PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[25 PA. CODE CHS. 215, 217, 219, 220, 224, 225, 226, 230 AND 232]
Radiological Health
[30 Pa.B. 4503] The Environmental Quality Board (Board) proposes to amend Chapters 215, 217, 219, 220, 224--226 and 230 and to add a new Chapter 232. The proposed amendments update the standards for protection against radiation.
This proposal was adopted by the Board at its regular meeting on June 20, 2000.
A. Effective Date
These amendments will be effective immediately upon publication in the Pennsylvania Bulletin as final-form rulemaking.
B. Contact Persons
For further information, the contact persons are Ray Urciuolo, Chief, Licensing Section, Bureau of Radiation Protection, 13th Floor, Rachel Carson State Office Building, P. O. Box 8469, Harrisburg, PA 17105-8469, (717) 787-3720; and Marylou Barton, Assistant Counsel, Bureau of Regulatory Counsel, Rachel Carson State Office Building, 9th Floor, 400 Market Street, P. O. Box 8464, Harrisburg, PA 17105-8464, (717) 787-7060.
C Statutory Authority
These amendments are proposed under the authority of the following statutes:
Sections 301 and 302 of the Radiation Protection Act (act) (35 P. S. §§ 7110.301 and 7110.302), which, respectively, direct the Department to develop and conduct comprehensive programs for the registration, licensing, control, management, regulation and inspection of radiation sources and radiation source users, and delegate to the Board the power to adopt the regulations of the Department to implement the act.
Section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20), which authorizes and directs the Board to adopt regulations necessary for the proper performance of the work of the Department.
D Background and Purpose
In 1995, the Board updated its radiological health regulations to provide for compatibility with other states and to serve as a basis for the Commonwealth to assume authority from the United States Nuclear Regulatory Commission (NRC) for radioactive material licensees in this Commonwealth as an agreement state. These updates were published at 25 Pa.B. 5088 and 5206 (November 18, 1995). Technological advances in the use of radioactive material and the need to establish and maintain radiation protection standards at least as stringent as the NRC standards provide the basis for these revisions to the existing radiological health regulations.
The proposed amendments are necessary for the Commonwealth to acquire agreement state status from the NRC. Under section 201 of the act (35 P. S. § 7110.201), the Governor is authorized to enter into agreements with the NRC transferring regulatory authority to the Commonwealth for radiation protection. Presently, the Commonwealth is responsible for the regulation of naturally occurring and accelerator-produced radioactive material (NARM) and radiation producing equipment. Under the Atomic Energy Act of 1954 (42 U.S.C.A. § 2021), the NRC is authorized to enter into an agreement with the Governor to discontinue NRC regulatory authority with respect to most by-product materials, source materials and special nuclear materials in amounts insufficient to form a critical mass.
The proposed amendments are based on the current NRC radiation protection regulations in 10 CFR Parts 19--150.
As required by section 301(c)(14) of the act (35 P. S. § 7110.301), the Department provided the Radiation Protection Advisory Committee (Committee) with an opportunity to review the proposed amendments and to advise the Department prior to submittal to the Board. On March 18, 1999, the Committee met and reviewed the proposed amendments. The chairperson announced by letter dated May 17, 1999, the Committee's concurrence to send the proposed amendments to the Board.
E. Summary of Regulatory Requirements
The proposed amendments revise current radiation protection regulations to reflect compatibility with NRC radiation protection regulations. The revisions are requisite to the Commonwealth's attainment of Agreement State status from the NRC. A description of the proposed regulations is provided as follows:
Chapter 215. General Provisions
Section 215.1 (relating to purpose and scope) is expanded to clarify that the effect of incorporation by reference under subsection (e) would not relieve a person from complying with Pennsylvania law nor would it expand the scope of authority granted the Department under statute in subsection (f). Locations are listed in new § 215.1(g) for purchasing copies of the Code of Federal Regulations (Title 10 Chapter I) to be incorporated by reference. An electronic version is also available on the United States Government Printing Office world wide web site. http://www.access.gpo.gov/ cgi-bin/cfrassemble.cgi?title=199910
Section 215.2 (relating to definitions) The following definitions were deleted because they are incorporated by reference: ''ALARA,'' ''A1,'' ''A2,'' ''absorbed dose,'' ''agreement State,'' ''airborne radioactive material,'' ''airborne radioactivity area,'' ''background radiation,'' ''becquerel,'' ''byproduct material,'' ''calendar quarter,'' ''collective dose,'' ''committed dose equivalent,'' ''committed effective dose equivalent,'' ''controlled area,'' ''curie,'' ''deep dose equivalent,'' ''depleted uranium,'' ''dose,'' ''dose equivalent,'' ''dose limits,'' ''effective dose equivalent,'' ''embryo/fetus,'' ''exposure,'' ''exposure rate,'' ''external dose,'' ''extremity,'' ''eye dose equivalent,'' ''generally applicable environmental radiation standards,'' ''gray,'' ''high radiation area,'' ''individual monitoring,'' ''individual monitoring devices,'' ''internal dose,'' ''licensed material,'' ''lost or missing licensed or registered source of radiation,'' ''member of the public,'' ''minor,'' ''monitoring,'' ''normal form,'' ''occupational dose,'' ''personnel monitoring equipment,'' ''prescribed dosage,'' ''public dose,'' ''rad,'' ''radiation area,'' ''radiopharmaceutical,'' ''rem,'' ''research and development,'' ''restricted area,'' ''sealed source,'' ''SI,'' ''shallow dose equivalent,'' ''sievert,'' ''site boundary,'' ''source material,'' ''special form,'' ''special nuclear material,'' ''special nuclear material in quantities not sufficient to form a critical mass,'' ''survey,'' ''TEDE,'' ''unrefined and unprocessed ore,'' ''unrestricted area,'' ''week,'' ''whole body,'' ''working level,'' ''working level month'' and ''year.''
The following definitions are updated: ''NRC,'' ''qualified expert'' and ''roentgen.'' The definition of ''misadministration'' is redefined for X-ray by using the appropriate parts of the NRC proposed definition for ''medical event.'' The definition of ''prescribed dose'' is changed to ''prescribed dose for X-ray therapy'' by deleting references to radioactive material modalities. The definition of ''written directive'' is changed to ''written directive for X-ray therapy'' by deleting references to radioactive material.
Section 215.3 (relating to units of exposure and dose) is amended to delete units of dose already incorporated by reference in 10 CFR 20.1004.
Section 215.4 (relating to units of activity) is deleted because it is replaced by incorporation by reference of 10 CFR 20.1005.
Section 215.5 (relating to effect of incorporation of the Code of Federal Regulations) is added for clarification.
Section 215.11 (relating to records) is amended to clarify the separate recordkeeping requirements of licensees and registrants.
Section 215.12 (relating to inspections) is amended to change the target inspection frequency for major medical facility X-ray operations from every 2 years to every 3 years.
Section 215.15 (relating to additional requirements) was amended by incorporating the requirements of § 219.73 (orders requiring furnishing of bioassay services).
A new § 215.25 (relating to deliberate misconduct) is added for compatibility with the NRC.
A new § 215.26 (relating to employe protection) is added for compatibility with the NRC.
A new § 215.27 (relating to vacating premises) is added to replace § 219.241 (relating to vacating premises). The requirement is extended to all licenses and is in addition to the decommissioning requirements of 10 CFR 30.36 that are incorporated by reference under Chapter 217.
A new § 215.28 (relating to deceptive exposure of a monitoring device) is added to prohibit using a monitoring device to indicate deceptively high or low doses to individuals.
Section 215.32 (relating to exempt qualifications) is amended to add the new Chapter 232 (relating to licenses and radiation safety requirements for irradiators) to the list of chapters.
Chapter 217. Licensing of Radioactive Material
Section 217.1 (relating to purpose and scope) is amended to include references to Chapters 218 and 232 (relating to licenses and radiation safety requirements for irradiators).
Section 217.2 (relating to address for communications) is updated with the new Department name and address.
Sections 217.11--217.18, 217.21--217.24, 217.31, 217.32, 217.41--217.49, 217.51--217.57, 217.65, 217.71--217.74, 217.81--217.93, 217.101, 217.121 and 217.122, Appendix A, B and D are deleted and replaced by new sections and new tables for NARM and renamed subchapters that incorporate applicable portions of 10 CFR Parts 30, 31, 32, 33, 40, 70 and 150 by reference.
A new Subchapter B (general provisions for radioactive material) is created to incorporate 10 CFR 30 (relating to rules of general applicability to domestic licensing of byproduct material).
Sections 217.131 and 217.132 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 30) explain incorporation by reference.
Section 217.133 (relating to persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an Agreement State as published in the Federal Register) is the existing § 217.24.
Section 217.134 (relating to filing application for specific licenses) is the existing § 217.51(d) and alerts the applicant for a license that a fee is required.
Section 217.135 (relating to renewal of licenses) is similar to the existing § 217.55 and is amended to alert the licensee to the Department's renewal requirements.
Section 217.136, relating to exempt concentrations and Table 1, replaced the existing requirements of § 217.12 and Appendix A for NARM isotopes which are not included in incorporation by reference.
Section 217.137, relating to exempt quantities and Table 2, replace the existing requirements of § 217.13 and Appendix B for NARM isotopes which are not included in incorporated by reference.
A new Subchapter C (relating to general licenses for radioactive material) is created to incorporate 10 CFR 31 (relating to general domestic licenses for byproduct material).
Sections 217.141 and 217.142 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 30) explain the incorporation by reference.
Section 217.143 (relating to certain measuring, gauging or controlling devices) is the existing § 217.42 amended to include some Department requirements that are not included in the incorporation by reference.
Section 217.144 (relating to incidental radioactive material produced by a particle accelerator) is the existing § 217.48 amended to include a Department requirement which is not included in the incorporation by reference.
A new Subchapter D (relating to specific licenses to manufacture or transfer certain items containing radioactive material) is created to incorporate 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) and to also include NARM radioactive material.
The requirements of existing Subchapter D (relating to transfer of radioactive material) are moved to new Subchapter I with the same title.
Sections 217.151 and 217.152 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 32) explain the incorporation by reference.
Section 217.153 (licensing the incorporation of NARM into gas and aerosol detectors) is the existing § 217.83 amended to include a Department requirement for using radium-226 that is not included in the incorporation by reference.
Section 217.154 (relating to special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226) is the existing § 217.86 amended to include a Department requirement for using radium-226 that is not included in the incorporation by reference.
Section 217.155 (relating to manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license) is the existing § 217.88 amended to include Department requirements for using NARM that are not included in the incorporation by reference.
A new Subchapter F (relating to specific domestic licenses of broad scope for radioactive material) is created to incorporate 10 CFR Part 33 (relating to specific domestic licenses of broad scope for byproduct material). This replaces deleted §§ 217.71--217.74 and Appendix D for licenses of broad scope.
Sections 217.161 and 217.162 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 32) explain the incorporation by reference.
Section 217.163, relating to types of specific licenses of broad scope and Table 3, replace the existing requirements of §§ 217.71--217.73 and Appendix D for NARM isotopes which are not included in incorporation by reference.
A new Subchapter G (relating to licensing of source material) is created to incorporate 10 CFR Part 40 (relating to domestic licensing of source material).
Sections 217.171 (relating to incorporation by reference) and 217.172 (relating to effect of incorporation of 10 CFR Part 40) explain the incorporation by reference.
A new Subchapter H (relating to licensing of special nuclear material) is created to incorporate 10 CFR 70 (relating to domestic licensing of special material).
Sections 217.181 and 217.182 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 70) explain the incorporation by reference.
A new Subchapter I (relating to transfer of radioactive material) is the existing Subchapter D and § 217.191 is the existing § 217.101.
A new Subchapter J (relating to reciprocity) is the existing Subchapter F amended to incorporate 10 CFR 150.2 (relating to scope), 10 CFR 150.11 (relating to critical mass) and 10 CFR 150.20 (relating to recognition of Agreement State licenses).
Sections 217.201 and 217.202 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 150) explain the incorporation by reference.
Section 217.203 (relating to reciprocity of licenses of naturally occurring and accelerator-produced radioactive material) is the existing § 217.122.
Chapter 219. Standards for Protection Against Radiation
Section 219.3 (relating to definitions) is deleted because of incorporation by reference of 10 CFR Part 20.
Section 219.4 (relating to implementation) is deleted because it is obsolete.
Sections 219.5 and 219.6 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 20) are added to clarify the differences between Chapter 219 and 10 CFR Part 20.
Sections 219.21 and 219.31--219.38 are deleted because of incorporation by reference of 10 CFR Part 20.
Existing Subchapter D (relating to radiation dose limits for individual members of the public) consists of §§ 219.51 and 219.52.
Section 219.51 (relating to dose limits for individual members of the public) is amended by incorporation by reference. The current exception that allows individual members of the public in unrestricted areas to receive a higher limit of 0.5 rem per year from medical diagnostic radiation producing machines is eliminated. However, the grandfather clause is retained allowing a higher limit of 0.5 rem per year from any radiation producing machines or other registered radiation sources installed prior to November 18, 1985.
Sections 219.52 (compliance with dose limits for individual members of the public) is deleted because of the incorporation by reference of 10 CFR Part 20.
Existing Subchapter E (relating to testing for leakage or contamination of sealed sources) is reserved but the requirements are retained as in addition to those incorporated by reference in 10 CFR Part 20.
Existing Subchapter F (relating to surveys and monitoring) is deleted. Sections 219.71 and 219.72 are deleted because of incorporation of 10 CFR Part 20 by reference. The current § 219.73 is deleted and the requirements are combined with § 215.15 (relating to additional requirements).
Existing Subchapter G (relating to control of exposure from external sources in restricted areas) consisting of §§ 219.91--219.93 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter H (relating to respiratory protection and controls to restrict internal exposure in restricted areas) consisting of §§ 219.111---219.113 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter I (relating to storage and control of licensed or registered sources of radiation) is amended so that existing §§ 219.131 and 219.132 now apply only to radiation producing machines while incorporation of 10 CFR Part 20 by reference applies to radioactive material.
Existing Subchapter J (relating to precautionary procedures) is amended as follows:
Sections 219.151--219.158 were deleted because of incorporation of 10 CFR Part 20 by reference.
Section 219.159 (relating to posting of radiation producing machines) is amended by changing the words ''The registrant'' at the beginning of the first sentence to ''The registrant or licensee'' because accelerators are now licensed.
Section 219.160 (relating to exceptions to posting requirements) is amended by deletion of those sections for radioactive materials that are superceded through incorporation by reference of 10 CFR Part 20.
Sections 219.161 and 219.162 (relating to exemptions from labeling requirements; and procedures for receiving and opening packages) are deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter K (relating to waste disposal) with §§ 219.181--219.186 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter L (relating to records) with §§ 219.201--219.211 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter M (relating to reports) consists of §§ 219.221--219.228
Section 219.221 (relating to reports of stolen, lost or missing licensed or registered sources of radiation) is amended by deletion of those sections for radioactive materials that are superseded through incorporation by reference of 10 CFR Part 20.
Section 219.222 (relating to notification of incidents) is amended by replacing the current text with incorporation by reference of the requirements for the notification of incidents under 10 CFR Part 20. The scope of the reference is also expanded to apply to radiation producing machines and NARM.
Sections 219.223--219.226 are deleted as a result of incorporation by reference of 10 CFR Part 20.
Existing § 219.227 (relating to reports of leaking or contaminated sealed sources) is retained.
Section 219.228 (relating to reports of misadministrations) was renamed to ''reports of misadministrations from X-ray.''
Existing Subchapter N (relating to additional requirements) which consists of § 219.241 (relating to vacating premises) is deleted. The conditions are transferred to new § 215.27 and expanded to apply to all licensees.
Chapter 219, Appendices A--C (relating to protection factors for respirators; annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage; and quantities of licensed or registered material requiring labeling) are deleted by incorporation by reference of 10 CFR Part 20.
Chapter 220. Notices, Instructions and Reports to Workers; Inspections and Investigations
Because of incorporation by reference of 10 CFR Part 19, the title of Chapter 220 has been expanded to include ''Investigations.''
Section 220.2 (relating to posting of notices to workers) is updated for compatibility with the NRC.
Sections 220.3--220.8 are deleted because of incorporation by reference of 10 CFR Part 19.
Sections 220.9 and 220.10 (relating to incorporation by reference; effect of incorporation of 10 CFR Part 19) are added to clarify the differences between Chapter 220 and 10 CFR Part 19.
Chapter 224. Medical Use of Radioactive Material
Sections 224.2--224.9 are deleted because of incorporation by reference of 10 CFR Part 35.
New §§ 224.10 and 224.11 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 35) are added to clarify the differences between Chapter 224 and 10 CFR Part 35.
Subchapter B (relating to general administrative requirements) is renamed (other requirements).
New § 224.21 (relating to supervision) clarifies which auxiliary personnel may handle radioactive material. It replaces current § 224.55 (supervision) that is deleted by incorporation by reference of 10 CFR Part 35.
New § 224.22 (relating to authorization for calibration and reference sources) allows sealed sources up to 27 mCi (1,000 MBq) apiece of radioactive material. It replaces current § 224.104 that is deleted because of incorporation by reference of 10 CFR 35.57.
New § 224.23 (relating to decay-in-storage) allows sealed sources of radioactive material with a physical half-life of up to 300 days to be held for decay-in-storage. It replaces current § 224.112 (relating decay-in-storage) that is deleted by incorporation by reference of 10 CFR 35.92.
Current §§ 224.51--224.60 are deleted because of incorporation by reference of 10 CFR Part 35. The requirements of current § 224.55 (relating to supervision) are now found in new § 224.21 (relating to supervision).
Current §§ 224.101--224.112 comprising all of Subchapter C are deleted because of incorporation by reference of 10 CFR Part 35. The requirements of current § 224.104 (relating to authorization for calibration and reference sources) are now found in new § 224.22 (relating to authorization for calibration and reference sources). The requirements of current § 224.112 (relating to decay-in-storage) are now found in new § 224.23 (relating to decay-in-storage).
Sections 224.151--224.501 comprising all of Subchapters D through K are deleted because of incorporation by reference of 10 CFR Part 35.
Chapter 225. Radiation Safety Requirements for Industrial Radiographic Operations
Chapter 225 is split into two subchapters: Subchapters A and B (relating to general provisions; and radiation producing machines general administrative requirements).
Existing § 225.1 (relating to purpose and scope) is expanded upon. An addition to subsection (a) clarifies applicability. New subsection (b) is added to exempt persons using only radiation producing machines from the requirements of 10 CFR Part 34 incorporated by reference except as may be noted in Subchapter B. New subsection (c) is added to clearly indicate that Chapter 225 does not apply to medical diagnosis or therapy.
Existing §§ 225.2, 225.11--225.18, 225.21--225.23, 225.31--225.33, 225.41--225.44 are deleted because of incorporation by reference of 10 CFR Part 34.
Existing §§ 225.51--225.53 are deleted because of incorporation by reference of 10 CFR Part 34 with the requirements of existing § 225.52 (relating to security) being transferred to new § 225.87 (relating to security) and existing § 225.53 (relating to posting) being transferred to new § 225.88 (relating to posting).
Existing Appendix A is retained.
New §§ 225.2a and 225.3a (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 34) are added to clarify the differences between Chapter 225 and 10 CFR Part 34.
Section 225.4a (relating to radiation safety programs) is added for radiation producing machine users only. This section includes a requirement that a person using radiation producing machines for industrial radiography shall have Department approval before commencing operations.
Section 225.5a (relating to reciprocity) is added to alert out-of-State users of radiation producing machines to the requirements of § 216.7 (relating to out-of-State radiation producing machines).
Section 225.6a (relating to prohibitions) is added to clarify that the use of radiation producing machines covered under this chapter is not permitted for diagnosis or therapy on humans or animals.
New Subchapter B (relating to radiation producing machines) requirements are added to apply to those persons who only have radiation producing machines because radiation producing machines do not fall under the requirements of sealed source radiography incorporated through reference of 10 CFR Part 34.
Subchapter B begins with a new heading, ''General Administrative Requirements,'' that includes new §§ 225.71--225.76 (relating to definitions; duties of personnel; training of personnel; training and testing; audits and safety reviews of radiographers and radiographer assistants; and reporting requirements).
Definitions introduced in Subchapter B are ''cabinet radiography,'' ''cabinet X-ray system,'' ''certified cabinet X-ray system,'' ''industrial radiography,'' ''permanent radiographic installation,'' ''personal supervision,'' ''radiation safety officer,'' ''radiographer,'' ''radiographer's assistant,'' ''radiographer trainee,'' ''radiographic operations,'' ''shielded room radiography'' and ''temporary job site.''
A new heading, ''General Technical Requirements,'' includes §§ 225.81--225.88 (relating to permanent radiographic installations; operating requirements; records required at temporary job sites; operating and emergency procedures; surveys and survey records; utilization logs; security; and posting.
A new heading, ''Radiation Survey Instrument and Personnel Monitoring,'' includes §§ 225.91--225.93 (relating to radiation survey meter requirements; radiation survey meter calibration requirements; and personnel monitoring control).
A new heading, ''Radiation Producing Machine Requirements,'' includes §§ 225.101--225.104 (relating to cabinet X-ray systems and baggage/package X-ray systems; shielded room X-ray machine radiography; temporary job site radiography; and X-ray detection systems for explosives, weapons and illegal items).
Chapter 226. Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies
Current Chapter 226 is renamed as ''Licenses and Radiation Safety Requirements for Well Logging'' to parallel 10 CFR Part 39.
Section 226.1 (relating to purpose and scope) is generally updated and revised to include persons using uranium sinker bars.
Section 226.2 (relating to definitions) is deleted because of incorporation by reference of 10 CFR Part 39.
Current § 226.3 (relating to prohibition) is renamed ''abandonment of a sealed source.'' Current requirements are deleted and replaced by incorporation by reference of 10 CFR Part 39 and current reference to § 78.111 (relating to abandonment).
Sections 226.4 and 226.5 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 39) are added to clarify the differences between Chapter 226 and 10 CFR Part 39.
New heading ''Particle Accelerators'' is created.
Section 226.34 (relating to particle accelerators) is renumbered to § 226.61 and a reference to licensing provisions of Chapter 228 (relating to radiation safety requirements for particle accelerators) is added.
Sections 226.11--226.51 and Appendixes A and B are deleted because of incorporation by reference of 10 CFR Part 39.
Chapter 230. Packaging and Transportation of Radioactive Material
Sections 230.2, 230.11, 230.12, 230.14, 230.21--230.26, 230.41--230.46, 230.51, Appendix A and Tables I--IV are deleted because of incorporation by reference of 10 CFR Part 71.
In Subchapter A (relating to scope and definitions), the phrase ''and definitions'' is dropped from the title because of the deletion of § 230.2 (relating to definitions).
Sections 230.3 and 230.4 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 71) are added to clarify the differences between Chapter 230 and 10 CFR Part 71.
Section 230.5 (relating to communications) is added to ensure that communications are sent to the Department's address.
Section 230.13 (relating to transportation of licensed material) is amended to include only the requirements of existing subsection (b) and incorporation by reference of 10 CFR Part 71.
Section 230.47 (relating to advance notification of transport of nuclear waste) is amended to ensure that the governor or governor's designee and the Department will receive the required notifications and information.
Chapter 232. Licenses and Radiation Safety Requirements for Irradiators
Chapter 232 is a new chapter that is compatible with 10 CFR Part 36 ''Licenses and Radiation Safety Requirements for Irradiators.''
Section 232.1 (relating to purpose and scope) explains that this chapter applies only to the use of radioactive material in sealed sources to irradiate objects or materials with gamma radiation.
Sections 232.2 and 232.3 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 36) clarify the differences between Chapter 232 and 10 CFR Part 36.
F. Benefits Costs and Compliance
Executive Order 1996-1 requires a cost/benefit analysis of the proposed amendments.
Benefits
As set forth in this proposal, users of radioactive material will be required to comply with radiation protection standards that will not only protect employes but will also protect the general public. The Commonwealth will also be able to continue pursuit of agreement state status with the NRC which will lead to an overall reduction in license fees for NRC licensees of this Commonwealth.
Compliance Costs
There are no compliance costs because licensees are currently complying with these regulations by virtue of their NRC licenses.
Compliance Assistance Plan
Compliance assistance is available to all existing license holders through the use of a comprehensive set of regulatory guides published by the NRC.
Paperwork Requirements
The proposed amendments will not change paperwork requirements because licensees are already complying with NRC requirements.
G. Sunset Review
These regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 8, 2000, the Department submitted a copy of the proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the Senate and House Environmental Resources and Energy Committees. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department. A copy of this material is available to the public upon request.
If IRRC has any objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review by the Department, the Governor and the General Assembly before final publication of the regulations.
I. Public Comments
Written Comments--Interested persons are invited to submit comments, suggestions or objections regarding the proposed amendments to the Environmental Quality Board, P. O. Box 8477 Harrisburg, PA. 17105-8477 (express mail: Rachel Carson State Office Building, 15th floor, 400 Market Street, Harrisburg, PA 17101-2301). Comments submitted by facsimile will not be accepted. Comments, suggestions or objections must be received by the Board by September 25, 2000 (within 30 days of publication in the Pennsylvania Bulletin). Interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must be received by September 25, 2000 (within 30 days following publication in the Pennsylvania Bulletin). The one-page summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which the final regulation will be considered.
Electronic Comments--Comments may be submitted electronically to the Board at RegComments@dep.state.pa.us and must also be received by the Board by September 25, 2000. A subject heading of the proposal and a return name and address must be included in each transmission. If an acknowledgment of electronic comments is not received by the sender within 2 working days, the comments should be retransmitted to ensure receipt.
JAMES M. SEIF,
ChairpersonFiscal Note: 7-350. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE V. RADIOLOGICAL HEALTH
CHAPTER 215. GENERAL PROVISIONS
GENERAL PROVISIONS § 215.1. Purpose and scope.
* * * * * (e) Title 10 Chapter I (Nuclear Regulatory Commission) Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and 150 of the CFR is incorporated by reference. Notwithstanding the requirements incorporated by reference, nothing in this article relieves or limits a person from complying with the laws of the Commonwealth, including the act and the Low-Level Radioactive Waste Disposal Act (35 P. S. §§ 7130.101--7130.905).
(f) If a provision of the CFR incorporated by reference in this article includes a section which is inconsistent with the Pennsylvania Code, the Pennsylvania Code controls to the extent Federal law does not preempt Commonwealth law. If a provision of the CFR incorporated by reference in this article is beyond the scope of authority granted the Department under statute, or is in excess of the statutory authority, the provisions shall be and remain effective only to the extent authorized by the Pennsylvania law.
(g) Appropriate parts of 10 CFR may be obtained from the following:
(1) The United States Government Printing Office, Book Store, Room 118, Federal Building, 1000 Liberty Avenue, Pittsburgh, Pennsylvania 15222, (412) 664-2721.
(2) The United States Government Printing Office, Book Store, 100 North 17th Street, Robert Morris Building, Philadelphia, Pennsylvania 19103, (215) 597-0677.
(3) The United States Superintendent of Documents, United States Government Printing Office, Washington, D.C. 20402, (202) 783-3238.
§ 215.2. Definitions.
The definitions in 10 CFR Chapter I Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and 150 are incorporated by reference in this article unless indicated otherwise. In addition, the following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
* * * * * [ALARA--As low as is reasonably achievable--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this article as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.
A11--The maximum activity of special form radioactive material permitted in a Type A package.
A22--The maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Chapter 230, Appendix A (relating to packaging and transportation of radioactive materials), Table I, or may be derived in accordance with the procedure prescribed in Chapter 230, Appendix A.
Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.]
* * * * * [Agreement state--A state with which the NRC or the AEC has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954 (42 U.S.C.A. § 2021(b)).
Airborne radioactive material--Radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors or gases.
Airborne radioactivity area--A room, enclosure or area in which radioactive materials exist in concentrations as set forth in one of the following:
(i) In excess of the derived air concentrations (DACs) specified in Chapter 219, Appendix B, Table I (relating to occupational values).
(ii) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.
Background radiation--Radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices. The term does not include sources of radiation from radioactive materials regulated by the Department.
Becquerel (Bg)--The SI unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps).]
* * * * * [Byproduct material--The term includes one of the following:
(i) Radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.
(ii) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute ''byproduct material'' within this definition.
Calendar quarter--Not less than 12 consecutive weeks, nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January, and subsequent calendar quarters shall be arranged so that no day is included in more than one calendar quarter and no day in one year is omitted from inclusion within a calendar quarter. No licensee or registrant may change the method observed by him of determining calendar quarters for purposes of this article except at the beginning of a calendar year.
Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
Committed dose equivalent (HT,50)--The dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.
Committed effective dose equivalent (HE,50)--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = SUM wT,HT,50).
Controlled area--An area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.
Curie (Ci)--The special unit or quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 1010 transformations per second (tps).
Deep dose equivalent (Hd), which applies to external whole body exposure--The dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).
Depleted uranium--The source material uranium in which the isotope uranium-235 constitutes less than .711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
Dose--A generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent or total effective dose equivalent. For purposes of this article, ''radiation dose'' is an equivalent term.
Dose equivalent (HT)--The product of the absorbed dose in tissue, quality factor and other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.
Dose limits--The permissible upper bounds of radiation doses established in accordance with this article. For purposes of this article, ''limits'' is an equivalent term.
Effective dose equivalent (HE)--The sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (WT) applicable to each of the body organs or tissues that are irradiated (HE = SUM WTHT).
Embryo/fetus--The developing human organism from conception until the time of birth.]
* * * * * [Exposure--The quotient of dQ by dm where ''dQ'' is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass ''dm'' are completely stopped in air. The special unit of exposure is the roentgen (R). See § 215.3 (relating to units of exposure and dose) for the SI equivalent.
Exposure rate--The exposure per unit of time, such as R per minute or mR per hour.
External dose--That portion of the dose equivalent received from a source of radiation outside the body.
Extremity--A hand, elbow, arm below the elbow, foot, knee or leg below the knee.
Eye dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300 mg/cm2).]
* * * * * [Generally applicable environmental radiation standards--Standards issued by the EPA under the authority of the Atomic Energy Act of 1954 (42 U.S.C.A. §§ 2011--22g-4) that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
Gray (Gy)--The SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
High radiation area--An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from a source of radiation or from a surface that the radiation penetrates.]
* * * * * [Individual monitoring--The assessment of one of the following:
(i) Dose equivalent by the use of individual monitoring devices or survey data.
(ii) Committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. See the definition of DAC-hours in § 219.3 (relating to definitions).
Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this article, ''personnel dosimeter'' and ''dosimeter'' are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers and personal air sampling devices.]
* * * * * [Internal dose--That portion of the dose equivalent received from radioactive material taken into the body.]
* * * * * [Licensed material--Radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department.]
* * * * * [Lost or missing licensed or registered source of radiation--A licensed or registered source of radiation whose location is unknown. The term includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
Member of the public--An individual in a controlled or unrestricted area. An individual is not a member of the public during a period in which the individual receives an occupational dose.
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