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Statement of Need: The DOE is developing the WIPP near Carlsbad in southeastern New Mexico as a potential deep geologic repository for the disposal of defense transuranic (TRU) radioactive waste currently being stored on Federal reservations in 10 states, including Washington, Ohio, Idaho, New Mexico, Tennessee, South Carolina, Nevada, and Colorado. TRU waste consists of materials containing one or more elements having atomic numbers greater than 92, in concentrations greater than 100 nanocuries of alpha-emitting TRU isotopes per gram of waste, with half-lives greater than twenty years. Most TRU waste consists of items that have become contaminated (e.g., rags, equipment, tools, and organic and inorganic sludges) as a result of activities associated with the production of nuclear weapons. TRU waste is often mixed with hazardous chemical constituents. Before beginning disposal of radioactive waste at the WIPP, DOE must demonstrate that the WIPP complies with the EPA's radioactive waste disposal standards at subparts B and C of 40 CFR 191. ^PThe WIPP LWA specifies that underground emplacement of transuranic wastes for disposal at the WIPP may not commence until EPA makes a positive compliance certification decision. If the Agency certifies compliance, the WIPP LWA requires EPA to subsequently conduct periodic re-certifications of continued compliance throughout waste disposal operations (estimated to last about 30 years) at the WIPP. Now that the final compliance criteria are promulgated as Agency regulations (40 CFR 194 on 2/1/96), DOE is responsible for submitting a compliance application to EPA. The Agency will review the application and make a decision as to WIPP's compliance with the disposal regulations. The WIPP compliance certification rule will be limited to consideration of the WIPP's compliance with the disposal regulations found in subparts B and C of 40 CFR 191 (which include containment requirements, assurance requirements, individual protection requirements, and groundwater protection requirements).

Summary of the Legal Basis: Under the authority of the Atomic Energy Act, as amended, of 1954, EPA has the responsibility to protect people and the environment from the harmful effects of ionizing radiation. In addition, Reorganization Plan No. 3 of 1970 provides EPA with the authority to establish standards for the protection of people and the environment from the effects of all radioactive materials. Finally, the WIPP Land Withdrawal Act of 1992 requires that EPA issue criteria to implement the Agency's radioactive waste disposal regulations specifically at the WIPP, and then certify, through use of such criteria, whether or not the WIPP complies with the regulations and should be allowed to open.

Alternatives: The compliance certification rule is intended to determine whether or not the WIPP should be allowed to open. The Agency recognizes the uncertainty inherent in projections of the WIPP's performance during the 10,000-year regulatory period. Accordingly, the Agency requires a demonstration of a reasonable expectation that compliance will be achieved. This demonstration will be based on consideration of the entire application for certification submitted by DOE. The criteria against which the WIPP's compliance will be evaluated contain four subparts, consisting of: ^P(1) subpart A, which specifies general administrative requirements with which DOE must comply during the compliance application and subsequent rulemaking processes. Requirements are specified which contain format and protocols for the submission of applications plus any subsequent suspension, revocation or modification of compliance status. ^P(2) subpart B, which outlines the information necessary for inclusion with compliance applications. The criteria require DOE to analyze the performance of WIPP and predict release of waste, doses received by individuals and doses received through ground water. The criteria list the information needs for such assessments. Subsequent applications for determinations must note any changes in such information that might have occurred since initial certification. ^P(3) subpart C, which implements the specific containment, assurance, individual and groundwater protection requirements of the disposal standards of 40 CFR 191. To account for the likelihood of human activity and human intrusion into the repository during the 10,000- year regulatory period, the criteria specify how the frequency and consequences of such events shall be determined. The results of compliance assessments of individual and groundwater protection shall be expressed to show the likelihood of a given exposure or greater occurring. To increase confidence in performance and compliance assessments, the criteria specify requirements on quality assurance methodologies and characterization of radioactive waste proposed for emplacement in the repository. Assurance requirements include criteria for _defense-in-depth,_ such as institutional controls to warn potential intruders about the hazards of the waste, monitoring of the repository to detect

Anticipated Costs and Benefits: The party primarily affected under this action is the DOE, owner and operator of the WIPP. The Agency prepared an Economic Impact Analysis (EIA) for the WIPP compliance criteria (40 CFR 194). This EIA estimated those costs imposed on the WIPP project in excess of those being incurred presently due to other applicable regulations or program requirements. While the total cost may have appeared sizeable, it did not appear to be so sizeable that it would have been "significant" as defined under the provisions of Executive Order No. 12866, i.e., more than $100 million per year. The portion of the criteria concerning human intrusion into the WIPP was the only potential contributor to significant increases in cost (i.e., as much as $20 million or less than one percent of the total cost; the total cost of the WIPP project is over $8 billion to date). Additional costs could be incurred if compliance could only be achieved through redesign of the repository or treatment of waste in order to reduce the likelihood and consequences of human intrusion.

Risks: Because this regulation is not setting standards, but implementing an existing standard (40 CFR 191) and making a compliance decision, no analysis of risk has been performed.