To update and provide current contact information and addresses for the Department, update references for applicable national standards, forms and federal regulations in the rule, and update forms for laser machine registration and reporting ...

 

DEPARTMENT OF HEALTH

Division of Environmental Health

RULE NOS.:RULE TITLES:

64E-4.001Registration

64E-4.002Definitions

64E-4.011Notification and Reports of Incidents

64E-4.015Report to Department

PURPOSE AND EFFECT: To update and provide current contact information and addresses for the Department, update references for applicable national standards, forms and federal regulations in the rule, and update forms for laser machine registration and reporting criteria for notifying the department about laser light shows.

SUMMARY: Updates required forms for laser registration, updates standards for safe operation and use of lasers, reporting of laser light shows to the Department, updates and specifies the editions of Title 21 CFR part 1040 that are applicable to laser machines generally and applicable to laser machines when they are manufactured. Updates contact information for interacting with the Department.

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 making a decision concerning whether a SERC is required for this rule the Department has determined that the rule will not cause an increase in regulatory costs associated with compliance with this rule chapter. The rule offers a more cost effective means of submitting registration forms to the department. Additionally, there are few entities that are required to register under these rules. Therefore this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in paragraph 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 FS.

LAW IMPLEMENTED: 501.122(2), 501.122(2)(a), (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.

(1) No change.

(2) A separate registration is required for each location with a laser device, on DH Form 1605, 09/14 Jul 96,   “Laser Device Registration Form,” which is herein incorporated by reference and which is available from the internet at _____ or www.FloridaHealth.gov/radiation department. Laser manufacturers must register on DH Form 1604, 09/14Jul 96, “Manufacturer’s Laser Device Registration Form,” which is herein incorporated by reference and which is available from the internet at _____ or www.FloridaHealth.gov/radiation department. 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) through (4) No change.

(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.

 

64E-4.002 Definitions.

As used in these rules:

(1) No change.

(2) “Accessible emission limit” means the maximum accessible emission level permitted within a particular class as set forth in 21 C.F.R. Part 1040 (see subsection 64E-4.002(59), F.A.C.) and ANSI.

(3) No change.

(4) “Act” means Section 501.122, Florida Statutes (F.S.).

(5) “American National Standards Institute (ANSI)” means ANSI Z136.1-2007, American National Standard for Safe Use of Lasers, which is herein incorporated by reference and which is available from the Laser Institute of America at www.lia.org– (ANSI Z136.1-1980) national standards for safe use of lasers. This 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 at 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.

(6) through (8) No change.

(9) “Certified laser product” means that the product is certified by a manufacturer pursuant to the requirements of 21 C.F.R. Part 1040 in effect at the time of manufacture.

(10) through (58) No change.

(59) “21 C.F.R. Part 1040” means Title 21 of the Code of Federal Regulations, Sections 1040.10 and 1040.11 that were in effect at the time of manufacture for those laser products certified by a manufacturer to be compliant with these sections on the date of manufacture. For all other laser products, it means Title 21 of the Code of Federal Regulations, Sections 1040.10 and 1040.11, April 1, 2013 edition, which is herein incorporated by reference and is available from the internet at __________ or http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol8/pdf/CFR-2013-title21-vol8-part1040.pdf or http://www.FloridaHealth.gov/radiation.

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,                            .

 

64E-4.011 Notification and Reports of Incidents.

(1) Immediate Notification. Each registrant shall notify the Department immediately by telephone at [phone] of any incident involving any source of laser or collateral radiation possessed by the registrant and which has or may have caused:

(a) An exposure to an individual of greater than 100 times the MPE or 21 C.F.R. Part 1040 limits of laser or collateral radiation; or

(b) through (c) No change.

(2) Twenty-four Hour Notification. Each registrant shall notify the Department by telephone at [phone] within 24 hours of any incident involving any source of laser or collateral radiation possessed by the registrant and which has or may have caused:

(a) An exposure to an individual of greater than five times the MPE or 21 C.F.R. Part 1040 limits of laser or collateral radiation; or

(b) No change.

(3) Each registrant shall make a report in writing within 30 days to the Department of:

(a) Each exposure of an individual to laser and collateral radiation in excess of the MPE limits or 21 C.F.R. Part 1040,

(b) No change.

(4) through (6) No change.

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.

 

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

In addition to the requirements of Rule 64E-4.005, F.A.C., before the laser light show is permitted to operate either at a permanent or temporary job site, the laser light show operator or an authorized representative shall provide the Department with sufficient information, data, and measurements to establish that the requirements of Rules 64E-4.013 and 64E-4.014, F.A.C.,above criteria will be met during use. This shall include sketches showing the location of laser, operators, performers, viewers, beam paths, viewing screens, walls, mirror balls, and other reflective or diffuse surfaces which may be struck by laser beam, scanning beam patterns, scanning velocity and frequency in occupied areas and where beam strikes wall or other structure, radiometric measurement data including output power and location of all measurements. In the case of open air shows where a laser beam is projected into the sky, the information submitted shall also include beam spot size, beam divergence, and beam power measured at the projector, and a copy of the notification provided to the Federal Aviation Administration.

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.

 

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: August 27, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 25, 2014