REGULATORY ANALYSIS
for Amendments to
6 CCR 1007-1, Radiation Control, Part 17, Transportation of Radioactive Materials
Adopted by the Board of Health on June 18, 2014
1.
A description of the classes of persons who will be affected by the proposed rule,
including classes that will bear the costs of the proposed rule and classes that will
benefit from the proposed rule.
The classes of persons potentially affected by the proposed rule amendments are those
entities licensed to use radioactive materials that ship, or prepare for shipment radioactive
materials. Specifically, those entities involved in the shipment of nuclear waste and others
shipping high activity quantities of radioactive material will have some additional
requirements. Entities shipping nuclear waste are typically under the jurisdiction of the
federal government for which these requirements currently apply. A very limited number of
licensees (licensed by Colorado) would be potentially impacted by the proposed changes
when they ship very high activity sources, although such licensees typically rely
significantly upon licensed contractors (e.g., manufacturers or other service providers) to
handle the logistics and other regulatory requirements.
The proposed change relating to the physician exemption from certain shipping
requirements potentially reduces the regulatory burden for the approximate 100 medical
licensees in Colorado and would potentially benefit from the rule. It is expected however
that most physicians working at licensed medical facilities would not be personally involved
in the transport of radioactive materials due to liability and other reasons.
The proposed changes relating to quality assurance for foreign packages is currently in
federal rule, where approval of packages and quality assurance programs must already be
reviewed and approved by the federal government. The proposed changes to Colorado rule
merely mirror these existing requirements that are outside of Colorado jurisdiction, but are
needed for compatibility with federal rule.
2.
To the extent practicable, a description of the probable quantitative and qualitative
impact of the proposed rule, economic or otherwise, upon affected classes of persons.
Quantitative:
As of January 2014, Colorado had approximately 325 active specific radioactive material
licensees. Specific licensees apply in writing to, and receive approval from, the Department
to operate within the State’s borders. Colorado also had approximately 1,000 locations that
use radioactive devices under a general license. Any licensee (specific or general) may be
involved in the transport of radioactive material as authorized by their license and would be
required to adhere to the requirements of Part 17 and those of the U.S. Department of
Transportation (DOT). However, the proposed changes pertaining to notifications and
exclusive use shipments would potentially apply only to very few licensees due to the type
and quantity of materials falling within the modified or added provisions in the rule.
Collectively, the proposed rule amendments are likely to have a minimal impact on
licensees both quantitively and qualitatively since they are already required by federal rule.
Entities shipping nuclear waste and other high activity (quantities) of radioactive material
must currently go through extensive notification processes and follow other regulatory
requirements. The added language/requirements do not significantly add to this regulatory
burden.
The quantitative impacts on the provisions related to a physician exemption would
potentially be a reduction in the regulatory impact on the licensee. It is expected that this
provision would not be invoked on any routine frequency however.
Qualitative:
The net qualitative effect of these changes is to keep Colorado rules consistent with changes
to the federal rules that became effective in 2004 and 2012, such that they are consistent
with the national framework governing radioactive material transportation and to help
licensees operate effectively within that national framework.
3.
The probable costs to the agency and to any other agency of the implementation and
enforcement of the proposed rule and any anticipated effect on state revenues.
There are no expected or probable costs to the department or other agency as a result of the
implementation and enforcement of the proposed rule. Shipments of nuclear waste and
high activity sources are infrequent. There is no anticipated effect on state revenues as a
result of the proposed rule.
4.
A comparison of the probable costs and benefits of the proposed rule to the probable
costs and benefits of inaction.
These changes are intended to reduce the extra time and effort needed to comply with the
requirements by ensuring consistency with the revised Federal regulations. Failure to
implement the proposed rules may result in incompatibility with Colorado’s Agreement
with the U.S. Nuclear Regulatory Commission (NRC) as an Agreement State.
5.
A determination of whether there are less costly methods or less intrusive methods
for achieving the purpose of the proposed rule.
There are no less costly methods or less intrusive methods for achieving the purpose of the
proposed rule. The rule changes are necessary for compatibility with federal rules on
transportation of radioactive materials and to allow Colorado’s licensees to operate
consistency within a national regulatory framework of regulations pertaining to inter and
intra-state transportation of radioactive materials.
6.
Alternative Rules or Alternatives to Rulemaking Considered and Why Rejected.
The proposed rules are necessary in order to maintain consistency with other Agreement
States, the NRC, and DOT in the transport of radioactive materials across and between state
borders. Alternative rules are not feasible as the rules must be implemented to maintain
Colorado’s compatibility with federal rule and its status as an Agreement State.
7.
To the extent practicable, a quantification of the data used in the analysis; the
analysis must take into account both short-term and long-term consequences.
As identified in item 1 and 2 above, the proposed changes would potentially quantitatively
impact a very few number of licensees since the modified and added provisions apply to a
very limited population of licensees, some of which would be regulated by the federal
government and for which these requirements already apply. The short-term and longterm consequences of failure to implement the proposed rule be Colorado’s inconsistency
with federal rules.