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Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device"...

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Board of Directors Chairperson Edgar D. Bailey <ebaileyadhs.ca.gov> California Chairperson-Elect Debra McBauah Washington Past Chairperson Richard A. Ratliff Texas Treasurer John Winston Pennsylvania Members-at-Large Debbie B. Gille Florida Jay C. Hvland Maine Kathleen A. McAllister Massachusetts Conference of Radiation Control Program Directors, Inc. Office of Executive Director * 205 Capital Avenue * Frankfort, KY 40601 Phone: 502/227-4543 * Fax: 502/227-7862 * Web Site: www.crcpd.org Central E-mail: [email protected] August 4, 2004 Paul Lohaus Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852 Dear Mr. Lohaus: Please find enclosed a draft copy of the latest suggested state regulation from the Conference of Radiation Control Program Directors. Part AA - Registration and Radiation Safety Requirements for Lasers is being presented for peer review. Currently, CRCPD members and industry stakeholders are peer reviewing this Part. We request that NRC likewise review the enclosed Parts relative to eventual Federal Concurrence. The CRCPD requests that correspondence relative to Parts S be sent to: Catherine Fontaine, Chairperson, SSR-AA Bureau of Radiation Control, Texas Department of Health, 1100 West 49 t St, Austin, TX 78756-3189. cathv.fontaine~tdh.state.tx.us Thank you for your attention to this important matter. Office of Executive Director Kentucky Executive Director Ronald G Fraass Tele: Ext. 2222 <[email protected]> Administrative Officer Patricia C. Gorman Tele: Ext. 2227 <pgorman~crcpd.org> Sincerel B'RPubi ci er S S~R Publication Manager, CRCPD 4= -v (I) -I4 71 Cc: Ron Fraass, Executive Director, CRCPD Patricia Gorman, Deputy Director Edgar D. Bailey, Chairperson, CRCPD Cr STW4"r7t5 R tosi S~PAL A Partnership Dedicated to Radiation Protection
Transcript
Page 1: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

Board of Directors

ChairpersonEdgar D. Bailey

<ebaileyadhs.ca.gov>California

Chairperson-ElectDebra McBauah

Washington

Past ChairpersonRichard A. Ratliff

Texas

TreasurerJohn WinstonPennsylvania

Members-at-LargeDebbie B. Gille

Florida

Jay C. HvlandMaine

Kathleen A. McAllisterMassachusetts

Conference of Radiation Control Program Directors, Inc.Office of Executive Director * 205 Capital Avenue * Frankfort, KY 40601

Phone: 502/227-4543 * Fax: 502/227-7862 * Web Site: www.crcpd.orgCentral E-mail: [email protected]

August 4, 2004

Paul LohausNuclear Regulatory CommissionOne White Flint North11555 Rockville PikeRockville, MD 20852

Dear Mr. Lohaus:

Please find enclosed a draft copy of the latest suggested state regulation from the Conferenceof Radiation Control Program Directors. Part AA - Registration and Radiation SafetyRequirements for Lasers is being presented for peer review. Currently, CRCPD membersand industry stakeholders are peer reviewing this Part. We request that NRC likewise reviewthe enclosed Parts relative to eventual Federal Concurrence.

The CRCPD requests that correspondence relative to Parts S be sent to: Catherine Fontaine,Chairperson, SSR-AA Bureau of Radiation Control, Texas Department of Health, 1100 West

4 9t St, Austin, TX 78756-3189. cathv.fontaine~tdh.state.tx.us

Thank you for your attention to this important matter.

Office ofExecutive Director

Kentucky

Executive DirectorRonald G Fraass

Tele: Ext. 2222<[email protected]>

Administrative OfficerPatricia C. Gorman

Tele: Ext. 2227<pgorman~crcpd.org>

Sincerel

B'RPubi ci erS S~R Publication Manager, CRCPD

4=

-v

(I)-I471

Cc: Ron Fraass, Executive Director, CRCPDPatricia Gorman, Deputy DirectorEdgar D. Bailey, Chairperson, CRCPD

Cr

STW4"r7t5R tosi S~PALA Partnership Dedicated to Radiation Protection

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DRAl;T SSRCR Volume I June 2004

PART AA

Registration and Radiation Safety Requirements for Lasers

Ree_ AA 1 - PE nce andi Repe

a. This Part establishes requirements for the registration of persons who receive, possess,acquire, transfer, or use Class 3b and Class 4 lasers in the healing arts, veterinary medicine,industry, academic, research and development institutions, and of persons who are in thebusiness of providing laser services. No person shall use lasers or perform laser servicesexcept as authorized in a certificate of laser registration issued by the agency in accordancewith the requirements of this Part.

b. This Part establishes requirements for protection against laser radiation hazards, laser hazardcontrol methods, training requirements, and notification of injuries. This Part includesresponsibilities of the registrant and the laser safety officer (LSO).

c. Except as otherwise specifically exempted, these regulations apply to all persons whoreceive, possess, acquire, transfer, own, or use lasers that emit or may emit laser radiation.[Individuals shall not use lasers on humans unless under the supervision of a licensedpractitioner of the healing arts if use of lasers is within the scope of practice of their license.]Nothing in these regulations shall be interpreted as limiting the intentional exposure ofpatients to laser radiation for the purpose of diagnosis, therapy, or treatment by a licensedpractitioner of the healing arts within the scope of practice of their professional license.[These regulations do not apply to the manufacture of lasers.]

d. Laser products certified by a manufacturer to be compliant with the Federal laser productperformance standard of Title 21, Code of Federal Regulations (21 CFR 1040) applicable atthe date of manufacture shall be maintained in compliance with such requirements. CertifiedUser products that have been modified shall comply with these regulations or the Federalstandard.

e. Uncertified lasers shall meet the requirements of these regulations.

f. If any conflict arises between the requirements of these regulations and the Federal laserproduct performance standard with respect to the same aspect of performance for laserproducts subject to the Federal standard, the requirements of the Federal standard shall apply.

g. In addition to the requirements of this Part, all registrants are subject to the applicableprovisions of the General Provisions (Part A), Standards for Protection (Part D) and Notices,Instructions and Reports (Part J) of these regulations.

SRe A A 9 - Definitinns As used in these regulations:

"Accessible emission level" means the magnitude of emission from laser or collateral radiation of awavelength and emission duration to which human access is possible as measured under theconditions specified in Section AA.31 of these regulations.

AA1

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SSRCR Volume liJune 2004 DRAFT

"Accessible emission limit (AEL)" means the maximum accessible emission level permitted within aparticular class in the most recent edition of American National Standard for Safe Use of Lasers,American National Standards Institute (ANSI) Z136.1.

"Act" means [cite State Radiation Control Act or appropriate State statute].

"Agency" means [cite appropriate State Agency responsible for administration of the Act].

"Aperture" means an opening through which laser or collateral radiation can pass allowing humanaccess to such radiation.

"Aperture stop" means an opening serving to limit the size and to define the shape of the area overwhich radiation is measured.

"Certified laser product" means that the product is certified by a manufacturer pursuant to therequirements of Title 21, Code of Federal Regulations (CFR), Part 1040.

"Class 1 laser, International Electrotechnical Commission (IEC) Class I M" means a laser or lasersystem containing a laser that may produce visible or invisible laser radiation. Under all normalconditions of operation, a Class 1 laser is considered to be incapable of causing injury from directlyviewing the radiation beam. For maximum permissible exposure limits, see the most recent editionof American National Standard for Safe Use of Lasers, ANSI Z136.1.

"Class 2 laser, IEC Class 2M" means a laser or laser system that produces low-power visible laserradiation not exceeding 1 mW. Eye protection is normally afforded by the natural blink reflex time(0.25 s). Direct viewing of the radiation beam from a Class 2 laser is prohibited. For maximumpermissible exposure limits, see the most recent edition of American National Standard for Safe Useof Lasers, ANSI Z136.1.

"Class 2a laser products, EEC Class 2M products" means any laser product that permits human accessto levels of visible laser radiation in excess of the Class 2 accessible emission limits, during itsoperation, but does not permit human access to levels of laser radiation in excess of the accessibleClass 2a emission limits. For maximum permissible exposure limits, see the most recent edition ofAmerican National Standard for Safe Use of Lasers, ANSI Z136.1.

"Class 3a laser, IEC Class 3R 3M" means a laser or laser system that produces moderate levels ofvisible or invisible laser radiation of 1 to 5 mW and requires-more stringent control than a Class 2laser. For those Class 3a lasers whose output is visible, the normal aversion response is generallysufficient to prevent eye injury. For maximum permissible exposure limits, see the most recentedition of American National Standard for Safe Use of Lasers, ANSI Z136.1.

"Class 3b laser" means a laser or laser system that produces visible laser radiation of 5 to 500 mW ofvisible continuous wave output and 5 to 500 mW of invisible infraredlaser radiation. A Class 3blaser is considered medium power laser and is capable of producing -eye injury when viewed directlyor with optics, even if viewed momentarily. For maximum permissible exposure limits, see the mostrecent edition of American National Standard for Safe Use of Lasers, ANSI Z136.1.

"Class 4 laser" means a laser or laser system that produces visible or invisible laser radiation capableAA2

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DRAFT SSRCR Volume I!June 2004

of causing injury to the eye and skin, and dangerous specular and diffuse reflections. For maximumpermissible exposure limits, see the most recent edition of American National Standard for Safe Useof Lasers, ANSI Z136.1.

"Collateral radiation" means any electronic product radiation, except laser radiation, emitted by alaser as a result of the operation of the laser(s) or any component of the laser product that isphysically necessary for the operation of the laser(s). (The accessible emission and maximumpermissible exposure limits for collateral radiation are specified in Title 21, CFR, Part 1040.10.)

"Continuous wave" (CW) means the output of a laser that is operated in a continuous rather than apulsed mode. For purposes of these rules, a laser operating with a continuous output for a period >0.25 seconds is regarded as a`CW laser.

"Controlled area" means any area where the occupancy and activity of those within is subject tocontrol and supervision for the purpose of protection from radiation hazards..

"Demonstration laser" means any laser manufactured, designed, intended, or used for purposes ofdemonstration, entertainment, advertising display, or artistic composition.

"Diffuse reflection" means the change of the spatial distribution of a beam of laser radiation when itis reflected in many directions by a surface or by a medium.

"Electronic product" means:

(1) Any manufactured or assembled product which, when in operation,

(i) Contains or acts as part of an electronic circuit and

(ii) Emits, or in the absence of effective shielding or other controls would emit,electronic product radiationor

(2) Any manufactured or assembled article that is intended for use as a component, part,or accessory of a product described in (1) and which when in operation emits, or inthe absence of effective shielding or.other controls would emit, such radiation.;

"Eletronic product radiation" means radiation that is emitted from an electronic product as the resultof the operation of an electronic circuit in such product, and includes:

(1) Any ionizing or nonionizing electromagnetic or particulate radiation, or

(2) Any sonic, infrasonic, or ultrasonic wave.

"Embedded laser" means'.an.enclosed laser with an assigned class number higher than the inherentcapability of the laser system in which it is incorporated, where the system's lower classification isappropriate due to the engineering features limiting accessible emission.

"Enclosed laser" means a laser that is contained within a protective housing of itself or of the laser orlaser system in which it is incorporated. Opening or removing of the protective housing provides

AA3

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SSRCR Volume HlJune 2004 DRAFT

additional access to laser radiation above the applicable maximum permissible exposure (MPE) thanpossible with the protective housing in place. (An embedded laser is an example of one type ofenclosed laser).

"Energy" means the capacity for doing work. Energy content is commonly used to characterize theoutput from pulsed lasers and is generally expressed in joules (J).

"Facility" means any location where one or more lasers are used or operated. The confines of anyfacility shall be designated by the owner of such facility. A part of a building, an entire building, orother structure or plant or, where appropriate, a specified out-of-doors location may be designated asa facility.

"Human access" means access to laser or collateral radiation by any part of the human body.

"Incident" means an event or occurrence that results in a real or suspected accidental exposure tolaser radiation that caused or is likely to cause biological damage.

"Individual" means any human being.

"Integrated radiance" means radiant energy per unit area of a radiating surface per unit solid angle ofemission, expressed in joules per square centimeter per steradian (J cm~ sf ).

["Intense-pulsed light (IPL) device" - means a device that emits radiation to energy density levelsthat could reasonably cause bodily harm and that is used for photothermolysis. This device is a Class2 or Class 3 surgical device certified as complying with the design, labeling, and manufacturingstandards of the United States Food and Drug Administration (FDA)."]

"Irradiance" means the radiant power incident on an element of a surface divided by the area of thatelement, expressed in watts per square centimeter (W cm 2).

"Joule" (J) means a unit of energy, I joule = 1 watt second.

"Laser" means any device that can produce or amplify electromagnetic radiation with wave lengths inthe range of 180 nanometers to 1 millimeter primarily by the process of controlled stimulatedemission. Laser is an acronym for Light Amplification by Stimulated Emission of Radiation.

"Laser energy source" means any device intended for use in conjunction with a laser to supply energyfor the operation of the laser, General energy sources such as electrical supply mains or batteriesshall not be considered to constitute laser energy sources.

"Laser product" means any manufactured product or assemblage of components which constitutes,incorporates, or is intended to incorporate a laser or laser system. A laser or laser system which isintended for use as a component of an electronic product shall itself be considered a laser product.(See AA.26a. for applicability requirements.)

"Laser protective device" means any device used to reduce or prevent exposure of personnel to laserradiation. Such devices may include protective eyewear, garments, engineering controls, andoperational controls.

AA4

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"Laser radiation" means all electromagnetic radiation emitted by a laser product within the spectralrange specified in the definition of "Laser" in Section AA.2 that is produced as a result of controlledstimulated emission or that is detectable with radiation so produced through the appropriate aperturestop having a diameter, a solid angle of acceptance, and collimating optics as specified in AA.3 1.

"Laser safety officer" (LSO) means any individual, qualified by training and experience in theevaluation and control of laser hazards, who is designated by the registrant and has the authority andTesponsibility to establish and administer the laser radiation protection program for a particularfacility or.a particular mobile laser.

"Laser system" means an assembly of electrical, mechanical, and optical components that includes alaser. - -

"Maintenance" means the performance of those adjustments or procedures by the user (specified inuser information provided by the manufacturer with the laser or laser system) that are to beperformed by the user to ensure the intended performance of the product.

"Maximum permissible exposure" (MPE) means that level of laser radiation to which persons maybe exposed without hazardous effect or adverse biological changes in the eye or skin. (The criteriafor the MPE for cornea (eye) and skin are detailed in the most recent edition of American NationalStandard for Safe Use of Lasers, ANSI Z136.1.)

"Mobile laser" means a laser which is used at temporary job sites..

"Operation" means performance of the laser or laser system over the full range of its intendedfunctions (normal operation).functions. It does not include maintenance or service tasks as definedin these reguilations.-

"Optical density" (OD) means a logarithmic expression of the optical attenuation afforded by amaterial.

OD =logeo WInMientpower)(Transmitted power)

wPerson" means any individual, corporation, partnership, firm, association, trust, estate, public orprivate institution, group, Agency, political subdivision of this State, any other State or politicalsubdivision or Agency thereof, and any legal successor, representative, agent, or Agency of theforegoing. [, but shall not include federal government agencies.]

"Practitioner of the healing arts (practitioner)" means for the purposes of this Part, a person licensedto practice the healing arts by either the [state] Board of Medical Examiners as a physician; the[state] Board of Dental Examiners; the [state] Board of Chiropractic Examiners; or the [state] Boardof Podiatry Examiners. A practitioner's use of a laser is limited to his/her scope of professionalpractice as determined by the appropriate licensing agency.

["Photothermolysis" means the non-invasive aesthetic application of intense-pulsed light (IPL)energy to selective superficial lesions such as unwanted body hair or veins. (Also see definition for

AA5

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SSRCR VolumeffJune 2004 D}RAFr

intense-pulsed light (IPL) device.)]

"Protective housing" means those portions of a laser product that are designed to prevent humanaccess to laser or collateral radiation in excess of the prescribed accessible emission limit.

"Pulse duration" means the duration of a laser pulse, usually measured as the time interval betweenthe half-power points on the leading and trailing edges of a pulse.

"Radiance" means time-averaged radiant power per unit area of a radiating surface per unit solidangle of emission, expressed in watts per square centimeter per steradian (W cm72 sf").

"Radiant energy" means energy emitted, transferred or received in the form of radiation, expressed injoules (J).

"Radiant exposure" means the radiant energy incident on an element of a surface divided by the areaof that element, expressed injoules per square centimeter (J cm).

"Radiant power" means power emitted, transferred, or received in the form of radiation, expressed inwatts (W).

"Registrant" means any person who registers a mobile laser, facility, or service organization with theAgency pursuant to these regulations.

"Safety interlock" means a device associated with the protective housing of a laser product, system orfacility which prevents human access to laser and/or collateral radiation in excess of the prescribedaccessible emission limit.

"Sampling interval" means the time interval during which the level Af accessible laser or collateralradiation is sampled by a measurement process. The magnitude of the sampling interval in units ofseconds is represented by the symbol (t).

"Secured enclosure" means an enclosure to which casual access is impeded by appropriate means,such as a door secured by a magnetically or electrically operated lock or latch or by fasteners thatneed a tool to remove.

"Sefvice" means the performance of those procedures or adjustments described in the manufacturer'sservice instructions that may affect any aspect of the performance of the laser or laser system.Service does not include operation or maintenance as defined in these regulations.

"Specular reflection" means mirror-like reflection.

"These regulations" mean all Parts of [cite appropriate rules or regulations].

"Watt" (W) means the unit of power or radiant flux; 1 watt = 1 joule per second (J secl).

Sec AA 3 - PxemptiAns The following are exempt from regulations in this Part:

AA6

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DRAFT SSRCR Volume HIJune 2004

a. Facilities containing only certified Class 1, Class 2, Class 2a, and Class 3a lasers or laserproducts, provided that the laser product is maintained as a certified Class 1, Class 2, Class2a, and Class' 3a laser product throughout its useful life except for those that allow access toClass 3b or Class 4 laser radiation during servicing;

b. Certified Class 3b visible (0.4 to 07 pn) or near-infrared (0.7 to 1.4 Pm) lasers or lasersystems that emit in excess of the AEL of Class 3a but which:

1. Cannot emit an average radiant power in excess of 5 W 2 0.25 s; and

ii. Cannot produce a radiant energy greater than 0.03 J per pulse.

c. Mobile lasers that are certified Class 1, Class 2, Class 2a, and Class 3a.; and

d.. Lasers that are in transit or in storage incident to transit or sale provided such lasers areinoperable or not operated.

SeP. A-A 4 PrnlhiihitpA Hges

a. An individual shall not be permitted to look directly into a laser beam or at specularreflections of a laser beam, or align a laser by eye while looking along the axis of a beamwhen the intensity of the beams or reflections exceed the MPE limits..

b. A registrant shall not permit any individual to enter a laser-controlled area if the skin-exposure would be in -excess of the MPE limits, unless the registrant provides and requiresthe use of protective clothing, gloves, and shields.

c. Laser:products emitting spatially scanned laser radiation shall not, as a result of scan failureor any other failure, causing a change in angular velocity or amplitude, permit human accesst6 laser radiation in excess of the accessible emission limits applicable to the class of theproduct.

d. The Agency may prohibit the use of lasers and IPL devices that pose significant threat orendanger occupational or public health and safety.

e. - Individuals shall not be intentionally exposed to laser and IPL radiation above the maximumpermissible exposure (MPE) unless such explusre has been, authorized by a licensedpractitioner of the healing arts. This provision specifically prohibits intentional expousre forthe following purposes:

i. Exposure of an individual for training, demonstration, or other non-healing artspurposes;."

ii. Exposure of an individual for the purpose of healing arts screening, except asspecifically authorized by the Agency, and

iii. Exposure of an individual for the purpose of research, except as authorized inresearch studies. Any research using radiation-producing devices on humans must be

AA7

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SSRCR Volume 11 June 2004 DRAY

approved by an institutional review board (IRB) as required by Title 45, Code ofFederal Regulations (CFR), Part 46 and Title 21, CFR, Part 56. The IRB mustinclude at least one practitioner of the healing arts to direct use of laser and IPLdevice radiation in accordance with AA.lc.

Sere AA S - G~enera1 Registration Reqiiirementg

a. All facilities using fixed or mobile lasers, and persons servicing lasers or laser systems,except as exempted in Section AA.3, shall register with the Agency.

b. Application for registration shall be made on forms furnished by the Agency or in a mannerotherwise approved by the Agency. The application shall contain all applicable informationincluded in Agency form AA. The Agency may, at any time after filing of the originalapplication and before issuance of the certificate of laser registration, require furtherstatements in order to enable the Agency to determine whether the application should begranted or denied. The applicant or registrant shall furnish the Agency with such otherinformation as the Agency may reasonably request.

d. Information designated as proprietary by the applicant or registrant shall be treated asprovided by law.

e. A laser safety officer (LSO) shall be designated on each application form. The qualificationsof that individual shall be submitted to the agency with the application. The LSO shall meetthe applicable requirements of Section AA.14 and carry out the responsibilities of SectionAA.15.

See AA-6 - Applica-tion fnirRegigtrtinn of 4egling Arts TjqgerFacilitieg and VeterinaryT -- erFarcilitiag-

a. In addition to the requirements of AA.5, each healing arts laser facility or veterinary laserfacility shall submit an application to the Agency[within 30 days after beginning operation ofthe laser].

b. An application for healing arts facilities shall be signed by a licensed practitioner of thehealing arts. An application for veterinary medicine shall be signed by a licensedveterinarian. The signature of the administrator, president, or chief executive officer will beaccepted in lieu of a licensed practitioner's signature if the facility is a licensed hospital or amedical facility. A signature by the administrator, president, or chief executive officer doesnot relieve the practitioner user or veterinarian user from complying with the requirements ofthis section.

c. If a facility is furnished a laser by a provider of lasers, that facilityis responsible for ensuringthat a licensed practitioner of the healing arts authorizes intentional exposure of laserradiation to humans.

Sec AA 7 - Applicatinn for Tndu'qtria1 Academic, and Researrh and Tevelopment T sser FacilitiesIn addition to the requirements of AA.5, each applicant for use of lasers in industrial, academic, andresearch and development facilities shall submit an application to the Agency[within 30 days after

AA8

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DRAFT SSRCJ? Volume HI June 2004

beginning operation of the laser].

Se- AA R - Arplicitinn fhr 1L eMnnnftrtinn fhr the Purpose nf Rsaleq nfoT aser

a. Each applicant shall apply for and receive a certificate of laser registration before thedemonstration for purpose of selling laser(s), including demonstration for the selling ofsurplus lasers.

b. In addition to the requirements of Section AA.5, the applicant shall submit a statementconfirming that no demonstration will be performed on humans unless directed by a licensedpractitioner of the healing arts.

Sec A A ( Applinstinn fnr Pmviderm nfT Lqer:

a. Each applicant shall apply for and receive.a certificate of laser registration before providinglasers.

b. In addition to the requirements of AA.5, the applicant shall submit the address of theestablished main location where the laser and records will be maintained for inspection andthe name of the on-site operator. This shall be a physical street address, not a post office boxnumber.

Ree AA -1 Aplinatinn fnr Alignmenti, rslihratinn, anl/nr Repair In addition to therequirements of AA.5, each applicant shall apply for and receive a certificate of laser registration foralignment, calibration, and/or repair before providing alignment, calibration, and/or repair of lasers.

.Se.Ad4 ~1 - Applicatinn fnr l aver T .ight shnw Pach applicant shall apply for and receive acertificate of laser registration for laser light show before beginning any show and shall meet therequirements of Appendix A.

a. In addition to the requirements of Section AA.5, each applicant shall submit the following:

i. A valid variance issued from the FDA for the laser intended to be used, with allapplicable documents required by the variance [to include operating and safetyprocedures];

i. The licensee shall notify the Agency in writing at least seven days in advance of theproposed laser show, and shall include the following information:

(1) The location, time, and date of the light show;

(2) Sketches showing the location of the laser, operators, performers, laser beampath, viewing screens, walls, mirror balls, and other reflective or diffusesurfaces which may be struck by the laser beam (Examples of sketches may befound in the diagram portion of Appendix A);

(3) Scanning beam patterns, scan velocity, and frequency in occupied areas;

AA9

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(4) Physical surveys and calculations made to ensure compliance with Part AA.

iii. Prior to the performance of an outdoor laser light show, the licensee shall notify theFederal Aviation Administration of the proposed show and provide documentation tothe Agency.

[Sec AA 17 - Applicatinn fnr TLaer Mnhile Services ITed in the Healing Artq nn Veterinny ArtqEach applicant shall apply for and-receive a certificate of laser registration for mobile services

before beginning to provide mobile services.

a. In addition to the requirements of AA.5, each applicant shall submit the address of theestablished main location where the laser, records, etc. will be maintained for inspection.This shall be a physical street address, not a post office box number.

b. An application for mobile services for healing arts shall be signed by a licensed practitionerof the healing arts and an application for mobile services for veterinary medicine shall besigned by a licensed veterinarian.]

[Sec A A 1 3 - ReqiiremLentq fnr Tntenge-PulgseA Tight Device (Phntntherrnmoy3iq) Facilitieq

a. Intense-pulsed light devices used for photothermolysis shall be Class 2 or Class 3 surgicaldevices certified as complying with the design, labeling, and manufacturing standards of theUnited States Food and Drug Administration (FDA).

b. An intense-pulsed light device used for medical purposes shall be used as directed by alicensed practitioner of the healing arts.

c. Intense-pulsed light devices used for photothermolysis shall only be sold to licensedpractitioners-of the healing arts.

d. Each registrant shall establish a safety training program that provides a thoroughunderstanding of the medical procedures being performed and shall require each userdemonstrate to the licensed practitioner the competence to use the intense pulsed light devicesafely. Documentation of the training shall be maintained for Agency review and as aminimum address the following:

i. Fundamentals of intense-pulsed light device operation;

ii. Bioeffects of intense-pulsed light device radiation on the skin and eye andcontraindications for its use;

iii. Non-beam hazards of intense-pulsed light device operation;

iv. Responsibilities of management and employee as related to control measures andemergencies; and

v. Regulatory requirements.

AA1O

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e. In addition to the requirements of Section AA.5, each photothermolysis facility shall submitan application to the Agency within 30 days after beginning operation of the laser. Anapplication for healing arts facilities shall be signed by a licensed practitioner of the healingarts.]

see AA 14 - Lacer Safety Officer (Tso) 1iQcatinn The registrant shall designate a lasersafety officer who is responsible for laser radiation protection. LSO qualifications shall be submittedto the Agency and shall include the following:

a. Training and experience as outlined in Appendix B;

b. Experience in the use and familiarity of the type of equipment or services registered for, and

c. Knowledge of potential laser radiation hazards and laser emergency situations.

.ee_ A A 15 - Niies nf T .cer Rafety Offierr Specific duties of the LSO shall include, but not belimited to the following:

a. Establishing and supervising a program of laser radiation safety for effective compliance withthe applicable requirements of these regulations;, to ensure that users of lasers are trained inlaser safety, as applicable for the class and type of lasers used;

b. Providing instructions concerning hazards and safety practices to individuals who may beexposed to laser radiation and to individuals who operate the lasers.

c. Assuming control and having the authority to institute corrective actions including shutdownof operations when necessary in emergency situations or unsafe conditions;

d. Specifying whether any changes in control measures are required following.

i. Any service and maintenance of lasers that may affect the output power or operatingcharacteristics; or

ii. Whenever deliberate modifications are made that could change the laser class andaffect the output power or operating characteristics;

e. Ensuring maintenance and other practices required for safe operation of the laser(s) areperformed; and

f. Ensuring the proper use of protective eyewear and other safety measures.

rec A A. 1- 1gTcrianrnr of Tser Registratinn.

a. Upon determination that an application meets the requirements ofthe regulations, the Agencyshall issue a notice of laser registration authorizing the proposed activity.

b. The Agency may incorporate in the notice of laser registration at the time of issuance, orthereafter by amendment, additional requirements and conditions with respect to the

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registrant's receipt, possession, use, and transfer of lasers subject to this Part as it deemsappropriate or necessary in order to:

i. Minimize danger to occupational and public health and safety,

ii. Require reports and the keeping of records for inspection by the Agency, and

iii. Prevent loss or theft of lasers subject to this section.

Sec AA 17 - Fxpiratinn of Lsser Regidtratinn Except as provided by AA.18b., each notice ofregistration shall expire at the end of the specified day in the month and year stated on the notice.

Sec AA 1R - Renewal nf TiRserRegistration

a. Application for renewal of laser registration shall be filed in accordance with Section AA.5and Sections AA.6 through AA.12, as applicable.

b. If a registrant files an application for a renewal in proper form before the existing-laserregistration expires, the existing laser registration shall not expire until the application statushas been determined by the Agency.

Sec AA 19C - Report of Change The registrant shall notify the Agency in writing within thirty daysof any change that would render the information contained in the application for registration and/orthe notice of laser registration no longer accurate.

Sec AA 20 - Terminatinn of Regintrgtinn When a registrant decides to terminate all activitiesinvolving laser or laser services authorized under the laser registration, the registrant shall:

a. Request termination of the laser registration in writing; and

b. Submit a record of the disposition of the lasers to the agency, if applicable.

Sec A A 21 - Validity of Regigtrftinn Registration accepted by the Agency as properly executedshall remain valid until terminated or until declared invalid by the Agency.

Rec A AA22 - Registration Sh!all Nnt Imply Appmval No person, in any advertisement, shall referto the fact that a facility is, registered with the Agency, and no person shall state or imply that anyactivity so registered has been approved by the Agency.

ISec AA 23 - [Reniprocal] Cit-nf-State T ser R adiatinn Sources

a. i. Whenever any source of laser radiation is to be brought into the State, for anytemporary use, the person proposing to bring the source of laser radiation into theState shall give written notice to the Agency [at least 7working days] before thesource of laser radiation is to be used in the State. The notice shall include:

(1) The type of laser radiation source;

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(2) The nature, duration, and scope of use; and

(3) The exact location(s) where the laser radiation source is to be used.

ii. If, for a specific case, the [7 working-day] period would impose an undue hardship onthe person, upon application to the Agency, permission to proceed sooner may begranted.

b. The person referred to in Paragraph AA.23a. shall:

i; Comply with all applicable regulations of the Agency,

ii. Supply the Agency with such other information as the Agency may reasonablyrequest; and

iii. Not operate within the State on a temporary basis in excess of 180 calendar days peryear.

.Ste A A 74 - Maximum Pcrmnisihle T1pnsiwra (MPP)

a. No individual shall be exposed to levels of laser or collateral radiation higher than are in themost recent edition of American National Standard for Safe Use of Lasers, ANSI Z136.1 orTitle 21, CFR, Part 1040 respectively. It is good practice to maintain exposure levels as farbelow the MPE values as is practicable.

b. In those cases where no MPE is shown for particular wavelengths and pulse durations, allexposure shall be prohibited.

AProtective measures used to avoid laser orcollateral radiation shall be implemented by a laser safety officer (LSO), or an individual designatedby management.

Set- AA -6 - Genersd Requirementq for the Safe Opentinn nf All lFailitieq

a. ApipAbility- These requirements are for laser products in their intended mode of operationand include special requirements for service, testing, maintenance, and modification. Duringmanufacture and research and development activities, some engineering controls may beinappropriate; the LSO shall specify alternate requirements to obtain equivalent laser safetyprotection.

b. Fnginering r-nntrolk

i. -PrtenfiveeHnwusing- Each laser product shall have a protective housing whichprevents human access during operation to laser and collateral radiation that exceedsthe limits of Class 1 in the most recent edition of American National Standard forSafe Use of Lasers, ANSI ZI36.1 and Title 21, CFR, Part 1040 respectively. whereverand whenever such human access is not necessary in order for the product to performits intended function. Wherever and whenever human access to laser radiation levels

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that exceed the limits of Class 1 in the most recent edition of American NationalStandard for Safe Use of Lasers, ANSI Z136.1 and Title 21, CFR, Part 1040 isnecessary, these levels shall not exceed the limits of the lowest laser class necessaryto perform the intended function(s).

i. SSfety Interlocks-

(1) A safety interlock, which shall ensure that radiation is not accessible aboveMPE limits, shall be provided for any portion of the protective housing which,by design, can be removed or displaced without the use of tools during normaloperation or maintenance, and thereby allows access to radiation above MPElimits.

(2) Adjustment during operation, service, testing, or maintenance of a lasercontaining interlocks shall not cause the interlocks to become inoperative orthe laser radiation to exceed MPE limits outside protective housing exceptwhere a laser controlled area as specified in Subparagraph AA.26b.v. isestablished.

(3) For pulsed lasers, interlocks shall be designed so as to prevent firing of thelaser, e.g., by dumping the stored energy into a dummy load.

(4) For Class 3b and Class4 CW lasers, the interlocks shall turn off the powersupply or interrupt the beam, e.g., by means of shutters.

(5) An interlock shall not allow automatic accessibility of laser radiation emissionabove MPE limits when the interlock is closed.

(6) If failure of a single interlock would allow:

(a) human access to levels of laser radiation in excess of the radiant poweraccessible emission limit of Class 3a laser radiation, or

(b) laser radiation in excess of the accessible emission limits of Class 2 tobe emitted directly through the opening created by removal ordisplacement of that portion of the protective housing; then, eithermultiple safety interlocks or a means to preclude removal ordisplacement of the interlocked portion of the protective housing uponsuch failure shall be provided.

iii. Viewing Optics and Win ows

(1) All viewing ports, viewing optics or display screens included as an integralpart of an enclosed laser or laser system shall incorporate suitable means toattenuate the laser and collateral radiation transmitted through the port to lessthan the MPE in the most recent edition of American National Standard forSafe Use of Lasers, ANSI Z136.1 and collateral radiation limits in Title 21,CFR, Part 1040,under any conditions of operation of the laser.

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(2) Since optical systems such as lenses, telescopes, and microscopes mayincrease the hazard to the eye or the skin, the laser safety officer shalldetermine the potential hazard and specify administrative procedures and theuse of controls such as interlocks or filters.

iv. Waining To3stems. Each Class 2, or 3a, laser product shall incorporate an emissionindicator that provides a visible or audible indication during emission of accessiblelaser radiation in excess of the limits for Class 1. Each laser system classified as aClass 3b or Class 4 laser product shall incorporate an emission indicator whichprovide a visible or audible signal during emission of accessible laser radiation inexcess of the accessible emission limits of class 1, and sufficiently prior to emissionof such radiation to allow appropriate action to avoid exposure to the laser radiation.

V. .T ner 'nMrnlkEi Ares With a Class 3b, except those that allow access only to lessthan 5 mW visible peak power, or Class 4 laser, a laser controlled area shall beestablished when exposure to the laser radiation in excess of the MPE in the mostrecent edition American National Standard for Safe Use of Lasers, ANSI Z136.1 andcollateral radiation limits in Title 21, CFR, Part 1040is possible. The controlled area

- shall meet the requirements of Subdivisions AA.26b.v.(l) through (3) for Class 3blasers and the requirements of Subdivisions AA.26b.v.(1) through (7) for Class 4lasers:

(1) The area shall be the responsibility of the laser safety officer.

(2) The area shall be posted as required by Section AA.29.

(3) Access to the laser controlled area shall be only by permission of the lasersafety officer or a trained designated representative.

(4) For Class 4 indoor controlled areas, latches, interlocks, or other appropriatemeans, as defined in written policy and procedure of the registrant, shall beused to prevent unexpected entry into laser controlled areas. Such measuresshall be designedto allow both rapid egress by the laser personnel at all timesand admittance to the'laser controlled area in an emergency condition. Forsuch emergency conditions, a control-disconnect switch or equivalent device(panic button) shall be available for deactivating the laser.

(5) For Class 4 indoor controlled areas, during tests requiring continuousoperation, the individual in charge of the controlled area shall be permitted tomomentarily override the safety interlocks to allow access to other authorizedpersonnel if it is clearly evident that there is no optical laser radiation hazardat-ohe point of entry and if the necessary protective devices are being worn bythe entering personnel.

(6) For Class 4 indoor controlled areas, optical paths (e.g., windows) from anindoor facility shall be controlled in- such a manner as to reduce thetransmitted values of the laser radiation to levels at or below appropriate

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ocular MPE limits in the most recent edition American National Standard forSafe Use of Lasers, ANSI Z136.l and collateral radiation limits in Title 21,CFR, Part 1040 When the laser beam must exit the indoor controlled area (asin the case of exterior atmospheric beam paths), the operator shall beresponsible for ensuring that the beam path is limited to controlled air space!'or controlled ground space when the beam irradiance or radiant exposure isabove the appropriate MPE and collateral radiation limits.

(7) In the case of the removal of panels or protective covers and/or overriding ofinterlocks becomes necessary, such as for service, testing, or maintenance, andaccessible laser radiation exceeds MPE limits in the most recent editionAmerican National Standard for Safe Use of Lasers, ANSI Z136.1 andcollateral radiation limits in Title 21, CFR, Part 1040, a temporary lasercontrolled area shall be established. The laser safety officer or a designatedrepresentative shall ensure that the necessary laser safety requirements for allpotentially exposed individuals shall be established.

C. Adminigtrmtive and Proc-erira1 Cnntmis;

i General Unless otherwise specified, administrative and procedural controls shallapply only to Class 3b and Class 4 lasers.

ii. Output mision T imitautions The minimum laser radiant energy or laser power levelrequired for the application shall be used.

iii. Eduication and Training The degree and level of education and training on lasersafety concepts and procedures shall be in accordance with Appendix C, Table 1 ofthese regulations.

iv. Opermtion and Maintenance Class 3b and Class 4 lasers shall be operated andmaintained only by qualified personnel.

v. Alignment Prnnediiren- Alignment of laser optical systems (e.g., mirrors, lenses, andbeam deflectors) shall be performed it such manner that assures that no one isexposed to laser radiation above MPE limits in the most recent edition AmericanNational Standard for Safe Use of Lasers, ANSI Z136.1, Appendix A. and collateralradiation limits in Title 21, CFR, PartlO40.

vi. yee Protection- Protective eyewear, as specified by the laser safety officer, shall beworn by all individuals with access to Class 4 levels of laser radiation. Protectiveeyewear, when specified by the laser safety officer, shall be worn by all individualswith access to Class 3b levels of laser radiation.

vii. 5.ervice Pmrcetdireq All service procedures shall be performed by qualified personnelwho, when appropriate, are trained in laser radiation protection. The servicepersonnel shall comply with applicable information supplied by the manufacturers

!/Contact FAA or other appropriate agencies, as necessany.AA16

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and instructions provided by the laser safety officer.

Sec- AA -7 - Atditinnal Requirementg for Spedsil T aqers snd Applinstinn&

a. 'bfaref T ser -Crpster than 71 0 Nannmetersq The beam from a Class 3b and Class 4 lasershall be terminated -in fire-resistant material where necessary. Periodic inspection ofabsorbent material shall be made since many materials degrade with use.

b. T Adszr ofinal Fiher Tranmiqmiinn Systetm:

i. Laser transmission systems which employ optical cables shall be considered enclosedsystems with the optical cable forming part of the protective housing.

;ii; Disconnection of a connector resulting in access to laser radiation in excess of theapplicable WPE limits in the most recent edition American National Standard forSafe Use of Lasers ANSI Z136.l, shall take place in a controlled'area. The use of atool shall be required for the disconnection of a connector for service andmaintenance purposes when the connector is not within a secured enclosure. Allconnectors shall bear the appropriate label or tag as specified in SubdivisionAA.29c.ix.

See AA OR - Aditinnal Requirementg fhr Safe Qpertinn

a. E.= Pranectinn.

i. Protective eyewear devices shall meet the following requirements:

(1) Provide a comfortable and appropriate fit all around the area of the eye.

(2) Be in proper condition to ensure the optical filter(s) and holder provide therequired optical density or greater at'the desired wavelengths, and retain allprotective properties during its use.

(3) The required optiq*l density shall be determined based on the type of potentialexposure requiring protection.

(4) Have the optical density or densities and associated wavelength(s)permanently labeled on the filters or otherwise permanently identified.

'i. At intervals not to exceed 6 months,:each registrant shall examine protective eyeweardevices to ensure the reliability of the protective filters and integrity of the protectivefilter frames. Eyewear with the integritycompromised or that is not serviceable asintended should be discarded..

b. Skin Prntectinn When there is a possibility of exposure to laser radiation that exceeds theMPE limits for skin as specified in the most recent edition American National Standard for

! Many metal surfaces which appear "dull' visually can act as specular reflectors of infrared radiation.AA17

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Safe Use of Lasers, ANSI Z136.1, the registrant shall require the appropriate use ofprotective gloves, clothing, and shields.

c. Other Perqena1 PRmtective Equipment Respirators and other personal protective equipmentshall be required, as a temporary control measure, whenever engineering controls cannotprovide protection from toxic air contaminants and other hazards.

d. Service and Maintenanime of T sserm Following any service or maintenance of lasers that mayaffect the output power or operating characteristics, the laser safety officer shall specifywhether any changes in control measures are required.

e. Madificration nf T -cer Whenever deliberate modifications are made which could change thelaser class and affect the output power or operating characteristics, the laser safety officershall specify whether any changes in control measures are required.

Sec AA ')( - ratiition 'Signa T she1l Annd Posting

a. (General

i. Except as otherwise authorized by the Agency, signs, symbols, and labels prescribedby this Section shall use the design and colors specified in Figures 1 and 2.

ii. In addition to the signs, symbols, and labels prescribed in this Section, a registrantmay provide near such signs, symbols, and labels any additional information whichmay be appropriate in aiding individuals to minimize exposure to laser or collateralradiation within a facility.

b. Instirntinnsg

i. Operating personnel of each laser shall be provided with adequate written instructionsfor safe use, including clear warnings and precautions to avoid possible exposure tolaser and collateral radiation in excess of the MPE limits in the most recent editionAmerican National Standard for Safe Use of Lasers, ANSI Z136.1, or collateralradiation limits in Title 21, CFR, Partl040.

-iH. Service personnel shall be provided with:

(1) Adequate training and instructions for service adjustments and procedures foreach laser or facility, including clear warnings or precautions to be taken toavoid possible exposure to laser or collateral radiation.

(2) Service instructions which shall contain a listing of controls and proceduresthat can increase accessible emission levels of laser or collateral radiation, anda clear description of the location of displaceable portions of the protectivehousing or enclosure that could allow access by personnel to laser andcollateral radiation in excess of the MPE limits in the most recent edition

1/ This need is particularly important in the ultraviolet region.AA18

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American National Standard for Safe Use of Lasers, ANSI Z136.1, orcollateral radiation limits in Title 21, CFR, Partl040.

c. T Rhe-ing an Pnoting vLabeling laser products and posting laser facilities.

i. -The controlled area shall be conspicuously posted with an appropriate sign or signs asspecified in Figures 1 and 2.

ii. Class 1 facilities need not be posted. Uncertified Class 1 lasers shall have a labelincluding the following wording: "CLASS 1 LASER";

iii. Class 2 laser facilities need not be posted. Class 2 lasers which do not exceedaccessible emission limits of Class I for any emission duration less than or equal to 1x 103 seconds shall have a label with the following wording: "Class 2 Laser (or LaserProduct) - Avoid Long Term Viewing of Direct Laser Radiation";

iv. Class 2 laser facilities need not be posted. Class 2 lasers other than those specified inSubdivision AA.29c.iii. shall have a label with the warning logotype A specified inFigure 1 and including the following wording:

(Position 1 on the logotype).

"LASER RADIATION - DO NOT STARE INTO BEAM"

(Position 3 on the logotype)

"CLASS 2 LASER (OR LASER PRODUCT)"

v. (1) Each laser or facility classified in Class 3a solely because of the emission ofaccessible laser radiation in the wavelength range of greater than 400 but lessthan or equal to 710 nanometers, with an irradiance of less than or equal to 2.5x 10 watts per square centimeter, and. with a radiant power less than or equalto 5.0 x 10 watts, shall have a labeland be posted with sign(s) with thewarning specified in Figure 1 and including the following wording:

(Position 1 on the logotype)

"LASER RADIATION - DO NOT STARE INTO BEAM OR VIEW DIRECTLYWiTH OPTICAL INSTRUMENTS"

(Position 3 on the logotype)

"CLASS 3a LASER (OR LASER PRODUCT)"

t With respect to laser products only, the labeling requirementsfound in 21 CFR Part 1040 may be used in lieu ofParagraph AA.29c.

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(2) Class 3b lasers or facilities other than those specified in SubdivisionAA.29c.v.(1) shall have a label and be posted with sign(s) with the warningspecified in Figure 2 and including the following wording:

(Position I on the logotype)

"LASER RADIATION - AVOID DIRECT EXPOSURE TO BEAM"

(Position 3 on the logotype)

"CLASS 3b LASER (OR LASER PRODUCT)"

vi. Class 4 lasers and facilities shall have affixed a label and be posted with sign(s) withthe warning specified in Figure 2 and including the following wording:

(Position 1 on the logotype)

"LASER RADIATION - AVOID EYE OR SKIN EXPOSURE TO DIRECTOR SCATTERED RADIATION"

(Position 3 on the logotype)

"CLASS 4 LASER (OR LASER PRODUCT)"

vii. Class 2, 3, or 4 lasers, except lasers used in the practice of medicine, shall have alabel(s) in close proximity to each aperture through which is emitted accessible laseror collateral radiation in excess of the limits specified in the most recent edition ofAmerican National Standard for Safe Use of Lasers, ANSI Z136.1 and the collateralradiation limits in Title 21, CFR, Part 1040 with the following wording as applicable:

(1) "AVOID EXPOSURE - Laser radiation is emitted from this aperture," if theradiation emitted through such aperture is laser radiation.

(2) "AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted fromthis aperture," if the radiation emitted through such aperture is collateralradiation.

(3) "AVOID EXPOSURE - Hazardous are emitted from this aperture," if theradiation emitted through such aperture is collateral x-ray radiation.

viii. Each Class 2, 3, and 4 laser shall state, at position 2 on the required warning logotype,the maximum output of laser radiation, the pulse duration when appropriate, and thelaser medium or emitted wavelength(s).

ix. Each noninterlocked or defeatably interlocked portion of the protective housing orenclosure which is designed to be displaced or removed during normal operation,maintenance, or servicing, and which thereby would permit human access to laser orcollateral radiation, shall have labels as follows:

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(1) For laser radiation in excess of the accessible emission limits of Class 1 butnot in excess of the accessible emission limits of Class 2, the wording:"CAUTION - Laser radiation when open. DO NOT STARE INTO BEAM."

(2) For laser radiation in excess of the accessible emission limits of Class I orClass 2 as applicable,. but not in excess of the accessible emission limits ofClass 3, the wording: "DANGER - Laser radiation when open, AVOIDDIRECT EXPOSURE TO BEAM."

(3) For laser radiation in excess of the accessible emission limits of Class 3, thewording: "DANGER - Laser radiation when open. AVOID EYE OR SKINEXPOSURE TO DIRECT OR SCATTERED RADIATION."

(4) For collateral radiation in excess of the emission limits of Title 21, CFR, Part1040.

(a) If the limits in Title 21, CFR, Part 1040 are exceeded, the wording:"CAUTION - Hazardous Electromagnetic Radiation when open"; and

(b) If the limits in Title 21, CFR, Part 1040 are exceeded, the wording:"CAUTION - Hazardous X-Ray."

(5) For protective housing or enclosures which provide a defeatable interlock, thewords "and interlock defeated" shall be included in the labels specified inSubdivisions AA.29c.ix.(l), (2), (3), and (4).

x. (1) The word "Invisible" shall immediately precede the word "radiation" on labelsand signs required by AA.29c. for wavelengths of laser and collateral radiationthat are outside of the range of 400 to 710 nanometers.

(2) The words "Visible and Invisible" shall immediately precede the word"radiation" on labels and signs required by AA.29c. for wavelengths of laserand collateral radiation that are both within and outside the range of 400 to710 nanometers.

xi. All labels placed on lasers or signs posted to laser facilities shall be positioned so asto make unnecessary, during reading, human exposure to laser or collateral radiationin excess of the MPE limits in the most recent edition of American National Standardfor Safe Use of Lasers, ANSI Z136.1 and the collateral radiation limits in Title 21,CFR, Part 1040.

xii. Labels and signs required by AA.29c. shall be clearly visible, legible, andpermanently attached to the laser or facility.

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I

-S

I( BLACK ) (YELLOW) (YELLOWI

E2O 6

0 so

( POSITION 1 )BOLD BLACK LETTERING /

I POSITION 2 |BOLD BLACK LETTERING /

( POSITION 3\BLACK LETTERING )

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WARNNG LOGOTYE B

_ A..

Figure 2See A A AQt - Rlqrvey=. Each registrant shall make or cause to be made such radiation protectionsurveys as may be necessary to comply with this Section. At intervals not to exceed 6 months,

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surveys shall be performed which include but are not limited to:

a. A determination that all laser protective devices are labeled correctly and functioning withinthe design specifications and are properly chosen for lasers in use.

b. A determination that all warning devices are functioning within their design specifications.

c. A determination that the laser controlled area is properly controlled and posted with accuratewarning signs in accordance with AA.29.

d. A re-evaluation of potential hazards from surfaces which may be associated with Class 3 andClass 4 beam paths.

e. Additional surveys required to evaluate the laser and collateral radiation hazard incident tothe use of lasers.

[Ser A A-1 - Mensurement and Tnstr11mentation Each determination requiring a measurement forcompliance with these regulations shall use instrumentation which is calibrated and designed for usewith the laser that is to be tested. The date of calibration, accuracy of calibration, wavelength range,and power/energy of calibration shall be specified on a legible, clearly visible label attached to theinstrument.

a. Measurement of accessible emission(s) for classification shall be made:

i. Under those operational conditions and procedures which maximize the accessibleemission levels including startup, stabilized operation, and shutdown of the laser orfacility,

ii. With all controls and adjustments listed in the operating and service instructionsadjusted for the appropriate maximum accessible emission level of laser radiationwhich is not expected to be detrimental to the functional integrity of the laser orenclosure,

iii. At points in space to which human access is possible for a given laser configuration,e.g., if operation may include removal of portions of the protective housing orenclosure and defeat of safety interlocks, measurements shall be made at pointsaccessible in that laser configuration,

iv. With the measuring instrument detector so positioned and so oriented with respect tothe laser as to result in the maximum detection of radiation by the instrument, and

v. For a laser other than a laser system, with the laser coupled to that type of laser energysource specified as compatible by the laser fabricator, and that produces the maximumemission of accessible laser radiation from that laser.

b. Compliance with the requirements of the regulations shall be determined by measurements ortheir equivalent that account for all errors and statistical uncertainties in the measurementprocess.

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c. Accessible emission levels for classification of laser and collateral radiation shall be basedupon the following measurements:

i. The radiant power (W) or radiant energy (J) detectable through a circular aperturestop having a diameter of 7 millimeters, except for scanned laser radiation, and withina circular solid angle of acceptance of 1 x 10- steradian with collimating optics of 5diopters or less.

-2 2ii. The irradiance (W cm ) or radiant exposure (J cm ) equivalent to the radiant power

(W) or radiant energy (J) detectable through a circular aperture stop having a diameterof 7 millimeters and, for irradiance, within a circular solid angle of acceptance of 1 x10'3 steradian with collimating optics of 5 diopters or less, divided by the area of theaperture stop (cm2).

iii. The radiance (W cm2 sf ) or integrated radiance ( cmr sf ) equivalent to the radiantpower (W) or radiant energy (J) detectable through a circular aperture stop having adiameter of 7 millimeters and within a circular solid angle of acceptance of 1 x 10-5steradian with collimating optics of 5 diopters or less, divided by that solid angle (sr)and by the area of the aperture stop (cm2).

iv. Accessible emission levels of scanned laser radiation shall be based upon themeasurement of radiation detectable through a stationary circular aperture stop havinga 7-millimeter diameter and within the circular solid angle of acceptance withcollimating optics applicable under AA.31c.i., ii., and iii. The direction of the solidangle of acceptance shall change as needed to maximize detectable radiation, with anangular speed of up to 5 radians per second.

d. Measurements for maximum permissible exposure shall be measured as specified in the mostrecent edition American National Standard for Safe Use of Lasers, ANSI Z136.1.].

qrc A A -3 - Meiirl Sinrve1Rlance' The Agency may require the registrant to provide such medicalexamination procedures as it considers necessary to protect the health and safety of personnel.Appendix A provides recommended procedures that apply primarily to users of Class 4 lasers.

e -A A a - Nntifiestion of Tncidents-

a. Tmmediate Nntifieation Each registrant shall notify the Agency immediately by telephone,fax or email of any incident involving any source of laser or collateral radiation possessed bythe registrant and that has or may have caused:

i. An exposure to an individual of greater than 100 times the MPE limits in the mostrecent edition American National Standard for Safe Use of Lasers, ANSI Z136.1, orcollateral radiation limits in Title 21, CFR, PartlO40.; or

ii. An exposure to an individual that involves the partial or total loss of sight in eithereye; or

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iii. An exposure to an individual that involves perforation of the skin or other seriousinjury exclusive of eye injury, or

iv. A loss of one working week or more of operation of any facility affected.

b. Twenty-foulr THour Notification Each registrant shall notify the Agency by telephone, fax oremail within 24 hours of any incident involving any source of laser or collateral radiationpossessed by the registrant and that has or may have caused:

i. An exposure to an individual of greater than 5 times the MPE limits in the mostrecent edition American National Standard for Safe Use of Lasers, ANSI Z136.1, orcollateral radiation limits in Title 21, CFR, Partl 040.; or

ii. An exposure to an individual with second- or third-degree burns to the skin orpotential injury and partial loss of sight.

Sfaec A A 34 - Reports of Overexpo~sres antrd Rxe5ssive T evek-

a. Each registrant shall make a report in writing within 30 days to the Agency of:

i. Each exposure of an individual to laser and collateral radiation in excess of the MPElimits in the most recent edition American National Standard for Safe Use of Lasers,ANSI Z136.1, or collateral radiation limits in Title 21, CFR, PartlO40.,

ii. any incident for which notification is required by AA.33.

b. Each report shall describe the extent of exposure of individuals to laser and/or collateralradiation, including estimates of each individual's exposure; levels of laser and/or collateralradiation involved; the cause of the exposure; and corrective steps taken or planned to betaken to assure against a recurrence.

c. Any report filed with the Agency pursuant to AA.34 shall include the full name of eachindividual exposed, an estimate of each individual's exposure, and a description of anyinjuries. The report shall be prepared so that this information is stated in a separate part ofthe report.

Sec AA -3 - Notificftionn snd Rertq to Individi1aig. When a registrant is required pursuant toAA.34 to report to the Agency any exposure of an individual to laser and/or collateral radiation, theregistrant shall also provide to the individual a report on the exposure data included therein. Suchreports shall be transmitted at a time not later than the date of transmittal to the Agency.

ISec AA 36 - RecordS.

a. Each registrant shall maintain current records, which shall be kept available for inspection bythe Agency, showing:

!/ This paragraph is suggestedfor use by States which have the authority to maintain the names of individuals asconfidential information

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DRAF;T SSRCR Volume II June 2004

i. The results of all surveys required under AA.28aii. and AA.30.

ii. The results of all instrument calibrations under AA.31.

iii. The results of medical surveillance perfouned under AA.32.. .

.

. .

.

iv. The reports of incidents- as descnDed under AA.35. -.

. .

b. I The registrant shall maintain such records required by this Section until the Agenqyauthorizes disposition. . - - :

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SSRCR Volume IlJune 2004 DRAFr

Part AA

APPENTIEX A

RFITIRRMENT9 FOR LASER TIGHT SH4lOWS

Each laser facility and mobile laser shall be registered in accordance with the provisions ofthese regulations.

2. The laser operator shall demonstrate his competency to operate the laser safely.[Demonstration of competency may include, but is not limited to, proof of having taken andpassed an acceptable laser training course such as given at several universities or sponsoredby technical organizations.]

3. Laser radiation outside the spectral range 400 to 710 nanometers shall be as low aspracticable but shall not, in any case, exceed the Class 1 limits under any possible conditionsof operation.

4. Levels of laser and collateral radiation, measured where the audience is normally located, andlaser and collateral radiation measured where the operators, performers, and employees arelocated if the radiation is intended to be viewed by them, shall not exceed the limits of ClassI during operation. Measured radiation shall include reflections from targets and scatteringmaterials. For example:

(a) If the average laser power collectable with appropriate apertures is below 0.39microwatts, then the limits of Class I will not be exceeded.

(b) For pulsed radiation and scanning radiation treated as pulsed radiation, if the energyin a pulse or series of pulses is less than 0.2 microjoule collectable with appropriateapertures, the limits of Class 1 will not be exceeded.

5. Operators, performers, and employees shall be able to perform their functions without theneed for exposure to laser and collateral radiation in excess of the limits of Class 2 when theradiation is not intended to be viewed by them. Areas where levels of laser radiation inexcess of the limits of Class 2 exist shall be clearly identified by posting and/or through useof barriers or guards to prevent entry of operators or performers into these areas.

6. Scanning devices shall incorporate a means to turn off the beam or to prevent laser emissionin case the beam stops scanning or slows down significantly. In cases where a mirror ball isused with a scanning beam, the limits of item 4 shall be met with the mirror ball stationary,or the mirror ball shall incorporate a means to turn off the beam or to prevent laser emissionif the mirror ball stops rotating or slows down significantly such that the limits of item 4 or 5are exceeded. Arly such scan failure safe-guard system must have a reaction time fast enoughto preclude audience access to levels in excess of Class 1.

7. Except as noted below, laser light shows shall be under the direct and personal supervision ofa competent laser operator, as specified in item 2, and the laser beam to which human access

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can be gained shall not exceed the limits of Class 2 at any point less than (a) 3.0 meters aboveany surface upon which the audience or general public is permitted to stand, and (b) 2.5meters in lateral separation from any position where a person in the audience or generalpublic is permitted during the performance or display, unless physical barriers are presentwhich obstruct access by the audience or general public to such levels.

Exception: In cases where the maximum laser output power level is less than 5 milliwattsincluding all wavelengths and the laser beam path is located at least 6 meters above anysurface upon which a person in the audience or general public is permitted to stand and at anypoint less than 2.5 meters in lateral separation from any position where a person in theaudience or general public is permitted during the performance or display, then a laseroperator need not be continuously present if other provisions of these Guidelines andRegulations are met. In other cases, upon application to the Agency, appropriatearrangements may be made for unattended operation.

8. All laser light shows shall be provided with a key operated "on-off" switch. In the case of theexception of item 7, there shall be a designated individual present who can turn off andsecure the laser in case of unsafe operating conditions.

9. The maximum laser output power shall be limited to a level required to obtain the intendedeffect.

10. The laser system, including projector, shall be rigidly mounted to prevent unintendedmovement or accidental misalignment.

11. The laser operator(s) shall be situated in a position such that performers, audience, beampath(s), and laser display can be viewed at all times during laser operation.

12. Where laser output power must be limited to less than the maximum power available in ordert6 comply with criteria 3 through 9, the laser output power shall be measured, adjusted, andrecorded before it is operated at each light show. All safety devices necessary to meet criteria3 through 9, such as scanning-beam power interlock, shall be functionally tested and recordedbefore each light show.

13. The laser system shall be secured against unauthorized operation._ 4..,,, ,

14. The following precautions shall be taken during alignment procedures.

(a) Alignment shall be performed by a competent and qualified individual and with thelaser radiation emission reduced to lowest practicable level.

(b) Only persons required to perform alignment shall be in or near the beam path(s).

(c) Protective eyewear shall be worn where necessary to prevent hazardous exposure.

15. In addition to the requirements of AA. 1, before the laser light show is permitted to operateeither at a permanent or temporary job site, the laser light show operator or an authorizedrepresentative shall provide the Agency with sufficient information, data, and measurements

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to establish that the above criteria will be met during use. [This shall include sketchesshowing the location of laser, operator(s), performer(s), viewers, beam paths, viewingscreens, walls, mirror balls, and other reflective or diffuse surfaces which may be struck bylaser beam, scanning beam patterns, scanning velocity and frequency in occupied areas andwhere beam strikes wall or other structure, radiometric measurement data including outputpower and location of all measurements. In the case of open air shows where a laser beam isprojected into the sky, the information submitted shall also include beam spot size, beamdivergence, and beam power measured at the projector, and a copy of the notificationprovided to the Federal Aviation Administration.]

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DRAFT SSRCR Volume H June 2004

- LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROL

MIoor Areal

I

NO OPERATOR IN CONTROL(Side View)

_ A..

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LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROL(Rising Floor Level)

OPERATOR IN CONTROL(Side View)

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DRAFI SSRCR Volume IIJune 2004

LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROLPHYSICAL OBSTRUCTION

(Top View)

OPERATOR IN CONTROLPHYSICAL OBSTRUCTION

(Side View)

Audhenceamsa I

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SSRCR Volume IH June 2004 DRAF'f

LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROLINCLINED LASER RADIATION FIELD

(Side View)

AuieneClass I

OPERATOR IN CONTROLINCLINED LASER RADIATION FIELD

(Top View)

Lasw

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Agency Form AA

[APPT.T(ATION FOR RPOTSTRATTON OF LASER FACIUTYMORnT.E TLASFR, OR SFRVICF ORG.ANIZATION

Registration is required for all uncertified laser products and for certified Class 3b (other than thoseexempted by AA.3b.) and Class 4 laser products.

1. Applicant's Name: Telephone No.:

Address:

2. Location of use (if different from Number 1):

3. Type of registration: Laser Facility ( ), Mobile Laser ( ), Service Organization ().

4. Prior Laser Registration Number, if any:

5. Sources of laser radiation (Class 3b and Class 4 only):a b c

Number of Sourcesof Laser Radiation Range of Average

Wavelength Range In Facility Mobile Power or Energy

UV (< 0.4 pm)Visible (0.4 - 0.71 lpm)Near IR (> 0.71 - 1.4 pm)Far TR (? 1.4 Mim)

Name of Laser Safety Officer:

Qualifications of Laser Safety Officer (use additional sheet if required):

6.

7.

8. Authorized Agent of Applicant:-(PrintName) (Title)

9. Signatures:Laser Safety Officer Application Date

Authorized Agent

See associated instruction sheet before completing this application.]

[Instruction Sheet for Registration of Sources of Laser Radiation

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(For exemptions to registration requirement see AA.3.)

PLEASE PRINT OR TYPE ALL INFORMATION

1. Applicant - The name, address, and telephone number of the person or facility in whose namethe registration is to be made.

2. Location of Use - Addressor location where laser sources are operated, serviced, ormanufactured. If lasers are serviced exclusively on customers' premises, so state.

3. Self-explanatory.

4. Self-explanatory.

S. Sources of Laser Radiation - Include data only for uncertified Class 3b and Class 4 lasersources, for certified Class 3b laser sources not exempted by AA.3b, and for certified Class 4laser sources. For each wavelength range, enter in column b the number of laser sources andin column c, the average power or energy of the minimum and maximum output source.

Service organizations should omit column b. In column c enter data describing lasersanticipated to be serviced during twelve-month period beginning with registration date.Laser source manufacturing facilities, enter words "Manufacturing Facility" iih column b; donot enter numbers. In column c enter data describing lasers anticipated to be manufacturedduring twelve-month period beginning with registration date.

6. Name of Laser Safety Officer - Name of person appointed by applicant to serve as LaserSafety Officer in compliance with Section AA.5e.

7. Qualifications of Laser Safety Officer - Briefly describe the Laser Safety Officer's trainingand experience which qualify him/her in the areas listed in Paragraph AA.14.

8. Self-explanatory.

9. Self-explanatory.

Mail [rWO] copies of your application for registration with [IWO] copies of your laser safetyprocedures to: [Name and address of Agency].]

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Part AA

APPTFWT)TX R

TRAll.

Training shall be provided in laser safety and laser health physics to all laser safety officers(LSO's) responsible for Class 3b and Class 4 Lasers. Training of LSO's responsible for Class 1,Class 2, and Class 3a lasers should be provided as needed. The degree and type of training shall beappropriate for the degree of potential laser and associated hazards. The LSO is responsible for -ensuring that users of laser products are trained at a level commensurate with the users duties and thedegree of hazard.

2. T rer Rnfety Twining Topics

Topics for inclusion in a laser safety training program should include all or part of thefollowing, as appropriate, for the class of lasers in use:

a. Description of Lasersi. Definitionsii. Lasing fundamentalsiii. Lasing medium and types of lasers - solid, liquid, and gasiv. Pumping methodsv. Optical cavities -

b. Characteristics of Laser Lighti. Directionality:ii. Single color (monocbromaticity)iii. Coherenceiv. Intensityv. Divergencyvi. Relations of specular and diffuse reflections

c. Biological Effects of Laser Lighti. Damage mechanisms: thermal-and non-thermal effects from pulsed and CW

lasersii. Eye hazardiii. Skin hazardiv. Criteria for setting Maximum Permissible Exposure (MPE) levels for eye and

skin

d. Associated Hazardi. Electrical hazardsii. Explosion hazardsiii. Chemical hazards

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iv. Fire, ionizing radiation, cryogenic hazards, and others, as applicable

e. Laser Safetyi. Laser classificationsii. Control measures including personnel protective equipmentiii. Management and user responsibilitiesiv. Medical surveillance practices (if applicable)v. Governmental regulatory requirements

f. Laser Health Physicsi. Calculation of MPE limits for eye and skin under various conditions of laser

ii.

i1.

useBasic radiometric units, measurement devices and measurement techniquesLaser hazard evaluations and range equations

Table 1Suggest Training for LSO's and Employees

HTIGHFST CLTASS LASFR

Training Vehicles 1 2 3a 3b 4Manufacturer's Guides M M M M M

& Operating Manuals

Safety Guide Literaturel N/R N/R R M M

Review of Applicable Standards N/R N/R R M M(ANSI, Federal, State, etc.)

Laser Safety Orientation N/R N/R R M MCourse2/

NIR - Not Required, R - Recommended, M - Mandatory

1/ Such as: American National Standardfor the Safe Use of Lasers, ANSI Z136. I; La'c'r InytitutP nfAmorirn Lnes.-(i-uimp AmPriaen (nnfPrp np {,f Crvernmpntal Induiirinl M-ygi~niv - 4 Guidefnr Cnntrn/ nf ',.cer rnrdq or

any other similar literature the Agency considers adequate.2/ Because of the greater potential hazardsfrom Class 3b and 4 Lasers, duration of course would be several days. Thistraining may be done by outside specialists if not available internally.

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Part AA

APPENDIXC

MPfTCTAT. ST IRVFTT I .ANCrF

L_ Pnrpne nfMeM imrl sIurveillance The basic reasons for performing medical surveillance ofpersonnel working in a laser environment are the same as for other potential health hazards. Medicalsurveillance examinations may include assessment of physical fitness to safely perform assignedduties, biological monitoring of exposure to a specific agent, and early detection of biologic damageor effect.

Physical fitness assessments are used to determine whether an employee would be at increased orunusual risk in a particular environment. For workers using laser devices, the need for this type ofassessment is most likely to be determined by factors other than laser radiation. Specific informationon medical surveillance requirements that might exist because of other potential exposures such astoxic gases, noise, ionizing radiation, etc., are outside the scope of this Appendix.

Direct biological monitoring of laser radiation is impossible, and practical indirect monitoringthrough the use of personal dosimeters is not available.

Early detection of biologic change or damage presupposes that chronic or subacute effects may resultfrom exposure to a particular agent at levels below that required to produce acute injury. Activeintervention must then be possible to arrest further biological damage or to allow recovery frombiological effects. Although chronic injury from laser radiation in the ultraviolet, near-ultraviolet,blue portion of the visible, and near-red regions appears to be theoretically possible, risks to workersusing laser devices are primarily from accidental acute injuries. Based upon risks involved withcurrent uses of lasef devices, medical surveillance requirements that should be incorporated into aformal standard appear to be minimal.

Other arguments in favor of performing extensive medical surveillance have been based on the fearthat repeated accidents might occur and that workers would not report minimal acute injuries. Thevery small number of laser injuries that have been reported in the past 15 years and the excellentafety records with laser devices does not provide 9upport to this argument.

2 Memiid Exnminstinng

.2-1 Ratinnnle for FxTmintiong-

2?1 . Proncignment Mepli"1 Fxaninaatnr& Except for examination following suspected injury,these are the only examinations required. One purpose is to establish a baseline against whichdamage (primarily ocular) can be measured in event of an accidental injury. A second purpose is toidentify certain workers who might be at special risk from chronic exposure to selected wavelengthlasers. For incidental workers, only visual acuity measurement is required. For laser workers,medical histories, visual acuity measurement and selected examination protocols are required. Thewavelength of laser radiation is the determinant for which specific protocols are required (see

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SSRCR Volume JIJune 2004 DRAFT

Paragraph 2.2). Examinations should be performed by or under the supervision of anophthalmologist or other qualified physician. Certain of the examination protocols maybeperformed by other qualified practitioners or technicians, under the supervision of a physician. Manyophthalmologists may prefer to perform more thorough eye examinations to assess total visualfunction as opposed to limiting examination to those areas that might be damaged by particular laserradiation. Some employers may find it advantageous to offer these more thorough examinations totheir workers as a health benefit. For example, certain of the additional examinations, such asgoniometry, may be of value in detecting unknown disease conditions; in this case glaucoma. Eventhough this type of problem is unrelated to work with lasers, appropriate medical intervention willpromote a healthier work force. Although chronic skin damage from laser radiation has not beenreported, and indeed seems unlikely, this area has not been adequately studied. Limited skinexaminations are suggested to serve as a baseline until future epidemiological study indicateswhether they are needed or not.

vJ1 . Perinic MepArir1 Fyxaminnatnnq Periodic examinations are not required. At the present timeno chronic health problems have been linked to work with laser radiation. Also, most uses of lasersdo not result in chronic exposure of employees even to low levels of radiation. A large number ofthese examinations have been performed in the past and no indication ofany detectable biologicchange was noted. Employers may wish to offer their employees periodic eye examinations or othermedical examinations as a health benefit; however, there does not appear to be any valid reason torequire such examinations as part of a medical surveillance program.

21.3 Terminrahtin Meylii PFxgmintionng The primary purpose of termination examinations is forthe legal protection of the employer against unwarranted claims for damage that might occur after anemployee leaves a particular job. The decision on whether to offer or require such examinations isleft to individual employers.

22 F xnsmination Protonenh

2 2 1 Medical History- The following protocols are required for preplacement examinations of alllaser workers:

• The patient's past eye history and family eye history are reviewed.* Any current complaints which he now has about his eyes are noted.* Any history of skin problems is reviewed.

Current and past medication use is reviewed.The patient's general health status should be inquired about with special emphasis upondiseases which can give ocular or skin problems.Certain medical conditions may cause the laser worker to be at increased risk if chronicexposure to ultraviolet or blue spectrum laser radiation is possible.

* Use of photosensitizing medications, such as phenothiazines and psoralens, lower thethreshold for biologic effects in the cornea, lens, and retina of experimental animals.

* Aphakic individuals would be subject to additional retinal exposure from near-ultravioletradiation.

Unless chronic viewing of lower levels of laser radiation in these wavelengths is required,there should be no reason to deny employment to these individuals. With current lasersystems, chronic exposure even to low levels of blue laser radiation is very unusual.

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222 See ANSI Z136.1, American National Standard for Safe Use of Lasers 6.3 and Appendix Efor additional exam protocols.

3 Medical Referral Fnllnwing Ripsec&M nr Known a Iser Injury Any employee with asuspected eye injury should be referred to an ophthalmologist. Persons with skin injuries should beseen by a physician.

AAS Referenceq

AA.5.IFriedmann, A.1., The Ophthalmic Screening of Laser Workers, Ann ar.Qc Hyg, 21:277-279,1978.

AA.5.2Hathaway, J.A., Stem, N., Soles, E.M., and Leighton, E., Ocular Medical Surveillance onMicrowave and Laser Workers, l 0=1.Med. 19:683-688, 1977.

AA.5.3Hathaway, J.A., The Needs for Medical Surveillance of Laser and Microwave Workers,Current Cnnceptq in Ergophthnlmolngy_ Societas Ergophthalmologica Internationalis,Stockholm, Sweden, 1978, pp. 139-160.

AA.5.4Wolbarscht, M.L., and Landers, M.B., Testing visual capabilities for medical surveillance orto ensure job fitness. J Main Me4 27:897-901, 1985.

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DRAiT SSRCR Volume 11 Juun-Ju9y wDJC 2004

PART AA

See- AAA1-P1T~ n Scnpe-

a. This Part establishes requirements for the registration of persons who receive posesafcqire transfer or use Bass 3b and Class 4 lasers in the healing arts veterinary medicineindustry academic research and development institutions ind of perMonS who are in thebusiness of providing Iaer aervices No person shall use lasers or perform laser sexcept as authorized in a certificate of laser regstration issled by the agency in accordancewith the reqiuiremnents of this Part

b This Part establishes requirements for protection agiinst laser radiation hazards laser haardcontrol methods training requirements and notification of injuries This Part includesrPisiblities of the registrant and the laser safety officer (LTS")

c-Except as otherwise specifically exempted, these regulations apply to all persons who receive,possess, acquire, transfer, own, or use lasers whihlbateemit or may emit laser radiation.[Individuak shall not rise lasers on humans tmnless under the supervision of a licensedpractitioner of the healing arts if use of lasers is withinl the scope of practice of their lIcense]Nothing in these regulations shall be interpreted as limiting the intentional exposure ofpatients to laser radiation for the purpose of diagnosis therapy or treatment by a licensedpractitione of tehealing arts within the scope of practice of their professional 1i-ense[Thesde regulations do not apply to the manufacture of lasers] tcatienul to use conniensmate

b-d. i-. Laser products certified by a manufacturer to be compliant with the Federal laserproduct performance standard of Title I1. Code of Federal Regulations (91 CFR 1040)

applicable at the date of =manufacture shall be maintained in compliance with suchrequirements. Certified laser products thatwhich have been modified shall comply with theseregulations or the Federal standard.

v ;;.- Uncertified lasers shall meet the requirements of these regulations.

cf. - If any conflict arises between the requirements of these regulations and the Federal laserproduct performance standard with respect to the same aspect of performance for laserproducts subject to the Federal standard, the requirements of the Federal standard shall apply.

In addition to the reqiirements of this Part all registrants are subject to the applicableVisions of the General Provisions (Part A) Standards for Protection (Part nh) and Notices

Tnstrictions and Reports (Part 1) of these regilations,

Sec AsA- - nefinitionns Asusedintheseregulations:

"Accessible emission level" means the magnitude of emission from laser or collateral radiation of a

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SSRCR V olume IJ.,9 i999204------L - -- =DRAFT

wavelength and emission duration to which human access is possible as measured under theconditions specified in Section AA.32J. of these regulations.

"Accessible emission limiU4EL)" means the maximum accessible emission level permitted within aparticular class in the most recent edition of American National Standard for Safe IIse of Lasers,American National Standardsq Tngtitute (ANS) b1 a s I-, I, Ha, Illa, if ,, and li.

"Acctna-" IiOcanIs Ld e of rcronfint of a nita5i1c to a sltanidad o a true Valuc amid turt t 1hdegri of ripe~atabilty 01 pCI ith Wuki Vl IIiI a Iias.)ulYTiitist pet tied.

'Act" means [cite State Radiation Control Act or appropriate State statute].

"Agency" means [cite appropriate State Agency responsible for administration of the Act].

"Aperture" means aeniing through whieh laser or collal i allowing humansp'res tn tbw~u'h rnrdiatin

a~y upellau s a juttctivc liousig t1 iuhIgh v1iddi Iadiatiou is erizitted, tho eby allow ing Lunain* aucces J1 Ldjatio.

"Aperture stop" means an opening serving to limit the size and to define the shape of the area overwhich radiation is measured.

i "nL tioualue i" awi fli d iase in thi. ladiant fIUt uf awry opticaf biur as it passeb fIluugh at_i/rsc t ir _ _ _di,_ _ .,

"Certified laser product" means that the product is certified by a manufacturer pursuant to thereqirements of litle 21 Code of Federal Reguationng (CFR) Part IQ4021 C , Ia~eL, i eFR ehap J....'

Class I duili li itsL LncauS, fi classifi.atiui puipumses, la1 e1 mid coIlateral adiatioin in tk.w a&ee~iiflz, 1aUg of gx eat11 dii 400 nW.k1UcteLs but less tLi o. equal t14oO ninuill c edshre accessiblen emis;sio m lmitso uf Class I it exceeds I oth.

(1) c eiasb Ci4 [ 4 accssb fucnsi iisi iadiaittieiiry W ithll any Igez OfCniaui~indation specified in , mid

(2) fire ess f accssibCrule Li its h bi if te gLa ated wpcuL.G wit lziniauy mO oLf

-i411wai mu satin specified 11 Tale 1, L-

"ClAg(2 1 laasr Itematinal F1ectrotcphnicasil Clmmiggion (rFO Class I M" means aR lsepr Ar lao-rsysteni intaninig a lasqer that many rdioue visible or invisible lager radiation Under all normalgcnnditg of~f Oneration a Cas 1 laser is cons.idetrw to be incapable of causing injury from directly3iewing the radiation beam: Fnr maximum pe mnkible exposure irmitqs see the most recent edpition nAmerican National Standard for Safe IJqe ofT aers ANST 7136 1

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"Class I lase" nicans any lase. inds w JhiA p its h uma access Ito lasc tadiati css t ianl tle accssibcMllisbiOll uilitS ufTable I fui aiy cosmsbiatiOI of ClllibSukil duration amid wavelengti raigue.

"Csiags 9 laser IEC Class 2M" means alaseer or lser, s'tem that prmduces Plbw-pner vise blerradiation not exceeding I mW Eye protection is nonn ally afforded by the nailral blink reflex time(Q 95 s) Direct viewing of the radiation beam from a Clasq 2 laser is prohihited For maximumpermiksihle exposuire limits. ee the most ree-ent edition of Amerian National Standard for Safe Ieof Laers ANST 7136 1

"Class la laer pwducts IFC Class ?M pomducts" memsn s my lserproiust that permits human acceto levels of vsible laser radiabtn in exces of the Class I) aceggible emission limits during itsoperation butt does not permit huiman access to levels of laser radiation in excess of the accessibleClass 2a emission limits For maximum pernisible expcoslure limits' see the most rece-nt editinn ofAmerican National Standard for Safe I ke of Lasers ANSI 7Z 36-1netass if iasc., inslcui ans y lasei whijch penits fiuiha accesii tu laeri tadiauusi au hC UIC accebibki

emission, limitLs of Table I up to the ac ssibic cuiniuin lifimits uf TalbJ II and duoes nut pcennil msnumaiaccss lt lasc, iLadiatio in e f tire accessibc emuissionu finits uf Class I fus any flues Ciiuissio

duiatiull ul wavycfmtlw i iaigc. et1a4 ff ascisr aic spatly des:igateid as elaCss if or lazs, Ha. ci:msiia l:cis aie fliUos lasCLS which do iUt cxceUd dIC acssbleIC AInission limit, ofe las f fiU anuyemissins dwation lessk than or Ual ta I X 10M S n-daL. Cla, II la tdesignatiusn is give to all OflOhL

ClaSS IIascs as defined albovc.

"Class a laser, TIC Class 3R M" meain a laser or lager systein that produces modnerte levels ovisible or invisible laser rmdiation, of 1 to 5 mW and requires more stringent contrAl than a Class 2la-ser For those Class 3a lasers whose Outtpnt iS visible the normal gversion response is generall)slufficient to prevent eye injhry Ear maximiun per'isible exposure limits see the most recenteiiitinn otf Amerie-an National~u Stand aorfafe I ke Af L ANSI 71 1

"Class 3h laser" means a lasex or laser system that producesw isible laser radiation of 5 to 500 mW ofvisible obntimnlmi wave output and 5 to 500 mW of invihie infrared laser radiation A Class 3blaser is considered medium power laser and is capable ofprodurcing eye injury when viewed directlyor with opti0 s even if yieureA momentarily For maxim-g permisible exposnre limits see the mostrecnt edition of American National Standard for Safe Use of Laers ANSI Z1 .6 1uass III la taen nimans any iascL whici pesIrits hmuan access lu lasei laadiatiuon abuve flic aessible

tL&uiSSiot! liL,;S of Table I amd, if applicable., Tale IIf, but below lhe aessible enmissiuon lilnzils, cTabfe III. Ceass III iasers ame scparately designated as .Ca~s Illa Ul Camss II b Cleass lIa lases asctlosue iasrs wiUmI a nskI iUn duratioU iicatml flia J.O A 1Uf sccond mid in tluC WavulellrUl Iau

gsiate, flthm 400 natishnetcs but less Jimu us equal tu 710 ssasiuusditaIS will, ami iiadiasicc of is thflot equal lu 2.5 X 10x watts ci and wif a amdiairt puweu of lCbS5 thM CIL eUal lo 5J. 10 watts. Cla5 sIIlb fase desigations is givmil to all ofluuc Class iff lasmuS as df^iCud aLuvC.

'Clag 4 laser" means a laser or laser system that produces vilile or invisible lager radiation capableof causinog injuly to the eye and skin and dangerou apecular and diffiuge reflections For maximumpenmksible exposure limits see the most recent edition of American National Standard for Safe UieAfIacserq ANSI Z1 t6 1

"C1a, IVs la.e," mseis my u lasCu wifich pctnnits liuman accss tO lase. radiatiouu abuove tlhe accesbib

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issinliaItSof TabIle i.

"Clazs I, i, III, o, IFV faLlity" LIta&S a facility wlich lias Oln t nice Ciass I, II, III, ok IV lasers,Zespctlimly. hI case ofiacilits s tSIan one lase class, the assiglsd favilityclassificatiui slhall bre deenLifincd by tolmS hiusl Iiadaslus Lass of las e. n*ltaiIed dlleicil.

"Collateral radiation" means any electronic product radiation, except laser radiation, emitted by a laseras a result of the operation of the laser(s) or any component of the laser product that is physicallynecessary for the operation of the laser(s). (The accessible emission and maximum permissibleexposure limits for collateral radiation are specified in Title 2 1 CER Part I YFl able'V.)

"Continuoug wave" (CW means the output of a lager that is onperated in a continuous rather than apulnsedmode For purposes of these riles a lager operating with a continuous output for a perind>A s' w~ecnds is regarded as a CW laser

"Controlled area" means any area where the occupancy and activity of those within is subject tocontrol and supervision for the purpose of protection from radiation hazards.

"Demonstration laser" means any laser manufactured, designed, intended, or used for purposes ofdemonstration, entertainment, advertising display, or artistic composition.

"Diffuse reflection' means the change of the spatial distribution of a beam of Lauradiation when it isreflected in many directions by a surface or by a medium.

"Electronic product" means:

(1) Any manufactured or assembled product which, when in operation,

(i) Contains or acts as part of an electronic circuit and

(ii) Emits, or in the absence of effective shielding or other controls would emit,electronic product radiation, or

(2) Any manufactured or assembled article whichthaLis intended for use as a component,part, or accessory of a product described in (1) and which when in operation emits, orin the absence of effective shielding or other controls would emit, such radiation.

"Electronic product radiation" means radiation which-thatis emitted from an electronic product as theresult of the operation of an electronic circuit in such product, and includes:

(1) Any ionizing or nonionizing electromagnetic or particulate radiation, or

(2) Any sonic, infiasonic, or ultrasonic wave.

"Fmbedded l mer" Aaean encsed laser with an assigned class nu er er than the inhe tcapability of the laser systemn in which it is incorporated where the sten's lnwer classificatin i

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appropriate due to the englineering features limiting accesqible.mi

"Enclosed laser" means a laser that is containeAd ithin a protective housing of itself or of the laser o.laser system in which it is incorporated Opening or removing of the protective housing providesadditional access to laser raoietin avP the applicable maximunpsribe h exposunre (MP) thanpossible with the pmtective housing in place: (An embedded laser is an example f e type ofenclosed lase)

"Energy" means the capacity for doing work. Energy content is commonly used to characterize theoutput from pulsed lasers and is generally expressed injoules (J)... ng .d .,enst"(e "Rdm epsr"..

"Facility" means any location where one or more lasers are used or operated. The confines of anyfacility shall be designated by the owner of such facility. A part of a building, an entire building, orother structure or plant or, where appropriate, a specified out-of-doors location may be designated as afacility.

"Human access" means access to laser or collateral radiation by any part of the human body.

"Incident" means an event or occurrence atwhich results in a real or suspected accidental exposureto laser radiation flatwhich caused or is likely to cause biological damage..

"Individual" means any human being.

"Integrated radiance" means radiant energy per unit area of a radiating surface per unit solid angle ofemission, expressed in joules per square centimeter per steradian (3 cmi si').

["Untense-~pulse light (IPR) device" - means a device that emits ridiation to energy density levels thatcould reasnably cause bodily harm and that is used for phntnthermmlysis Ti ce devic is a Class orClass 3 surgical device certified s comnplying with the design abheling. and manufacturing etandardsif the ITnited States Food and Drug Administration (FflA) "I

"Irradiance" means the radiant power incident on an element of a surface divided by the area of thatelement, expressed in watts per square centimeter (W cm 2).

"Joule" (J) means a unit of energy: I joule = 1 watt second.

"Laser" means- any device that can produce or amplify electromamnetic radiation wig wave lengths inthe range of 1 80 nanometers to 1 millimeter prim'rily by the processof controlled stimiulatedemission Laer is an acmw= for Light Amplif iation by Stimulated Emission of Radiatinndevie wI1 h cau UF a 4pfilfy Gl CCrUiLairU fIi ui iiquenciCs betwenII 3 A Ipi andl67--10 l1 m (us veleigts ill ail betee 10 -and-1.8A-x-+ 1-n1mteby the-process ocons1 trlled sLimulated emi;ss.ioir inlzuding addiltion ncotporated coiizpotiils provid;ig fbi a lOlal

lasesystenr

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"Laser energy source" means any device intended for use in conjunction with a laser to supply energyfor the operation of the laser. General energy sources such as electrical supply mains or batteries shallnot be considered to constitute laser energy sources.

"Laser product" means any manufactured product or assemblage of components which constitutes,incorporates, or is intended to incorporate a laser or laser system. A laser or laser system which isintended for use as a component of an electronic product shall itself be considered a laser product.(See Pmararph-AA.21a6a. for applicability requirements.)

"Laser protective device" means any device used to reduce or prevent exposure of personnel to laserradiation. Such devices may include protective eyewear, garments, engineering controls, andoperational controls.

"Laser radiation".means all electromagnetic radiation emitted by a laser product within the spectralrange specified in the definition of "Laser" in Section AA.2 that is produced as a result of controlledstimulated emission or that is detectable with radiation so produced through the appropriate aperturestop having a diameter, a solid angle of acceptance, and collimating optics as specified in AA.331.

"Laser safety officer" (LSO) means any individual, qualified by training and experience in theevaluation and control of laser hazards, who is designated by the registrant and has the authority andresponsibility to establish and administer the laser radiation protection program for a particularfacility or a particular mobile ilaser.

"Laser system" means an aemblvy of electrical mechanical anid optical components that includes aK aSe.a aash in coilrnbinaltion all a.I ugiiaso lasi MC umce, witl Ut wilthut addiiinial

Plorlwoatedtompon~u^ents,ls ;

"Maintenance" means the performance of those adjustments or procedures by the user(pecifiedinuser information provided by the manufacturer with the lager or laser sQstem) that are to he perfrmedrbyt Meuser to'ensure me intend'e performance of the producttu c cIqjuipaMit hl io 1ik 11t d i Ujtlandelop ating 9. 1 du0, nUt in1 J vUk OPM360i1. ui

se vie aS u w inl thleseri Icgulatilzts.

"Maximum permissible exposure" (MPE) means that level of laser -collateral radiation to whichpersons may be exposed without hazardous effect or adverse biological changes in the eye or skin.(The criteria for the MPE for cornea (eye) and skin are detailed 4nl he srnt editionnf AmericanNational Standard for Safe Ll-e of asers ANSI 71 76 1 Tale WVa, IVb, IVC., and V.)

"Mobile laser" means a laser which is used at temporary job sites.

"OXpcrabl laserd" incanis a la se system whidl ctal pioduce las, radiatioun.

"Operation" means the-performance of= the lager or laser system Quer the 5flil range of it intendesfiInctions (normial opid" - ratJd fi tlc eqUitnt lo pet ietJfinctions. Itdoes not include maintenance or service tasks as defined in these regulations.

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"Optical density" (OD) means a logarithmic expression of the optical attenuation afforded by amaterial.

OD = log10 F (flncident pnwe)t(tlransmitted power)=]

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public orprivate institution, group, Agency, political subdivision of this State, any other State or politicalsubdivision or Agency thereof, and any legal successor, representative, agent, or Agency of theforegoing. [ hut sall not include federal govemment agencie]

"Practitioner of the healing arts (practitioner)" means for the purposes of this Part a person licensedto practice the healing arts by either the [state] Board of Medical Examiners as-a physician; the [state]Board of Dental Exainier'er the [state] Roard of Chiropractic Fxaminers. or the [state] Roard ofPodiatry Examiners A practitioner's lse of a laser is limited thiohbifer scope of pmrfessional

as determined by the appropriate lcensing agency

["Photthernnolysis" means the non-invasive aesthetic application ofintenle-pukedlight( ) eto selective superfcial lesions such as imwanted body hair or veins (Also see definition for intenge.

pulsed light (IPL device

"Protective housing" means those pnortions of a laser prmduct that are degien t prevet npmipmulition, di idiwg wall, hi si relax &v e icl h 1E ts human access to laser andfor collateralradiation in excess of the prescribed accessible emission limit.

"Pulse duration" means the diration of a laser pulse usually measured as the time interval betweenthe half-power pnintcq Afl tuini injreiiirti1 msuied betwe 1 tire hiaff-pi.ea k puin at-e leading

and trailing edges of a pulse."Pulse ihitet val" mIIs the time j duration. between idtical moints oui twi sac e ve pulses.

"Radiance" means time- averagedradiant power per unit area of a radiating surface per unit solid angleof emission, expressed in watts per square centimeter per steradian (M' cm sri-).

"Radiant energy" means energy emitted, transferred or received in the form of radiation, expressed injoules (J).

"Radiant exposure" means the radiant energy incident on an element of a surface divided by the area2of that element, expressed in joules per square centimeter (J cm).

"Radiant power" means power emitted, transferred, or received in the form of radiation, expressed inwatts (W).

"Registrant" means any person who registers a mobile laser, facility, or service organization with theAgency pursuant to these regulations.

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"Safety interlock' means a device associated with the protective housing of a laser product, system orfacility which prevents human access to laser and/or collateral radiation in excess of the prescribed

K2 accessible emission limit.

"Sampling interval" means the time interval during which the level of accessible laser or collateralradiation is sampled by. a measurement process. The magnitude of the sampling interval in units ofseconds is represented by the symbol (t).

"Secured enclosure means an enclosure to which casual access is impeded by appropriate means,such as a door secured by amagnetically or electrically operated lock or latch or by fasteners that needatool to rnv ate, o ry screws.

"Service" means.the performance of thee procedures or adjiustments described in the manufatlrpr'QService ingtruti n that ayi affect any aspect of the perfonmance of the laser or laser systemaMISM. quired to rui iit to its .n. d.d state. .. *..

ust ts amid pJroulULed uresbUly 'aalizeiii ialEd Lrajigmdia, tools. Service does not includeoperation or maintenance as defined in these regulations.

"Specular reflections" means mirror-like reflections.

"These regulations" mean all Parts of [cite appropriate rules or regulations].

"Watt" (W) means the unit of power or radiant flux; 1 watt = 1 joule per second (Q sec l).

"Ehtsm.nv 'U hlfed arca" ineans arry area ce is Ismt co 1 olled by tdie regis ait fir pposes ofprotvdtiVi fiU iadion l daas.

R~eyi A A -1 1zimpmn Tbe fllowina are Pexempt 'mm, nregulation-g in thig Part-

a Facilifies containi only certified Class 2 Class 2 Class 729 and Class. a lasers or aer*promdIt prnvidId that me laser product is maintainedias a cer ified Class 1 Clas' 9 Class 2a- nal 1 a lae1 pronduct througbout at its sepfi lllifp fnr those that allow access to Clas

n3 or Class 4 laser radiation duirin s icing .

a. *All cerified Class L Class I, Class Ha, aid Class fHa lasm prvdtits, eAxept fbi thosv that- anlvw awc to Class fIlL oi Class IV laser radiation ming VWIIng, ate exAeliLpted Lvuo

these cgtulations, pvvide.d that Iloc laser pidudt is miii; itainied as a Wfied Clas I, Class 11,etass lra, s eai fa.a5spi jjovduc.t I ueoutv its uetd iac.

h Certified Class h visible (A 4 to 07 um) or nea -infrared (Q7 to 14 jim) lagers or lIrerthat emit in e 3 a hbt which:

i 'Cannot e nit an average radiant pnower in excess of 5 mW > 0.'5 s- and

11 Cannot produce a radiant energy reater than 0 03 J per PIJIaS

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M Mnhile lirasesthat are certified Class 1 Class 2 Class 2a, and Classq a and

bd. I aes that are in transit or ins twrage incident to tranit or sal1e Tes .ehulatius do it asply~lu lasi, iii; toiagc, duiii;g siLipitiieiL ui salc. provided such lasers are inoperable or notoperated.

. :ihe A*geciy may. upoui application by peisons or upuon its ownt iniliative. gant suc}.eC^Illptivilb u eAceiptioi fitlsi tie I Lt ofthfese iegulaitios aS it detminines arc autfiviizdby law and will Inot irsult in widuc h LdPi lu ucuptiulial oi p lic lbaili and safcly oi to theCii vii UuitIJ~nL~

Sec. AA. - Addition1al Reuiftemtsn. T lie Agecly ...ay, by rule, iigulatini, O, ()1dli, illpose Upon

aly pliVis such i equixernentii s 11iadditiou Lo tlihose cablislhed in fliese i ugniatiosu aS it is adutllVizedby law mid as it cleteninnes to le appoupiiate oi c.cessyi. to lecitUie Ui ciuinate any hamald whihlcauses or tiatiiins to cau se my dm11iger lo occupatioual ui public licailh amid safiey o. I to IeenivioromTcrnt

Sec. AA.5 - 'Viulatiuns. [SLae tou cite pealties used fbi enifbiLcwinrit uf tleL Acl.]

I.Jr A A A n - I v W £.nmd . w.* J 1.t lft ; S ;ltf' e Atel %II 1ftq 011-l

_- .> * . ... 1--- *- r -. * .- * r - _-' __ !. -_ .1_auUiity in th LiCVCIi t OfU1 all IIICIgey LIiCY tu iipUd 0n vidm l1e inupuuding oflasil in thipusesio f airy periuio who is nUt cquipped tU obse ve or fails u toolscee tdle proVisions of lftiis Acto, amy rules oi iLulatiuois isseud IihciuindeI fuszualiy sHpcified by State stalte].

Sec. AA.7 - hisLdcionls.

a. Ench cisonui sliail affOud tlhe Agencty at all easonable Lincs opportmUhity to inspect tlhe lasefa~cilfy or Inloble lascr.

b. Eac persotn sall mlakL available Lu l Algencly fbr fimpevLiul., upuol Ieasobab le Vtice,Iecoids maintlainLed jutiUaIt .t these l tgulaiuln~s.

Sec. AA.8 - Tests. Each persn slhall peafbini, aponV insiaLions and IcasnlIabe otice fioL thleAge.ny, 0l shall PCnIllit lie AgecLy lo peLful in, suihl i-asoiabhle tetLs aS tldi AgenLcy deeLLsapplUpijate Ui II~eSSaIy lo aSNUi Leo.ipliaLce wit, these regulationis.

Se. AA.9 - Adininiistiative Review. [Ceit Adininisiative P1ocedures of Slale enablingu legiblatio.]

See AA lfl 4_- Prohihited I Jses Urdrl-)

a An individual shall not be penmitted to lool directly into a laser beam or at specularreflections of a laser beam or align a laer by eye while lnoking alongy the axis of a beam'when the intensity of the beamns or reflections exceed the MPE limits

b A registrant -hbll not P=nit any individual to enter a lager-controlled area if the skin exp-sureivd he in excess of the MPE linitg inless the registrant prIidel snd requires the use of

protective clothing glnves and shields

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c I prmducts emitting spatially scanned laser radiation shall not. as a result of scan faihtre oranyo causing ange in angular velocity or amplihtde penmit han alaser radiainn in cxcess of the aspibe emissionn limits applicable to the class of thpmduct

The Agency may prnhibit thbeIuse of lagers and IPIT deviees that pose sigyificant threat orenr1an=er Arcilpatinal or publiclhealth andL afety

p Individuals shall not be intentionally exponed to laser and IPL radiation above the maximinmpennissible expasure (MPE) In~es such- explusre has been' authori7ed by -a licensedpractitinner of the healinig art This priviion specifically prohibits intentional expousre forthe follnwing pirpnses

i. xpnqure of an individual for training demonstration or other non-healing art

iL Expomire of an individlual for the pirpnse of healiniz arts screening except a*pei-ifically allthori7ed bhy the A =npsy and .

iii '-xposure of an individ1Ral for the ir- mose of rsearh eweet as authorized in researchstuldies Any researe~h 'sing rdiation-rpmducine devices on humans must be apprmvedby an institutional review board (TRuB) f required by Title 45. ode of FederalRr sti (CFR) Part 46 and Title 21 ('PP Part 5a. The TP1 must indlude at leatoneqractitioner of the healing arts to direct ine of laser and TPT device radiation in

* ar'rlanrce with AA lc

Sec. AA. I1 - Cuuiciatinus.. All ctnin ansid .imeotls ,cnain,,g these ,cglatlio,,s, midappicatlions fid theicuand, sIhall Iw tod11ssed lu lllc Agiany at its offiec loc 4 ed at [

]--

Sec. **.12 - Scviabilily. hisofma as tLe Ag±cytiaypiuovide, cacLh Section. Ou PuLt dicufuf tlleseirculations iall 1JC w as se atu, to tLe ernd ltat, if awy Secioi, SGixtCI.C, clause, or pin asc,shcal be hljd itivalid fbu aLmy icasoni, dl. aimnafiild, of Lfese iulaatiuns sLall coLLtinc in full ftc.

Re siaLdAo.

3ec. A*.13 - Purpuos. The pupse of tlls Pail is Lu provide fio 1.C 1tgitLatiCI,, of fahiitics, ,inbilclases, and pel sLn1s sevL.cnlass. - -.

S A. . .cp .

a. Ev.Ly pPM5u= puOSesinl a lase, or lase, systey , amid pcluisi ^,viding lase, a4d laseL system,installatioi, a ric;, hiiniLatWiacc, miJUL S.i /vices ivoIlving thL use of a lasc, o, laser

AAIO..

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systemi slily! giiste, in accordance wide this Ira-.

l. hlie .egisttamzt shall bse subject to all appicable requirnen.ts of thioe xeguatiors.

Sec AA +5 - GlenernRegistratinn Requirementg

a. All facilitie iusing fixed lasmm, mobile lasers, and persons servicing lasers or laser systems,except as exempted in Section AA.11, shall be-registered with the Agency.

b. Application for registration shall be made on forms finished by the Agency or in a mannerotherwise approved by the Agency. The application shall containsetfrth all applicableinformation inluded incalled fbi by Agency form 'AA".

c. The Agency may at any time after filing of the orginal application and before isunmadce of theertifiate ofblaer reoritr tinn require further statements in order to enable the Agenwcyat

determine whether the appliation huld be mie r eniet The applicant or registrantshall fiunish the Agency with such other information as the Agency may reasonably request.

d. Information designated as proprietary by the applicant or registrant shall be treated as providedby law.

e A laser safety offieer (L90) shall be designated on each application form The qualificationsaf that individual shall be smbmitted t th eny with the applicatin The TISOb shall meet

the anpplicable requirements of Section A A 14 and carry out the resAnsbilities of Section

Sec A A 6 - Application for Registration of Healing Arts Taser Facilities and Veterinary Ia-,

a. L addition to the requirements of A A 5 each healing asrt laser facility or veterinary lagerfacility shall submit in application to the Agen [within days after e p tin othe laser]

b Anappliecation for healing arts facilities shall be signed by a licenged practitioner ofthehealing arts An application for veterinary medicine shall he signed by licensed veternaranThesipAhlre If the administrator prident or chief executive officer will he acceted in

lieu of a licensed practiioner's iaure if the facility is a licensed hospital or a meicalfacility A signature by the administrator president or chief executive officer does not relievethe practitioner iuser or veterinarian iuser from cnomplyng with the reWuirementq of thibs ection

c If a facility is furnished a laser by a provider of lasers that facility is responsible for ensurin,that a licensed.practitioner of the healing arts aumthorize intentinn evpsudre ofLaser mdiafin

-± reAPPE:1mlirTe

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Reo A A '7 - Amli-tion for Industrial AcdmicS and Research and Dleuel ie ias ...er..i.iitieIn addition to the irement, Af A A S .eah Rppliant for iuse of laers in indauctri cademic- andresearch and meln t facilities shall submit an application to the tAgen crwithin 30 days after

beginnin onperation of the lser]

Rec A A 8 - Application for 1emonstration for the Purpose of Sales of Laser

a. Eab amppicant shall apply for and receive a certificate of-laser registration before thedemonstration for p rose of gelling laer~Q) inelndinp demnstration for the selling of

:subi as' - . . : ..

In addition to the requirements of eetion A A 5 the pplicant shall submit a statement

confirming that no demonstration wuill be perf rmed on humans unless directed by a licensedpractitioner of the heafing arts

Sec AA 0 -A' Applieation for Providers of Laser.

a Each applicant shall apply for and receive a certifcicte oflaer registration before prnviding

h In addition to the requirements of A A 5 the applicant shall submit the-he address of the* ektligbed main location-where the laser and records will be maintained for inspection and

- the name of the On-gite operator This -hall be a physical qtreet addreq, not a pnot nffiee box'nijmbcr

A -i -. fi. L. At- nt . . .i

Ser A A 10 - Application for Alignment Calibhrtion and/nx Repair In addition to the requireentof AA 5 each applicant shall aWly for and receive a certificate nflaser ti regtratinfralignment calibration, and/or repair before providing alignment calihration, and/or repair of laser

See AA 11 - Application fo rLaser Light Show Fach applicant shall apply f3ir and receiue a

certificate of laser reistration for laser light show before beinning any show and shall meet the=if1iremient~ fApni

a_ taddition to the requiremnents of ertin.AA .5 each applicant shall guhmit the following

i A valid vi iance issed fmm the PEDA for the laser intended to be usged with all

-- :apple dnrimientg reiquired by the Uarianpe inslude operating and safety

ii The licensee shall notify the Agency in writing at least seven days in advane of the

-mproosed laser show and shall include the following information:

(1) The location, time and date ofthe lidth s

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leSketches showing the location of the laI*er operators, performers, lager beampath viewing screens, walls mirror balls and other reflective or diffigesurfaces which haybe struck by the laser beam (Examples of sketches may beifound in the diagram portion of Appendin A);

(3) !Rcanning beam patterns scan veocity and fleauency in occupied areas

(4) Physical sumeym and calculations made to ensure compliance with Part A A

iii Prior to the performance of an outdoor laser ligt show the licensee shall notify the- Federal Aviation Administration of the prposed show and provide documentation to

[See A A 12 - Application for Laser Mobile Services Us Ied in the Healing Arts and Vetenary ArtsEach applicant shall apply for and receive a certificate of laser rfgistration fr mobile services beforebeginning to provide mobile services

a In addition to the requirements of A A 5 each applicant shall submit the addre.sq of theestablished main location where the laser records etc will be maintained for inspection Thisshall be a physical street address, not a post office box number

b An application for mobile services for healing arts shall be gined by a licensed practitioner ofthe healing art- and ain application for mobile -,ervices for veterinary medicine shall be. signaby a licensed-vete.rinaria]

[5.ec AA 13 - Reauirements for ntene-Puelsed Light tevice (Photothe~rmolysis) Facilities

a Tntense-piuled light devices used for photothermnlysis shall be Class 2 or Class 3 surgicalde~vies certified as complying with the desion lahbeling- and manlifachiii standardq of the.United States Food and Dml Administration (FCEA)

h An intenwe.plsed light device used for medical p rpoqe.s shall he used as directed by alicen=e pnictitioner of the healing artq

c Intense-pulsed liuht devices uuged for phototheronlysis shall only be sold to licensedprctitioner of the heaing art

d Each re-istrant shall establish a sAfety training program that pmvideq a thoroughunderstandin ' of the imedical procedures being performed and shall require eacb ugerdemonstrate to the licensed pratitioner he competence to iuse the infense pulsed ligbt devicesafely Documentation of the training shalI be maintained for Agency review And as a

mAnnini= address the following.

i. Fundamentals of intense-.pulsed lidht device oneration

ii Rioeffects of intense-puilsed light device radiation on the'skin and eye and

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SSRCR Volume Hdimwu99mM1991. -DnRAFT

contraindication for it. use -

iii Non-beam ha7ards of intense-pulsed liglt device operat ion

iv Responsihilitie.s of management and employee a-, relatedo tocontrol measiiresand

e In adition tn the requirements ofSe.tin A A 5 each photothennolysis facility shall submita2n aplirAtinn to the3 0Ageny wihin 0 dayrs after beginning operation of the lser Anapplie~itinn for healin, arts facilities shall be signed by a licensed practitioner of the healing

Aren ik fi.-! +.Exann.inso. fin,.n Reg;istiniin R,eqr.,e..,tmc. .

a. Tlie followin~g are ekenit fionts aIc LwgiStlatimis requlirements of tlis Part..4 . .

(I) Ctfied Ciass I, Class I, Cleass Ifau Cass. IlIa lasm proiuducs, ad/uL

(2)etifiedet-ass 1% iaset psoducts ini ftl wavJeklutt L4 o1k,; f 400 tlugh u H 710pa1uniztrssb mid lhaviuL a pcak radiaun.t power of ess than orUL .urvLu to ,5 x0z

watts- and

Lo. bfikc lass which arc certified Class iL Ceass II, Class Ha; and Ceass lIa.

b. S__vici of cm _ified fasi In ,ducts wifi aIAemibiliy tu.eiass ffb o, Ciass fy iasi iadiations;5 I t exc,.t finus the rcgisitatipi, i eqaeujutiits uofthis Part.

Rec AA -14 - TsLer Sasfety Offi=er (LSO) ualificat� The registrant shall designate a lasersafety officer who is responsible for laser radiation protection.. Sudi individual siall;.LSQquslificatinnsg shall be mibimittedA to the A gency- andl sha incle the ffowinl

a B13 desiglnaled ftom suwL pulsonneC aS dise radiatiol protectionv office,, indlustrial Llry coffilcc,, safety officer, 1wee pccialist, ot la=c Operator..' .

: Be gmflifeLJ by Lliaining and experience in lhe fioll w hg mcas (secas notin'i in Appendix

i. Fan±ML4 1CLIs aLoflaasc, uplatiuor.

! 5 7K LSO naly la si-Lpu ium a usiutn UvIXII uU L4EI dhi' limw! !rLLJUipt u4ifil-uiw r liii 1.

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DRAFI SSRCR Volume lJwmmrt, 99fj z M

M Biological.. cfiecs ofil zadiation un th* eye mid s

ii. Rclatilos of specuiar and difuse eflections.

iv. Eascr andc lase, systemi classificatioir

V . enit UIUIainasmsulc.

-. *Ai

, .. | o . ._.a.

'ii fv odi*- sm-elac *1te (-if _pplicable).'

v;;;. LaSel telklizuloy."

iA. ayzJpi:.O Uiaberlslwavel.ngfbaid, pulseuil;1lt Movides powen i mrlul W1W

A. Basic rad:ionrietric ullits mrdt inleasmemmitl~ devices mid technliques. o-

AI. Maxilluil Permliissi.ble Exposmule (?IvPE5 l ls fo, eye and skiu uldCt all M.&,ditions.-

A;;I. Laserirlazaid evalaadons, irmige equatlios, mlid othert icuakwions-."

b eExperience in the use and familiarity of the type of eauipment ar rvices tered fnr and

c IKnowledge of pntential laser radiation ha7ardq and laser emereny situlations

9c. Eslabllisdl amd iud~i vis a gruglaln Of laSeL zadiatiun safelty fba cfficclive ompliamce with-t hlapplicable tauIIltilit of Ulls tI gl;UIaUIIo.

Zd. Pic v ide in ultiUlac C.UciIhligazmdism 4 1db safetyp riaclices lu inrdividual swiiurayexApusct 10 laisei adiatiol lai lu ildividuap wliu ujloate dhe lasels.

Slec AAR A9 - A -whim..e mf fTscer qafn t v3fficni V99mzll ill thle o1JiniUo of tlre*gcllscythvinctiviUuI designatedt Lo be me h1se:l saiey oful;e does ntul hlave .LuallolnalulIS sumlclelit to Cmry uutdie opuuienilents of Section AA.26 of tLhse cglulatiozsI, the fency iay oiLdle dl;e legismLiat loU ifpatc Amiolic. indivldua4l ;

qmc- AA-!19 - Ami.uffl ReXLn Tlhe iegistaimi slall rtife~y the Agency aintluafly of ciroliges, if m , ;,lth~e ILOLIIIabOll SupljtlCu UOL llhe LqpstiatLon applicatiuo o. ini lhle previctis aiukLl iepJolla.Sec AA 1 5 - Dlties of T aer iSafety Officer Specific duties of the LST fshall include. but not helimited to the following

!!tTrsoarrUasJ are upiormffi^abui" 1 l L l 9 .l' 61.0.3 I I, ILL f IJ vrd in thiv .. n rtgih , o.sf 46Vtih, uastqh

7i & a mV jig.) t j'd a pc 1uk adhinL pu wri U./f) thra g ttju: V a t xi - a A

A A 1 7 .

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am Fstablishing and Qupervi ing Plal..Uh ad...1 se. .a program of laser radiation safety foreffective compliance with the applicable reqisemns of these reguIlations- to ensIIre that

si-ers of lasers are trained in lIaer safety a applicable for the slass and type of laers used

hi Providing Prmrile inctriictions concerning ha7ards and safety practices to individuals whomaybe expoced to laer radiation and to individuals who operate the lasers

c Assuming control and hai3ng the authority to institute corrective action- including shutdownof operations when necessary in emergenc sitations or unsafe conditiong

d Specifidnj whether any changes in control measures are required following

Any service and maintenance of lers that may affect the OUtpolt power or operating

ii Whenever deliberate modifications are made that could change the laser classQ andaffect the otrt power or operating characteristics;

Fnsuring -maintenance and other practices required for safe operation of the laser(s) arenffopmed- and

f Ensuiring the proper use of protective eyewear and other safety measires

Sec AA 16- Issu'anceofLas.er Registration

A I rpon determination that an application meets the reitiremesnt of the regilations the Agencyshall kisie a notice of lager registration authorizingr the pmposed activity

b The Agency may incorporate in the notice of lager registration at the time of issuance orthereafter by amendment, additional reqilirementer and conditions with respect to the

ri rtnt'g receipt posesion use, and transfer of lasers subject to thkis =e1inrPart as it:deemsg appropriate or necessary in order to-

i Minimize danger to occupational and public-health and sfe

it Reqauire reports and the keeping of records for inspectionbythe

iii Prevent Io= or theft of lagers subject to this section

Ser AdA 17 - Expiration of aser Registration Except a rmvided by Sec AA 18-b, each noticeof reagi~tmtion -hall expire at the end of the specified dayin mthe month and year stated on the notice

S.ec AA 1I8 - Renewal of Taser Registration

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a Application for renewal of laser reistration shall be filed in accordance with Sectin AA 'Send Sctions AA 6 thrriuh AA 11 aspplicable.

b If a registrant files an application for a renewal in proper form before the existing laserregitrti xpres, the existing laser registration shllno epre until the application -status

ha been determined by the Agency

Sec AA 10- RenortofChange TheregistrantshRall notifytle A vency in writing within thirty days.Oflre f-Mai= g any change that would render the information contained in the aupplication forregistration andonr the notice ofblaser reeistration no long= accuratr

Sec AA 90 - Terningtinn ofRegiqtrqtin.. 1.e [..y] [.Jin11 1u...i..an.z.,.6tfie .in . ate *w 1.n1 .11 I et!~ f no II1 l r. I.i. torip _b~e- Wlen a rpegitrnt decides to terminate all activities involving 1asr or lasr smluthorized uinder the laser registration the regisftrant shall-

a Request termination of the laser registrmtion in writing and

b Submit n record of the dispnoition of the lasers to the agency if applicablek-(mdIn:

Sec A A -1 - Validity nf Regitrmtimn Registration accepted by the Agency as properly executedshall remain valid until terminated or until declared invalid by the Agency.

Sen A A 92 - Registration ShAll Not Tmply Approval No person, in any advertisement, shall refer tothe fact that a facility is registered with the Agency, and no person shall state or imply that anyactivity so registered has been approved by the Agency.

Set' AA -'? - [Reci =mILOut-Of State L amer R Rdintimn Snurree.,

a. i. Whenever any source of laser radiation is to be brought into the State, for anytemporary use, the person proposing to bring suchi source of laser radiation into theState shall give written notice to the Agency [at least 7 worlding days] before suchtoesource of laser radiation is to be used in the State. The notice shall include-

(1) The type of laser radiation source;

(2) The nature, duration, and scope of use; and

(3) The exact location(s) where the laser radiation source is to be used.

ii. If, for a specific case, the (7 working-day] period would impose an undue hardship onthe person, upon application to the Agency, permission to proceed sooner may begranted.

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b. The person referred to in Paragraph AA.23a. shall:

i. Comply with all applicable regulations of the Agency,

ii. Supply the Agency with such other information as the Agency may reasonably request;and

iii. Not operate within the State on a temporary basis in excess of 180 calendar days pery. .year.: -,

h i k4.TV 1 ***r 1 . -_tvj Aga inst _bs.L _td _i_! _

als. . - z^dw>aSzf Tizisfa t rstablstrsoz regulationDGs for p~i oteti againsat faseradiatidn. Ifany ar,~f ises b etwLeenIMM irerentsi f of Legiualioins auir th. Federal lase,product pa A rdard with LcSPCCt to dIC sync aspOct Of p.I6Lfui,1au fOJ laSC pioductssubct to tlh IFederal alstuaqi, u jeinL~ts of thL F1cdexat siwaidm d all aIly.

Rec A A 95- '- Mnximunm Permissible Posunre (MPM)-

a. No individual shall be exposed to levels of laser or collateral radiation higher than are ilhem'ngt recent editionofAmerian NationaI Standard-forSfe Ike of Lasrs ANSIT 7136 1 orTitle 71 CER Part pect mci~d a Tables Pl~a, IVF I9 c alli V. It is goodpractice to maintain exposure levels as far below the MPE values as is practicable.

b. In those cases where no MPE is-shown for particular wavelengths and pulse durations, allexposure shall be-prohibited. :-

qre A A 9596 - Tmplementatinn nf Prntechve Means Protective measures used to avoid laser orcollateral radiation shall be implemented by a laser safety officer (LSO), oi tc rcase of those lasesnot registered an individual designated by management.

Serb AA 26H Greneral Reqi1irementg for the 'Sfe Operatinn nf All Earilitim-

a. Appliahility- These requirements are for laser products in their intended mode of operationand include special requirements for service, testing, maintenance, and modification. Duringmanufacture and research and development activities, some engineering controls may beinappropriate; the LSO shall specify alternate requirements to obtain equivalent laser safetyprotection.

b. - Rngjieering Cnntmnl I - -,

. Pratective 14iusing Each laser product shall have a protective housing which preventshuman access duinig operation to laser and collateral radiation that exceeds the limitsof Class I in the moAt rernt edition of American National Standard for Safe I1se toIasers. ANSI a136 1 and Title 21 - FR Part1 040 reectively1-ain-Paragraphs-A

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DRAFT SSRCR Volume IZaimr, I 199fJunc2004

nnd B of Table V, wherever and whenever such human access is not necessary in orderfor the product to perform its intended function. Wherever and whenever humanaccess to laser radiation levels that exceed the limits of Class 1f midal Paiagraphs A mid <B-Of

I asers ANST 7136 1 and Title 71 CFR Part flQ4 is necessary, these levels shall notexceed the limits of the lowest laser class necessary to perform the intendedfunction(s).

ii. Safety Tnterlodkok

(1) A safety interlock, which shall ensure that radiation is not accessible aboveMPE limits, shall be provided for any portion of the protective housing which,by design, can be removed or displaced without the use of tools during normaloperation or maintenance, and thereby allows access to radiation above MPElimits.

(2) Adjustment during operation, service, testing, or maintenance of a lasercontaining interlocks shall not cause the interlocks to become inoperative or thelasezradiation to exceed MPE limits outside protective housing except where alaser controlled area as specified in Subparagraph AA.26Tb.v. is established.

(3) For pulsed lasers, interlocks shall be designed so as to prevent firing of thelaser, e.g.,, by dumping the stored energy into a dummy load.

(4) For Class fflb-3band Class-tV4 CNMconftinuas wave-(cW)-lasers, theinterlocks shall turn off the power supply or interrupt the beam, e.g., by meansof shutters. - -

(5) An interlock shall not allow automatic accessibility of Iloradiation emissionabove MPE limits when the interlock is closed.

(6) If failure of a single interlock would allow:

(a) human access to levels of laser radiation in excess of the radiant poweraccessible emission limit of Class Hia-3a laser radiation, or

(b) laser radiation in excess of the accessible emission limits of Class H-2to be emitted directly through the opening created by removal ordisplacement of that portion of the protective housing; then, eithermultiple safety interlocks or a means to preclude removal ordisplacement of the interlocked portion of the protective housing uponsuch failure shall be provided.

ii. Viewing Opticr and Windnwg

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(1) All viewing ports, viewing optics or display screens included as an integral partof an enclosed laser or laser system shall incorporate suitable means toattenuate the laser and collateral radiation transmitted through the port to lessthan the MPE in the mnst recent edition of American National Standard for

Safe Ue of I asers, ANS 7136 1 andt collateral radiation limits in Titip 1CFRl Part 1040 anldl Table V lim;its -under any conditions of operation of thelaser.

(2) Since optical systems such as lenses, telescopes, and microscopes may increasethe hazard to the eye or the skin, the laser safety officer shall determine thepotential hazard and specify administrative procedures and the use of controlssuch as interlocks or filters.

iv. Wnaning s.ystems. Each Class of 3 1, Hi, m, FL l laser product shafsbal11n4nrpflra an emission indicator that providesa vsuisior aurahidiblindication during dt-emission of accessible laser radiation in excess of the limits forClass 1.I RFach laser system classified as A Class 3b or Class4 4 laser prnduct shall-ncroratema emission indicator which provide a visible or audible signal during- ntsion of accessible laser radiation inexcess' of the accessible emigsion limits of,clasq 1, and sufficiently rior to emission of such radiation to allow appronpriate action-n tyofid expouire to t lasr radiatinn ; Ice iJ tk a ufCks 3JIfflb, exceptt1Ise *vhic alltJ c c s ,dy tos dran 5 nrW a i las -ai*iatio, d Ei-mMY laseis, uiis iuzdicatiuo sovials b fsl io to 1 isiis: of sucl U adiatiou LUallow appuopiate o cin to avuoi exApftuic. All; viual ski in atox sliall be clemalyvisible duongl FetW~v eyyewe, designled specfically fodie ts wavclengl*;iss of thse*leiitted lasi 1adiiji1 1. If d16 la d 4 d lasei energy somc cax luosu jsiarately midcal beoperaeted at aisep4Laatiuo diASa.uCof. greate, than Lwou wetis, bodi taset mid lasc=eneugy somcc all s uincjuuakiat visual o. aumal iuicatms. TLh visual indic,.atois shallbe positi-led su fliat viewing, doe3s uot ze1uiLI¢ luaniacs a Lo - zaLi inexcess of tle. MPE.

V. T swqer CnntmnIIeP Arems With a Class 3bflib, except those whbirlb low access onlyto less than 5 mW visible peak power, or Class 4W laser, a laser controlled area shallbe established when exposure to the laser radiation in excess of the MPE inhfmosrpecnt peitinn Ameran- Nton tandraiafnr sqafeT use ofT .r ANE 7 1 .6 1 and

CP s possible. Thecontrolled area shall meet the requirements of Subdivisions AA.267b.v.(l) through (3)for Class 3fflb lasers and the requirements of Subdivisions AA.26Tb.v.(l) through (7)for Class 4W lasers:

(1) The area shall be the responsibility of the laser safety officer.

(2) The area shall be posted as required by Section AA.293e.

(3) Access to the laser controlled area shall be only bypermission of the laser

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safety officer or a trained designated representative.

(4) For Class AH indoor controlled areas, latches, interlocks, or other appropriate \_Jmeans as defined in written policy and procedure of the regitrant shall beused to prevent unexpected entry into laser controlled areas. Such measuresshall be designed to allow both rapid egress by the laser personnel at all timesand admittance to the laser controlled area in an emergency condition. Forsuch emergency conditions, a control-disconnect switch or equivalent device(panic button) shall be available for deactivating the laser.

(5) For Class AW indoor controlled areas, during tests requiring continuousoperation, the individual in charge of the controlled area shall be permitted tomomentarily override the safety interlocks to allow access to other authorizedpersonnel if it is clearly evident that there is no optical~la= radiation hazard atthe point of entry and if the necessary protective devices are being worn by theentering personnel.

(6) For Class AH indoor controlled areas, optical paths (e.g., windows) from anindoor facility shall be controlled in such a manner as to reduce the transmittedvalues of the laser radiation to levels at or below appropriate ocular MPER limitsin the most recut edition American National Standard for Safe I Te of I aersANSI 7136 1 and Collateral rdiatijn limitq in Title 91 CER Part AlOAM4Table IV nimits. When the laser beam must exit the indoor controlled area (as inthe case of exterior atmospheric beam paths), the operator shall be responsiblefor ensuring that the beam path is limited to controlled air spaces or controlled ,>ground space when the beam ifadiance or radiant exposure is above theappropriate MP and aterl rditi md Tal limits.

(7) In the case of the removal of panels or protective covers and/or overriding ofinterlocks becomes necessary, such as for service, testing, or maintenance, andaccessible laser radiation exceeds MjPF limits in the most recent editionAmnerican National Stanrd for Safe Usge ofT Laers ANSI 7136 1 andcollaterml radiation limits in Title 21 ('rFR Part 1 e.4 3ai- T~.e V linits, atemporary laser controlled area shall be established. The laser safety officer ora designated representative shall ensure that the necessary laser safetyrequirements for all potentially exposed individuals shall be established.

c. Atiminigtrative and Pmreediiral Cnntmlq.

i. GCeneral Unless otherwise specified, administrative and procedural controls shallapply only to Class Nfflb and Class Ai lasers.

ii. Oitlpt Fmiision T .imitatinng The minimum laser radiant energy or laser power levelrequired for the application shall be used.

!/Contact FAA or other appropriate agencies, as necessary.

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iii. Ftliientinn and Training The degree and level of education and training on laser safetyconcepts and procedures shall be in accordance with Appendix B-_..tabk.4of theseregulations.

iv. Open=tinn œnl Maintenance Class fflb and Class #W lasers shall be operated andmaintained only by qualified personnel.

v. Alignment Prn1MireR Alignment of laser optical systems (e.g., mirrors, lenses, andbeam deflectors) shall be performed in such manner that assures that no one is exposed

-. to lase radiation above MPF limits in the most recent edition American NationalStand ard for Safe IeofLaers ANf 1 7136 1 Appendix A- and collateral radLiatinlimits in *rte1r CtR at14 ae Tie V l;,lits.

vi. Eye.Protectinn Protective eyewear, as specified by the laser safety officer, shall beworn by all individuals with access to Class 4W levels of laser radiation. Protectiveeyewear, when specified by the laser safety officer, shall be worn by all individualswith access to Class Mflb levels of laser radiation.

Vii -Servi&e Prne-Mmisreg All service procedures shall be performed by qualified personnelwho, when appropriate, are trained in laser radiation protection. The service personnel

- shall comply with applicable information supplied by the manufacturers andinstructions provided by the laser safety officer.

see AA )6- 7 - Afiditinnal Requirements for SpeMial Taner. %;nd Applicstions-

a. TnfrirepA TI er - Greater than 71 0 Nnntmeterm The beam from a Class 3fflb and Class AWlaser shall be terminated in fire-resistant material where necessary. Periodic inspection ofabsorbent material shall be made since many materials degrade with use?

b~. . l 17hi iM~dz .. f. ... A. B.

ch. T aer flpfi d Fer Trrnsmissinn ystem:

i. Laser transmission systems which employ optical cables shall be considered enclosed

-. systems with the optical cable forming part of the protective housing.

ii. Disconnection of a connector resulting in access-to laser radiation in excess of the

applicable WE limits in the mosnt rAemnt ediaatnional Standa forSafeTLos of Lasers A NISI 7361-ko Ix Taul v b"Mssilltkpac in-a controlled area.

The use of a tool shall be required for the disconnection of a connector for service and

maintenance purposes when the connector is not within a secured enclosure. All

connectors 'shall bear the appropriate label or tag asspecified in Subdivision

AA5Oc2.9c.i(ix4

Many metal surfaces which appear "dull" visually can act as specular reflctors of infrared radiation.

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ReA A A.?4 I- Additinnal Requiremenk for Safe Operatinn

a. Fye Prntectinn-

i. Protective eyewear devices shall meet the following requirements:

(1) Provide a comfortable and appropriate fit all around the area of the eye.

(2) Be in proper condition to ensure the optical filter(s) and holder provide therequired optical density or greater at the desired wavelengths,, and retain allprotective properties during its use.

(3) The required optical density shall be determined based on the type of potentialexposure requiring protection.

(4) Have the optical density or densities and associated wavelength(s) permanentlylabeled on the filters or otherwise permanently identified.

ii. At intervals not to exceed 6 months, each registrant shall examine protective eyeweardevices to ensure the reliability of the protective filters and integrity of the protectivefilter fiames. Eyewear with the integrity comprnmised or that is not sepniceabhle asintpdpe sbhould be di scardeAcias con dition shall bte discared a. tested forxacceptabilfty.

b. (1k-in Prntectinn When there is a possibility of exposure to laser radiation which-diaLexceedsthe MPE limits for skin as specified in Me not recnt idition Amirion Nstin ndrdfrc afe ITis'e o f L ANI 1 36 1 "Table lVc, the registrant shall require the appropriateuse of protective gloves, clothing, and shields.

C. Other Persnnal Prntective Equipment Respirators and other personal protective equipmentshall be required, as a temporary control measure, whenever engineering controls cannotprovide protection from toxic air contaminants and other hazards.

d. Service antl Maintenance of Tmserm Following any service mud-maintenance of laserswhich-thaLmay affect the output power or operating characteristics, the laser safety officershall specify whether any changes in control measures are required.

e. Modificatinn nfT aser Whenever deliberate modifications are made which could change thelaser class and affect the output power or operating characteristics, the laser safety officer shallspecify whether any changes in control measures are required.

see AA an -79- Cratinn 'Rigps Tj hel and Pneting

t/ This need is particularly important in the ultraviolet region.

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a. G:eneral.

i. Except as otherwise authorized by the Agency, signs, symbols, and labels prescribedby this Section shall use the design and colors specified in Figures 1 and 2.

ii. In addition to the signs, symbols, and labels prescribed in this Section, a registrant mayprovide near such signs, symbols, and labels any additional information which may beappropriate in aiding individuals to minimize exposure to laser or collateral radiationwithin a facility.

b. Prmitnvan±InsuctichnnL

i: T'ie confLflld amca sall ,t tu pirously posted witl an appu±opiate FISH WI viSs

-spified , l a A.230. anad Figures 1 mid 2.

i*. Operating personnel of each laser shall be provided with adequate written instructionsfor safe use, including clear warnings and precautions to avoid possible exposure tolaser and collateral radiation in excess of the WE limits in the most reeient editionAmeriean National Standard fr Safe I se ofL sers ANST 716 1 orenlbatpral

- - -Radiation limits in Iitle2l, CEFR Parl4alsTb Veni.

iiif. Service personnel shall be provided with:

(1) Adequate training and instructions for service adjustments and procedures foreach laser or facility, including clear warnings or precautions to be taken toavoid possible exposure to laser or collateral radiation.

-(2) Service instructions which shall contain a listing of controls and procedureswhich-baLcan increase accessible emission levels of laser or collateralradiation,'and a clear description of the location of displaceable portions of theprotective housing or enclosure whic-tbaLcould-allow access by personnel tolaser and collatera radiation in excess of the-MPE limits in tme most reentedition American National SRtandagrd for Safe Ue of Lasers ANSI 7136 1 orcollateral radiation limits in TitMe 21 CER Part Il 40 -and Tatb V limits.

C.- Tbheling Rnd Poshng 1Labeling laser products and posting laser facilities.

T-he contfrne1d area shall be conspicuously noted m with an apprpriate sign or signs a

- spnecified In Figures I and--

ii. Clasq 1 facilities need not be Atea Uncertified Class -JIasers shall have a labelincluding the following wording: "CLASS Ui LASER"; Class I f4acliities need nt- e

V With respect to laser products only, the labeling requirements found in 21 CFR Part 1040 may be used in lieu ofParagraph AA.3*r29r

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DRAFT SSRCR Volume IIJwmunwi i99fJun 21)D

Class2 laser facilities need not e s ted C 2ff lasers which do not exceedaccessible emission limits of Class .lf for any emission duration less than or equal to I Jx 103 seconds shall have a label with the following wording: "Class ffrlLaser (orLaser Product) - Avoid Long Term Viewing of Direct Laser Radiation"; Class ffa laserfiit zie ut be. posted.

iiiim. Class 2ff laser facilities need not be posted. Class 2ff lasers other than those specifiedin Subdivision AA.3ec22c.iii.(2) shall have a label with the warning logotype Aspecified in Figure 1 and including the following wording:

(Position I on the logotype)

"LASER RADIATION - DO NOT STARE INTO BEAM"

(Position 3 on the logotype)

"CLASS f-2.LASER (OR LASER PRODUCT)"

4=-(a4 Each laser or facility classified in Class ff-3a solely because of theemission of accessible laser radiation in the wavelength range of greater than400 but less than or equal to 710 nanometers, with an irradiance of less than orequal to 2.5 x IO watts he square centimeter, and with a radiant power lessthan or equal to 5.0 x 10 watts, shall have a label and be posted with sign(s) \_J

with the warning specified in Figure 1 and including the following wording:

(Position 1 on the logotype)

"LASER RADIATION - DO NOT STARE INTO BEAM OR VIEW DIRECTLYWITH OPTICAL INSTRUMENTS"

(Position 3 on the logotype)

"CLASS ffla-3a&LASER (OR LASER PRODUCT)"

(b2) Class ff-Wlasers or facilities other than those specified in SubdivisionAA3c22c.i;4X) shall.have a label and be posted with sign(s) with thewarning specified in Figure 2 and including the following wording:

(Position 1 on the logotype)

A-LASER RADIATION -~ AVOID DIRECT EXPOSURE TO BEAMS"

(Position 3 on the logotype)

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SSRCR VolumeS Hdmun,., 19911iunt .2WA4 noA VrSSRCR Volume IJ*mm�rv-)-99#Jwz��2OM. flPAUT

n=CLASS flfb-3LASER (OR LASER PRODUCT)n

- t5 Class IvC Jasers and facilities shall have affixed a label and be posted with sign(s)with the warning specified in Figure 2 and including the following wording:

(Position I on the logotype)

"LASER RADIATION - AVOID EYE OR SKIN EXPOSURE TO DIRECT.'OR SCATrERED RADIATION".

(Position 3 on the logotype)

"CLASS W-LLASER (OR LASER PRODUCT)"

vii.(6) Class M,1113, or W4lasers, except lasers'ised in the practice of medicine, shall havea label(s) in close proximity to each aperture through which is emitted accessible laseror collateral radiation in excess of the limits specified in Tatles I nal 5±1Lredition of American National Standard for Rafe Ise of Lagers ANST 7136 1 and thecollaterat radiation limits in Title 91 CLO; Part 1Q4Q with the following wording asapplicable:

-(tl) ' "AVOID EXPOSURE - Laser radiation is emitted from this aperture," if theradiation emitted through such aperture is laser radiation.

(b2) "AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted fromthis aperture," if the radiation emitted through such aperture is collateralradiation.

(c3) "AVOID EXPOSURE - Hazardous xrays-are emitted from this aperture," ifthe radiation emitted through such aperture is collateral x-ray radiation.

diLff Each Class 2,1113, and N-i0aser shall state, at position 2 on the required warninglogotype, the maximum output'of laser radiation, the pulse duration when appropriate,and the laser medium or emitted wavelength(s).

-iL8) Each noninterlocked or defeatably interlocked portion of the protective housing orenclosure which is designed to be displaced orremoved during normal operation,maintenance, or servicing, and which thereby would permit human access to laser orcollateral radiation, shall have labels as follows:

(aL) For laser radiation in excess of the accessible emission limits of Class f-Lbutnot in excess of the accessible emission limits of Class 2, the wording:"CAUTION - Laser radiation when open. DO NOT' STARE INTO BEAM."

(b2) For laser radiation in excess of the accessible emission limits of Class f-1orClass flas applicable, but not in excess of the accessible emission limits of

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DRAFT SSRCR Volume IJivzitan. 991J MW ne a

Class fMl, the wording: "DANGER - Laser radiation when open, AVOIDDIRECT EXPOSURE TO BEAM."

(cI) For laserradiation in excess ofthe accessible emission limits of Class RU, thewording: "DANGER - Laser radiation when open. AVOID EYE OR SKINEXPOSURE TO DIRECT OR SCATTERED RADIATION."

(dd) For collateral radiation in excess of the emission limits of Title 21 CEFR PartYf4Dabl V.

(ia) If the limits in pagrapli A p fThbk V Title ) CIFR Part 1l40 areexceeded, the wording: "CAUTION - Hazardous: ElectromagneticRadiation when open"; and

(fih) If the limits in Title 21 CFR Part- 1 4Q orgraph It f Table V areexceeded, the wording: "CAUTION - Hazardous X-Ray-Radiatin."

(d5). For protective housing or enclosures which provide a defeatable interlock, thewords "and interlock defeated" shall be included in the labels specified inSubdivisions AA.30c22cix-.(al), (b2), (ac), and (dd).

( (al) The word "Invisible" shall immediately precede the word "radiation" on labelsand signs required by ?mragraph-AA.3ec2c. for wavelengths of laser andcollateral radiation that are outside of the range of 400 to 710 nanometers.

(b2) The words "Visible and Invisible" shall immediately precede the word"radiation" on labels and signs required by ParagraphrAA.3e29n. forwavelengths of laser and collateral radiation that are both within and outsidethe range of 400 to 710 nanometers.

xL( All labels placed on lasers or signs posted to laser facilities shall be positioned so as tomake unnecessary, during reading, human exposure to laser or collateral radiation inexcess ofthe MPE end Table Vlimits in the most rpeent edition of Amperic NatinluStandard for Safe I se of Laserg ANST 7116 1 and the collateril radiation limits inTitle 91 CFRE Part 14O.

xij(llLabels and signs required by ?aragraphAA.3e2c. shall be clearly visible, legible,and permanently attached to the laser or facility.

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C C CII. I

mmI

( BLACK)I

(YELLOW) (YELLOW)

NJ

. a%

-POSITIONi 'I

\OLD BLACK LFITERINGI

(POSITION 2F\ BLACK SYMBOL) DOLD BLACK LETtERIt/

( POSITION 3BLACK LETTERIN G

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~I1

MUTE)

\, '1 X, {POSITIONl Io LIO BLACK UTE

X5{ ~~POSITION 2 -:s w \ . . . BOLD BLACK LEltERWO..

(POSITION 3- BLACK LETTER )

(

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ISSRCR Volume 11 rn A LrSSRCR Volume IJJmmv-I-99-fJun�jLJOO4� Whti A E"T'

-- �-...L5A�J�Z I A

Sec A A t3w* - Rurvey . Each registrant shall make or cause to be made such radiation protectionsurveys as may be necessary to comply with tliLSection-A.3+. At intervals not to exceed 6 months,surveys shall be performed which include but are not limited to:

a. A determination that all laser protective devices are labeled correctly and functioning withinthe design specifications and'are properly chosen for lasers in use.

b. A determination that all warning devices are functioning within their design specifications.

c. A determination that the laser controlled area is'properly controlled and posted with accuratewarning signs in accordance with Sectian-AA.3629.

d. A re-evaiuation of potential hazards from surfaces which may be associated with Class ff-1and Class v-4=beam paths.

e. Additional surveys required to evaluate the laser and collateral radiation hazard incident to theuse of lasers.

[Ser- A AA9-1 A- Meamirement Rfl TnhtnirmLntietinn Each determination requiring a measurementfor compliance with these regulations shall use instrumentation which is calibrated and designed foruse with the laser that is to be tested. The date of calibration, accuracy of calibration, wavelengthrange, and power/energy of calibration shall be specified on a legible, clearly visible label attached tothe instrument. -

a. Measurement of accessible emission(s) for classification shill be made:

i. uUnder those operational conditions and procedure which maximize the accessibleemission levels including startup, stabiliz~d-operation, and shutdown of the laser orfacility,

ii. wRaith all controls and adjustments listed in the operating and service instructionsadjusted for the appropriate maximum accessible emission level of laser radiationwhich is not expected to be detrimental Wh' ,iunction integrityof the laser orenclosure, '.itegrio ,:

M iii. 'aAt points mn space to which human access is possible for a given laser configuration,e.g., if operation may include removal of pdrtibrnskof the 'protective housing orenclosure and defeat of safety interlocks" a be made at points-accessible in that laser configuration, -

iv. wWith the measuring instrument detector so positind andisso oriened with respect tothe laser as to result in the maximum detection'ofrliation by te ihnsr e, and

y.......uent and

v. ffor a laser otert'han a laser system, with the laser coupled to that type of laser energysource specified as compatible by the laser fabricator, and whid rtiaLproduces themaximum emission of accessible laser radiation from that laser.

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DRAFT SSRCR Volume JIJzfanim 199!Junz2OD

b. Compliance with the requirements of the regulations shall be determined by measurements ortheir equivalent whichthatccount for all errors and statistical uncertainties in themeasurement process.

c. Accessible emission levels for classification of laser and collateral radiation shall be basedupon the following measurements:

i. The radiant power (W) or radiant energy a) detectable through a circular aperture stophaving a diameter of W2millimeters, excet for scanned laser radiation, and within acircular solid angle of acceptance of I x 10. steradian with collimating optics of 5diopters or less.

ii. The irradiance (W cm' ) or radiant exposure (J cm ) equivalent to the radiant power(W) or radiant energy (J) detectable through a circular aperture stop having a diameterof 7 millimeters and, for irradiance, within a circular solid angle of acceptance of 1 x1 3 steradian with collimating optics of 5 diopters or less, divided by the area of theaperture stop (cm2).

iii. The radiance (W cm-2 srf) or integrated radiance (J cm' srf) equivalent to the radiantpower (W) or radiant energy (J) detectable through a circular aperture stop having adiameter of 7 millimeters and within a circular solid angle of acceptance of 1 x 10-5steradian with collimating optics of 5 diopters or less, divided by that solid angle (sr)and by the area of the aperture stop (cm2).

iv. Accessible emission levels of scanned laser radiation shall be based upon themeasurement of radiation detectable through a stationary circular aperture stop havinga 7-millimeter diameter and within the circular solid angle of acceptance withcollimating optics applicable under Sabparagraphs-AA.32t3r±.i., ii., and iii. Thedirection of the solid angle of acceptance shall change as needed to maximizedetectable radiation, with an angular speed of up to 5 radians per second.

d. Measurements for maximum permissible exposure shall be measured as specified in AppendixE and MP? i,.... i. Ile mosmnt reent edition Amercan National Standard for Safe nTI :ases AN v w e1;1 ]ables P id b'%-c.

See A A -313- Meinale slrfveillance- The Agency may require the registrant to provide suchmedical examination procedures as it considers necessary to protect the health and safety ofpersonnel. Appendix A provides recommended procedures which tha±apply primarily to users ofClass diV lasers.

Sec AA 4-n - Nntifictinn nf Tneident.

a. Imnmetriate Nntifirstion Each registrant shall notify the Agency immediately by telephone,faxor einaiL or telegraph of any incident involving any source of laser or collateral radiationpossessed by the registrant and whichithaLhas or may have caused:

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SSRCR Volume ll..snu '... r1 H99lu_2004 "ID~ A X1'.-_-. . - .-.- -.- . - - --.-..._.... _-. .. .- _ __ v L E I A

aAn exposure to an individual of greater than 100 times the MPF limit-, in themot.r e~nt editio n A ~ i n N tn ~ ~ ~ i ,t n-~~ IT Tnf as 'rs AN ~T 71 36 1 or- resent edtion Natiinal Standard for Safe RIIse ofLaesAS l61,ocollateral radiation limits in TitMe 21, CFR Pr.tlA4fl s Tatk V Iiruils Of lose1 Ca

c0llatelU riodiatiozz; or

ii. aAn exposure to an individual whicrh-anvolves the partial or total loss of sight ineither eye; or

iii. uAn exposure to an individual whicrh-aLinvolves perforation of the skin or otherserious injury exclusive of eye injury, or

u .

iv. vA loss of one working week or more of operation of any facility affected.

b. Twentyfolnr t4nir Wntifilction Each registrant shall notify the Agency by telephonenaxrcail n rtetegi ap within 24 hours of any incident involving any source of laser or collateralradiation possessed by the registrant and which-thatbas or may have caused:

i. aAn exposure to an individual of greater than 5 times the MP limits inrecent edition, Ameirkcan Natinnal Standard for SafeU I anew, ANRT 7136i 1 orcollateral radiation limits in Title 21 CEFR: Partld 40 TJll V alsts ,f al4sc or- II~k~d 1aa r ation; or

i. aAn exposure to an individual with second- or third-degree bums to the skin orpotential injury and partial loss of sight.

=ec AA 5-3 4 - Rpnrt cf(rexpanires Alnd Ice~sive Tevels-

a. Each registrant shall make a report in writing within 30 days to the Agency of:

L. e~ach exposure of an individual to laser and collateral radiation in excess of the MPElimitm in the most recnt edition American National Standard for Safe Use of Las- A~NSI 736 I or collateral rmdiationlimits-in Tittle 1 CR Part 1 040

ii. any incident for which notification is required by SectionrAA.3433.

b. Each report shall describe the extent of exposure of individuals to laser and/or collateralradiation, including estimates of each individual's exposure; levels of laser and/or collateralradiation involved; the cause of the exposure; and corrective steps taken or planned to betaken to assure against a recurrence.

c. Any report filed with the Agency pursuant to SectionAA.345 shall, include the full name ofeach individual exposed, an estimate of each individual's exposure, and a description of anyinjuries. The report shall be prepared so that this information is stated in a separate part of the

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DRAFT SSRCR Volume HJJunuuni 99tfJuneC2lQ

report.-

See- AA I-i - Nntificationg antd Reports to Tndividunal. When a registrant is required pursuant tog jSctimonAA.15-3Ato report to the Agency any exposure of an individual to laser and/or collateralradiation, the registrant shall also provide to the individual a report on the exposure data includedtherein. Such reports shall be transmitted at a time not later than the date of transmittal to the Agency.

S5c AA-+7-6 - Remrds-

a. Each registrant shall maintain current records, which shall be kept available for inspection bythe Agency, showing:

i. The results of all surveys required under Subpatagraph-AA.2948a.ii. and SectianAA.H3Q3.

ii. The results of all instrument calibrations under S=itm-AA.3RI

iii. The results of medical surveillance performed under SrctionAA.3332

iv. The reports of incidents as described under 5=ctioAA.363.

b. The registrant shall maintain such records required by dfii5.Section *Au-7-until the Agencyauthorizes disposition.

;L.This paragraph is suggestedfor use by States which have the authority to maintain the names of individuals asconfidential information

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SSRCR Volume I J....., WI 9i11 .��DRm CTnhbl 1- Mlc, I - A*e.t1ilde F P.ivin.lT .airit'. fn. Iv.te Radivitioin

Wavele Eng.tiivil on jatin. T - Acce .hk.c11 en III I . i i

f VA PM ,n .iv~ A

z801but -.3-.0 A6 ip---------2.4 A f foak&'eJ s (J) ~ radiant erm'py>300 -----A-8.0 A l0~lklt* Watts (wV* ladiant Dower

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-11e v uiAle i-it IAI r biV*1 -i die iina* nitude o thet ampling i*-x ; vat (t, in uits of- secnds.

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DRAT SSRCR Volume IIJm,,ctt" 1wze92Dglfd

rr I I l I A t 1 -- -- * I * ._ I

- .

4 butO 0 3.9. 1oI

T'i'lle ffT FI.q fV A 11 IMM i* fillh Fe T.q R.I

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(nanoictido ,) (cds)

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CSSRCR Volume IIJ6,mmnT-l99fhtn -2 ..2

C CCRAI? A

tasz lllif a av s: entisivaiuii 1indi aid euntilm' t aaccesiblegInision finiLt eA *.

W'avelength l Emlissionl dur-ations .MRac T - Ace.r.tlsll rnik.,;Ncn 1;C............. ;LCn

:3.8x1O 2.75 X. .O . Wni ir\a , . -

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Tlie var iable fit the expression is lwin~ iade of the satipiliiiginite, val (t, in units of 5ecoirds.

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SSRCR Volume JJMzratit 99+1une-2D- W~n A IC'r--. ~ .. ~-. -..- .-.- ---. --. .-..---..--. .. . - - - - - r n � A

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AA2R

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DRAFT SSRCR Volume llmuuy f199bfjune70)04

rvlaXlIMIuTl1Permissible Notes for

apvlgl4kEzosule Thr,.c, l I:^s f (PEA-) eatcaiations(1(1Z (s ('1) &Mn~ee

Mean ... erird

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iuiai National Stmidmd fb1 UI1d ic v5afl U L UI *Nl~V, ASI Z136J.1-980.I

NO T 3. E -1 Ib 1X k- 0.400 - 0.700 F111

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T+ =t OI f = O-.55JJ - 0.700 (see Figuze 9).

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SSRCR Volume Hdrum ... V ne ff 004- WIM ICr- -1 - --- I XMILE a

MaxinnnPern isilvqle Fnismwie MP:R r.i 'viie;, v Bi~fimTN -M - ---- -f

Jc ~ n I -| - F3e , 2e1.. 1 .il kill .1"2i.. 1 m e

MaXIIIIUM

wirveleng~th, -k Expovsure 9FiLIle, t PiS~si tMP4)ClcllAnA O! )rI 1c ic & Men-saret t

- - .. . . . .. I . . . . .. k. .

., T re - :.6 -

0.304

0.30G

0.309

0.3]0

0.313

0.314 (40

0.3 1 5 - 0.700

_S9 -3 _0 4 A -f -3 +cm -

i* 4 -10' -3 !o 4 xU 7 ev,] - at 0ru .56t J a1^-j ---- -G 6 I Cnim- wviriwiveris

d9fxf 4 f x -10 .l -:-= .s ^9 ̂ , x t 4 , t. H-O T +c

* n X9 f 4, 4 A t 6'+ ni

* ng9 4 -lsan2 -2

*, n9 - _ x 1 4 ,. x tO -+ .m1V q W A. rv t See Jime 5 &

44 x H +c for glaolicAV9 -3 x 60 .3 x 10 - - - qXeCSCIltatioII.fe9 - 1 O.S5tGcri4zm

*n *n x- W c

0.'400 - 0.70O f^ 10* 1 v n t _lfrtitn

V.t6U V.556ieV1 - fIV ' i1 apcl tiU O,AT -t nsr n e fdT 441

V.J .VUI .83t a cm I whidrelverU.JJU - U. 7UU Ai 2e +j 1Vi OLJ ~ 10 rWLGm"OcE

0.400 - 0.700 104 -3 x 104 2.1 eT ir 3ee i>cl& Figu-es 7, o, 9,H1 &12 forgrapliic

- lepxcsatltatiornatiplllle pulse

- ifiitafivLvS.

Me. 1n hr.4*

0.700 - H oe-

(.70( - i.46(-0.700 - I . T0(

fe-t teen,,Pn ffiI-seIfe - fe I. l1*n ̂n 4 ^ An *1Z. 7 e +1~ V 3 IV J o*tV- -ST

*Sre: ft;l,, E: Ffi1 gruphk1 I UI/I LMIuIP60i.

* AA30

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DRAFT SSRCR Volume IIJa4mmni-j 199fJwr12

MarvltLluUl

Painissble tfutes furVravelgfl4 k EApUoU1S Ti11M, t EAEUSULI (IvMAPE) CaeCUiatiUon

(1 1) (I3 (' -1 A MERcMM.... e

1 - 10 1eFar 1nffir d1 4 3 C1O 109J-m -T7k II

10%- 10 f _CMSeTbe-!? 6~~.56t * tcrim fbiL apmituis.-10 0.1 V. L11 4 Se AppweLdAbE

r.l Coectiollfactoirs& Fismtr. 1 .. .r.6-7

Thl vamiabks;, in eic exApessiUos ar, tlrc inagni utad of die exposme ti;,e (t)n uirit.ls OseLiods, and flie miagnitude of flfe wavrctikgth (k) in Units of iunicicincets. This Liratmial is fiAinLmican Naliuoal Stiadmd fbi flie Safc Use of fems, ANSI Z136.i-f980.

NOTES. e* - i fbr k - 0.4e0 - 0.700 . .,

6- 070e0 - 1*.50pin (be f 8',

t ,- 1 fo1 k- 0.40 - 0.550 I u-,

O-.550 - .0.700 pni (_ f*gm_ 9).C9§5h° ;°} EX k - 0.5JO - 0.700 $[1I (se ;gia 9)..

AA31

Page 83: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

SSRCR Volume>7Jr~zatit 199iJune .OO2.4 nWD A Xr-- _ -. _. .... � a

'r" I_ I- raT. n y~.lG |V L

MeViVT1111. II rl~l "MIe M, I-,XIt Mcl~l PfmP (M i M.I ,Sk| I I I M .c I IM I M IO il TMf i lie, ME

- -% Maxillimn,Penni~ss~ibl Nolcs fbi

Wavelen~gth.. k - Exposaic Thilze, l Ex&posue %I ,zMPLE) (Calcmlaidot(m1il) (R) -m (6i i ) ' &: me-,..l it r

fftrtv.__ -t -

0.200V - 0.36VE0.3030.364V.JVJd

V.JVU0.3070.309

0.311

0.312 (ef

0.3 1 J - O. TOO-0% .3 is; - O.-4TO

sa9 r4 -5 ot4 *0.560 _

f V,"9 3 x ^4 0 4 inwel

J 1-,lls I;,;li,,IV le- t x i o.

IO9 -9 3 x 10 4 i.6 A IV -2f1 fli,4

n4 .4 -i^tT..

1V 4x ^U 61 IU JIJCIUII.10tLr-3 x t e 6.J X ~l ev.' e Fg s

f ̂ -9 fb S4t rapisA-9 4 rf

1O- 13 x leJfO-

le. -3 x flo t x 10 iW

V.'TV - I .--V

T r -G-dm 17|1 GU

-7 . .1 ._; ( IV 1.It J~

9-i nin limiltin

ZPC~tires .

10 - 3 A 10. 2. e R W See Figates 6 & S.

I .- T -- f 1 Vel IVIv J 1 -111111 !i1111 tir

- 10 H.1 sV H to 100

*~~ nnn t11 o! i I1UI.

TIIC ~aiZials. in theC cxpCSS;ions mc dieC ~agiritude of the eouimC tl;,,, (l), int mfits of

secondsI~ ndll tIC luamtitude of theS wavefengulthJ M vnmcrmetl

'AA32

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DRAFI SSRCR Volume IIJwnum-I 99fJune '24

Acceq-61 I- F n i IItr Y r ti

fca>. .N c sv. FM i^r Ma sltl. (?ffi , ~ ffi:

A. Accessile entission lmits fiu cllateial ,adiati- n having wav1 1ng4lis 41atei llan m eqiatLu 1 80 lull luat fs tw ua equalu t i inn as cidm1 t1 1 Lu 1il a ziblu niisionu h 1initL OCeass I lase. 1ad iatui as detenniined fioi Table I fbL the apfpoiat wavakelagt 1(s))a.id

wssi:on~ dulatiors

1. Lh tl.e wavelengfil twaige uf s 400 tun, frL all cizzission. duaiLuu i.I

2. hi flic vvavciqkudts Lmuge> 400 Jinn, fuL all elission datations lss Iirhi uI equal to Ii-e3 od mid, when aplicabl e Sp 2.2Th.., fbi all enrasulodurat. __

B. A*cwcssibic cinission finft 'Lid MPE fRir coilatel4 radiat;iot witduii Le X-lay Laug Ug

WaVCICIIglhS iS 0.5 1piillfLOCjAgti;i ill m1 hou, aLv.aged oveL aan aMa of 10 squaie ct~ltfinctewith no dinimislli ss L1atet12aU J ce5itiltiretts.

C. Tlic MWE fiu optical 1cllateral raaliati iloall n bie letenin.uJd aS specifed iL AjpenduiA E.

AA33

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SSRCR Volume If .aI .- i99une-2004- nRA~rSSRCR Volume II*rmmty-S9I1un�2OO± flD A i�F

-1 I

VSMM..s 11M WtvnveL*elv .g 1* Iew...I.t

(h., i MI iktol r P - -I It 1,1t2 g ,

Wavelen Tt

.1.0

>3 02.4 tO 31; 3S01 - 1.0

>30 IO 800 330.0P 1.0

>800L~t 1 1060 V

___.._._.__..._..

>-00 to 7006 .-- 6 1.0

.J

AlJ.e L545Vu1AL 0 -h e if-: 1.0 1.. then. iz=.00

-OV to .V^ -51 . .

_ i

L-rr - P . * _ r _ _ _ I., ! _

rLqtptr. IiUth Uli maeI UIV41 (£Il U;.L, VI

seods, and flzic waemgl (, inmits~ ofa

I AA34

Page 86: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

DRAFT SSRCR VolumefJfz.aaiwj i99!Jum=ZM

~ 1 *- I r s I I , . . - _ . 1 .

- ---- ,, - r-,Ilmtl N(linil- -- -- -- I I!,

1 1 . I I

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t, 10(,00 cE e we_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Fo r_ _ _ _ _ _ _ _ _ __I_ __-

-_- ---- 1 _ _ __I fli^ I ^

3104 -2

30652307 9

-300- -±J V7 4v. V.7

. ^... I. � t 4

. . .JJ. sr

pj i pjj

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770--- - .37 - - 1 7.0 210-

780 f-3 -----1- -2A-8.0 -240--80.0'70A - 1-4A- 1 a7gnOI I - a

9-9V-A .'IJV a _. I 7 V ,l./V

AA3S

Page 87: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

SSRCR Volume II *muur *991rn .2OO- 7004- DRAFT

830 1.56 1 3.0 10.0 30.0

853 1.95 1 3.0 10.0) 30.0

903 2.44 3 10. 3

953 3.05 3.0 10.0 30.0

1000 3.82 3.0 1 0.0 30.0

1050 4.78 1 3.0 10.0 0.

-t00:0

060 53 . 003.

-+00:0

1100 5.00 1 3.0 10.0 30.0

1400V 5.00 3.0 10.0 30.0

AA36

Page 88: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

DRAFT SSRCR Volume HIidunw,,if991&nJ~2e>QQ

nanulOmvtestC5)- -to - t-130- l-1,000- -13,000

SC ec sec sevsc bec

IJO 1.01;40d.vI GOO 1.0 1.

in^ 3 (oI JVV\ e .

*Fhtfaim ki . --3 yec-rmdand - 1.0 i ;>1 o.

w I Ace - *_1_1I., .. S _ s _ _ rue _s-_ _ !_s____1 *_ ____!._ i<

NE- IH.: I he YMlaD!C tt; lb MS M36se 1MCM OTlae- g s lt r

AA3X7

Page 89: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

SSRCR Volume H1zhaninn; i *991imn...201)4 D~rrSSR�R Volume lIz rmmrv-i99-Jjme 2004 DR AI�'T

m1 I * tIt * - t * *.- A* ,I* *et. V ** * I VIX ***1ic Avon A*IC*I*f

1.I lIJe

-Eosure-- 'Vsilble and Medimn, and

(S ( . T ' . 2-S.4 Tan ET r s- (64-. r-e pin (B f -o 1tV~~ S11 -D1tU1 atioumt- v-Ultavrokt- -Nadfae Fa -h l w v -USizbmillilmitGr

E yc-?WE i-m - -m26- 1 i -t-1-mmSk 1ME..o .~o' .--m- im--: .lu .Imies MFIE 7aetn t3xt- -0mm-- -7- --- t lUI fO1T 1fl

BE)~~wtii 11nn14 8 lll 80 llllln 80 Ual~ll80li

* I * .. -- ,. I . I I d -r V1 I-W r '' rT^ 4 * fI Ills TLMIltd IS 1W11 tAllU114al aik aUIUI tIUIVaI 1 tul UCia aL JU5C. UL Lab SL tr1UN1 4L, I 0.l-lOPJ.

WAT-; Tl Ie fi vt ..1 Las !If.% fell II oit di riml R rv .. lfl tryv. it!x~ inl 24iIM Z13G.16-1980.). s .............. . ............... , _ ... _ __^...._,..w .. _... ._.. ._ .. , . ,.. _. . _ _., ., _ _ .

b1 Sire s4:puI tzgli Up AA.32'a

coffti/ n1g , vc c I nl:uloUwe, by n an 80 anpu i Ul, jU, v.

Fru Uiic spc;ific case of omptial viewhL, (bemJ collectilng) fistunrMltS, U±hC ajCI luLCS listed fbi cyMPE anf ski 1 MPE a*ply to tL exit am of

AAIR

Page 90: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

I

4>

E;�6

Q

CNI

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C C C

A -

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3n

.9

i'1'

SE

Page 92: Letter enclosing a draft copy of the latest suggested ... · ["Intense-pulsed light (IPL) device" -means a device that emits radiation to energy density levels that could reasonably

DRAFF SSRCR Volume Jdufnuij-f99fJ ie2D

Ani1tiai National Slacludwd ZI 36.1-1980-.,; 2

IJ)

5 a a a P . -a . P 9 s -_NOTE:. Extktisd o asr e ula subtcnse ot appauiit viaual angle Baa.A*nguhTstttcjzbsso (a~~l midua minges) <amm- adrmonlsileed fit~ietlll Viir,geLLI

L;oit;ig An1gttd Subtense (Appaucilt Vi5umd Aargle). jmmbTO-.Animtic iual oStaidard Z! 36.1-1980

AA41

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SSRCR Volume IJizy... ,y-199+1JjmcQP4,4 m2A' A MVr-- -. --------.-----. -.---. .I-,--..-----.-.- ------- £a

I II . I . I I . I ..1- - .......................... . . * . . ...............

2 .t.$ C I 4' %. *0 - t 4 9 1. 't 4 * I *1 4 * 4I t 6I 2.4 601 :

-64-4

l0 lasS - lo-t l0-, 10

- -- -- - I

NOT 4 u1 COILCA L ittio awtuI ilntlonallilol at wavelcTgiI bcwIc U.7 i x.ii 1.4 F ci, s laieJ.

Bi. ln 1 ct Ei.cular Expsa c bxVisibk icJ a~r N~fiflaid RadiaitVII(9-0.4-1.4 t iitab~r~eig- b~nl~~ssrxom

1/ Angular subtense a.,, in Figure 3. The variable in the expression is the magnitude of the exposure duration (t) inK.> unitis of seconds

AA42

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DRAFT DRFTSSRCR VolumeI-lmin~-j H1wnIM2o

-AMC1es=11. NlAtiIIIAl :,I'll,^ B^^^ - ^ ̂ - and ^ w - A.... dcud Zi 36. 1- i98E01-1 10

I - - .X J -,1020 022 024 0.26- 0.28 030 0.32

AfPE f[bL Direct Sualat Exposmue l U1to l- Radiatiotfoi fExpo sure Durations f -oi f0a to 3 A 10-0s

!/Unless 0.56 Ad is exceeded (possiblefor exposure durations < 10 s at A= 0.305-0.315,um).

AA43

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SSRCR Volume IIhanspit9911ynn21QQf- : ---_ _ DRAFT

2AizceiicaltNatiojta} StaitcfdadZf36. 1-1980 .

N69E. for cirucction factois it i.5 4 pm, see Appdix E, Lgraph 5.Tlie vatiab~le rtc xissimi' is llic tnlpitadc of die czxposate dulation t s1ull f eo.s

- - --- . FJIURE GMfPE fol Dixcdt Ocai 1 Es05ac to Uhtpviolet :d Lsf Radiation

(- 0.315-0.4 ptlirmi 1.4 n- 1 inn) fbi sistec iitscs 6, eotiLuou Exposmes

AA44

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DRAFI SSRCR Volume IUJanumw) 99f!JneQJ)4

4i9.ai, Nax iunal Standard Z13G. 1-1980Y Y _9

. .

Q

me .

- a.- C =

* II U 1 3 3 � I i a - I

F.

.1! I

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a

lK

tA

I1 I I I II I I II I I ixrl IT 1 r Fco m l unwv~w~ auvom

IIIIII IIII I I 111',*' H N " ' 1ln 1 _ _ISo. a 000 v S*4 a -on U a @ -w S -

I _. 2 * *

NOTE. For coUnectio. factors at waveIei~q1is bewel 0.7 amd 1.05f p.m, see FUigul 3.Tlie vamiazb in tllhe expicssiiU is U1c mnagnitude uf die expostce dmUatiuo (l) in mrits uf secnuds.

FIGURE 7MPE Cuz Ditect Eocuiar Exosme U Lto la Rl"ialion (k - 0.4-0.7 miu aud 1.051-1.4 JMn)

fiUln EliExtld JcSa fui s l SiLI Pulscsoi .upStic

*/ Angular subtense 2 anrin in Figure 3.

A A45

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SSRCR Volume 11 daninvy i SSRC Volme J~mn -1- ... ..... RAFIRAFT

5 -- n1r061i Nationa Stadr f5.f- 8

44

0. 3.80910II121 .

NE)TE.ek:-::fo k- e= =.

-e-k- -- -- -

-- - WTLEG45UI

w'avckngthI (?) is in tuits OfAl1LcAU1UckkJ,.

eCnecionUf r4~tor EC fi -Wavekugths 0.7-1.4 innu from Table 5 mid-6

AA46

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DRAFT SSRCR VolumeIldruaj lY99ijungs00

AITICITCMI Natlollal:jtmlldud ZIMA.-1980

B6

4

8

6

4

2

.C..

2

1.000a6

. 4

2

a6

2

a

4 4

2

10 10a

6

4 4

2 2

I frL. l. I . l - _ -

0.50 05h 0.600 0625 0.650 0.675 0.700

NOTE. See Tables Va mid JV7b.

FIGURE 9eottectUio Factuo ts %elm"lu 1 + fbut WVavelengflio V.JJ-V.7 st p1

PlI I IU1I IrmaL It1 LLILI

AA47

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SSRCR Volume i mm -i - - -.---QAIX} XA T

104-- .. ..

I oo .

_ 4.

- ---- -- 1-l W> * 1.

- I . -- - ..L'JL%.fUA.rI iv

W%.UI r Mk;I -r, lUL nabean Ivibcwjoju,- v ;sn a l. .J D H p1-_ -- - - - TV V- Vs Av&irUW

*/ Angular subiense < a,",, in Figure 3.

AA4R

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DRAFF SSRCR Volume Al HJummi 99-Aune V)Wd

Amm im.1 Unfif.11:11 qIVIIIIIIH 1 71 ;A i -4-P ;, 5A...._& ._.... . ...... L. ._v. .- ,

ao 100

FbIURE i iOLUulm MPE for Exterided go Ceva a Functim of Exposme Dmation muid Wa~vetirdvirs

*/ Angular subtense Ž artin in Figure 3

AA49

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SSRCR Volume Hllursucs, Oive204-~ --- -~RfT

r~zi~ ILdiNIational Stwiardha Z! 36. . i- f 8

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AA50

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* DRAF SSRCR Volume IJuua"-j 1991AWw-2DO!

Pad Ak

A 1prPNOs¶. *AA

. .~TT ^ * rT -r v rT' * -Tx . A . . .. v I | \ _ l , S | . R . A s s x E;

A A 1: : - P.I rt.f ll;.l rt^. weiffmi. - Thve basic icasonzs fiu pet forinlvlg l1jedlical sm v eillasce -OfPCIS011.1.l WouIicLg, in a lase, envirotumint are dle iami aS fi uodic! potential lhealdi lazwads. MedicalSUi &ilaliice exalaii&ratiulis 11ay include assessiiit of plhysical QhcsIs to Safly pe, ficfin assigi.ed

duties. bioluogical unitouinig ofexpJosure to a specific agm, aud aly dle liuu III 'iologic dmiard

o, effect.

Physical fitIIs a Miftt are 4 sed to ldetml,.,init wfictlieri a nlnauy cc would be at inac~ased orUtnusUal Lsk i1 a plicuai c ,nCViiunentt. Fo, wotkcns uuisiir lasea devices, llie 1 eed fbi thLis tle ofassessict i isous likely to lb detb m ,lifed by factous uo tiii 11 laser 1 Jadi.iorc. pe. se.Specifi.

infbimation uon mcdical 5u veilI4acc reLqieiPtS thLa muigit cAist b ocause of oui~ pukotmtiaiexJoSa~s CS uchs aS toIUAC se i ionliZinlg tadliatioir, etc., meC outside llie scope of llhis A-ppcixx.

Dhclt bioucica1 niuioul ig ofolaf ascaditiul iS iuipossible, a nd pzact ial itndiLiCt uiulit~finl

duuuIgh tle EISe ufOfi isona1 dosiineters is nut available.

Eal dktection ofbooi diaung ot damage pibUppub~b If at Jnu~iCu. OL subacute~ efet 1114 iesu~ltfiuom eAposUIC to a patii.ulal agent at leve ls below that Mquired lu piouuc acute injmy. Acliv

i;.tc vLtioin inust tle., lc possibl lo atoml csfi 1 1 di biological danage OL tou allouw icovmy fiouii

bjiological cflects. Altthough cIfonic nuJm fiuln lassi radiatiou. in die allrpiolct, ticar-ultiaviotet,

bloc puitUin oftdi visib amid nen-id iCgiUns appmas to bu di ciudicuafly posusi fs tu wuotwcs

using lase. deviccs arc plifiilily fiuin acidXenal acutc itrjuics. Based uponU lisl involved with

cannt ascs uf lasc, d ~viccs, ,.edical Sulv'millmi4 lui atsi S d1 al shuuld bc incoitorate ;.lo afoi inal sltidm d appJ~ear lu bc Iuiniinal.

VUtICI MgLTICiltb it! faVH4l Of a uJPillfliinr, CAkt1ltiVe llGUIdiC USveifllanGc havc bImi based Un U1C fear

thal lepeated acciLlILts .,,iglilt OCuEU mid LIIal WOLr would not cpmt1 i niniual acute injuzis. Thie

v el y Mnali ,itniu.lber ot lase, ,IfIJMS ttlatttaVe baee,. 1 tedx in the past 1; years aid thLe IxAItkntsafcty ,ecods ^ wit laser leviccs duos n.ot pruvidc suppo tu to d i uiil rnIt.

AA-_ 7 !" rm~~l rA.lli1lnl

A A - * Rat.n* 1 if' f. , .A A *11 ailllIwr Pt F w' ll si}{[

A2A11 P r j !5I. ' . M..-l&Al Pxa ;. ErtA 4 Jtcpt fbi cAdirmatinU ffulHowing suspectd

ilijur.y. tlicse ..t tlMe ull - -iilatuis ieqttir-d. ence vp.osc -is to cstabilishs a basclinec agailnst wifich

daiiage (ptim11 ily uocua,) ctani bc menasuimd in cvtIL uf aI- Adetal injuzy. A Secnd puiposc is loide1 lftiiy cei Lain iWO~k 1 s wliu Iliglht be at spicial1 ,is in dut;nci 2&jusue Lu t lbiCtd wavielength

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SSRCR Volume lleammrp-1-9'*tlww 7004. .. ____ ____D

hilscis. Fo,. kincideatal w~otkceis, unXiy Vib~al avuity *II=LeasCsalb 1,74 ,sl~usd Fur iaSCL wvokets,t.eical h1;stlois vifl citg nicsaincit aud sclectcd mallinintivon protocols aMC Lephled. nis

itt~. wavc.kIegt1 of lasci radialiu, is thc dctcnnijianz fb which specific piutocols me iequitcd (sce

A s 2 Ecaniniiatiuns shluuld be pci.miticd by a, wideI the supa visiun uf anoplhtlhahl ,ogist ot o hqucalifled pliysiian. ecrain of de cIa.ninatio piotocols ,.ay lpysfa~incWd by odlic, qualified pracdtionio kuso tduri.ian, mniid flli sc elv ionf a plysician. MianyOphLliahuuluogists Inay PLefiel Lu to ui i p lUrI tlI usIl~ eycI. dlliLaLn tu asse total visaalfuctioun as oppuosd to finiitini exanhiuation to thse aeas that nigIht b1 dainaged by vadticalai s

taiatin.. So.iu. ezinlpyicrcia may fid t adva"IIgcuus to offla th1 se awiAL tdiuouag eAai e iiadLms tofIicih wair.kiz as a licalfli bciz1 fit. Fui e~ampic, ccratin of die &aAziiaius, stri as

tuloilleun.t.g ji -.t y niay be of vallc in detctclin 5 ulduiiow disease coniditiovns, in llis cascglaaconlia. Eveni l langh this lype of uplfbla is muclabcd to ovik with lasers, ajlppLiatcr Ildc;ati ntaentiuyn will pruoinuo a licai fuc. Ailltdu. 1c.oiii slkin dawiage floni lascr iadiatiunhas na t *cn _ atd _ n d ivlikly, _i _ _ a la_ b 1t been11 ade.uately studied. i.nikdsk 11n mAanfinatauiInS sagg scd t Lu SCi vY aS a baseline umtil ftupc CluepideLnhJost*ludy iiicatis w dic.i lhy ac uie Akd or uot.

AA2 P.1. rexio- Merf i-X Pr~ni;.nl T.. iu odic exAanliatiuiamifioll nttequiLtd. Alt thpieelnt tiilc Jnuottic ficaldi piobenku iravc cnsLfd to wouk wirt laci tadiatiun. Abu, iniUot

uSCS- Ofi-hsS dt uiti~t inl JIuuOniC CX1/SMUiO ufI PlIOyS CVCvn tlulow ICvdS of Ladiatiuil. * laignuiberi uf ditcsc cxaniinatiis hzavc beci pmfGitzied in die past and uw indiciation of awy detcutabi

* iulogic. cilaii& waS 11ukd. Einploymsu nay wisli tu tou ffum (i ripluyow)s pmiudic u aui..atioLs- u1 vthi.ei mdiical tIaciuitIUlU as a haiutalic buiifit, lhuwucml, diumel docs nmut appar lo lo anyr valid

teawon tou tlqulic suchi umauiiiziafiuos aS piLt of a zinudical suaCifflcc piruLamn.

Toit-.A A 1 , i; Medical mnalissis lupriinmaiy .utPOSC Ouf LitLiniationMaillinatiuoLs is fbi tile legal putoetmio of flie cinployel agais2t uIWMLMana.Cd clai.s fb dainage tLatuilt vuu aftne a eunipllyce leaves a pari~cuiua jot.. 'Hie decisionvio wheftlfm lo uffICL .icqutii

nul~l uwaniuditslI is efl Lut individuail inployems.

AA o 7uiuu .. ;..uii nf all as wumkuc.

nThcjmticentspast uyc iivist and fainily uyu hibtovmy iu vii.wud-.

*AA y ? i71 nt iomplaintl whsich hu now h aboat his cycs arc ruted.Any listoiy of skill probimns is teviewed.eu.i i eL and paSt ziiuduatlvn . is invicuwd.THe patinels goi.ieal licatll statuS should bc inquiied abiot wifli spcial Miuiplihasi upun diciases

whihl h g. ve uuulal O1 ski.. Pi UUICbIIS.Ci rain niediall cunditioLns amiay cause the fascu wvkei to be atii hiceased 1isk if cl ulai ot ApV~ u

: o ultiaviul olut puucctiu iz asuCl Ladiation is psvSibkc.Uisc ofi plotovctsuitiiLng medicatiuons, sUim aSil phluleiu iaz.ines amid pboulaaicims, lauwdIe iuelild

fo. biologic effects in th1. coulra, ics, and rutiLra uf expuimintntal awiinzials.Api*akic indivdi 1d s would bc subject lo additional tietmal u jxpoic ficin n aL-ultravioict

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DRAFT SSRCR Volume11 Jwa.j -t99-flmtnjjm

radiation.

UI,;s Ch.I RJ viwiVW, 0 fIlower of laser tadiationz in liise waftlesngli s is requiue d, _thmei; silouuld elc lo LuaS~Un to dity emlnploymiienit lo l individuals. With curreint laserSystems, Juolh arJO vnii; toiev lt low levels of blue laser radiatiou is very uuasual.

S -r£___] !*_ _N1711 _________1AtAnnedi- t i.mili A RT(T'h1d fx*pr p*acancIit exmi Vt ations

f all aui,.;mde anmd laser Woikers. Distaic;c visu aauity simu0 i be tested loth wilL and witlhutconecctie leses; lo 215. Resui ssould be tecodd in Snilknfi s. lii visual acuitg at iLearis tested at 35 ciL annd iicoideld ui Jaegci-tuztec figkd S oi Suni&Clu figULCt ~witt amid without fmes,- i[any. V'isual a=.uity sciicifin iztiinits Lnaay bIe; used.

AAM !:? a Mnif.ife.c! Ref.cindo.. Required fb rep ,lacenicti exmniL~tmdons of all lases wmkcils

wl*c.. indiatked. Tlis i; to ,,,easmc Lthe patielnts zefiac;tie enzor, and s niew vifSuai acuity of thepalienl miust ble noted if tlhe visual acuity i i5npioved Ovfer llat a4Uiieved widL die patiilL's old knlPi ebwliptioll, O if fie has no lelnses at dthe tini of Lth eAanmiritiou. Tfis ;Aariiration h slAl be eicdoul i;ll 4 h peisomiel wlhose best corrected distlm1lc vitualyaiuity in eithei eye is less tian 20/20.

AAk-t ? F.~xt.i -nIl t cllln Pni.-lin. Requti;d fiol p ei~plceLnilt emihiatiouns fb laserWoLkcLnC usinig laseI systeIms pr1oduizM tadiationi below 350 nin ul above 1400 inn. Tlis includescxmitinationl of browvs. lids, lashes, coljuljmciva; sclera; conesic i ad illarg size, esuality,MaCtilVity, WuLd tcguiarity'.

AA.:.2:2 . .Fka;l.al;n.i by Slif T}.nl Requi.rd fio pieplacezUeInt iAaciihiations of lacel woikcrs \_J

using laszi systemius produciLg ladiiou below 420 ILI or ab 0ove 750 IIUI. Tlhe cmunea, i;;, and iensai; iwauinzid- wluh a iiunuziLzsuzLup; auu ucslw

A =liii f. nn ihinnli* Ffle clFPe.Ji mi1...n ti. 0 p 1 ( ll.Itifij.IG Required for

piLeplc~cinLe;l eMallillatiulnS of laseL workcers aSiali hIse Ls Oduiiuy itadiation bcetweei 390 IUll

and i400 nn amid mny apitakic. w~tka-. Iu U1G ii;Lr~dini of dU potiOn Of the mlilflatin lluIo pOilnt.lo ble cov-eLd me. iote pi CLiSC;L O alsence of opacities in. liie Liiedia, lie~ sliaipiL.ess of otlini;e of theopt; icnt vc; d1 iize of tlhe plysiological cap, if pieseit, die ratio Of tIe s;i-e of tle retinal veinjs todial vf llic iriitial arLeticb, the pjesecLie 0L absenice of a well-d¢fied lilia adid thie pi eismie 01

aubce of a fovcolai iwflcA, mid amy retinal patloluoy that casn be seen with a UllCt

6plJlitaimLoUsiL . Even siniall deviationlis fLom, miial slould ble descibed and L clfflly locaIIedL.

AA2k2? 7 k. k1in F.-n. n'n.'M..r Not ,eqxufted fio pi eilacenitiit exauiiatiouss of lasei w otk ss,I to w vi ,s ;t ICog nfo llployci; wi di itoy of pfroto-smitivityU1 ml ri c il; nwljit Wltl ultiavioeIlasis. ExaiiiathinL f Utle sk;,. fbo peseice of abnioiuni p;ligmeitation o0 depigincittatior, keiatoscs,mlalignancies. ctc.

AAzi.2_n d Nlt i _ijLud. ThIe Annsekids s t io pesentd to uach ey; :s;paatwlyand aniy disltio,, -ft grid is .noted by tlhe paltiilnt and drawn by hifin; may be parl of a LlorouglI

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SSRCR Volume Ildhrit..n r v199iz 'i 1rSIDALrS .S.R V e _ l A A

A A=L19 -T. .L p. Not ,cyuired. Tlii5 ; 5 flIC .. ,eaSU Lbcizt of inraoctlai pyessuIr,; shlould bejail Of a flmlVgli opIaInlE IEUlUogic examaEinion,.

A=A -;o2 nzrl .. , ,. .1. nf t *e of.; e .; mI r. *r 1 1f *e .. NutrL7Aized. T'His iaudes die n.eaof tlle i.nala and head of tdie uoti vit ave mid sholud be taken i11 culor; nay b obtLained by titexatn.inin physiciy~.an Lu tonoie Iulty dCSC iib letillal abiuiuliuatitiCS. APyjupLiae ltcluhugics to zeduceilI patiiLTitS eXAOSLIC lo optical raIiatios should Le eniijoyed. :

A2Ji1 ~ (l F.crth exA iliatio.. iss d lcdbe dontle aS deneid necessary by

Nlceatic.- .. rar F.Ahvn qi[%III41-KNWI fj. y.nlycw

suspectcd eye isjuiy stdould -bh drn lo ano upiialulugist. Psonss witih sti1n injuics sromiu1d b1vit.LI by a r-liy-icianl. A . . :

* AaX T * *s@. L r~-' J r* .~ * . *S 1 B tt W* f 1.* .tt t

s ~ ~ ~ - - - - - t. - - - -- - -- *----- * T. - * -

Actual expiurui iu tlas.. s huIk~las been Uinhl&LUU Oi uveut WlAi~kIIt. Lf ib LUt SnLiSL. datac~ue accideifed ilbjty h4as bcici rare amrd that die few repoils of repeated eye exAainiations 1mave notsimted miy cinoic eye c1.gcs. FO. lLhcs leaSOI.S, MaAllilratiOulsq~i e c.4nLts arie u iah. IIwreva,aldinal expelineil ts buh Iv an d ajLuw-lbanLd iadiatiui idcate die ptential fn clJunijcdu1 1age frIon !utli ahuavuC %..% LFA UbUAOLU to =tahU waveicistisof ufnadiatiuo. 1Is opacitis=havie blei pLoduce'd by tadatimi i41 ldc 295-450 mUnI imaig and a, also thcoiuticaily oussibic fium95O-40AOmir

i Pitotoiiciialiti;tis appi)aito~u l., 1os.iblgl lo mduice ly Luelo 350-500 un. iadiatiuii. Iflaser s zinmai c vdo d _thrcqaiiV _luic _XPOFUUL Of r &worke. to evert low leel _

.. _ - . ..1 I_ ..___ 1_ It *__ *r *_ I___ __ _tA_ L _ I t .s * Is __aclalion uin tlhese wave-fiegth tegonS, It lb LUcoIJIn.IIctM uiat su~ i wuMateSs IJC i..Ieb in,,, tit Mulg-

tinii ep)ideflviUogi stludies amid have priiodic exmninatiumis of the appiuopiate cyc stiuicues.

Epiderniolvgi stuJies pf wobkcrs with.cinoic skin mpsuare Lu, iascr iadialuio (particalmly"itravioiet) me suggested-. ' .. , ,

AA.5.!F~ii~I~iaM!,*AJ, Tki eOphtahnici.8cici~nfing I==a Workcisn, 6u~a4, 1277--279

AA.5.2fIalhaway, J.A. Stair, N., 3Sles, E.M., amid Lpiglton, .E., Ecilar 'Medical Survefflalce ou.Nfict way and Laset MoWie Ls, ,T f 1CtLd 1 19.83 -688, 1977.

AA.5.f lhathliaWtay. J3.A., T I Id Me1 l.dicial S ut vcilai.c of LaEwa and Ivliwruwavw Wu ik, ke(Rlrt. etIr 1,11 t c i..,POIA Fltozl.3ar llcbgy, So~elas EL g*Itfllhllulgiwa filtm rationaiis;

S: to.kholl . 1975, pp. 139-lG6.

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DRAFT SSRCR Volume HJainnmu) ti99ijua2,Q1

Part AA

Each laser facility and mobile laser shall be registered in accordance with the provisions ofthese regulations.

2. The laser operator shall demonstrate his competency to operate the laser safely.[Demonstration of competency may include, but is not limited to, proof of having taken andpassed an acceptable laser training course such as given at several universities or sponsoredby technical organizations.}

3. Laser radiation outside the spectral range 400 to 710 nanometers shall be as low aspracticable but shall not, in any case, exceed the Class f-Llimits under any possibleconditions of operation..

4. Levels of laser and collateral radiation, measured where the audience is normally located, andlaser and collateral radiation measured where the operators, performers, and employees arelocated if the radiation is intended to be viewed by them, shall not exceed the limits of Class fLduring operation. Radiation wind shall bemesurMeamired radiation includesreflections from targets and scattering materials. For example:

(a) If the average laser power collectable with appropriate apertures is below 0.39microwatts, then the limits of Class f-Lwill not be exceeded.

(b) For pulsed radiation and scanning radiation treated as pulsed radiation, if the energyin a pulse or series of pulses is less than 0.2 microjoule collectable with appropriateapertures, the limits of Class f-will not be exceeded.

5. Operators, performers, and employees shall be able to perform their functions without theneed for exposure to laser and collateral radiation in excess of the limits of Class fH-Zwhenthe radiation is not intended to be viewed by them. Areas where levels of laser radiation inexcess of the limits of Class H-2exist shall be clearly identified by posting and/or through useof barriers or guards to prevent entry of operators or performers into these areas.

6. Scanning devices shall incorporate a means to turn off the beam or to prevent laser emissionin case the beam stops scanning or slows down significantly. In cases where a mirror ball isused with a scanning beam; the limits of item 4 shall be met with the mirror ball stationary,or the mirror ball shall incorporate a means to turn off the beam or to prevent laser emissionif the mirror ball stops rotating or slows down significantly such that the limits of item 4 or 5are exceeded. Any such scan failure safe-guard system musthave a reaction time fast enoughto preclude audience access to levels in excess of Class UL.

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SSRCR Volume IIminr.r.y 1 99fu120O4 Tno' A cr_111 _-- ... .. .____ _ ___ W -- U_ GAit

7. Except as noted below, laser light shows shall be under the direct and personal supervision ofa competent laser operator, as specified in item 2, and the laser beam to which human accessran be gained shall not exceed the limits of Class Ff2at any point less than (a) 3.0 metersabove any surface upon which the audience or general public is permitted to stand, and (b)2.5 meters in lateral separation from any position where a person in the audience or general-public is permitted during the performance or display, unless physical barriers are presentwhich obstruct access by the audience or general public to such levels.

Exception: In cases where the maximum laser output power level is less than 5 milliwattsincluding all wavelengths and the laser beam path is located at least 6 meters above anysurface upon which a person in the audience -o general public is permitted to stand and at anypoint less than 2.5 meters in lateral separation from any position where a person in theaudience or general public is permitted during the performance or display, then a laseroperator need not be continuously present if other provisions of these Guidelines andRegulations are met. In other cases, upon application to the Agency, appropriatearrangements may be made for unattended operation.

8. All laser light shows shall be provided with a key operated "on-off" switch. In the case of theexception of item 7, there shall be a designated individual present who can turn off andsecure the laser in case of unsafe operating conditions.

9. The maximum laser output power shall be limited to a level required to obtain the intendedeffect.

lo 10. The laser system, including projector, shall be rigidly mounted to prevent unintendedmovement or accidental misalignment.

11. The laser operator(s) shall be situated in a position such that performers, audience, beampath(s), and laser display can be viewed at all times during laser -operation.

12. Where laser output power must be limited to less than the maximum power available in orderto comply with criteria 3 through 9, the laser output power shall be measured, adjusted, andrecorded before it is operated at each light show. All-safety.devices necessary to meet criteria3 through 9, such as scanning-rbeam power interlock, shall be functionally tested and recorded'before each light show.

13. The laser system shall be secured against unauthorized operation.

14. The following precautions shall be taken during alignment procedures.

(a) Alignment shall be performed by a competent and qualified individual and with thelaser radiation emission reduced to lowest practicable level.

(b) Only persons required to perform alignment shall be in or near the beam path(s).

(c) Protective eyewear shall be worn where necessary to prevent hazardous exposure.

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DRAFT SSRCR Volume f ... mi-- Y99fJuiw 'D4

15. In addition to the requirements of AA.l 1, before the laser light show is permitted to operateeither at a permanent or temporary job site, the laser light show operator or an authorizedrepresentative shall provide the Agency with sufficient information, data, and measurementsto establish that the above criteria will be met during use.-4This shall include sketchesshowing the location of laser, operator(s), performer(s), viewers, beam paths, viewingscreens, walls, mirror balls, and other reflective or diffuse surfaces which may be struck bylaser beam, scanning beam patterns, scanning velocity and frequency in occupied areas andwhere beam strikes wall or other structure, radiometric measurement data including outputpower and location of all measurements. In the case of open air. shows where a laser beam isprojected into the sky, the information submitted shall also include beam spot size, beamdivergence, and beam power measured at the projector, and a copy of the notificationprovided to the Federal Aviation Administration.4

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M�SSRCR Volume IlAm-any 7 7 n7Ah PTSSRCR Volume IJ*mmuy-I-9914u&?200A. flflAIT

* LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROL

IFloor Area)

NO OPERATOR IN CONTROL(Side View)

AA5R

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DRAFF SSRCR Volume LIfwnvuu,. Y 99IJwm.10)4

LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROL(Rising Floor Level)

OPERATOR IN CONTROL(Side View)

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SSRCR Volume M_ __ DRAFT

LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROLPHYSICAL OBSTRUCTION

(Top View)

Rope Barr

Audience

OPERATOR IN CONTROL* 1.PTYSICAL OBSTRUCTION

(Side View)

;W.*-.:

.'AutdlenesIa<

. :

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DRAFT SSRCR VolumefIfAu.r) i99-Ijune O1

LASER LIGHT SHOWS

Application of Safety Criteria

OPERATOR IN CONTROLINCLINED LASER RADIATION FIELD

(Side View)

OPERATOR IN CONTROLINCLINED LASER RADIATION FIELD

(Top View)

Lasw

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SSRCR Volume II dimirmy W A rrSSRCR Volume Ilium ur-199�I*,ne 20041 A VTI.-, .

Agency Form AA7 PPFlWFl)!N*- A

[APPT ICATON FOR RPGIRTR ATTON OF TARPR FACITITY,MOBTIF TLASFR OR SERVICE ORWANT7.AON

Registration is required for all uncertified laser products and for certified Class Hflr3b(other thanthose exempted by Subpaagi aph-AA-3Lbtaii) and Class W-Llaser products.

1. Applicant's Name:

Address:

2. Location of use (if different from Number 1):

- Telephone No.:

3. Type of registration: Laser Facility( ), Mobile Laser ( ), Service Organization ().

4. Prior Laser Registration Number, if any:

!% niirt~- nf laqer radiation (Class ffl-firl ndi C!hs~q f -4inl v)A.

a b . c

Number of Sourcesof Laser Radiation Range of Average

Wavelength Range In Facility Mobile Power or Energy

UV (< 0.4 Spm)Visible (0.4 - 0.71 jlm) -; .

Near IR (> 0.71 - 1.4.n) .Far TR (> 1.4 Wm)

Name of Laser Safety Officer.

Qualifications of Laser Safety Officer(use additional sheet if required):

6.

7.

-

8 A i A o A

8. Authorized Agent of Applicant: ' ,- .. . . .. . .. ] (Print Name) (Title)

9. Signatures:I Laser Safety Officer I. Application Date

Authorized Agent

See associated instruction sheet before completing this application.

, AA62

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DRAI;r SSRCR Volume lJ",,unuz Hf99fJung,'D

[Instruction Sheet for Registration of Sources of Laser Radiation(For exemptions to registration requirement see SccitkmAA.+63)

PLEASE PRINT OR TYPE ALL INFORMATION

tc. eare i;, compq.ling aid enteinug all .quiiet infb 11 lintio i the applicalion will hlpd tO oeertt

Undue delay amd to l educe the lniouLt of cotnL espondence necessaiy. Hom - WjyCo a tiu is eillysolicitc ..

1. Applicant - The name, address, and telephone number of the person or facility in whose namethe registration is to be made.

2. Location of Use - Addressor location where laser sources are operated, serviced, or'manufactured. If lasers are serviced exclusively on customers' premises, so state.

3. Self-explanatory.

4. Self-explanatory.

5. Sources of Laser Radiation - Include data only for uncertified Class fflfb-3and Class IV-dlaser sources, for certified Class HlbH-iaser sources not exempted by SubdivisionAA.3]i-6xj2), and for certified Class V-4Jaser sources. For each wavelength range, enterin column b the number of laser sources and in column c, the average power or energy of theminimum and maximum output source.

Service organizations should omit column b. In column c enter data describing lasersanticipated to be serviced during twelve-month period beginning with registration date.Laser source manufacturing facilities, enter words "Mafacturing Facility" in column b; donot enter numbers. In column c enter data describing lasers anticipated to be manufacturedduring twelve-month period beginning with registration date.

6. Name of Laser Safety Officer - Name of person appointed by applicant to serve as LaserSafety Officer in compliance with Section AA.5LEh

7: Qualifications of Laser Safety Officer - Briefly describe the Laser Safety Officer's trainingand experience which qualify him/her in the areas listed in Paragraph AA.i-+

8. Self-explanatory.

9. Self-explanatory.

Mail [TWO] copies of your application for registration with [TWO] copies of your laser safetyprocedures to: [Name and address of Agency].;

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SSRCR Volume iAMMr" i i vl-991 fnb2Q TMV2 A r.-!---- , ____,.____......- .. ... . .. _._ ... v a

Part AA

* -'APPF.NnlX **RATWWRT~~ ANN

Gieneraml

Training shall be provided in laser safety and laser health physics to all laser safety officers(LSO's) responsible for Class Hffbl3bLand Class V-&Lasers. Training of LSO's responsible for Classi±, Class *92, Ilass-Harid Class ffhaaWasers should be provided as needed. .The degree and type oftraining shall be appropriate for the degree of potential laser and associated hazards. The LSO isresponsible for ensuring that users of laser products are trained at a level commensurate with theusers duties and the degree of hazard.

2. I ser !Rsfety Training Tnpics

Topics for inclusion in a laser safety training program should include all or part of thefollowing, as appropriate, for the class of lasers in use:

.a. Description of Lasersi. Definitions .ii. Lasing fundamentalsiii. Lasing medium and types of lasers - solid, liquid, and gas

.. iv. Pumpingmethodsv. Optical cavities

b. Characteristics of Laser Light . .i. Directionalityii. Single color (monochromaticity)iii. CoherenceIV. Intensityv. Divergency'vi. Relations of specular and diffuse reflections

c. Biological Effects of Laser Lighti. Damage mechanisms: thermal and non-thermal effects from pulsed and cw

-W. asersii. Eye hazardiii. Skin hazardiv. Criteria for setting Maximum Permissible Exposure (MPE) levels for eye and

skin

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d. Associated Hazardi. Electrical hazardsii. Explosion hazardsiii. Chemical hazardsiv. Fire, ionizing radiation, cryogenic hazards, and others, as applicable

e. Laser Safetyi. Laser classificationsii. Control measures including personnel protective equipmentiii. Management and user responsibilitiesiv. Medical surveillance practices (if applicable)v. Governmental regulatory requirements

f. Laser Health Physicsi. Calculation of MPE limits for eye and skin under various conditions of laser

useii. Basic radiometric units, measurement devices and measurement techniquesiii. Laser hazard evaluations and range equations

3. T~inhii A. g Gide Fin. r ,le. %~iyFnje, ves A................ Frtwlen R .N.x v, mili. ci vnnr fce tn-%l cnifirn{ihTable 1

Su1ggest Training for T SO's and Fmpnloyee

I-TGTRFST (TEARSS LARERTraining Vehicles 1 ff~i*2 fflaa fflb3h IV-4Manufacturer's Guides A M M M M M

& Operating Manuals

Safety Guide Literaturel] N/R N/R R M M

Review of Applicable Standards N/R N/R R M M(ANSI, Federal, State, etc.)

Laser Safety Orientation N/R N/R R M MCourse2/

NIR - Not Required, R -Recommended, M{- Mandatory

1/ Suchas: AmericanNationalStandardfortheSafeUseofLasers,ANSIZ136.1; Ynzqvr fbstittp-,rfApmnpii.n Tran_Sofety Guide' Amerircn annferenra nf anvrcrynntnm Wayt[nI FMjpoigty - A (nMfir ('nmtrn nfrny r 1vzn-rd or

any other similar literature the Agency considers adequate.2/ Because of the greater potential hazards from Class ffIb-Iand ff zLasers, duration of course would be severaldays. This training may be done by outside specialists ifnot available internally.

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SSRCR Volumel1 IJdmrm 9jI a ALJIje2 *0D AE}

MEDICATLUTRVFL TANCE

1 - Purpose of Medical Sirveillance The basic reasons ecf orming medical sirveillancp AfPerscnnel oring in a laser environment are the game as for other potential health hazards Medical

rveillance examintion may include ssiment ofphysical fitness to sfelyperform asigneduties biological monitoring of exposure to a secifc agent and ean rly dtection of biologic damageor effectL

thyical 6itness assessments are used to determine whether an employee would be at increased orIinimusxaa rige in palticlar envmirnment Forworkaer using lastdevices, the need for thi type ofa:seysm osent iq most likely to be determined hy factors other than laser radiation Specific informationQflsedical surveillance requirements that might exist because of other potential exposures iuch atoxic gases, noe ionizing radiatio6n etc are outside the scope of this A rendimx

Direct biological monitoring of laser radiation is impossible, and practical indirect monitoringthrough the use ofpersonal dosimeters is not available

Early detection of biologi o iAmage presupposes that chronic or subacute effects may resultfmm e-m llre to a partic aubr vigent at levels below that required to produce acute injury Activeintervention must then be possible to arrest fiurther biological damage or to allow recovery from

aiological effects Although chronic injury from laser radiation in the ultraviolet near-ultravioletbhue portion of the visile and near-red regions appears to be theoretically possible risks to workersiing laser devices Are primarily from accidental acute injurie Based upon riskq involved with

consent iuses o~flaser devi~e~s medical surveillance reuirements that should he incororated into aformal standard appear to be minimal

Oiuther uguments in favor of performing extensive medical uIrveillance have been based on the fearthatreeated accidents might ocuar and that workers would not report minimal acute injuries. he

.. .1

safety rerords with devices does not pmvide sipnort to his argument

Medical Fxaminationg

2 1 Rationale for c x amination.

.? 1 1 Preassignrnent Medical Examination- Except for examination followin? qu nected inijurythese are the only examinations required One purpose is to establish a baseline against whichdamage (primarily orl ar) can be meAsired in event of an accidental injily A second purpose is to

i-sw-- o might be at special risk from chronic exposure to selected *vaelengthlaw ersEFor incidental workers only vismial acuity measurement is required For laser workers,

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rilialJ~t~ris~ es-visural acuity measirement and selected examination protocols are required Thea velcngth soflafser radiation is the deteiminant fnr which specifie prntncnls are required (tee

Paraarnhl '2 Examnin ns should be performed by or under the supervisinn of anQph gisaLn.o=other qualified physician Certain of the examinotion protocols may epoxfbrme~~ther aqualified practitioners or technicians under the supervision of a phvsician Manyophthaolnulogi9&may prefer to perform more thorough eye examinations to assess total visuatfl.ltion as osed to limiting examination to those areas that might be damaged by partcular i aerrad ia e nMplnyer= may find it advantageous to offer these more thomu rh examinationg totheinr worker-, as, Health heneft For example certain of the additional examinationt ch asgufliometry ~y he nfkm ndeettp:nommn diseas'e conditionsg in th guinlve

thnubthig type ofproblem is inrelated to work with lasers appmpriate medicsal intervention wdllpromote a healthier work force Althniugh cbrnnic skin damage fron laser radiation has not beenreportedsand indeed seems inlikely this area has not been adequately studied T imited gslinnmiwnatinns are suiggested to serve as a baseline until future epidemionloical study indirateswhether tbey- reneeded or nt

I) 1 I Perndic Medical Examinations Periodic examinations le ntreruired At the preet tienn chronic health problems have been linked to wlerk with laser radiation Als maot uges of lnerdo not resultin chronic exposure of emplnoyees even to low levels ofiradiation A large number ntthese exanminations have been perfnrmed in the past and no indication of anydettahleitlogie

hmange was noted Employers may wish to offer theiremployees periodic eye examinationsr or ntberntiedir rinationn as ~a health benefit however there does not appear to be any valid reason larequire such examinatio.n as part of a medical surveillance program

.) 1 2 Tennination Medical xaaminations The pri-may piurpoe of terminatiori examinationg is forthe leggal prntection of the employer against imwarranted claims for damage that might cwiir after ane mpl leaves a partieuihwjob The decision on whether to offer or require miuh examinations isleft to individual emplnyer

I Medical History The following protocols are requird for preplacement examinationsi ofall

lager wvorkcem:

Theiati's past eye historyand fil eye history are reviewedAny current mpints which he now has .about hbikyes are noted

a Any history of skin problems is reviewedCuurrent and past medication use is reviewed

.The patient's greneral beaith stthis. should be itinared about width snedal ep~i~nn

digenaqes which can give ocular or skin problner. Certain medical conditions may cause the laser worker to be at increased risk if chomnic

- XpasuIrc ultraviolet or blue spectrum Iscer radiation is pnnsibletse OfPhotosengitizing medicationst such as phenathiazines and pnsoralen, lower the

thresholdftrhbinologic effect in the cornea, len, and retina ofexperimental animalsAphakic individulafs would be subject to additinal retinal exposure frnm near-uIltravilet

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SSRCR Volume Hzinfu,.my I a" fifnO Inn.1 IM"> A r.I7I I - -- iU T _fll W I a

1nlessc'hronic viewing nf nwEr levels of laser radiation in the sewavelengths isrequir.d,dtlar= ishonldde- nareason to deny employnent to these indivduals. With current lasers~yQmS chronic exposuire even to w leve f be laer diation is vey unusmial

.9 2 ce ANSI ZJ6 1 American National Standard for Safe Use of Lasers 6 3 and Appendix E±X:d(1,inlflEYi11ipnatlfwxa

3 Med1irc Referra1 tFlnwing SnpcedI or Known I aser Injuly Any employee ith asispected eye injury shnuld he re ferred io an ophthalmolngi t Persns with sin injuries should be

cepn by ai physieian

AA 5 Referencg4e.

AA 5 1Friedmnn A I The ophthalmic Screenn ofT aser Workers Ann °C-llp Hyg, 1 977-990192L

A A 5 M-atha-iay I A Stern, N. Soles, P M, and I aighton. F. Ocular Medical Suireillance nMicrcwvae and L aser Worke-r J fCCNP 1 N 107

A A 5 athaway I A The Needs for Medical Su1 eillance nf Tf aer and Mierowave Workers,-,, Curent C'nneeptq in Ergophthalmology, Societas Eraophthalmoloica ITntenmationalis,

Stockholm Sweden 19 8, pp 139-16Q-

AA 5 4Wolbarscht MT nl1nde Mr lesting vislalciltiesfor medical sunreillance rt: ensure job fitnes I Oup MeA 27RQ7-90l 1985

AI'PP1RFJTTM AA

. _ __ ._ _ _ _-44_ __

fvU-A9I T1E1EIT F.FN-FOIR MANK'ThITFM PFRlM1ifl RfF FEXPO)4f REI1

I . rniiith ji±ezi Tlc Ilitig a s~cc.fied itz Tabll VIII s tall tfcic nt xn'nwll cirulCa OVwl Wl i :ad C aLrd taiaiwt exApUswILe lCMb.c averaged fbiu Lnemmu 1 ent1es mid fckUlfatio~s

-- - u all MPE value.s. ;

2. , T..i-. nl,.., n. F .. l'.l. F ..e .impose o ts,.ln. tixon

(i)- i) l11C suau as laim PLays,

diodes, an~d diffus6 flenctling sm faces slrll lbe considaced exteizdcd somxces if Ihei. Mllgnaisnztisc,* i.e., app[alient vistmI agle., is equal to o. greatm f~l cminin a5 speifiedi hi figme 3. An

extentidw souice sdl. ends ai, rmgic at tlhe ubsCL vez's e" aquaial tU U1 gjlcat=I hia the L1 lgi sibtellscu

aT- aS ps fied ;u In;igmue 3, =oss'fllc greatest auhuni dinlimuii of dlies vue as d lby lthe

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DRAFT SSRCR Volume II Jzraawm 99!J7ac2MD

obser ver.

(ii) Ail other lascis, sucll as dw~sewitht cotlinzatedte beas wbh p4 oduce n Sa i all, i.e., neury dirnatiuo-linLted; eLtiaLi ;image 41k alsopo;int souics, sliall b~e conssidered intibeiralsview;I iae ld shsall lave anl anlguai sbtiben~s, e;.,

dPaCIzel t ei Wil, Iguqe. klss thi.u umm as specified ini Figure 3. Soutce-s suti as lasex ma~rs, 1 ILipkdi ids, ui iiiultipl diffuse enflc.tng stufiices l sh e b is&d ei viswiiie cdsab facs af y of

tic sepaiate images w/hose anguimul subtelse is less fklan min. A*Tr y wlios Uuitels aLe

sewataed by an angle less dian um tre teatexl as exteded som .

(iii) If lineasm emients ox caictllation~sWLe LiqtiLtel dLstiLiLiIlisll fiislt be mladle betw eat intrakdkb miiwiul ad exteded-som icWie

in die 0.4 tl 1.4 ui.nicuirete wav elngtLh Legion.

i

1-'_fPU(I4 n hiavH i,L unit Ui aiatI5irs PMt.~ US! Ji'iU~i UWffC CM WUV~ MknftU Or IIF5ilI C pld4LV3 M IC 3IplU&J.JU.tpV44 ml1 U

Lountisluom ii usC ( 4W) VU.ivgmf computaii1n vft/.e MIPE is comphl. EbvuSwesfitnl 1/ise uJ' a! Wlvdcidlt s in J/53SlUClinIC- d(,,su aies, ,. udiimi c gsP apo ptionlalbauis fspcuf.pl, ui e pii. dcen wiWim cmvG u11 , ionActuZ. 7i Reshnuhmmum mpm-ous r !5ar Jpau~cs uand cPr audoiafn is rivJ1i Sf i uib ii O filr~ C nw VG5igdgSn

L~ildtV^5'o J v rdi fJou resesihitions anfil o v datc i a~sre a. rihhblk;

Th 1cungul4a, .>abt nse ;.> flui MLwe l1" cvd ivei me qfJn v r fi Jru-ucJ isu lgru ~laue fio"vnt he

SVgLL.i adst1ifisfunlefi tr fIr c Hr In, aif;~ g teula, i"Jg s thit am", em r is56 ange k Pv ic di i iesffit t6be"Ill t ;i illgfi ont el enIe-saw LLc{itx8

(1) WE values fbi diiect actlmua exyvsme txCLU~lS 1IS .)A..UIJ t- * *m _h 4 31 *);Stcd3 * ' m : P .i P4. ?. .

Lh,.SIgYfl2U. I1lS-. { Ullfil fcs VGWlY 15CSGl5.G) E CiSCG^ i1 V5)5UJGlif~ __ 1| :LiJ..

IsI

-sX' s OV ~~ WOX s V s _~~ .. J_s~W *.. . VAs - . _ -u W ~ l

Lnd use ruue.uiie~iLn t CPuvided in Appendi. Akasm el ens ftol MaxnLiUIU PM niss;bte

EIxpmLsU 4 id. 5 ad FiguIcs 4, 5,6,m ad 10.

(C) ?VIPE values fin oUlca expoue to

exltelAk d sourcs fbi sizte pLdsA s expo~sms me sp cified in T94 rle IVl fiw U1e coJ SpIAa. eciaqualificati 0ons a1 ld use rCquilCnlCu S are P 0 vided ill APILI AA Me ets fox Mailiulu

Pc nissible Ex~pps)e 4 and 5 4m-d Fi;gures 5, 6 and i7.

- -: .. d) WrE vaiacs fblibiLoatl-loand colateraladliatioi islMal be wcigle1d witi .egl lo spectal t mLt in 50 Iamonictmi ;iciutsi using9 Talbks

0Va or IVl, as appiopLiam.

3. MPF Fr1. 91ii. Rt.'m I'.r f fz Ren.. .MrE valies f&m S1 I1 sidirpoSlme to a laslex bani aspecifid Jin Table IVc. Titese levels RnC fwLusLb-CaSC Cm.sditions and arl boasd ou thil best aVailale

inlfoiniation. for repetitiv~e-poused lasets, ffz ME s fu kinX exposme are applied as fcoflows.Exposure ouf tle skin sali not exceed die vTE based upOil a singls-pJuls exposmue, and diem aviasgLnadomiPcA, ofiIe pulse train sl (.not exIcaed t MPE ap8 cal Rfo the total M exposmettai length:

Qua*I# 1ificarim - W ~ Viibe /i ca-I sa Nfldvi Pi T

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SSRCR Volume IIJunrrZlIIv, 199LJine n_2004_ _ _DRAFT

(a) ~ll;i~l-P~se T "; ,sP.TIRMI a. .d

RM.i v, 1.ss;ill MN iile ,. T F. hPE CuiS Tile ggy i powvL ei tiiultipic-pulse or,jnUIt4JIl-c^upSUeI laiia; wl. dii e iLi. U1Jtaiit41ous puls lepititiq ufiaqi.sy of a Py pulses wihlin a

t ai1 ex~ceeds I pCi SCCIId ha5 tsie l;.its specified in App iixi AA Melanenzicits fiuL Maxiuniun- . ~Pennlis5;sib ExpsOurCe .(a)(i) fluoulghl(v).

(i) Te zinadianLis uo radian±t

IAiusULc (tialice ot integziated. iadianice) ii iy i ndividual puisc in a train is litited tou die MWE fUi

a co.inipabil pulse, as spiied ;1 AilppiIiA AA MCfSM.CIZVICL4b M Ma Sx I IT1 PeinSSIbi

; . II.. . ExEpusme 2.(b), (), amid (3).

(ii) The avmiae ftadiuauic. i raeAx Uaic (indimaic lU i c tadiau fbryi thle pulise tai ias lIfnited ol the WE w sc a fic ii1

Appeindix AA f uaSw n LIeltb fbu Maximiuint Pe nssii1ic Expuasa 2.(b), (c), ami (3) for one paise- cthis inadiamici or daiante-kposme (tadianc cn integiated iadianice) wimse datatiun is thle s~an asa

-th~at vft (1iie puis tain

-iMmi (i;) A and all giuups uf puiseswilit flic tLOi of o lputse withdie sant dahtion as thle gxaI L tit

annui e specified in A2kppidix AA Nkasulemucits, fbi NfaximmiAI Pantuassflc EjxpLsueI 4.(a)(ii).

(i V) FI frdividual ps withdtUIatiu les tl1han 10 mUi.cJU ,ds, tin. TAPE of AkMejjasteuiiniAs ful Mlvhiun

i Pcnnissw ibk Eposur 4.(a)(i) is reiduced aS specified iru Figme 12. hi no case sihall this ieduction bcICSS anal IlvIibi ijui.al of tfic untzbb of jubses Within 0.25 5u.id whun the pulse lhanul dmatiuj is

l;ess flan 0.25 sei.nd.

(v, 'Mii th* .idividwa ptb.dauta1 on is rO nuics.ec.und or gakter, the MWIE fbn an idtividufl plsle in a Lapin salhll be calucaLexfmu in thu MPE fui tutal W0tite ,ubu (TO-T), whili Las a tiun uijual lu tin. SUIU o all Le9

ididvidai palse duaatiouzs in the ltain, as frlouvs:. Tin. WE In i mie uf al individtal puise withiniue tLain iceadl u. tuofu l k, [sT E fu PluE futL ti 9TOP. Th WAE tadianuta uexpaiuc or intgi at

radiancelU Uf -- d UpIVIdual UU witin diU tll X sha1 i 1b r duced u the TPE fWi die TOT9 UP divideU dydie nuhlbet uf pulses within tic ti ain. TlHe fuilow ing fi nulua slall bIe use Lu t-v luafu at di PE

- aplcl} lu euilm phuls.-

ili taji, -individual puisu width; and MPE..I~i - WAE iqpplic.abk to a pause of widt m it, in secounds.Ampaditimma linitaius Fia t tin. avumage. iumadi aninu in the pcz, tain stud! trot exceeud fliu TPE-as

spcififcu in *ppcniaai'Aak Tvkasaiunutnt fbi Mvaxinimini Pueinisuibk Exposurei 4 .(a)(ii) cuzd tlzuM~PE's~ fbi1 Ah inii ual ,b OL Pulsed epjetifian fiequunicy shall bc.Ledaced to keep withrin this

- - MPEiv

* AA70

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DRA~ SSRCR Volume lI-J46 fJw l99fJwn2OOA

(b) RcyPtilive pulse at ipCtiLiO1u Latcs ofIc55 tlimi I lc (I it) slail ble olnsidie addilive uove a 24-l1ow- pmiod.

(C) Pulse l, ainls svlosc dm at oj l1i,;cLowuLlids uo less shall lave licii puiscs sUai1illAd intO a sinigle pauls with llhe applicabc WPE.

(t1) Pailse trahis whousc dumation is less fliman0.25 SCcolid muid wlhos i sltalmitconLs r uu sc icptition fiequcisy ; 10 Hz r less skha11 fft iave tcir

MPE's tetiUccd by tdic limitatiuon uf *yppaidi:A iok asuiCk TwWntS fri M P -Pmisblk,~osure A-(a)(4

Si9 ;At -I Ql,.:! Firnt f * . Avabilack data ate rut suffile11t lo &lfeie wavlcf4 il 1 cont.,iVLowrelati, tLoJi Uv :i tIh entilh IflCUiLr,.L (k1 A. - 1 .I-LLI). A1 .54 jim, theMPlE giv n Talles WI a mid lYb is ini asexld by a fhictu uf 10 fiV Lung pieiiud 5 i sola 1

l~lbCUIid. Hfowfor, no cxtmP4M raiT'to adim wavteleh s;jusiid an the bmsi§ of pileser

.. :..

* . .1,~ :

. I ... . ..II . . ; †,

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DRAFT 2004 Rationalefor Part AA

2004Rationale for Revisions

Part AARegistration and Radiation Safety Requirements for Lasers

Introduction.

The current Part AA is divided into six major sections that include General Provisions,Registration, Requirements for Protection Against Laser Radiation, Tables, Figures, andAppendices. Part AA has been revised and the title of this part was changed to more accuratelyreflect the contents. Sections AA.3(c) addressing general exemptions, AA.4 - AdditionalRequirements, AA.5 - Violations, AA.7 - Inspections, AA.8 - Tests, AA.9 - AdministrativeReview, AA. 11 - Communications and AA. 12 - Severability have been deleted from Part AA asthey are addressed in Part A, General Provisions. and Part J, Notices, Instructions, and Reports.Laser registrants will be required to comply with Parts A and J under Section AA.J Purpose andScope instead of delineating separate sections within Part AA.

Because the American National Standards Institute (ANSI) Z136.1, Safe Use of Lasers is widelyused in the laser industry, Part AA was revised and updated using ANSI Z136-1, Safe Use ofLasers as a basis for the changes. Outdated tables and graphs have been deleted. References totables and graphs in ANSI Z136.1, Safe Use of Lasers and to Title 21, Code of FederalRegulations (CFR), Part 1040.10 are inserted.

Optional language is shown as bracketed language.

Section AA.I - Purpose and Scope.

This section has been reformatted and revised to combine several sections in the part and to moreaccurately describe the purpose and scope.

Section AA.2 - Definitions.

The definitions of Continuous wave, Embedded laser, Enclosed laser, Limiting duration, andPractitioner of the healing arts were added to define lanugage in the section and to be consistentwith language in ANSI Z-136.1, Safe Use of Lasers. The definition of photothermolysis wasadded as a section on the registration and use of intense-pulsed light devices (IPL) is nowincluded in Part AA. The definitions of Accuracy, Attenuation, Class I, IIIl, or IV facility,Operable laser, and Uncontrolled area were deleted as they are not used in the final version ofPart SR-AA. Many of the other definitions were changed to clarify the meaning and to beconsistent with ANSI Z-136.1. The definitions for Class 1, 2, and 3a lasers are revised to alsoinclude the current numbering system utilized by the International Electrotechnical Commissionas well as references to the applicable, accessible emission limits in ANSI Z136.1-2000, SafeUse of Lasers.

Section AA.3 - Exemvtions

-1-

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2004 Rationale for Part AA DRAFT

Exemptions from Section AA.16 and AA.3 were combined into Section AA.3 for clarification.

Old Section AA4 - Additional Requirements - This was deleted as it was repetitive of languagein Part A, General Provisions.

Old Section AA5 - Violations - This was deleted as it was repetitive of language in Part A,General Provisions.

Old Section AA6 - Impouinding - This was deleted as it was repetitive'of language in Part A,General Provisions..

Old Section AA7 - Inspections - This was deleted as it was repetitive of language in Part A,General Provisions.

Old Section AA8 - Tests - This was deleted as it was repetitive of language in Part A, GeneralProvisions.

Old Section AA9 - Administrative Review - This was deleted as it was repetitive of language inPart A, General Provisions.

New Section AA.4 - (Old AA.10 - Reserved) - Prohibited UsesBecause of the potential for misuse and possible injury, prohibitions were added to Part AA.

Old Section AA.l 1- Communications - This was deleted as it was. repetitive of language in PartA, Gieneral Provisions.

Old Section AA. 12 - Severability - This was deleted as it was repetitive of language in- Part A,General Provisions. -

Old Section AA.13 - Puolose - This was combined with Purpose and Scope in Section AA.1 forclarification.

Old Section AA.14 - Scoe --This was combined with Purpose and Scope in Section AA.1 forclarification.

New Section AA.5 - Old Section AA.lS--General Registration Requirements- The title of thissection was revised to indicate general registration requirements that apply to all applicants forregistration of lasers. The requirement that a laser safety officer be designated on eachapplication and his/her qualifications be submitted to the agency was added to ensure thatqualified individuals serve in this capacity.

New Sections AA.6 - AA.12 - 'These sections contain specific requirements fbr. registrationapplications for different uses of lasers including healing arts and veterinary facilities, industrial,academic, and research and development facilities, demonstration for the purpose of sales,providers of lasers, alignment, calibration, and repair of lasers, laser light shows, and lasermobile services. Applicants for laser registration would be required to submit documentation or

-2-

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DRAFT 2004 Rationalefor Part 4

comply with items specific to the type of registration -in question in addition to the generalrequirements.

New Section AA.13 - Requirements for Intense-Pulsed Light Device (Photothermolysis)Facilities - This new section contains requirements for intense-pulsed light devices that arecommonly used for hair removal. Since not all states regulate these devices, the language wasadded as bracketed optional language

NewrSection AA.14 - (Old Section AA.17) - Laser Safety Officer Oualifications - This sectionwas revised and language that was also referenced in the Training and Experience Appendix forRadiation Safety Officers was deleted as it was repititous. The duties of the Laser Safety Officerwere moved to new Section AA.15..

(Old Section AA.- 18 - Acceptance of Laser Safety Officer) - When an application is submittedfor registration that includes the qualifications for laser safety officer, the agency makes adecision on the application as a whole including the laser safety officer. This language isunnecessary and was deleted.

(Old Section AA. 19 - Annual Report.) - A registrant is required to report changes throughout theyear as they occur as delineated in new Section AA.19. An annual report is unnecessary and thissection was deleted.

New AA.15 - Duties of Laser Safety Officer. - The requirements were moved from the oldSection AA.17 and were expanded to more accurately reflect the duties of this individual.

New AA.16 - Issuance of Laser Registration. - This section was added to delineate that a laserregistration will be issued if the applicant has met the requirements. It alsoallows the agency toamend the registration as necessary when circumstances so dictate.

New Section AA. 17 - Expiration of Laser Registration. - This section provides a time frame forexpiration of the laser registration.

New Section AA.18 - Renewal of'Laser Registration. -. This'section contains requirements forrenewal of laser registrations.

NwStionAA.19.-RMrtof Chang. - This 'section'contains requirements for reporting anychanges to the application.

New Section AA.20 - Termination of Registration. - This section contains requirements forterminating a laser registration.

(Old Section AA.24 - Purpose and Scope.) - This section was combined with Section AA.1,Purpose and Scope.

New Section AA..26b.iv. - (Old Section AA.27(b)iv) - Warning Systems - This section wasrevised to be more consistent with ANSI Z-136.1, Safe Use of Lasers.

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2004 Rationalefor Part AA DRAFT

New Section AA.31 (Old Section AA.32) - Measurement and Instrumentation - This section hasbeen bracketed as optional language. ANSI Z-136.1, Safe Use of Lasers indicates thatmeasurements should be attempted only by personnel trained or experienced in laser technologyand radiometry. Routine survey measurements of lasers or laser systems are neither required noradvisable when the laser classifications are known and the appropriate control measuresimplemented. Generally this would apply to research and development facility registrants.

Tables I. Ia. lIa. IVa. Mb. Mc. V.VI. VII. and VIII have been deleted and reference made toANSI Z-136.1, Safe Use of Lasers and Title 21, Code of Federal Regulations (CFR), Part 1040.

Figures 3. 4. 5. 6. 7. 8. 9. 10. 11. and 12 have been deleted and reference made to ANSI Z-136.1,Safe Use of Lasers and Title 21, Code of Federal Regulations (CFR), Part 1040.

Appendix AA. Medical Surveillance has been revised to be less prescriptive and to be moreconsistent with language in ANSI Z1136.1, Safe Use of Lasers. It is shown as bracketed optionallanguage and renumbered to Appendix C.

Appendix AA. Guideslines for Laser Light Shows has been renumbered to Appendix A.

Appendix AA. Training has been renumbered to Appendix B.

Appendix AA. Measurements for Maximum Permissible Exposure has been deleted. See therationale in Section AA.3 1.

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Conference of Radiation ControlProgrena Directors. Inc.

205 Capitol Avenue

www.crcpd.org Frankfort, KY 40601

/' Iil

FIRST CLASS MAIL__E_11

APaul H. Lohaus, DirectorOffice of State and Tribal ProgramsU. S. Nuclear Regulatory CommissionWashington, DC 20555 I

IA&

A L A � k


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