals) and characteristics (e.g.,
acidity) are relevant to the WIPP's performance; show how they
affect performance; and identify and track significant waste
components as they are placed in the WIPP. The last of these
activities is the subject of Sec. 194.8(b). The waste
characterization requirements are discussed in great detail in the
preamble to the May 18, 1998, Certification Decision final rule. (63
FR 27389-27393)
\2\ The term ``waste stream'' means wastes derived from a single
process or activity that are similar in material, physical form,
isotopic makeup, and hazardous constituents. (Certification Decision
proposed rule 62 FR 58813.)
\3\ Process knowledge (``PK'') refers to knowledge of waste
characteristics derived from information generated contemporaneously
with the waste on the materials or processes used to generate the
waste. This information may include administrative, procurement, and
quality control documentation associated with the generating
process, or past sampling or analytical data. Usually, the major
elements of process knowledge include information about the process
used to generate the waste, material inputs to the process, and the
time period during which the waste was generated. (Certification
Decision final rule 63 FR 27390.)
\4\ The system of controls for waste characterization includes,
but is not limited to: Measurement, sampling, chain of custody
records, record keeping systems, waste loading schemes used, and
other documentation. 40 CFR 194.24(c)(4).
\5\ The term ``waste component'' means ``an ingredient of the
total inventory of the waste that influences a waste
characteristic''. 40 CFR 194.2. The term ``waste characteristic''
means ``a property of the waste that has an impact on the
containment of waste in the disposal system''. 40 CFR 194.2. The
important waste components with regard to the WIPP's compliance are
radionuclides, ferrous and nonferrous metals, organic materials such
as paper and rubber, and free water.
\6\ The WWIS is described in Chapter 4 (page 4-35) of the WIPP
Compliance Certification Application as ``a computerized data
management system used * * * to gather, store, and process
information pertaining to transuranic (TRU) waste destined for or
disposed at the WIPP.'' [Air Docket A-93-02, Item II-G-1.]
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To evaluate compliance with the above-mentioned requirements, we
must inspect and approve each DOE transuranic waste site that wishes to
ship waste to the WIPP for disposal. We must inspect the site's use of
process
[[Page 51935]]
knowledge and witness a demonstration of waste characterization
processes for each waste stream, or group of waste streams, that the
site intends to ship. If a site receives our approval to ship a single
waste stream, that site cannot ship a different waste stream until we
perform an additional inspection under authority of Sec. 194.8(b). EPA
imposed these requirements as a condition of the certification to
ensure full compliance with the waste characterization regulations at
Sec. 194.24(c).
Once DOE has submitted waste characterization program plans for a
given site, we place the plans in our docket and publish one or more
notices in the Federal Register that announce the availability of the
plans and our intent to inspect the site on a specific date
(Sec. 194.8(b)(2)). We also open a comment period of at least 30 days
for others to comment on the waste site's plans. After the inspection,
we notify DOE of our compliance determination by letter, and place the
letter and the report of the inspection in our docket
(Sec. 194.8(b)(3)). Finally, we perform follow-up inspections at a site
to verify the continuing compliance of approved waste characterization
programs (Sec. 194.8(b)(4)).
The following two subsections explain the purpose of the
requirements described above and the basic elements of a waste
characterization inspection.
1. What Is the Purpose of EPA's Waste Characterization Inspections?
The purpose of EPA inspections at DOE sites is to verify that TRU
waste sites are characterizing and tracking the waste such that EPA is
confident that the volume and characteristics of the wastes conform
with the requirements of the WIPP LWA and the specific conditions of
the Certification Decision. The requirements set forth at Sec. 194.8(b)
establish a process by which EPA determines whether DOE is in
compliance with Condition 3 of the Certification Decision. Condition 3
states, ``[t]he Secretary [of Energy] shall not allow shipment of any
waste from any additional LANL [Los Alamos National Laboratory] waste
stream(s) or from any waste generator site other than LANL for disposal
at the WIPP until the Agency has approved the processes for
characterizing those waste streams for shipment using the process set
forth in Sec. 194.8.'' (40 CFR part 194, Appendix A.) Accordingly,
Sec. 194.8(b) sets forth procedural requirements for EPA's approval of
DOE TRU waste sites to ship specific waste streams or groups of waste
streams to WIPP.
The basis for applying Condition 3 to the WIPP project is rooted in
our rationale for the waste characterization criteria in Sec. 194.24.
We developed these criteria because, ``in order to make meaningful
predictions about the performance of the WIPP over long periods of
time, it is necessary to have a good understanding of the
characteristics of the waste proposed to be emplaced in the disposal
system.'' (Compliance Criteria proposed rule, 60 FR 5771). We required
DOE to show, in its compliance application for the WIPP, that a
``system of controls'' was in place to ensure that ``the actual
characteristics of waste will be identified before the waste is
emplaced in the WIPP.'' (60 FR 5772).
The DOE developed an extensive set of technical and quality
assurance requirements with which all transuranic waste sites must
comply before shipping waste to the WIPP for disposal. At the time of
application, DOE had incorporated these requirements into such
documents as the Quality Assurance Program Plan (QAPP), Waste
Acceptance Criteria (WAC), and Quality Assurance Project Plan (QAPjP).
However, DOE did not submit the necessary information about all
transuranic waste site programs in the application. At the time that
DOE submitted the CCA, most sites had not begun the complex process of
complying with the WIPP waste characterization requirements and the
information therefore was not available to EPA during the certification
process. (Certification Decision proposed rule 62 FR 58813-58814).
Consequently, we were not able to determine during the
certification rulemaking that the technical and quality assurance
requirements for waste characterization activities had been established
and properly executed at all transuranic waste sites. LANL was the only
transuranic waste site to demonstrate during the certification
rulemaking that it could meet the waste characterization requirements
for certain wastes. Therefore, as stated in Condition 3 of the
certification, EPA only authorized DOE to ship legacy debris waste from
LANL to the WIPP. DOE was not authorized to ship other than legacy
debris waste from LANL, or any waste streams from other TRU waste
sites, until DOE had demonstrated the ability to properly characterize
these wastes.
DOE's Carlsbad Field Office (CBFO), which operates the WIPP, is
responsible for maintaining compliance with EPA's waste
characterization requirements. DOE transuranic waste sites vary
considerably with regard to the types of waste they characterize and
the manner in which they implement the program requirements of CBFO.
Therefore, confirmation that waste characterization is adequate must
take place where waste characterization occurs, that is, at the
transuranic waste sites themselves. (Certification Decision final rule,
63 FR 27392). Inspections of waste characterization programs at
individual sites are the best way for us to verify that the sites have
identified the actual characteristics of the waste.
During inspections, we have access to the site personnel who
perform the work, to the facilities and equipment used at the site, and
to the operators' extensive documentation. Direct observation of the
site's activities greatly increases our confidence in their
effectiveness. Confidence in the results of waste characterization is
particularly important at this early stage of disposal, when DOE is
characterizing waste that TRU waste sites packaged years before the
establishment of the WIPP Compliance Criteria.\7\
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\7\ EPA specifically addressed public comments concerning the
importance of Condition 3 in EPA's Response to Comments Document for
the Certification Decision. See EPA Air Docket A-93-02, Item V-C-1,
pages 2-5 to 2-9.
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2. What Are the Elements of an EPA Waste Characterization Inspection?
After EPA determines that an inspection is necessary, we define the
scope of the inspection based on information provided by DOE. We then
prepare, and share with DOE, a checklist for each of the activities
that we will inspect. During the inspection, our evaluation of a site's
waste characterization activities typically involves the activities
listed below. EPA inspectors may or may not perform these and other
activities depending on the scope of the inspection.
Review procedures, records of the maintenance and
calibration of equipment and instruments, and personnel training files.
Interview responsible personnel (such as equipment
operators) and site managers overseeing program implementation.
Observe analytical testing of waste drums selected by EPA
inspectors to ensure that approved procedures are followed and an
instrument is capable of analyzing a given waste stream.
Observe equipment operation to determine whether the
operator has deviated from the procedures and why and how the deviation
may haven affected the waste characterization.
Review waste stream data reports.
Track waste characterization data through various phases
of its generation and confirmation and eventual inclusion in the WWIS.
[[Page 51936]]
The inspectors' determinations are recorded in the checklist for
each activity that we inspect. At the end of each inspection, we
prepare an inspection report. The completed checklists are included in
the inspection report. The inspection report also describes any
findings or concerns that the inspectors identified, and states whether
EPA requires a response showing how any unresolved finding or concern
was resolved.\8\ It is sometimes necessary to return to a site to
confirm the adequate resolution of a finding. After a site is approved,
EPA may review the site's progress on issues that we identified
previously during a subsequent compliance inspection.
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\8\ In the context of its 194.8 inspections, EPA has defined a
finding as ``a determination that a specific item or activity is not
in compliance with 40 CFR part 194.'' Similarly, EPA has defined a
concern as ``an opinion that a specific item or activity may lead to
noncompliance with 40 CFR part 194 at a future time''.
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B. What Are the Proposed Changes to Sec. 194.8(b)?
Section 194.8 will continue to describe the process by which EPA
will inspect and approve waste characterization activities at TRU waste
sites. However, we are proposing to alter the process so that the
individual waste generator sites will only need one Sec. 194.8 approval
from EPA to conduct waste characterization activities related to all
on-site waste streams. This single Sec. 194.8 approval will, however,
specify any limitations on the approval that will necessitate
additional inspections by EPA. Any such additional inspections will be
conducted under authority of Sec. 194.24(h), not under Sec. 194.8. The
second key change is that the opportunity for public comment will come
after EPA has completed its inspection, but before EPA has approved the
site. Therefore, EPA will request public comment on the Agency's
inspection report and proposed compliance decision for a site under
Sec. 194.8. The revised process by which the Agency will verify
compliance with Condition 3 of the certification is described below,
followed by an explanation of the two principal procedural changes that
result from the revisions.
Under today's proposal, first, we require DOE to implement waste
characterization programs and processes in accordance with
Sec. 194.24(c)(4) to confirm that the total amount of each waste
component that will be emplaced in the WIPP will not exceed the upper
limiting value or fall below the lower limiting value described in the
introductory text of paragraph (c) of Sec. 194.24. Waste
characterization processes include the collection and use of acceptable
knowledge; destructive and/or nondestructive techniques for identifying
and measuring waste components; and the validation, control, and
transmittal to the WIPP Waste Information System database of waste
characterization data in accordance with Sec. 194.24(c)(4).
Second, DOE must notify EPA in writing that a waste
characterization program at a transuranic waste site is prepared to
characterize waste destined for disposal at the WIPP. The Department
will also send documents that explain the site's system of controls for
waste characterization, including the use of acceptable knowledge, as
described in Sec. 194.24(c)(4).
Third, EPA will conduct a baseline inspection of the waste
characterization program at the site to verify that an adequate system
of controls has been established in plans and technical procedures, and
that those plans and procedures are adequately implemented. The
inspection will include a demonstration by DOE of the following:
collection and appropriate use of acceptable knowledge data;
destructive and nondestructive techniques for measuring waste
components identified in accordance with Sec. 194.24(b)(2), performed
on the wastes proposed for disposal; verification of the qualifications
of the personnel responsible for performing waste characterization
activities; and the validation, control, and transmittal to the WIPP
Waste Information System database of waste characterization data, in
accordance with Sec. 194.24(c)(4). It may be necessary to conduct
follow-up inspection activities or continuation of the baseline
inspection in order to obtain additional information and/or confirm the
implementation of corrective actions.
Fourth, EPA will announce in the Federal Register our proposed
Baseline Compliance Decision to accept the site's compliance with
Sec. 194.24(c)(4). In the notice, we will solicit public comment on the
relevant inspection report(s) and all supporting materials that we rely
upon in making our proposed Baseline Compliance Decision. These
materials will be placed in the public docket described in Sec. 194.67.
The notice will describe any limitations on approved waste streams or
waste characterization processes and identify (through tier
designations) what changes to the approved waste characterization
process must be reported to and approved by EPA before they can be
implemented. EPA will designate significant changes as Tier 1; minor
changes will be designated as Tier 2. The notice will open a 30-day
public comment period on the proposed compliance decision.
Fifth, after the end of the public comment period our written final
Baseline Compliance Decision will be conveyed in a letter from the
Administrator's authorized representative to DOE. DOE will comply with
any reporting requirements identified in the Baseline Compliance
Decision and the accompanying inspection report. A section summarizing
significant comments and issues arising from comments received on the
compliance decision, as well as the Administrator's response to those
comments and issues, will be included in our final inspection report
and will be made available to the public through our public docket. A
copy of our compliance decision letter will also be placed in the
docket.
Last, after a site receives our Baseline Compliance Decision, EPA
will conduct inspections under Sec. 194.24(h) to confirm the continued
compliance of the programs approved and/or to verify the adequacy of
any tier-assigned changes to the waste characterization processes not
authorized by our Baseline Compliance Decision. DOE must report to EPA
any changes as identified in the inspection report of our Baseline
Compliance Decision. The reporting will inform EPA's decision whether
to perform follow-up inspections. The results of EPA's inspections will
be made available to the public through the public docket. If we
determine that the system of controls used by the site is not adequate
to characterize certain waste streams, then the site may not dispose of
materials from those waste streams at the WIPP until the Agency's
findings have been adequately resolved.
1. Changes to the Scope of EPA Approvals of Waste Characterization
Programs
Under the proposed new provisions, EPA will issue a proposed
Baseline Compliance Decision that describes what we inspected and found
to be technically adequate and also identifies DOE's subsequent
reporting requirements for the waste characterization program in
question. The various elements of the waste characterization program
will be tiered, and the basis for the tiering will be described in the
inspection report that accompanies the proposed Baseline Compliance
Decision.
The proposed tiering approach is a mechanism by which EPA can
specify which changes to an approved waste characterization program
require EPA approval before waste characterized by
[[Page 51937]]
that program is disposed of in the WIPP. TRU waste sites would have a
clear understanding of which changes must be approved by EPA prior to
shipment and disposal. The tiering of elements of the system of
controls for waste characterization will vary depending on the type of
analytical systems that a site has demonstrated, the types of
retrievably-stored waste at a site, and the type and quality of
information the site has compiled to describe waste contents. The
proposed tiered approach applies only to waste characterization
activities subject to Sec. 194.8(b) requirements.
We propose to institute two tiering levels. Tier 1 designation will
be given to activities for which changes have a potentially significant
impact on compliance with EPA regulations, such as changes that
directly affect measurements and/or estimates of isotopes and other
limited waste components. Tier 1 activities are those for which EPA
approval would be necessary prior to shipment and disposal of waste.
For example, EPA approval would be necessary if a site introduced a new
radioassay technique, because radioassay is a critical element of the
system of waste characterization controls. Technical areas that are
likely to be subject to Tier 1 designation are acceptable knowledge and
radioassay. DOE will be required to submit documentation to EPA in
advance that describes planned changes to Tier 1 activities. This
documentation will inform EPA's decision regarding which actions, such
as performance of an inspection, are necessary in order to approve the
changes.
Tier 2 activities are those for which EPA approval would not be
necessary prior to shipment and disposal of waste. An approved site
could implement changes to elements of the waste characterization
program with Tier 2 designation without first being inspected or
approved by EPA. However, DOE must report changes in the manner
prescribed by EPA in the Baseline Compliance Decision. DOE's reporting
of changes to Tier 2 activities will assist EPA with the planning of
follow-up inspections at sites.
Tier 2 designation will be given to activities that have a minor
impact on compliance with the WIPP Compliance Criteria or are
sufficiently standardized that they would not be expected to change
significantly. For example, the actual operation of radiographic
equipment does not vary greatly from machine to machine or from site to
site. Also, minor revisions to procedures are a regular part of
operations and usually serve to clarify or improve work processes.
Technical areas that are likely to be subject to Tier 2 designation are
radiography and visual examination. The required reporting by DOE of
Tier 2 changes will enable EPA to monitor the overall waste
characterization program at a site and develop targeted inspection
plans for continuing compliance inspections.
When we approve a waste characterization program, we will assign
tiering designations based chiefly on the following topics: the extent
to which a process was demonstrated at the time of our Sec. 194.8(b)
inspection(s); quality of documentation; the range of possible waste
streams at a site; the demonstrated proficiency of waste
characterization personnel; and the site's compliance with DOE's waste
acceptance criteria for the WIPP, as reviewed and approved by EPA. Our
inspection report will describe EPA's requirements for reporting of
changes to waste characterization activities, including the scope and
frequency of reporting.
Sites that have not been authorized by EPA to ship waste to the
WIPP under the current provisions of Sec. 194.8(b) will be subject to
the new process immediately after we issue the final version of this
rule. For sites that already have received EPA's approval to ship
certain waste streams, we are proposing to reinspect those sites using
the revised process. In other words, we will perform a full-scope
inspection at approved sites (Hanford Site, Idaho National Energy and
Environment Laboratory, Los Alamos National Laboratory, Rocky Flats
Environmental Technology Site, and the Savannah River Site) in order to
reset the Baseline Compliance Decision based on current activities at
the sites. We will place our proposed compliance decision for each
approved site in our docket and open comment on it. TRU waste sites
with an approved waste characterization program may continue to ship
waste within the scope of the existing approval while the baseline
inspection process is taking place, provided that they continue to
operate in accordance with the WIPP Compliance Criteria.
DOE has initiated an effort called the Central Characterization
Project (CCP) to assist small quantity TRU waste sites with the
completion of the waste characterization activities required by EPA and
State agencies. Under the CCP, a single DOE contractor assumes
responsibility for the characterization of a site's transuranic waste.
The CCP sends a mobile waste characterization laboratory to the site to
complete certain activities, such as radioassay.
EPA has approved the CCP's operation at the Savannah River Site,
where it was first tested [Air Docket A-98-49, Item II-A4-19]. Under
the existing provisions for Sec. 194.8, EPA must first inspect and
approve the CCP at each site, for each waste stream or group of waste
streams. Under the proposed new provisions, EPA approval under
Sec. 194.8(b) will still be required for CCP operations at each site.
However, once we have approved the CCP at a site, the CCP will be
approved to characterize all waste streams at that site. Moreover, any
subsequent inspections by EPA will be performed under Sec. 194.24(h).
The same processes described above for TRU waste sites will apply to
our compliance decisions for the CCP.
2. Changes to Public Notice of Waste Characterization Inspections
Under the existing provisions of Sec. 194.8(b), EPA opens comment
on DOE waste characterization plans each time that we plan to inspect a
waste characterization program at a site, if that program involves new
waste streams or changes to the system of waste characterization
controls. We announce comment periods and dates of inspections in the
Federal Register. Because each site has multiple waste streams and
evolving waste characterization programs, we have opened multiple
comment periods on different documents for each site that we have
approved to ship waste. We respond to the relevant comments that we
receive in our inspection reports, and docket the inspection reports
and compliance decisions.
Under the new provisions of Sec. 194.8(b), EPA will request comment
on our proposed Baseline Compliance Decision for each site, which
includes the results of our inspection(s) in the form of an inspection
report, and any appropriate supporting documentation, such as objective
evidence in support of Agency findings. We will open comment periods
only in relation to baseline inspections under Sec. 194.8(b). We will
continue to respond to the relevant comments that we receive in our
inspection reports, and to docket the inspection reports and compliance
decisions. The results of subsequent inspections of waste
characterization programs that we perform, including for the purpose of
approving Tier 1 changes, will be placed in our docket.
In addition to these steps, we plan to continue to announce our
inspections and other WIPP-related activities on our WIPP home page at
www.epa.gov/radiation/wipp and our WIPP Information Line (1-800-331-
9477). We
[[Page 51938]]
encourage the public to visit our Website and to contact us with
questions or information regardless of whether we have opened a public
comment period. (Comments in response to an announcement in the Federal
Register should be sent directly to the EPA docket specified in the
announcement.)
C. How Has EPA Addressed the Alternative Provision Analysis Required by
Sec. 194.6?
The proposed changes to Sec. 194.8(b) are needed to increase the
options available to EPA in implementing our regulatory oversight of
DOE's waste characterization program, and to simplify the public notice
process.
1. How Do the Proposed Changes Comport With 40 CFR part 191?
Considered individually and as a group, the proposed changes
comport fully with the radioactive waste disposal regulations at 40 CFR
part 191. The inclusion of requirements for waste characterization in
order to implement the disposal regulations was established by the
rulemaking that resulted in the WIPP Compliance Criteria at 40 CFR part
194. Today's proposed changes do not alter the scope of the part 191
requirements. The Compliance Criteria will continue to apply waste
characterization requirements to the WIPP project. The principal
difference between the existing and proposed provisions is the process
by which EPA verifies compliance with the provisions and notifies the
public of that process. This new process will not substantively affect
the Compliance Criteria's implementation of EPA's radioactive waste
disposal regulations at 40 CFR part 191. Moreover, EPA believes that
the proposed changes to the 194.8 approval process will allow for more
meaningful public participation.
2. Why Do the Existing Provisions Appear Inappropriate?
EPA considers the existing provisions inappropriate for the reasons
explicated below. EPA explained the basis for the existing provisions
in the May 18, 1998, Certification Decision final rule (63 FR
27354).\9\ The importance of independently verifying the adequacy of
waste characterization activities conducted by DOE has not grown any
less relevant. However, our experience with site inspections since the
1998 certification decision has raised two key issues that we believe
must be addressed through alternative provisions.
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\9\ The existing provisions were designed to address the fact
that at the time of certification, DOE was able to demonstrate the
effectiveness of the proposed system of controls for waste
characterization only for certain waste streams at Los Alamos
National Laboratory [see 63 FR 27390].
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First, for a variety of reasons, the focus of the existing
provisions on waste streams as the determining factor for initiation of
an inspection is overly restrictive for EPA. The requirement at
Sec. 194.8(b)(1) that DOE must demonstrate the system of controls for
each waste stream or group of waste streams reflects the fact that some
waste streams are better documented than others. Consequently, there
may be variations in how a given site uses information in the
acceptable knowledge (AK) record in relation to the AK confirmatory
program that DOE employs under the terms of the Certification Decision.
DOE sites must report to WIPP as part of the TRU waste tracking
requirement on a container basis, quantities of 10 WIPP-tracked
radionuclides (americium-241, cesium-137, plutonium-238, plutonium-239,
plutonium-240, plutonium-242, strontium-90, uranium-233, uranium-234,
and uranium-238) disposed of at the WIPP. Reporting on a container
basis may require sites to perform additional waste analysis if using
the site-compiled AK is not adequate to estimate these radionuclides.
Similarly, sites are responsible for reporting the quantities of
cellulosics, paper, and rubber (CPR) present in each waste container.
During the certification rulemaking, we were concerned about the need
to monitor the effect of these variances on the quality of waste
characterization data. Section 194.8(b) was therefore constructed such
that changes to the system of controls, in addition to the introduction
of new waste streams, would be sufficient cause to require separate
approval. As explained in the 194.8 BID document, EPA's regulatory
experience over the past four years suggests that this narrow focus on
specific waste streams is no longer necessary.
Second, the public notice process described in Sec. 194.8(b) has
not yielded the level of comment that we anticipated. As demonstrated
by the quantity and type of comments we have received following
publication of inspection announcements in the Federal Register, the
process may actually be a source of confusion for the public. Each of
these issues is discussed below.
a. Why are the existing provisions overly restrictive for EPA? EPA
now has several years of experience with inspections at DOE sites where
waste characterization takes place. Since certifying the WIPP in May
1998, we have completed over twenty inspections under authority of
Sec. 194.8. We also have completed numerous other inspections of waste
characterization activities under authority of Secs. 194.21 and
194.24(h). We conducted the Sec. 194.8 inspections at Los Alamos
National Laboratory, Rocky Flats Environmental Technology Site, Idaho
National Engineering and Environmental Laboratory, the Nevada Test
Site, the Savannah River Site, and the Hanford Site. In addition, we
inspected the operation of the DOE Central Characterization Program
(CCP) at the Savannah River Site. We approved all of the programs we
inspected except for the Nevada Test Site. We also have observed DOE
audits at Lawrence Livermore Laboratory and Battelle Columbus
Laboratory for the purpose of learning about the system of waste
characterization controls those sites are developing.\10\
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\10\ EPA has prepared a document entitled ``Background
Information Document for Sec. 194.8(b) Modification'' (Air Docket
OAR-2002-0005-0001), which explains in more detail the technical
elements examined during waste characterization inspections,
summarizes EPA's inspection experiences to date, and presents
lessons learned. This document expands and complements this preamble
discussion for the proposed revisions to Sec. 194.8(b).
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Based on this experience, we have determined that the existing
provisions constrain EPA's ability to apply limited resources to a
burgeoning waste characterization program for maximum regulatory
benefit. Under the existing provisions, we must conduct a Sec. 194.8
inspection at a site if any of the following conditions is true: the
site has not previously been approved by EPA to ship waste; the site
seeks approval for one or more new waste streams that will be
characterized using approved processes; the site seeks approval for one
or more new waste streams that will be characterized using at least one
new or revised process; or the site seeks approval to introduce a new
or revised process to characterize one or more previously approved
waste streams.
DOE is currently engaged in waste characterization at five major
sites, and plans to begin operations at four or more additional sites
in the near future. The number of DOE sites that ultimately will ship
waste to the WIPP could grow to approximately two dozen. There are or
will be hundreds of waste streams at these sites, and the methods used
to characterize them will change as sites acquire new instruments and
techniques. Consequently, the expansion of DOE's national transuranic
waste shipment program could lead to an indefinite expansion of EPA's
inspection program. If EPA must complete a Sec. 194.8 inspection for
each
[[Page 51939]]
new waste stream, group of waste streams, or waste characterization
process, the demands of this inspection regime will overwhelm our
resources.
We believe that it is appropriate to amend the Compliance Criteria
to increase the flexibility of our waste characterization inspection
program. At present, the most restrictive factor in the existing
provisions is that Sec. 194.8(b) requires EPA to issue approvals that
are specific to individual waste streams or groups of waste streams.
Our experience with DOE's waste characterization activities since 1998
has shown that there are multiple factors that must be considered when
verifying technical adequacy, including but not limited to waste
groupings. Moreover, for purposes of waste characterization as required
under the Compliance Criteria, the applicable waste groupings at the
site are often of limited relevance. Typically, DOE TRU waste sites
define and delineate waste streams on the basis of factors related to
hazardous components of the waste, not radiological waste components.
Thus, while the waste stream groupings may have significant relevance
for RCRA purposes, they are often of less relevance for purposes of
waste characterization requirements conducted under authority of the
WIPP LWA.
In order to approve a site's waste characterization program, we
must be confident that the site is capable of identifying and reporting
waste components (particularly certain radioisotopes) identified in the
1998 Certification Decision as important to compliance (see Compliance
Application Review Document (CARD) 31, Air Docket A-93-02, Item V-B-2).
As DOE stated in Chapter 4 of the Compliance Certification Application
(Air Docket A-93-02, Item II-G-1), a combination of qualitative and
quantitative methods would be used to identify and report waste
components.
These methods are: acceptable knowledge, which provides information
about waste stream contents and the processes that generated the waste;
nondestructive examination of waste containers using radiographic
techniques, which provides qualitative estimates of physical waste
components; destructive and nondestructive examination of waste
containers using radioassay techniques, which was the only quantitative
means proposed by DOE to quantify radioisotopic components; destructive
(visual) examination of sampled containers to confirm the results of
radiography through direct observation and measurement; and data
reporting via the WIPP Waste Information System (WWIS). Confirmation of
data validity at various points is an integral part of these
processes.\11\ All of these technical processes constitute the ``system
of controls'' specified in Sec. 194.24(c)(4).
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\11\ For quality assurance purposes, we verify that data
validation occurs in accordance with site procedures, and that
properly qualified and independent QA personnel review the data.
This step takes place during a QA audit or inspection. For technical
purposes, we independently verify the quality of a sample of data.
This step takes place during a waste characterization inspection.
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The demonstrated effectiveness of a given element of the system of
controls may or may not be constrained by the specific features of a
waste stream. A TRU waste site's implementation of certain elements of
the system of controls, such as the WWIS, may not change at all from
one waste stream to the next. In contrast, which nondestructive assay
techniques may be effective for a given waste stream depends in part on
the physical form of the waste and the quality of the acceptable
knowledge for that waste.
The result most often has been that we have defined limitations on
approved waste streams based on the element of the system of controls
whose effectiveness is tied most closely to the characteristics of
individual waste streams, that is, nondestructive assay (NDA). We have
limited (or narrowed) our approvals to certain NDA equipment because
factors such as the calibration and physical location of an individual
instrument are important to the technical adequacy of the method, and
because instrument performance varies based on the radioisotopes in a
waste container. DOE may only ship waste streams characterized with
certain equipment; otherwise, EPA must conduct another Sec. 194.8
inspection to approve new equipment.
Our new approach to waste characterization inspections, with the
new tiering approach, will require DOE to report changes such as the
introduction of new nondestructive assay equipment, but will allow EPA
to determine whether an inspection is needed for the new equipment.
Under Tier 2, it is possible that a ``desktop'' review of procedures
and data packages will be sufficient to demonstrate the similarity of a
new process to an approved process. Alternatively, under Tier 1, EPA
will have flexibility to schedule an inspection whose scope covers
multiple processes and waste streams, etc. \12\
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\12\ Currently, EPA is able to conduct such a broad scope
inspection. However, new processes and/or waste streams must be
inspected under Sec. 194.8(b), and previously approved processes
and/or waste streams must be inspected under Secs. 194.21 and
194.24(h). Today's proposal would allow EPA to review new processes
and waste streams under Sec. 194.24(h) after a site has been
initially approved under Sec. 194.8(b).
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Ultimately, the critical factor in our decision making on the
initial approval is how effectively TRU waste sites set and enforce
appropriate limitations on the usage of certain techniques, and how
carefully they confirm and control the results of those techniques.
Issuance of our approval under Sec. 194.8(b) means that we have found
that the site developed appropriate procedures for waste
characterization processes; the site properly implemented those
procedures; and we are confident, based on our independent evaluation,
that the data reported to the WWIS are properly controlled.
We will continue to make this assessment during the initial
Sec. 194.8 inspection(s) at a site. Under the existing provisions,
introduction of any waste streams or processes outside the scope of the
initial approval necessitates potentially many more Sec. 194.8(b)
inspections. The changes that we are proposing today will not alter our
authority to limit the scope of any site approval. Rather, the changes
will enable EPA to determine independently whether a subsequent
inspection is appropriate, and when it should occur. We reserve the
authority to specify any appropriate limitations on the waste streams
that may be shipped and the processes that may be used to characterize
waste.
b. How can the public notice process for Sec. 194.8 inspections be
improved? Under the existing provisions, EPA must publish a notice in
the Federal Register announcing a scheduled inspection under authority
of Sec. 194.8(b)(2). In the same notice or a separate notice, we must
solicit public comment for at least thirty days on waste
characterization program plans and other documents relevant to the
inspection. DOE sends these plans and other documents to EPA and we
place copies in our public docket and supplemental dockets. After the
comment period has ended, we notify DOE by letter of our compliance
determination and place the resulting inspection reports in our dockets
(Sec. 194.8(b)(3)).
In our 1998 Certification Decision, we explained the rationale for
the process described in Sec. 194.8(b). In particular, we explained
that our compliance decision must be based on our independent
inspections of waste characterization processes. Inspections involve
review of many different documents, interviews with staff, and on-site
demonstrations, which are then summarized and made
[[Page 51940]]
public in our inspection reports [see, for example, EPA Air Docket A-
93-02, Item V-C-1, pp. 2-8 to 2-11 and 6-26]. We are not able to
provide all potentially relevant information in our dockets when we
open a public comment period. Under the existing provisions, we open
comment on the top-tier program plans that describe the fundamental
requirements for and organization of waste characterization activities
at a site, plus additional procedures if appropriate to the scope of
the inspection.
Such documents inform our preparation for an inspection and are
sufficient to allow the public to raise compliance concerns or
questions, or provide additional information to EPA, so that we are
aware of that information prior to reaching a compliance decision. We
refrain from reaching a final compliance decision until we have
reviewed and responded to public comment. Our inspection reports
reference the specific materials that we reviewed at the site and
contain objective evidence in support of our findings.
As mentioned above, we have completed a significant number of
inspections under authority of Sec. 194.8(b) since May 1998. We have
published a total of twenty-one Federal Register notices related to
those inspections. In response, we received only nine sets of comments,
which we believe to be low. Also, several comments consisted of
requests to extend a public comment period, which suggests there may be
a misunderstanding of the purpose of the comment period under current
procedures (that is, to comment on the waste characterization documents
in the docket and/or raise concerns to EPA). Specifically, at least one
of the requests argued that an extension was appropriate so that
information other than the waste characterization plans and procedures
could be docketed and reviewed by the public. Both of these factors
indicate that the existing provisions for public notice are not optimal
for either EPA or the public.
There is also evidence to suggest that the conditions that
necessitate additional Sec. 194.8 inspections at an approved site may
not be widely understood, even within the DOE transuranic waste
complex. The most serious example occurred in July 2001, when EPA
learned that waste was shipped from DOE's Idaho site (INEEL) and
disposed of in the WIPP despite having been assayed by equipment that
had not approved by EPA following inspection. INEEL had received our
approval to use certain waste characterization processes on certain
waste streams in 1999, but the equipment in question was not included
in the previous approval. During an inspection to investigate the
nonconformance, we learned that its cause was an isolated failure to
follow document control procedures. Nevertheless, our interviews with
site personnel and Carlsbad Field Office personnel revealed confusion
over whether a Sec. 194.8(b) inspection (including public notice) was
required for the new equipment (see Air Docket A-98-49, Item II-A1-28).
In response to these issues, the new public notice process that we
are proposing would change three key aspects. First, each site would be
inspected only once under Sec. 194.8(b), therefore only one comment
period would be opened for each site under Sec. 194.8. Second, EPA
would solicit comment not only on DOE documentation, but also on our
baseline inspection report(s) and proposed compliance decision for each
site. The comment period would begin after we have completed all
necessary inspections and assembled the inspection report(s). Third,
the inspection report resulting from a site's Sec. 194.8(b) baseline
inspection(s) would identify and explain EPA's tier assignments for DOE
reporting of changes to the approved waste characterization processes,
based on the conditions and maturity of the waste characterization
program particular to that site. This reporting would inform EPA that a
site has implemented or is considering changes to the approved waste
characterization processes. For those changes requiring EPA approval,
we would perform follow-up inspections prior to allowing changes in the
site's system of controls, or in the waste streams shipped from the
site. We believe that this approach is more straightforward than the
existing provisions and should serve to reduce any confusion about the
public notice process that may exist.
3. What Are the Costs, Risks, and Benefits of Compliance With the
Alternative Provisions?
Since 1998, we have conducted over twenty inspections under
Sec. 194.8(b), at an average cost of approximately $22,350 each (this
estimate includes contractor travel and technical support plus labor
and travel costs of EPA personnel). These inspections were conducted to
approve both new waste streams and new waste characterization processes
proposed by DOE. DOE has identified 569 different waste streams as
potentially eligible for disposal at the WIPP facility [Air Docket A-
93-02, Item II-G-1, Vol.s III-IV, Appendix BIR-Transuranic Baseline
Inventory Report]. If we were to continue to approve site waste
characterization activity on a waste stream basis, the costs and
logistics of our inspection schedule would rapidly become unmanageable.
DOE incurs costs as a result of being inspected by EPA. Operations
may be interrupted to some extent while key personnel respond to the
inquiries of inspectors and operators respond to EPA's requirements for
testing of equipment. The additional reporting requirements introduced
by the proposed new provisions also represent costs to DOE. However, we
do not anticipate that the long-term costs to DOE due to the proposed
new provisions will be greater than at present.
The risk associated with the proposed new provisions is the same as
that which exists for the existing provisions. There is always a
possibility that a compliance issue may continue undetected by EPA for
a period of time, leading to the improper placement of waste in the
repository. With regard to this possibility, we note several important
considerations. First, EPA will maintain a rigorous inspection program
for WIPP waste characterization activities. Second, DOE is required to
maintain an active quality assurance program that audits waste
characterization programs on an annual basis for compliance with
applicable regulatory requirements. Last, as the operator of the WIPP,
DOE is responsible for maintaining the quality of waste
characterization programs. As a regulator of the WIPP, EPA's role is to
verify independently that DOE is adequately maintaining quality. The
combination of DOE's internal quality assurance audits and EPA's
independent regulatory inspections has proven able to identify
compliance issues and correct them. Therefore, we conclude that the
proposed new provisions do not carry greater risks for compliance with
the disposal regulations than the existing provisions.
The benefits of the new provisions were described in the preceding
section. We expect site shipment activity to increase as approved waste
generator sites incorporate new waste streams to their current
characterization activities and new waste generator sites seek EPA
approval for their shipments for the first time. Under the proposed new
provisions, EPA will have more control over our inspection schedule,
which will enable us to manage limited resources for maximum regulatory
benefit. The proposed changes will not alter EPA's technical approach
to
[[Page 51941]]
inspections of the waste characterization capabilities at DOE waste
generator sites. Inspections will continue to involve in-depth
interviews of personnel, careful reviews of analytical procedures, and
demonstrations of waste characterization techniques and equipment. We
will approve only sites that can effectively characterize wastes
destined for disposal at the WIPP. Once those sites are approved, we
will continue to oversee their programs through ongoing inspections.
Additionally, we expect that the changes to the public notice
process that we are proposing will make the comment period for
inspections more relevant. The public will now have an opportunity to
review and comment on EPA's proposed decisions and inspection reports
prior to site approvals.
Finally, the new provisions will be beneficial to DOE because
reporting requirements for DOE will be established on a site-by-site
basis. It will be clearer to the sites when a particular change in
their activities will trigger review, inspection, or approval on EPA's
part. Also, DOE will be able to implement changes in the Tier 2
elements of their waste characterization activities without prior
approval. Sites with more effective waste characterization programs,
including sites that successfully demonstrate the applicability of
waste characterization controls to the broadest possible spectrum of
waste at the time of EPA's inspection, are likely to have more
activities listed in Tier 2 than sites with less effective programs.
V. How Is EPA Revising the Submission of Compliance Applications
and Reference Materials Requirements in Secs. 194.12 and 194.13?
A. What Are the Current Requirements in Secs. 194.12 and 194.13?
Section 194.12 of the Compliance Criteria requires DOE to submit 30
copies of the compliance applications and any accompanying materials to
the Administrator in printed form. This provision also applies to the
compliance applications periodically submitted by DOE for re-
certification of compliance.
Section 194.13 requires that 10 printed copies of referenced
materials be submitted to the Administrator, unless such materials are
generally available.
B. What Are the Proposed Changes to Secs. 194.12 and 194.13?
EPA proposes to revise Sec. 194.12 by changing the number of copies
of compliance applications in printed form from 30 to 5 (one original
and four printed copies). In addition, the Agency is revising
Sec. 194.12 to require that DOE submit 10 complete compliance
applications in alternative format (e.g., compact disk) or other
approved format.
Also, the Agency is proposing to revise Sec. 194.13 by changing the
number of copies in printed form of the reference materials from 10 to
5 and to require DOE to submit 10 copies of reference materials in
alternative format (e.g., compact disk) or other approved format.
C. How Has EPA Addressed the Alternative Provision Analysis Required by
Sec. 194.6?
The proposed changes to Secs. 194.12 and 194.13 are intended to
minimize the number of copies in printed form that need to be submitted
and to allow for the submission of compliance applications and
reference materials in alternative format (e.g., compact disk). The use
of alternative format will facilitate compliance with 40 CFR part 194
requirements because it will expedite EPA's evaluation of the
compliance application and reduce costs associated with the review of
compliance applications and reference materials. Receipt of application
materials in alternative format will also improve information sharing
with the public by enabling the Agency to more easily make these
materials available via the Internet.
1. Why Do the Existing Provisions in Secs. 194.12 and 194.13 Appear
Inappropriate?
The existing provisions in Secs. 194.12 and 194.13 are
inappropriate because EPA does not need DOE to deliver 30 printed
copies of the complete compliance application, nor 10 printed copies of
all reference materials. In 1996, when the Compliance Criteria were
finalized, the Agency required that 30 copies of the compliance
application and 10 copies of the referenced material be submitted for
use in our review and evaluation activities. Printed form copies were
necessary because the Agency had a limited time period for review and
the complexity of the application material required many reviewers.
Also, EPA placed copies of these documents in various public dockets.
EPA's requirements for the submission of compliance applications
and reference materials have changed since the promulgation of the
Compliance Criteria in 1996. If material is submitted in alternative
format (e.g., compact disk) or other approved format instead of printed
matter, it is only necessary to have 5 printed copies of the compliance
application and 5 printed copies of the reference materials not
included in previous compliance applications (provided that the
information has remained true and accurate) for our four public dockets
(including an official copy for EPA).
New advances in information management require the use of new
submission methods, such as the use of alternative format (e.g.,
compact disk). Information and data in alternative format are easier to
view, share, navigate, and analyze. However, current regulatory
language in Secs. 194.12 and 194.13 does not allow for the submission
of compliance applications and reference materials in alternative
format. Therefore, today's action proposes to revise the regulatory
language in these sections to require alternative format (or other
approved format) submission of both compliance application (also re-
certification applications) and reference materials.
2. How Do the Proposed Changes in Secs. 194.12 and 194.13 Comport With
40 CFR Part 191?
The proposed changes to Secs. 194.12 and 193.13 comport fully with
the radioactive waste disposal regulations at 40 CFR part 191. The
inclusion of submission requirements for compliance applications and
reference materials in order to implement the disposal regulations was
established by the rulemaking that resulted in the WIPP Compliance
Criteria at 40 CFR part 194. Today's proposed changes do not alter the
scope of those requirements. The Compliance Criteria would continue to
apply submission requirements to the WIPP project. The principle
differences between the existing and proposed new provisions are that
the number of printed copies to be submitted to EPA has been reduced
considerably and alternative format (or other approved format)
submission of compliance applications and reference materials is now
required. The proposed revisions to this part do not impact the
Compliance Criteria's implementation of 40 CFR part 191.
3. What Are the Costs, Risks, and Benefits of Compliance With the New
Provisions in Secs. 194.12 and 194.13?
Sections 194.12 and 194.13 require DOE to submit a specified number
of copies in printed form of the compliance application and reference
materials. This provision also applies to the compliance applications
periodically submitted by DOE for recertification of compliance. The
[[Page 51942]]
proposed revisions reduce the number of copies required and requires
submission of compliance applications and references in alternative
format (or other approved format). We do not anticipate any cost
increase related to our implementation of the changes to Secs. 194.12
and 194.13. These changes will improve our ability to view, share,
navigate, print, and analyze submitted materials. We expect to be able
to conduct our review of compliance applications in a more efficient
and cost effective manner. Also, the implementation of these changes
will facilitate our ability to share information with the public in a
more timely fashion. As we received information and data in alternative
format, it would be easier to post this information in our webpage.
Similarly, we do not anticipate that DOE will experience any cost
increase as a result of their compliance activities with this part
because the technology to produce alternative format submittals exists
and is currently in use.
We do not anticipate any significant risks related to the
implementation of the proposed revisions to this part. Submission of
information and data in other than paper form is a widely accepted
process that will ease the transfer of information between DOE and EPA
and therefore, improve compliance with 40 CFR part 194.
In summary, the benefits of the proposed revisions for Secs. 194.12
and 194.13 are several. First the Agency will benefit from an improved
evaluation process and reduced costs associated with the review of
compliance applications and reference materials. Second, the public
will be able to have better and faster access to information used in
support of WIPP compliance activities. This change will improve the
public's ability to participate more actively in the public comment
process. Third, the proposed changes to Secs. 194.12 and 194.13 are
intended to reduce the number of copies in printed form that must be
submitted, thereby reducing paper usage.
VI. How Is EPA Revising the Waste Characterization Requirements in
Sec. 194.24(c)(3)?
A. What Are the Current Waste Characterization Requirements in
Sec. 194.24(c)(3)?
Section 194.24, waste characterization, generally requires DOE to
identify, quantify, and track the chemical, physical, and radiological
components of the waste destined for disposal at WIPP that may
influence disposal system performance. Section 194.24(c)(3) requires
DOE to demonstrate that the use of process knowledge to quantify waste
components conforms with the quality assurance (QA) requirements
outlined in Sec. 194.22. To demonstrate compliance DOE must have
information and documentation to substantiate that process knowledge
data acquired and used during waste characterization activities are in
compliance with the QA requirements. EPA verifies compliance with this
requirement through inspections, where EPA conducts proper review of
such information to determine whether use of process knowledge data is
appropriate and reliable.
B. What Are the Proposed Changes to Sec. 194.24(c)(3)?
The Agency is proposing to revise Sec. 194.24(c)(3) by replacing
the term ``process knowledge'' with the term ``acceptable knowledge.''
The term ``acceptable knowledge'' has been the term used by EPA and DOE
since DOE submitted the Compliance Certification Application, during
both the certification rulemaking and subsequent site inspections. Use
of the term ``acceptable knowledge'' in Sec. 194.24(c)(3) in lieu of
``process knowledge'' will not alter our technical approach to
verifying compliance during an inspection; rather, it will reflect our
actual practice more accurately.
For consistency with the change being proposed today for
Sec. 194.24(c)(3), the Agency is also proposing to add the following
definition of ``acceptable knowledge'' to Sec. 194.2: ``Acceptable
knowledge means any information about the process used to generate
waste, material inputs to the process, and the time period during which
the waste was generated, as well as data resulting from the analysis of
waste conducted prior to or separate from the waste certification
process authorized by EPA's Certification Decision, to show compliance
with Condition 3 of the certification decision (40 CFR part 194,
Appendix A).'' \13\
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\13\ This definition is consistent with EPA's and DOE's use of
the term ``acceptable knowledge'' during the WIPP certification
rulemaking. See, for example: Air Docket A-93-02, Item II-G-1, page
4-45; Item V-B-2, Compliance Application Review Document (CARD) 24,
page 24-1; and 63 FR 27390, footnote 32.
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Section 194.2 is contained in Subpart A (General Provisions) of the
rule, which describes the purpose and scope of the regulation,
clarifies terms, specifies dates, and imparts a range of administrative
information. Section 194.2 focuses on providing an explanation of all
terms and abbreviations contained in 40 CFR part 194 for clarification
purposes.
C. How Has EPA Addressed the Alternative Provision Analysis Required by
Sec. 194.6?
The proposed changes for both Secs. 194.2 and 194.24(c)(3) are
intended to clarify exactly what information EPA requires from DOE. EPA
expects that with these changes, acceptable knowledge (AK) will be more
clearly identified as an integral part of the system of controls for
waste characterization and will require DOE to provide information
about the entire system of controls (including AK) and implement the
systems at each site. Again, these proposed changes in terminology do
not alter our technical approach to verifying compliance during an
inspection, but will reflect our actual practice more accurately.
1. Why Do the Existing Provisions in Sec. 194.24(c)(3) Appear
Inappropriate?
We do not consider the existing provisions in Sec. 194.24(c)(3) to
be fully inappropriate because process knowledge remains a crucial
component of the waste characterization system of controls. However,
the Agency seeks to improve communication with DOE and the public and
the use of consistent and clear language is an important factor towards
meeting that goal. Section 194.24(c)(3) is used to verify compliance in
the collection and appropriate use of process knowledge during waste
characterization, and that the procedures adhere to the quality
assurance requirements identified in Sec. 194.22. During the EPA
inspection of a TRU waste site, we review the establishment and
implementation of procedures for collection and use of process
knowledge, demonstration of waste characterization processes, and the
qualifications and practices of technical personnel.
The term ``process knowledge,'' as currently used by EPA in the
Compliance Criteria, incorporates information about the process or
operation that led to the creation of the transuranic waste.\14\ The
term ``acceptable knowledge'' includes process knowledge, any data
resulting from analysis of waste prior to WIPP waste characterization,
and any other information about the physical form of
[[Page 51943]]
the waste and its base components. The two terms are related; process
knowledge is a subset of acceptable knowledge.
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\14\ Examples of processes or operations that create transuranic
waste are molding of plutonium with crucibles, laboratory analysis
of radioactive samples, and chemical separation of plutonium from
other materials. The number and types of processes in use at a DOE
site depends on the nature and complexity of the site's mission.
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In Chapter 4 of the Compliance Certification Application, DOE used
the term ``acceptable knowledge'' and explained that this term
incorporates ``information regarding the physical form of the waste,
the base materials composing the waste, and the process that generates
the waste.'' DOE derived this usage from an EPA document entitled,
``Waste Analysis at Facilities that Generate, Treat, Store, and Dispose
of Hazardous Waste: A Guidance Manual (EPA530-R-94-024, April 1994.''
This guidance defines AK broadly as including process knowledge, waste
analysis data from waste generators, and records of analysis performed.
A hazardous waste treatment, storage, and disposal facility when
accepting hazardous waste for management may test waste to confirm that
the hazardous waste determination done by a generator is accurate and
the facility indeed can handle that particular waste type. The
referenced guidance document applies specifically to compliance with
the Resource Conservation and Recovery Act; however, its definition of
AK is consistent with the definition that we are proposing for use in
the WIPP Compliance Criteria.
It is important that both EPA and DOE have the same understanding
on the terminology applicable to the requirements in Sec. 194.24(c)(3).
The use of the term ``process knowledge'' in the Compliance Criteria to
date has not interfered with DOE's compliance with the terms and
conditions of the certification. However, EPA seeks to avoid the
possibility for miscommunication now or in the future.
2. How Do the Proposed Changes in Sec. 194.24(c)(3) Comport With 40 CFR
part 191?
The proposed changes to Sec. 194.24(c)(3) comport fully with the
radioactive waste disposal regulations at 40 CFR part 191. The
inclusion of requirements for waste characterization requirements in
order to implement the disposal regulations was established by the
rulemaking that resulted in the WIPP Compliance Criteria at 40 CFR part
194. Today's proposed changes do not alter the scope of those
requirements. The Compliance Criteria would continue to apply waste
characterization requirements to the WIPP project. The principle
difference between the existing and proposed new provisions is the
replacement of the term process knowledge with acceptable knowledge.
The use of the new term would not substantively affect the Compliance
Criteria's implementation of 40 CFR part 191.
3. What Are the Costs, Risks, and Benefits of Compliance with the New
Provisions in Sec. 194.24(c)(3)?
We do not anticipate any cost increase related to our
implementation of the changes to Sec. 194.24(c)(3). EPA will continue
to conduct waste characterization oversight in the same manner as
before. Similarly, we do not anticipate that DOE will experience any
cost increase as a result of their compliance activities with this
part. Essentially, DOE will continue to comply with the requirement of
this part as they previously have.
We do not anticipate any risks related to the implementation of the
proposed revisions to this part. The Agency anticipates that the use of
the term acceptable knowledge will serve to enhance communication with
the regulated party and therefore, compliance with 40 CFR part 194.
The benefits of the proposed revisions for Sec. 194.24(c)(3) are
two-fold. First, the proposed changes will not affect the actual
technical approach to verifying compliance during our independent
audits and inspections of the relevant WIPP activities. Therefore, EPA
will continue to enforce the waste characterization requirements in the
Compliance Criteria and ensure that DOE's waste characterization
programs are properly implemented. Second, the clarification of the
applicable terminology will ensure that no confusion arises regarding
the specific waste characterization information required for
compliance.
VII. Administrative Requirements
A. Executive Order 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 legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. Pursuant to the terms
of Executive Order 12866, it has been determined that this rule is not
a ``significant regulatory action.''
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') generally requires an
agency to conduct a regulatory flexibility analysis of any rule subject
to notice and comment rulemaking requirements unless the agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. This proposed rule will not have a significant impact on
a substantial number of small entities because it sets forth
requirements which apply only to Federal agencies. Therefore, I certify
that this action will not have a significant economic impact on a
substantial number of small entities.
C. Paperwork Reduction Act
This proposed action does not impose an information collection
burden under the provisions of the Paper Reduction Act, 44 U.S.C. 3501
et seq. The Compliance Criteria in 40 CFR part 194 requirements are
applicable only to both DOE and EPA and do not establish any form of
collection of information from the public.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (``UMRA''),
Public Law 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. Pursuant to Title II of the
UMRA, we have determined that this regulatory action is not subject to
the requirements of sections 202 and 205, because this action does not
contain any ``federal mandates'' for State, local, or tribal
governments or for the private sector. This rule applies only to
Federal agencies.
E. Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations,'' the Agency has considered
environmental justice
[[Page 51944]]
related issues with regard to the potential impacts of this action on
the environmental and health conditions in low-income, minority, and
native American communities. We have complied with this mandate.
However, the requirements specifically set forth by the Congress in the
Waste Isolation Pilot Plant Land Withdrawal Act (Pub. L. 102-579),
which prescribes EPA's role at the WIPP, did not provide authority for
EPA to examine impacts in the communities in which wastes are produced,
stored, and transported, and Congress did not delegate to EPA the
authority to consider the issue of alternative locations for the WIPP.
During the development of the existing provisions in 40 CFR part
194, the EPA involved minority and low-income populations early in the
rulemaking process. In 1993, EPA representatives met with New Mexico
residents and government officials to identify the key issues that
concern them, the types of information they wanted from EPA, and the
best ways to communicate with different sectors of the New Mexico
public. The feedback provided by this group of citizens formed the
basis for EPA's WIPP communications and consultation plan. To help
citizens (including a significant Hispanic population in Carlsbad and
the nearby Mescalero Indian Reservation) stay abreast of EPA's WIPP-
related activities, the Agency developed many informational products
and services. The EPA translated into Spanish several documents
regarding WIPP, including educational materials and fact sheets
describing EPA's WIPP oversight role and the radioactive waste disposal
standards. The EPA also established a toll-free WIPP Information Line,
recorded in both English and Spanish, providing the latest information
on upcoming public meetings, publications, and other WIPP-related
activities. The EPA also developed a mailing list, which includes many
low-income, minority, and native American groups, to systematically
provide interested parties with copies of EPA's public information
documents and other materials. Even after the final rule, in 1998, EPA
has continued to implement outreach services to all WIPP communities
based on the needs determined during the certification.
This proposed action does not add or delete any certification
criteria. The proposal would revise the public notice process for the
approval of waste characterization activities at DOE waste generator
sites, which produce and store wastes destined for disposal at WIPP.
Affected communities and the public in general would have the
opportunity to comment on EPA's proposed waste generator site approval
decision. The existing provision does not offer such opportunity. The
proposed revision makes the public comment period more meaningful to
all communities. The Agency also intends to continue its outreach
activities to make information on waste characterization activities
more accessible by using the Internet, EPA information line, and fact
sheets.
F. National Technology Transfer & Advancement Act of 1995
Section 12 of the National Technology Transfer & Advancement Act of
1995 is intended to avoid ``re-inventing the wheel.'' It aims to reduce
costs to the private and public sectors by requiring federal agencies
to draw upon any existing, suitable technical standards used in
commerce or industry. To comply with the Act, EPA must consider and use
``voluntary consensus standards,'' if available and applicable, when
implementing policies and programs, unless doing so would be
``inconsistent with applicable law or otherwise impractical.'' We have
determined that this regulatory action is not subject to the
requirements of National Technology Transfer & Advancement Act of 1995
as this rulemaking is not setting any technical standards.
G. Executive Order 13045: Children's Health Protection
This rule is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it does not involve
decisions on environmental health risks or safety risks that may
disproportionately affect children.
H. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed action revises
specific portions of the Compliance Criteria in 40 CFR part 194. These
criteria are applicable only to both DOE (operator) and EPA (regulator)
of the WIPP disposal facility. Thus, Executive Order 13132 does not
apply to this rule.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.
I. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175. This
proposed action revises specific portions of the Compliance Criteria in
40 CFR part 194. The Compliance Criteria are applicable only to Federal
agencies. Thus, Executive Order 13175 does not apply to this rule.
In the spirit of Executive Order 13175, and consistent with EPA
policy to promote consultation and coordination with Indian Tribal
Governments, EPA specifically solicits comment on this proposed rule
from Tribal officials.
J. Executive Order 13211: Energy Effects
This proposed rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it
is not a significant regulatory action under Executive Order 12866.
List of Subjects in 40 CFR Part 194
Environmental protection, Administrative practice and procedure,
Nuclear materials, Radionuclides, Plutonium, Radiation Protection,
Uranium, Transuranics, Waste Treatment and Disposal.
[[Page 51945]]
Dated: July 30, 2002.
Christine Todd Whitman,
Administrator.
For the reasons set out in the preamble, 40 CFR Part 194 is
proposed to be amended as follows.
PART 194--CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF
THE WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART
191 DISPOSAL REGULATIONS
1. The authority citation for Part 194 continues to read as
follows:
Authority: Pub. L. 102-579, 106 Stat. 4777, as amended by Public
Law 104-201, 110 Stat. 2422; Reorganization Plan No.3 of 1970, 35 FR
15623, Oct. 6, 1970, 5 U.S.C. app. 1; Atomic Energy Act of 1954, as
amended, 42 U.S.C. 2011-2296 and 10101-10270.
2. Section 194.2, is amended by adding definitions in alphabetical
order for ``acceptable knowledge'' and ``minor alternative provision''
to read as follows:
Sec. 194.2 Definitions.
* * * * *
Acceptable knowledge means any information about the process used
to generate waste, material inputs to the process, and the time period
during which the waste was generated, as well as data resulting from
the analysis of waste, conducted prior to or separate from the waste
certification process authorized by EPA's Certification Decision, to
show compliance with Condition 3 of the certification decision
(Appendix A of this part).
* * * * *
Minor alternative provision means an alternative provision to the
Compliance Criteria that clarifies a regulatory provision, or does not
substantively alter the existing regulatory requirements.
* * * * *
3. Section 194.6 is revised to read as follows:
Sec. 194.6 Alternative provisions.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute
for any of the provisions of this part alternative provisions, or minor
alternative provisions, in accordance with the following procedures:
(a) Alternative provisions may be substituted after:
(1) Alternative provisions have been proposed for public comment in
the Federal Register together with information describing how the
alternative provisions comport with the disposal regulations, the
reasons why the existing provisions of this part appear inappropriate,
and the costs, risks and benefits of compliance in accordance with the
alternative provisions;
(2) A public comment period of at least 120 days has been completed
and public hearings have been held in New Mexico;
(3) The public comments received have been fully considered; and
(4) A notice of final rulemaking is published in the Federal
Register.
(b) Minor alternative provisions may be substituted after:
(1) The minor alternative provisions have been proposed for public
comment in the Federal Register together with information describing
how they comport with the disposal regulations, the reasons why the
existing provisions of this part appear inappropriate, and the benefit
of compliance in accordance with the minor alternative provision;
(2) A public comment period of at least 30 days has been completed
for the minor alternative provisions and the public comments received
have been fully considered;
(3) A notice of final rulemaking is published in the Federal
Register for the minor alternative provisions.
4. Section 194.8 is amended by revising paragraph (b) to read as
follows:
Sec. 194.8 Approval process for waste shipment from waste generator
sites for disposal at the WIPP.
* * * * *
(b) Waste Characterization Programs at Transuranic Waste Sites. The
Agency will establish compliance with Condition 3 of the certification
using the following process.
(1) DOE will implement waste characterization programs and
processes in accordance with Sec. 194.24(c)(4) to confirm that the
total amount of each waste component that will be emplaced in the
disposal system will not exceed the upper limiting value or fall below
the lower limiting value described in the introductory text of
paragraph (c) of Sec. 194.24. Waste characterization processes will
include the collection and use of acceptable knowledge; destructive
and/or nondestructive techniques for identifying and measuring waste
components; and the validation, control, and transmittal to the WIPP
Waste Information System database of waste characterization data, in
accordance with Sec. 194.24(c)(4).
(2) The Agency will verify the compliance of waste characterization
programs and processes identified in paragraph (b)(1) of this section
using the following process.
(i) DOE will notify EPA by letter that a transuranic waste site is
prepared to ship waste to the WIPP and has established adequate waste
characterization processes and programs. DOE also will provide the
relevant waste characterization program plans and documentation. EPA
may request additional information from DOE.
(ii) EPA will conduct a baseline inspection at the site to verify
that adequate waste characterization program plans and technical
procedures have been established, and that those plans and procedures
are effectively implemented. The inspection will include a
demonstration or test by the site of the waste characterization
processes identified in paragraph (b)(1) of this section. If an
inspection does not lead to approval, we will a send an inspection
report to DOE identifying deficiencies and place the report in the
public docket described in Sec. 194.67. More than one inspection may be
necessary to resolve compliance issues.
(iii) The Agency will announce in the Federal Register a proposed
Baseline Compliance Decision to accept the site's compliance with
Sec. 194.24(c)(4). In the notice, we will solicit public comment on the
relevant inspection report(s) and any supporting materials, which will
be placed in the public docket described in Sec. 194.67. The proposal
will describe any limitations on approved waste streams or waste
characterization processes and identify (through tier designations)
what changes to the approved waste characterization processes must be
reported to and approved by EPA before they can be implemented.
(iv) Our written decision regarding compliance with the
requirements for waste characterization programs and processes
described in paragraph (b)(1) of this section will be conveyed in a
letter from the Administrator's authorized representative to DOE. EPA
will not issue a compliance decision until after the end of the public
comment period described in paragraph (b)(2)(iii) of this section.
EPA's compliance decision will respond to significant and timely
received comments. A copy of our compliance decision will be placed in
the public docket described in Sec. 194.67. DOE will comply with any
requirements identified in the compliance decision and the accompanying
inspection report.
(3) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iv) of this section, the Agency intends
to conduct inspections, in accordance with Sec. 194.24(h), to confirm
the continued compliance of approved waste characterization programs
and processes
[[Page 51946]]
at transuranic waste sites. EPA will make the results of these
inspections available to the public in the dockets described in
Sec. 194.67.
(i) If the Agency determines, at a subsequent inspection of an
approved transuranic waste site, that waste characterization programs
or processes are not adequately established or implemented, then we may
suspend shipments and disposal of affected and potentially affected
waste streams, or take other action in accordance with Sec. 194.4(b)(1)
and (2), until we determine that the deficiencies have been adequately
resolved.
(ii) [Reserved]
5. Section 194.12 is revised to read as follows:
Sec. 194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of any compliance
application(s), any accompanying materials, and any amendments thereto
shall be submitted in a printed form to the Administrator's authorized
representative. In addition, DOE shall submit 10 copies of the complete
application in alternative format (e.g., compact disk) or other
approved format, as specified by the Administrator's authorized
representative.
6. Section 194.13 is revised to read as follows:
Sec. 194.13 Submission of reference materials.
Information may be included by reference into compliance
applications(s), provided that the references are clear specific and
that unless, otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of reference
information are submitted to the Administrator's authorized
representative. Reference materials that are widely available in
standard text books or reference books need not to be submitted.
Whenever possible, DOE shall submit 10 copies of reference materials in
alternative format (e.g., compact disk) or other approved format, as
specified by the Administrator's authorized representative.
7. Section 194.24 is amended by revising paragraph (c)(3) to read
as follows:
Sec. 194.24 Waste characterization.
* * * * *
(c) * * * (3) Provide information that demonstrates that the use of
acceptable knowledge to quantify components in waste for disposal
conforms with the quality assurance requirements of Sec. 194.22.
* * * * *
[FR Doc. 02-19796 Filed 8-8-02; 8:45 am]
BILLING CODE 6560-50-P