Source: http://www.wipp.energy.gov/library/CRA/CRA-2014/CRA/Section_08/Section_08.htm
Timestamp: 2019-04-26 11:57:26+00:00

Document:
(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 § 194.22(a)(1) for the items and activities of §§ 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 § 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 § 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 § 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 §§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 § 194.67.
(1) DOE will implement waste characterization programs and processes in accordance with § 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 § 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 § 194.24(c)(4).
(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 inspection report to DOE identifying deficiencies and place the report in the public docket described in § 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 § 194.24(c)(4). We will place the inspection report(s) and any supporting documentation in the public docket described in § 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 § 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 § 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 § 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 § 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.
(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 § 194.67.
(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 § 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.
(ii) Implement a system of controls at the site, in accordance with § 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 § 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 § 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 § 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 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 § 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 § 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 §§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 § 194.67.
The requirements of 40 CFR § 194.8 (U.S. EPA 2004a) apply to the process used by the U.S. Environmental Protection Agency (EPA) to approve the shipment of transuranic (TRU) waste from U.S. Department of Energy (DOE) waste generator sites to the Waste Isolation Pilot Plant (WIPP) facility for disposal.
The requirements were established at the time of the EPA's 1998 Certification Decision to address compliance of site-specific quality assurance (QA) programs and a system of waste characterization and controls at waste generator sites.
In order to clarify its original intent for the compliance criteria regarding approval of site-specific activities, the EPA amended the compliance criteria at 40 CFR Part 194 to include the site-specific approval process (U.S. EPA 1998, pp. 27404-406). Appendix A of the EPA's Certification Decision contains the requirements for the approval process and four certification-related conditions. Two of the four conditions included in this appendix are related to QA and waste characterization. Condition 2 specifies that no waste generator site other than the Los Alamos National Laboratory (LANL) shall be allowed to ship waste for disposal at the WIPP until the EPA determines that the site has established and executed a QA program in accordance with 40 CFR §§ 194.22(a)(2)(i) (U.S. EPA 1996), 194.14(c)(3) (U.S. EPA 1996), and 194.24(c)(5) (U.S. EPA 2004a) for waste characterization activities and assumptions. Condition 3 specifies that no waste from any additional LANL waste streams (other than the ones already certified) or from any waste generator site other than LANL shall be shipped for disposal at the WIPP until the EPA has approved the process for characterizing those waste streams for shipment using the process set forth in section 194.8. The approval process includes an opportunity for public comment and an inspection (of a DOE audit) or audit of the waste generator site by the EPA. The procedures for demonstrating compliance with Conditions 2 and 3 of the EPA's 1998 Certification Decision were incorporated in the final rule as a new section to section 194.8, "Approval Process for Waste Shipment from Waste Generator Sites for Disposal at the WIPP."
For both QA and waste characterization programs, the approval process includes placement in the docket of site-specific documentation submitted by the DOE, publication of a Federal Register notice by the EPA announcing a scheduled inspection or audit, a period of at least 30 days for the public to comment on information placed in the docket, and the EPA's written decision regarding the approval of these programs in the form of a letter from the EPA to the DOE. The EPA proposed to approve QA programs on a site-wide basis and to approve waste characterization measures and controls on the basis of waste streams or, where multiple waste streams may be characterized by the same waste characterization processes and techniques, groups of waste streams.
A discussion of the requirements for section 194.8 was added to the Compliance Recertification Application of 2004 (CRA-2004) (U.S. DOE 2004, Chapter 4.0). The CRA-2004 notes, "based on EPA acceptance of the site-specific TRU waste characterization and QA program, the Carlsbad Field Office Manager is responsible for granting and revoking the program certification that allows the TRU waste site to characterize and to ship waste to WIPP," but also adds, "consistent with the provisions of section 194.8, EPA also has a role in the approval process. The EPA determines compliance with requirements for site-specific QA programs."
In addition to determining QA compliance, the EPA also approves relevant portions of the waste characterization programs at generator sites to ensure that the system of controls required to track important components is technically adequate.
The CRA-2004 noted that as of September 30, 2002, the following five sites had approved QA and waste characterization programs under section 194.8 requirements: Hanford-Richland (RL), the Idaho National Engineering and Environmental Laboratory (now called the Idaho National Laboratory [INL]), LANL, the Rocky Flats Environmental Technology Site (RFETS), and the Savannah River Site (SRS). Additionally, the DOE's Central Characterization Project (CCP) had been approved to characterize and ship waste from SRS, Argonne National Laboratory (ANL), and the Nevada Test Site (NTS).
The CRA-2004 did not identify instances where waste had been shipped to the WIPP facility from a generator site prior to approval of its waste characterization programs by the EPA before the CRA-2004 cutoff date of September 22, 2002. However, there were instances where waste was shipped before approval of instrumentation or techniques used to characterize that waste by the EPA Compliance Application Review Document (CARD) 8 (U.S. EPA 2006a). In these cases, the DOE discontinued shipment of the waste under investigation until the EPA completed its inspection and approval. The EPA received no public comments on the DOE's continued compliance with the approval process for waste shipment from waste generator sites for disposal at the WIPP facility.
Based on its review and evaluation of the CRA-2004, supplemental information provided by the DOE, and the EPA inspections and audits, the EPA determined that the DOE continued to comply at that time with the requirements of section 194.8 (U.S. EPA 2006b).
The TRU waste sites approved by the EPA to ship CH-TRU waste to the WIPP facility in accordance with the requirements of section 194.8 were RL, INL/CCP, the Advanced Mixed Waste Treatment Project (AMWTP), SRS/CCP, Oak Ridge National Laboratory (ORNL)/CCP (EPA-ORNL-CCP-CH-11.07-8) (U.S. EPA 2008a), and LANL/CCP.
The TRU waste sites identified in the CRA-2004 that had shipped CH-TRU waste to the WIPP facility but were not currently active were Lawrence Livermore National Laboratory (LLNL), NTS, ANL, and RFETS.
RFETS had completed shipping its TRU waste. LLNL was certified after the CRA-2004 was submitted (EPA-LANL-CCP-5.04-8) (U.S. EPA 2004b). Since the CRA-2004, TRU waste characterization at LANL, SRS, and INL that had previously been performed using site resources was being performed by CCP resources.
On March 26, 2004, the EPA announced its final decision (Marcinowski 2004) to approve the DOE's Remote-Handled TRU Waste Characterization Program Implementation Plan (U.S. DOE 2003a) and (U.S. DOE 2003b). The EPA stated that on-site inspections and approval of site-specific, remote-handled transuranic (RH-TRU) waste characterization programs will be conducted under the authority at section 194.8 or 40 CFR § 194.24, as appropriate. Table 8-1 lists all EPA inspections and tier evaluations at generator sites for the period between the CRA-2004 and CRA-2009.
The QA program was approved on December 20, 2006, and the characterization program was approved on January 16, 2007. As with INL/CCP, the baseline approval designated the initiation of the WWIS for RH-TRU waste as a Tier 1 change.
The EPA determined that the DOE continued to comply with the requirements of section 194.8 and there were no outstanding issues with the EPA related to section 194.8.
Detailed technical evaluation of the CRA-2009 (U.S. DOE 2009), Section 8, was provided in CARD 8 (U.S. EPA 2010a). The CRA-2009 did not identify instances where waste had been shipped to the WIPP facility from a generator site prior to approval of its waste characterization programs by the EPA before the CRA-2009 cutoff date of December 31, 2007. However, AMWTP and LANL shipped uncertified waste containers to the WIPP facility for disposal during 2007 and 2009, respectively. The QA Specialists at these sites identified errant drums of waste that were mistakenly sent to the WIPP facility. The DOE stopped all TRU waste shipments from these sites to the WIPP facility for disposal until the EPA completed its inspection and concurred with the DOE's decision to resume shipments. The issues associated with errors were ultimately resolved and corrective actions were taken to avoid future occurrences.
The EPA received no public comments on the DOE's continued compliance with the approval process for waste shipment from waste generator sites for disposal at the WIPP facility. Based on a review and evaluation of the CRA-2009, supplemental information provided by the DOE, and EPA inspections and audits, the EPA determined that the DOE continued to comply with the requirements of section 194.8 (U.S. EPA 2010b).
The TRU waste sites approved by the EPA to ship RH-TRU waste to the WIPP facility in accordance with the requirements of section 194.8 since the CRA-2009 are ANL/CCP, Bettis Atomic Power Laboratory (BAPL)/CCP, General Electric Vallecitos Nuclear Center (GEVNC)/CCP, INL/CCP, , ORNL/CCP, and SRS/CCP.Since the CRA-2009, suspension of RH-TRU waste characterization activities has occurred at BAPL/CCP, GEVNC/CCP, RL/CCP, and ORNL/CCP.
Table 8-2 summarizes the EPA waste characterization inspections and tier 1 evaluations at generator sites for the period since the CRA-2009.
Other EPA approvals, including Tier 1 and 2 changes, and other decisions since the CRA-2009 are summarized in Table 8-3.
The DOE continues to comply with the requirements of section 194.8 and there are no outstanding issues with the EPA related to section 194.8.

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