CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Division of Public Health Protection and Safety
(New Administrative Regulation)
902
KAR 100:037. Physical protection of category 1 and category 2 quantities of
radioactive material.
RELATES
TO: KRS 194A.005(1), 211.180(1), 211.842 - 211.852, 211.990(4), 10 C.F.R. Part
37
STATUTORY
AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1)
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and
Family Services to provide by administrative regulation for the registration
and licensing of the possession or use of sources of ionizing or electronic
product radiation and the handling and disposal of radioactive waste. This
administrative regulation establishes requirements for the physical security of
Category 1 and Category 2 quantities of radioactive material.
Section
1. Definitions. (1) "Cabinet" is defined by KRS 194A.005(1).
(2)
"Licensee" means a person subject to 10 C.F.R. Part 37, Physical
protection of category 1 and category 2 quantities of radioactive material.
Section
2. Applicability. This administrative regulation shall apply to a licensee. The
licensee shall comply with 10 C.F.R. Part 37 except as established in subsections
(1) and (2) of this section. (1) The licensee shall not be subject to:
(a)
10 C.F.R. 37.7;
(b)
10 C.F.R. 37.13;
(c)
10 C.F.R. 37.107; or
(d)
10 C.F.R. 37.109.
(2)
Reference to the commission or NRC shall be deemed to be a reference to the cabinet,
Department for Public Health, Radiation Health Branch, except in:
(a)
10 C.F.R. 37.5, Definitions: Agreement State, Byproduct material, Commission,
Fingerprint orders, and Person;
(b)
10 C.F.R. 37.25;
(c)
10 C.F.R. 37.27;
(d)
10 C.F.R. 37.29; or
(e)
10 C.F.R. 37.71.
Section
3. Reporting of events or notifications. The required reporting of events or
notifications to the Radiation Health Branch shall be directed to:
(1)
275 East Main Street, Mailstop HS1C-A, Frankfort, Kentucky 40621;
(2)
(502) 564-3700, Monday through Friday from 8 a.m. to 4:30 p.m.; or
(3)
(800) 255-2587, at other hours.
STEPHANIE MAYFIELD GIBSON, MD, FCAP, Commissioner
AUDREY TAYSE HAYNES, Secretary
APPROVED BY AGENCY: October 8, 2015
FILED WITH LRC: October 14, 2015 at 1 p.m.
PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public
hearing on this administrative regulation shall, if requested, be held on
November 23, 2015, at 9:00 a.m. in the Health Services Auditorium, Health
Services Building, First Floor, 275 East Main Street, Frankfort, Kentucky. Individuals
interested in attending this hearing shall notify this agency in writing by
November 16, 2015, five (5) workdays prior to the hearing, of their intent to
attend. If no notification of intent to attend the hearing is received by that
date, the hearing may be canceled. The hearing is open to the public. Any
person who attends will be given an opportunity to comment on the proposed
administrative regulation. A transcript of the public hearing will not be made
unless a written request for a transcript is made. If you do not wish to attend
the public hearing, you may submit written comments on the proposed
administrative regulation. You may submit written comments regarding this
proposed administrative regulation until November 30, 2015. Send written
notification of intent to attend the public hearing or written comments on the
proposed administrative regulation to:
CONTACT PERSON: Tricia Orme, Office of Legal
Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40602, phone 502-564-7905,
fax 502-564-7573, email Tricia.Orme@ky.gov.
REGULATORY IMPACT ANALYSIS AND
TIERING STATEMENT
Contact Person: Laura Begin
(1) Provide a brief summary of:
(a) What this administrative regulation does: This
administrative regulation requires affected entities to comply with the federal
requirements contained in 10 C.F.R. Part 37. The U.S. Nuclear Regulatory
Commission (NRC) issued orders requiring licensees to implement enhanced
security to control access to radioactive material quantities of concern and to
protect sensitive security-related information and requiring criminal history
records checks for unescorted access to certain radioactive material. In
conjunction, Agreement States (states that regulate the use of certain radioactive
material pursuant to an agreement with the NRC) were required to issue compatible
requirements within their regulatory jurisdiction. The Agreement State
Radiation Health program is required to issue legally binding requirements to
its licensees consistent with NRC regulations. Kentucky is required to do this
as an Agreement State with the primary authority to regulate, inspect, and take
enforcement actions against licensees.
(b) The necessity of this administrative
regulation: As an Agreement State with the authority to operate its radiation
program, the Department for Public Health, Radiation Health Branch, is required
to maintain a compatible set of regulations to those of the NRC which govern
the receipt, transfer, possession, use, and distribution of radioactive
material in the Commonwealth. The NRC adopted the federal counterpart to this
regulation on March 19, 2013, and the Department has three years to promulgate
a compatible regulation in its own program. KRS 194A.050(1) requires the
Secretary of the Cabinet for Health and Family Services to adopt administrative
regulations necessary to protect the health of the individual citizens of the
Commonwealth and necessary to operate the programs and fulfill the
responsibilities vested in the Cabinet.
(c) How this administrative regulation conforms to
the content of the authorizing statutes: KRS 194A.050(1) requires the Secretary
of the Cabinet for Health and Family Services to adopt administrative
regulations necessary to protect the health of the individual citizens of the
Commonwealth and necessary to operate the programs and fulfill the
responsibilities vested in the Cabinet. KRS
211.844(1) requires the Cabinet to provide by administrative regulation for the
registration and licensing of the possession or use of sources of ionizing or
electronic product radiation and the handling and disposal of radioactive
waste. 902 KAR Chapter 100 contains the Cabinet’s requirements for the receipt,
transfer, possession, use, and distribution of radioactive material in the
Commonwealth.
(d) How this administrative regulation currently
assists or will assist in the effective administration of the statutes: This
administrative regulation assists in the effective administration of the
statutes by protecting the health of the individual citizens of the
Commonwealth and giving the Cabinet the authority to enforce the requirements
contained in 10 C.F.R. Part 37, Physical protection of category 1 and category
2 quantities of radioactive material. Housing these requirements for
radioactive material in the Kentucky Administrative Regulations Chapter 100
creates less of a burden for regulated entities, as that is where other
radioactive material requirements are found.
(2) If this is an amendment to an existing
administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing
administrative regulation: This is a new administrative regulation.
(b) The necessity of the amendment to this
administrative regulation: This is a new administrative regulation.
(c) How the amendment conforms to
the content of the authorizing statutes: This is a new administrative
regulation.
(d) How the amendment will assist in the effective
administration of the statutes: This is a new administrative regulation.
(3) List the type and number of individuals,
businesses, organizations, or state and local governments affected by this
administrative regulation: Of the
approximately 400 entities in the Commonwealth of Kentucky issued specific
radioactive material licenses by the Cabinet, only 18 will be affected by this
new 902 KAR 100:037. This administrative regulation will not change or adjust
the number of licensees currently operating under the requirements established
by the NRC. Aside from the University of Kentucky and the University of
Louisville, the other licensees subject to this new regulation are privately
owned businesses and publicly traded corporations, many of which are already complying
with the corresponding 10 C.F.R. Part 37 in other states.
(4)
Provide an analysis of how the entities identified in question (3) will be
impacted by either the implementation of this administrative regulation, if
new, or by the change, if it is an amendment, including:
(a)
List the actions that each of the regulated entities identified in questions
(3) will have to take to comply with this administrative regulation or
amendment: This administrative regulation adopts federal standards released as
orders published by the NRC that all category 1 and category 2 licensees are
subject to, but contains a couple additional requirements since the orders were
issued: As a result of the federal requirements, these 18 licensees are
required to perform a background investigation every 10 years. Licensees are
also required to reinvestigate individuals granted unescorted access of
radioactive material every 10 years. The cost for the FBI fingerprint criminal
history records check currently imposed by the NRC is $26.00 per person. These
18 licensees are also required to take their existing Increased Controls
Policies and Procedures and divide the policy into a separate Access
Authorization Program, Access Control Program, Security Program and Physical
Protection Program including a Maintenance and Testing Program. The foundations
for these currently exist in their Policies and Procedures already so this is
not a burden or hardship.
(b)
In complying with this administrative regulation or amendment, how much will it
cost each of the identities identified in question (3): The 18 licensees subject
to this administrative regulation will be required to reinvestigate individuals
granted unescorted access of radioactive material every 10 years, costing them
$26.00 per person.
(c)
As a result of compliance, what benefits will accrue to the entities identified
in question (3): Compliance with federal and state requirements ensures safety
when transferring category 1 and category 2 quantities of radioactive material.
Licensees who are compliant will not be subject to enforcement actions.
(5)
Provide an estimate of how much it will cost the administrative body to
implement this administrative regulation:
(a)
Initially: There are no additional costs to implement this administrative
regulation.
(b)
On a continuing basis: There are no additional costs to implement this
administrative regulation.
(6)
What is the source of the funding to be used for the implementation and
enforcement of this administrative regulation: Agency fees and general funds
are currently being used and will continue to be used to operate the
radioactive material program. No additional funds are required to implement
this regulation.
(7)
Provide an assessment of whether an increase in fees or funding will be
necessary to implement this administrative regulation, if new or by the change,
if it is an amendment: No increase in fees or funding is necessary to implement
this administrative regulation.
(8)
State whether or not this administrative regulation established any fees or
directly or indirectly increased any fees. This administrative regulation does
not establish any fees directly or indirectly.
(9)
TIERING: Is tiering applied? No, this administrative regulation applies to all
subject licensees equally.
FISCAL NOTE ON STATE OR LOCAL
GOVERNMENT
1. What units, parts or divisions of state or
local government (including cities, counties, fire departments, or school
districts) will be impacted by this administrative regulation? Only the
Department for Public Health, Radiation Health Branch, will be affected by this
administrative regulation as the Department will be responsible for enforcing
it.
2. Identify each state or federal statute or
federal regulation that requires or authorizes the action taken by the
administrative regulation. KRS 194A.050(1) requires the Secretary of the Cabinet
for Health and Family Services to adopt administrative regulations necessary to
protect the health of the individual citizens of the Commonwealth and necessary
to operate the programs and fulfill the responsibilities vested in the Cabinet. KRS 211.844(1) requires the Cabinet to provide by
administrative regulation for the registration and licensing of the possession
or use of sources of ionizing or electronic product radiation and the handling
and disposal of radioactive waste. 10 C.F.R. Part 37, Physical protection of
category 1 and category 2 quantities of radioactive material is the federal
regulation for this material.
3. Estimate the effect of this administrative regulation
on the expenditures and revenues of a state or local government agency (including
cities, counties, fire departments, or school districts) for the first full
year the administrative regulation is to be in effect.
(a) How much revenue will this administrative
regulation generate for the state or local government (including cities,
counties, fire departments, or school districts) for the first year? This
administrative regulation generates no revenue.
(b) How much revenue will this administrative
regulation generate for the state or local government (including cities,
counties, fire departments, or school districts) for subsequent years? This
administrative regulation generates no revenue.
(c) How much will it cost to administer this
program for the first year? Adding this administrative regulation to the
radioactive material program will not require additional costs.
(d) How much will it cost to administer this
program for subsequent years? Adding this administrative regulation to the
radioactive material program will not require additional costs.
Note: If specific dollar estimates cannot be
determined, provide a brief narrative to explain the fiscal impact of the
administrative regulation.
Revenues (+/-):
Expenditures (+/-):
Other Explanation:
FEDERAL MANDATE ANALYSIS
COMPARISON
1. Federal statute or regulation constituting the
federal mandate. The Energy Policy Act of 2005 and 10 C.F.R. Part 37.
2. State compliance standards. This regulation
adopts the federal standards for the physical protection of category 1 and
category 2 quantities of radioactive material.
3. Minimum or uniform standards contained in the
federal mandate. The federal mandate requires state regulations to be
compatible with the equivalent federal regulations.
4. Will this administrative regulation impose
stricter requirements, or additional or different responsibilities or
requirements, than those required by the federal mandate? No.
5. Justification for the imposition of the
stricter standard, or additional or different responsibilities or requirements.
There are no different, stricter or additional responsibilities or
requirements.