George E. Dials
U.S. Department of Energy
Carlsbad Area Office

Malcolm H. Philips, Jr. and John Fehrenbach
Winston & Strawn

In the early 1970s, the federal government selected an area in southeastern New Mexico containing large underground salt beds as potentially suitable for radioactive waste disposal. An extensive site characterization program was initiated by the federal government. This site became the "Waste Isolation Pilot Plant," better known as "WIPP."

It is now 1998, over two decades after the initial selection of the New Mexico site as a potential radioactive waste repository. Numerous scientific studies, construction activities, and environmental compliance documents have been completed. The United States Department of Energy (DOE) has addressed all relevant issues regarding the safety of WIPP and its ability to isolate radioactive waste from the accessible environment.

Throughout the last two decades and up to the present time, DOE has negotiated through a political, regulatory, and legal maze with regard to WIPP. During this time, self-regulation has given way to external regulation, new laws enacted and regulations issued, lawsuits initiated, and public involvement brought to the forefront of the decision-making process. All of these factors combined to bring WIPP to its present status -- at the final stages of working through the regulatory requirements for receipt of transuranic (TRU) waste for disposal.

Throughout its history, DOE has stayed true to Congress' mandates regarding WIPP. Steps taken have been necessary to demonstrate to Congress, the State of New Mexico, and the public in general, that the nation's first radioactive waste repository will be safe and environmentally sound. At this time, compliance demonstrations submitted by DOE's Carlsbad Area Office (CAO) are presently under consideration by the cognizant regulatory agencies, and WIPP is closer than ever to waste receipt.

This paper provides a concise summary of key CAO stratagems and lessons learned in the efforts at WIPP to adapt to changes in requirements and other challenges in complying with the external regulatory oversight of the WIPP TRU waste repository. It also provides a summary of potential external regulatory oversight-related challenges to the scheduled opening of the WIPP TRU waste repository in May 1998.

The safe and environmentally acceptable disposal of long-lived radioactive waste is a global societal concern. Radioactive residues from more than 50 years of civilian and military applications of nuclear energy continue to amass in temporary stockpiles around the world awaiting the opening of the world's first disposal system for long-lived radioactive waste. Although the international scientific community at large agrees that long-lived radioactive waste may be safely disposed of in well-sited and carefully designed deep geological disposal systems (repositories), the development and opening of repositories for radioactive waste typically experience delays. These delays are often caused by interest groups that negatively influence public opinion. Unfortunately, most citizens are either uninformed about or unable to understand the advanced state of science and engineering governing the safe performance of a deep geological repository for disposal of long-lived radioactive waste and, thus, unable to discern between facts and demagoguery. In order to achieve and enhance public acceptance, it is imperative to inform the public about the inherent safety of well-sited and carefully designed repositories in contexts that are more readily understood by the public.

Long-lived radioactive waste is currently stored at sites across the United States. Many of these sites are near major population centers. Continued storage poses risks to human health and the environment, which many citizens find unacceptable. (The classification of radioactive waste in the United States is essentially based on source rather than activity. This paper only addresses defense-generated TRU waste.) The ingestion and/or inhalation of TRU waste radionuclides (mainly alpha-emitters) poses risks to the public. The internationally favored approach of burying them in a deep, stable, virtually impervious geologic formation would remove them from the biosphere. Recognizing the inherent safety of this disposal approach and in order to alleviate public concerns, the United States decided to construct and operate WIPP.

The decision to proceed with the phased construction and operation of WIPP resulted in immediate reactions from environmental groups and the New Mexico Attorney General. Lawsuits were filed within months after DOE's decision. Plaintiffs in these 1981 lawsuits included: the Citizens for Alternatives to Radioactive Dumping; the New Mexico Attorney General; and the Southwest Research and Information Center. Defendants in the lawsuits were: DOE; the Bureau of Land Management; the Department of Interior; and the respective directors of these entities. The plaintiffs all sought an injunction prohibiting commencement of construction at the WIPP site. The New Mexico Attorney General also sought to force execution of the Congressionally mandated Consultation and Cooperation Agreement with the State of New Mexico. At the time the lawsuits were filed, negotiations to reach such an agreement between the State and DOE were well underway. However, the parties had not yet reached a final agreement.

On July 1, 1981, DOE and the State of New Mexico executed a Stipulated Agreement settling the litigation; a Consultation and Cooperation Agreement was an addendum to the Stipulated Agreement. In general, these agreements required DOE to conduct various tests, provide periodic reports to the State, and assist the State in resolving concerns such as funding, monitoring, and potential State liabilities. The State agreed to withdraw its application for preliminary injunction, and the court stayed the lawsuits in recognition of the parties' agreements to address the concerns at issue.

The court subsequently ruled that the environmental groups had failed to prove that continued construction of the WIPP would cause irreparable harm. This ruling was issued largely because DOE had promised, in its agreements with the State, to undertake test, experiments, etc. prior to waste emplacement. Resolution of these lawsuits allowed DOE to continue with site construction without the immediate threat or burden of litigation. However, the many tests, experiments, reports, and other conditions of the agreements resulted in additional work and additional delays.

Meanwhile, in the federal regulatory arena, EPA had been developing (since the 1970's) its radioactive waste disposal standards. The final environmental radiation protection standards were issued in 1985. Lawsuits challenging the final standards were initiated by several groups. Then, in 1987, a court decision vacated and remanded the standards to EPA. The court found problematic only the standards related to individual and ground-water protection. However, the court remanded not only those standards but also all of the other requirements, although they were either unchallenged or upheld. On rehearing, the court reinstated the management and storage standards, but left in remand all of the disposal standards, including the individual and groundwater protection standards. During that remand, DOE did not have a formal yardstick for measuring the safe, long-term performance of the WIPP TRU waste repository.

In 1992, Congress attempted to propel WIPP forward by passing the Land Withdrawal Act (LWA). Congress expressly withdrew the public lands that had been needed for WIPP since the 1970s. Moreover, Congress reinstated EPA's radioactive waste disposal standards, with the exception of the individual and groundwater protection standards, and required EPA to establish criteria to determine DOE's compliance with the disposal standards. In December 1993, EPA issued final radioactive waste disposal standards (40 CFR Part 191, Subparts B and C) incorporating the remanded disposal standards and other radioactive waste standards that had been vacated by the court in 1987. EPA issued its compliance criteria in February 1996 (40 CFR Part 194).

DOE had been essentially self-regulating at the WIPP site prior to the enactment of the LWA, except for the voluntary agreement with the State of New Mexico in 1981. However, the LWA changed that. The LWA required DOE to develop a Compliance Certification Application (CCA) demonstrating its compliance with EPA's Part 191 final radioactive waste disposal standards. Further, EPA was authorized -- as an external regulator -- to review the CCA and certify whether the WIPP will comply with those standards. In addition, the LWA required WIPP to comply with certain applicable environmental laws and regulations.

Once EPA's Part 191 standards were finalized in 1993, DOE moved full speed ahead to demonstrate its compliance and environmental acceptability. There was now a degree of predictability which would place WIPP on a clear path to waste receipt. DOE now knew what it had to do to satisfy the LWA.

In September 1996, Congress passed an amendment to the LWA (LWAA) which, among other things, mandated that EPA rule on the CCA within one year after finding it administratively complete. The LWAA also reduced the waiting period for WIPP's opening from 180 days following EPA's certification of compliance to 30 days.

In 1996, DOE submitted its 21-volume CCA. On May 16, 1997, EPA declared the CCA administratively complete, starting the statutory one-year clock for its technical review of and ruling on the CCA. Thus, EPA must rule on the CCA by May 17, 1998. EPA's ruling should be favorable because the CCA demonstrates that the calculated maximum radiation exposure to an individual is 1/32 of that permitted by the related EPA regulations, which, actually, is 1/766 of the average natural background radiation in the United States. If EPA rules favorably on the CCA in April 1998, then, contingent upon the Secretary of Energy's prompt decision, the WIPP TRU waste repository could open 30 days later, i.e., sometime in May 1998.

While WIPP is a first-of-a-kind project and subject to unique and costly requirements, it is similar in many ways to other facilities and projects going through a "licensing" process. For example, DOE has had to confront two facts of life in dealing with external regulators: the regulator has the responsibility and prerogative to promulgate regulations (within its statutory authority) that satisfy its concerns about protection of public health and the environment, and the applicant has to comply with those applicable regulations. Further, one must give the regulator what it wants/needs to make its decision. DOE's acceptance of that reality at WIPP has been a fundamental working principle in its interactions with EPA and a necessary ingredient in our success to date.

In its review of the CCA, EPA has made continued requests for information. Constrained by a fixed budget, DOE rescheduled previously planned activities and reallocated staff and financial resources to promptly address these new post-application challenges introduced by EPA. For example, on April 25, 1997, EPA requested an expert elicitation on WIPP post-closure waste particle size. The CAO and its contractors complied in as forthright and prompt a manner as possible. Funding was promptly reallocated, applicable procedures and plans were developed, one expert-panel elicitor and six qualified experts were identified and contracted before the expert elicitation panel convened on May 5, 1997. The final expert elicitation report on post-closure waste particle size was issued on June 3, 1977. EPA also wanted DOE to conduct three sets of verification PA calculations based on a broader and less conservative range of parameter values defined by EPA than those used by DOE in the CCA. The additional PA calculations were completed in August 1997 and showed that, even under extremely unlikely conditions, the WIPP TRU waste repository readily complies with the very stringent safety criteria defined in the applicable EPA regulations. DOE remains confident that the WIPP TRU waste repository is very robust/safe and complies with all applicable laws and regulations. Further, DOE will be able to respond in a prompt manner to any future additional EPA information requests and, thus, facilitate EPA's favorable ruling on the CCA in April 1998.

Another challenge to WIPP has been the rather abrupt change in the regulatory status of so-called "mixed waste" under the Resource Conservation and Recovery Act (RCRA) of 1976. RCRA established a federal/state structure to track and regulate hazardous waste. Congress gave EPA the authority to implement and enforce RCRA, and also authorized EPA to delegate to the states the right to implement and enforce RCRA within their borders. Congress specifically excluded source, special nuclear, and byproduct material subject to the AEA from the requirements of RCRA, allowing these materials to remain under DOE's exclusive control. Congress, however, did not specifically address radioactive waste that is mixed with hazardous constituents.

About 60 percent of the existing inventory of TRU waste is estimated to also contain hazardous components. Throughout the construction phase in the early 1980s, DOE considered its radioactive mixed waste to be subject only to the AEA and not subject to the requirements of RCRA. However, in 1986, EPA issued a notice in the Federal Register, stating its position that the hazardous waste components of mixed wastes were regulated by RCRA. In 1987, DOE issued the Byproduct Rule, which concluded that the radioactive constituents of mixed wastes were byproduct material and therefore subject to the AEA, and that only the hazardous constituents in mixed waste would be subject to RCRA. DOE's recognition that its mixed waste was subject to RCRA resulted in a number of additional regulatory requirements WIPP had to meet, including RCRA permit requirements. DOE moved forward expeditiously to fulfill RCRA requirements.

The State of New Mexico was granted mixed waste authority by EPA in 1990, authorizing the State to implement the RCRA mixed waste program, with some exceptions. With the State's new authority over the hazardous component of mixed wastes, DOE's mixed waste became subject to additional State oversight and authority. In addition to fulfilling the requirements of the Stipulated Agreement and the Consultation and Cooperation Agreement, DOE would have to satisfy applicable RCRA requirements prior to radioactive mixed waste receipt or mixed waste disposal at WIPP. These new roles, responsibilities, and requirements created a new direction for DOE.

DOE began the RCRA permitting process in May 1995 by submitting to the New Mexico Environment Department (NMED) the RCRA Part B Permit application for the hazardous waste components. We are hopeful that the permit will be issued in 1998. In any event, RCRA permit requirements do not apply to the non-mixed TRU waste. Consequently, a RCRA Part B permit, as the Secretary of NMED has acknowledged, is not required to open WIPP for non-mixed TRU waste. DOE therefore intends to open WIPP prior to receiving a RCRA Part B permit.

Prior to December 1993, the opening of the WIPP TRU waste repository was scheduled for 2001. However, as a result of a few key decisions, WIPP is now scheduled to open in May 1998. This accelerated schedule has been made possible, in part, by DOE's establishment of an area office in Carlsbad, New Mexico in late 1993. Prior to this reorganization, the primary DOE decision-makers for WIPP resided 275 miles away in Albuquerque, New Mexico, and opening the WIPP was one of many issues for these decision-makers to address. CAO was given responsibility for the WIPP Program and responsibility to implement the National TRU Waste Program (NTP). The NTP was tasked to coordinate TRU waste matters with DOE generator sites, such as coordinating issues regarding the WIPP TRU waste acceptance criteria. With renewed vitality, the CAO developed and began to implement an aggressive schedule towards completing all final regulatory requirements necessary for the commencement of WIPP waste disposal operations.

In April 1994, the CAO published the accelerated schedule, which is known as the Disposal Decision Plan (DDP). The DDP was based on a detailed analysis of the entire TRU waste management system, including waste availability, and the experiments and other data required to comply with applicable disposal regulations.

Between March 1994 and August 1995, the CAO conducted a thorough evaluation, the System Prioritization Method (SPM), of the experimental data and other information required to comply with the applicable disposal regulations. The SPM identified eight experimental programs/activities that would provide a 96-percent confidence level that all the scientific information needed to demonstrate compliance with the applicable regulations would be obtained. The SPM involved 116 potential experimental programs/activities, 46,000 combinations of thereof, and 1,300,000 related computational analyses depicting compliance with applicable regulations in terms of complementary cumulative distribution functions (CCDFs) based on assumed outcomes of these programs/activities.

Of paramount importance to the successful implementation of the DDP and the SPM were the focused and motivated contributions provided by the involved management and staff at DOE, including the Secretary of Energy, and its contractors. The advancement of the WIPP schedule and the successful submittal of the required applications to open the WIPP TRU waste repository are largely attributable to the CAO's iterative dialogue with regulators, oversight groups, and other interested parties during the implementation of the DDP and the SPM and the preparation of the applications, and the unwavering local political and public support.

The major challenges to opening of the WIPP TRU waste repository by May 1998, and possibly the future of the WIPP TRU waste repository, may not be those imposed on the CAO, but rather actions against EPA. For example, any hypothetical inadvertent human intrusion scenario can be used to legally challenge a favorable ruling by EPA on the CCA. Although the probability of inadvertent human intrusion scenarios is very low, the consequences could be very grave. Fears of such very unlikely events could unduly affect the public's trust in the inherent robustness and safety of the WIPP disposal system; a condition well known and commonly used by interest groups opposed to nuclear energy. Furthermore, certain interest groups, including the New Mexico Attorney General's office, have already unsuccessfully sued EPA twice over 40 CFR Part 194 and have vowed to continue to take legal action to prevent the opening of the WIPP TRU waste repository. Thus, continued attempts to interfere legally with the opening of the WIPP TRU waste repository are anticipated.

When opened, the WIPP TRU waste repository will become a first-of-a-kind facility for safe disposal of long-lived radioactive waste that will provide a road map to the rest of the world for the successful development and operation of a deep geologic repository for long-lived radioactive waste, including a safe national transportation system. The CAO is committed to provide the rest of the world access to the successful policies employed and experiences gained during the development and operation of a safe TRU waste repository at the WIPP site. However, whether and when the WIPP TRU waste repository will open depends primarily on the NMED's and EPA's rulings on the RCRA Permit and the CCA, respectively, and any legal challenge to these rulings. The CAO is confident that it will continue to be successful in addressing any future scientific challenge to the opening and operation of the WIPP TRU waste repository in a prompt, scientifically credible, and legally compliant manner because existing data and safety analyses demonstrate that the geologic setting at the WIPP site, if undisturbed, is inherently robust and will contain and isolate radionuclides well beyond the 10,000-year regulatory post-closure period.

From its earliest beginnings to the present, DOE has remained true to Congressional mandates. During the 1970s and 80s, Congress mandated numerous changes to the traditional manner in which it had handled federal entities. These changes altered the manner in which federal organizations conduct business. With the rise in environmental protection legislation in the 1970s and 80s, and the move towards openness in government programs, national projects slowed as public concerns about environmental health and safety rose to the forefront of public debate. Also, unprecedented in its past history, Congress subjected its once secret AEC to standards promulgated by another government agency, EPA. The Congress' prior philosophy was that each federal agency knew best how to develop and implement its own guidelines for the management and control of the agency's Congressionally delegated functions.

DOE has overcome many hurdles, realigning its policies and strategies to be consistent with Congressional mandates. The public has been provided countless opportunities to address issues and concerns regarding WIPP. DOE has, through its stakeholder outreach programs, made its scientific and technical information regarding the WIPP project available to the public. In view of the many questions that have been answered by DOE, with strong scientific and engineering demonstrations, the WIPP is ready to move to its final stage, waste disposal, upon EPA's certification.

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