902 KAR 100:037. Physical protection of category 1 and category 2 quantities of radioactive material

Link to law: http://www.lrc.ky.gov/kar/902/100/037reg.htm
Published: 2015

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.
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