8.0 Approval Process for Waste Shipment From Waste Generator Sites for Disposal at the WIPP (40 CFR § 194.8)

8.1 Requirements

§ 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 § 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.

(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 § 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).

(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 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.

(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 § 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.

(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 § 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.

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

8.2 Background

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.

8.3 1998 Certification Decision

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.

8.4 Changes in the CRA-2004

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).

8.5 EPA's Evaluation of Compliance for the 2004 Recertification

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).

8.6 Changes or New Information Between the CRA-2004 and the CRA-2009 (Previously: Changes or New Information Since the 2004 Recertification)

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.

Table 8-1. EPA Activities Performed Between the CRA-2004 and CRA-2009 at TRU Waste Generator Sites

Site	Activity Performed	Date Performed	Results	References
LANL/CCP	Baseline Inspection	April 2004	Approval was granted in August 2004 for the CCP to characterize and ship CH-TRU waste from LANL	EPA-LANL-CCP-4.04.08 U.S. EPA 2004c
LANL/CCP	Baseline Inspection	February 2008	In February 2008, the EPA approved the baseline for RH-TRU Waste Characterization for LANL/CCP	EPA-LANL-CCP-RH-05.07-8 U.S. EPA 2008d
INL/CCP	Baseline Inspection and QA Audit	May 2005	Approval was granted on November 1, 2005, for the CCP to characterize and ship CH-TRU waste from INL	EPA-INL-CCP-05.05-08 U.S. EPA 2004d
	Baseline Inspection	June 2006 and August 2006	Approval of the characterization program was granted on January 12, 2007. The baseline approval designated the initiation of the WWIS for RH-TRU waste as a Tier 1 change	EPA-INL-CCP-RH-6.06-8 U.S. EPA 2007a
	Tier 1 Change Evaluation	January 2008	The EPA approved the Tier 1 change to add K-Cell waste to the RH-TRU Waste Certification for INL/CCP	U.S. EPA 2008b
	Baseline Inspection and QA Audit	May 2005	Approval was granted on November 1, 2005, for the CCP to characterize and ship CH-TRU waste from the INL	EPA-INL-CCP-05.05-08 U.S. EPA 2004d
INL/CCP and ANL/CCP	Inspection	November 2006	The WWIS system was determined to be adequate for RH-TRU waste characterized	Reyes 2007
ANL/CCP	Baseline Inspection and QA Audit	September 2006	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.	EPA-ANL-CCP-RH-09.06-08 Reyes 2006 and U.S. EPA 2007b
ANL/CCP	Tier 1 Change Evaluation	July 2008	The EPA approved the Tier 1 change to add newly packaged waste to the RH-TRU Waste Certification for ANL/CCP	U.S. EPA 2008c
SRS-Battelle Columbus Laboratory (BCL/CCP)	Baseline Inspection	July 2007	In August 2008, the EPA approved the baseline for RH-TRU Waste Characterization for BCL/CCP	EPA-SRS-CCP-RH-07.07-8 U.S. EPA 2008e
ORNL/CCP	Baseline Inspection	July 2008	On February 3, 2009, the EPA approved RH-TRU waste characterization for ORNL/CCP	EPA Docket No. A-98-49; II-A4-111

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.

8.7 EPA's Evaluation of Compliance for the 2009 Recertification

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).

8.8 Changes or New Information Since the CRA-2009

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 since the CRA-2009 are as follows: AMWTP, RL/CCP, INL/CCP, LANL/CCP, ORNL/CCP and SRS/CCP. Since the CRA-2009, suspension of CH-TRU waste characterization activities occurred at ORNL/CCP and RL/CCP

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.

Table 8-2. EPA Waste Characterization Inspections/Tier 1 Evaluations Conducted Since the CRA-2009 Application

Site	Inspection/Tier 1 Evaluation	Date Performed	Date Approved	EPA Docket
AMWTP	Tier 1 addition of BN-510 waste stream	March 2, 2010	June 10, 2010	EPA Docket No. A-98-49; II-14-127
	Continued Compliance Inspection	November 17-18, 2010	March 16, 2011	EPA Docket No. A-98-49; II-A4-143
	Continued Compliance Inspection	October 30 to November 1, 2012	Not yet received	Not yet received
ANL/CCP	Tier 1 RH Visual Examination (VE) newly packaged waste	May 28, 2008	July 10, 2008	EPA Docket No. A-98-49; II-A4-102
	Tier 1 addition of 30 containers to Argonne East Remote Handled Debris Mixed (AERHDM) waste stream	May 20-21, 2010	September 13, 2010	EPA Docket No. A-98-49; II-A4-132
	Tier 1 addition of 120 containers to AERHDM waste stream	June 29, 2010	September 28, 2010	EPA Docket No. A-98-49; II-A4-134
	Tier 1 addition of 30-gallon containers of fuel examination waste (FEW) to previously approved RH debris AERHDM waste stream	May 4 and 18, 2010	November 22, 2010	EPA Docket No. A-98-49; II-A4-140
	Tier 1 to add eight 55-gallon K-Wing FEW containers to RH debris waste stream AERHDM	September 2011	February13, 2012	EPA Docket No. A-98-49; II-A4-158
	Tier 1 to evaluate Radiation Characterization Approach of Solidified Liquid Waste from K-Wing, Building 205, 55-gallon	January 3, 2012	June 14, 2012	EPA Docket No. A-98-49; II-A4-162
	Tier 1 for debris from the Reduced Enrichment for Research and Test Reactors program and the second batch of FEW packaged in 30-gallon containers	February - June, 2012	October 4, 2012	EPA Docket No. A-98-49; II-A4-140
	Tier 1 of the Analytical Chemistry Lab (ACL)	July 31-August 1, 2012	September 4, 2012	EPA Docket No. A-98-49; II-A4-165
BAPL/CCP	Baseline Inspection	August 30, 2010, September 23, 2010, December 8, 2010, and April 12-13, 2011	July 28, 2011	EPA Docket No. A-98-49; II-A4-151
GEVNC/CCP	RH Initial Certification	December 2-4, 2008	August 26, 2009	EPA Docket No. A-98-49; II-A4-115
RL/CCP	CH Baseline Inspection	April 27-29, 2010	December 21, 2010	EPA Docket No. A-98-49; II-A4-138
INL/CCP	Tier 1 Waste Area Groups density range extension	June 9, 2008	October 7, 2008	EPA Docket No. A-98-49; II-A4-107
	Tier 1 addition of VE CH S5000 retrievably stored waste stream	December 9-11, 2008	March 4, 2009	EPA Docket No. A-98-49; II-A4-110
	Tier 1 addition of ID-HFEF-S5400-RH Lot 1A and ID-ANLE-S5000 waste streams	December 9-11, 2008	February 1, 2010	EPA Docket No. A-98-49; II-A4-122
	Tier 1 addition of ID-MFC-S5400-RH waste stream	April-May 2010	June 11, 2010	EPA Docket No. A-98-49; II-A4-126
	Tier 1 addition of ID-INTEC-RH waste stream	December 8-9, 2009, January 12-13, 2010, and February 17, 2010	August 17, 2010	EPA Docket No. A-98-49; II-A4-130
	Tier 1 addition of Osprey and ID-HFEF-S5400-RH Lot 1B waste streams	July 13, 2009, to June 2010	August 23, 2010	EPA Docket No. A-98-49; II-A4-131
	Tier 1 High Efficiency Neutron Counter (HENC) operating range extension	July 1, 2009	September 22, 2010	EPA Docket No. A-98-49; II-A4-119
	Tier 1 addition of ID-RTC-S3000 waste stream	September 22, 2009	November 1, 2010	EPA Docket No. A-98-49; II-A4-137
	Tier 1 addition of IN-ID-NRF-153 waste stream	August 9-10, 2010	November 1, 2010	EPA Docket No. A-98-49; II-A4-135
	Continued Compliance Inspection	November 16-17, 2010	March 16, 2011	EPA Docket No. A-98-49; II-A4-142
	Tier 1 to include RH waste stream IN-ID-NRF-SPC	October 4-5, 2011	March 12, 2012	EPA Docket No. A-98-49; II-A4-159
	Tier 1 to include Lot 2 waste ID-ANLE-S5000	May 8-9, 2012	July 25, 2012	EPA Docket No. A-98-49; II-A4-163
LANL/CCP	Initial RH Certification	May 8-10, 2007	February 19, 2008	EPA Docket No. A-98-49; II-A4-96
	Tier 1 HENC2 Report (Non-Approval)	May 25-26, 2010	November 8, 2010	EPA Docket No. A-98-49; II-A4-139
	LANL/CCP CH TRU Continued Compliance Inspection	May 25-26, 2010	February 9, 2011	EPA Docket No. A-98-49; II-A4-141
	CH Tier 1 request expanding the calibration range to the HENC2 to accommodate CH lead-lined 55-gallon drums	April 28, 2010	April 30, 2012	EPA docket No. A-98-49; II-A4-139
	CH Tier 1 request for calibration range extension for the Super High Efficiency Neutron Counter (SuperHENC) and the extendability for the HENC unit 1 to assay lead-lined 55-gallon drums containing solidified materials	June 20-21, 2012	August 14, 2012	EPA Docket No. A-98-49; II-A4-164
	Tier 1 approval to add Summary Category Group S4000	September - November, 2012	December 31, 2012	EPA Docket No. A-98-49; II-A4-168
ORNL/CCP	CH Baseline Inspection	November 2007	August 25, 2008	EPA Docket No. A-98-49; II-A4-103
	Tier 1 CH Calibration Extension for segmented gamma scanner	Unknown	October 8, 2008	EPA Docket No. A-98-49; II-A4-108
	Tier 1 CH Calibration Extension for Drum Waste Assay System Imaging Passive Active Neutron	November 17, 2008	January 8, 2009	EPA Docket No. A-98-49; II-A4-109
	RH Baseline Inspection	June 30-July 2, 2008	February 3, 2009	EPA Docket No. A-98-49; II-A4-111
	Tier 1 OR-REDC-RH-HET to include Solvent Extraction Test Facility Time Period (November 1978-November 1991) waste	May 6, 2009	November 30, 2009	EPA Docket No. A-98-49; II-A4-120
	Tier 1 addition of CH Summary Category Group S4000 waste	August 11-12, 2009	October 7, 2009	EPA Docket No. A-98-49; II-A4-117
	Tier 1 addition of CH VE and adding the IQ3	February 23-24, 2010	March 30, 2010	EPA Docket No. A-98-49; II-A4-125
	Tier 1 addition of RH Solvent Extraction Test Facility Pre-79 waste stream	February-March, 2010	April 21, 2010	EPA Docket No. A-98-49; II-A4-124
SNL/CCP	Tier 1 to include RH containers generated from waste groups PKE00027/54 and PKE00047 in existing waste stream SNL-HCF-S5400-RH	December 2011 to January 2012	March 28, 2012	EPA Docket No. A-98-49; II-A4-160
SRS/CCP	Tier 1 addition of SRS Battelle Columbus Laboratory waste stream SR-RL-BCLDP.001	July 17-19, 2007, July 31-August 2, 2007, and December 4-5, 2007	August 25, 2008	EPA Docket No. A-98-49; II-A4-104
	Tier 1 addition of Nondestructive Assay Box Counter (NABC)	March 24-26, 2009	August 4, 2009	EPA Docket No. A-98-49; II-A4-114
	Tier 1 addition of CH S3000 waste	September 30, 2010	March 23, 2010	EPA Docket No. A-98-49; II-A4-123
	Tier 1 addition of SR-BCLDP.001.001, SR-BCLDP.001.002, SR-BCLDP.002, SR-BCLDP.003, SR-BCLDP.004.002, SR-BCLDP.004.003 waste streams	November 2009 - March 2010	September 13, 2010	EPA Docket No. A-98-49; II-A4-129
	Tier 1 extension of calibration to the NABC	March 24-26, 2009	September 14, 2010	EPA Docket No. A-98-49; II-A4-133
	Tier 1 allowing use of American Society for Testing and Materials standard efficiency calibration method for NABC	May 12, 2011 timeframe	May 31, 2011	EPA Docket No. A-98-49; II-A4-148
	RH Baseline Inspection	July 26, 2011	April 18, 2012	EPA Docket No. A-98-49; II-A4-161
	Tier 1 request for using 5-foot setback configuration for the NABC	August 14-15, 2012	September 11, 2012	EPA Docket No. A-98-49; II-A4-166

Other EPA approvals, including Tier 1 and 2 changes, and other decisions since the CRA-2009 are summarized in Table 8-3.

Table 8-3. Other EPA Approvals and Decisions Since the CRA-2009 Application

Site	Implementing Document or Changed Activity	Description of Change (Approval Not Required for Tier 2)	Date Approved	EPA Docket
ANL/CCP	Tier 1 Request	Approval of request for the addition of the K-Wing solidified liquid waste to the RH waste stream AERHDM at ANL	June 14, 2012	EPA Docket No. A-98-49; II-A4-162
	Tier 1 Request	Approval of the RH AERHDM K-Wing FEW waste	February 13, 2012	EPA Docket No. A-98-49; II-A4-158
	Evaluation	Evaluation of the ACL located at ANL resulted in numerous technical deficiencies identified, and the EPA informed the DOE that no data generated by the ACL after July 31, 2012, can be used by ANL/CCP to characterize WIPP-destined TRU waste until deficiencies are addressed and ACL receives EPA approval	September 4, 2012	EPA Docket No. A-98-49; II-A4-165
	Tier 1 Request	Approval to add two RH debris types to the AERHDM waste stream	October 4, 2012	EPA Docket No. A-98-49; II-A4-167
RL/CCP	Tier 1 Request	Approval of waste stream RLCCPPUNIT	November 10, 2011	EPA Docket No. A-98-49; II-A4-154
INL/CCP		Confirmation that INL/CCP characterization of Small Quantity Site waste from Nuclear Radiation Development is consistent with the conditions and limitations set forth in the EPA's baseline approval and subsequent Tier 1 changes	January 4, 2012	EPA Docket No. A-98-49; II-A4-157
INL/CCP	Tier 1 Request	Approval for disposal at the WIPP of the "RH TRU" waste stream IN-ID-NRF-SPC	March 12, 2012	EPA Docket No. A-98-49; II-A4-159
	Tier 1 Request	Approval of Tier 1 request to add Lot 2 waste to the "RH TRU" waste stream ID-ANLE-S5000	July 25, 2012	EPA Docket No. A-98-49; II-A4-163
LANL/CCP	Tier 1 Request	Approval of two Tier 1 requests: (1) extension of the gamma density range of the HENC No. 1 non-destructive analysis, and (2) extension of the gamma density range of the SuperHENC	August 14, 2012	EPA Docket No. A-98-49; II-A4-164
LANL/CCP	Tier 1 Request	Approval of the addition of Summary Category Group S4000 to the baseline approval of LANL/CCP	December 31, 2012	EPA Docket No. A-98-49; II-A4-168
SNL/CCP	Baseline Inspection	Determination that the RH debris waste stream SNL-HCF-S5400-RH waste characterization program was adequate for: (1) the Acceptable Knowledge process for 19 containers of group PKE00044, and (2) the radiological characterization process in CCP-AK-SNL-501, revision 1	November 23, 2011	EPA Docket No. A-98-49; II-A4-155
SNL/CCP	Baseline Inspection	Approval to add containers generated from waste groups PKE00027/54 and PKE00047 to waste stream SNL-HCF-S5400-RH	March 28, 2012	EPA Docket No. A-98-49; II-A4-160
SRS/CCP	Tier 1 Request	Approval of request for a 5-foot setback configuration (55-gallon drums only) for the NABC	September 11, 2012	EPA Docket No. A-98-49; II-A4-166
AMWTP and CCP activities at ANL, RL, INL, LANL, ORNL and SRS	Fiscal Year (FY) 11 Quarterly Tier 2 reports, second quarter	Concurrence of FY11 second quarter Tier 2 changes at AMWTP and CCP	July 5, 2011	N/A
	FY11 Quarterly Tier 2 reports, third quarter	The EPA did not object to any of the Tier 2 changes for the third quarter of FY11	November 9, 2011	N/A
	FY12 Quarterly Tier 2 reports, first quarter	The EPA did not object to any of the Tier 2 changes for AMWTP and CCP reported for the first quarter of FY12	March 28, 2012	N/A
	FY12 Quarterly Tier 2 reports, second quarter	The EPA did not object to any of the Tier 2 changes reported for the second quarter of FY12	June 4, 2012	N/A
WIPP	Annual WIPP Inspection	Determination that WIPP activities related to emissions monitoring during waste management and storage, monitoring of the ten parameters for long-term containment and waste emplacement were adequate and compliant with 40 CFR Part 191, Subpart A and the 1998 Certification Decision	November 23, 2011	EPA Docket No. A-98-49; II-B3-116
WIPP	Planned Change Request, Planned Change Notice	Conditional approval of the shielded container planned change request for "RH TRU" waste inventory disposal	August 8, 2011	EPA Docket No. A-98-49, II-B3-117
CBFO	Quality Assurance Audit	EPA audits determined that the Carlsbad Field Office QA Program continues to be properly executed and did not find any nonconformance with NQA-1-1989	April 9, 2012	EPA Docket No. A-98-49; II-A1-110
CBFO	RH TRU Waste Characterization Program Implementation Plan	Approval of the "RH-TRU" Waste Characterization Program Implementation Plan, DOE/WIPP-02-3214, Revision 3, Draft E, with exceptions	September 4, 2012	Peak 2012

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.

8.9 References

(*Indicates a reference that has not been previously submitted.)

Marcinowski, F. 2004. Letter (with attachments) to R. Paul Detwiler. 26 March 2004. Washington, DC: U.S. Environmental Protection Agency, Office of Air and Radiation. [PDF / Author]

Peak, T. 2012. Letter to Jose R. Franco, Manager. 4 September 2012. Washington, DC: U.S. Environmental Protection Agency, Office of Air and Radiation.* [PDF / Author]

Reyes, J. 2006. Memorandum to Dr. David Moody, Manager. 20 December 2006. Washington, DC: U.S. Environmental Protection Agency, Office of Air and Radiation. [PDF / Author]

Reyes, J. 2007. Memorandum to David Moody, Ph.D., Manager. 17 January 2007. Washington, DC: U.S. Environmental Protection Agency, Office of Air and Radiation. [PDF / Author]

U.S. Department of Energy (DOE). 2003a. Remote-Handled TRU Waste Characterization Program Implementation Plan (Revision 0D, October 30). DOE/WIPP 02-3214. Carlsbad, NM: Carlsbad Field Office. [PDF / Author]

U.S. Department of Energy (DOE). 2003b. Notification of Planned Change to the EPA 40 CFR Part 194 Certification of the Waste Isolation Pilot Plant: Remote-Handled TRU Waste Characterization Plan (April 30). Carlsbad, NM: Carlsbad Field Office. [PDF / Author]

U.S. Department of Energy (DOE). 2004. Title 40 CFR Part 191 Compliance Recertification Application for the Waste Isolation Pilot Plant (March). 10 vols. DOE/WIPP 2004-3231. Carlsbad, NM: Carlsbad Field Office. [Author]

U.S. Department of Energy (DOE). 2009. Title 40 CFR Part 191 Compliance Recertification Application for Waste Isolation Pilot Plant (March). DOE/WIPP 2009-3423, Carlsbad, NM: Carlsbad Field Office.* [Author]

U.S. Environmental Protection Agency (EPA). 1996. "40 CFR Part 194: Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the 40 CFR Part 191 Disposal Regulations; Final Rule." Federal Register, vol. 61 (February 9, 1996): 52234-45. [PDF /Author]

U.S. Environmental Protection Agency (EPA). 1998. "40 CFR Part 194: Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the Disposal Regulations: Certification Decision; Final Rule." Federal Register, vol. 63 (May 18, 1998): 27353-406. [PDF /Author]

U.S. Environmental Protection Agency (EPA). 2004a. "40 CFR Part 194: Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the Disposal Regulations; Alternative Provisions" (Final Rule). Federal Register, vol. 69 (July 16, 2004): 42571-583. [PDF /Author]

U.S. Environmental Protection Agency (EPA). 2004b. Waste Characterization Inspection Report: EPA Inspection No. EPA-LLNL-CCP-05.04-8 of the Central Characterization Project (CCP) as Implemented at the Lawrence Livermore National Laboratory (LLNL) Site May 4-7, 2004 (August). Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2004c. EPA Inspection No. EPA-LANL-CCP-4.04-08 of the Central Characterization Project (CCP) as Implemented at the Los Alamos National Laboratory, April 26-April 30, 2004 (August). Waste Characterization Inspection Report. Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2004d. EPA Inspection No. EPA-INL-CCP-05.05-08 of the Central Characterization Project (CCP) as Implemented at the Idaho National Laboratory, May 3 - 5, 2005. Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2006a. "Recertification CARD No. 8: Approval Process for Waste Shipment from Waste Generator Sites for Disposal at the WIPP." Compliance Application Review Documents for the Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the 40 CFR Part 191 Disposal Regulations: Final Recertification Decision (March) (pp. 8-1 through 8-10). Washington, DC: Office of Radiation and Indoor Air. [PDF / Author]

U.S. Environmental Protection Agency (EPA). 2006b. "40 CFR Part 194: Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the Disposal Regulations: Recertification Decision" (Final Notice). Federal Register, vol. 71 (April 10, 2006): 18010-021. [PDF / Author]

U.S. Environmental Protection Agency (EPA). 2007a. Waste Characterization Inspection Report: EPA Baseline Inspection No. EPA-INLl-CCP-RH-6.06-8 of the Central Characterization Project Remote-Handled Transuranic Waste Characterization Program at the Idaho National Laboratory June 12-16, and August 9 and 29, 2006 (January). Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2007b. Waste Characterization Inspection Report EPA Baseline Inspection No. EPA-ANL-CCP-RH-9.06-8 of the Central Characterization Project Remote-Handled Transuranic Waste Characterization Program at the Argonne National Laboratory September 12-14, 2006 (January). Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2008a. Waste Characterization Inspection Report and Approval: EPA Baseline Inspection No. EPA-ORNL-CCP-CH-11.07-8 of the Central Characterization Project Waste Characterization Program at the Oak Ridge National Laboratory November 13-15, 2007 (August). Washington, DC: Office of Radiation and Indoor Air. [PDF] [Author]

U.S. Environmental Protection Agency (EPA). 2008b. Waste Characterization Report: Tier 1 Change: Evaluation of the Modification of the Central Characterization's Remote Handled TRU Waste Characterization Program at the Idaho National Laboratory to Add Containers of K-Cell Waste to Waste Stream ID-ANLE-S5000 (January). Washington, DC: Office of Radiation and Indoor Air. [PDF / Author]

U.S. Environmental Protection Agency (EPA). 2008c. Waste Characterization Report: Tier 1 Change Evaluation: New Process for Visual Examination for Newly-Packaged Waste at the Central Characterization Program's Remote-Handled TRU Waste at Argonne National Laboratory May 28, 2008 (June). Washington, DC: Office of Radiation and Indoor Air. [PDF] / [Author]

U.S. Environmental Protection Agency (EPA). 2008d. EPA Baseline Inspection No. EPA-LANL-CCP-RH-5.07-8 of the Central Characterization Project: Remote-Handled Transuranic Waste Characterization Program at the Los Alamos National Laboratory, May 8-10, 2007 (February). Waste Characterization Inspection Report. Washington, DC: Office of Radiation and Indoor Air. [PDF] / [Author]

U.S. Environmental Protection Agency (EPA). 2008e. Waste Characterization Inspection Report: EPA Baseline Inspection No. EPA-SRS-CCP-RH-7.07-8 of the Central Characterization Project Remote-Handled Transuranic Waste Characterization Program for Battelle Columbus Laboratories Decommissioning Project Wastes Stored at the Savannah River Site July-December 2007 (August). Washington, DC: Office of Radiation and Indoor Air. [PDF] / [Author]

U.S. Environmental Protection Agency (EPA). 2010a. "2009 Compliance Recertification Application (CRA-2009) Compliance Application Review Document (CARD) No. 8, "Approval Process for Waste Shipment From Waste Generator Sites for Disposal at the WIPP." EPA Docket FDMS Docket ID No. EPA-HQ-OAR-2009-0330-0031. Washington, DC: Office of Radiation and Indoor Air.* [PDF / Author]

U.S. Environmental Protection Agency (EPA). 2010b. "40 CFR Part 194: Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the Disposal Regulations: Recertification Decision; Final Rule." Federal Register, vol. 75 (November 18, 2010): 70584-595.* [PDF / Author]

List of Tables

Table of Contents

Acronyms and Abbreviations