[Code of Federal Regulations]
[Title 40, Volume 24]
[Revised as of July 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR194.8]

[Page 41-44]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
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--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 194.8  Approval process for waste shipment from waste generator 
sites for disposal at the WIPP.

    (a) Quality Assurance Programs at Waste Generator Sites. The Agency 
will determine compliance with requirements for site-specific quality 
assurance programs as set forth below:
    (1) Upon submission by the Department of a site-specific quality 
assurance program plan the Agency will evaluate the plan to determine 
whether it establishes the applicable Nuclear Quality Assurance (NQA) 
requirements of Sec. 194.22(a)(1) for the items and activities of 
Sec. Sec. 194.22(a)(2)(i), 194.24(c)(3) and 194.24(c)(5). The program 
plan and other documentation submitted by the Department will be placed 
in the dockets described in Sec. 194.67.
    (2) The Agency will conduct a quality assurance audit or an 
inspection of a Department quality assurance audit at the relevant site 
for the purpose of verifying proper execution of the site-specific 
quality assurance program plan. The Agency will publish a notice in the 
Federal Register announcing a scheduled inspection or audit. In that or 
another notice, the Agency will also solicit public comment on the 
quality assurance program plan and appropriate Department documentation 
described in paragraph (a)(1) of this section. A public comment period 
of at least 30 days will be allowed.
    (3) The Agency's written decision regarding compliance with the 
requisite quality assurance requirements at a waste generator site will 
be conveyed in a letter from the Administrator's authorized 
representative to the Department. No such compliance determination shall 
be granted until after the end of the public comment period described in 
paragraph (a)(2) of this section. A copy of the Agency's compliance 
determination letter will be placed in the public dockets in accordance 
with Sec. 194.67. The results of any inspections or audits conducted by 
the Agency to evaluate the quality assurance programs described in 
paragraph (a)(1) of this section will also be placed in the dockets 
described in Sec. 194.67.
    (4) Subsequent to any positive determination of compliance as 
described in paragraph (a)(3) of this section, the Agency intends to 
conduct inspections, in accordance with Sec. Sec. 194.21 and 194.22(e), 
to confirm the continued compliance of the programs approved under 
paragraphs (a)(2) and (a)(3) of this section. The results of such 
inspections will be made available to the public through the Agency's 
public dockets, as described in Sec. 194.67.
    (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 Sec. 194.24(c). 
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 at 
sites without EPA approval prior to October 14, 2004, 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 compliance 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 send an

[[Page 42]]

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). We will place the inspection report(s) and any supporting 
documentation in the public docket described in Sec. 194.67. The site 
inspection report supporting the proposal will describe any limitations 
on approved waste streams or waste characterization processes. It will 
also identify (through tier designations in accordance with paragraph 
(b)(4) of this section) what changes to the approved waste 
characterization processes must be reported to and approved by EPA 
before they can be implemented. In the notice, we will solicit public 
comment (for a minimum of 45 days) on the proposed Baseline Compliance 
Decision, including any limitations and the tier designations for future 
changes or expansions to the site's waste characterization program.
    (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 at transuranic waste sites. EPA will make the results of these 
inspections available to the public in the dockets described in Sec. 
194.67.
    (4) Subsequent to any positive determination of compliance as 
described in paragraph (b)(2)(iv) of this section, the Department must 
report changes or expansions to the approved waste characterization 
program at a site in accordance with the tier designations established 
in the Baseline Compliance Decision.
    (i) For changes or expansions to the waste characterization program 
designated as ``Tier 1,'' the Department shall provide written 
notification to the Agency. The Department shall not ship for disposal 
at WIPP any waste that has been characterized using the new or revised 
processes, equipment, or waste streams until EPA has provided written 
approval of such new or revised systems.
    (ii) For changes or expansions to the waste characterization program 
designated as ``Tier 2,'' the Department shall provide written 
notification to the Agency. Waste characterized using the new or revised 
processes, equipment, or waste streams may be disposed at WIPP without 
written EPA approval.
    (iii) EPA may conduct inspections in accordance with Sec. 194.24(h) 
to evaluate the implementation of Tier 1 and Tier 2 changes or 
expansions to the waste characterization program at a site.
    (iv) Waste characterization program changes or expansions that are 
not identified as either ``Tier 1'' or ``Tier 2'' will not require 
written notification by the Department to the Agency before 
implementation or before shipping waste for disposal at WIPP.
    (5) Subsequent to any positive determination of compliance as 
described in paragraph (b)(2)(iii) of this section, EPA may revise the 
tier designations for approving changes or expansions to the waste 
characterization program at a site using the following process:
    (i) The Agency shall announce the proposed tier changes in a letter 
to the Department. The letter will describe the Agency's reasons for the 
proposed change in tier designation(s). The letter and any supporting 
inspection report(s) or other documentation will be placed in the 
dockets described in Sec. 194.67.

[[Page 43]]

    (ii) If the revised designation entails more stringent notification 
and approval requirements (e.g., from Tier 2 to Tier 1, or from 
undesignated to Tier 2), the change shall become effective immediately 
and the site shall operate under the more stringent requirements without 
delay.
    (iii) If the revised designated entails less stringent notification 
and approval requirements, (e.g., from Tier 1 to Tier 2, or from Tier 2 
to undesignated), EPA will solicit comments from the public for a 
minimum of 30 days. The site will continue to operate under the more 
stringent approval requirements until the public comment period is 
closed and EPA notifies DOE in writing of the Agency's final decision.
    (6) A waste generator site that EPA approved for characterizing and 
disposing transuranic waste at the WIPP under this section prior to 
October 14, 2004, may continue characterizing and disposing such waste 
at the WIPP under paragraph (c) of this section until EPA has conducted 
a baseline compliance inspection and provided a Baseline Compliance 
Decision under paragraph (b)(2) of this section.
    (i) Until EPA provides a Baseline Compliance Decision for such a 
site, EPA may approve additional transuranic waste streams for disposal 
at WIPP under the provisions of paragraph (c) of this section. Prior to 
the effective date of EPA's Baseline Compliance Decision for such a 
site, EPA will continue to conduct inspections of the site in accordance 
with Sec. 194.24(c).
    (ii) EPA shall conduct a baseline compliance inspection and issue a 
Baseline Compliance Decision for such previously approved sites in 
accordance with the provisions of paragraph (b) of this section, except 
that the site shall not be required to provide written notification of 
readiness as described in paragraph (b)(2)(i) of this section.
    (c) Waste characterization programs at waste generator sites with 
prior approval. For a waste generator site that EPA approved for 
characterizing and disposing transuranic waste at the WIPP under this 
section prior to October 14, 2004, the Agency will determine compliance 
with the requirements for use of process knowledge and a system of 
controls at waste generator sites as set in this paragraph (c). 
Approvals for a site to characterize and dispose of transuranic waste at 
WIPP will proceed according to this section only until EPA has conducted 
a baseline compliance inspection and provided a Baseline Compliance 
Decision for a site under paragraph (b)(2) of this section.
    (1) For each waste stream or group of waste streams at a site, the 
Department must:
    (i) Provide information on how process knowledge will be used for 
waste characterization of the waste stream(s) proposed for disposal at 
the WIPP; and
    (ii) Implement a system of controls at the site, 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 Sec. 194.24(c). The 
implementation of such a system of controls shall include a 
demonstration that the site has procedures in place for adding data to 
the WIPP Waste Information System (``WWIS''), and that such information 
can be transmitted from that site to the WWIS database; and a 
demonstration that measurement techniques and control methods can be 
implemented in accordance with Sec. 194.24(c)(4) for the waste 
stream(s) proposed for disposal at the WIPP.
    (2) The Agency will conduct an audit or an inspection of a 
Department audit for the purpose of evaluating the use of process 
knowledge and the implementation of a system of controls for each waste 
stream or group of waste streams at a waste generator site. The Agency 
will announce a scheduled inspection or audit by the Agency with a 
notice in the Federal Register. In that or another notice, the Agency 
will also solicit public comment on the relevant waste characterization 
program plans and Department documentation, which will be placed in the 
dockets described in Sec. 194.67. A public comment period of at least 
30 days will be allowed.
    (3) The Agency's written decision regarding compliance with the 
requirements for waste characterization programs described in paragraph 
(b)(1) of this section for one or more waste

[[Page 44]]

streams from a waste generator site will be conveyed in a letter from 
the Administrator's authorized representative to the Department. No such 
compliance determination shall be granted until after the end of the 
public comment period described in paragraph (b)(2) of this section. A 
copy of the Agency's compliance determination letter will be placed in 
the public dockets in accordance with Sec. 194.67. The results of any 
inspections or audits conducted by the Agency to evaluate the plans 
described in paragraph (b)(1) of this section will also be placed in the 
dockets described in Sec. 194.67.
    (4) Subsequent to any positive determination of compliance as 
described in paragraph (b)(3) of this section, the Agency intends to 
conduct inspections, in accordance with Sec. Sec. 194.21 and 194.24(h), 
to confirm the continued compliance of the programs approved under 
paragraphs (b)(2) and (b)(3) of this section. The results of such 
inspections will be made available to the public through the Agency's 
public dockets, as described in Sec. 194.67.

[63 FR 27404, May 18, 1998, as amended at 69 FR 42581, July 16, 2004]