Subchapter C. REGIONAL FACILITY LICENSE

§ 236.201. Scope.

 This subchapter addresses the requirements for licensing the regional disposal facility operator. The requirements included are as follows:

   (1)  Application for a license.

   (2)  License application review procedures and standards.

 (a)  A person may not construct, alter, own or operate a low-level waste disposal facility or may receive, possess or dispose of waste received from other persons at the regional disposal facility unless authorized by a license issued by the Department under this chapter.

 In addition to the requirements in §  236.212 (relating to filing and distribution of license application), an application to receive from others, possess and dispose of wastes shall consist of:

   (1)  General information, program plans, a quality assurance/quality control program, specific technical information, institutional control information and financial information as set forth in § §  236.205—236.211.

   (2)  An impact analysis report. The report shall address the impact of licensing the activity and include:

     (i)   A detailed assessment of the radiological and nonradiological impacts to the public health and the environment.

     (ii)   A detailed assessment of the impact on the quality and quantity of the surface and groundwater within a 5-mile radius of the site.

     (iii)   A discussion of the long term public health and environmental impacts, including closure, decommissioning, decontamination and reclamation of the site and facilities associated with the licensed activities and management of radioactive materials which will remain on the site after closure, decommissioning, decontamination and reclamation.

     (iv)   A discussion of the short and long term social and economic impacts of the regional disposal facility on the host and affected municipalities. These impacts will be used to create a minimum set of items to be considered as part of the host and affected municipality benefit negotiations. At a minimum, the study shall include the impacts on local tax revenues, public and private infrastructures, emergency management capabilities and social service demands.

     (v)   A preoperational environmental radiation survey and a preoperational health survey of cancer and other disease rates and birth defects within 5 miles of the site.

     (vi)   Justification for the choice of the proposed site over the other two preferred potentially suitable sites.

 The license application shall include general information as follows:

   (1)  The identity of the applicant, including:

     (i)   The full name, address, telephone number and description of the business or occupation of the applicant.

     (ii)   The name and address of each partner and the principal location where the partnership does business, if the applicant is a partnership.

     (iii)   The following, if the applicant is a corporation or an unincorporated association:

       (A)   The state in which it is incorporated or organized and the principal location at which it does business.

       (B)   The names and addresses of its directors and principal officers.

     (iv)   Information required under this section with respect to the other person, if the applicant is acting as an agent or representative of another person in filing the application.

   (2)  Qualifications of the applicant as follows:

     (i)   The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority, key positions and assignments of responsibilities, whether in the form of administrative directives, contract provisions or otherwise.

     (ii)   The technical qualifications, including training and experience, of the applicant and members of the applicant’s staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling key positions described in subparagraph (i) shall be provided.

     (iii)   A description of the applicant’s personnel training program.

     (iv)   The plan to maintain an adequate complement of trained personnel to carry out waste receipt, handling and disposal operations in a safe manner.

   (3)  A description of:

     (i)   The location of the proposed disposal site.

     (ii)   The general character of the proposed activities.

     (iii)   The types and quantities of waste to be received, possessed and disposed of.

     (iv)   The proposed facilities and equipment.

   (4)  Proposed schedules for construction, receipt of waste and first emplacement of waste at the disposal facility.

   (5)  A description of the applicant’s compliance with State and Federal environmental protection statutes including the Radiation Protection Act and Low-Level Radioactive Waste Disposal Act, the Appalachian States Low-Level Radioactive Waste Compact Act or other state or Federal statute relating to environmental protection or to protect the public health and safety.

 (a)  The applicant shall submit the following detailed program plans:

   (1)  A siting plan under §  236.103 (relating to siting plan).

   (2)  A quality assurance/quality control plan under §  236.207 (relating to quality assurance/quality control program).

   (3)  A monitoring plan under §  236.409 (relating to monitoring plan).

   (4)  A security plan under §  236.403(a)(1) (relating to facility operation plan).

   (5)  An operations plan under §  236.403.

   (6)  A contingency plan under §  236.404 (relating to contingency plans).

   (7)  A radiation control plan under §  236.403(c).

   (8)  A construction plan under §  236.402 (relating to construction plan).

   (9)  A site closure and decommissioning plan under §  236.411 (relating to site closure and decommissioning plan).

 (b)  The plans set forth in subsection (a), and subsequent changes thereto, will be reviewed and approved by the Department. The requirement to implement the approved plans will be incorporated into the facility license.

 (c)  The plans shall demonstrate that the necessary technical information and analyses can be obtained and used to demonstrate compliance with the performance objectives.

 A quality assurance/quality control plan shall be submitted to the Department for approval. The plan shall include a description of the quality assurance/quality control program for the determination of natural disposal site characteristics and for quality assurance/quality control during the design, construction, operation and closure of the disposal facility and the receipt, handling and emplacement of waste. Audits and managerial controls shall be included.

 The specific technical information shall include information needed for demonstrating that the performance objectives and the applicable technical requirements of this chapter will be met. The following shall be included:

   (1)  A description of the natural and demographic disposal site characteristics as determined by site screening and characterization activities contained in Subchapter B (relating to requirements for siting the regional disposal facility). The description shall include demographic, meteorologic, climatologic, biotic, ecologic, hydrologic, geologic (including geochemical and geotechnical) and natural resource features of the disposal site and vicinity.

   (2)  A description of the design features of the disposal facility and the disposal units. The description shall include those design features related to the following:

     (i)   Minimization of water intrusion.

     (ii)   Integrity of covers for disposal units.

     (iii)   Structural stability.

     (iv)   Contact of wastes with standing water.

     (v)   Disposal site drainage.

     (vi)   Closure and stabilization.

     (vii)   Recoverability.

     (viii)   Elimination to the extent practicable of long term active maintenance.

     (ix)   Protection from inadvertent intrusion.

     (x)   Occupational exposures.

     (xi)   Monitoring.

     (xii)   Adequacy of the size of the buffer zone for monitoring and potential remedial measures.

   (3)  A description of the principal design features and their relationship to the performance objectives.

   (4)  A description of the engineered structures which the applicant has incorporated into the design and which will apply to construction of the disposal facility.

   (5)  A description of codes and standards which the applicant has applied to the design and which will apply to construction of the disposal facility.

   (6)  A description of the construction and operation of the disposal facility. The description shall include at a minimum:

     (i)   Methods of constructing the disposal units.

     (ii)   Waste emplacement.

     (iii)   Procedures for and areas of waste segregation.

     (iv)   Types of intruder barriers.

     (v)   Onsite traffic and drainage systems.

     (vi)   Survey control program.

     (vii)   Methods and areas of waste storage.

     (viii)   Methods to control water access to the wastes.

     (ix)   The methods to be employed in the handling and disposal of wastes containing chelating agents or other nonradiological substances that might affect meeting the performance objectives of Subchapter A (relating to general provisions).

   (7)  A description of the disposal site closure and decommissioning plan under §  236.411 (relating to site closure and decommissioning plan); specifically those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

   (8)  An identification of the known natural resources at the disposal site, exploitation of which could result in inadvertent intrusion into the waste after removal of active institutional control.

   (9)  A description of the various low-level waste streams and the physical and chemical properties, and the volumes and different classes of waste proposed to be received, possessed and disposed of at the disposal facility. The description shall include consideration of projected variations in future waste streams and volumes and their potential affect on the disposal facility.

   (10)  A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the performance objective in Subchapter A and occupational radiation exposure to ensure compliance with Chapter 219 (relating to standards for protection against radiation) and to control contamination of personnel, vehicles, equipment, buildings and the disposal site. Both routine operations and accidents shall be addressed. The program description shall include procedures, instrumentation, facilities and equipment. Application of as low as reasonably achievable shall be discussed.

   (11)  A description of the monitoring program under §  236.409 (relating to monitoring plan) to provide data to evaluate disposal facility performance, potential health and environmental impacts and the plan for taking remedial measures.

   (12)  A description of the administrative procedures that the applicant will apply to control activities at the disposal facility.

   (13)  A description of potential operational accidents and the methodology to assure that likely accident scenarios are bounded.

 The specific technical information shall also include the following analyses needed to demonstrate that the performance objectives of Subchapter A (relating to general provisions) will be met:

   (1)  Analyses of the pathways demonstrating protection of the general population from releases of radioactivity. Pathways analyzed shall include air, soil, groundwater, surface water, plant uptake and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural site characteristics and design features in isolating and segregating the wastes. The analyses shall clearly demonstrate that there is assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in the performance objectives in Subchapter A.

   (2)  Analyses of the protection of individuals from inadvertent intrusion. The analyses shall include a demonstration that there is assurance that the waste classification and segregation requirements will be met and that barriers to inadvertent intrusion will be provided.

   (3)  Analyses of the protection of individuals during operations. The analyses shall include assessments of expected exposures due to routine operations and likely accidents during handling, storage and disposal of waste. The analyses shall provide assurance that exposures will be controlled to meet the requirements of Chapter 219 (relating to standards for protection against radiation).

   (4)  Analyses of the long term stability of the disposal site to determine the need for ongoing active maintenance after closure. These analyses shall consider active natural processes, including erosion, mass wasting, slope failure, settlement of wastes, infiltration through disposal covers and surface drainage of the disposal site. The analyses shall provide assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

 The institutional control information submitted by the applicant shall include:

   (1)  A certification by the Commonwealth that the custodial agency is prepared to accept transfer of the license when §  236.246 (relating to application and transfer of license to the Commonwealth) is met and will assume responsibility for institutional control after site closure and the postclosure observation and maintenance period.

   (2)  If the proposed disposal site is on land not owned by the Federal government or the Commonwealth, the applicant shall submit evidence that arrangements have been made for assumption of ownership by the Commonwealth before the Department issues a license.

 The financial information shall be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet the financial assurance requirements of section 316 of the act (35 P. S. §  7130.316) and Subchapter G (relating to financial assurances and liability). The applicant shall provide documented evidence of the availability of funds. If debt capital will be used, letters of commitment from the financial sources shall be provided.

 (a)  An application package to obtain a license under this chapter and the Department licenses and permits necessary to construct and operate the disposal facility shall be filed with the Secretary. The applicant shall submit one signed original and 35 copies to the Secretary.

 (b)  The application package shall contain a statement, signed by a responsible official of the applicant and attested by a notary public, that certifies that the information contained in the application package is true and correct to the best of the official’s information and belief.

 (c)  The application package shall consist of the following:

   (1)  The application for a license.

   (2)  An impact analysis report.

   (3)  The Department license and permit applications necessary for construction and operation of the disposal facility.

 Except as otherwise specified, communications and reports concerning this chapter and applications filed under it shall be addressed to the Secretary, Department of Environmental Resources, Post Office Box 2063, Harrisburg, Pennsylvania 17120.

LICENSE REVIEW PROCEDURES AND STANDARDS

§ 236.221. Verification of receipt of application.

 (a)  Upon receipt of the license application, the Department will notify the public of receipt of the application. The notification will include a listing of the locations in which the application can be reviewed by the public. Notification will be provided in the Pennsylvania Bulletin, local media, newspapers of wide general circulation and newspapers in the area the regional facility is proposed to be located.

 (b)  The Department will make the license application available for review in the host municipality.

 (a)  The Department will hold one public hearing and one public information meeting on the initial license application in the area the regional facility is proposed to be located. The Department will issue a 30-day public notice in the Pennsylvania Bulletin and newspapers of general circulation in the area of the proposed host municipality to announce the hearing and meeting dates. There will be a minimum of 30 days time between the public hearing and the public meeting.

 (b)  Interested persons may submit to the Department written comments regarding the application. Comments shall be submitted within 180 days after notification has been made under §  236.222 (relating to public notice). Interested persons may submit comments at the hearing. A person wishing to examine witnesses shall submit to the Department a numbered list of contentions. The contentions shall be limited to failure of the license application and its contents to conform with the act and this chapter. The applicant shall submit two copies of its testimony 2 weeks before the date the hearing is scheduled. The applicant or licensee shall make its staff available to answer questions. The Department may establish the duration for oral testimony and may limit the scope of questioning during the hearing.

 (c)  Written comments and the transcript of the hearing will be considered in the Secretary’s decision on the application and become part of the public record.

 (d)  The Department will provide a written response to comments or testimony at the time a final action is taken.

 (a)  If the license application is rejected, a revised application may be submitted and may incorporate the portions of the previous application that were not the bases of the rejection.

 A license will not be issued unless the applicant affirmatively demonstrates to the satisfaction of the Department that:

   (1)  The operation will not endanger public health, safety and welfare or the environment.

   (2)  The application is accurate and complete and the requirements of the act and this chapter have been satisfied.

   (3)  The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property.

   (4)  The applicant’s proposed disposal site, disposal facility design, disposal facility operations, including equipment, facilities and procedures, disposal site closure and postclosure institutional control are adequate to protect the public health and safety by providing assurance that the general population will be protected from releases of radioactivity as specified in the performance objective in §  236.13 (relating to protection of the general population and environment from releases of radioactivity).

   (5)  The applicant’s proposed disposal site, disposal facility design, disposal facility operations, including equipment, facilities and procedures, disposal site closure and postclosure institutional control are adequate to protect the public health and safety by providing assurance that individual inadvertent intruders are protected in accordance with the performance objective in §  236.14 (relating to protection of individuals from inadvertent intrusion).

   (6)  The applicant’s proposed disposal facility design and disposal facility operations, including equipment, facilities and procedures, are adequate to protect the public health and safety by providing assurance that the standards for radiation protection in Chapter 219 (relating to standards for protection against radiation) will be met.

   (7)  The applicant’s proposed disposal site, disposal facility design, disposal facility operations, disposal site closure and postclosure institutional control are adequate to protect the public health and safety by providing assurance that long term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing active maintenance following closure.

   (8)  The technical requirements of Subchapters B and D—F will be met.

   (9)  The applicant’s proposal for institutional control, as required in §  236.210 (relating to institutional control information), provides assurance that the control will be provided for the long term care period.

   (10)  The financial or surety arrangements meet the requirements of Subchapter G (relating to financial assurances and liability).

 (a)  A license issued under this chapter, or a right thereunder, may not be transferred, assigned or disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to another person, unless the Department finds, after securing full information, that the transfer is in accordance with the act and the Department gives its consent in writing in the form of a license amendment.

 (b)  The licensee shall submit written statements under oath upon request of the Department, before termination of the license, to enable the Department to determine whether the license should be modified, suspended or revoked.

 (c)  The license will be transferred to the custodial agency on the full implementation of the site closure and decommissioning plan as approved by the Department, including postclosure observation and maintenance.

 (d)  The licensee shall be subject to the act and to this title and orders of the Department. The terms and conditions of the license are subject to amendment, by reason of amendments to, or by reason of this title and order issued under the act.

 (e)  The person licensed by the Department under this chapter shall confine possession and use of materials to the locations and purposes authorized in the license.

 (f)  The licensee may not dispose of waste until the Department has inspected the disposal facility and has found it to be in conformance with plans described in the application for a license and approved by the Department.

 (g)  The Department may incorporate in the license at the time of issuance, or thereafter, by appropriate rule, regulation or order, additional requirements and conditions with respect to the licensee’s receipt, possession and disposal of waste as the Department deems appropriate or necessary to:

   (1)  Protect health or minimize danger to life or the environment.

   (2)  Provide for inspections or activities under the license that may be necessary or appropriate to effectuate the purposes of the act and regulations thereunder.

   (3)  Require tests, reports and the keeping of records.

 (h)  The authority to dispose of wastes expires on the date stated in the license. The Department will, on a 5-year basis, review the license and conditions of the license. An expiration date on the license applies only to operational activities and to the authority to dispose of waste. Failure to revise the license does not relieve the licensee of responsibility for implementing site closure and decommissioning, postclosure observation and transfer of the license to the Commonwealth.

 (i)  The license may be revoked, suspended or modified for a material false statement in the application, or because of conditions revealed by a report, record or inspection or other means which would warrant the Department to refuse to grant a license for the original application.

 (j)  The licensee shall allow the Department, its agents and employes, and the host municipality and host county inspectors, without advance notice or search warrant, upon presentation of appropriate credentials and without delay, to have access to areas where disposal activities are conducted and to examine the records and books relating thereto.

 The initial decision to issue a license under this chapter or an amendment to the license shall become effective immediately upon signed order of the Secretary or a delegated representative.

CHANGES TO THE REGIONAL FACILITY LICENSE

§ 236.241. Amendments for closure and transfer.

 (a)  An application for closure under §  236.245 (relating to content of a license application for closure) shall be filed at least 90 days prior to license expiration.

 (a)  Prior to final closure of the disposal site, or as otherwise directed by the Department, the licensee shall submit an application to amend the license for closure. This closure application shall include a final revision and specific details of the disposal site closure and decommissioning plan submitted under §  236.206 (relating to program plans) that includes the following:

   (1)  Additional geologic, hydrologic or other data pertinent to the long term containment of emplaced wastes obtained during the operational period.

   (2)  The results of tests, experiments or other analyses relating to the long term containment of emplaced waste within the disposal facility.

   (3)  Proposed revision of plans for:

     (i)   Decontamination or dismantlement of facilities, or both.

     (ii)   Stabilization of the disposal site for postclosure care.

   (4)  Significant new information regarding the environmental impact of closure activities and long term performance of the disposal site.

 (b)  Upon review and consideration of an application to amend the license for closure submitted under this section, the Department will issue an amendment authorizing closure if there is assurance that the long term performance objectives of Subchapter A (relating to general provisions) will be met.

 (a)  Following closure and the postclosure observation and maintenance period, the licensee may apply for an amendment to transfer the license to the Commonwealth. The license will not be transferred unless the licensee demonstrates to the Department’s satisfaction that:

   (1)  The closure of the disposal site has been made in conformance with the licensee’s site closure and decommissioning plan, as approved as part of the license.

   (2)  The performance objectives of Subchapter A (relating to general provisions) have been met and will continue to be satisfied.

   (3)  Funds collected for the Account and necessary records for care have been transferred to the Commonwealth.

   (4)  The monitoring program is operational for implementation by the Commonwealth.

   (5)  The custodial agency which will assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional requirements found necessary under §  236.225(i) (relating to requirements for issuance of a license) will be met.

 (b)  Upon demonstration of the requirements of subsection (a), the disposal facility license will be transferred to the Commonwealth and the operator’s license will be terminated.

 (a)  At any period of time during the long term care period, the custodial agency—licensee—may apply for an amendment to terminate the license.

 (b)  The application shall be filed under §  236.212 (relating to filing and distribution of license application) and the requirements of this section.

 (c)  The licensee shall demonstrate to the satisfaction of the Department that the standards of §  236.508 (relating to determination of hazardous life of the waste) are met.