PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289. RADIATION CONTROL
SUBCHAPTER G. REGISTRATION REGULATIONS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes an amendment to §289.301, concerning Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices.
BACKGROUND AND PURPOSE
The purpose of the proposal is to amend Texas Administrative Code, Title 25, Chapter 289 concerning registration and radiation safety requirements for lasers and intense-pulsed light devices. The proposed amendment adds and clarifies registration requirements, personnel requirements, facility requirements, and radiation machine requirements to protect workers and the public from laser radiation machine hazards.
The signage requirements are updated to match the guidelines set forth by the American National Standards Institute (ANSI). Specific warning labels, such as "Danger," "Warning," and "Caution," communicate the potential hazards associated with laser operations and promote a safer working environment for employees and visitors. Referencing the standard allows laser facilities to adhere to the most current national standards, which are often proposed and updated faster than regulatory amendments can be implemented.
SECTION-BY-SECTION SUMMARY
The proposed amendment replaces "agency" with "department," "title" with "chapter," and "shall" with "must." Edits are made to improve grammar and clarity, update references, and clarify laser class throughout the rule. Formatting edits are made to update numbering.
The proposed amendment to §289.301(a)(2) adds language to "class of laser" to include both International Electrotechnical Commission (IEC) and United States Food and Drug Administration (FDA) classifications.
The proposed amendment to §289.301(a)(3)(A) requires users of a Class 3B or Class 4 laser to register with DSHS.
The proposed amendment to §289.301(a)(3)(B) expands the application of the rule to anyone who receives, possesses, uses, owns, or acquires a Class 3B or Class 4 laser.
The proposed amendment to §289.301(b)(1) adds language requiring veterinary facilities to follow applicable laser rules.
The proposed amendment to §289.301(c)(2)(C)(i)-(ii) adds requirements and exemptions for research facilities.
The proposed amendment to §289.301(d) adds definitions of "American National Standards Institute (ANSI)," "engineering controls," "laser light show," "manufacturer," "personal protective equipment (PPE)," "practitioner," "supervision," "veterinarian," and "veterinary medicine." The subsection amends definitions of "access to laser radiation," "accessible laser radiation," "class 1 (I) laser, IEC Class 1 and 1M," "class 2 (II) laser, IEC Class 2 and 2M," "class 3a (IIIa) laser, IEC Class 3R," "class 3b (IIIb) laser, IEC Class 3B," "class 4 (IV) laser, IEC Class 4," "coherent," "collateral radiation," "continuous wave," "controlled area," "divergence," "electromagnetic radiation," "electronic product," "energy," "healing arts," "infrared radiation," "inoperable," "Institutional Review Board (IRB)," "intense-pulsed light (IPL) device," "invisible radiation," "joule," "laser," "laser product," "laser safety officer (LSO)," "maximum permissible exposure (MPE)," "medical event," "mobile service operation," "nominal hazard zone (NHZ)," "optical density," "protective housing," "provider of lasers," "pulse duration," "pulsed laser," "reflection," "transmission," "ultraviolet radiation," "visible radiation (light)," and "wavelength (&lgr;)." The proposal deletes "apparent visual angle" and "practitioner of the healing arts (practitioner)."
The proposed amendment to §289.301(g)(1)(C) updates RC form 226-01 for laser registration and requires the form to contain the legal name of the entity or business.
The proposed amendment to §289.301(g)(2)(D) clarifies laser machines may only be operated by a person qualified by training and experience to use the laser machines.
The proposed amendment to §289.301(g)(3)(B) requires that applications to use Class 3B or Class 4 lasers in industrial, academic, and research and development institutions, be signed by the applicant or registrant, or a person duly authorized to act for and on behalf of the applicant or registrant, and the Laser Safety Officer (LSO).
The proposed amendment to §289.301(g)(4) requires companies that service laser machines to register with DSHS. The application must be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant, and the LSO. Additionally, service companies are required to verify the facility has a valid certificate of registration issued by DSHS before providing services. The language "application for demonstration for the purpose of sales of Class 3b or 4 lasers" was removed.
The proposed amendment to §289.301(g)(5) requires an application for a laser light show be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant, and the LSO. The language "application for providers and the application for alignment, calibration, and/or repair of Class 3b or 4 lasers" was removed.
The proposed amendment to §289.301(h)(1) clarifies a certificate of registration application will only be approved if DSHS determines the application meets all requirements of the chapter.
The proposed amendment to §289.301(j)(1) requires the registrant to comply with the section and the conditions of the certificate of registration.
The proposed amendment to §289.301(j)(2) requires the registrant to designate an LSO and ensures the LSO performs the duties required of the subsection (p).
The proposed amendment to §289.301(j)(3) prohibits a person from making, selling, leasing, transferring, or lending lasers unless such machines and equipment meet the applicable requirements of this section.
The proposed amendment to §289.301(j)(7) adds language registrants must follow in the event of a bankruptcy.
The proposed amendment to §289.301(j)(11) requires an individual to apply for a certificate of registration within 30 days of beginning to use the laser machines.
The proposed amendment to §289.301(j)(12) prohibits a service company from providing laser services to a person who cannot produce evidence of a completed application for registration, or a valid certificate of registration issued by DSHS, except for the initial installation or for demonstration and sales.
The proposed amendment to §289.301(j)(13) adds requirements for a person authorized to perform alignment, calibration, installation, and repair of lasers, in Texas, to maintain a daily log that includes the date of service, name, customer address, certificate of registration number, and records of all services for inspection.
The proposed amendment to §289.301(j)(14) adds requirements for providers of lasers. Providers are required to keep a log of lasers supplied in Texas and only provide lasers to facilities with a valid certificate of registration.
The proposed amendment to §289.301(j)(15) adds requirements for a person authorized to demonstrate and sell lasers in Texas. The registrant is required to maintain records, perform demonstrations only on phantoms, and prohibits deliberate exposure to an individual unless ordered by a licensed practitioner of the healing arts.
The proposed amendment to §289.301(j)(16) adds requirements for a person using loaner laser machines to apply for a certificate of registration or amend a valid certificate of registration within 30 days of receiving the machine.
The proposed amendment to §289.301(l)(1)(A) clarifies the request for termination must be signed by the LSO, owner, or an individual authorized to act on behalf of the registrant.
The proposed amendment to §289.301(n)(3) clarifies that DSHS will notify a registrant in writing, of the department's intent to suspend or revoke a certificate of registration and be provided an opportunity to demonstrate compliance before proceedings to suspend or revoke begin.
The proposed amendment §289.301(o) removes the language concerning bankruptcy and places the language in §289.301(j)(7).
The proposed amendment to §289.301(u)(3) updates laser signage and posting requirements to include updated language in the Danger, Warning, and Caution signs. The updated signage and posting requirements replace §289.301(dd).
The proposed amendment to §289.301(cc) requires records and documentation be maintained at each site, including mobile services. This subsection replaces §289.301(ee).
FISCAL NOTE
Christy Havel Burton, DSHS Chief Financial Officer, has determined, for each year of the first five years the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
DSHS has determined that during the first five years the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of DSHS employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to DSHS;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will not expand, limit, or repeal existing regulation;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Christy Havel Burton, Chief Financial Officer, has also determined there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.
PUBLIC BENEFIT AND COSTS
Dr. Timothy Stevenson, Associate Commissioner, Consumer Protection Division, has determined, for each year of the first five years the rule is in effect, the public will benefit from adoption of the rule. The anticipated public benefit of enforcing or administering the rule is improved protection from unnecessary exposure to radiation for the public, patients, workers, and the environment.
Christy Havel Burton, Chief Financial Officer, has also determined, for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule updates procedural requirements, and does not increase equipment testing frequency or fees to the facility.
TAKINGS IMPACT ASSESSMENT
DSHS has determined the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Radiation Section, Consumer Protection Division, DSHS, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347, or street address 1100 West 49th Street, Austin, Texas 78756; fax (512) 206-3793 or by email to CPDRuleComments@dshs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule 23R012" in the subject line.
The amendment is authorized by Texas Health and Safety Code Chapter 401 (the Texas Radiation Control Act), which provides for DSHS radiation control rules and regulatory program to be compatible with federal standards and regulation; §401.051, which provides the required authority to adopt rules and guidelines relating to the control of sources of radiation; §401.064, which provides for the authority to adopt rules related to inspection of x-ray equipment; §401.101, providing for DSHS registration of facilities possessing sources of radiation; Chapter 401, Subchapter J, which authorizes enforcement of the Act; and Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.
The amendment implements Texas Health and Safety Code Chapters 401 and 1001; and Texas Government Code Chapter 531.
§289.301.Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices.
(a) Purpose.
(1) This section establishes requirements for protection against all classes of laser radiation and intense-pulsed light (IPL) device hazards. This section includes the responsibilities of the registrant and the laser safety officer (LSO), laser and IPL device hazard control methods, training requirements, and notification of injuries.
(2) For the purpose of this section, any reference to a class of laser includes both International Electrotechnical Commission (IEC) and United States Food and Drug Administration (FDA) classifications, as appropriate.
[(2) This section establishes requirements
for the registration of persons who receive, possess, acquire, transfer,
or use Class 3b (IIIb), International Electrotechnical Commission
(IEC) Class 3B and Class 4 (IV), IEC Class 4 lasers in the healing
arts, veterinary medicine, industry, academic, research and development
institutions, and of persons who are in the business of providing
laser services. No person shall use Class 3b (IIIb), IEC Class 3B
or 4 (IV), IEC Class 4 lasers or perform laser services except as
authorized in a certificate of laser registration issued by the agency
in accordance with the requirements of this section. Class 1 (I) lasers,
IEC Class 1 and 1M, Class 2 (II) lasers, IEC Class 2 and 2M, and Class
3a (IIIa) lasers, IEC Class 3R and IPL devices are not required to
be registered. However, use of Class 1 (I) lasers, IEC Class 1 and
1M, Class 2 (II) lasers, IEC Class 2 and 2M, and Class 3a (IIIa) lasers,
IEC Class 3R and IPL devices are subject to other applicable requirements
in this section.]
(3) This section establishes requirements for the registration of a person who receives, possesses, acquires, uses, or transfers Class IIIb (3B), or Class IV (4) lasers in the healing arts, veterinary medicine, and industrial, academic, research and development institutions, and of a person in the business of providing laser services.
(A) A person must not use a Class 3B or Class 4 laser or perform laser services except as authorized in a certificate of registration issued by the Texas Department of State Health Services (department) as specified in this section.
(B) A person who receives, possesses, uses, owns, or acquires a Class 3B or Class 4 laser before receiving a certificate of registration is subject to the requirements of this chapter.
(4) Class I (1) lasers, Class II (2) lasers, FDA Class IIIa (3a) lasers, IEC Class 3R lasers, and IPL devices are not required to be registered. However, the use of Class 1, Class 2, Class 3a, Class 3R lasers, and IPL devices is subject to applicable requirements in this section.
(b) Scope.
(1) Except as otherwise [specifically] provided,
this section applies to a person who receives, possesses, acquires,
transfers, or uses [all persons who receive, possess, acquire,
transfer, or use] lasers that emit or may emit laser radiation. Lasers [Individuals shall not use lasers] or IPL
devices must not be used on humans or animals unless
under the supervision of a licensed practitioner of the healing arts (practitioner) or veterinary medicine and unless the use of
lasers or IPL devices is within the scope [of practice]
of their professional license. This section does not limit [Nothing in this section shall be interpreted as limiting] the
intentional exposure of patients to laser or IPL device radiation
for the purpose of diagnosis, therapy, or treatment by a [licensed]
practitioner of the healing arts or veterinary medicine within
the scope [of practice] of their professional license.
This section does not apply to the manufacture of lasers or IPL devices.
(2) This section applies to lasers operating [that operate] at wavelengths between 180 nanometers (nm) and
1 millimeter (mm).
(3) This section applies to IPL devices. These devices must [shall] be Class 2 or Class 3 surgical devices
certified as complying with the designing [design],
labeling, and manufacturing standards of the FDA [United
States Food and Drug Administration (FDA)].
(4) This section applies to lasers meeting [that meet] the requirements of IEC standards 60825-1 and 60601-2-22
as allowed by the FDA [United States Food and Drug
Administration] Centers for Devices and Radiological Health
in the guidance document, Laser Notice No.50[, dated
July 26, 2001].
(5) In addition to the requirements of this section,
all registrants authorized to use Class 3B [3b]
and Class 4 lasers are subject to the following requirements:
(A) §289.203 of this chapter [title]
(relating to Notices, Instructions, and Reports to Workers; Inspections) except for [with the exception of] subsection (d),
"Notifications and reports to individuals," and information
relating to ionizing radiation or exposure history contained in subsection
(i), "Notice to employees."
(B) §289.204 of this chapter [title]
(relating to Fees for Certificates of Registration, Radioactive Material
Licenses, Emergency Planning and Implementation, and Other Regulatory Services);
(C) §289.205 [subsections]
(a), (b), and (h) - (n) [of §289.205] of this chapter
[title] (relating to Hearing and Enforcement Procedures); and
(D) §289.231 [subsections]
(d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5)
of [§289.231 of] this chapter [title]
(relating to General Provisions and Standards for Protection Against
Machine-Produced Radiation) and the applicable definitions in §289.231(c)
[subsection (c) of §289.231] of this chapter
[title].
(c) Prohibitions.
(1) The department prohibits [agency
may prohibit] the use of lasers and IPL devices posing
a [that pose] significant threat or endangering [endanger] occupational or public health and safety as specified
[,] in [accordance with] §289.205
[of this title] and §289.231 of this chapter
[title].
(2) An individual must [Individuals
shall] not be intentionally exposed to laser or [and
] IPL radiation above the maximum permissible exposure (MPE)
unless a practitioner has authorized such exposure [such
exposure has been authorized by a licensed practitioner of the healing arts].
(A) Exposure of an individual for training, demonstration,
or other non-healing arts purposes is prohibited unless authorized
by a practitioner [licensed practitioner of the healing arts].
(B) Exposure of an individual for the purpose of healing
arts screening is prohibited, except as specifically authorized by
the department [agency].
(C) Research and development using radiation machines
on humans is prohibited except for the following. [Exposure
of an individual for the purpose of research is prohibited, except
as authorized in research studies. Any research using radiation-producing
devices on humans must be approved by an institutional review board
(IRB) as required by Title 45, Code of Federal Regulations (CFR),
Part 46 and Title 21, CFR, Part 56. The IRB must include at least
one practitioner of the healing arts to direct use of laser and IPL
device radiation in accordance with subsection (b)(1) of this section.]
(i) Any research using radiation machines on humans must be approved by an Institutional Review Board (IRB) as required by 45 Code of Federal Regulations (CFR) Part 46, and 21 CFR Part 56. The IRB must include at least one physician to direct any laser radiation or IPL device use as specified in subsection (b)(1) of this section.
(ii) Facilities with radiation machines, with investigational device exemptions, involved in clinical studies must follow regulations governing the conduct of clinical studies and applying to the manufacturers, sponsors, clinical investigators, IRBs, and the medical device. These regulations include:
(I) 21 CFR Part 812, Investigational Device Exemptions;
(II) 21 CFR Part 50, Protection of Human Subjects;
(III) 21 CFR Part 56, Institutional Review Boards;
(IV) 21 CFR Part 54, Financial Disclosure by Clinical Investigators; and
(V) 21 CFR Part 820, Subpart C, Design Controls of the Quality System Regulation.
(d) Definitions. The following words and terms, when
used in this section, [shall] have the following meanings,
unless the context [clearly] indicates otherwise.
(1) Access to laser radiation--Proximity to radiation
[that is] not blocked by an intervening barrier or filter.
(2) Accessible emission limit (AEL)--The maximum accessible emission level permitted within a particular class.
(3) Accessible laser radiation--Proximity to radiation
[that is] not blocked by an intervening barrier or filter.
(4) American National Standards Institute (ANSI) standards--Specific standards for lasers and IPL devices published by the American National Standards Institute.
(5) [(4)] Aperture--An opening
through which radiation can pass.
[(5) Apparent visual angle--The angular
subtense of the source as calculated from source size and distance
from the eye. It is not the beam divergence of the source.]
(6) Beam--A collection of rays characterized by direction, diameter (or dimensions), and divergence (or convergence).
(7) Class 1 [(I)] laser [, IEC Class
1 and 1M]--Any laser not permitting human exposure [that does not permit access] during [the] operation
to levels of visible laser radiation more than [in excess of] the accessible emission limits contained in ANSI
[American National Standards Institute (ANSI) Z136.1-2000,
Safe Use of Lasers].
(8) Class 2 [(II)] laser [, IEC Class
2 and 2M]--Any laser permitting [that permits]
human exposure [access] during operation to
levels of visible laser radiation more than [in excess
of] the accessible emission limits of Class 1 lasers contained
in ANSI [Z136.1-2000, Safe Use of Lasers,] but does not
permit human exposure [access] during operation
to levels of visible laser radiation more than [in excess of] the accessible emission limits of Class 2 lasers
contained in ANSI [Z136.1-2000, Safe Use of Lasers].
(9) Class 3a [(IIIa)] laser, IEC Class 3R--Any
laser permitting [that permits] human exposure
[access] during operation to levels of [visible]
laser radiation more than [in excess of] the
accessible emission limits of Class 2 lasers contained in ANSI [Z136.1-2000,
Safe Use of Lasers,] but does not permit human exposure [access] during operation to levels of laser radiation more
than [in excess of] the accessible emission limits
of Class 3a lasers contained in ANSI [Z136.1-2000, Safe Use of Lasers].
(10) Class 3B [3b (IIIb)] laser[, IEC Class 3B]--Any laser permitting [that
permits] human exposure [access] during
operation to levels of laser radiation more than [in
excess of] the accessible emission limits of FDA Class
3a lasers in ANSI [Z136.1-2000, Safe Use of Lasers] but
does not permit human exposure [access] during
operation to levels of laser radiation in excess of the emission limits
of Class 3B [3b] lasers contained in ANSI [Z136.1-2000,
Safe Use of Lasers].
(11) Class 4 [(IV)] laser[, IEC Class
4]--Any laser permitting [that permits]
human exposure [access] during operation to
levels of laser radiation more than [in excess of]
the accessible emission limits of Class 3B [3b]
lasers contained in [the most recent edition of] ANSI [Z136.1-2000,
Safe Use of Lasers].
(12) Coherent--A light beam is [said to be]
coherent when the electric vector at any point in it is related to
[that at] any other point by a definite, continuous function.
(13) Collateral radiation--Any electromagnetic radiation,
except laser radiation, emitted by a laser that is physically necessary
for its operation. The applicable, accessible emission limits for
collateral radiation are [may be] found in 21
CFR §1040.10 [Title 21, CFR, Part 1040.10].
(14) Continuous wave--A [The output
of a laser that is operated in a continuous rather than a pulsed mode.
In this section, a] laser operating with a continuous output
for greater than or equal to [a period of ≥
]0.25 seconds is regarded as a continuous wave laser.
(15) Controlled area--An area where the occupancy and
activity of those within are [is] subject to
control and supervision by the registrant for the purpose of protection
from radiation hazards.
(16) Divergence--The increase in the diameter
of the laser beam with propagation distance from the exit aperture.
This is also referred to as beam spread [For the purposes
of this section, divergence is taken as the plane angle projection
of the cone that includes 1 - 1/e (for example 63.2%) of the total
radiant energy or power]. The value of the divergence is expressed
in radians or milliradians.
(17) Electromagnetic radiation--Radiation consisting
of electromagnetic waves, including x-ray [The flow of
energy consisting of orthogonally vibrating electric and magnetic
fields lying transverse to the direction of propagation. X-ray],
ultraviolet, visible, infrared, and radio waves occupying [occupy] various portions of the electromagnetic spectrum and differing
[differ] only in frequency, wavelength, or photon energy.
(18) Electronic product--Any product or article defined as follows:
(A) any manufactured or assembled product [that],
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
(B) any manufactured or assembled article [that
is] intended for use as a component, part, or accessory of a
product described in subparagraph (A) of this paragraph and [that]
when in operation emits, or in the absence of effective shielding
or other controls would emit[, such] radiation.
(19) Energy--The capacity for doing work. Energy content
is commonly used to characterize the output from pulsed lasers[,]
and is [generally] expressed in joules (J).
(20) Engineering controls--Control measures designed or incorporated into the laser or laser system (e.g., interlocks, shutters, watchdog timer) or its application.
(21) [(20)] Healing arts--Any
system, treatment, operation, diagnosis, prescription, [or practice
for the ascertainment,] cure, relief, palliation, adjustment,
or correction of any human disease, ailment, deformity, injury, or
unhealthy or abnormal physical or mental condition.
(22) [(21)] Infrared radiation--The
region of the electromagnetic spectrum between the long-wavelength
extreme of the visible spectrum (about 0.7 micrometer (µm))
[µm)] and the shortest microwaves (about
1 mm).
(23) [(22)] Inoperable--Incapable
of operation because [by reason] of damage,
disassembly, removal, or inactivation of key components that cannot
be restored without significant repair or renovation.
(24) [(23)] Institutional Review
Board (IRB)--Any board, committee, or other group formally designated
by an institution to review, approve the initiation of, and conduct a periodic review of biomedical research involving human subjects.
(25) [(24)] Intense-pulsed light
(IPL) device--A device that emits radiation to energy density levels
that could [reasonably] cause bodily harm and [that
is] used for photothermolysis. This device is a Class 2 or Class
3 surgical device certified as complying with FDA designing,
labeling, and manufacturing standards [the design, labeling,
and manufacturing standards of the United States Food and Drug Administration (FDA)].
(26) [(25)] Invisible radiation--Laser
or collateral radiation having wavelengths greater than or [of] equal to [or greater than] 180 nm but less than
or equal to 400 nm or greater than 710 nm but less than or equal to
1.0 x 106 nm (1 millimeter).
(27) [(26)] Irradiance--Radiant
power incident per unit area upon a surface, expressed in watts-per-square-centimeter (W-cm-2).
(28) [(27)] Joule (J)--A
unit of energy. One joule is equal to one watt • [•
] second.
(29) [(28)] Laser--An electronic
device that emits stimulated radiation to energy density levels that
could [reasonably] cause bodily harm. A laser may also
produce an intense, coherent, directional beam of light by stimulating
electronic or molecular transitions to lower energy levels. The term
"laser" [also] includes the assembly of electrical, mechanical,
and optical components associated with the laser. A laser can be a
component of a product or system.
(30) Laser light show--Use of lasers for entertainment, advertising display, or artistic composition.
(31) [(29)] Laser product--Any
manufactured product or assemblage of components constituting,
incorporating, or intending [that constitutes, incorporates,
or is intended] to incorporate a laser and is classified as
a Class 1 [(I), IEC Class 1 and 1M], Class 2 [(II),
IEC Class 2 and 2M], Class 3a [(IIIa), IEC Class 3R],
Class 3B, [3b (IIIb), IEC Class 3B] or Class
4 [(IV), IEC Class 4] laser product according to the performance
standards set by the FDA [United States Food and Drug
Administration (FDA)]. A laser [that is] intended
for use as a component of an electronic product must [shall
itself] be considered a laser product. A laser product can contain
an enclosed laser with an assigned class number higher than the inherent
capability of the laser product in which it is incorporated and where
the product's lower classification is appropriate due to the engineering
features limiting accessible emission.
(32) [(30)] Laser safety officer
(LSO)--An individual with [who has a] knowledge
of and the authority and responsibility to apply appropriate laser
radiation protection rules, standards, and practices, and is [who must be] specifically authorized on a certificate of laser
registration.
(33) Manufacturer--Any person who designs, manufactures, assembles, fabricates, or processes a finished laser device.
(34) [(31)] Maximum permissible
exposure (MPE)--The level of laser radiation [to which]
a person may be exposed to without hazardous effects [effect] or adverse biological changes in the eye or skin. Maximum
[For the purposes of this section, maximum] permissible
exposures to [for] laser radiation may be found
in ANSI [Z136.1-2000, Safe Use of Lasers].
(35) [(32)] Medical event--Any
adverse patient health effect directly resulting from the use
of laser equipment on an individual [that is a result of
failure or misuse of laser safety equipment].
(36) [(33)] Mobile service operation--The
provision of lasers and personnel at temporary sites for limited time
periods. The lasers may be fixed inside a motorized vehicle or [may
be] a portable laser that can [may] be
removed from the vehicle and taken into a facility for use.
(37) [(34)] Nominal hazard zone
(NHZ)--The space where [within which] the level
of direct, reflected, or scattered radiation during operation exceeds
the applicable MPE. Exposure levels beyond the boundary of the NHZ
are below the applicable MPE level.
(38) [(35)] Optical density (D&lgr;) [(D&lgr; )
]--The logarithm to the base ten of the reciprocal of the transmittance.
D&lgr;= -log10&tgr;&lgr; [-log10 &tgr; &lgr;], where &tgr;&lgr;
is transmittance.
(39) Personal protective equipment (PPE)--Device used to mitigate hazards associated with laser use, including laser eye protection (LEP), protective clothing, and gloves.
(40) Practitioner--A person licensed under Texas Occupations Code Title 3 Health Professions. A practitioner's use of a laser is limited to the person's scope of professional practice as determined by the appropriate licensing agency.
[(36) Practitioner of the healing arts (practitioner)--For the purposes of this section, a person licensed to practice the healing arts by either the Texas Medical Board as a physician; the Texas State Board of Dental Examiners; the Texas Board of Chiropractic Examiners; or the Texas State Board of Podiatric Medicine. A practitioner's use of a laser is limited to his/her scope of professional practice as determined by the appropriate licensing agency.]
(41) [(37)] Protective housing--An
enclosure surrounding the laser preventing [that prevents
] access to laser radiation above the applicable MPE level.
The aperture through which the useful beam is emitted is not part
of the protective housing. The protective housing may enclose associated
optics and a workstation [work station] and must
[shall] limit access to other associated radiant
energy emissions and to electrical hazards associated with components
and terminals.
(42) [(38)] Provider of lasers--A person providing [Provision of] lasers on a routine
basis to a facility for limited time periods.
(43) [(39)] Pulse duration--The
duration of a laser pulse. This is [usually] measured as
the time interval between the half-power points on the leading and
trailing edges of the laser pulse.
(44) [(40)] Pulsed laser--A laser delivering [that delivers] its energy in the form
of a single pulse or a train of pulses. In this section, the duration
of a pulse is less than 0.25 seconds [<5seconds].
(45) [(41)] Reflection--The deviation
of laser radiation following incidence on a surface.
(46) [(42)] Source--A laser or
a laser-illuminated reflecting surface.
(47) Supervision--Delegating to a person under the practitioner's authority, the task of applying laser radiation to persons or animals under this section. The practitioner assumes full responsibility for these tasks and must ensure the tasks are administered correctly.
(48) [(43)] Transmission--Passage
of laser radiation through a medium.
(49) [(44)] Ultraviolet radiation--Electromagnetic
radiation with wavelengths shorter than those of visible radiation;
for [the purposes of] this section, 0.18 to
0.4 µm.
(50) Veterinarian--A person licensed as a veterinarian by the Texas Board of Veterinary Medical Examiners.
(51) Veterinary medicine--When used in this chapter, has the same meaning as found in Texas Occupations Code Chapter 801.
(52) [(45)] Visible radiation
(light)--Electromagnetic [In this section, the term
is used to describe electromagnetic] radiation that can be detected
by the human eye. This term is commonly used to describe wavelengths
[that lie] in the range of 0.4 to 0.7 µm.
(53) [(46)] Watt--The unit of
power or radiant flux. 1 watt equals 1 joule per second.
(54) [(47)] Wavelength (&lgr;)--The
distance between two successive points on a periodic wave having [that have] the same phase.
(e) Exemptions.
(1) Lasers in storage or [transit or
in storage incident to] transit are exempt from the requirements
of this section. This exemption does not apply to the providers of lasers.
(2) Inoperable lasers are exempt from the requirements of this section.
(3) Class 1 [(I), IEC Class 1 and 1M], Class
2 [(II), IEC Class 2 and 2M], and Class 3a [(IIIa)
] lasers, IEC Class 3R lasers, or products
and IPL devices are exempt from the registration requirements of subsections
(f) and (g) of this section.
(4) Facilities, including academic institutions and
research or development facilities, registered for the use of lasers
are exempt from the registration requirements of subsection [subsections] (f) of this section, regarding laser services,
and the applicable paragraphs of subsection (g) of this section, to
the extent [that] their personnel perform laser services
only for the registrant by whom they are employed.
(f) Registration for the [of]
use of Class 3B [3b] and Class 4
lasers and laser services.
(1) For purposes of this section, use of Class 3B [3b] or Class 4 lasers and laser services includes [shall include, but may not be limited to]:
(A) possession and use of lasers in the healing arts,
veterinary medicine, industry, academics [academic],
and research and development institutions;
(B) demonstration or sale [and sales]
of lasers requiring [that require] the person [individual] to operate or cause a laser to be operated [in
order] to demonstrate or sell;
(C) provision of lasers on a routine basis to a facility
for limited time periods by a provider of lasers. For healing arts
facilities, the use of lasers must [shall] be
directed by a practitioner employed by the contracting facility;
(D) alignment, calibration, installation, or [and/or] repair; or
(E) laser light shows.
(2) A person who applies [has made
application] for registration as specified in [accordance
with] this section and uses [is using]
a Class 3B [3b] or Class 4 laser before
[prior to] receiving a certificate of laser registration
is subject to the requirements of this chapter.
(g) Application requirements.
(1) General application requirements.
(A) Application for certificate of laser registration must [shall] be completed on forms prescribed by
the department [agency] and must [shall
] contain all the information required by the form and accompanying instructions.
(B) An LSO must [shall] be designated
on each application form. The qualifications of that individual must
[shall] be submitted to the department [agency] with the application. The LSO must [shall]
meet the applicable requirements of subsection (o) [(p)]
of this section and carry out the responsibilities of subsection (p)
[(q)] of this section.
(C) Each application must [shall]
be accompanied by a completed RC [BRC] Form 226-01
[226-1] (Business Information Form), which
must contain the legal name of the entity or business. Unless exempt
under Texas Business and Commerce Code Chapter 71, the applicant must:
(i) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and
(ii) file an assumed name certificate with the Texas SOS if using an assumed name in their application.
(D) Each application for a certificate of laser registration must [shall] be accompanied by the appropriate fee
prescribed in §289.204 of this chapter [title].
(E) An application for a certificate of laser registration may include a request for authorization of one or more activities.
(F) At [The agency may, at] any
time after filing [of] the original application, the
department may require further information [statements
in order to enable the agency] to determine whether the certificate
of laser registration will [should] be issued [granted] or denied.
(G) Applications and documents submitted to the department
[agency] may be made available for public inspection, except [that] the department [agency]
may withhold any document or part of a document [thereof]
from public inspection as specified in [accordance
with] §289.231(aa) of this chapter [title].
(2) Application for the use of Class 3B [3b] or Class 4 lasers on humans or animals.
(A) In addition to the requirements of subsection (g)(1)
of this section, each person having a Class 3B [3b]
or Class 4 laser for use in the healing arts[,]
or for use on animals must[, shall] submit an
application to the department [agency] within
30 days after beginning operation of the laser.
(B) Application signatures.
(i) An application for healing arts use
must be signed by a practitioner [shall be signed by a
licensed practitioner of the healing arts].
(ii) An application for veterinary medicine use must [shall] be signed by a licensed veterinarian.
(iii) The signature of the administrator,
president, or chief executive officer will be accepted instead
of the [in lieu of a licensed] practitioner's signature
if the facility is a licensed hospital or a medical facility.
(iv) A signature by the administrator, president,
or chief executive officer does not relieve the practitioner [user]
or veterinarian [user] from following [complying
with] the requirements of this section. The LSO must also
sign the application.
(C) If a person is furnished a Class 3B [3b
] or Class 4 laser by a provider of lasers, that
person is responsible for ensuring [that] a practitioner [licensed practitioner of the healing arts] authorizes intentional
exposure of laser radiation to humans.
(D) The applicant must ensure a laser machine is operated by a person qualified by training and experience to use the laser machine for the purpose requested, and in a manner minimizing danger to occupational and public health and safety.
(3) Application for the use of Class 3B [3b] or Class 4 lasers in industrial, academic, and
research and development institutions.
(A) In addition to the requirements of subsection
(g)(1) of this section, each person [applicant]
having a laser [laser(s)] for use in industrial,
academic, and research and development institutions must apply [shall submit an application] to the department [agency
] within 30 days after beginning operation of the laser.
(B) An application for the use of Class 3B or Class 4 lasers in industrial, academic, and research and development institutions must be signed by the applicant or registrant or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.
(4) Application for registration of laser services.
(A) In addition to the requirements of subsection (g)(1) of this section, an applicant who intends to provide laser services described in subsection (f)(1) of this section must apply and receive a certificate of registration from the department before providing the services.
(B) An application for laser services must be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.
(C) Providing services specified in subsection (f)(1) of this section, that are not specifically authorized by the department, is prohibited.
(D) A service provider must not provide laser machine services for a person who cannot produce evidence of a completed registration application or a valid certificate of registration issued by the department, except for the initial installation of the first machine for a new certificate of registration.
[(4) Application for demonstration
for the purpose of sales of Class 3b or 4 lasers. Each applicant shall
apply for and receive a certificate of laser registration before the
demonstration for purpose of selling laser(s) in accordance with paragraph
(1) of this subsection.]
[(5) Application for providers of Class 3b or 4 lasers.]
[(A) Each applicant shall apply for and receive a certificate of laser registration before providing Class 3b or 4 lasers.]
[(B) In addition to the requirements of subsection (g)(1) of this section, the applicant shall submit the address of the established main location where the laser and records will be maintained for inspection. This shall be a physical street address, not a post office box number.]
[(6) Application for alignment, calibration, and/or repair of Class 3b or 4 lasers. In addition to the requirements of subsection (g)(1) of this section, each applicant shall apply for and receive a certificate of laser radiation for alignment, calibration, and/or repair before providing alignment, calibration, and/or repair of Class 3b or 4 lasers or other lasers that allow access, through alignment, calibration, and/or repair, to Class 3b or 4 lasers.]
(5) [(7)] Application for laser
light show.
(A) Each applicant must [shall apply
for and] receive a certificate of laser registration for a laser
light show before beginning any show.
(B) An application to use Class 3B or Class 4 lasers in a laser light show must be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.
(C) [(B)] According to [In accordance with] subparagraph (A) of this paragraph and in
addition to the requirements of subsection (g)(1) of this section,
each applicant must [shall] submit [the following]:
(i) a valid variance issued by [from]
the FDA, or evidence of an Annual Report on Radiation Safety
Testing of Laser and Laser Light Show Products meeting FDA variance
requirements, for the laser intended to be used, with
all applicable documents required by the variance; and
(ii) a written notice of the laser light show to be
performed in Texas. The information contained in RC Form 301-05
must [BRC Form 301-3 shall] be provided at least
seven days before [prior to] each show. If,
in a specific case, the seven-day period would impose an undue hardship
on the applicant, the applicant may, upon written request to the department
[agency], obtain permission to proceed sooner.
(6) [(8)] Application for mobile
service operation for Class 3B [3b] or Class 4
lasers used in the healing arts and veterinary medicine [arts].
(A) Each applicant must [shall]
apply for and receive a certificate of laser registration for mobile
service operation involving Class 3B [3b] or Class
4 lasers before beginning mobile service operation.
(B) In addition to the requirements of subsection (g)(1)
of this section, each applicant must [shall]
submit the address of the established main location where the laser and[,] records[, etc.,] will be maintained
for inspection. This must [shall] be a physical
street address, not a post office box number.
(C) An application for mobile service operation for
the healing arts must be signed by a practitioner [shall
be signed by a licensed practitioner of the healing arts] and
an application for mobile services for veterinary medicine must [shall] be signed by a licensed veterinarian. The LSO must
also sign the application.
(h) Issuance of certificate of laser registration.
(1) A certificate of registration application will be approved if the department determines an application meets the Texas Radiation Control Act (Act) requirements and the requirements of this chapter. The certificate of registration authorizes the proposed activity and contains the conditions and limitations the department requires. The certificate of laser registration must be maintained as specified in subsection (cc) of this section.
[(1) Upon determination that an application meets the requirements of the Texas Radiation Control Act (Act) and the rules of the agency, the agency may issue a certificate of laser registration authorizing the proposed activity in such form and containing such conditions and limitations as the agency deems appropriate or necessary.]
(2) The department [agency] may incorporate in the certificate of laser registration at the time of issuance, or [thereafter] by amendment, additional requirements and conditions concerning [with respect to] the registrant's receipt, possession, acquisition, use, and transfer of lasers subject to this section, as it deems
appropriate or necessary [in order] to:
(A) minimize danger to occupational and public health and safety;
(B) prevent loss or theft of lasers; or [require
additional reports and the keeping of additional records as may be
appropriate or necessary; and]
(C) require additional reports and maintenance
records as may be appropriate or necessary [prevent loss
or theft of lasers subject to this section].
(3) At the request of the department [The
agency may request, and] the registrant must [shall
] provide[,] additional information after the certificate
of laser registration has been issued for [to enable]
the department [agency] to determine whether
the certificate of laser registration will [should]
be modified in accordance with subsection (n) of this section.
(i) Specific terms and conditions of certificates of laser registration.
(1) Each certificate of laser registration issued as
specified in [accordance with] this section is [shall be] subject to the applicable provisions of the Act [,
now or hereafter in effect,] and [to] the applicable
rules in this chapter and orders issued by the department [agency].
(2) Each person registered by the department [agency] for laser use as specified in [accordance
with] this section must [shall] confine
use and possession of the laser registered to the locations and purposes
authorized in the certificate.
(3) A [No] certificate of laser
registration issued [or granted] under this section must
not [shall] be transferred, assigned, or in any manner
disposed of, either voluntarily or involuntarily, to any person unless
the department [agency] authorizes the transfer, in writing.
(4) In determining [making a determination
] whether to issue [grant], deny, amend,
renew, revoke, suspend, or restrict a certificate of laser registration,
the department [agency] may consider the technical
competence and compliance history of an applicant or holder of a certificate
of laser registration.
(5) After an opportunity for a hearing,
the department will deny an application, amendment, or renewal of
a certificate of laser registration if the applicant's compliance
history reveals, within the previous six years, three or more actions
have been issued against the applicant assessing administrative or
civil penalties, or revoking or suspending a certificate of laser
registration [After an opportunity for a hearing,
the agency shall deny an application for a certificate of laser registration,
an amendment to a certificate of laser registration, or renewal of
a certificate of laser registration if the applicant's compliance
history reveals that at least three agency actions have been issued
against the applicant, within the previous six years, that assess
administrative or civil penalties against the applicant, or that revoke
or suspend the certificate of laser registration].
(j) Registrant responsibilities [Responsibilities
of registrant].
(1) The registrant is responsible for complying with this section and the conditions listed on the certificate of registration.
(2) The registrant must designate a qualified individual as the LSO as specified in subsection (o) of this section and ensure the individual continually performs the responsibilities of the LSO as identified in subsection (p) of this section.
(3) A person must not make, sell, lease, transfer, or lend lasers unless the machine and equipment, when properly placed in operation and used, meet the applicable requirements of this section.
(4) [(1)] The registrant must [shall] notify the department [agency]
in writing within 30 days of a change in any of the following:
(A) [business] name and mailing address;
(B) street address where laser [laser(s)]
will be used;
(C) LSO; or [laser safety officer (LSO).]
(D) additional use location.
[(2) No person shall make, sell, lease,
transfer, or lend lasers unless such machines and equipment, when
properly placed in operation and used, meet the applicable requirements
of this section.]
(5) [(3)] Each registrant must [shall] inventory all Class 3B and Class 4 lasers
in their possession at an interval not to exceed 12 months [one year]. The inventory record must [shall]
be maintained for inspection by the department as specified [agency] in [accordance with] subsection (cc) [(ee)] of this section and must [shall] include:
(A) the manufacturer's name;
(B) the model and serial number of the laser
[laser(s)];
(C) a description of the laser [laser(s)] (for example, yag, silicon, CO2 , neon);
(D) the location of the laser [laser(s)] (for example, room number); and
(E) a complete inventory of equipment supplied
by a provider of lasers [if using a provider of lasers]
as defined in subsection (d)(42) [(d)(38)] of
this section[, a statement with the inventory that the registrant
is using lasers provided by a provider of lasers].
(6) [(4)] Notification to the department
[agency] is required within 30 days of [the
following]:
(A) any increase in the number of lasers above those authorized by the certificate of laser registration; or
(B) any change in the category of the machine
type or type of use as specified in §289.231(ll) or as authorized
on the certificate of registration [if the registrant begins
or terminates the use of a provider of lasers as defined in subsection
(d)(38) of this section].
(7) The registrant, or the parent company, must notify the department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. The notification must include:
(A) the name of the bankruptcy court; and
(B) the case name, and number, when known, and the date the petition was filed.
(8) [(5)] A registrant must
not engage a [No registrant shall engage any] person
for services described in subsection (f)(1) [(g)(6)]
of this section until the service provider demonstrates current [such person provides to the registrant evidence of] registration
with the department [agency].
[(6) The registrant is responsible
for complying with this section and the conditions of the certificate
of laser registration.]
(9) [(7)] Registrants with certificates
of laser registration as specified in [accordance
with] subsection (g)(5) [(g)(7)] of this
section must [shall] have the following documents
on site at each laser light show:
(A) certificate of laser registration;
(B) FDA variance, or evidence of Annual Report on Radiation Safety Testing of Laser and Laser Light Show Products meeting FDA variance requirements, with all applicable documents required by the variance; and
(C) instructions for the safe use of lasers as
specified in [accordance with] subsection (q)(2) [(r)(2)] of this section.
(10) [(8)] Each registrant must
[shall] maintain records of receipt, transfer, and
disposal of Class 3B [3b] or Class 4
lasers for inspection by the department [agency].
The records must [shall] include the following
information and be maintained as specified in subsection (cc)
of this section [shall be kept until disposal is authorized
by the agency]:
(A) manufacturer's name;
(B) model and serial number of [from]
the laser;
(C) date of the receipt, transfer, and disposal;
(D) name and address of the person the
laser was [laser(s)] received from, transferred to,
or disposed by [of]; and
(E) name of the person [individual]
recording the information.
(11) A laser must not be used unless an application for registration is filed with the department, as specified in subsection (g) of this section, within the first 30 days of use. This section does not apply to operation of a laser for installation and calibration.
(12) A service provider must not provide laser services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the department, except for:
(A) the initial installation of the first machine for a new certificate of registration; and
(B) the registrant authorized for demonstration and sale, demonstrates a laser machine as specified in paragraph (15) of this subsection.
(13) A person authorized to perform alignment, calibration, installation, and repair of lasers in Texas must maintain:
(A) a daily log including:
(i) date of service;
(ii) name and address of the customer; and
(iii) customer's certificate of registration number, unless the service provided is an initial installation as described in paragraph (12)(A) of this subsection; and
(B) records of all services for inspection by the department as specified in subsection (cc) of this section.
(14) A person authorized to provide lasers must comply with the following.
(A) Providers of equipment must:
(i) ensure all lasers used on humans meet the requirements of this chapter;
(ii) provide lasers only to facilities holding a valid certificate of registration; and
(iii) keep a log of lasers provided in Texas, and record the following information:
(I) date machine provided;
(II) name of customer; and
(III) customer's certificate of registration number.
(B) Records of machines provided must be made and maintained for inspection by the department as specified in subsection (cc) of this section.
(15) A person authorized to demonstrate and sell lasers in Texas must comply with the following.
(A) Maintain a log including:
(i) date of all demonstrations and sales of lasers performed in Texas;
(ii) name and address of the customer; and
(iii) customer's certificate of registration number unless the service provided is an initial demonstration as described in paragraph (12)(B) of this subsection.
(B) Prevent exposure of individuals to a laser except for healing arts purposes and unless a licensed practitioner of the healing arts has authorized such exposure. This provision specifically prohibits the deliberate exposure of an individual for training, demonstrating, or other non-healing arts purposes.
(C) Demonstrate lasers on phantoms only.
(D) Document all tests required by this section when a demonstration of a laser involves exposure specifically and individually ordered by a practitioner.
(E) Records of demonstrations and sales must be made and maintained for inspection by the department as specified in subsection (cc) of this section.
(16) A person using loaner laser machines must comply with the following.
(A) For a person having a valid certificate of registration, loaner radiation machines may be used for up to 30 days. Within 30 days, the registrant must:
(i) notify the department of a change in the category of the machine type or type of use as specified in §289.231(ll) of this title and as authorized in the certificate of registration; or
(ii) notify the department of any increase in the number of machines beyond those authorized by the certificate of registration in any machine type or type of use category.
(B) For a person who does not hold a valid certificate of registration, a loaner laser may be used for human use for up to 30 days, by or under the direction of a practitioner, before applying for a certificate of registration as specified in subsection (g) of this section. This does not include mobile services.
(k) Expiration of certificates of laser registration.
(1) Except as provided by subsection (m) of this section, a [each] certificate of laser registration expires
at 11:59 p.m. Central Time [the end of the day,]
in the month and year stated in the certificate of laser registration.
(2) If a registrant does not submit an application
for renewal of the certificate of laser registration as specified in
[accordance with] subsection (m) of this section, as applicable,
the registrant must, [shall on or] before the
expiration date specified in the certificate of laser registration,
terminate use of all lasers and laser services as specified in subsection
(l) of this section.[:]
[(A) terminate use of all lasers and/or
terminate laser servicing or laser services authorized under the certificate
of laser registration;]
[(B) submit to the agency a record of the disposition of the lasers, if applicable, and if transferred, to whom it was transferred within 30 days following the expiration date; and]
[(C) pay any outstanding fees in accordance with §289.204 of this title.]
(3) The expiration [Expiration]
of the certificate of laser registration does not relieve the registrant
of the requirements of this chapter.
(l) Termination of certificates of laser registration.
(1) When a registrant decides to terminate
all activities involving laser or laser services authorized under
the certificate of laser registration, the registrant must [shall] immediately [do the
following]:
(A) [(1)] request termination
of the certificate of laser registration in writing, signed by
the LSO, owner, or a person authorized to act on behalf of the registrant; and
(B) [(2)] submit to the department
[agency] a record of the disposition of the laser [radiation machines], and, if applicable, include [; and] if the laser was transferred and [,]to whom it was transferred.[;
and]
(2) [(3)] The registrant
must pay any outstanding fees as specified in [accordance
with] §289.204 of this chapter [title].
(m) Renewal of certificate of laser registration.
(1) An application for renewal of a certificate of
laser registration must [shall] be filed as
specified in [accordance with] subsection (g)(1)(A)
- (G) and (g)(2) [(g)(1)(A) - (B), and (E) - (G) of this
section and applicable paragraphs of subsections (g)(2), (4), and
(7)] of this section.
(2) If a registrant applies [files
an application] for a renewal [in proper form] before
the existing certificate of laser registration expires, the [such] existing certificate of laser registration does [shall] not expire until the application status has been determined
by the department [agency].
(n) Modification, suspension, and revocation of certificates of laser registration.
(1) The terms and conditions of all certificates of
laser registration are [shall be] subject to
revision or modification.
(2) Any certificate of laser registration may be revoked,
suspended, or modified, in whole or in part for [,
for any of the following]:
(A) any materially [material]
false statement in the application or any false statement
of fact required by [under the provisions of] the Act;
(B) information received by the department indicating
a certificate of laser registration should not be issued [conditions
revealed by such application or statement of fact, or any report,
record, or inspection, or other means that would warrant the agency
to refuse to grant a certificate of laser registration on an original application];
(C) violation of, or failure to observe any of the
terms and conditions of the Act, this chapter, or of the certificate
of laser registration, or order of the department or a court [agency]; or
(D) existing conditions threatening occupational
safety, [that constitute a substantial threat to the]
public health and [or] safety, or
the environment.
[(3) Each certificate of laser registration
revoked by the agency ends at the end of the day on the date of the
agency's final determination to revoke the certificate of laser registration,
or on the revocation date stated in the determination, or as otherwise
provided by the agency order.]
(3) [(4)] Except in cases in
which [the] occupational and public health or safety requires
otherwise, a registrant will be notified, in writing, of the
department's intent to suspend or revoke a certificate of registration
and be provided an opportunity to demonstrate compliance before proceedings
to suspend or revoke begin [no certificate of laser registration
shall be suspended or revoked unless, prior to the institution of
proceedings therefore, facts or conduct that may warrant such action
shall have been called to the attention of the registrant in writing
and the registrant shall have been afforded an opportunity to demonstrate
compliance with all lawful requirements].
[(o) Notifications. The following
applies to voluntary or involuntary petitions for bankruptcy.]
[(1) Each registrant shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the registrant or its parent company. This notification shall include:]
[(A) the bankruptcy court in which the petition for bankruptcy was filed; and]
[(B) the date of the filing of the petition.]
[(2) A copy of the "petition for bankruptcy" shall be submitted to the agency along with the written notification.]
(o) [(p)] LSO qualifications.
LSO qualifications must [shall] be submitted
to the department and [agency and shall] include
[the following]:
(1) education [educational courses]
related to laser radiation safety or a laser safety officer course; or
(2) experience in the use and familiarity of the type
of equipment or services registered [for]; and
(3) knowledge of potential laser radiation hazards, [and] laser emergency situations, and the appropriate response
to an injury.
(p) [(q)] LSO duties. The
LSO must [Specific duties of the LSO shall include, but
not be limited to the following]:
(1) ensure [ensuring that] users
of lasers are trained in laser safety, as applicable for the class
and type of lasers used [the individual uses];
(2) assume control and have the authority to institute
corrective actions to include the shutdown of operations, when necessary,
in emergencies [assuming control and having the authority
to institute corrective actions including shutdown of operations when
necessary in emergency situations] or unsafe conditions; [and]
(3) specify [specifying] whether
any changes in control measures are required after [following]:
(A) any service and maintenance of lasers affecting [that may affect] the output power or operating characteristics; or
(B) a [whenever] deliberate modification
is [modifications are] made that could change the
laser class and affect the output power or operating
characteristics;[.]
(4) ensure [ensuring] maintenance
and other practices required for the safe operation of
the laser [laser(s)] are performed;
(5) ensure [ensuring] the proper
use of protective eyewear and other safety measures; and
(6) ensure [ensuring] compliance
with the requirements in this section, the conditions of the
certificate of laser registration, and [with] any
engineering or operational controls specified by the registrant.
(q) [(r)] Requirements for protection
against Class 3B [3b] or Class 4
lasers and IPL device radiation. These requirements are for Class 3B
[3b] or Class 4 lasers and IPL devices
in their intended mode of operation and include special requirements
for service, testing, maintenance, and modification. During some operations,
certain engineering controls may be inappropriate. When [In situations where] an engineering control may be inappropriate,
for example, during medical procedures or surgery, the LSO must [shall] specify alternate controls to obtain equivalent safety
protection.
(1) MPE. A [Each] registrant
or user of any laser may [shall] not permit
any individual to be exposed to levels of laser or collateral radiation
higher than are specified in ANSI [Z136.1-2000, Safe Use of Lasers]
and 21 CFR §1040.10 [Title 21, CFR, §1040.10], respectively.
(2) Instructions to personnel. Personnel using
a laser must [operating each laser presently being used
or listed on the registrant's current inventory, shall] be provided
with written instructions for safe use, including clear warnings and
precautions to avoid possible exposure to laser and collateral radiation more than [in excess of] the MPE, as specified [delineated] in ANSI [Z136.1-2000, Safe Use of Lasers]
and the collateral limits listed in 21 CFR §1040.10 [Title 21, CFR, §1040.10]. The instructions to personnel must
[shall] be maintained as specified in
[accordance with] subsection (cc) [(ee)]
of this section for inspection by the department [agency].
(3) Engineering controls.
(A) Protective housing.
(i) Each laser must [shall] have
a protective housing preventing [that prevents]
human exposure [access] during the operation
to laser and [to] collateral radiation that exceeds the
limits of Class 1 lasers as specified [delineated]
in ANSI [Z136.1-2000, Safe Use of Lasers] and 21 CFR
§1040.10, if [Title 21, CFR, Part 1040.10, respectively,
wherever and whenever such] human exposure [access]
is not necessary [in order] for the laser to perform its
intended function.
(ii) If [Wherever and whenever]
human exposure [access] to laser radiation levels more than [that exceed] the limits of Class 1 is
necessary, these levels must [shall] not exceed
the limits of the lowest laser class required [necessary]
to perform the intended function [function(s)].
(B) Safety interlocks.
(i) A safety interlock ensuring[, that
shall ensure that] radiation is not accessible above MPE limits
as specified [delineated] in ANSI must [Z136.1-2000, Safe Use of Lasers, shall] be provided for any
portion of the protective housing that, by design, can
be removed or displaced during normal operation or maintenance, and
thereby allows exposure [access] to radiation
above the MPE limits.
(ii) Adjustment during operation, service, testing,
or maintenance of a laser containing interlocks must [shall
] not cause the interlocks to become inoperative or the radiation
to exceed MPE limits outside protective housing except where a laser
controlled area as specified in subparagraph (E) of this paragraph
is established.
(iii) For pulsed lasers, interlocks must [shall] be designed [so as] to prevent the firing
of the laser; for example, by dumping the stored energy into a dummy load.
(iv) For continuous wave lasers, the interlocks must [shall] turn off the power supply or interrupt the beam; for
example, by using [means of] shutters.
(v) An interlock must [shall]
not allow automatic accessibility of radiation emission above MPE
limits when the interlock is closed.
(vi) Either multiple safety interlocks or a means to
preclude removal or displacement of the interlocked portion of the
protective housing upon interlock failure must [shall]
be provided[,] if failure of a single interlock would allow
the following:
(I) human exposure [access] to
levels of laser radiation more than [in excess of]
the accessible emission limit of FDA Class 3a laser radiation; or
(II) laser radiation more than [in
excess of] the accessible emission limits of Class 2 [to
be] emitted directly through the opening created by removing
or displacing [removal or displacement of] that portion
of the protective housing.
(C) Viewing optics and windows.
(i) All viewing ports, viewing optics, or display screens
included as an integral part of an enclosed laser or laser product must
[shall] incorporate suitable means[, (]such
as interlocks, filters, or attenuators[,] to maintain the
laser radiation at the viewing position at or below the applicable
MPE as specified [delineated] in ANSI [Z136.1-2000,
Safe Use of Lasers] and the collateral limits listed in 21
CFR §1040.10 [Title 21, CFR, §1040.10],
under any conditions of operation or use of the laser.
(ii) All collecting optics, such as lenses, telescopes,
microscopes, or endoscopes, [etc.,] intended
for viewing use with a laser must [shall] incorporate
suitable means[,] such as interlocks, filters, or attenuators[,] to maintain the laser radiation transmitted through the collecting
optics to levels at or below the appropriate MPE, as specified [delineated] in ANSI [Z136.1-2000, Safe Use of Lasers].
Normal or prescription eyewear is not considered collecting optics.
(D) Warning systems. Each Class 3B [3b]
or Class 4 laser or laser product must [shall]
provide visual or audible indication during the emission of accessible
laser radiation. In the case of Class 3B [3b]
lasers, except those only allowing access [that allow
access only] to less than 5 milliwatt (mW) peak visible laser
radiation, and Class 4 lasers, the [this] indication must [shall] be sufficient before [prior
to] emission of such radiation to allow appropriate action to
avoid exposure. Any visual indicator must [shall]
be [clearly] visible through protective eyewear designed
specifically for the wavelength [wavelength(s)]
of the emitted laser radiation. If the laser and laser energy source
are housed separately and can be operated at a separation distance
of greater than two meters, both laser and laser energy source must [shall] incorporate visual or audible indicators. The visual
indicators must [shall] be positioned so [that
] viewing does not require human exposure [access]
to laser radiation more than [in excess of]
the MPE, as specified [delineated] in ANSI [Z136.1-2000,
Safe Use of Lasers].
(E) Controlled area. With a Class 3B [3b]
laser, except those only allowing access [that allow
access only] to less than 5 mW visible peak power, or Class
4 laser, a controlled area must [shall] be established
when exposure to the laser radiation more than [in
excess of] the MPE, as specified [delineated]
in ANSI [Z136.1-2000, Safe Use of Lasers] or the collateral
limits listed in 21 CFR §1040.10 [Title 21, CFR,
§1040.10], is possible. The controlled area must
[shall] meet the following requirements, as applicable.
(i) The area is [shall be] posted with hazard signs as required by subsection (u) [(v)
] of this section.
(ii) Access to the controlled area is [shall
be] restricted.
(iii) For Class 4 indoor controlled areas, latches,
interlocks, or other appropriate means are [shall
be] used to prevent unauthorized entry into controlled areas.
(I) Such measures are [shall be]
designed to allow rapid exit [egress] by [the]
laser personnel [at all times] and allow admittance
to the controlled area for emergency personnel [in
an emergency condition]. For such emergency conditions, a control-disconnect
switch or equivalent device (panic button) must [shall]
be available for deactivating the laser.
(II) Where safety latches or interlocks are not feasible
or are inappropriate, for example, during medical procedures,
such as surgery, the following applies [shall apply].
(-a-) All authorized personnel are [shall
be] trained in laser safety, and appropriate PPE
is [personal protective equipment shall be] provided
upon entry.
(-b-) A door, blocking barrier, screen, or curtains is
[shall be] used to block, screen, or attenuate the
laser radiation at the entryway. The level at the exterior of these
devices cannot be more than [shall not exceed]
the applicable MPE, as specified [delineated]
in ANSI [Z136.1-2000, Safe Use of Lasers, nor shall personnel
experience any exposure above the MPE immediately upon entry].
(-c-) Within the laser controlled area, [At
the entryway] there is [shall be] a visible
or audible signal indicating [that] the laser is energized
and operating at Class 4 levels. A lighted laser warning sign, flashing
light (visible through laser protective eyewear), and other appropriate
signage are [some of the] methods to accomplish this requirement.
[Alternatively, an entryway warning light assembly may be interfaced
to the laser in such a manner that one light will indicate when the
laser is not operational (high voltage off) and by an additional light
when the laser is powered up (high voltage applied, but no laser emission)
and by an additional (flashing optional) light that activates when
the laser is operating.]
(iv) For Class 4 indoor controlled areas, during tests
requiring continuous operation, the person [individual]
in charge of the controlled area is [shall be]
permitted to momentarily override the safety interlocks to allow access by [to] other authorized personnel if it is [clearly
] evident [that] there is no optical radiation hazard
at the point of entry, and if the necessary protective devices are
being worn by the entering personnel.
(v) For Class 4 indoor controlled areas, optical paths
(for example, windows) from an indoor facility must [shall
] be controlled [in such a manner as] to reduce the
transmitted values of the laser radiation to levels at or below the
appropriate ocular MPE, as specified [delineated]
in ANSI [Z136.1-2000, Safe Use of Lasers] and the collateral
limits listed in 21 CFR §1040.10 [Title 21, CFR,
§1040.10]. When the laser beam must exit the indoor controlled
area (as in the case of exterior atmospheric beam paths), the operator is [shall be] responsible for ensuring [that]
air traffic is protected from any laser projecting into navigable
air space (contact Federal Aviation Administration (FAA) or other
appropriate agencies, as necessary) or controlled ground space when
the beam irradiance or radiant exposure is above the appropriate MPE,
as specified [delineated] in ANSI [Z136.1-2000,
Safe Use of Lasers].
(vi) When the removal of panels or protective covers or [and/or] overriding of interlocks becomes necessary,
such as for servicing, testing, or maintenance, and accessible laser
radiation exceeds the MPE, as specified [delineated]
in ANSI [Z136.1-2000, Safe Use of Lasers] and the collateral
limits listed in 21 CFR §1040.10 [Title 21, CFR,
§1040.10], a temporary controlled area must [shall
] be established and posted.
(4) Key control. Each Class 3B [3b]
or Class 4 laser and IPL device must [shall]
incorporate a key-actuated or computer-actuated primary [master] control. The key must [shall]
be removable, and the Class 3B [3b]
or Class 4 laser or IPL device must [shall]
not be operable when the key is removed. When the device is not
being prepared for operation or is unattended, the key must [will] be removed from the device and stored in a location away
from the machine.
(r) [(s)] Additional requirements
for special lasers and applications.
(1) Infrared laser. The beam from a laser must [shall] be terminated in fire-resistant material, where
necessary. Inspection intervals of absorbent material and actions
to be taken in the event [or evidence] of degradation must
[shall] be specified in the operating and safety procedures.
(2) Laser optical fiber transmission system.
(A) Laser transmission systems employing [that employ] optical cables are [shall be]
considered enclosed systems with the optical cable forming part of
the protective housing.
(B) Disconnection of a connector resulting in exposure
[access] to radiation more than [in
excess of] the applicable MPE limits, as specified [delineated] in ANSI [Z136.1-2000, Safe Use of Lasers]
and the collateral limits listed in 21 CFR §1040.10 [Title 21, CFR, §1040.10], must [shall]
take place in a controlled area. Except for medical lasers whose manufacture
has been approved by the FDA, the use of a tool is [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 must [shall] bear
the appropriate label or tag as specified in subsection (u)(3)
[(v)(3)] of this section.
(s) [(t)] Additional requirements for safe operation.
(1) Eye protection. Protective eyewear must [shall] be worn by each individual exposed to laser radiation
from IPL, [all individuals with access to] Class 3B,
or [3b and/or] Class 4 levels of laser radiation.
Protective eyewear devices must [shall] meet
the following requirements:
(A) provide a comfortable and appropriate fit all around the area of the eye;
(B) be in proper condition to ensure the optical filter
[filter(s)] and holder provide the required optical
density or greater at the desired wavelengths, and retain all protective
properties during its use;
(C) be suitable for the specific wavelength of the laser and be of optical density adequate for the energy involved;
(D) have the optical density or densities and associated wavelength [wavelength(s)] permanently labeled on
the filters or eyewear; and
(E) be examined, at intervals not to exceed 12 months,
to ensure the reliability of the protective filters and integrity
of the protective filter frames. Unreliable eyewear must [shall] be discarded. Documentation of the examination is
required to be [shall be made and] maintained as
specified in [accordance with] subsection (cc) [(ee)] of this section for inspection by the department [agency].
(2) Skin protection. When there is a possibility of
exposure to laser radiation more than [that exceeds]
the MPE limits for skin as specified in ANSI [Z136.1-2000 Safe
Use of Lasers,] the registrant must [shall]
require the use of appropriate PPE [use
of protective gloves, clothing, or shields].
(t) [(u)] NHZ. Where applicable,
in the presence of unenclosed Class 3B [3b]
and Class 4 laser beam paths, an NHZ must [shall]
be established. If the beam of an unenclosed Class 3B [3b
] and Class 4 laser is contained within a region by adequate
control measures to protect personnel from exposure to levels of radiation more than the [above the appropriate] MPE, as specified
[delineated] in ANSI [Z136.1-2000, Safe Use
of Lasers], that region is [may be considered
to be] the NHZ. The NHZ may be determined by information supplied
by the laser manufacturer, by measurement, or by using the appropriate
laser range equation or other equivalent assessment.
(u) [(v)] Hazard [Caution
] signs, labels, and posting for lasers and IPL devices.
(1) General requirements. Except as otherwise authorized
by the department [agency], signs, symbols,
and labels prescribed by this section must [shall]
use the design and colors as specified in paragraph
(3) of this subsection [subsection (dd) of this section].
(2) Posting. The laser controlled area must [shall] be conspicuously posted with a sign or signs as specified
in paragraph (3) of this subsection [and subsection (dd) of this
section].
(3) Labeling lasers and posting laser facilities. All
signs and labels associated with Class 2, 3a, 3B [3b],
and 4 lasers must [shall] contain the following
wording or sign posting requirements found in ANSI.
(A) Danger sign.
(i) The signal word "DANGER" indicating death or serious injury will occur if required control measures are not implemented to mitigate the hazards within the laser controlled area. This signal word is restricted to those Class 4 lasers with high (e.g., multi-kilowatt) output power or pulse energies with exposed beams.
(ii) The danger sign must include:
(I) The signal word "DANGER" in white letters on a rectangular safety red background placed at the top of the sign.
(II) "Class 4 Laser Controlled Area."
(III) "Avoid eye or skin exposure to direct or scattered radiation. Do not enter when light is illuminated."
(IV) "Laser eye protection required: OD>7@ 1070 nm. Yb: Fiber Laser, 1070nm. 10 kilowatt (kW) maximum average power."
(iii) The safety alert symbol must precede the signal word.
(I) The base of the symbol must be on the same horizontal line as the base of the letter of the signal word.
(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.
(III) The words "Avoid eye or skin exposure to direct or scattered radiation" must appear to the right of the safety alert symbol.
(iv) The following sign meets the requirements of this subparagraph.
Figure: 25 TAC §289.301(u)(3)(A)(ii) (.pdf)
[(A) The signal word "CAUTION" shall
be used with all signs and labels associated with all Class 2 lasers
and all Class 3a lasers that do not exceed the appropriate MPE, as
designated in ANSI Z136.1-2000, Safe Use of Lasers. This signal word
is used in accordance with the sign in subsection (dd)(1) of this section.]
(B) Warning sign.
(i) The signal word "WARNING" must be used with all signs and labels associated with lasers and laser systems whose output is more than the applicable MPE for irradiance, including all Class 3B and most Class 4 lasers and laser systems.
(ii) The warning sign must include:
(I) The signal word "WARNING" in black letters on a rectangular orange background placed at the top of the sign.
(II) "Class 4 Laser Controlled Area."
(III) "Avoid eye or skin exposure to direct or scattered radiation."
(IV) "Do not enter when light is illuminated."
(V) "Laser eye protection required: OD≥ 5@ 532 nm. Diode laser, 670 nm. Freq. Doubled Nd: YAG laser, 532 nm. 10 watts maximum average power."
(iii) The safety alert symbol must precede the signal word.
(I) The base of the symbol must be the same horizontal line as the base of the letter of the signal word.
(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.
(III) The words "Avoid eye or skin exposure to direct or scattered radiation" must appear to the right of the safety alert symbol.
(iv) The following sign meets the requirements of this subparagraph.
Figure: 25 TAC §289.301(u)(3)(B)(ii) (.pdf)
[(B) The signal word "DANGER" shall
be used with all Class 3a lasers that exceed the appropriate MPE,
as designated in ANSI Z136.1-2000, Safe Use of Lasers, and all Class
3b and 4 lasers. This signal word is used in accordance with the sign
in subsection (dd)(2) of this section.]
(C) Caution sign.
(i) The signal word "CAUTION" must be used with all signs and labels associated with Class 2 and Class 2M lasers and laser systems not more than the applicable MPE for irradiance.
(ii) The caution sign must include:
(I) The signal word "CAUTION" in black letters on a rectangular yellow background placed at the top of the sign.
(II) "Class 2M Laser In Use."
(III) "Do not stare into beam or view directly with optical instruments. Diode laser, 670 nm. 20 mW maximum power."
(iii) The safety alert symbol must precede the signal word.
(I) The base of the symbol must be on the same horizontal line as the base of the letters of the signal word.
(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.
(III) The words "Do not stare into beam or view directly with optical instruments" must appear to the right of the safety alert symbol.
(iv) The following sign meets the requirements of this subparagraph.
Figure: 25 TAC §289.301(u)(3)(C)(ii) (.pdf)
[(C) Position 1 in the signs in subsection
(dd)(1) and (dd)(2) of this section shall contain the following information,
as applicable:]
[(i) for all Class 2 lasers, the words "LASER RADIATION - DO NOT STARE INTO BEAM";]
[(ii) for Class 3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z136.1-2000, Safe Use of Lasers, the words "LASER RADIATION - DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS";]
[(iii) for all other Class 3a lasers, the words "LASER RADIATION - AVOID DIRECT EYE EXPOSURE";]
[(iv) for all Class 3b lasers, the words "LASER RADIATION - AVOID DIRECT EYE EXPOSURE"; or]
[(v) for Class 4 lasers, the words "LASER RADIATION - AVOID EYE or SKIN EXPOSURE to DIRECT or SCATTERED RADIATION".]
[(D) Positions 2 and 3 in the signs in subsections (dd)(1) and (2) of this section shall contain the following information, as applicable.]
[(i) Position 2 shall contain the type of laser or the emitted wavelength, pulse duration (if appropriate), or maximum output.]
[(ii) Position 3 shall contain the class of laser.]
(D) [(E)] Lasers, except a laser [lasers] used in the practice of medicine or veterinary medicine, must[, shall] have a label [ label(s)] in close proximity to each aperture emitting [ through which is emitted] accessible laser or collateral radiation
in excess of the limits specified in ANSI [Z136.1-2000, Safe
Use of Lasers] and the collateral limits listed in 21 CFR
§1040.10 [Title 21, CFR, §1040.10], labeled
with the following [wording] as
applicable:[.]
(i) "AVOID EXPOSURE - Laser radiation is emitted from
this aperture," if the radiation emitted through the [such
] aperture is laser radiation;[.]
(ii) "AVOID EXPOSURE - Hazardous electromagnetic radiation
is emitted from this aperture," if the radiation emitted through the
[such] aperture is collateral radiation;
or[.]
(iii) "AVOID EXPOSURE - Hazardous x-rays are emitted
from this aperture," if the radiation emitted through the [such] aperture is collateral x-ray radiation.
(E) [(F)] Each defeatable
or non-interlocked [noninterlocked or defeatably interlocked]
portion of the protective housing or enclosure [that is]
designed to be displaced or removed during normal operation or servicing[, and] that permits [would permit] human exposure [access] to laser or collateral radiation[,] must have the following label [shall have labels as follows]:
(i) for Class 3B [3b] accessible
laser radiation, the wording, "DANGER - LASER RADIATION
WHEN OPEN. AVOID DIRECT EXPOSURE TO BEAM";
(ii) for Class 4 accessible laser radiation, the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION"; or
(iii) for collateral radiation more than [in excess of] the emission limits as specified [described
] in 21 CFR §1040.10 [Title 21, CFR, §1040.10
], "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN"
and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable.
(F) [(G)] For protective housing
or enclosures providing [that provide] a defeatable
interlock, the words "and interlock defeated" must [shall
] be included in the labels as specified in subparagraph (E)(i) and (ii) [(F)(i) and (ii)] of this
paragraph.
(G) [(H)] Other required information.
(i) The word "invisible" must [shall]
immediately precede the word "radiation" on labels and signs required
by this subparagraph for wavelengths of laser and collateral radiation
[that are] outside of the range of 400 to 700 nm.
(ii) The words "visible and invisible" must [shall] immediately precede the word "radiation" on labels and
signs required by this subparagraph for wavelengths of laser and collateral
radiation [that are] both within and outside the range
of 400 to 700 nm.
(H) [(I)] Labels and signs required
by this subparagraph must [shall] be clearly
visible, legible, and permanently attached to the laser or facility.
[Signs required by this subparagraph shall be clearly visible,
legible, and securely attached to the facility.]
(4) In lieu of the requirements in paragraphs (1) -
(3) of this subsection [and subsection (dd) of this section],
the department [agency] will accept labeling
and signage as specified [designated] by [the
following]:
(A)
21 CFR §1040.10 [Title 21,
CFR, §1040.10];
(B) ANSI [Z136.1-2000, Safe Use of Lasers]; and
(C) IEC standards 60825-1 and 60601-2-22.
(v) [(w)] Surveys. Each registrant must conduct [shall make or cause to be made such]
surveys [as may be] necessary to comply with this section
and maintain records of the surveys as specified in [accordance
with] subsection (cc) [(ee)] of this section
for inspection by the department [agency]. Surveys must [shall] be performed at intervals not to exceed
12 months, and [to] include [but not be
limited to the following]:
(1) a determination if [that]
all laser and IPL protective devices are labeled correctly, functioning
within the design specifications, and properly chosen for lasers and
IPL devices in use;
(2) a determination if [that]
all warning devices are functioning within their design specifications;
(3) a determination if [that]
the controlled area is properly controlled and posted with accurate
warning signs as specified in [accordance with]
subsection (u) [(v)] of this section;
(4) a re-evaluation of potential hazards from surfaces
[that may be] associated with beam paths; and
(5) additional surveys [that may be required]
to evaluate the primary and collateral radiation hazard incident to
the use of lasers and IPL devices.
(w) [(x)] Records or documents [Records/documents]. Each registrant must [shall]
maintain current records or documents [records/documents]
required by this subsection as specified in [accordance
with] subsection (cc) [(ee)] of this section
for inspection by the department [agency].
(x) [(y)] Measurements and instrumentation.
Each determination requiring a measurement for compliance with this
section must use instrumentation calibrated and designed for
use with the laser or IPL device to be tested. Records of measurements
and instrumentation must be maintained as specified in subsection
(cc) of this section [shall use instrumentation that is
calibrated and designed for use with the laser or IPL device that
is to be tested].
(y) [(z)] Notification of injury
other than a medical event.
(1) Each registrant of Class 3B [3b]
or Class 4 lasers or user of an IPL device must [shall] immediately seek appropriate medical attention for the injured individual and notify the department [agency
] by telephone of any injury involving a laser possessed by
the registrant or an IPL device, other than intentional exposure of
patients for medical purposes, that has or may have caused:
(A) an injury to an individual involving [that involves] the partial or total loss of sight in either eye; or
(B) an injury to an individual involving [that involves] intentional perforation of the skin or other
serious injury excluding [exclusive of] eye injury.
(2) Each registrant of Class 3B [3b]
or Class 4 lasers or user of an IPL device must [shall], within 24 hours of the discovery of an injury, notify [report to] the department of any [agency each] injury involving a [any]
laser possessed by the registrant or IPL device possessed by a user,
as applicable, other than intentional exposure of patients for medical
purposes, that has or may have caused, or threatens to
cause, [an] exposure to an individual with second or third-degree
burns to the skin or potential injury and partial loss of sight. Record
of a notification of injury must be documented and maintained as specified
in subsection (cc) of this section.
(z) [(aa)] Reports of injuries.
(1) Each registrant of Class 3B [3b]
or Class 4 lasers or user of an IPL device must [shall] make a report, in writing, or by electronic
transmittal, within 30 days to the department [agency]
of any injury required to be reported as specified in [in
accordance with] subsection (y) [(z)]
of this section.
(2) Each report must [shall]
describe [the following]:
(A) the extent of injury to each individual [individuals] from radiation caused by [from]
lasers or IPL devices;
(B) power output of laser or IPL device involved;
(C) the cause of the injury; and
(D) corrective steps taken or planned [to be taken]
to prevent a recurrence.
(3) A [Any] report filed with
the department [agency] as specified in
[accordance with] this subsection must [shall]
include the full name of each individual injured and a description
of the injury. The report must include personally identifying [shall be prepared so that this] information [is stated]
in a separate part of the report.
(4) When a registrant or user of an IPL device is required, as specified in [accordance with] paragraphs (1)
- (3) of this subsection, to report to the department [agency] any injury of an individual caused by [from
] radiation from a laser or IPL device [from
lasers or IPL devices], the registrant or user of an IPL device must [shall also] notify the individual. The [Such] notice must [shall] be sent [transmitted] to the individual at the same [a]
time the report is sent to the department [not later
than the transmittal to the agency]. Record of a report
of injury must be documented and maintained as specified in subsection
(cc) of this section.
(aa) [(bb)] Medical event.
(1) The registrant of a Class 3B [3b] or Class 4 laser [lasers]
or user of an IPL device must [shall] notify
the department [agency], by telephone or electronic
transmittal, within 24 hours of the discovery of a medical
event involving a Class 3B or Class 4 laser resulting in [or of any] injury [to] or death of a patient. Within
30 days after a 24-hour [24 hour] notification
is made, the registrant of a Class 3B [3b]
or Class 4 laser [lasers] or the user
of an IPL device must [shall] submit a written
report to the department [agency] of the event. Record of a medical event must be documented and maintained as specified
in subsection (cc) of this section.
(2) The written report must [shall]
include [the following]:
(A) the registrant's or user's name;
(B) a brief description of the event;
(C) the effect on the patient;
(D) the action taken to prevent recurrence; and
(E) whether the registrant or user informed the patient or the patient's responsible relative or legal guardian.
(3) When a medical event occurs, the registrant or
user must [shall] promptly investigate its cause,
make a record for department [agency] review,
and retain the records as specified [stated]
in subsection (cc) [(ee)] of this section.
(bb) [(cc)] Reports of stolen,
lost, or missing Class 3B [3b] or Class 4
lasers and IPL devices.
(1) Each registrant of Class 3B [3b]
or Class 4 lasers or user of an IPL device must [shall] report to the department [agency]
by telephone at (512) 458-7460, or email at RAMAssist@dshs.texas.gov,
a stolen, lost, or missing laser or IPL device within 24 hours
after its occurrence becomes known to the registrant or IPL device user.
(2) Each person required to make a report as specified
in [accordance with] paragraph (1) of this subsection must [shall], within 30 days after making the telephone or email report, make a written report to the department
including [agency that includes the following information]:
(A) a description of the laser or IPL device involved, including the manufacturer, model, serial number, and class;
(B) a description of the circumstances under which the loss or theft occurred;
(C) a statement of disposition, or probable disposition, of the laser or IPL device involved;
(D) actions [that have been] taken, or to [will] be taken, to recover the laser or IPL device; and
(E) procedures or measures [that have been]
taken to prevent a recurrence of the loss or theft of lasers or IPL devices.
(3) Report of a stolen, lost, or missing Class 3B or Class 4 laser and IPL device must be maintained as specified in subsection (cc) of this section.
(cc) Record or document retention requirements for registration of a radiation machine. Each registrant must maintain the following records or documents at each site, including authorized records sites for mobile services at the time intervals specified for inspection by the department.
Figure: 25 TAC §289.301(cc) (.pdf)
[(dd) Caution and danger signs. The
following contains signs required in accordance with subsection (v)(3)
of this section.]
[(1) This sign shall be used with all Class 2 lasers and Class 3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z.136-2000, Safe Use of Lasers.]
[Figure: 25 TAC §289.301(dd)(1)]
[(2) This sign shall be used with all Class 3a lasers that exceed the appropriate MPE, as designated in ANSI Z.136-2000, Safe Use of Lasers, and all Class 3b and Class 4 lasers.]
[Figure: 25 TAC §289.301(dd)(2)]
[(ee) Keeping records/documents. The following chart contains time requirements for keeping records/documents:]
[Figure: 25 TAC §289.301(ee)]
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on August 29, 2024.
TRD-202404042
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: October 13, 2024
For further information, please call: (512) 834-6655