This part specifies criteria for the certification or any re-certification, or subsequent actions relating to the terms or conditions of certification of the Department of Energy's Waste Isolation Pilot Plant's compliance with the disposal regulations found at part 191 of this chapter and pursuant to section 8(d)(1) and section 8(f), respectively, of the WIPP LWA. The compliance certification application submitted pursuant to section 8(d)(1) of the WIPP LWA and any compliance re-certification application submitted pursuant to section 8(f) of the WIPP LWA shall comply with the requirements of this part.

Unless otherwise indicated in this part, all terms have the same meaning as in part 191 of this chapter.

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).

Administrator's authorized representative means the director in charge of radiation programs at the Agency.

Certification means any action taken by the Administrator pursuant to section 8(d)(1) of the WIPP LWA.

Compliance application(s) means the compliance certification application submitted to the Administrator pursuant to section 8(d)(1) of the WIPP LWA or any compliance re-certification applications submitted to the Administrator pursuant to section 8(f) of the WIPP LWA.

Compliance assessment(s) means the analysis conducted to determine compliance with § 191.15, and part 191, subpart C of this chapter.

Delaware Basin means those surface and subsurface features which lie inside the boundary formed to the north, east and west of the disposal system by the innermost edge of the Capitan Reef, and formed, to the south, by a straight line drawn from the southeastern point of the Davis Mountains to the most southwestern point of the Glass Mountains.

Deep drilling means those drilling events in the Delaware Basin that reach or exceed a depth of 2,150 feet below the surface relative to where such drilling occurred.

Department means the United States Department of Energy.

Disposal regulations means part 191, subparts B and C of this chapter.

Management systems review means the qualitative assessment of a data collection operation or organization(s) to establish whether the prevailing quality management structure, policies, practices, and procedures are adequate to ensure that the type and quality of data needed are obtained.

Minor alternative provision means an alternative provision to the Compliance Criteria that only clarifies an existing regulatory provision, or does not substantively alter the existing regulatory requirements.

Modification means action(s) taken by the Administrator that alters the terms or conditions of certification pursuant to section 8(d)(1) of the WIPP LWA. Modification of any certification shall comply with this part and part 191 of this chapter.

Population of CCDFs means all possible complementary, cumulative distribution functions (CCDFs) that can be generated from all disposal system parameter values used in performance assessments.

Population of estimates means all possible estimates of radiation doses and radionuclide concentrations that can be generated from all disposal system parameter values used in compliance assessments.

Quality assurance means those planned and systematic actions necessary to provide adequate confidence that the disposal system will comply with the disposal regulations set forth in part 191 of this chapter. Quality assurance includes quality control, which comprises those actions related to the physical characteristics of a material, structure, component, or system that provide a means to control the quality of the material, structure, component, or system to predetermined requirements.

Re-certification means any action taken by the Administrator pursuant to section 8(f) of the WIPP LWA.

Regulatory time frame means the time period beginning at disposal and ending 10,000 years after disposal.

Revocation means any action taken by the Administrator to terminate the certification pursuant to section 8(d)(1) of the WIPP LWA.

Secretary means the Secretary of Energy.

Shallow drilling means those drilling events in the Delaware Basin that do not reach a depth of 2,150 feet below the surface relative to where such drilling occurred.

Suspension means any action taken by the Administrator to withdraw, for a limited period of time, the certification pursuant to section 8(d)(1) of the WIPP LWA.

Waste means the radioactive waste, radioactive material and coincidental material subject to the requirements of part 191 of this chapter.

Waste characteristic means a property of the waste that has an impact on the containment of waste in the disposal system.

Waste component means an ingredient of the total inventory of the waste that influences a waste characteristic.

WIPP means the Waste Isolation Pilot Plant, as authorized pursuant to section 213 of the Department of Energy National Security and Military Applications of Nuclear Energy Authorization Act of 1980 (Pub. L. 96-164; 93 Stat. 1259, 1265).

WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act of 1992 (Pub.L. 102-579, 106 Stat. 4777).

(a) Compliance application(s) shall be:

(1) Addressed to the Administrator; and

(2) Signed by the Secretary.

(b) Communications and reports concerning the criteria in this part shall be:

(1) Addressed to the Administrator or the Administrator's authorized representative; and

(2) Signed by the Secretary or the Secretary's authorized representative.

(a) Any certification of compliance issued pursuant to section 8(d)(1) of the WIPP LWA may include such conditions as the Administrator finds necessary to support such certification.

(b) Whether stated therein or not, the following conditions shall apply in any such certification:

(1) The certification shall be subject to modification, suspension or revocation by the Administrator. Any suspension of the certification shall be done at the discretion of the Administrator. Any modification or revocation of the certification shall be done by rule pursuant to 5 U.S.C. 553. If the Administrator revokes the certification, the Department shall retrieve, as soon as practicable and to the extent practicable, any waste emplaced in the disposal system.

(2) Any time after the Administrator issues a certification, the Administrator or the Administrator's authorized representative may submit a written request to the Department for information to enable the Administrator to determine whether the certification should be modified, suspended or revoked. Unless otherwise specified by the Administrator or the Administrator's authorized representative, the Department shall submit such information to the Administrator or the Administrator's authorized representative within 30 calendar days of receipt of the request.

(3) Any time after the Administrator issues a certification, the Department shall report any planned or unplanned changes in activities or conditions pertaining to the disposal system that differ significantly from the most recent compliance application.

(i) The Department shall inform the Administrator, in writing, prior to making such a planned change in activity or disposal system condition.

(ii) In the event of an unplanned change in activity or condition, the Department shall immediately cease emplacement of waste in the disposal system if the Department determines that one or more of the following conditions is true:

(A) The containment requirements established pursuant to § 191.13 of this chapter have been or are expected to be exceeded;

(B) Releases from already-emplaced waste lead to committed effective doses that are or are expected to be in excess of those established pursuant to § 191.15 of this chapter. For purposes of this paragraph (b)(3)(ii)(B), emissions from operations covered pursuant to part 191, subpart A of this chapter are not included; or

(C) Releases have caused or are expected to cause concentrations of radionuclides or estimated doses due to radionuclides in underground sources of drinking water in the accessible environment to exceed the limits established pursuant to part 191, subpart C of this chapter.

(iii) If the Department determines that a condition described in paragraph (b)(3)(ii) of this section has occurred or is expected to occur, the Department shall notify the Administrator, in writing, within 24 hours of the determination. Such notification shall, to the extent practicable, include the following information:

(A) Identification of the location and environmental media of the release or the expected release;

(B) Identification of the type and quantity of waste (in activity in curies of each radionuclide) released or expected to be released;

(C) Time and date of the release or the estimated time of the expected release;

(D) Assessment of the hazard posed by the release or the expected release; and

(E) Additional information requested by the Administrator or the Administrator's authorized representative.

(iv) The Department may resume emplacement of waste in the disposal system upon written notification that the suspension has been lifted by the Administrator.

(v) If the Department discovers a condition or activity that differs significantly from what is indicated in the most recent compliance application, but does not involve conditions or activities listed in paragraph (b)(3)(ii) of this section, then the difference shall be reported, in writing, to the Administrator within 10 calendar days of its discovery.

(vi) Following receipt of notification, the Administrator will notify the Secretary in writing whether any condition or activity reported pursuant to paragraph (b)(3) this section:

(A) Does not comply with the terms of the certification; and, if it does not comply,

(B) Whether the compliance certification must be modified, suspended or revoked. The Administrator or the Administrator's authorized representative may request additional information before determining whether modification, suspension or revocation of the compliance certification is required.

(4) Not later than six months after the Administrator issues a certification, and at least annually thereafter, the Department shall report to the Administrator, in writing, any changes in conditions or activities pertaining to the disposal system that were not required to be reported by paragraph (b)(3) of this section and that differ from information contained in the most recent compliance application.

(a) The following publications are incorporated into this part by reference:

(1) U.S. Nuclear Regulatory Commission, NUREG-1297 “Peer Review for High-Level Nuclear Waste Repositories,” published February 1988; incorporation by reference (IBR) approved for §§ 194.22, 194.23 and 194.27.

(2) American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA) Standard, NQA-1-1989 edition, “Quality Assurance Program Requirements for Nuclear Facilities;” IBR approved for § 194.22.

(3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition “Quality Assurance Requirements for Nuclear Facility Applications;” IBR approved for § 194.22 and § 194.23.

(4) ASME NQA-3-1989 edition, “Quality Assurance Program Requirements for the Collection of Scientific and Technical Information for Site Characterization of High-Level Nuclear Waste Repositories” (excluding section 2.1 (b) and (c)); IBR approved for § 194.22.

(b) The publications listed in paragraph (a) of this section were approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected or obtained from the Air Docket, Docket No. A-92-56, room M1500 (LE131), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, or copies may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. or copies may be obtained from the following addresses:

(1) For ASME standards, contact American Society of Mechanical Engineers, 22 Law Drive, P.O. Box 2900, Fairfield, NJ 07007-2900, phone 1-800-843-2763.

(2) For Nuclear Regulatory Commission documents, contact Division of Information Support Services, Distribution Service, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or contact National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161, phone 703-487-4650.

The Administrator may, by rule pursuant to 5 U.S.C. 553,substitute,or,in,the,and,risks;

(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.

The criteria in this part shall be effective on April 9, 1996. The incorporation by reference of certain publications listed in the criteria is approved by the Director of the Federal Register as of April 9, 1996.

(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.