Statement of Basis and Purpose s4

STATEMENT OF BASIS AND PURPOSE AND SPECIFIC STATUTORY AUTHORITY FOR AMENDMENTS TO THE COLORADO STATE BOARD OF HEALTH RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL 6 CCR 1007-1

Part 17, Transportation of Radioactive Material

Adopted by the State Board of Health on July 18, 2007

Basis and Purpose.

The Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes (the Act), Section 25-11-104, requires the State Board of Health to formulate, adopt and promulgate rules and regulations pertaining to radiation control. Section 25-11-103 of the Act requires the Colorado Department of Public Health and Environment (Department) to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation, including to requiring registration of sources of ionizing radiation such as radiation machines and to issuing licenses pertaining to radioactive materials. Section 25-11-104 of the Act requires Colorado’s radiation regulations to be modeled after the Suggested State Regulations for Control of Radiation (SSRCR) of the Conference of Radiation Control Program Directors, Inc., except when the Board of Health concludes, on the basis of detailed findings, that a substantial deviation from the SSRCR is warranted.

These amendments modify Part 17, Transportation of Radioactive Material. Part 17 was last amended May 20, 1998, effective July 30, 1998.

Regulatory Framework Governing Transportation of Radioactive Materials

The U.S. Department of Transportation (DOT) has preemptive primary authority to establish and enforce domestic hazardous materials packaging and transport regulations. The regulations of the U.S. Nuclear Regulatory Commission (NRC) in 10 Code of Federal Regulations (CFR) Part 71 are in addition to those of DOT in 49 CFR. NRC does not promulgate rules that duplicate those of DOT.

DOT regulates both interstate and intrastate commerce. DOT encourages States to adopt equivalent rules and to cooperate in enforcement. States are encouraged to help implement certain DOT rules for which NRC must defer to DOT as lead cognate federal agency. Thus, 10 CFR 71.13 and 71.14(b) are omitted from Colorado’s Part 17. 49 CFR applies overall. This revision of Colorado’s Part 17 conforms to DOT rules and incorporates the appropriate NRC rules, as detailed in Regulatory Action Tracking System (RATS) 2004-1 (June 6, 2005).

1 A 2007 draft revised Part T of the Suggested State Regulations for the Control of Radiation was used in support of this revised Part 17. In general, the 1999 Part T and the revision of Part T that is now undergoing peer review within the Conference of Radiation Control Program Directors, Inc., include only the provisions necessary to govern radioactive materials transportation to and from licensed and project sites.

These amendments incorporate needed additions, corrections and modifications. As detailed below, these changes are required for compatibility of Colorado’s program under the Agreement by which NRC has relinquished control of certain radioactive materials to the state so long as Colorado’s program is compatible and adequate by national criteria. NRC publishes the needed revisions in the Federal Register, specifying a date, usually up to three years, by which the 34 Agreement States are to have equivalent rules in place. In the interim until an Agreement State successfully promulgates its equivalent rules, the national provision is to be implemented by an alternative legally binding requirement, such as a license condition, usually added when an affected license next comes up for renewal.

The symbols “A”, “B”, “C”, “D”, “NRC”, or “H&S” signify the categories into which NRC may designate a particular provision of regulation, as follows:

A = Basic radiation protection standard or related definitions, signs, labels or terms necessary for a common understanding of radiation protection principles. The State program element should be essentially identical to that of NRC.

B = Program element with significant direct transboundary implications. The State program element should be essentially identical to that of NRC.

C = Program element, the essential objectives of which should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be the same as NRC, provided the essential objectives are met.

D = Not required for purposes of compatibility.

NRC = Not required for purposes of compatibility. These are NRC program elements that address areas of regulation that cannot be relinquished to Agreement States pursuant to the Atomic Energy Act or provisions of 10 CFR regulations. The State should not adopt these program elements.

H&S = Program elements identified by H&S are not required for purposes of compatibility; however, they do have particular health and safety significance. The State should adopt the essential objectives of such program elements in order to maintain an adequate program.

2 NRC is the primary agency issuing a certificate of compliance for the packages in which more highly radioactive material is transported. Of special concern is fissile material. Colorado’s Part 17 includes the sections that are minimally necessary and sufficient to maintain a consistent national framework for regulating radioactive materials. Colorado’s Part 17 includes by reference, but not repetition, the extensive sections in 10 CFR 71 and Part T which govern fissile material transportation. A licensee involved with such material is better served by being referred directly to and conforming precisely to 10 CFR 71 and 49 CFR.

Colorado’s rule is intended to be as user-friendly as possible. For this reason, several provisions are differently placed in Part 17 than the equivalent text in Part T or 10 CFR 71. A crosswalk Excel spreadsheet that places each provision of Part 17 side-by-side with the related model state code or federal rule section is at http://www.cdphe.state.co.us/hm/rad/regs/rules.htm .

Specific Changes Being Made In Part 17 At This Time

1. Section 17.1, Purpose and Scope, is modified to be consistent with the standard format now used for all parts of Colorado’s radiation regulations. The usage “RH” is dropped throughout Part 17, consistent with the standard format.

2. Subsection 17.1.4 retains applicability of Part 17 to any person, as defined in Part 1, who transports radioactive material or delivers radioactive material to a carrier for transport. Subsection 17.1.4.1 is required to maintain compatibility with NRC governing Type B packages. Subsection 17.1.4.2 includes, in a slightly more user-friendly order than SSRCR Part T, provisions of Sections T.1c through T.1e [analogous to components of 10 CFR 71.0(c) through (g) that are not reserved to NRC]. Subsections 17.1.4.1(2) through (6) direct user cognizance to important later sections. Subsections 17.1.4.2 and 17.1.4.3 are equivalent to the content of SSRCR T.1b [10 CFR 71.0(b)].

3. Subsection 17.1.5 is added to be explicit about how published material incorporated by reference is made available (former Section 17.21 is eliminated).

4. The introductory provisions in Section 17.2, Definitions, are improved and made more explicit.

5. In Section 17.2, definitions of “certificate holder”, “certificate of compliance”, “consignment”, “containment system”, “conveyance”, “deuterium”, “graphite”, “nuclear waste” (for purposes of Part 17), “Type A packaging”, “Type AF package”, “Type BF package”, “Type B(U)F package”, and “Type B(M)F package” are added.

6. In Section 17.2, definitions of “fissile material package”, “low specific activity material”, “low toxicity alpha emitters”, “packaging”, “regulations of the DOT”, “regulations of the NRC”, “surface contaminated object”, “transport index”, “Type A quantity”, “Type A package”, and the footnote to the definition of “Type B package” are modified.

7. In Section 17.2, the definitions of “fissile material”, “specific activity”, and “State” are

3 deleted because these definitions are in Part 1 and thus available across 6 CCR 1007-1. In a coordinated modification, generally acceptable definitions of “quality assurance” and “quality control” are added to Part 1 for use in Part 17 and other parts.

8. Section 17.4.2 is modified in accord with the international and federal framework, which eliminates the obsolete definition of radioactive material which had been used for transportation purposes (greater than 2 picocuries per gram regardless of the radionuclide) and now provides Table 17A2, “Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides”.

9. New Section 17.4.3 redefines which fissile materials are exempt from fissile material packaging standards.

10. Section 17.5, the list of cognizable DOT requirements, is updated by adding reference to security plans required by 49 CFR 172, Subpart I.

11. Section 17.6 is edited slightly for format.

12. In Section 17.7, the general license for NRC-approved packages is modified.

13. In Section 17.8, the general licenses are modified for use of foreign-approved (formerly Section 17.10) and other approved packages (formerly 17.8 and 17.9). Note that former 17.9 is moved to 17.8.2 because this general license expires October 1, 2008; subsection 17.8.2 will be deleted from Part 17 after that date.

14. In Section 17.9, the general license for fissile material transport (formerly 17.11 and 17.12) is modified.

15. Section 17.10 now contains the quality assurance requirements that were formerly in Section 17.20.

16. Section 17.11 now contains the advance notification of transport of nuclear waste requirements formerly in Section 17.19.

17. Section 17.12 now contains the air transport of plutonium requirements formerly in Section 17.16.

18. In Section 17.15.8, the specifications for the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment are modified.

19. In Section 17.15.10, regarding radiation levels external to a package transported in exclusive use by rail, highway or water, the format is modified slightly.

20. Section 17.16 now contains the requirements for reports formerly in Section 17.18.

4 21. Appendix A and its table names are modified slightly to be consistent with newer format for all parts of Colorado’s radiation regulations. Footnotes are numbered. Values in the tables conform to international and national changes in the numeric criteria.

Specific Statutory Authority. These rules are promulgated pursuant to the provisions of Sections 25-1.5-101(1)(l), 25-1-108, and 25-11-104, C.R.S.

Major Factual and Policy Issues Encountered.

As summarized above, these revisions do not involve major factual issues. The NRC compatibility category determinations governing Agreement State implementation of these changes are listed in Procedures Manual SA-200, available at http://www.hsrd.ornl.gov/nrc/procedures/sa200.pdf.

These changes to Parts 17 are also being made to achieve significant improvements.

Alternative Rules Considered and Why Rejected.

Because the primary purpose of this revision to Part 17 of Colorado’s radiation regulations is to update and improve Part 17, in conformance with the national framework of the DOT and NRC and with the Suggested State Regulations for the Control of Radiation, minor wording improvements were considered across a narrow range. Colorado’s rules need to closely mirror and be compatible with those of DOT and NRC and the 33 other Agreement States under the U.S. Atomic Energy Act.

The Colorado Radiation Advisory Committee is approved this proposed revision in full to Part 17 at the May 9, 2007 meeting.