Caroline Laikin and Mary Kruger
U.S. Environmental Protection Agency
Office of Radiation and Indoor Air
401 M Street, NW (6602J)
Washington, DC 20460
(202)564-9310

On October 30, 1997, the United States (U.S.) Environmental Protection Agency (EPA) issued a proposed rulemaking¹ to certify that the U.S. Department of Energy's (DOE) Waste Isolation Pilot Plant (WIPP) will comply with the radioactive waste disposal regulations set forth at 40 CFR Part 191.² The WIPP would become the nation's first deep underground disposal facility for transuranic (TRU) radioactive waste generated as a result of defense activities. Since WIPP is a first-of-a-kind facility, the EPA's regulatory program contains an abundance of unique technical questions, as well as controversial policy considerations and legal issues. The purpose of this paper is to discuss the process that EPA undertook to reach its proposed decision.

The EPA is required by the WIPP Land Withdrawal Act (LWA) of 1992,³ as amended,⁴ to evaluate whether the WIPP will comply with Subparts B and C of 40 CFR Part 191,² known as the disposal regulations. The EPA's certification of compliance, if finalized, would allow the emplacement of radioactive waste in the WIPP to begin, provided that all other applicable health and safety standards have been met. The proposed certification would allow Los Alamos National Laboratory and other TRU-waste sites to ship TRU waste from specific waste streams for disposal at the WIPP. However, the proposed certification is subject to several conditions. Most notably that the EPA must approve site-specific waste characterization measures and quality assurance plans before allowing other TRU-waste sites to ship waste for disposal at the WIPP.

The EPA received DOE's 84,000 page Compliance Certification Application (CCA) in October 1996, and immediately began the rulemaking process with publication of an advance notice of proposed rulemaking.⁵ The EPA then reviewed the CCA, met with the public, considered public comments, and performed independent testing of performance assessment calculations, which are used to demonstrate that WIPP will comply with EPA's disposal regulations.²

Congress authorized development and construction of the WIPP in 1980,⁶ "for the express purpose of providing a research and development facility to demonstrate the safe disposal of radioactive wastes resulting from the defense activities and programs of the United States." The DOE is developing the WIPP near Carlsbad in southeastern New Mexico as a potential deep geologic repository for the disposal of defense-generated TRU waste. TRU waste consists of materials containing alpha-emitting radio-isotopes, with half-lives greater than twenty years and atomic numbers greater than 92, in concentrations greater than 100 nano-curies per gram (3.7 x 10⁶ becquerels per kilogram) of waste. Most TRU waste proposed for disposal at the WIPP consists of items, e.g., rags, equipment, tools, protective gear, and organic or inorganic sludges, contaminated as a result of activities associated with the production of nuclear weapons. Some TRU waste is mixed with hazardous chemicals. Some of the waste proposed for disposal at the WIPP is currently stored on Federal lands across the U.S., including locations in Colorado, Idaho, New Mexico, Nevada, Ohio, South Carolina, Tennessee, and Washington. Much of the waste proposed for disposal at the WIPP will be generated in the future as weapons are disassembled and additional facilities are decontaminated and decommissioned.

Before disposal of radioactive waste can begin at the WIPP, the EPA must certify that the WIPP facility will comply with EPA's radioactive waste disposal regulations.² The purpose of the October 1997 rulemaking¹ was to propose EPA's certification decision.

The EPA's oversight of the WIPP facility is governed by the WIPP LWA, passed initially by Congress in 1992³ and amended in 1996.⁴ The LWA delegates to the EPA three main tasks, to be completed sequentially, for reaching a compliance certification decision. First, the EPA must finalize general regulations which apply to all sites -- except Yucca Mountain -- for the disposal of spent nuclear fuel, transuranic and high level radioactive waste. The regulations, located at Subparts B and C of 40 CFR Part 191 (disposal regulations),² limit the amount of radioactive material which may escape from a disposal facility, and protect individuals and ground water resources from dangerous levels of radioactive contamination. The EPA published the disposal regulations in the Federal Register in 1985 and 1993.

Second, the EPA must develop criteria, by rulemaking, to implement and interpret the generic radioactive waste disposal regulations specifically for the WIPP. EPA issued these WIPP "Compliance Criteria," which are found at 40 CFR Part 194,⁷ on February 9, 1996. The criteria describe in detail what information the DOE must submit in any certification application for EPA's review, and clarify the basis on which the EPA's compliance determination will be made. The State of New Mexico challenged certain aspects of the EPA's Compliance Criteria in the Court of Appeals for the District of Columbia Circuit (No. 96-1107). The Court upheld the Compliance Criteria in their entirety.

Although not a requirement, the EPA also published the "Compliance Application Guidance for the Waste Isolation Pilot Plan: A Companion Guide to 40 CFR Part 194 (CAG)"⁸ in March 1996, which provided detailed guidance on the submission of a compliance application. The EPA developed this guidance to assist the DOE with the preparation the CCA for the WIPP and, in turn, to assist in the EPA's review of the CCA for completeness and generally to enhance the readability and accessibility of the CCA for the EPA and public scrutiny.

Third, the EPA must review information submitted by the DOE and publish a certification decision (WIPP LWA, section 8(d)).³ On October 29, 1996, the DOE submitted a CCA containing information intended to demonstrate that WIPP will comply with the disposal regulations. Since then, the DOE has submitted additional information. On May 22, 1997, the EPA announced that the DOE's (now 100,000-page) application was deemed to be complete (62 FR 27996-27998). On October 30, 1997, the EPA issued its proposed certification decision, as required by section 8 of the LWA.³ The proposed certification is based on the EPA's conclusion that the CCA and supplementary materials satisfy the requirements of the Compliance Criteria.⁷

Section 8(d)(2) of the LWA ³ requires that the EPA's certification decision be conducted by informal (or notice-and-comment) rulemaking pursuant to section 553 of the Administrative Procedure Act (APA).⁹ Notice-and-comment rulemaking under the APA requires that an agency provides notice of a proposed rulemaking, an opportunity for the public to comment on the proposed rule, and a general statement of the basis and purpose of the final rule adopted.

The WIPP is a first-of-a-kind project, and New Mexico citizens have expressed a great deal of interest in the safety of the site. The WIPP Compliance Criteria, at Subpart D of 40 CFR Part 194,⁷ established a process of public participation that exceeds the APA's basic requirements, and provides the public with the opportunity to participate in the regulatory process at the earliest opportunity. The WIPP Compliance Criteria contain provisions that require the EPA to: publish an advance notice of proposed rulemaking (ANPR) in the Federal Register; allow public comment on the DOE's CCA for at least 120 days, prior to proposing a certification decision; hold public hearings in New Mexico, if requested, on the CCA; provide a minimum of 120 days for public comment on the EPA's proposed certification decision; hold public hearings in New Mexico on the EPA's proposal; produce a document summarizing the EPA's consideration of public comments on the proposal; and maintain informational dockets in the State of New Mexico to facilitate public access to the voluminous technical record, including the CCA. The EPA either has or will comply with each of these requirements.

In addition, the EPA has taken other measures to assure that the public is involved in the present rulemaking. The EPA allowed the New Mexico Environment Department, the New Mexico Environmental Evaluation Group, and more recently, the New Mexico Attorney General's Office, to observe meetings between the EPA and the DOE staff to discuss technical issues during the pre-proposal period. The EPA also committed to summarize all meetings between the EPA and the DOE (including management level meetings and meetings between the EPA and the DOE legal staff) and to place such summaries in the public docket. While these commitments are not required by the APA, the EPA believes that they are useful given the importance of this rulemaking to the nation as a whole, and to New Mexico in particular.

The EPA received DOE's CCA on October 29, 1996. Upon receipt of the CCA, the EPA immediately began its review of the application in accordance with 40 CFR 194.11,⁷ "Completeness and accuracy of compliance applications." On November 15, 1996, the EPA published in the Federal Register (61 FR 58499)⁵ an ANPR announcing that the CCA had been received, and announcing the EPA's intent to conduct a rulemaking to certify whether the WIPP facility will comply with the disposal regulations. The notice also announced a 120-day public comment period, requested public comment "on all aspects of the CCA," and stated EPA's intent to hold public hearings in New Mexico.

The EPA held three days of meetings in New Mexico, on January 21, 22, and 23, 1997, with the principal New Mexico Stakeholders, including the New Mexico Attorney General's Office, the New Mexico Environmental Evaluation Group, Concerned Citizens for Nuclear Safety, Citizens for Alternatives to Radioactive Dumping, and Southwest Research and Information Center. Detailed summaries of these meetings were placed in the EPA docket.

The EPA published a separate notice in the Federal Register announcing hearings to allow the public to address all aspects of DOE's certification application (62 FR 2988). Public hearings were held on February 19, 20 and 21, 1997, in Carlsbad, Albuquerque, and Santa Fe, New Mexico, respectively. All individuals who requested an opportunity to address the EPA panel during the hearings were afforded five minutes if they were representing themselves, or ten minutes if they were representing a group. In Albuquerque and Santa Fe, the EPA extended the hours of the hearings in order to accommodate all individuals who requested that they be allowed to address the panel.

The EPA received over 220 sets of written and oral public comments in response to the ANPR. All comments received on the ANPR were made available to members of the public through the public docket. In accordance with 40 CFR 194.61(f),⁷ the DOE submitted to the EPA additional information specifically addressing many of the comments received; these submittals were treated by the EPA as public comments.

The EPA reviewed all public comments submitted during the ANPR 120-day comment period or presented at the preliminary meetings with stakeholders. Public comments received in response to the ANPR generally focused on the completeness of the CCA, specific technical issues relating to compliance with the disposal regulations, and the EPA's approach to public participation in accordance with the provisions of the WIPP Compliance Criteria, the LWA and the APA.

The EPA provided responses to these comments in the preamble to the proposed rule as well as in the compliance application review documents (CARDs) which the EPA developed as part of the proposed certification decision. The CARDs also address late comments -- and comments on completeness. All relevant public comments, whether received in writing, or orally during the public hearings, were considered by the EPA as the proposed certification decision was developed.

Section 8(d)(1)(B) of the LWA³ establishes a one-year time frame for the EPA to reach a certification decision regarding WIPP's compliance with the disposal regulations. Section 8(d)(4) of the LWA³ requires that EPA make its certification determination only after DOE has submitted the "full application" to EPA. The Compliance Criteria, at §194.11,⁷ interpret these requirements to mean one year from receipt of a "complete" certification application from DOE. This assures that the one-year review period is devoted exclusively to substantive, meaningful review of the CCA.

Upon receipt of the CCA in October 1996, the EPA began reviewing the CCA for both completeness and, to the extent possible, technical adequacy. Pursuant to section 8(d)(1) of the LWA,³ the EPA provided requests to the DOE for specific information needed for completeness on December 19, 1996. DOE submitted the requested information with letters dated January 17, January 24, February 7, February 14, and February 26, 1997. On May 16, 1997, the EPA Administrator informed the Secretary of Energy, in writing, that the CCA was complete. The completeness determination was announced in the Federal Register on May 22, 1997 (62 FR 27996-27998).

The determination of completeness meant only that all sections of the disposal regulations and Compliance Criteria had been addressed in the CCA. The completeness determination did not state or imply that compliance with the disposal regulations or the WIPP Compliance Criteria had been achieved. In short, the completeness determination was an interim administrative step to announce that the CCA contained the information necessary for the EPA to proceed with its one-year technical evaluation of compliance.

The EPA received numerous public comments regarding the timing of the EPA's completeness determination. While some comments stated that the CCA was administratively complete upon submission, others argued that the CCA was incomplete and simply should be returned to the DOE. The latter set of commenters expressed that it was not appropriate for the EPA to close the public comment period on the ANPR prior to the EPA's determination of completeness, and that the public hearings should be delayed until after the completeness determination. Other commenters requested an additional 120-day comment period after the completeness determination was issued, as well as an additional set of public hearings during such a comment period.

In making its completeness determination, the EPA considered public comments which explicitly addressed the issue of completeness and were submitted to the docket or to the EPA's Office of Radiation and Indoor Air. In response to concerns expressed by commenters, the EPA notified the public in the Federal Register announcement regarding the completeness determination that EPA would continue to accept public comments on the CCA subsequent to the completeness determination (62 FR 27997).

Public comments received during and after the ANPR comment period also requested that the EPA clarify what specific material constitutes the "complete" CCA. This concern was raised because, at the EPA's request, the DOE supplemented the docket with substantial additional materials beyond what was initially submitted on October 29, 1996. Many of the issues raised by public comments were addressed in a December 19, 1996 letter to the DOE in which the EPA identified additional information necessary for the CCA to constitute a complete application. To address completeness concerns, the EPA requested and the DOE submitted additional information on (among other topics) site conditions, documentation of computer codes, and the effects of explosions -- issues all identified in public comments. The complete CCA consists of the application that was submitted to the EPA on October 29, 1996, and supplementary materials provided by the DOE that were identified by EPA in the December 19, 1996 letter, as necessary for completeness.

The October 30, 1997 (62 FR 58793)¹ proposed rule states the EPA's proposed determination that the WIPP will comply with the disposal standards and Compliance Criteria, taken as a whole. In addition, the proposal specifies all conditions which would apply to the certification. EPA's evaluation of compliance was made by comparing the CCA and other relevant information -- including supplementary information requested by EPA from DOE and the results of EPA's confirmatory audits and inspections -- to the Compliance Criteria. In making its decision, the EPA conducted an exhaustive scientific review of the CCA, considered public comments, and performed independent testing of the performance assessment calculations, which are used to demonstrate that WIPP will comply with the EPA's radioactive waste disposal regulations. The proposed certification decision is based on the EPA's conclusion that the CCA and supplemental materials satisfy the requirements of the EPA's Compliance Criteria, and that the WIPP will, therefore safely contain radioactive waste.

The EPA developed the preamble to the proposed rule to addresses each of the technical WIPP Compliance Criteria in turn. It describes the EPA's basis for evaluating compliance with each criterion, and discusses briefly how the CCA submitted by the DOE, and other relevant information, demonstrated compliance with the disposal regulations. In addition, although not a requirement under the APA, the EPA responded to all public comments - over 800 - received before August 7, 1997, in the support documents for the proposed rule.

The EPA's October 30, 1997, proposed decision finds that the WIPP will comply with the radioactive waste disposal regulations at Part 191, Subparts B and C.² The proposed certification includes several conditions of compliance. If these conditions are finalized in the final rule, the DOE and the EPA will be required to perform additional technical and procedural duties.

The following describes the proposed conditions of certification and the proposed administrative procedures:

Only one WIPP waste generator site, the Los Alamos National Laboratory (LANL) has established adequate quality assurance (QA) programs. With respect to other TRU-waste generator sites, the EPA is proposing to certify compliance conditioned on separate, subsequent approvals from the EPA that site-specific QA programs for waste characterization activities and assumptions have been established and executed.

In making any determination to approve a site-specific QA program for a waste generator, the EPA will conduct an audit or an inspection of a DOE audit of a waste generator site. The EPA will publish a notice in the Federal Register announcing its scheduled audit or inspection of a DOE audit and will provide at least a 30-day comment period during which interested parties may submit written comments. The EPA will place in the docket copies of the site-specific QA program documents and other documentation relevant to the audit or inspection. Thus, the EPA's decision whether to approve the establishment and execution of a QA program at a specific waste generator site will be informed by both public comments and the results of the EPA's own independent evaluation of the site's compliance with the applicable Nuclear Quality Assurance standards.

The EPA would indicate its approval of site-specific QA programs by a letter from the EPA to the DOE; a copy of the letter will be placed in EPA's public docket. Continued adherence to the executed QA program as it applies to disposal system monitoring would be confirmed by the EPA in future inspections under its authority at §194.21 and §194.22(e).⁷

The EPA proposed to certify that the DOE may ship certain retrievably stored (legacy) debris waste streams from LANL for emplacement at the WIPP. No other waste streams from LANL or other generator sites may be disposed in WIPP until the EPA approves the QA programs for the site and the system of controls that will be used to characterize a given waste stream, including determining the radionuclides and other components (i.e., iron, cellulosic, non-ferrous metals, and percent-free liquids) of waste disposal containers currently stored at waste generator sites.

The EPA proposed that the decision to allow a waste generator site to dispose of a waste stream at the WIPP will be made only after public comments have been solicited on the DOE's proposed site-specific waste characterization programs and after the EPA has conducted an audit or an inspection of the DOE audit of the waste generator site. The EPA will make available, in its public docket, the site-specific program documents being considered by the EPA, and will publish a notice in the Federal Register announcing its intent to evaluate such plans. The EPA will allow at least a 30-day public comment period for interested parties to comment on the DOE's proposed programs for process knowledge and systems of controls for one or more specific waste streams. The EPA's approval of the waste characterization plans will be indicated in a letter from the EPA to the DOE.

In the CCA, the DOE described an extensive system of passive institutional controls (PICs) - including both markers and archives. The EPA found the proposed system to meet the requirement for PICs to be as permanent as practicable to convey the hazards of the WIPP to potential future intruders. The DOE proposed to take most of the steps necessary for implementing the PICs, such as making arrangements with archives and record centers and refining marker messages, during the WIPP's operational period. However, the DOE also plans to extend some activities, particularly testing of markers, over nearly 100 years after closure (i.e., during the proposed active institutional control period) before finalizing important aspects of the design of PICs, in the belief that future technology may improve the design.

Given that the EPA considered the design proposed in the CCA to be final for the purposes of its compliance review, the EPA finds that the DOE has not justified sufficiently the need for additional testing of markers after closure of the repository or the need to delay implementation for many years after closure. The EPA believes that PICs should be implemented as soon as possible after the WIPP facility is sealed, and that measures necessary to prepare for such implementation should be accomplished during the operational period for the WIPP, unless doing so would compromise the effectiveness of the CCA design. While the DOE will not be precluded in the future from implementing other measures in addition to those comprising the CCA design for PICs, the DOE may not alter or delete aspects of the approved plan in the CCA without notifying the EPA and subjecting the certification to modification, if the EPA deems it necessary. Thus, the EPA proposed to find the DOE in compliance with the PICs requirements on the condition that the DOE provide a schedule for implementing PICs that has been revised to show that markers will be fabricated and emplaced, and other measures will be implemented, as soon as possible following closure of the disposal system.

The EPA is also proposing that the DOE implement the panel seal design designated in the CCA as Option D design, with Salado mass concrete replacing fresh water concrete. The Option D the design is the most robust design proposed in the DOE's application and is needed to reduce the flow of brine into the waste. The EPA believes it is important to ensure that the proposed design on which compliance was based is actually implemented at the site.

In May of 1998, in compliance with the one-year statutory deadline,⁴ the EPA will publish a final rule in the Federal Register announcing the EPA's final decision, pursuant to section 8(d)(1) of the LWA³ and in accordance with the Compliance Criteria at 40 CFR 194.63,⁷ whether to issue a certification that the WIPP facility will comply with the disposal regulations. The EPA will make its final decision only after reviewing all public comments received on the proposed rule.

The EPA opened a 120-day public comment period on the proposed decision with the October 30, 1997 Federal Register notice.¹ Comments on the proposal will be accepted if the EPA receives them on or before February 27, 1998. The EPA will consider all comments received during the comment period in making its final decision. A document summarizing significant comments and issues arising from comments received on the proposed rule, as well as the EPA's response to such significant comments and issues, will be prepared and will be made available for inspection in the EPA's docket. The EPA expects to respond to numerous public comments. Comments regarding the ANPR and completeness that are address in the proposed rule and support documents have already been considered and will not be addressed again in the response to comments for the final rule.

In an effort to get early comments on the proposed decision, the EPA held meetings on December 10 and 11, 1997 with the major New Mexico stakeholders including, the Environmental Evaluation Group set up by the State of New Mexico, the New Mexico Attorney General, and three citizen groups. Similar meetings were conducted after the publication of the ANPR to obtain early input on the DOE's compliance application.

The EPA also held public hearings in New Mexico on January 5 through 9, 1998 to allow the public to address all aspects of the proposed rulemaking. The hearings were held in Carlsbad, Albuquerque and Santa Fe, New Mexico. The EPA publish a notice in the Federal Register on December 5, 1997 (62 FR 64334) announcing the hearings and describing the hearing and registration procedures. EPA extended the hours of the public hearings to assure that all persons interested in testifying were accommodated.

In response to early public comments that air drilling techniques should be considered in the performance of WIPP, EPA analyzed the potential impacts that air drilling could have on the performance of WIPP and made it available for review in the EPA's dockets. The EPA published a notice of availability in the Federal Register on January 27, 1998 (63 FR 3863) announcing the availability of the EPA's analysis and requesting public comments.

The requirements which apply to the rulemaking process used to develop the EPA's certification decision (including measures for soliciting and considering public input) do not prescribe what form the final decision must take. In analogous situations where the EPA issues or denies hazardous waste no-migration petitions for landfills or other sites, public notice of the decision is provided by publication in the Federal Register, and such notice serves as the record of EPA's action. Because of the one-of-a-kind nature of the WIPP facility, the EPA has determined that it is appropriate to provide a more permanent record of the Agency's decision. To that end, the EPA's decision is being published in the Federal Register and also will be codified as an appendix to the WIPP Compliance Criteria at 40 CFR Part 194. A lasting record of the EPA's certification decision will be established since the appendix will be included each time in the future that the Code of Federal Regulations is compiled and published.

If, after reviewing public comments, the EPA concludes that the WIPP will comply with these radioactive waste disposal regulations, the EPA will issue a final rule to the Secretary of Energy certifying that the WIPP complies with these regulations. At that time, the Secretary of Energy would be authorized to make a decision whether to open the WIPP 30-days later, once all other applicable health and environmental requirements for radioactive waste have been met.

This paper describes only a small selection of the policy, procedural, and legal issues examined by the EPA in developing a proposed certification decision for the WIPP. The EPA conducted an exhaustive scientific review of over 100,000 pages of documentation, held 5 days of public hearings, and responded to over 800 public comments.

More detailed discussion of the issues discussed above, as well as many other technical issues considered by the EPA, can be found in the Federal Register notice for the proposed rule (62 FR 58791-58838, October 30, 1997).¹ CARDs and Technical Support Documents in the EPA's docket provide further information concerning EPA's compliance evaluation and independent analysis (See Docket A-93-02, Category III-B).

Copies of the Federal Register notice for the proposal can be obtained by calling the EPA's WIPP Information Line at 1-800-331-WIPP. Electronic copies of the Federal Register notice and supporting documents can also be found at the EPA's WIPP Internet Homepage (http://www.epa.gov/radiation/wipp).

1. U.S. ENVIRONMENTAL PROTECTION AGENCY, "Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance With the 40 CFR Part 191 Disposal Regulations: Certification Decision; Proposed Rule." Published in the Federal Register on October 30, 1997 (Vol. 62, No. 210, pp. 58792-58838).
2. U.S. ENVIRONMENTAL PROTECTION AGENCY, "Environmental Radiation Protection Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes: Final Rule." Codified at Chapter 40 of the Code of Federal Regulations, Part 191 (40 CFR Part 191). Published in the Federal Register on September 19, 1985 (Vol. 50, No. 182, pp. 38066-38089) and December 20, 1993 (Vol. 58, No. 242, pp. 66398-66416).
3. WIPP Land Withdrawal Act of 1992. Pub. L. No. 102-579.
4. 1996 WIPP LWA Amendments. Pub. L. No. 104-201.
5. U.S. ENVIRONMENTAL PROTECTION AGENCY, "Decision to Certify Whether the Waste Isolation Pilot Plant Complies With the 40 CFR Part 191 Disposal Regulations and the 40 CFR Part 194 Compliance Criteria: Advance Notice of Proposed Rulemaking." Published in the Federal Register on November 15, 1996 (Vol. 61, No. 222, pp. 58499-58500).
6. Department of Energy National Security and Military Applications of Nuclear Energy Authorization Act of 1980, Pub. L. 96-164, section 213.
7. U.S. ENVIRONMENTAL PROTECTION AGENCY, "Criteria for the Certification and Re-certification of the Waste Isolation Pilot Plant's Compliance with the 40 CFR Part 191 Disposal Regulations." Codified at Chapter 40 of the Code of Federal Regulations, Part 194 (40 CFR Part 194). Published in the Federal Register on February 9, 1996 (Vol. 61, No. 28, pp 5224-5245).
8. U.S. ENVIRONMENTAL PROTECTION AGENCY, Compliance Application Guidance for the Waste Isolation Pilot Plant: A Companion Guide to 40 CFR Part 194. March 1996.
9. Administrative Procedures Act. 5 U.S.C. sec. 551-559, 701-706, 1305, 3105, 3344, 5372, 7521. June 11, 1946. Pub. L. 404, 60 Stat. 237, Ch. 324, sec. 1-12. 

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