PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[25 PA. CODE CHS. 221, 227 AND 228]
Radiological Health
[31 Pa.B. 792] The Environmental Quality Board (Board) proposes to amend Chapters 221, 227 and 228 (relating to X-rays in the healing arts; radiation safety requirements for analytical X-ray equipment, X-ray gauging equipment and electron microscopes; and radiation safety requirements for particle accelerators). The proposed amendments update the standards for protection against radiation.
This proposal was adopted by the Board at its meeting on October 17, 2000.
A. Effective Date
These proposed amendments will become effective immediately upon publication in the Pennsylvania Bulletin as final rulemaking.
B. Contact Persons
For further information, the contact persons are William Kirk, Chief, Radiation Control Division, Bureau of Radiation Protection, 13th Floor, Rachel Carson State Office Building, P. O. Box 8469, Harrisburg, PA 17105-8469, (717) 787-2480; and Marylou Barton, Assistant Counsel, Bureau of Regulatory Counsel, RCSOB, 9th Floor, 400 Market Street, P. O. Box 8464, Harrisburg, PA 17105-8464, (717) 787-7060. Information regarding submitting comments on this proposal appears in Section I of this Preamble. Persons with a disability may use the AT&T Relay Service by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposal is available electronically through the Department of Environmental Protection's (Department) website (http://www.dep.state.pa.us).
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, regulation and inspection of radiation sources and radiation source users, and delegates 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
The proposed amendments, for the most part, correct printing errors, clarify existing wording or modify existing wording to accommodate changes in equipment since the last amendments.
The only major change is the addition of four new sections in Chapter 227 for the purpose of specifically extending X-ray protection requirements to X-ray calibration systems. Accompanying changes in the chapter title, contents, general provisions and definitions are also recommended. These sections were originally proposed and approved by the Radiation Protection Advisory Committee (RPAC) in 1998 as part of Chapter 225 (relating to radiation safety requirements for industrial radiographic operations) which pertains to industrial radiography. The Department decided, however, that these regulations would be more appropriately placed in Chapter 227, which deals with miscellaneous X-ray equipment.
As required by section 301(c)(14) of the act, the Department provided the RPAC with an opportunity to review the proposed amendments and to advise the Department prior to submittal to the Board. On May 10, 2000, the RPAC met and reviewed the proposed amendments. The Chairperson announced by letter dated May 17, 2000, the committee's concurrence to forward the proposed regulations to the Board.
E. Summary of Regulatory Requirements
A description of the proposed amendments is provided as follows:
Chapter 221, X-Rays in the Healing Arts
§ 221.11. Registrant responsibilities.
Subsection (h)(4) is being deleted. Similar language exists in § 221.56, which is being relocated to this section and renumbered as subsections (m)--(p). This consolidation of requirements was inadvertently omitted in the previous revisions to this chapter.
Subsection (k) is being modified to provide some regulatory flexibility. The proposal changes ''shall'' to ''should'' to make using spectrally compatible film and screen system a recommendation rather than a mandatory requirement. This change is necessary due to the wide range of spectral characteristics of X-ray films on the market today, which makes it difficult for practitioners to maintain an exact match.
Subsection (l) is being modified to allow the Department to establish guidelines for quality assurance programs rather than adopting guidelines from specified ''accredited'' organizations. This change will make it easier for the Department to add and change guidelines as needed without specifically acknowledging each new quality assurance guideline issued by medical specialty organizations.
§ 221.13. Information to be submitted by persons proposing to conduct healing arts screening.
Paragraph (14) is being modified to clarify that mammography facilities must comply with 21 CFR Part 900 (relating to mammography).
§ 221.29. Kilovoltage accuracy.
Section 221.29 is being modified to clarify that the 10% variation permitted under the existing language applies only to the range of technique factors used.
§ 221.32a. Beam limitation.
Subsection (d)(1) is being modified to state that the requirement for an indicator only applies to machines having a variable angle between the X-ray beam axis and the image receptor plane and to exempt portable and mobile X-ray units from the requirement. Typically, these units do not have this type of indicator.
§ 221.33a. Radiation from capacitor energy storage equipment in standby status.
Section 221.33a is being modified to correct a typographical error in the published text. The unit should be 0.516 µC/kg rather than 0.516 µmC/kg. The unit as currently published is a factor of 1,000 lower than intended.
§ 221.36a. Limitation of useful beam of fluoroscopic equipment.
Subsection (d) is being modified to adopt the wording used by the Food and Drug Administration in 21 CFR 1020.32(b) (relating to fluoroscopic equipment). This eliminates confusion regarding the permissible size and shape of the useful beam.
§ 221.56. Administrative controls.
This section is deleted and moved to § 221.11 as new subsections (m)--(p). No changes in the text are proposed.
§ 221.202. Equipment requirements.
Subsection (c) is being modified to delete paragraph (2), relating to an audible signal indicating termination of exposure. This change is recommended because many units do not have such a feature which is not required by the Food and Drug Administration.
Chapter 227. Radiation Safety Requirements for Analytical X-ray Equipment, X-ray Gauging Equipment and Electron Microscopes.
This chapter is being modified to add four new sections under the heading titled X-ray Calibration Systems. These sections were originally proposed and approved by the RPAC in 1998 as part of Chapter 225 which pertains to industrial radiography. The Department decided, however, that the content would be more appropriately placed in Chapter 227, which deals with miscellaneous X-ray equipment. These sections are needed to specifically extend X-ray protection requirements to this type of operation, which is becoming more common. The chapter title, contents, general provisions and definitions were also changed to reflect the new sections.
Chapter 228. Radiation Safety Requirements for Particle Accelerators.
Changes to §§ 228.22a and 228.36 are being recommended for purposes of clarification.
§ 228.22a. Issuance of specific licenses.
Section 228.22a contains a minor revision recommended by the RPAC. The RPAC felt that, by definition, if an application met the requirements of the act and article, the operation would not be ''inimical to the safety of the public'' as indicated in subsection (a). As such, it recommended that the phrase be removed from subsection (a).
§ 228.36. Radiation monitoring requirements.
This section is modified to provide that: (1) an independent radiation monitoring system be provided so that the individuals entering or present become aware of the existence of the hazard; and (2) that the system be tested for response, rather than calibrated, at least annually and after servicing or repair. The Department and the RPAC agree that calibration, which implies that the response be accurate within a specified limit, is not necessary for this function.
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 X-ray machines and particle accelerators will benefit from the regulations being clarified to conform better to present equipment and installations and elimination of a 1,000-fold error in units in § 221.33a. The additions to Chapter 227 specifically extend the safety requirements set forth for other types of X-ray installation to X-ray calibration systems.
Compliance Costs
The compliance costs under the proposed amendments should not differ appreciably from the costs presently incurred.
Compliance Assistance Plan
Compliance assistance requirements are expected to be negligible. Outreach and assistance will be provided by regional inspectors and technical staff in the Radiation Control Division.
Paperwork Requirements
No additional paperwork will be required under these proposals.
G. Sunset Review
These regulation 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), the Department submitted a copy of the proposed amendments on January 29, 2001, 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 objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committee's 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 regulation.
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 March 12, 2001 (within 30 days following 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 Marcy 12, 2001 (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 March 12, 2001. A subject heading of the proposal and a return name and address must be included in each transmission. If an acknowledgement 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: 7-360. 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 221. X-RAYS IN THE HEALING ARTS
ADMINISTRATIVE CONTROLS § 221.11. Registrant responsibilities.
* * * * * (h) If a patient or film requires auxiliary support during a radiation exposure the following apply:
* * * * * [(4) For intraoral dental radiography, neither the tube housing nor the cone shall be held during an exposure.]
* * * * * (k) The screen and film system used [shall] should be spectrally compatible and evaluated with respect to screen condition to assure proper system speed. Film cassettes without intensifying screens may not be used for any routine diagnostic radiological imaging, with the exception of standard dental radiography film packets.
(l) The registrant shall have a quality assurance program. This quality assurance program shall be in accordance with guidelines [promulgated by the ACR, the AAPM or another accredited organization] established by the department.
(m) A dentist or an assistant may not hold patients or film during exposures.
(n) Only the patient shall be in the useful beam.
(o) Neither the tube housing nor the cone may be hand-held during the exposure.
(p) Intraoral fluoroscopy may not be used in dental examinations.
§ 221.13. Information to be submitted by persons proposing to conduct healing arts screening.
A person requesting that the Department approve a healing arts screening program shall submit in writing the following information and evaluation. If information submitted to the Department becomes invalid or outdated, the registrant shall immediately notify the Department.
* * * * * (14) [This section does not apply to operations conducted by registrants under] mammography facilities shall comply with 21 CFR Part 900 (relating to mammography).
DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS § 221.29. Kilovoltage (kV) accuracy.
The kV output may not vary from the set-indicated value by more than 10% over the range of technique factors normally used. Discrepancies of more than 10% between set-indicated[-]and measured kV values shall be investigated by a qualified expert or service engineer and appropriate action taken.
§ 221.32a. Beam limitation.
* * * * * (d) A means shall be provided to:
(1) Indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor if the angle between the axis of the X-ray beam and the plane of the image receptor is variable. This paragraph does not apply to portable and mobile units.
* * * * * § 221.33a. Radiation from capacitor energy storage equipment in standby status.
Radiation emitted from an X-ray tube when the exposure switch or timer is not activated may not exceed a rate of 2 milliroentgens (0.516 µ[m]C/kg) per hour at 5 centimeters from an accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
§ 221.36a. Limitation of useful beam of fluoroscopic equipment.
* * * * * (d) The minimum field size at the greatest source to image receptor distance shall be [equal to or less than 25 square centimeters] containable in a square of 5 centimeters by 5 centimeters unless otherwise provided in 21 CFR 1020.32(b) (relating to fluorascopic equipment).
* * * * * § 221.56. [Administrative controls] (Reserved).
[(a) A dentist or an assistant may not hold patients or film during exposures.
(b) Only the patient shall be in the useful beam.
(c) Neither the tube housing nor the cone may be hand-held during the exposure.
(d) Intraoral fluroscopy may not be used in dental examinations.]
§ 221.202. Equipment requirements.
* * * * * (c) Status indicators and control switches.
* * * * * (2) [A signal, audible to the operator, shall indicate that the exposure has terminated.
(3)](2) * * *
[(4)](3) * * *
* * * * * CHAPTER 227. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT, X-RAY GAUGING EQUIPMENT [AND], ELECTRON MICROSCOPES AND X-RAY CALIBRATION SYSTEMS
GENERAL PROVISIONS § 227.1. Purpose and scope.
This chapter establishes the requirements for the use of analytical X-ray equipment, X-ray gauging equipment [and], electron microscopes and X-ray calibration systems. Registrants who use analytical X-ray equipment, X-ray gauging equipment [or], electron microscopes or X-ray calibration systems shall comply with this chapter. The requirements of this chapter are in addition to, and not in substitution for, other applicable provisions of this article.
§ 227.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * X-ray calibration systems---Radiation-producing machines and equipment used to calibrate radiation detection or measuring devices.
* * * * *
X-RAY CALIBRATION SYSTEMS § 227.101. Scope.
This section and §§ 227.102--227.104 apply to registrants who calibrate equipment used to measure the output of radiation for medical diagnosis and therapy, or for radiation survey meters and similar instrumentation.
§ 227.102. Area Requirements.
A room or enclosure used for calibration shall be shielded so that every location on the exterior meets conditions for an unrestricted area, and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of 10 CFR 20.1601 (relating to control of access to high radiation areas).
§ 227.103. Operating requirements.
(a) The operator shall conduct a physical radiation survey to determine that the radiation machine X-ray tube is de-energized prior to each entry of any body part into the radiographic exposure area.
(b) As an alternative to subsection (a), the registrant may use an independent radiation monitoring system that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels.
§ 227.104. Personnel Requirements.
A registrant may not permit an individual to operate or conduct maintenance on any X-ray calibration system until the individual has received a copy of, instruction in, and demonstrated an understanding of, the operating procedures necessary to ensure radiation safety.
CHAPTER 228. RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS
NOTIFICATION AND LICENSING PROCEDURES § 228.22a. Issuance of specific licenses.
(a) Upon determination that an application meets the requirements of the act[,] and this article, [and the operation of the facility will not be inimical to the safety of the public,]the Department will issue a specific license authorizing the proposed activity and containing conditions and limitations as it deems appropriate or necessary.
* * * * * § 228.36. Radiation monitoring requirements.
[(a) In addition to the requirements of §§ 219.91 and 219.154 (relating to control of access to high radiation areas; and posting of high radiation areas) an] LAN independent radiation monitoring system shall be provided so that the individuals entering or present become aware of the existence of the hazard. Independent radiation monitors shall be [calibrated] tested for response at least annually and after each servicing or repair.
[(b) The calibration of the independent radiation monitoring system described in subsection (b) shall verify the response of the instrument to radiation fields of different intensity, and does not require complete accuracy with respect to radiation energy if the accelerator produces radiations greater than 3.0 MeV.]
[Pa.B. Doc. No. 01-218. Filed for public inspection February 9, 2001, 9:00 a.m.]
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