Title 902 | Chapter 100 | Regulation 019
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CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Division of Public Health Protection and Safety
(Amendment)
902 KAR 100:019.Standards for protection against radiation.
Section 1.
Radiation Protection Implementation.(1)
This administrative regulation shall not limit actions required in order to protect against an immediate danger to public health and safety.(2)
This administrative regulation shall apply to a person(3)
The limits in this administrative regulation shall not apply to doses due to background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, or voluntary participation in medical research programs.Section 2.
Radiation Protection Programs. A person(1)
Develop, document, and implement a radiation protection program commensurate with the scope and extent of the person's activities and sufficient to ensure compliance with the provisions of this administrative regulation.(2)
Use procedures and engineering controls based upon sound radiation protection principles, to the extent practical, to achieve occupational doses and doses to members of the public that shall be as low as reasonably achievable (ALARA) pursuant to 902 KAR 100:015, Section 2.(3)
Annually review the radiation protection program content and implementation(4)
(a)
(b)
Section 3.
Occupational Dose Limits for Adults.(1)
A person(a)
An annual limit, which shall be the more limiting of the:1.
Total effective dose equivalent being equal to five (5) rems (0.05 SV); and2.
Sum of the deep-dose equivalent and the committed dose equivalent to an individual organ or tissue, other than the lens of the eye, being equal to fifty (50) rems ((0.50) Sv); and(b)
The annual limits to the lens of the eye, the skin, and the extremities, which shall be:1.
A lens dose equivalent of fifteen (15) rems (0.15 Sv); and2.
A shallow-dose equivalent of fifty (50) rems (five-tenths (0.50) Sv) to the skin of the whole body or to the skin of an extremity.(2)
Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime as established in Section 5(3)
The assigned deep-dose equivalent and shallow-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous ten (10) square centimeters of skin receiving the highest exposure. If the individual monitoring device was not in the region of highest potential exposure, the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits.(4)
(a)
(b)
(5)
(6)
A personSection 4.
Compliance with(1)
Section 5.
(2)
(3)
(4)
(5)
(a)
(b)
(c)
(6)
(7)
Section 5.
(1)
(2)
(3)
Section 6.
(1)
(a)
(b)
(c)
(d)
(2)
(3)
(a)
(b)
(c)
(4)
(5)
(a)
(b)
(6)
(7)
(a)
(b)
(c)
(8)
(a)
(b)
Section 7.
Planned Special Exposures.(1)
A(a)
The(b)
The(c)
Before a planned special exposure, the1.
Informed of the purpose of the planned operation;2.
Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that may be involved in performing the task; and3.
Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.(2)
Prior to permitting an individual to participate in a planned special exposure, a(3)
Subject to Section 3(2) of this administrative regulation, a(a)
The numerical values of the dose limits in Section 3(1) of this administrative regulation in a year; and(b)
Five (5) times the annual dose limits in Section 3(1) of this administrative regulation during the individual's lifetime.(4)
A(a)
Maintain records of the conduct of a planned special exposure pursuant to Section 21(b)
Submit a written report pursuant to Section 28(5)
ASection 6.Section 8.
Occupational Dose Limits for Minors. The annual occupational dose limits for minors shall be ten (10) percent of the annual dose limits specified for adult workers in Section 3 of this administrative regulation.Section 7.Section 9.
Dose Equivalent to an Embryo or Fetus.(1)
A(2)
A(3)
The dose equivalent to an embryo or fetus shall be taken as the sum of:(a)
The deep-dose equivalent to the declared pregnant woman; and(b)
The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman.(4)
If the dose equivalent to the embryo or fetus is found to have exceeded five-tenths (0.5) rem (five (5) mSv), or is within 0.05 rem (five-tenths (0.5) mSv) of this dose, by the time the woman declares the pregnancy to a registrant, theSection 8.Section 10.
Radiation Dose Limits for Individual Members of the Public.(1)
A(a)
Total effective dose equivalent to individual members of the public from1.
Background radiation;2.
A medical administration the individual received; and3.
4.
Voluntary participation in medical research programs; and5.
(b)
Dose in an unrestricted area from external sources(2)
If a(3)
A(a)
Demonstration of the need for, and the expected duration of, operations in excess of the limit in subsection (1) of this section;(b)
A(c)
The procedures to be followed to maintain the dose ALARA.(4)
(5)
The cabinet may impose additional restrictions on radiation levels in unrestricted areas(6)
(a)
(b)
Section 9.Section 11.
Compliance with Dose Limits for Individual Members of the Public.(1)
To demonstrate compliance with the dose limits for individual members of the public in Section 8(a)
radiation levels in unrestricted and controlled areas(b)
(2)
A(a)
Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the registered(b)
Demonstrating that1.
2.
if an individual were continually present in an unrestricted area, the dose from external sources shall not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (five-tenths (0.5) mSv) in a year.(3)
Section 10.Section 12.
Surveys and Monitoring.(1)
A(a)
Necessary for the(b)
Reasonable under the circumstances to evaluate:1.
The magnitude and extent of radiation levels; and2.
3.
The potential radiological hazards.(2)
A(3)
Personnel dosimeters, except direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities, that require processing to determine the radiation doses used by(a)
Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and(b)
Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.Section 11.Section 13.
Conditions Requiring Individual Monitoring of External (1)
A(2)
At a minimum, the(a)
Adults likely to receive, in one (1) year from radiation sources external to the body, a dose in excess of ten (10) percent of the limits in Section 3(1) of this administrative regulation;(b)
Minors likely to receive, in one (1) year from sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of five-tenths (0.5) rem (5 mSv);(c)
Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1mSv). All of the occupational doses in Section 3 continue to be applicable to the declared pregnant worker as long as the embryo or fetus dose limit is not exceeded; and(d)
Individuals entering a high or very high radiation area.(2)
(a)
(b)
(c)
Section 12.Section 14.
Control of Access to High Radiation Areas.(1)
A(a)
A control device that, upon entry into the area, shall cause the level of radiation to be reduced below the level an individual may receive a deep-dose equivalent of 0.1 rem (one (1) mSv) in one (1) hour at thirty (30) centimeters from the radiation source or from a surface that the radiation penetrates;(b)
A control device that shall energize a conspicuous visible or audible alarm signal so the individual entering the high radiation area and the supervisor of the activity shall be made aware of the entry; or(c)
Entryways that shall be locked, except during periods that access to the areas is required, with positive control over each individual entry.(2)
In place of the controls required by subsection (1) of this section for a high radiation area, a(3)
A(4)
A(5)
(6)
(a)
(b)
(7)
Section 13.Section 15.
Control of Access to Very High Radiation Areas.(1)
In addition to the provisions in Section 12(2)
A registrant shall not be required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as established in subsection (1) of this section if the registrant has met the specific requirements for access and control specified in 902 KAR 100:115, 100:136, 100:137, and 100:155.Section 16.
(1)
(2)
(a)
1.
2.
(b)
(3)
(a)
1.
2.
3.
(b)
1.
2.
(c)
1.
2.
(d)
1.
2.
(e)
(f)
1.
2.
(g)
(h)
(i)
1.
2.
3.
(j)
(k)
(4)
(a)
1.
2.
(b)
(c)
(5)
Section 17.
Section 18.
(1)
(a)
(b)
(c)
(d)
(2)
Section 19.
(1)
(a)
1.
2.
a.
b.
(b)
1.
2.
3.
4.
a.
b.
c.
d.
e.
f.
g.
h.
i.
5.
6.
(c)
1.
2.
3.
(d)
1.
2.
3.
4.
5.
(e)
1.
2.
3.
(f)
1.
2.
3.
4.
(g)
(h)
1.
2.
3.
4.
5.
(i)
(j)
1.
2.
3.
(2)
(a)
(b)
Section 20.
(1)
(2)
Section 21.
Section 22.
Section 14.Section 23.
Caution Signs and Standard Radiation Symbol.
(1)
Unless otherwise authorized by the cabinet, the symbol established in this section shall use the colors magenta, purple, or black on yellow background. The symbol established in this section shall be the three (3) bladed design:(a)
Cross-hatched area shall be magenta, purple, or black; and(b)
The background shall be yellow.(2)
(3)
Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this section, a Section 15.Section 24.
Posting Requirements.(1)
Posting of radiation areas. A(2)
Posting of high radiation areas. A(3)
Posting of very high radiation areas. A(4)
(5)
Section 16.Section 25.
Exceptions to Posting Requirements.(1)
A (1)(a)
The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation (2)(b)
The area or room is subject to the (2)
(3)
(4)
(a)
(b)
Section 26.
(1)
(a)
1.
2.
3.
4.
5.
6.
(b)
(2)
(a)
(b)
Section 27.
(1)
(a)
(b)
(c)
(d)
(e)
(f)
(2)
Section 28.
(1)
(a)
(b)
(2)
(a)
1.
2.
(b)
(3)
(a)
(b)
(4)
(a)
(b)
(5)
(a)
(b)
(6)
Section 17.Section 29.
General Provisions for Records.(1)
(a)
A(b)
1.
All quantities shall be recorded as stated in paragraph (a) of this section, except that the registrant2.
(2)
A(a)
Total effective dose equivalent;(b)
Shallow-dose equivalent;(c)
Eye dose equivalent;(d)
Deep-dose equivalent; and(e)
Committed effective dose equivalent.Section 18.Section 30.
Records of Radiation Protection Programs.(1)
A(a)
The provisions of the program; and(b)
Audits and other reviews of program content and implementation.(2)
A(3)
ASection 19.Section 31.
Records of Surveys.(1)
A(a)
Maintain records showing the results of surveys and calibrations required by Section 10(b)
Retain records for at least three (3) years after the record is made.(2)
A(a)
results of surveys to determine the dose from external sources of radiation and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents until the cabinet terminates the pertinent registration requiring the record(b)
(c)
(d)
Section 20.Section 32.
Determination of Prior Occupational Dose.(1)
For an individual likely to receive, in a year, an occupational dose requiring monitoring under Section 11(a)
Determine the occupational radiation dose received during the current year; and(b)
Attempt to obtain the records of lifetime cumulative occupational radiation dose.(2)
Prior to permitting an individual to participate in a planned special exposure, a(a)
The(b)
Doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.(3)
In complying with the requirements of subsection (1) of this section, a(a)
Accept, as a record of the occupational dose the individual received during the current year, a written signed statement from the individual or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and amount of an occupational dose the individual may have received during the current year;(b)
Accept, as the record of lifetime cumulative radiation dose, an up-to-date Nuclear Regulatory Commission (NRC)1.
Appropriate official of the most recent employer for work involving radiation exposure; or2.
The individual's current employer if the individual is not employed by the(c)
Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer if the individual is not employed by the(4)
A(a)
The form or record shall:1.
Show each period the individual received occupational exposure to radiation2.
Be signed by the individual who received the exposure.(b)
For each period a(c)
For a period in which a(5)
If a registrant(a)
In establishing administrative controls under Section 3(4)(b)
That the individual is not available for planned special exposures.(6)
A(a)
Retain the records on NRC Form 4, Cumulative Occupational Dose History, or equivalent, at least until the cabinet terminates the pertinent(b)
Retain records used in preparing NRC Form 4, Cumulative Occupational Dose History, for at least three (3) years after the record is made.Section 21.Section 33.
Records of Planned Special Exposures.(1)
For each use of the provisions of Section 5(a)
The name of the management official who authorized the planned special exposure;(b)
A copy of the signed authorization; and(c)
Description of:1.
The exceptional circumstances requiring the use of a planned special exposure;2.
What actions were necessary;3.
Why the actions were necessary;4.
How doses were maintained ALARA;5.
What individual and collective doses were expected to result; and6.
The doses actually received in the planned special exposure.(2)
ASection 22.Section 34.
Records of Individual Monitoring Results.(1)
A(a)
By individuals for whom monitoring was required by Section 11(b)
During planned special exposures, accidents, and emergency conditions.(2)
The recordkeeping requirements shall include, if applicable:(a)
Deep-dose equivalent to the whole body;(b)
Lens dose equivalent;(c)
Shallow-dose equivalent to the skin and extremities; and(d)
(e)
(f)
(g)
Total effective dose equivalent, if required by Section 4 of this administrative regulation(h)
(3)
A(4)
A(5)
The records required under this section shall be protected from public disclosure because of their personal privacy nature.(6)
A(a)
Records of dose to an embryo or fetus with the records of dose to the declared pregnant woman; and(b)
Declaration of pregnancy on file, which may be maintained separately from the dose records.(7)
A(8)
Assessments of dose equivalent and records made using units in effect before aSection 23.Section 35.
Records of Dose to Individual Members of the Public.(1)
A(2)
ASection 36.
(1)
(2)
Section 24.Section 37.
Form of Records.(1)
Records required by 902 KAR Chapter 100 shall be legible throughout the specified retention period.(2)
The record shall be:(a)
The original; or(b)
A reproduced copy(c)
(3)
The record may be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.(4)
Records such as letters, drawings, and specifications shall include pertinent information such as stamps, initials, and signatures.(5)
ASection 25.Section 38.
Reports of Theft or Loss of (1)
A registrant shall report to the cabinet a lost, stolen, or missing registered radiation producing machine(a)
1.
2.
within thirty (30) days after the occurrence.(2)
The report shall include:(a)
A description of the registered machine involved, including:1.
Type of machine;2.
Make and model of machine; and3.
Maximum outputs;(b)
The date the loss or theft became known to the registrant; and(c)
A description of the circumstances under which the loss or theft occurred(b)
(2)
(a)
1.
a.
b.
c.
2.
3.
4.
5.
6.
(b)
(3)
(4)
Section 26.Section 39.
Notification of Incidents.(1)
Immediate notification. A(a)
an individual to(a)1.
A total effective dose equivalent of twenty-five (25) rems (0.25 Sv) or more;(b)2.
A lens dose equivalent of seventy-five (75) rems (0.75 Sv) or more; or(c)3.
A shallow-dose equivalent to the skin or extremities of 250 rads (two and five-tenths (2.5) Gy) or more(b)
(c)
(d)
(2)
Twenty-four (24) hour notification. A(a)
an individual to receive, in a period of twenty-four (24) hours:(a)1.
A total effective dose equivalent exceeding five (5) rems (0.05 Sv);(b)2.
A lens dose equivalent exceeding fifteen (15) rems (0.15 Sv); or(c)3.
A shallow-dose equivalent to the skin or extremities exceeding fifty (50) rems (five-tenths (0.5) Sv)(b)
(c)
(d)
(3)
A(4)
A(5)
The provisions of this section shall not include doses that result from planned special exposures that are within the limits for planned special exposures, and are reported under Section 28Section 27.Section 40.
Reports of Exposures and(1)
Reportable events. In addition to the notification required by Section 26(a)
An incident for which notification shall be required by Section 26(b)
Doses in excess of one (1) of the following:1.
Occupational dose limits for adults in Section 3 of this administrative regulation;2.
Occupational dose limits for a minor in Section 63.
Limits for an embryo or fetus of a declared pregnant woman in Section 74.
Limits for an individual member of the public in Section 85.
Applicable limit in the6.
(c)
Levels of radiation1.
A restricted area in excess of an applicable limit in the2.
An unrestricted area in excess of ten (10) times an applicable limit set forth in this administrative regulation(d)
(2)
Contents of reports.(a)
A report required by subsection (1) of this section shall describe the extent of exposure of individuals to radiation1.
Estimates of each individual's dose;2.
The levels of radiation3.
The cause of the elevated exposures or4.
Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits(b)
A report filed under subsection (1) of this section shall include for each individual exposed:1.
Name of the individual;2.
Social Security number; and3.
Date of birth.(c)
The report shall be prepared so that information is stated in a separate and detachable part.(d)
With respect to the limit for the embryo or fetus, the identifiers shall be of the declared pregnant woman.(3)
ASection 28.Section 41.
Reports of Planned Special Exposures.(1)
A(2)
A(a)
Inform the Manager of the Radiation Health Branch that a planned special exposure was conducted;(b)
Indicate the date the planned special exposure occurred; and(c)
Provide the information required by Section 21Section 42.
(1)
(a)
(b)
(c)
(2)
(a)
(b)
(3)
(4)
(a)
(b)
Section 43.
Section 44.
Section 45.
(1)
(a)
(b)
(c)
(2)
STEVEN J. STACK, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: June 5, 2023
FILED WITH LRC: June 12, 2023 at 12:35 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on August 21, 2023, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by August 14, 2023, 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. This hearing is open to the public. Any person who attends virtually 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 be heard at the public hearing, you may submit written comments on this proposed administrative regulation until August 31, 2023. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-6746; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes standards for the protection of the user and general public against radiation exposure and establishes standards for protection against ionizing radiation resulting from activities conducted by persons issued registrations by the cabinet. This administrative regulation establishes standards to control the receipt, possession, use, transfer, and disposal of sources of radiation by a person or registrant so the total dose to an individual (including doses resulting from registered and unregistered radiation sources other than background radiation) shall not exceed the standards for protection against radiation established in this administrative regulation.
(b) The necessity of this administrative regulation:
Exposure to radiation can have long lasting effects on the individual’s health. The occupational exposure controls and limits established in this administrative regulation ensure the individual is protected from an overexposure of radiation.
(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 promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844 requires the cabinet to provide by administrative regulation for the registration of the possession or use of sources of ionizing or electronic product radiation.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures those registered with the cabinet to possess or use sources of ionizing radiation are properly registered, and individual are properly monitored to avoid an overexposure to radiation.
(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:
The amendment to this administrative regulation clarifies that the requirements for registration and monitoring are applicable to sources of ionizing radiation and those who work with those machines, updates the dose limits to current industry standards, and makes other changes necessary for KRS Chapter 13A compliance.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to avoid confusion regarding the applicability of the requirements for monitoring dose limits. Those who are licensed to possess radioactive materials should not be referencing this administrative regulation. This administrative regulation is applicable to those who are registered with the cabinet to possess and utilize sources of ionizing radiation.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 211.842(1) establishes the Cabinet for Health and Family Services as the radiation control agency for the State of Kentucky. KRS 211.844 requires the cabinet to provide by administrative regulation for the registration of the possession or use of sources of ionizing or electronic product radiation.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure all those who are registered to possess and use sources of ionizing radiation are properly registered with the cabinet and will ensure any occupational exposure to radiation is properly monitored.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently 4,250 registrants. Registrants include those in the fields of medicine, research, industry, as well as academia, and all employees who use sources of ionizing radiation in their employment.
(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 question (3) will have to take to comply with this administrative regulation or amendment:
Individuals who are registered to possess and use sources of ionizing radiation will need to be aware of the occupational exposure limits, and registrants will need to be aware of the exposure limit, signage, and reporting requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There will be no cost to the regulated entities as compliance with this administrative regulation is currently a condition of registration.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Workers who use sources of ionizing radiation in their employment will be properly protected from overexposure to radiation.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This is an ongoing program, there are no initial costs.
(b) On a continuing basis:
This administrative regulation does not impact cost for the agency.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
The Radiation Health Branch is funded through a mix of state general fund dollars and the fees paid by registrants to possess and use sources of ionizing radiation.
(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:
And increase in fees or funding is not necessary to implement the requirements of this amended administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established in this administrative regulation.
(9) TIERING: Is tiering applied?
Tiering is not applied as the requirements of this administrative regulation are applied equally to all registrants.
FISCAL NOTE
(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?
The Radiation Health Branch in the Department for Public Health will be impacted by the amendment to this administrative regulation.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 194A.050 and 211.844.
(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 does not generate 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 does not generate revenue.
(c) How much will it cost to administer this program for the first year?
This administrative regulation does not impact cost for the agency.
(d) How much will it cost to administer this program for subsequent years?
This administrative regulation does not impact cost for the agency.
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:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
Cost savings for the regulated entities will result from ensuring the occupational dose to employees does not exceed established limits. Overexposure to occupational sources of ionizing radiation can result in increased time away from work and other related health concerns for the employee.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
Registrants will continue to see costs savings by protecting workers from overexposure to occupational sources of ionizing radiation in subsequent years.
(c) How much will it cost the regulated entities for the first year?
There will be no cost to regulated entities in the first year as the requirements of this administrative regulation are not new requirements.
(d) How much will it cost the regulated entities for subsequent years?
There will be no change in the cost for regulated entities in subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation does not have a major economic impact.
CABINET FOR HEALTH AND FAMILY SERVICES
Department for Public Health
Division of Public Health Protection and Safety
(Amendment)
902 KAR 100:019.Standards for protection against radiation.
Section 1.
Radiation Protection Implementation.(1)
This administrative regulation shall not limit actions required in order to protect against an immediate danger to public health and safety.(2)
This administrative regulation shall apply to a person registered by the cabinet to receive, possess, use, transfer, or dispose of sources of radiation.(3)
The limits in this administrative regulation shall not apply to doses due to background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, or voluntary participation in medical research programs.Section 2.
Radiation Protection Programs. A person or registrant shall:(1)
Develop, document, and implement a radiation protection program commensurate with the scope and extent of the person's activities and sufficient to ensure compliance with the provisions of this administrative regulation.(2)
Use procedures and engineering controls based upon sound radiation protection principles, to the extent practical, to achieve occupational doses and doses to members of the public that shall be as low as reasonably achievable (ALARA) pursuant to 902 KAR 100:015, Section 2.(3)
Annually review the radiation protection program content and implementation.Section 3.
Occupational Dose Limits for Adults.(1)
A person or registrant shall control the occupational dose to individual adults, except for planned special exposures as established in Section 5 of this administrative regulation, to:(a)
An annual limit, which shall be the more limiting of the:1.
Total effective dose equivalent being equal to five (5) rems (0.05 SV); and2.
Sum of the deep-dose equivalent and the committed dose equivalent to an individual organ or tissue, other than the lens of the eye, being equal to fifty (50) rems ((0.50) Sv); and(b)
The annual limits to the lens of the eye, the skin, and the extremities, which shall be:1.
A lens dose equivalent of fifteen (15) rems (0.15 Sv); and2.
A shallow-dose equivalent of fifty (50) rems (five-tenths (0.50) Sv) to the skin of the whole body or to the skin of an extremity.(2)
Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime as established in Section 5(3)(a) and (b) of this administrative regulation.(3)
The assigned deep-dose equivalent and shallow-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous ten (10) square centimeters of skin receiving the highest exposure. If the individual monitoring device was not in the region of highest potential exposure, the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits.(4)
A person or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by a person as described in Section 20 of this administrative regulation.Section 4.
Compliance with Summation of Doses from Radiation Producing Machines and Radioactive Materials. A registrant who is required to monitor for dose received by exposure to both radiation producing machines and radioactive materials shall demonstrate compliance with the dose limits by following the requirements of 902 KAR Chapter 100.Section 5.
Planned Special Exposures.(1)
A registrant may authorize an adult worker to receive doses in addition to, and accounted for separately from the doses received under, the limits specified in Section 3 of this administrative regulation provided each of the following conditions are satisfied:(a)
The registrant authorizes a planned special exposure only in an exceptional situation if alternatives that may avoid the dose estimated to result from the planned special exposure are unavailable or impractical;(b)
The registrant, and employer if the employer is not the registrant, specifically authorize the planned special exposure, in writing, before the exposure occurs; and(c)
Before a planned special exposure, the registrant ensures that the individuals involved are:1.
Informed of the purpose of the planned operation;2.
Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that may be involved in performing the task; and3.
Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.(2)
Prior to permitting an individual to participate in a planned special exposure, a registrant shall ascertain prior doses as required by Section 20(2) of this administrative regulation during the lifetime of the individual for each individual involved.(3)
Subject to Section 3(2) of this administrative regulation, a registrant shall not authorize a planned special exposure that shall cause an individual to receive a dose from planned special exposures and doses in excess of the limits to exceed:(a)
The numerical values of the dose limits in Section 3(1) of this administrative regulation in a year; and(b)
Five (5) times the annual dose limits in Section 3(1) of this administrative regulation during the individual's lifetime.(4)
A registrant shall:(a)
Maintain records of the conduct of a planned special exposure pursuant to Section 21 of this administrative regulation; and(b)
Submit a written report pursuant to Section 28 of this administrative regulation.(5)
A registrant shall record the best estimate of the dose resulting from the planned special exposure in the individual's record and inform the individual, in writing, of the dose within thirty (30) days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual by Section 3(1) of this administrative regulation but shall be included in evaluations required by subsections (2) and (3) of this section.Section 6.
Occupational Dose Limits for Minors. The annual occupational dose limits for minors shall be ten (10) percent of the annual dose limits specified for adult workers in Section 3 of this administrative regulation.Section 7.
Dose Equivalent to an Embryo or Fetus.(1)
A registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five-tenths (0.5) rem (5 mSv). Recordkeeping requirements are established in Section 22 of this administrative regulation.(2)
A registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman to satisfy the limit in subsection (1) of this section.(3)
The dose equivalent to an embryo or fetus shall be taken as the sum of:(a)
The deep-dose equivalent to the declared pregnant woman; and(b)
The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman.(4)
If the dose equivalent to the embryo or fetus is found to have exceeded five-tenths (0.5) rem (five (5) mSv), or is within 0.05 rem (five-tenths (0.5) mSv) of this dose, by the time the woman declares the pregnancy to a registrant, the registrant shall be in compliance with subsection (1) of this section if the additional dose equivalent to the embryo or fetus does not exceed 0.05 rem (five-tenths (0.5) mSv) during the remainder of the pregnancy.Section 8.
Radiation Dose Limits for Individual Members of the Public.(1)
A registrant shall conduct operations to ensure that the:(a)
Total effective dose equivalent to individual members of the public from registered, and other operations shall not exceed 0.1 rem (one (1) mSv) in a year, exclusive of the dose contributions from:1.
Background radiation;2.
A medical administration the individual received; and3.
Voluntary participation in medical research programs; and(b)
Dose in an unrestricted area from external sources shall not exceed 0.002 rem (0.02 mSv) in one (1) hour.(2)
If a registrant permits members of the public to have access to controlled areas, the limits for members of the public specified in this section shall apply to those individuals.(3)
A registrant or applicant for registration may apply for prior authorization to operate up to an annual dose limit for an individual member of the public of five-tenths (0.5) rem (five (5) mSv). The application shall include:(a)
Demonstration of the need for, and the expected duration of, operations in excess of the limit in subsection (1) of this section;(b)
A registrant's program to assess and control dose within the five-tenths (0.5) rem (five (5) mSv) annual limit; and(c)
The procedures to be followed to maintain the dose ALARA.(4)
The cabinet may impose additional restrictions on radiation levels in unrestricted areas.Section 9.
Compliance with Dose Limits for Individual Members of the Public.(1)
To demonstrate compliance with the dose limits for individual members of the public in Section 8 of this administrative regulation, a registrant shall make or cause to be made surveys ofradiation levels in unrestricted and controlled areas.(2)
A registrant shall show compliance with the annual dose limit in Section 8 of this administrative regulation by:(a)
Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the registered operation shall not exceed the annual dose limit; or(b)
Demonstrating thatif an individual were continually present in an unrestricted area, the dose from external sources shall not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (five-tenths (0.5) mSv) in a year.Section 10.
Surveys and Monitoring.(1)
A registrant shall make or cause to be made, surveys that are:(a)
Necessary for the registrant to comply with the provisions in this administrative regulation; and(b)
Reasonable under the circumstances to evaluate:1.
The magnitude and extent of radiation levels; and2.
The potential radiological hazards.(2)
A registrant shall ensure that instruments and equipment used for quantitative radiation measurements (for example, dose rate) are calibrated periodically for the radiation measured.(3)
Personnel dosimeters, except direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities, that require processing to determine the radiation doses used by registrants to comply with Section 3 of this administrative regulation, other applicable provisions of 902 KAR Chapter 100, or conditions specified, shall be processed and evaluated by a dosimetry processor:(a)
Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and(b)
Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.Section 11.
Conditions Requiring Individual Monitoring of External Occupational Dose.(1)
A registrant shall monitor exposures to radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this administrative regulation.(2)
At a minimum, the registrant shall monitor occupational exposure to radiation, from registered and unregistered radiation sources under the registrant's control, and shall supply and require the use of individual monitoring devices by:(a)
Adults likely to receive, in one (1) year from radiation sources external to the body, a dose in excess of ten (10) percent of the limits in Section 3(1) of this administrative regulation;(b)
Minors likely to receive, in one (1) year from sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of five-tenths (0.5) rem (5 mSv);(c)
Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1mSv). All of the occupational doses in Section 3 continue to be applicable to the declared pregnant worker as long as the embryo or fetus dose limit is not exceeded; and(d)
Individuals entering a high or very high radiation area.Section 12.
Control of Access to High Radiation Areas.(1)
A registrant shall ensure that each entrance or access point to a high radiation area shall have at least one (1) of the following features:(a)
A control device that, upon entry into the area, shall cause the level of radiation to be reduced below the level an individual may receive a deep-dose equivalent of 0.1 rem (one (1) mSv) in one (1) hour at thirty (30) centimeters from the radiation source or from a surface that the radiation penetrates;(b)
A control device that shall energize a conspicuous visible or audible alarm signal so the individual entering the high radiation area and the supervisor of the activity shall be made aware of the entry; or(c)
Entryways that shall be locked, except during periods that access to the areas is required, with positive control over each individual entry.(2)
In place of the controls required by subsection (1) of this section for a high radiation area, a registrant may substitute continuous direct or electronic surveillance that shall be capable of preventing unauthorized entry.(3)
A registrant may apply to the cabinet for approval of alternative methods for controlling access to high radiation areas.(4)
A registrant shall establish the controls required by subsections (1) and (3) of this section that shall not prevent individuals from leaving a high radiation area.Section 13.
Control of Access to Very High Radiation Areas.(1)
In addition to the provisions in Section 12 of this administrative regulation, a registrant shall institute additional measures to ensure that an individual shall not be able to gain unauthorized or inadvertent access to areas in which radiation levels may be encountered at 500 rads (five (5) grays) or more in one (1) hour at one (1) meter from a radiation source or a surface through which the radiation penetrates.(2)
A registrant shall not be required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as established in subsection (1) of this section if the registrant has met the specific requirements for access and control specified in 902 KAR 100:115, 100:136, 100:137, and 100:155.Section 14.
Caution Signs and Standard Radiation Symbol.(1)
Unless otherwise authorized by the cabinet, the symbol established in this section shall use the colors magenta, purple, or black on yellow background. The symbol established in this section shall be the three (3) bladed design:(a)
Cross-hatched area shall be magenta, purple, or black; and(b)
The background shall be yellow.(2)
Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this section, a registrant may provide on or near the required signs and labels additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.Section 15.
Posting Requirements.(1)
Posting of radiation areas. A registrant shall post a radiation area with a conspicuous sign or signs bearing the radiation symbol and the words: "CAUTION, RADIATION AREA".(2)
Posting of high radiation areas. A registrant shall post a high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words: "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA".(3)
Posting of very high radiation areas. A registrant shall post a very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words: "GRAVE DANGER, VERY HIGH RADIATION AREA".Section 16.
Exceptions to Posting Requirements.A registrant shall not be required to post caution signs in areas or rooms containing sources of radiation for periods of less than eight (8) hours if the following conditions are met:(1)
The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation in excess of the limits established in this administrative regulation; and(2)
The area or room is subject to the registrant's control.Section 17.
General Provisions for Records.(1)
(a)
A registrant shall use the units roentgen, rad, and rem, including multiples and subdivisions, and shall clearly indicate the units of quantities on records required by this administrative regulation.(b)
All quantities shall be recorded as stated in paragraph (a) of this section, except that the registrant may record quantities in the International System of Units (SI) in parentheses following each of the units specified in paragraph (a) of this section.(2)
A registrant shall make a clear distinction among the quantities entered on the records required by this administrative regulation, such as:(a)
Total effective dose equivalent;(b)
Shallow-dose equivalent;(c)
Eye dose equivalent;(d)
Deep-dose equivalent; and(e)
Committed effective dose equivalent.Section 18.
Records of Radiation Protection Programs.(1)
A registrant shall maintain records of the radiation protection program, including:(a)
The provisions of the program; and(b)
Audits and other reviews of program content and implementation.(2)
A registrant shall retain records required by subsection (1)(a) of this section until the cabinet terminates each pertinent registration requiring the record.(3)
A registrant shall retain records required by subsection (1)(b) of this section for at least three (3) years after the record is made.Section 19.
Records of Surveys.(1)
A registrant shall:(a)
Maintain records showing the results of surveys and calibrations required by Section 10 of this administrative regulation; and(b)
Retain records for at least three (3) years after the record is made.(2)
A registrant shall retain results of surveys to determine the dose from external sources of radiation and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents until the cabinet terminates the pertinent registration requiring the record.Section 20.
Determination of Prior Occupational Dose.(1)
For an individual likely to receive, in a year, an occupational dose requiring monitoring under Section 11 of this administrative regulation, the registrant shall:(a)
Determine the occupational radiation dose received during the current year; and(b)
Attempt to obtain the records of lifetime cumulative occupational radiation dose.(2)
Prior to permitting an individual to participate in a planned special exposure, a registrant shall determine:(a)
The external doses from previous planned special exposures; and(b)
Doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.(3)
In complying with the requirements of subsection (1) of this section, a registrant may:(a)
Accept, as a record of the occupational dose the individual received during the current year, a written signed statement from the individual or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and amount of an occupational dose the individual may have received during the current year;(b)
Accept, as the record of lifetime cumulative radiation dose, an up-to-date Nuclear Regulatory Commission (NRC) Form 4, Cumulative Occupational Dose History, available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html, or equivalent, signed by the individual and counter-signed by an:1.
Appropriate official of the most recent employer for work involving radiation exposure; or2.
The individual's current employer if the individual is not employed by the registrant; or(c)
Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer if the individual is not employed by the registrant, by telephone, electronic media, or letter. If the authenticity of the transmitted report cannot be established, a registrant shall request a written verification of the dose data.(4)
A registrant shall record the exposure history, as required by subsection (1) of this section, on NRC Form 4, Cumulative Occupational Dose History, or other clear and legible record, of the information required on that form.(a)
The form or record shall:1.
Show each period the individual received occupational exposure to radiation; and2.
Be signed by the individual who received the exposure.(b)
For each period a registrant obtains reports, the registrant shall use the dose shown in the report in preparing NRC Form 4, Cumulative Occupational Dose History.(c)
For a period in which a registrant does not obtain a report, the registrant shall place a notation on NRC Form 4, Cumulative Occupational Dose History, indicating the periods of time for which data are not available.(5)
If a registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the registrant shall assume:(a)
In establishing administrative controls under Section 3(4) of this administrative regulation for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (twelve and five-tenths (12.5) mSv) for each quarter for which records were unavailable and the individual was engaged in activities that may have resulted in occupational radiation exposure; and(b)
That the individual is not available for planned special exposures.(6)
A registrant shall:(a)
Retain the records on NRC Form 4, Cumulative Occupational Dose History, or equivalent, at least until the cabinet terminates the pertinent registration requiring this record; and(b)
Retain records used in preparing NRC Form 4, Cumulative Occupational Dose History, for at least three (3) years after the record is made.Section 21.
Records of Planned Special Exposures.(1)
For each use of the provisions of Section 5 of this administrative regulation for planned special exposures, a registrant shall maintain records that include:(a)
The name of the management official who authorized the planned special exposure;(b)
A copy of the signed authorization; and(c)
Description of:1.
The exceptional circumstances requiring the use of a planned special exposure;2.
What actions were necessary;3.
Why the actions were necessary;4.
How doses were maintained ALARA;5.
What individual and collective doses were expected to result; and6.
The doses actually received in the planned special exposure.(2)
A registrant shall retain the records at least until the cabinet terminates the registration requiring these records.Section 22.
Records of Individual Monitoring Results.(1)
A registrant shall maintain records of doses received:(a)
By individuals for whom monitoring was required by Section 11 of this administrative regulation; and(b)
During planned special exposures, accidents, and emergency conditions.(2)
The recordkeeping requirements shall include, if applicable:(a)
Deep-dose equivalent to the whole body;(b)
Lens dose equivalent;(c)
Shallow-dose equivalent to the skin and extremities; and(d)
Total effective dose equivalent, if required by Section 4 of this administrative regulation.(3)
A registrant shall make entries of the records specified in subsection (1) of this section at least annually.(4)
A registrant shall maintain the records specified in subsection (1) of this section on NRC Form 5, Occupational Dose Record for a Monitoring Period, available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html, in accordance with the instructions for NRC Form 5, or in clear and legible records containing the information required by NRC Form 5.(5)
The records required under this section shall be protected from public disclosure because of their personal privacy nature.(6)
A registrant shall maintain the:(a)
Records of dose to an embryo or fetus with the records of dose to the declared pregnant woman; and(b)
Declaration of pregnancy on file, which may be maintained separately from the dose records.(7)
A registrant shall retain each required form or record at least until the cabinet terminates the pertinent license or registration requiring the record.(8)
Assessments of dose equivalent and records made using units in effect before a registrant's adoption of this administrative regulation need not to be changed.Section 23.
Records of Dose to Individual Members of the Public.(1)
A registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public.(2)
A registrant shall retain the records required by subsection (1) of this section at least until the cabinet terminates the pertinent registration requiring the record.Section 24.
Form of Records.(1)
Records required by 902 KAR Chapter 100 shall be legible throughout the specified retention period.(2)
The record shall be:(a)
The original; or(b)
A reproduced copy.(3)
The record may be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.(4)
Records such as letters, drawings, and specifications shall include pertinent information such as stamps, initials, and signatures.(5)
A registrant shall maintain adequate safeguards against tampering with and loss of records.Section 25.
Reports of Theft or Loss of Registered Sources of Radiation.(1)
A registrant shall report to the cabinet a lost, stolen, or missing registered radiation producing machine within thirty (30) days after the occurrence.(2)
The report shall include:(a)
A description of the registered machine involved, including:1.
Type of machine;2.
Make and model of machine; and3.
Maximum outputs;(b)
The date the loss or theft became known to the registrant; and(c)
A description of the circumstances under which the loss or theft occurred registered becomes known to the registrant,.Section 26.
Notification of Incidents.(1)
Immediate notification. A registrant shall immediately report an event involving radiation producing machines possessed by the registrant that may have caused, or threatens to cause, an individual to receive:(a)
A total effective dose equivalent of twenty-five (25) rems (0.25 Sv) or more;(b)
A lens dose equivalent of seventy-five (75) rems (0.75 Sv) or more; or(c)
A shallow-dose equivalent to the skin or extremities of 250 rads (two and five-tenths (2.5) Gy) or more.(2)
Twenty-four (24) hour notification. A registrant shall, within twenty-four (24) hours of discovery of the event, report an event that may have caused, or shall threaten to cause,an individual to receive, in a period of twenty-four (24) hours:(a)
A total effective dose equivalent exceeding five (5) rems (0.05 Sv);(b)
A lens dose equivalent exceeding fifteen (15) rems (0.15 Sv); or(c)
A shallow-dose equivalent to the skin or extremities exceeding fifty (50) rems (five-tenths (0.5) Sv).(3)
A registrant shall prepare and file a report with the cabinet as required by this section so that names of individuals who have received exposure to radiation are stated in a separate and detachable part of the report.(4)
A registrant shall make reports required by subsections (1) and (2) of this section to the cabinet by telephone.(5)
The provisions of this section shall not include doses that result from planned special exposures that are within the limits for planned special exposures, and are reported under Section 28 of this administrative regulation.Section 27.
Reports of Exposures and Radiation Levels Exceeding the Limits.(1)
Reportable events. In addition to the notification required by Section 26 of this administrative regulation, a registrant shall submit a written report within thirty (30) days after learning of one (1) or more of the following occurrences:(a)
An incident for which notification shall be required by Section 26 of this administrative regulation; or(b)
Doses in excess of one (1) of the following:1.
Occupational dose limits for adults in Section 3 of this administrative regulation;2.
Occupational dose limits for a minor in Section 6 of this administrative regulation;3.
Limits for an embryo or fetus of a declared pregnant woman in Section 7 of this administrative regulation;4.
Limits for an individual member of the public in Section 8 of this administrative regulation; or5.
Applicable limit in the registration; or(c)
Levels of radiation in:1.
A restricted area in excess of an applicable limit in the registration; or2.
An unrestricted area in excess of ten (10) times an applicable limit set forth in this administrative regulation or the registration, regardless of exposure of an individual in excess of the limits in Section 8 of this administrative regulation occurs.(2)
Contents of reports.(a)
A report required by subsection (1) of this section shall describe the extent of exposure of individuals to radiation including, as appropriate:1.
Estimates of each individual's dose;2.
The levels of radiation involved;3.
The cause of the elevated exposures or dose rates; and4.
Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits.(b)
A report filed under subsection (1) of this section shall include for each individual exposed:1.
Name of the individual;2.
Social Security number; and3.
Date of birth.(c)
The report shall be prepared so that information is stated in a separate and detachable part.(d)
With respect to the limit for the embryo or fetus, the identifiers shall be of the declared pregnant woman.(3)
A registrant who makes a report under subsection (1) of this section shall submit the report, in writing, to the Manager of the Radiation Health Branch, Department for Health Services, 275 East Main Street, Frankfort, Kentucky 40621.Section 28.
Reports of Planned Special Exposures.(1)
A registrant shall submit a written report to the Manager of the Radiation Health Branch, Department for Health Services, 275 East Main Street, Frankfort, Kentucky 40621, within thirty (30) days following a planned special exposure conducted in accordance with Section 5 of this administrative regulation.(2)
A registrant shall:(a)
Inform the Manager of the Radiation Health Branch that a planned special exposure was conducted;(b)
Indicate the date the planned special exposure occurred; and(c)
Provide the information required by Section 21 of this administrative regulation.STEVEN J. STACK, Commissioner
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: June 5, 2023
FILED WITH LRC: June 12, 2023 at 12:35 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on August 21, 2023, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by August 14, 2023, 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. This hearing is open to the public. Any person who attends virtually 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 be heard at the public hearing, you may submit written comments on this proposed administrative regulation until August 31, 2023. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-6746; fax 502-564-7091; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes standards for the protection of the user and general public against radiation exposure and establishes standards for protection against ionizing radiation resulting from activities conducted by persons issued registrations by the cabinet. This administrative regulation establishes standards to control the receipt, possession, use, transfer, and disposal of sources of radiation by a person or registrant so the total dose to an individual (including doses resulting from registered and unregistered radiation sources other than background radiation) shall not exceed the standards for protection against radiation established in this administrative regulation.
(b) The necessity of this administrative regulation:
Exposure to radiation can have long lasting effects on the individual’s health. The occupational exposure controls and limits established in this administrative regulation ensure the individual is protected from an overexposure of radiation.
(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 promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844 requires the cabinet to provide by administrative regulation for the registration of the possession or use of sources of ionizing or electronic product radiation.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation ensures those registered with the cabinet to possess or use sources of ionizing radiation are properly registered, and individual are properly monitored to avoid an overexposure to radiation.
(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:
The amendment to this administrative regulation clarifies that the requirements for registration and monitoring are applicable to sources of ionizing radiation and those who work with those machines, updates the dose limits to current industry standards, and makes other changes necessary for KRS Chapter 13A compliance.
(b) The necessity of the amendment to this administrative regulation:
The amendment to this administrative regulation is necessary to avoid confusion regarding the applicability of the requirements for monitoring dose limits. Those who are licensed to possess radioactive materials should not be referencing this administrative regulation. This administrative regulation is applicable to those who are registered with the cabinet to possess and utilize sources of ionizing radiation.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 211.842(1) establishes the Cabinet for Health and Family Services as the radiation control agency for the State of Kentucky. KRS 211.844 requires the cabinet to provide by administrative regulation for the registration of the possession or use of sources of ionizing or electronic product radiation.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment to this administrative regulation will ensure all those who are registered to possess and use sources of ionizing radiation are properly registered with the cabinet and will ensure any occupational exposure to radiation is properly monitored.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
There are currently 4,250 registrants. Registrants include those in the fields of medicine, research, industry, as well as academia, and all employees who use sources of ionizing radiation in their employment.
(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 question (3) will have to take to comply with this administrative regulation or amendment:
Individuals who are registered to possess and use sources of ionizing radiation will need to be aware of the occupational exposure limits, and registrants will need to be aware of the exposure limit, signage, and reporting requirements.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There will be no cost to the regulated entities as compliance with this administrative regulation is currently a condition of registration.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Workers who use sources of ionizing radiation in their employment will be properly protected from overexposure to radiation.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This is an ongoing program, there are no initial costs.
(b) On a continuing basis:
This administrative regulation does not impact cost for the agency.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
The Radiation Health Branch is funded through a mix of state general fund dollars and the fees paid by registrants to possess and use sources of ionizing radiation.
(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:
And increase in fees or funding is not necessary to implement the requirements of this amended administrative regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
There are no fees established in this administrative regulation.
(9) TIERING: Is tiering applied?
Tiering is not applied as the requirements of this administrative regulation are applied equally to all registrants.
FISCAL NOTE
(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?
The Radiation Health Branch in the Department for Public Health will be impacted by the amendment to this administrative regulation.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 194A.050 and 211.844.
(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 does not generate 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 does not generate revenue.
(c) How much will it cost to administer this program for the first year?
This administrative regulation does not impact cost for the agency.
(d) How much will it cost to administer this program for subsequent years?
This administrative regulation does not impact cost for the agency.
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:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
Cost savings for the regulated entities will result from ensuring the occupational dose to employees does not exceed established limits. Overexposure to occupational sources of ionizing radiation can result in increased time away from work and other related health concerns for the employee.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
Registrants will continue to see costs savings by protecting workers from overexposure to occupational sources of ionizing radiation in subsequent years.
(c) How much will it cost the regulated entities for the first year?
There will be no cost to regulated entities in the first year as the requirements of this administrative regulation are not new requirements.
(d) How much will it cost the regulated entities for subsequent years?
There will be no change in the cost for regulated entities in subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation does not have a major economic impact.