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PA Bulletin, Doc. No. 03-1731



[25 PA. CODE CHS. 215--221,
223--228, 230 AND 240]

Radiological Health

[33 Pa.B. 4393]

   The Environmental Quality Board (Board) proposes to amend Chapters 215--221, 223--228, 230 and 240. The primary purpose of the proposed amendments is to correct cross references that were rendered inaccurate by changes made in previous rulemakings where the sections linked by reference were not open to amendment. The regulations are also being generally updated and clarified as necessary.

   This proposal was adopted by the Board at its meeting of July 15, 2003.

A.  Effective Date

   These proposed amendments will go into effect upon publication in the Pennsylvania Bulletin as final-form rulemaking.

B.  Contact Persons

   For further information contact Louis Ray Urciuolo, Chief, Division of Radiation Control, P. O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 787-3720, or Marylou Barton, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Information regarding submitting comments on this proposal appears in Section J 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

C.  Statutory Authority

   These amendments are proposed under the authority of the following statutes:

   Sections 301 and 302 of the Radiation Protection 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 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

   In 2001 the Board updated chapters of 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 under the Agreement State program. These updates were published at 31 Pa.B. 5239 (September 15, 2001) and 31 Pa.B. 6280 and 6282 (November 17, 2001). Incorporation by reference of certain radiation safety standards of the NRC that are Nationally recognized, also formed the basis for a single consistent set of standards to be applied to the radiological safety of not only radioactive materials, but, radiation-producing machines as well.

   As a result of the revisions, many sections in Article V (relating to radiological health) now reference code that no longer exists. Those references show as ''reserved.'' These proposed amendments only replace the orphaned references with the corresponding regulations incorporated by reference and impose no new requirements. Other amendments address the recent changes to NRC regulations that are incorporated by reference, most notably the comprehensive revision to 10 CFR Part 35 (relating to the medical use of by-product material). Licensees of this Commonwealth are already subject to these requirements by virtue of their radioactive material licenses and incorporation by reference of 10 CFR. Several amendments clarify the wording of existing regulations and their requirements, in most part involving radiation-producing machines. The existing regulations in § 216.6(c) (relating to assembly, transfer and disposal obligations) require persons involved in certain commercial and service activities involving radiation-producing machines to register their activities with the Department. There is a new § 216.2a (relating to the registration of radiation-producing machine service providers) along with the provision for registration fees and reporting requirements. Overall, the proposed amendments are necessary to improve the clarity, coherency and effectiveness of the regulations and restore linkages between sections that were broken in separate limited rulemakings.

   As required by section 301(c)(14) of the act (35 P. S. § 7110.301), the Department provided the Radiation Protection Advisory Committee (RPAC) with an opportunity to review the proposed amendments and to advise the Department prior to submittal to the Board. On October 24, 2002, and November 20, 2002, the RPAC met and reviewed the proposed amendments. Most of the committee's discussion and input on this matter centered around how best to re-word parts of the regulations to improve clarity. This involved definitions such as ''stray radiation,'' the use of impersonal pronouns such as the substitution of ''individual'' for ''person'' where actions are performed and the general use of words in syntax and context such as replacing ''initial'' with ''prior to first use.'' Many of the comments are appropriate and incorporated in the proposed Annex A. The RPAC, by letter dated December 18, 2002 from the Chairman, recommended that the amendments to the radiological health regulations be sent to the Board as proposed rulemaking.

E.  Summary of Regulatory Requirements

   Unless otherwise specified, the proposed amendments reflect, and are not more stringent than Federal requirements in areas of Federal jurisdiction such as the use of byproduct material, the control of which would be assumed by the Commonwealth after attaining agreement state status. Other proposed regulations address areas where there is no Federal jurisdiction such as the use of radiation-producing machines and naturally occurring or accelerator-produced radioactive material (NARM) but the regulations attempt to assure application of a consistent regulatory structure for similar hazards through incorporation by reference of radiation protection standards that are common to both. Incorporation by reference increases the ability of the regulatory community to participate in rulemaking, once at the Federal level and again when published in the Pennsylvania Bulletin as proposed rulemaking or by appeal to the Department. The Department may also issue Fact Sheets or Guidance on the regulations. The Department uses its website to help disseminate relevant information.

   The significant parts of the proposed rulemaking are summarized as follows.

Chapter 215. General Provisions.

§ 215.1.  Purpose and scope.

   Subsection (e) lists which NRC regulations in 10 CFR are incorporated by reference. References to NRC sections 150.20(a)(1), 150.20(a)(2) and 150.20(b) are replaced by a reference to section 150.20.

   Subsection (e)(4) lists which NRC regulations governing general licenses in 10 CFR Part 31 are not incorporated by reference. The reference excluding NRC section 31.3 dealing with a general license for certain devices distributed nationally is being deleted. The NRC now requires that the regulation be adopted for compatibility to become an Agreement State.

   Subsection (e)(8) lists which NRC regulations governing medical use of radioactive material in 10 CFR Part 35 are not incorporated by reference. In a revision to 10 CFR Part 35 effective October 24, 2002, the previous sections 35.990 and 35.991 relating to violations and civil penalties respectively were renumbered to 35.4001 and 35.4002 in the revised CFR. The same changes have been made in subsection (e)(8) to avoid pointing to a nonexistent reserved reference.

   Subsection (e)(11) lists which NRC regulations governing the licensing of source material in 10 CFR Part 40 are not incorporated by reference. Reference to NRC section 40.33 has been added to the list of regulations that are not incorporated by reference because that section deals with the authorization of licenses for uranium enrichment facilities. The NRC does not relinquish that authority to the states.

   Subsection (e)(13) lists those NRC regulations governing the packaging and transportation of radioactive material in 10 CFR Part 71 that are not incorporated by reference. The reference to exclude NRC section 71.47 dealing with external radiation standards for packages is being deleted. The NRC now requires the regulation be adopted for compatibility to become an Agreement State. A reference to NRC section 71.61 dealing with irradiated nuclear fuel shipments has been added to the list to be excluded from incorporation by reference because the NRC does not relinquish that authority to the states. The reference to exclude NRC subsection 71.83 dealing with assumptions of properties in fissile packages is being deleted. The NRC no longer reserves this authority and allows states to regulate small quantities of fissile material. Adoption of this NRC regulation is now required for compatibility to become an Agreement State.

§ 215.2.  Definitions.

   License--The current definition of ''license'' in this section is for the possession and use of radioactive material. However, there are license requirements in Chapter 228 for accelerators that are not covered under this definition or any other because an accelerator is not radioactive material. An accelerator is a type of radiation-producing machine. The current definition has been modified. ''Radiation sources'' replaces ''radioactive material.'' This accommodates accelerators and any other radiation sources that may be authorized for licensure under future rulemaking.

   Major X-ray system component--A new term is defined. It is based on components identified in the United States Food and Drug Administration regulations 21 CFR Chapter I, Subchapter J, Radiological Health, Part 1020 Performance Standards for Electronic Products: General. It is used in conjunction with new § 216.2b, to identify which components fall under the new reporting and recordkeeping requirements for registered radiation-producing machine service providers.

   Qualified expert--Similar terms exist under the definitions in §§ 215.2, 221.2 and 228.2. The term may be applicable to any chapter so the definition will be removed from §§ 221.2 and 228.2 and combined into the definition in § 215.2.

   Radiological physicist--A radiological physicist is a type of qualified expert. The term is being deleted and references to it will be added to the revised definition of ''qualified expert.''

§ 215.12.  Inspections and investigations.

   In addition to inspections, the Department may also conduct investigations. ''Investigations'' has also been added to the title of this section.

   Subsection (a) dealing with the maintenance of records requires that records be available for inspection by the Department. The requirement has been clarified to specify that these records be available at the permanent sites or facilities of use identified in a license or registration. Radioactive material licenses in particular, may authorize use at multiple sites anywhere in this Commonwealth. Those licenses have fees determined by the number of noncontiguous sites covered under the licenses. The intent of this requirement is that compliance records be available locally for reference during an inspection.

   Subsection (c) dealing with inspections by the Department has been expanded for clarity to reference investigations. This is consistent with other references to inspections such as Chapter 220 (relating to notices, instructions and reports to workers; inspections and investigations). The scope of this subsection is also clarified to cover inspection and investigation of regulated activities as necessary to demonstrate compliance with the act or this article. References to inspection periods have been removed as the frequency of inspection, as just stated, is determined by the Department ''as necessary'' to ensure compliance. This provides the flexibility necessary for the Department to carry out its obligations. Agreements may be entered into with Federal agencies that dictate certain inspection periods. For example, to conform to Agreement State standards, radioactive material licenses would have a range of routine inspection periods from 1 to 5 years. This does not signal a shift in policy. The routine inspection period for the majority of regulated activities is still anticipated to be four years. Compliance history has not indicated a class of regulated activity that requires a routine inspection period more frequent than annual.

   Subsection (d) dealing with the right to conduct follow-up inspections has been expanded to include investigations to be consistent with subsection (c).

§ 215.14.  Availability of records for public inspection.

   In paragraph (2), the reference to inspection records not pertaining to safety or health is removed. Inspection records do not contain the information referred to. In any case, all access to department inspection records is subject to the act of June 21, 1957 (P. L. 390, No. 212), Right to Know Law (65 P. S. §§66.1--66.4) as implemented through Departmental policy.

§ 215.24. Human use.

   Subsections (b) and (c) dealing with auxiliary personnel have been added. Rather than repeat this requirement throughout Article V, the same references to auxiliary personnel in §§ 221.11(a), 224.21 and 228.35(g) were removed and consolidated in this chapter of general provisions.

   Subsection (d) is new. The status of uncertified individuals in clinical training programs not covered under subsection (b) or (c) who use radiation sources on humans in the course of their training has never been clearly addressed in the regulations. This new regulation gives legitimacy to such individuals, subject to approval by the Department of the clinical training program.

§ 215.28.  Improper use of a monitoring device.

   Monitoring devices are relied upon to determine the radiation exposure of record. The data they provide has health and compliance consequences. The intent of this regulation is to prohibit actions that would result in misleading exposure data. This prohibition has been expanded to include the failure to use, or the improper use of a monitoring device by an individual. To reflect these changes, the heading of this section has been made more general and changed from ''Deliberate exposure of a monitoring device'' to ''Improper use of a monitoring device.''

§ 215.32.  Exemption qualifications.

   The exemptions listed in this section are applicable to activities covered under Chapter 240 (relating to radon certification); therefore, Chapter 240 has been added to the scope of this section.

Chapter 216.  Registration of radiation-producing machines and service providers.

   Engaging in certain commercial activities involving radiation-producing machines requires registration with the Department. The heading of this chapter is modified to include reference to radiation-producing machine service providers.

§ 216.1.  Purpose and scope.

   The existing regulation has become subsection (a) and modified to include reference to radiation-producing machine service providers. To avoid potential misunderstanding, new subsection (b) is a reminder that accelerators are not subject to registration.

§ 216.2.  Registration of radiation-producing machines.

   The heading of this section has been changed from ''Registration'' to clarify that it applies to radiation-producing machines only.

§ 216.2a. Registration of radiation-producing machine service providers.

   This is a new section. The requirements for assemblers previously in § 216.6(c) have been moved here and expanded upon. The process of registration is now described, including a requirement for annual renewal. There is a new provision requiring the payment of fees to recover costs of registration and the issuance of a registration certificate. There is a new 60 day grandfather clause for persons already subject to the regulation since prior registration is now required and the previous regulation did not specify whether registration of services was required before or after engaging in that activity.

§ 216.2b.  Reporting and record keeping requirements for registered radiation-producing machine service providers.

   This is a new section that describes reporting and recordkeeping requirements for persons providing radiation-producing machine services. It expands upon the requirements for assemblers previously found in § 216.6(a). For certified X-ray equipment, this requirement is satisfied by submittal of the information required in United States Food and Drug Administration (FDA) assembler's Form 2579. For noncertified equipment not subject to Federal reporting, submittal of the equivalent information is required. The new definition of ''major X-ray system component'' is used here to limit the scope of reporting. This regulation provides for the Department to be informed of new installations or significant changes in existing installations in a timely manner (15 days) by the service provider so that the necessity for follow-up inspection can be determined and to help ensure the proper recording of registration and inventory and submission of any fees that may be due within the 30 day period specified in § 216.2. New § 216.2b(c) specifies the time period that service provider records shall be kept available for inspection. New § 216.2b(d) is provided to help ensure that knowledge of unregistered X-ray equipment will be reported to the Department.

§ 216.3.  Exemptions.

   ''Radiation machines'' in paragraph (2) is changed to ''radiation-producing machines'' for clarity. The reference to ''storage incidental thereto'' is removed to avoid confusion. The wording is clarified to show that the exemption from registration is intended to apply to carriers that are in possession of X-ray machines belonging to another while the machines are in transit. It is not intended to remove the registration requirement for machines while they are still owned by, in the possession of or under the control of a person who would otherwise be required to maintain a registration, even if the machines are being shipped. For example, a nonfunctioning portable X-ray machine that is in transit from a repair facility when re-registration is due is still considered to be subject to re-registration. But a registrant's X-ray machine while in transport by a party other than the registrant for the purpose of being permanently transferred to another person is no longer subject to registration by the originator, provided the transfer is culminated.

   In paragraph (4) the exemption of accelerators from registration is repeated for clarity as well as the admonition that registration of service providers for accelerators is not exempt.

§ 216.4a.  Expiration and termination of certificates of registration.

   Subsection (c)(1) is updated to include the reference to the new certificate of registration of radiation-producing machine services under § 216.2a. Failure to renew a certificate of registration for radiation-producing machine services requires the registrant to cease all services subject to registration.

   Subsection (c)(2) is clarified by specifying only radiation-producing machines ''subject to registration under § 216.2'' are applicable to the requirements in the subsection. The reference to § 216.6 has also been updated to show that ''assembly'' has been removed from the section title assembly, transfer and disposal obligations, as discussed previously under new § 216.2b.

§ 216.6.  Transfer and disposal obligations.

   Reference to assembly, installation and all of subsection (c) (relating to registration of service activities) have been removed from this section and treated elsewhere in this chapter as previously discussed. Transfer and disposal related obligations remain. Subsection (a) is a safety net provision to require that persons report the transfer of radiation-producing machines not otherwise reported under the service provider reporting provisions of § 216.2b. The general reference to ''equipment'' has been removed and the existing requirement has been enhanced to include reporting the transfer of any major X-ray system components because that could signal the need for registration or inspection related activities. The existing reporting period of 90 days has been reduced to 30 days to allow for a more timely follow-up by the Department if it is warranted.

§ 216.7.  Out-of-State radiation producing machines.

   Currently, registration and registration fees are waived for persons who bring radiation-producing machines into the Commonwealth for temporary use (not more than 180 days per calendar year). In light of the term ''temporary'' and in the absence of a fee to cover related activities by the Department, it is appropriate to reduce the temporary period in the Commonwealth to 60 days per year (approximately one day per week). Furthermore, the time period to register with the Department following 60 days in this Commonwealth is shortened from 30 days to 15 days.

Chapter 217.  Licensing of radioactive material.

   § 217.136.  Exempt concentrations.

   Reference to the isotope Cadmium-109 in Table 1 Exempt Concentrations is deleted. The quantity for this isotope is already incorporated by reference in 10 CFR Part 20.

§ 217.141.  Incorporation by reference.

   Subsection (b) repeats the information in § 215.1(e)(4) for convenience. In § 215.1(e)(4), NRC section 10 CFR 31.3 was removed from the list of sections in 10 CFR Part 31 that are not incorporated by reference for reasons already discussed. Reference to NRC section 10 CFR 31.3 is removed from subsection (b) for the same reasons.

§ 217.143.  Certain measuring, gauging or controlling devices.

   Devices in this category are eligible for the simpler regulatory structure of the general license in this section. License fees are correspondingly lower than the class of specific licenses to which these devices would otherwise be subject. The threshold for admittance into this category for accelerator-produced material is being lowered from 10 millicuries (mCi) to 1 mCi. This will allow the inclusion of a group of X-ray fluorescence (XRF) devices that are currently specifically licensed, but suitable for general license. It will provide for consistency with the NRC who generally license certain XRF devices under their jurisdiction. Many of the XRF licensees are also sole proprietors for whom the higher fees associated with a specific license represent a significant business cost.

§ 217.171.  Incorporation by reference.

   Subsection (b) repeats the information in § 215.1(e)(11) for convenience. In § 215.1(e)(11), NRC section 10 CFR 40.33 was added to the list of sections in 10 CFR Part 40 that are not incorporated by reference for reasons already discussed. Reference to NRC section 10 CFR 40.33 is added to subsection (b) for the same reasons.

§ 217.201.  Incorporation by reference.

   This section repeats the information in § 215.1(e) regarding incorporation by reference of 10 CFR Part 150 for convenience. In § 215.1(e), the references to various subsections of NRC section 10 CFR 150.20 were replaced with a reference to section 150.20 in its entirety as being equivalent. The same change has been made in this section.

§ 217.202.  Effect of incorporation of 10 CFR Part 150.

   In this section the title of 10 CFR Part 150 was misquoted. The word ''authorization'' was replaced by the words ''authority in.''

§ 217.203.  Reciprocity of licenses for byproduct, source, naturally occurring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass.

   Sections 217.201 and 217.202 currently provide for reciprocal recognition of Agreement State licensees use of NARM in this Commonwealth for up to 180 days per calendar year and Agreement State byproduct, source and special nuclear material when the Commonwealth becomes an Agreement State. Section 217.203 currently provides for the same recognition for NARM used by nonagreement states. But there is no provision for recognition of NRC licensees who operate in the Commonwealth on a temporary basis when the Commonwealth becomes an Agreement State. Without reciprocity, those NRC licensees would have to secure a specific license from the Department. They would not be treated on an equal basis with similar agreement state licenses. To avoid this potential situation, the reciprocity provisions of § 217.203 are expanded to include byproduct, source and special nuclear material in quantities not sufficient to form a critical mass. References to holders of an NRC license have been added. The reference to a ''licensing state'' has been replaced by ''state'' as licensing state has a strict meaning regarding certification that the licensing programs in many competent nonagreement states do not technically have.

   Subsection (a) has an added reminder that Commonwealth authority does not extend into areas of exclusive Federal jurisdictions.

   Reciprocity is considered to be a type of general license. As such, new subsection (e) is a reminder that implementation of the requirements for byproduct, source and special nuclear material is subject to the safe harbor provisions of § 217.133 on the day the Commonwealth becomes an Agreement State.

Chapter 218.  Fees.

§ 218.1.  Purpose and scope.

   Subsection (a) is expanded to clarify the criteria the Department uses to determine the scope of registration or licensing of radiation-producing machines. Radiation-producing machines have always been registered under the facility in which they were located. In some cases, for the convenience of the Department, radiation-producing machines in the same building, at the same address or in a contiguous group of buildings under the same administrative control have been treated as a single registration. The Department determines the appropriate manner of registration. Subsequently, when the Department announced its intention to discontinue the registration of accelerators and license them instead, the intent was the same. Accelerators that were previously covered under the same registration number would be under the same license.

   Subsection (b)(1) is updated to show the applicability of the new category of ''radiation-producing machine services'' in Chapter 216.

§ 218.11.  Registration, renewal of registration and license fees.

   Subsection (a) is clarified to show its applicability to ''X-ray'' tubes or other ''radiation generating devices'' such as electron microscopes that are regulated. Similar wording is added to the header of column three in the fee table.

   Subsection (b) reference to § 216.2 is updated to show the new title of that section is ''registration of radiation-producing machines.''

   Subsection (d) is clarified to show that the fees for accelerators are ''annual.'' Under subparagraphs (i) and (ii), ''site'' is replaced by ''facility'' on the basis of the preceding discussion in § 218.1. The phrase ''of the same general type'' is deleted for simplification. The term was undefined and confusing. The way fees are assessed has not changed. The intent of ''of the same general type'' was to refer to one of the three categories of accelerators in the regulation, not the brand, the use or whether it's a linear accelerator or a cyclotron. In (iii), the Professional Fee Hourly Rate applicable to Department personnel time spent in licensing, inspection and the like is now specified here and the reference to Appendix A is removed because the Fee Category PF in Appendix A is being deleted. Another change to subparagraph (iii) is the specification of the minimum annual fee for accelerators above 50 MeV. It is equal to the next lower fee category, ''accelerators below 50 MeV, other than ion implantation.'' This clarifies what initial fee is required under subsection (e) to be remitted as required by subsection (f) when applying for a license in the category ''greater than 50 MeV.'' It also avoids the potential for the licensee of an accelerator greater than 50 MeV to pay less than would be payed for an accelerator below 50 MeV in any given year. It should be noted that as of yet there are no licensable accelerators above 50 MeV in this Commonwealth.

   Wording is added to subsection (e) to exclude full cost recovery licenses in Appendix A from the requirement to submit a specified fee with the submittal of a license application. Otherwise, the provisions of subsection (f) would make a full cost recovery license application invalid if there is no accompanying fee.

   Subsection (h) is new. It provides for recovery of the costs of registration of radiation-producing machine service providers under new § 216.2a. No fees had been collected previously under the activities of § 216.6(c) that formed the basis for new § 216.2a.

Appendix A.  Fees for radioactive material licenses.

   The header of the third column was changed to ''Annual Fee.'' The words ''Proposed Pa'' are removed and new footnote 7 is referenced. Once the fees were passed, they were no longer proposed. Footnote 7 clarifies that reduced fees under Small Business Categories 1 and 2 are not consistent with the intent of full cost recovery and the requirement to post financial assurance for major licenses. Abbreviations in the descriptions are spelled out for clarity. The description of Category 14 is reworded for clarity to better match the description of its corresponding NRC fee category.

   There is a new fee category, 3Q, for generally licensed devices under § 217.143. The NRC added this category to provide for more rigorous tracking of the most significant types of generally licensed devices that the NRC had difficulty accounting for. The annual fee for 3Q has been set at 70 % of the current NRC fee according to the provisions of the formula in footnote 3. Note that the formula includes a prorated portion of the NRC application fee to account for the difference that the Commonwealth uses a simplified annual single fee system with no separate application fees. In this category license, the NRC fee schedule has no annual fee, only an application fee, but the applicant must reapply yearly instead of once every 10 years, so the NRC license application fee used in the formula was not modified by the 10 year 0.1 pro-ration factor. The licensee community will benefit from specifying a fee for the 3Q category because the fee will be fixed. The NRC has scheduled an increase in this fee. Without a fixed fee, the fee as currently determined by formula will rise.

   Licenses subject to ''Full Cost'' recovery now display an asterisk in the fee column to reference a new footnote. The new asterisk footnote clarifies the meaning of ''Full Cost.''

   Fee category 8A1 currently applies only to NRC licenses for materials used by Civil Defense. It was originally intended to be identical to category 8A2 for NARM licenses to provide reduced fees for certain minor NRC licenses when the Commonwealth becomes an Agreement State.

   Fee category 8A1 and 8A2 have been modified to limit the duration of storage-only licenses to 2 years. It is required under incorporation by reference of 10 CFR 30.36(d)(3) for a licensee who has ceased all licensed activity other than secured storage of licensed material for 2 years to begin decommissioning and termination of the license.

   In the table of Fee Categories in Appendix A, PF (Professional Fee) has been removed. PF is not actually a license category. Professional fees for full cost recovery licenses are discussed under the new footnote referenced by an asterisk on ''Full Cost'' licenses. The Professional Fee Hourly Rate previously specified under PF has been moved to the footnoted asterisk.

   Footnote 1 has been clarified to show how fees for radioactive material licenses with more than four non-contiguous sites will be determined. The base fee is increased by 25% for each additional non-contiguous site above four. Note the maximum fee will be subject to the NRC fee limitation in footnote 4.

Chapter 219.  Standards for protection against radiation.

   § 219.3.  Definitions.

   A grammar correction has been made by inserting the word ''in'' between the words ''used this.''

   In the definition of ''medical reportable event for radiation-producing machine therapy'' under subparagraph (iii), an additional condition of ''outside the prescribed dose range'' has been added. This recognizes that a therapy treatment plan may specify a dose range instead of a dose. It is consistent with the requirements for the use of radioactive material in therapy in 10 CFR 35.3045(a)(1)(ii).

§ 219.6.  Effect of incorporation of 10 CFR Part 20.

   Certain X-ray procedures result in occupational exposures to individuals that are nonuniform, usually resulting from the common practice of wearing personnel dosimeters on the outside of lead aprons. The existing regulations require an overly conservative method for recording that exposure that may give the appearance that safety limits have been exceeded, thereby resulting in individuals curtailing participation in necessary medical procedures, or continuing and violating the regulations. Wording has been added in paragraph (8) to allow X-ray exposures to be weighted by methods approved by the Department to arrive at a more accurate determination of the total effective dose equivalent. This can reduce the current unnecessary adverse impact on the medical community. This concept is consistent with the NRC's position in Regulatory Issue Summary (RIS) 2002-06 Evaluating Occupational Dose For Individuals Exposed To NRC-Licensed Material And Medical X-rays. The referenced document is currently available on the NRC's website at the following address:

§ 219.8.  Requirement for a radiation safety committee.

   Previously the need for a radiation safety committee was addressed through the licensing process. The NRC has recently codified this requirement in 10 CFR 35.24 (relating to authority and responsibilities for the radiation protection program). This new section clarifies how incorporation by reference of this requirement applies to registrants and licensees of radiation-producing machines and NARM.

§ 219.61.  Testing for leakage or contamination of sealed sources.

   Subsection (a)(2) and (3) are clarified to show that the origin of the specification for alternative intervals of sealed source leak testing is the National Sealed Source and Device Registry maintained by the NRC. Reserved references resulting from previous rulemaking are removed. The specification of a ''licensing'' state is removed. Use of the word ''licensing'' implies a certification that is unduly restrictive. The limitation of 3 years between leak test intervals is removed. A limitation on the maximum leak test interval that can be specified in the registry is not codified by the NRC. Limits are established through the licensing process for each source manufacturer.

   Subsection (b)(6) is expanded to exempt any sealed source in storage from leak testing while in storage and the maximum interval of 3 years between leak tests is removed to avoid unnecessary exposure to personnel. If individual exceptions are warranted, they can be addressed through license condition on the user.

§ 219.229.  Other medical reports.

   The word ''discovery'' is replaced with ''determination by a physician'' to clarify who may make the determination of function damage. The word ''tissue'' is too generic. It is replaced by ''an organ or a physiological system'' for clarity.

Chapter 220.  Notices, instructions and reports to workers; inspections and investigations.

   § 220.2.  Posting of notices to workers.

   Section (c) reference to Department Form ER-BRP-3 ''Notice to Employees'' has been updated to reflect the Form's new designation 2900-FM-RP0003.

Chapter 221.  X-rays in the healing arts.

   § 221.2.  Definitions.

   ''Filter,'' ''filtration'' and ''half-value layer'' are defined more comprehensively.

   ''Healing arts screening'' sentence structure is re-arranged to avoid misinterpretation of the definition. The phrase ''for the purpose of diagnosis or treatment'' in its current position at the end of the sentence might mislead one to think it describes a type of licensed practitioner (one authorized to prescribe tests) rather than a condition placed on the purpose of the test (tests that are performed as an adjunct to a patient's diagnosis or treatment by a physician for a medical condition).

   ''Qualified expert'' is deleted since the definition was consolidated previously in § 215.2.

§ 221.11.  Registrant responsibilities.

   Subsection (a)(2) and (3) is deleted. The requirements were consolidated and moved to new § 215.24(b) and (c).

   Subsection (b) includes a requirement for continuing education. The continuing education requirement in Appendix A (relating to determination of competence) was moved from paragraph (6) and expanded upon.

   Subsection (e)(2) and (3) references to ''scatter'' radiation are replaced by the more appropriate term ''stray'' radiation. The subsection (l) requirement for a quality assurance program is expanded upon to clarify the minimum program components, the need for documentation and the associated record retention requirements.

§ 221.13.  Information to be submitted by persons requesting approval to conduct healing arts screening.

   Healing arts screening is an activity regulated by the Department that occurs when asypmtomatic individuals self-refer themselves for an X-ray test that has not been prescribed by a physician for the purpose of diagnosing or treating a condition. Nothing in the proposal will deny individuals access to diagnostic tests deemed necessary by a physician to diagnose or treat a patient. X-ray tests ordered, prescribed or obtained through referral of a patient under the care of a physician are not affected by this proposal.

   In the section heading, ''requesting approval'' has replaced ''proposing'' to emphasize that healing arts screening is subject to approval as stated in subsection (b).

   The format of the existing section is rearranged from paragraphs to subsections with the addition of new subsection (a). Subsection (a) addresses the efficacy of the proposed healing arts screening procedures. Efficacy is the first factor to be considered in evaluating a proposed healing arts screening procedure. The greater the radiation dose to the individual being screened, the more compelling the case should be for ensuring that the efficacy of the procedure compensates for the risk to the individual and for other detrimental factors. The Department considers the consensus positions taken by appropriate National medical organizations, relevant scientific and medical literature and information from appropriate Federal agencies. The Department does not determine efficacy but weighs the merit of these sources of information to support or deny approval of the procedure. Guidance for scientific and technical personnel to perform the evaluations is available through the National Council on Radiation Protection and Measurements Commentary No. 13 ''An Introduction to Efficacy in Diagnostic Radiology and Nuclear Medicine (Justification of Medical Radiation Exposure).''

   New subsection (a) also introduces a requirement for the Department to consult the Department of Health (DOH) in reviewing the efficacy of procedures that exceed a certain level of exposure to the screened population. The new requirement to seek assistance from the DOH in reviewing the efficacy of healing arts screening in such cases recognizes that actions taken by the Department may set defacto public health policy. The Department already collaborates with the DOH in other areas of overlapping concern such as the issuance of potassium iodide during certain reactor emergencies.

   A level of 100 mrem to the screened population was set to trigger consultation with the DOH. The Department sets standards for exposure to large populations of the general public from the activities it regulates based upon a limit of 100 mrem per year to the hypothetical maximally exposed individual. The expectation is that the majority of individuals will not receive the maximum exposure. There is also a performance based companion requirement, ALARA (as low as reasonably achievable), that controls operational implementation of this limit. An exposure of 100 mrem is below the threshold of producing an inevitable effect. It represents a risk for an individual that is potential or proportional rather than certain. For an individual or a small group of individuals, the Department routinely assumes the responsibility of weighing the risk versus the benefit of permitting those members of the general public to receive exposures at the level of 100 mrem. When higher exposures are involved, particularly across large groups, the potential for adverse health effects within the community approaches a certainty. Memoranda of Understanding are established as necessary to coordinate interdepartmental activities.

   The existing paragraphs become part of subsection (b). Subsection (b)(5) is expanded to require a comparison with any alternate method to the proposed X-ray screening exam, even if it is a different type of X-ray exam. Previously, comparisons were restricted to nonradiation alternatives. Subsection (b)(6) is clarified to explain what is meant by measurement of patient exposure. Subsection (b)(7) addresses new technology by not requiring film for diagnostic imaging. Subsection (b)(8) also addresses new technology in which exposure parameters may be set by machine rather than manually. Subsection (b)(9) requires information on the qualifications of all individuals who will be operating the X-ray systems, not just one individual. Subsection (b)(11) now requires information on the qualifications of individuals interpreting the screening test results (note: the antiquated reference to radiographs is removed). Subsection (b)(12) is reworded to better show the intent of ''implied consent'' and what that entails. Subsection (b)(13) once again replaces antiquated references to radiographs. Subsection (b)(15) is a new requirement to specify relevant information regarding the frequency and duration of the entire screening program. Subsection (b) was originally patterned after the Suggested State Regulations for Radiation Control which includes the provisions of subsection (b)(15).

§ 221.15.  Use of X-rays in research on humans.

   Subsection (b)(3), (6) and (9) is changed in like manner to their corresponding § 221.13(a)(5), (8) and (11). Subsection (b)(11) is new. It is intended to provide assurance of safeguards comparable to subsection (a).

§ 221.25.  Beam quality.

   Subsection (a) Table II has been updated. The values are the same as the current FDA hardware standards in 21 CFR 1020.30 Table 1. Footnotes of explanation have been added. Interpolation or extrapolation may be used between values in Table II. There is a column for specified intraoral dental systems manufactured after December 1, 1980. For those specified dental systems, the minimum half value layer below 71 kVp is 1.5 mmAl equivalent regardless of filtration. The FDA also prints leading zeros on decimals in the table to avoid misinterpretation.

§ 221.29.  Kilovoltage (kV) accuracy.

   The accuracy requirement for kilovoltage has been split into two specifications, one for variable kV units and one for fixed. The original precision of 10% was retained for variable units but the allowable error for units in which the kV can not be changed was relaxed to 20% because fixed kV units do not rely on kV for fine control of penetration and contrast.

§ 221.36a.  Limitation of useful beam of fluoroscopic equipment.

   The spelling of fluoroscopic is corrected in subsection (d).

§ 221.38a.  Entrance exposure rate.

   To emphasize the importance of output checks, subsection (c) is reworded to require that output measurements must be made at least annually, not just annually and they must be done in a manner sufficient to show compliance with the standards in this section.

§ 221.61.  Radiation therapy simulation systems.

   The current manner in which section numbers are referenced here is unnecessarily confusing. The references to the applicable sections have been restated in a clearer manner. The existing references also only apply to fluoroscopic based simulators. There is similar confusion in the way the applicable requirements for CT based simulators are addressed in existing § 221.202(h). A new subsection (b) has been created and the CT simulator references in § 221.202(h) have been clarified and moved to this section.

§§ 221.73, 221.74 and 221.75.

   The references to radiological physicist has been deleted under the expanded definition of qualified expert in § 215.2.

§ 221.202.  Equipment requirements.

   Subsection (f) relating to beam quality is deleted as redundant to the requirements of § 221.25. Subsection (h) has been moved to new § 221.61(b) as previously discussed.

§ 221.204.  Radiation measurements and performance evaluations.

   The spelling of the abbreviation MSAD has been corrected from MSDAD.

§ 221.205.  Operating procedures.

   Subsection (a)(3), specifying the distance to the tomographic plane, is unnecessary and deleted.

Appendix A.  Determination of competence

   The existing wording is deleted and restated to be more adaptable and less proscriptive. As discussed previously, the continuing education requirement of paragraph (6) was moved to § 221.11(b).

Chapter 223.  Veterinary medicine.

§ 223.21.  In vitro testing.

   Reserved references have been corrected to point to the regulations of the NRC that replace them in incorporation by reference.

§ 223.22.  Sealed sources.

   Reserved references have been corrected to point to the regulations of the NRC that replace them in incorporation by reference.

Chapter 224.  Medical use of radioactive material.

   § 224.10.  Incorporation by reference.

   Subsection (b) references were updated to correspond to their counterparts in the new 10 CFR Part 35.

§ 224.21.  Supervision.

   This section is reserved. The requirements for supervision are incorporated by reference to 10 CFR Part 35 and the requirements of paragraphs (1) and (2) have been moved to new § 215.24(b) and (c).

§ 224.22.  Authorization for calibration, transmission and reference sources.

   This section has been updated because of incorporation by reference of the new requirements of 10 CFR 35.65 and includes transmission sources. Notwithstanding, a more restrictive limit is set for radium because it is more hazardous and the NRC did not consider radium use in deriving new 10 CFR 35.65.

§ 224.23.  Decay-in-storage.

   The spelling of half-life is corrected.

Chapter 225.  Radiation safety requirements for industrial radiographic operations.

   § 225.1.  Purpose and scope.

   Section 225.2a (relating to incorporation by reference) is no longer reserved. The reference to it in subsection (b) is corrected.

§ 225.4a.  Radiation safety program.

   This section currently requires that the Department approve of radiation safety programs for industrial radiography before operations can be conducted. New subsection (b) clarifies that any change to a registrant's radiation safety program also requires prior Departmental approval.

§ 225.71.  Definitions.

   ''Temporary job site'' is a term usually associated with radiography utilizing radioactive sources. It is replaced by a new definition ''field radiography'' that better describes the type of radiography conducted with radiation-producing machines in Subchapter B. A new definition ''safety device'' is also defined for use in Subchapter B.

§ 225.73.  Training of personnel.

   In subsection (b), the new definition of ''field radiography'' replaces ''temporary job site'' radiography. The reference to 10 CFR 34 Subpart D (relating to radiation safety requirements) is replaced by Appendix A since the requirements of subchapter B relate to radiography with radiation-producing machines rather than radioactive materials and § 225.1(b) established the intent to minimize the effect of incorporation by reference of 10 CFR Part 34 on Subchapter B.

§ 225.82.  Operating requirements.

   Subsection (a) describes personnel requirements for field radiography. The list of individuals who may be called upon to assist the radiographer is increased by the addition of radiographer trainee.

§ 225.83.  Records required at field radiography sites.

   The new definition of field radiography is used in place of temporary job site in the heading and text of this section.

§ 225.101.  Cabinet X-ray systems and baggage/package X-ray systems.

   The intent of subsection (d) is to assure the X-ray systems continue to meet the performance standards relating to leakage radiation. Subsection (d) was reworded to clarify this. References to other manufacturer hardware standards in 10 CFR 20.1301 and 21 CFR 1020.40 were removed. Those standards are enforced under subsection (a).

§ 225.102.  Shielded room X-ray radiography.

   Existing subsection (b) is deleted and existing subsection (c) is renumbered. If the provisions of subsection (a) limiting radiation leakage from the room and existing subsection (c) requiring surveying before entry are followed, operator exposure can not reasonably be expected to exceed the threshold of 500 mrem per year that would require personnel monitoring.

   A new subsection (c) is added that allows the use of an independent radiation monitoring system in lieu of a typical portable radiation survey meter to verify that the radiation-producing machine is off before entering the room.

   Subsection (d) is new. Shielded room radiography is exempted from all other provisions of this chapter except §§ 225.4a and 225.84 (relating to radiation safety program; and operating and emergency procedures) because of its safe operating history.

§ 225.103.  Field site radiography.

   The new term field site radiography replaces temporary job site radiography in the section title.

Chapter 226.  Licenses and radiation safety requirements for well logging.

   § 226.3a.  Abandonment of a sealed source.

   The general reference to incorporation by reference of 10 CFR Part 39 is replaced by specific references to sections of Part 39 for clarity.

Chapter 227.  Radiation Safety Requirements for analytical X-ray equipment, X-ray gauging equipment, electron microscopes and X-ray calibration systems.

   § 227.11a.  Equipment requirements.

   In subsection (a)(2), the reference to ''devices'' is changed to ''safety devices'' for consistency with the previous reference to safety devices in subsection (a).

§ 227.12a.  Area requirements.

   The reference to reserved § 219.51 is replaced by 10 CFR 20.1301, its equivalent from incorporation by reference of NRC regulations.

§ 227.13a.  Operating requirements.

   Subsection (d) is new. It provides for emergency instructions for operation of analytical equipment. Analytical X-ray equipment is capable of inflicting physical injury from radiation before an operator can react.

§ 227.14.  Personnel requirements.

   Subsection (a) is updated to require instruction in the new requirement for emergency procedures under subsection (a)(3) and the applicable regulations in general under subsection (a)(7).

   Subsection (c) reference to § 219.31 (relating to occupational dose limits for adults) is actually reserved and misprinted. It is replaced with the equivalent reference to 10 CFR 20.1201 under incorporation by reference of NRC regulations.

Chapter 228.  Radiation Safety Requirements for Particle Accelerators.

   § 228.2.  Definitions.

   The definition of ''accelerator'' is expanded to indicate that ''particle accelerator'' has the same meaning. (The term is used in § 228.37 referencing § 217.144.)

   The definition of ''filter'' as used in the context of the application of radiation has also been modified for consistency with a similar definition used in § 221.2.

   The new term ''particle accelerator'' is cross referenced to accelerator.

   The term ''Qualified expert'' is deleted as the term has been consolidated under the definitions of § 215.2 discussed previously.

§ 228.11a.  Licensee responsibilities.

   Subsection (a) requirements also apply to persons possessing an accelerator, not just operators.

   Subsection (d) is deleted since it is redundant to the requirements of § 215.28 (relating to improper use of a monitoring device).

§ 228.12.  Information and maintenance record and associated information.

   The reference to registrant is deleted, as accelerators cannot be registered, only licensed. The length of time records must be kept by the licensee for inspections by the Department is increased from 4 to 5 years.

§ 228.21a.  Notification and license requirements.

   Subsection (a)(1) is clarified to describe how an application for license is to be filed with the Department.

   Subsection (g) requiring written permission of the Department to transfer an accelerator license is new. It is consistent with similar existing requirements in § 216.2(e) and 10 CFR 30.34(b) dealing with the transfer of radiation-producing machine registrations and radioactive material licenses respectively.

§ 228.23a.  Expiration and termination of a license.

   Subsection (d)(1) is expanded to clarify that if an accelerator licensee does not intend to renew their license, they must not only stop use of it after the deadline but transfer or dispose of the accelerator. This is consistent with revised § 221.11a(a) prohibiting possession of an accelerator that does not meet the requirements of this article.

   Subsection (d)(3) updates the reference to Department Form ER-BRP-314 to its new designation 2900-PM-RP0314.

§ 228.31a.  Limitations.

   Subsection (b)(2) is revised to delete reference to registration. Accelerators are no longer registered.

§ 228.32a.  Shielding and safety design requirements.

   Subsection (a) is revised to indicate the type of qualified expert required. The existing requirement to have a safety survey performed prior to first use and after changes is deleted because it is already addressed in § 228.38(a).

   Subsection (b) reference to reserved § 219.51 is replaced by 10 CFR Part 20 Subpart D, the NRC equivalent regulation incorporated by reference.

§ 228.34a.  Accelerator controls and interlock systems.

   Subsection (b) references to reserved §§ 219.91 and 219.54 are replaced by 10 CFR Part 20 Subpart G and 10 CFR 20.1902 respectively, which are the NRC equivalent regulations incorporated by reference.

§ 228.35.  Operating procedures.

   In subsection (g)(4), the term ''misadministration'' no longer exists. It has been replaced by its successor, ''medical reportable event for radiation-producing machine therapy.'' Existing subsection (g)(5) and (6) are deleted. Those requirements are covered in new § 215.24 (b) and (c) discussed previously. Existing subsection (g)(7) is renumbered as subsection (g)(5) and the requirement for continuing education is moved from Appendix A to subsection (g)(5), similar to the treatment of continuing education in Chapter 221 Appendix A (relating to determination of competence).

§ 228.37.  Production of radioactive material.

   Subsection (a) reference to reserved § 217.48 is replaced by its successor § 217.144 (relating to incidental radioactive material produced by a particle accelerator).

   Subsection (b) reference to reserved §§ 217.51--217.57 is replaced by reference to Chapter 217 (relating to licensing of radioactive material). It should be noted that Chapter 217 in turn incorporates requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material).

§ 228.38.  Radiation safety surveys.

   Subsection (a) requirements are clarified to ensure that the initial survey requirements in this subsection, replace those deleted from existing § 228.32(a). The type of qualified expert required is also clarified.

   Subsection (d) references to reserved §§ 219.31 and 219.51 are replaced by the NRC equivalent regulations incorporated by reference, 10 CFR 20.1201 and 21.1301 (relating to occupational dose limits for adults; and dose limits for individual members of the public).

§ 228.39.  Records.

   Reference to reserved §§ 219.201--219.211 is replaced by the NRC equivalent regulations incorporated by reference, 10 CFR Part 20, Subpart L (relating to records).

§ 228.41a.  Warning devices.

   Subsection (b) reference to reserved § 219.91 is replaced by 10 CFR 20.1601 (relating to control of access to high radiation areas), the NRC equivalent regulation incorporated by reference.

§ 228.43.  Radiation surveys.

   A subsection (c) reference to a qualified expert is clarified.

   A subsection (d) reference to reserved Subchapter L of Chapter 219 is replaced by the NRC equivalent regulations incorporated by reference, 10 CFR Part 20, Subpart L (relating to records).

§ 228.44.  Ventilation systems.

   A subsection (a) reference to reserved § 219.34 is replaced by 10 CFR 20.1204 (relating to determination of internal exposure), the NRC equivalent regulation incorporated by reference.

   A subsection (b) references to reserved §§ 219.51 and 219.52 are replaced by the NRC equivalent regulations incorporated by reference, 10 CFR 20.1301 (relating to dose limits for individual members of the public) and 10 CFR 20.1302 (relating to compliance with dose limits for individual members of the public) respectively.

§ 228.61.  Leakage radiation to the patient area.

   A subsection (a)(2) reference to registrant is deleted because accelerators are no longer registered, only licensed.

§ 228.75.  Calibrations.

   A references to the type of qualified expert in subsection (b) and subsection (c)(4) are clarified.

§ 228.76.  Spot checks.

   A reference to the type of qualified expert in paragraph (1) is clarified.

Appendix A.  Determination of Competence.

   The existing wording is deleted and restated to be more adaptable and less proscriptive. As discussed previously, the existing continuing education requirement of paragraph (6) was moved and added to new § 228.35 (g)(5).

§ 230.3.  Incorporation by reference.

   Subsection (b) references to 10 CFR 71.47 and 10 CFR 71.83 are deleted and reference to 10 CFR 71.61 is added as previously discussed under § 215.1(e)(13).

Chapter 240.  Radon Certification.

   § 240.2.  Scope.

   New subsection (b) is added to clarify that this chapter is in addition to, and not in substitution for, other applicable provisions of this article. For example, individuals subject to this chapter who are required to have health and safety plans for their activities are subject to the standards for protection against radiation in Chapter 219. Individuals who use certain radium or radon sources are subject to the licensing provisions for radioactive material in Chapter 217.

F.  Benefits, Costs and Compliance

   Executive Order 1996-1 requires a cost/benefit analysis of the proposed amendments.


   The primary benefit of the proposed rulemaking is to correct linked references that are no longer accurate as a result of changes in previous rulemakings and changes in the regulations of the NRC incorporated by reference. This is part of a comprehensive effort to provide additional clarity to the regulations for radiological health to benefit the regulated community. Existing requirements are clarified in many areas, including: registration, licensing, fee assessment, radiation producing machine service providers, healing arts screening and human research, determination of competence for auxiliary medical personnel, filtration, radiation safety committees, medical event reporting and radiation therapy simulators. The new requirement for concurrence by the Department of Health for approval of certain healing arts screening provides additional health protection by bringing in a competent independent third party regulator. There are also additional benefits to the regulated community in more flexible requirements for personnel exposure to X-rays, quality assurance programs, leak testing of sealed sources, general licenses for sealed source devices, cabinet radiography and shielded room radiography operations. Eligibility for lower fees for general license devices has been extended. In fairness to registrants and the recovery of fees to support this program, the time that an X-ray machine from outside the Commonwealth may be operated before being subjected to registration and payment of associated fees is reduced. Radiation producing machine service providers are assessed a registration fee to cover the cost of oversight of their activities and a minimum annual fee for accelerators greater than 50 MeV is created.

Compliance Costs

   The majority of changes represent clarifications of requirements. For them, the underlying requirements have not actually changed so the there is no additional cost to comply. Implementing the more flexible requirements for personnel exposure to X-rays, quality assurance programs, leak testing of sealed sources, general licenses for sealed source devices, cabinet radiography and shielded room radiography operations will add no additional costs and generally reduce existing costs. The new cost for out of state X-ray providers who establish semi-permanent operations in the Commonwealth is no more than fees charged by other states for the equivalent activities. The new codified category 3Q annual general license fee of $315 is identical to what the current uncodified fee is pursuant to the formula in Chapter 218 Appendix A footnote 3. However, the proposed regulations would permit extension of this fee to certain current category 3P licensees resulting in a fee decrease for about 70 licensees who currently pay $750. There is a new annual fee of $100 for registration of radiation-producing machine service providers. The net loss of income from switching some category 3P licenses to category 3Q is expected to be about equal to the increase in income from the new radiation-producing machine service provider registration fee.

Compliance Assistance Plan

   The majority of changes clarifying references and definitions are self-explanatory. They are being made as part of compliance assistance. Guidance is being prepared to explain acceptable alternate methods of determining personnel exposure to X-rays and acceptable X-ray quality assurance programs. Outreach and assistance will be provided by regional inspectors and technical staff of the central office Radiation Control Division.

Paperwork Requirements

   Changes dealing with clarification of existing regulations add no additional paperwork beyond the original requirements. Regulations made more flexible may or may not result in a decrease in record-keeping requirements depending on what options the registrant or licensee avails themselves. Those persons providing radiation-producing machine services will be required to file a registration of activities form that has yet to be developed with the Department. Any paperwork for reporting the details of actual services being provided is already being filed with the Commonwealth through United States Food and Drug Administration (FDA) form 2579. The application form for new general license category 3Q has not been developed yet. However, it requires less supporting documentation than any current category and will constitute a reduction in paperwork over the current alternative licenses.

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 20, 2003, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House and Senate 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.

   Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed amendments within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria that have not been met. The Regulatory Review Act specifies detailed procedures for review of these issues by the Department, the General Assembly and the Governor prior to final publication of the regulations.

I.  Public Comments

   Written Comments--Interested persons are invited to submit comments, suggestions or objections regarding the proposed rulemaking 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 29, 2003. Interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must also be received by September 29, 2003. 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. and must also be received by the Board by September 29, 2003. 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.


   Fiscal Note:  7-387. No fiscal impact; (8) recommends adoption.

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