The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for use of radioactive materials or radiation from radioactive materials, address processes not ...

 

DEPARTMENT OF HEALTH

Division of Environmental Health

RULE NOS.:RULE TITLES:

64E-5.206General Licenses - Radioactive Material Other Than Source Material

64E-5.217Bonding of Persons Licensed Pursuant to Subpart II C

PURPOSE AND EFFECT: The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for use of radioactive materials or radiation from radioactive materials, address processes not permitted by statute and update financial surety methodology. Changes will also include the use of discrete sources of radium 226, naturally occurring radioactive material or accelerator produced radioactive materials and use of radioactive materials within the State of Florida. Some of the proposed rule changes will provide possession and use of radioactive materials under a new general license instead of a specific license. Changes will also be in requests for exemption from financial surety processes, requirements for financial surety and clarification of financial surety mechanisms.

SUMMARY: The substantive changes will be in providing general licenses for use of discrete sources of radium 226, naturally occurring radioactive materials or accelerator produced radioactive materials; changes in requests for exemptions from financial surety process; requirements for financial surety and clarification of acceptable financial surety mechanisms and other subjects encompassed by the above cited rules.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The majority of the proposed changes to the regulations are to add a general license to maintain required compatibility with the U.S. Nuclear Regulatory Commission regulations for the possession and use of radioactive materials and are generally revenue neutral or provide regulatory relief to licensees. Subsection 64E-5.206(11), F.A.C., may cost a small amount to the regulated community for the reporting and disposal of a damaged product. Therefore this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 404.051, 404.061, 404.071, 404.111, 404.141 FS.

LAW IMPLEMENTED: 404.022, 404.051, 404.061, 404.071, 404.081, 404.111, 404.141 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Brenda Andrews, 4052 Bald Cypress Way, Bin C21, Tallahassee, FL 32399-1741; [phone]; [e-mail]

 

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

 

64E-5.206 General Licenses – Radioactive Material Other Than Source Material.

(1) through (3) No change.

(4) Certain Measuring, Gauging and Controlling Devices.

(a) No change.

(b)1. The general license in paragraph (4)(a), above, applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the Department pursuant to subsection 64E-5.210(4), F.A.C., or in accordance with the specifications contained in a specific license issued by the NRC, or an Agreement State, which authorizes distribution of devices to persons granted a general license by the NRC, or an Agreement State. Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in Section 179.21 of 21 C.F.R. Part 179, section 179.21, April 1, 2013 edition, and is herein incorporated by reference and may be obtained from the internet at _______or at http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol3/pdf/CFR-2013-title21-vol3-part179-subpartB.pdf. (Pursuant to Section 120.54(6), F.S., subparagraph 64E-5.206(4)(b)1., F.A.C., is substantively identical to 10 CFR 31.5(b)(1) published on 01/01/2007.)

2. No change.

(c) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in paragraph (4)(a), above;

1. through 3. No change.

4. Shall maintain records showing compliance with the requirements of subparagraphs (4)(c)2. and 3., above. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing testing, installation, servicing and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by subparagraph (4)(c)2., above, shall be maintained for at least three years after the next required leak test is performed or until the transfer or disposal of the sealed source. Records of tests of the on-off mechanism and indicator required by subparagraph (4)(c)2., above, shall be maintained for at least three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed. Records which are required by subparagraph (4)(c)3., above, shall be maintained for a period of at least 3 years from the date of the recorded event or until the transfer or disposal of the device.; (Pursuant to Section 120.54(6), F.S., subparagraph 64E-5.206(4)(c)4., F.A.C.,  is substantively identical to 10 CFR 31.5(c)(4)i published on 01/01/2007.)

5. through 13. No change.

14. Shall not hold devices that are not in use longer than 2 years. If the devices with shutters are not being used, the shutters must be locked in the closed position. The testing required by subparagraph 64E-5.206(4)(c)2., F.A.C., need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter trested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs physical inventories at intervals not to exceed three months while they are in standby. (Pursuant to Section 120.54(6), Florida Statutes, subparagraph 64E-5.206(4)(c)14., F.A.C., is substantively identical to 10 CFR 31.5(c)(15) published on 01/01/2007.)

15. No change.

16. Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department, a written justification for the request for extension of time. (Pursuant to Section 120.54(6), Florida Statutes, subparagraph 64E-5.206(4)(c)16., F.A.C., is substantively identical to 10 CFR 31.5(c)(11) published on 01/01/2007.)

(d) through (e) No change.

(5) through (10) No change.

(11) Certain Items and Self-Luminous Products Containing Radium-226.

(a) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of subsections 64E-5.206(11)(b), (c), and (d), F.A.C., radium-226 contained in the following products manufactured prior to November 30, 2007.

1. Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanatory  jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

2. Intact timepieces containing greater than 0.037 megabecquerel (1 microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

3. Luminous items installed in air, marine, or land vehicles.

4. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

5. Small radium sources containing no more than 0.037 megabecquerel (1 microcurie) of radium-226. For the purposes of this paragraph, ‘‘small radium sources’’ means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.

(b) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in subsection 64E-5.206(11)(a), F.A.C., of this section are exempt from the provisions of Parts III and IX, to the extent that the receipt, possession, use, or transfer of radioactive materials is within the terms of the general license.  This exemption shall not apply to any such person specifically licensed under Chapter 64E-5, F.A.C.

(c) Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in subsection 64E-5.206(11)(a), F.A.C., must also comply with the following requirements:

1. Shall notify the Department should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the Department within 30 days;

2. Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to Rule 64E-5.328, F.A.C., or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the Department;

3. Shall not export products containing radium-226 except in accordance with 10 C.F. R. Part 110, 1-1-14 edition which is herein incorporated by reference and can be obtained from the internet at______or at http://www.gpo.gov/fdsys/pkg/CFR-2014-title10-vol2/pdf/CFR-2014-title10-vol2-part110.pdf;

4. Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under Part III, or equivalent regulations of an Agreement State or the NRC, as otherwise approved by the Department.

5. Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department a written justification for the request.

(d) Except for disassembly and repair of timepieces described in sub-paragraph 64E-5.206(11)(a)2., F.A.C., the general license in subsection 64E-5.206(11)(a), F.A. C., does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226.

Rulemaking Authority 404.051, 404.061, 404.071 FS. Law Implemented 404.022, 404.051(1), (4), (6), (8), (9), (10), (11), 404.061(2), 404.071(1), (3), 404.081(1), 404.141 FS. History–New 7-17-85, Amended 4-4-89, 1-1-94, Formerly 10D-91.306, Amended 9-28-06, 2-28-08, 12-26-13,________.

 

64E-5.217 Bonding of Persons Licensed Pursuant to Subpart II C.

(1) No change.

(a) The bond shall be payable to the State of Florida and shall be in an amount determined by the Ddepartment as sufficient to provide for the protection of the environment and the public health and safety in the event of abandonment, insolvency or other inability of the licensee to meet the requirements of the Ddepartment. The Ddepartment shall use the Bond Risk Factors Calculation Worksheet - March 2014 which is herein incorporated by reference and which can be obtained from the internet at_______or at http://www.floridahealth.gov/prevention-safety-and-wellness/radiation-control/, (3), below, of this part to determine the amount of the bond required for each applicant or licensee. The mathematical product of the risk factors will be the amount of the required bond in dollars. In the event that an applicant or licensee feels that the amount of the bond determined by the use of the applicable risk factors is inappropriate, he may submit evidence to the Ddepartment in support of a change to the bond amount. The Ddepartment shall determine whether the evidence supports the requested change in the bond amount.

(b) An applicant or licensee may apply to the Department for exemption from the requirement of a bond if he can demonstrate that funds will accrue to the State of Florida which are sufficient to provide for the protection of the environment and the public health and safety in the event of abandonment, insolvency or other inability of the licensee to meet the requirements of the Department. If the Department does not grant the exemption from the requirement of a bond, the licensee may request a hearing in accordance with the provisions of Chapter 120, Florida Statutes.

(b)(c) Licensees must provide the required bond within 90 days after being given notice by the Department of the requirements of a bond and its amount.

(c)(d) The Department may re-evaluate, at any time, the adequacy of an existing bond or guaranty and may require an adjustment by either increasing or decreasing the amount of the bonding or guaranty required.

(d)(e) A bond may be issued by a fidelity or surety company authorized to do business in the State of Florida or it may be a cash bond. The bond must initially provide for at least 24 months of coverage from the date of issuance and at no time thereafter shall the period of coverage be less than 12 months, for as long as the license remains in effect.

1. The bond must contain, without limitation, the following conditions:

a. The bond must be open-ended or, if written for a specific term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Department’s Bureau of Radiation Control, the beneficiary, and the licensee of its intention not to renew;

b. The bond must provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forteiture if the licensee fails to provide replacement acceptable to the Department within 30 days after receipt of notification of cancellation; and

c. The bond must be payable to the State of Florida;

2. The bond must remain in effect until the Department has terminated the license or the requirements of subparagraph 64E-5.217(1)(d)1.b., F.A.C., are met.

(e)(f) The Department may order the bond to be forfeited if it finds any of the following:

1. through 3. No change.

(f)(g) Upon determining that a bond shall be forfeited, the Department shall issue a notice to that effect.

(2) The following are exempt from the provisions of this subpart:

(a) No change.

(b) Licensees who are only authorized for possession or use of radioisotopes with a half-life less than or equal to 120 days. Educational institutions accredited by the Southern Association of Colleges and Schools and such other educational institutions as may be specifically exempted by the Department if the Department determines that such exemption will not endanger the public health, safety and welfare.

(c) Any licensee whose mathematical product of the risk factors in the Bond Risk Factors Calculation Worksheet - March 2014 ,is less than or equal to 30,000. Licensees of the State Licensing Board for the Healing Arts and those medical facilities possessing or using radioactive materials for medical purposes when supervised by such licensees.

(d) Any licensee whose mathematical product of the risk factors in (3), below, is less than 15,000.

(3) At the time of license application, license renewal and at intervals not to exceed 3 years, the applicant or licensee must submit the bonding determination described in subsection 64E-5.217(1), F.A.C., above, with adjustments as necessary to account for changes in chemical and physical form of radioactive material, radioisotopes authorized, their radiotoxicity and quantity, authorized licensed activities, actual costs and the potential costs of decontamination, treatment, or disposal of radioactive materials and contaminated equipment or facilities.  Risk factors for purposes of bonding:

RadioisotopesRisk FactorsPhysical FormFactors

U-nat, U-235, U-238,Non-encapsulated

and associated decayform20

products1Single encapsulated

or source plated3

Transuranics, Ra-226,

Ra-228, Th-230, Th-228,

Pa-231, Ac-227, Ac-225,

I-12950

Th-nat, Th-232, Sr-90,

Ra-223, Ra-224, U-232,

I-126, I-131, I-133

I-125, H-3, C-145

Half-Life ofRiskFacilityRisk

RadioisotopeFactorsand ProcedureFactors

Greater than 6 years30Greater than 5000 ft.2

6 months to 6 years10– High Risk30

10 days to 6 months5– Low Risk10

500 to 5000 ft.2

– High Risk10

– Low Risk5

Less than 500 ft.2

– High Risk5

RiskRisk

ActivityFactorsActivityFactors

Greater than 100,000License issued

curies2,000for storage

10,000 to 100,000only3

curies1,000

1,000 to 10,000 curies500

100 to 1,000 curies200

10 to 100 curies30

1 to 10 curies2

License issued forSealed sources

manufacturing,– not contained

benefication orin a device

processing ofwith integral

non-encapsulatedsolid shielding3

radioactive materials3

Rulemaking Authority 404.051, 404.061, 404.111, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), 404.061(2), 404.111, 404.141 FS. History–New 7-17-85, Amended 4-4-89, 5-12-93, Formerly 10D-91.322, Amended ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Cynthia Becker, Bureau Chief, Bureau of Radiation Control

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General & Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 13, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 4, 2014