To update and adopt all but one chapter rule into one rule section.

 

DEPARTMENT OF HEALTH

Division of Environmental Health

RULE NOS.:RULE TITLES:

64E-4.001Registration

64E-4.002Definitions

64E-4.003Exemptions

64E-4.004Laser Safety Officer (LSO)

64E-4.005Out-of-State Laser Radiation Sources

64E-4.006Maximum Permissible Exposure (MPE)

64E-4.007General Requirements for the Safe Operation of All Facilities

64E-4.008Caution Signs, Labels, and Posting

64E-4.009Surveys

64E-4.010Measurement and Instrumentation

64E-4.011Notification and Reports of Incidents

64E-4.012Records

64E-4.013Laser Radiation

64E-4.014Scanning Devices

64E-4.015Report to Department About Laser Light Shows

64E-4.016Measurements for Maximum Permissible Exposure

PURPOSE AND EFFECT: To update and adopt all but one chapter rule into one rule section.

SUMMARY: Repeal all rule text – except rule 64E-4.001, F.A.C. – and move repealed text into an incorporated publication adopted therein. The text relates to: definitions of terms; exemptions from registration requirements; laser safety officer requirements; out-of-state laser radiation sources; maximum permissible exposure; general requirements for the safe operation of facilities; caution signs, labels, and posting; surveys; measurement and instrumentation; notification and reports of incidents; records; laser radiation; scanning devices; report to department about laser light shows; measurements for maximum permissible exposure. The rule updates the ANSI standard related to maximum permissible exposure.

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: In preparing a checklist for determining the need for a SERC, the department has determined there will be no increased costs or adverse impact associated with this rulemaking. 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: 501.122(2) FS.

LAW IMPLEMENTED: 501.122(1), (2), (a), (b), (c), (d) 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, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741; [phone]; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64E-4.001 Registration and Laser Radiation Requirements.

(1) Except as otherwise specifically exempted under these rules, all persons who receive, possess, acquire, transfer, own, manufacture, or use lasers which emit or may emit laser radiation shall register within 30 days after acquisition of a laser product and comply with these rules. Nothing in these rules shall be interpreted as limiting the intentional exposure of patients to laser radiation for the purpose of treatment or use commensurate with the licensed practitioner’s use of the healing arts.

(2) A separate registration is required for each location with a laser device, on DH Form 1605, (09/14), “Laser Device Registration Form,” which is herein incorporated by reference and which is available from the internet at https://www.flrules.org/Gateway/reference.asp?No=Ref-04839 or www.FloridaHealth.gov/radiation. Laser manufacturers must register on DH Form 1604, (09/14), “Manufacturer’s Laser Device Registration Form,” which is herein incorporated by reference and which is available from the internet at https://www.flrules.org/Gateway/reference.asp?No=Ref-04838 or www.FloridaHealth.gov/radiation. Subsequent registrations for each facility or mobile laser facility are required whenever additional laser devices are installed or previously registered laser devices are disposed of, altered, destroyed or moved to new locations. Subsequent registrations for each manufacturer are required only when the description of the laser devices manufactured by the manufacturer changes.

(3)(a) Laser products certified by a manufacturer to be compliant with the Federal laser product performance standard of 21 C.F.R. Part 1040 in effect at the date of manufacture shall be maintained in compliance with such requirements. Certified laser products which have been modified shall comply with these rules.

(b) Uncertified lasers shall meet the requirements of these rules.

(4) If any conflict arises between the requirements of these rules and the federal laser product performance standard, the requirements of the federal standard shall apply.

(5) Except as provided in this rule section, the contents of this rule chapter are contained in the Department of Health publication “Laser Radiation Requirements” (December 15, 2016 edition) incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-####.

(6) Title 21 C.F.R. sections 1040.10 and 1040.11 (April 1, 2013 edition) are incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-####.

(7) The publication ANSI Z136.1-2014, “American National Standard for Safe Use of Lasers” (ANSI), is incorporated by reference and available at www.lia.org. This publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control, 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and 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.

(8)(5) Completed registration forms or other correspondence or reports required by Chapter 64E-4, F.A.C., to be sent in writing to the Department can be mailed to Florida Department of Health, Bureau of Radiation Control, 4052 Bald Cypress Way, Bin #C-21, Tallahassee, Florida 32399-1741; or faxed to [phone]; or scanned and emailed to [e-mail] in PDF, JPG, or TIF format.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.101, Amended 4-20-15,             .

 

64E-4.002 Definitions.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(1) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.102, Amended 10-8-00, 4-20-15, Repealed            .

 

64E-4.003 Exemptions.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(a), (c) FS. History–New 9-6-84, Amended 12-12-96, Formerly 10D-89.103, Amended 10-8-00, Repealed            .

 

64E-4.004 Laser Safety Officer (LSO).

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(a), (d) FS. History–New 9-6-84, Amended 12-12-96, Formerly 10D-89.111, Repealed            .

64E-4.005 Out-of-State Laser Radiation Sources.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.114, Repealed            .

 

64E-4.006 Maximum Permissible Exposure (MPE).

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(a), (d) FS. History–New 9-6-84, Formerly 10D-89.116, Repealed            .

 

64E-4.007 General Requirements for the Safe Operation of All Facilities.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.118, Repealed            .

 

64E-4.008 Caution Signs, Labels, and Posting.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.121, Repealed            .

 

64E-4.009 Surveys.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(c), (d) FS. History–New 9-6-84, Formerly 10D-89.122, Repealed            .

 

64E-4.010 Measurement and Instrumentation.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.123, Repealed            .

 

64E-4.011 Notification and Reports of Incidents.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, Formerly 10D-89.124, Amended 4-20-15, Repealed            .

 

64E-4.012 Records.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, Formerly 10D-89.127, Repealed            .

 

64E-4.013 Laser Radiation.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(d) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.130, Repealed            .

 

64E-4.014 Scanning Devices.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(a), (d) FS. History–New 9-6-84, Formerly 10D-89.131, Repealed            .

 

64E-4.015 Report to Department About Laser Light Shows.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2)(a), (b), (c), (d) FS. History–New 9-6-84, Formerly 10D-89.133, Amended 4-20-15, Repealed            .

 

64E-4.016 Measurements for Maximum Permissible Exposure.

Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2) FS. History–New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.134, Repealed            .

 

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

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, M.D., MPH,

Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 7, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 25, 2016