The purpose of the proposed rule change to Florida Administrative Code (F.A.C.) Rule 64E-5.502 is to add administrative controls for ionizing radiation machines that are manufactured and used only for security purposes in jails and penal ...

 

DEPARTMENT OF HEALTH

Division of Environmental Health

RULE NO.:RULE TITLE:

64E-5.1602Administrative Requirements

64E-5.502General Requirements

64E-5.511Registration of Radiation Machines

64E-5.801Registration Requirements

PURPOSE AND EFFECT: The purpose of the proposed rule change to Rule 64E-5.502, Florida Administrative Code (F.A.C.), is to add administrative controls for ionizing radiation machines that are manufactured and used only for security purposes in jails and penal institutions on legal detainees. DH Form 1107, 9/14, “Radiation Machine Facility Registration,” incorporated by reference in Rule 64E-5.511, F.A.C., is used for x-ray machine registration. This form is being modified to include check boxes so that those registering ionizing radiation machines that are manufactured and used for security purposes in jails and penal institutions on legal detainees can acknowledge compliance with ANSI/HPS N43.17-2009 edition, “Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation.” Reference to DH 1107, 9/14 in Rules 64E-5.1602 and 5.801, F.A.C., will also reflect the modified form. The Department intends to clarify language in paragraph 64E-5.511(5)(a), F.A.C., regarding registrant and assembler reporting requirements, remove the reference to a federal form, and modify DH Form 1114, 4/97 to include installation requirements for certified x-ray systems.

SUMMARY: The substantive changes to Rule 64E-5.502, F.A.C., will make provision for approved security scanners to be utilized legally with detainees for security purposes in jails and penal institutions. Updating of DH Form 1107, 9/14 which is incorporated by reference in Rule 64E-5.511, F.A.C., will allow registrants to verify compliance with ANSI/HPS N43.17-2009 edition. The substantive changes to paragraph 64E-5.511(5)(a), F.A.C., will clarify registrant and assembler reporting requirements. DH Form 1114, 4/97 will be modified to include requirements for the installation of certified or non-certified x-ray systems.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not 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 not 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: This rule amendment specifically provides for administrative controls and limitations on the use of x-ray systems in jails and penal institutions for security screenings of detainees. The Agency has determined that the proposed Rule 64E-5.511, F.A.C., is not expected to require legislative ratification based on the information expressly relied upon and described herein: DH Form 1107, 9/14 is incorporated by reference in Rule 64E-5.511 F.A.C. The form is being modified so that persons registering security screening systems in accordance with Rule 64E-5.502, F.A.C., can verify that their machines are in compliance with ANSI/HPS N43.17-2009 edition, “Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation”. Reference to DH 1107, 9/14 in Rules 64E-5.1602 and 5.801, F.A.C., will also reflect the modified form. 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, 404.22 FS.

LAW IMPLEMENTED: 404.022, 404.051, 404.061, 404.162, 404.163, 404.071, 404.081, 404.091, 404.101, 404.111, 404.141, 404.22, 404.302 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-5.1602 Administrative Requirements.

(1) Registration and Notification.

(a) through (c) No change.

(d) Each person who acquires an electronic brachytherapy device shall apply for registration of the radiation device with the D department within 30 days after acquisition. Application for registration shall be on DH Form 1107, 10/15 09/14, “Radiation Machine Facility Registration,” as incorporated in subparagraph 64E-5.511(2)(a)1., F.A.C. The application must include the following documents:

1. through 6. No change.

(e) No change.

(2) through (3) No change.

Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS. History–New 3-12-09, Amended 6-3-15,________.

64E-5.502 General Requirements.

(1) Administrative Controls.

(a) Registrant. The registrant shall be responsible for directing the operation of the x-ray systems which are subject to registration as described in Rule 64E-5.511, F.A.C. The registrant or the registrant’s agent shall assure that the following requirements are met in the operation of the x-ray system.

1. No change.

2. An x-ray system operator shall receive instruction on and be competent in the safe use of the x-ray system.  A medical x-ray system operator shall also be certified or authorized in accordance with Chapter 468, Part IV, Florida Statutes. Individuals who will be operating any x-ray system shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. Nonphysician operators of medical x-ray systems shall be certified in accordance with Chapter 64E-3, F.A.C.

3. through 6. No change.

7. An x-ray system is exempt from the requirements of subparagraph 64E-5.502(1)(a) 6., F.A.C., only if:

a. The system is a stationary, non-mobile system installed and used only in a jail or penal institution;

b. The system is used only on legal detainees in a jail or penal institution, and never on detainees’ family members, children, institution employees, contractors, visitors, the public, or any other persons;

c. The system is manufactured, maintained, and operated solely for security screening purposes in strict compliance with, and fully according to, the most restrictive standards found in ANSI/HPS N43.17-2009, “Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation,” which is herein incorporated by reference and available from the American National Standards Institute, Inc. at http://www.ansi.org; and,

d. The institution tracks radiation dose for each detainee, as specified by ANSI/HPS N43.17-2009, “Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation,”  to ensure the detainee does not exceed the recommended dose limit. This ANSI publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control at Building 4042, Suite 210, Tallahassee, Florida 32399-1741, and at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250. The agency has determined that posting the publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law.

7. through 10. renumbered to 8. through 11.

Rulemaking Authority 404.051, 404.081, 404.141, 404.22 FS. Law Implemented 404.051, 404.081, 404.141, 404.22, 468.302 FS. History–New 7-17-85, Amended 4-4-89, 1-1-94, 11-20-94, 1-5-95, Formerly 10D-91.603, Amended 5-18-98, 8-16-07,                             .

64E-5.511 Registration of Radiation Machines.

(1) Exemptions.

(a) through (b) No change.

(2) Application and Fees for Registration of Radiation Machines.

(a) Each person who acquires a radiation machine or an additional radiation machine shall:

1. Apply for registration of the radiation machine with the D department within 30 days after acquisition and before use. Application for registration shall be on DH Form 1107, 10/15 09/14, “Radiation Machine Facility Registration,” which is herein incorporated by reference and available from the internet at http://www.floridahealth.gov/radiation, or at https://www.flrules.org/Gateway/reference.asp?No=Ref-xxxx.

2. through 3. No change.

(b) through (c) No change.

(3) through (4) No change.

(5) Assembler or Transferor Obligation.

(a)1. Any registrant or person who sells, leases, transfers, relocates, lends, assembles, installs or disposes of one or more radiation machines or major components of one or more such machines shall notify the Department within 15 days after such action. Notification shall be made on DH Form 1107, 10/15, “Radiation Machine Facility Registration.”

2. Any assembler who relocates, assembles, installs or disposes of one or more radiation machines or major components of one or more such machines shall notify the Department within 15 days after such action. Notification shall be made on DH Form 1114, 10/15 4/97, “Report of Assembly of Certified or Non-Certified X Ray Systems,” which is herein incorporated by reference and available from the internet at http://www.floridahealth.gov/radiation and at https://www.flrules.org/Gateway/reference.asp?No=Ref-xxxx or a similar form which captures all the information required on DH Form 1114, 10/15 if the system contains certified components, on Form FDA 2579, which is herein incorporated by reference and which is available from the FDA at http://www.fda.gov/aboutfda/reportsmanualsforms/forms/default.htm.

(b) through (c) No change.

(6) through (7) No change.

Rulemaking Authority 404.051, 404.131, 404.22 FS. Law Implemented 404.071, 404.091, 404.101, 404.131, 404.141, 404.161, 404.162, 404.163, 404.22 FS. History–New 12-12-96, Formerly 10D-91.612, Amended 8-16-07, 6-3-15,                             .

64E-5.801 Registration Requirements.

(1) No change.

(2) Application for registration shall be made on DOH Form 1107, 10/15 09/14, “Radiation Machine Facility Registration,” (see Rule 64E-5.511, F.A.C.) and shall contain all information required by the form and accompanying instructions. Rules 64E-5.502 and 64E-5.511, F.A.C., contain requirements concerning registration and the payment of registration fees.

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.022, 404.051(1), (4), (9), 404.22(1) FS. History–New 7-17-85, Amended 5-15-96, Formerly 10D-91.902, Amended 6-3-15,________.

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 and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 18, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 9, 2015