TITLE health-services

Part I. Texas Department of Health

Chapter 289. Radiation Control

The Texas Department of Health (department) adopts the repeal of existing §289.2 and new §289.301, concerning registration and radiation safety requirements for lasers with changes to the proposed text as published in the October 2, 1998, issue of the Texas Register (23 TexReg 9936), as a result of comments received during the 30-day comment period. The repeal of §289.2 is adopted without changes and therefore will not be republished.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.2 has been reviewed and the department has determined that reasons for adopting the section continue to exist; however, a new rule was proposed. The department published a Notice of Intention to Review the section as required by Rider 167 in the Texas Register (23 TexReg 9079) on September 4, 1998. No comments were received by the department on this section. 

The section adopted for repeal adopts by reference the Texas Regulations for Control of Laser Radiation Hazards. The new section incorporates language from the Texas Regulations for Control of Laser Radiation Hazardsthat has been rewritten into Texas Registerformat and includes the addition and revision of several subsections of the section. The repeal and new section are part of the renumbering phase in the process of rewriting the department’s radiation rules in the Texas Register format. The new section reflects the renumbering.

The new section establishes requirements for the registration of persons who possess and use class IIIb and IV lasers in the healing arts, veterinary medicine, industry, academic and research and development institutions, and of persons who provide laser services. The revision includes new definitions that support terminology used in the new section. It also establishes requirements for protection against laser radiation hazards, responsibilities of the registrant and the laser safety officer; laser hazard control methods; training requirements; and notification of injuries. The rule revision updates the current 20-year old requirements by addressing changes in technologies and uses of lasers. Other minor grammatical changes are made to the section for clarification.

The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning §289.301(b)(3), the department deleted the words "Code of Federal Regulations" because the term is already spelled out in subsection (b)(2). Change is reflected in §289.301(b)(2).

Change: Concerning §289.301(d)(2), the department changed the words "millirad (mrad)" to "milliradians" because millirad is a unit of absorbed ionizing radiation dose and is not the appropriate term for this definition.

Change: Concerning proposed §289.301(d)(50), the department deleted the definition of "PRF" because it was not necessary and it was not used anywhere else in the rule. The department renumbered subsequent definitions as reflected in §289.301(d)(50)-(62).

Change: Concerning §289.301(f)(1)(C), the department deleted the last sentence because it is redundant. The requirement is stated in subsection (b)(1) of this section.

Change: Concerning §289.301(g)(2)(B), the department changed the wording and added another sentence to specifically state that an application for healing arts shall be signed by a licensed practitioner of the healing arts and an application for veterinary medicine shall be signed by a veterinarian.

Change: Concerning §289.301(j)(3), the department deleted the word "annual" to allow the department to request information when needed.

Change: Concerning §289.301(k)(2), the department deleted subparagraphs (A)-(C) and added the words "terminate use and/or services of laser(s) and request termination as outlined in subsection (l) of this section" to simplify the subsection.

Change: Concerning §289.301(n)(1)-(3), the department deleted paragraphs (1)-(3) and added the sentence, "Modification, suspension, and revocation of certificates of laser registration shall be in accordance with §289.205 of this title" to simplify the subsection and avoid repetition. Change is reflected in §289.301(n).

Change: Concerning §289.301(p)(1), the department changed the word "non-ionizing" to "laser" and added the word "or" after "course;" to clarify that educational courses or experience will suffice as an LSO qualification.

Change: Concerning §289.301(q)(1), the department changed the words "in use with the users duties" to "the individual uses" to clarify the intent of the rule.

Change: Concerning §289.301(r), the department changed the word "requirements" to "controls" to clarify the intent of the rule.

Change: Concerning §289.301(r)(2)(E)(iii)(I), the department deleted the word "both" after "allow," added the word "and" after "all times," and deleted the words "and/or" to clarify the requirements to prevent unauthorized entry into controlled areas.

Change: Concerning §289.301(w)(5), the department added the words "that may be" after the word "surveys" to clarify that such surveys may only be necessary when a laser is modified from the manufacturer’s specifications.

Change: Concerning §289.301(z)(1), the department added the words "seek appropriate medical attention for the individual and" after the word "immediately" to clarify the intent of the rule.

Change: Concerning §289.301(dd)(1)-(2), the department changed the words "signs and graphs" to "sign" to clarify the intent of the rule.

Change: Concerning §289.301(dd)(3)-(10), the department changed the words "signs and graphs" to "graph" to clarify the intent of the rule.

The following comments were received concerning the proposed section. Following the comments are the department’s responses.

Comment: Concerning the section in general, the commenter noted that holding working group discussions prior to draft and proposed changes should result in a more mature document at the time of the initial comment period, resulting in more efficient use of the department’s limited resources. These working groups should include both regulators and industry experts interested.

Response: The department has in the past held stakeholder meetings when significant regulatory changes and rule revisions were being considered. This process was used in the development of this rule. No change was made as a result of the comment.

Comment: Concerning the section in general, the commenter noted that as of now, a laser program is not funded by the legislature. The commenter suspected these regulations are a backdoor justification to acquire funding (and the certain fee increase) by pointing out that the department does not have the ability to enforce such broad regulatory equipments.

The commenter stated there is no hint of the promised move toward adoption of the American National Standards Institute (ANSI) and suspects the statement was something of a bone tossed to the Texas Radiation Advisory Board (TRAB) after it was clear that the ANSI was an acceptable alternative per legal counsel.

The commenter stated the rules continue to suffer from the fact that there is no provision for updates as the science, technology and consensus standards change. More than other rules there is a certain feeling of programmed obsolescence. The static nature of the laser rules over the last 24 years should cause a fundamental rethinking of how we (the state) want to do business.

Response: The department has presented an initiative to the legislature during the last three legislative sessions to increase funding in order to implement a more complete laser regulatory program. The TRAB has supported these initiatives. Because the initiatives have been unsuccessful, the proposed rules are more performance-based rather than prescriptive. This gives the registrant and the laser safety officer more latitude and more responsibility for ensuring laser safety and for updating the laser safety program concurrently with changes in science and technology.

Referencing the ANSI standard is acceptable in rulemaking. However, the legality of referencing is not the only consideration the department must take into account in responsible rulemaking. Referencing a standard is legal and is acceptable if the agency makes the standard or a method for obtaining the standard available to registrants. The department has always made the radiation rules available to registrants at no cost. The department does not believe that making a registrant seek out and pay for a referenced standard encourages compliance. The rules represent a minimum standard for safe use of lasers and the department has incorporated the portions of the ANSI standard believed necessary to achieve that minimum level. While "large" laser registrants (those with multiple lasers) may have and routinely use ANSI standards, the majority of laser registrants are registered for a single laser. The department does not believe it to be cost effective to force those registrants to pay approximately $60 for an ANSI standard when the rule provides an acceptable level of safety. The rule does not prohibit a registrant from incorporating additional ANSI standards nor does it conflict with ANSI standards. No change was made as a result of the comment.

Comment: Concerning the section in general, the commenter noted that it would be much simpler and more justifiable to adopt the current ANSI standards for safe use of lasers. ANSI is almost universally accepted as the standard for safe laser operation. The rules could be kept current by treating ANSI in the same manner as the Department of Transportation regulations are used for regulations involving transport of radioactive material in Texas. ANSI would also provide a much more efficient way to keep the regulations updated as laser science, technology and consensus standards change.

Response: Referencing the ANSI standard is acceptable in rulemaking. However, the legality of referencing is not the only consideration the department must take into account in responsible rulemaking. Referencing a standard is legal and is acceptable if the agency makes the standard or a method for obtaining the standard available to registrants. The department has always made the radiation rules available to registrants at no cost. The department does not believe that making a registrant seek out and pay for a referenced standard encourages compliance. The rules represent a minimum standard for safe use of lasers and the department has incorporated the portions of the ANSI standard believed necessary to achieve that minimum level. While "large" laser registrants (those with multiple lasers) may have and routinely use ANSI standards, the majority of laser registrants are registered for a single laser. The department does not believe it to be cost effective to force those registrants to pay approximately $60 for an ANSI standard when the rule provides an acceptable level of safety. The rule does not prohibit a registrant from incorporating additional ANSI standards nor does it conflict with ANSI standards. No change was made as a result of the comment.

Comment: Concerning §289.301(a)(1), the commenter noted that the stated purpose is to establish requirements for class IIIb and IV lasers. There must also be some statement that these rules apply only to class IIIb and IV lasers. Statements in the body of the draft refer simply to "lasers" or to classes in addition to IIIb and IV, and imply a level of regulation of other classes. The commenter suggested constraining language is necessary to prevent confusion.

Response: Subsection (a)(1) and (2) clearly specify the intentions of the rule to address registration and use requirements for class IIIb and IV lasers. Unless stated otherwise, the word "lasers" refers to those covered by the rule. No change was made as a result of the comment.

Comment: Concerning §289.301(a)(1), the commenter questioned whether there is sufficient evidence to show that class IIIb lasers need to be registered with the state and questioned how many accidents in Texas, the United States, and the world have occurred from using class IIIb lasers.

The commenter noted that subsection (a)(1) seems to cover businesses and institutions, but questioned whether it covers individuals. By this statement, anyone can order and use a laser of any type if it is used at home and if it is not used in the healing arts, veterinary medicine, etc.

Response: The department believes that the potential for increased injury exists because of the increased use of lasers by individuals that are not properly trained or aware of the hazards of improper use of class IIIb and IV lasers. The word "person" is defined in the §289.201 of this title to include any individual. No change was made as a result of the comment.

Comment: Concerning §289.301(a)(1), the commenter noted that the purpose is to establish requirements for "class IIIb and class IV lasers." Other areas in the draft refer to simply "lasers" and to classes other than class IIIb and class IV. If it is intended to exempt class I, II, and IIIa lasers, then this should be unambiguously stated.

Response: Subsection (a)(1) and (2) clearly specify the intentions of the rule to address registration and use requirements for class IIIb and IV lasers. Unless stated otherwise, the word "lasers" refers to those covered by the rule. No change was made as a result of the comment.

Comment: Concerning §289.301(a)(2), the commenter suggested this sentence be restructured so that it is more clearly understood.

Response: The department changed the one sentence into two sentences for easier readability.

Comment: Concerning §289.301(b)(2), the commenter stated that this sentence seems very vague. Lasers shall meet the requirements of any applicable federal standard. The commenter suggests that those standards or some of them should be listed here to help registrants with compliance. 

Response: The department added the specific citation to the federal standard.

Comment: Concerning §289.301(c)(2), the commenter noted that the rule states that "Individuals shall not be intentionally exposed to laser radiation unless such exposure has been authorized by a licensed practitioner of the healing arts." Use of class I, class II, and class IIIa lasers in engineering materials research and manufacturing can involve incidental exposure (as opposed to deliberate exposure) of persons to this radiation that has been determined to be below established hazardous levels. These facilities are sometimes large open buildings without barriers to break up line of sight. The commenter stated that enforcement of this clause would result in a major impact on laboratory operations, and potentially could have a negative impact on safety if visibility in the building is lost to a proliferation of barriers. The commenter suggested that this statement be modified to a term less general than "laser radiation".

Response: The rule does not apply to class I, II, and IIIa lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(c)(2), the commenter questioned whether the training/demonstration often done in medical school is considered to be healing arts.

Response: Such training/demonstration is considered to be healing arts. No change was made as a result of the comment.

Comment: Concerning §289.301(d), the commenter suggested that laser safety officer (LSO) training be defined. Different entities have different applications and specializations for LSO’s.

Response: The department declines to add additional requirements for LSO training. Because of the multiple types and uses of lasers, the department does not believe it to be prudent to set specific time requirements for training at this time. When selecting an LSO, the registrant should ensure the individual is adequately trained and capable of handling the responsibilities for the type of lasers used at the registered facility. No change was made as a result of the comment.

Comment: Concerning §289.301(d), the commenter noted that research laser is a term that is used but not defined and suggests the term "research" or "research laser" should be defined.

Response: A research laser is a laser used in research. The word "research" is defined in 25 TAC §289.201. No change was made as a result of the comment.

Comment: Concerning §289.301(d)(7), the commenter suggested adding a comma after "rays."

Response: A comma is not grammatically necessary. No change was made as a result of the comment.

Comment: Concerning §289.301(d)(30), the commenter noted that this is the only place that the words "fail-safe" are mentioned in the text of these proposed regulations and questioned whether it is necessary here, or is it necessary to have it some where else in the text.

Response: The department deleted the definition for "fail-safe interlock" because it is not used anywhere else in the rules. The department renumbered subsequent definitions as reflected in §289.301(d)(30)-(48).

Comment: Concerning proposed §289.301(d)(33), the commenter suggested deleting "nanometer" and using "nm" instead.

Response: The department deleted the word nanometer because the abbreviation "nm" was already spelled out previously in the section. Change is reflected in §289.301(d)(32).

Comment: Concerning proposed §289.301(d)(39) in the first sentence, the commenter suggested adding the words "according to the performance standards set" after the word "product."

Response: The department acknowledges the comment and changed the rule accordingly. Change is reflected in §289.301(d)(38).

Comment: Concerning proposed §289.301(d)(45), the commenter stated that the purpose of the first part of this definition is unclear. The boundary of the nominal hazard zone (NHZ) is the maximum permissible exposure (MPE), therefore the potential for exposing a patient above the MPE outside the NHZ is zero. The commenter stated that the definition for NHZ explains this phenomenon. The exposure of a patient outside the established laser controlled area for surgery suites could be considered a medical event. The commenter believes exposure when unintentional is what was intended, but not what was said.

Response: The department changed the definition of medical event to read "Any adverse patient health effect that is a result of failure or misuse of laser or laser safety equipment" to more clearly state the intent of the rule. Change is reflected in §289.301(d)(44).

Comment: Concerning proposed §289.301(d)(50), the commenter noted that the abbreviation "PRF" could be handled by identifying it in parentheses the first time the term is used.

Response: The department deleted the definition because it is not used anywhere else in the rule. The department renumbered subsequent definitions as reflected in §289.301(d)(50)-(62).

Comment: Concerning proposed §289.301(d)(52), one commenter stated that clarification of definitions for "mobile services," "provider of services," and "healing arts facility" is needed. The department should clarify that lasers in doctors’ offices are under the Safe Medical Devices Act (SMDA).

Response: The department changed the definition of provider of services to "provider of lasers" and added subsection (g)(2)(C) to clarify that if a person is furnished a laser by a provider of lasers, that person is responsible for ensuring that a licensed practitioner of the healing arts authorizes intentional exposure of humans to laser radiation. Change is reflected in §289.301(d)(50).

Comment: Concerning proposed §289.301(d)(52), the commenter suggested taking the word "routine" out of the definition. The commenter stated that this may only happen one time.

Response: The department changed the definition of "provider of services" to "provider of lasers" to clarify that a provider of laser(s) is a person who furnishes a laser(s) on a routine basis for a limited time period to a facility(ies) that operates the laser(s) during that limited time period. If a person furnishes a laser to another person only one time, it could be considered a transfer of the laser. Change is reflected in §289.301(d)(50). 

Comment: Concerning §289.301(e), the commenter noted that under Texas Regulations for Control of Laser Radiation (TR-CLR) 70.4(d), class IIIb hand held pointers were exempt from registration as "mobile lasers." These proposed changes contain no such exemption. These hand held pointers are commonly available, inexpensive, and widely used in classrooms and presentations. In a company with thousands of employees, controlling their use would essentially require banning all such laser pointers from company premises, since it is sometimes difficult to determine the actual class due to deficiencies in the manufacturer’s markings, or absence of markings.

Response: The department added paragraph (4) to this subsection to clarify that class IIIb mobile lasers of continuous wave (CW) in the wavelength range of 400 <  £ 700 nm and having a peak radiant power of less than or equal to 5 x 10 -3 watts are exempted from this section.

Comment: Concerning §289.301(e)(2), the commenter questioned whether or not inoperable lasers are exempted from these regulations.

Response: The department only requires lasers in operation to be registered. No change was made as a result of the comment. 

Comment: Concerning §289.301(e)(3), the commenter noted that in the future, there may be changes in the classification scheme from the International Electrotechnical Commission (IEC) that would impact the rule. The commenter recommended the statement read "laser products less than class IIIb are exempt from the requirements of this section."

Response: The department reviews and make changes to the rules when federal rules mandate and will change the classification scheme when changed at the federal level. No change was made as a result of the comment.

Comment: Concerning §289.301(f), the commenter recommended that there should be a section directly indicating what lasers are required to be registered with the state. It should be clearly stated that anyone possessing and using a class IIIb or class IV laser must obtain a certificate of registration and register that laser.

Response: Subsection (a)(1) of this section clearly specifies the classified lasers that are required to be registered with the department. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(1)(B), the commenter questioned whether an LSO can or should be named for multiple sites, whether the LSO needs to reside within Texas, and whether the LSO needs to be present at the site full time, part time, or not at all.

Response: Subsection (q) specifies the duties for the LSO. It is the responsibility of the registrant to determine how the LSO can best fulfill those duties. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(1)(C), the commenter noted that this subparagraph was not in the previous version of regulation and questioned why it was being added now. Response: This requirement is consistent with other permitting sections of this chapter and is required by state law. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(2)(B), the commenter noted that the department allows the radiation safety officer (RSO) for M.D. Anderson to have signature authority for its broad scope license and multiple use ionizing radiation registration similar to a hospital administrator. A LSO for a multiple use laser registration should have similar signature authority. Requiring signatures from each laser research/ physician/veterinarian owner/user gives no real control or safety value, but merely increases the administrative burden of the safety program.

Response: Subsection (g)(2)(B) clearly states that the signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner’s signature if the facility is a licensed hospital or a medical facility. A signature of each individual user is not required. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(2)(B), the commenter noted that the wording here is very similar to §289.226(d)(5). The department has agreed that the RSO for this university has the signature authority in a manner similar to a hospital administrator. Given a university system of multiple lasers, internal controls, and assigned permits, the language here should not preclude the LSO from this signature authority. Specifically, a veterinarian professor’s signature on the application at Texas A&M contributes no control or safety value and actually increases the administrative burden of the safety program.

Response: Subsection (g)(2)(B) clearly states that the signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner’s signature if the facility is a licensed hospital or a medical facility. A signature of each individual user is not required. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(2)(B), the commenter stated that there needs to be delineation about healing arts versus veterinary medicine. The commenter noted that there are veterinarians who are purchasing devices then used for human treatment and questioned whether this is allowed. The commenter also questioned how this clause applies to a rental or mobile surgical company without a single named practitioner/owner/user.

Response: The rules address who uses the lasers and not who purchases the lasers. Subsection (i)(2) specifies that each person registered by the department for laser use in accordance with this section shall confine use and possession of the laser registered to the locations and purposes authorized in the certificate of laser registration. Subsection (g)(5) of this section applies to mobile services. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(4)(A), the commenter noted that many of these medical devices are in the possession of a reseller for less than 30 days and questions whether this will create a preponderance of paperwork. These devices are not of the same risk as an ionizing device. The commenter questioned if they require the same control and scrutiny. 

Response: Each individual laser does not require a unique registration. The persons who receive, possess, acquire, transfer, use, or demonstrate lasers for the purpose of sale, class IIIb and IV lasers must be registered. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(5)(B)(ii), the commenter noted that this requirement seems an impossible or endless function for a mobile service. Some mobile sites may be a one-time event. Again, this may create a preponderance of paperwork.

Response: The requirements of this section are for providers of lasers, not for mobile services. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(6), the commenter questioned whether this requirement is an additional registration for the described functions that are required in Part 21 of the Code of Federal Regulations (CFR) as requirements for use. The commenter asked whether this is another layer of registration, or is it meant as a method of registering and controlling after-market functions by non-manufacturers.

Response: This subsection clearly specifies that persons providing alignment, calibration, and/or repair of lasers must be registered with the department. The requirement is meant to register persons who are in the business of performing alignment, calibration, and/or repair of lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(8), one commenter suggested that when performing mobile services, the physician who actually performs the procedure with the laser needs to be registered. 

Response: Subsection (b)(1) of this section states that lasers shall not be used on humans unless under the supervision of a licensed practitioner of the healing arts. No change was made as a result of the comment.

Comment: Concerning §289.301(g)(8)(C), two commenters suggested that it be made clear that healing arts devices may be signed for only by a healing arts practitioner. There are rumors of healing arts devices being purchased for human application at nonstandard locations through a veterinary signature. 

Response: The department changed subsection (g)(8)(C) to specifically state that an application for mobile services for healing arts shall be signed by a licensed practitioner of the healing arts and an application for veterinary medicine shall be signed by a veterinarian.

Comment: Concerning §289.301(g)(8)(D), the commenter questioned how facilities know of this regulation, how and through whom should they verify this information, and will or can a state office promulgate this information.

Response: The department agreed that this paragraph was inappropriate and deleted it. The department added subsection (j)(4) to clarify that the mobile service company providing mobile services shall provide evidence of registration with the agency to each facility receiving the services. The department renumbered the subsequent paragraph as reflected in §289.301(j)(5).

Comment: Concerning §289.301(i)(2), the commenter stated that this will potentially exclude spontaneous use for clinical purposes in locations other than mobile services. For example: UT Southwestern may move a laser to St. Paul of the Dallas Veterans Administration (sister hospitals) for a single procedure. This requirement would preclude any such use and add the burden of additional expense for a non-exceptional procedure. These lasers are not ionizing devices that must be closely monitored to protect the public from invisible and potentially fatal exposure unknowingly.

Response: The department suggests the commenter handle the example situation as a temporary use authorization on the registration or obtain a mobile services authorization. No change was made as a result of the comment.

Comment: Concerning §289.301(i)(2), the commenter asked how this applies to multiple locations that have separate certificates but are under one "person."

Response: The department allows the registrant to register multiple facilities under one certificate of registration or to have a seperate certificate of registration for each facility. No change was made as a result of the comment.

Comment: Concerning §289.301(j)(2), the commenter suggested the department define "make" a laser. Texas A&M as a research institution "makes" lasers as part of the normal business of research and development. Relationships with funding sources or other institutions may involve testing of temporary devices at other locations under research and development conditions. These tests may be made in a variety of conditions. The lasers may be intentionally subjected to destructive forces so that they can be analyzed for cause of the failure. Relief can be provided by a suitably broad definition of research, as noted above. The commenter suggested that the rules should recognize the operating life of a newly made laser may be minutes to weeks and the department should offer appropriate regulatory guidance.

Response: The department defines research and development in §289.201 of this title and the definition incorporates the situation described by the commenter. If a registrant is authorized for research and development, this situation is addressed. No change was made as a result of the comment.

Comment: Concerning §289.301(j)(3), the commenter noted that in the past whenever a laser was taken out of use, they simply sent in a request saying this item had been dropped. The commenter questioned if this is a change in policy. 

Response: The registrant is required to submit an inventory of lasers only when requested by the department. When a registration is terminated, the requirements for disposition of lasers in subsection (l) of this section must be met. The word "annual" was deleted for clarification.

Comment: Concerning §289.301(o)(1), the commenter noted that this was not in the previous rule and questioned why it has been included for nonionizing devices. There are already federal rules for use, sale, and transfer of these devices if they are medical.

Response: This requirement is consistent with other permitting sections of this chapter and ensures proper disposition or transfer of lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(p), the commenter stated that this requirement is too broad and that the department needs to be more specific on who qualifies, what kind of training is required, and how many hours of training are required.

Response: The department declined to further define LSO training. Because of the multiple types and uses of lasers, the department does not believe it to be prudent to set specific time requirements for training at this time. When selecting an LSO, the registrant should ensure the individual is adequately trained and capable of handling the responsibilities for the type of lasers used at the registered facility. No change was made as a result of the comment.

Comment: Concerning §289.301(p)(1), the commenter stated that there needs to be delineation of educational courses to define content to match current national guidelines. A course should have been attended no longer than 2 years prior and included at least 4 hours classroom and 4 hours hands-on practical for each wavelength per ANSI Z 136.3.

Response: The department declined to further define LSO training. Because the multipe types and uses of lasers, the department does not believe it to be prudent to set specific time requirements for training at this time. When selecting an LSO, the registrant should ensure the individual is adequately trained and capable of handling the responsibilities for the type of lasers used at the registered facility. No change was made as a result of the comment.

Comment: Concerning §289.301(p)(3), the commenter noted that it is difficult to understand how knowledge of emergency precautions is an adequate substitute for knowledge of laser radiation hazards.

Response: The department changed the word "or" to "and" to clarify that the LSO shall have knowledge of potential laser radiation hazards and laser emergency situations. 

Comment: Concerning §289.301(p)(3), the commenter suggested changing "emergency precautions" to "laser emergency situations."

Response: The department changed the words "emergency precautions" to "laser emergency situations."

Comment: Concerning §289.301(p)(3), the commenter suggested changing the clause to read "and," not "or."

Response: The department changed the word "or" to "and" to clarify that the LSO shall have knowledge of potential laser radiation hazards and laser emergency situations. 

Comment: Concerning §289.301(p)(3), the commenter suggested that the term "or emergency precautions" should be eliminated or "emergency precautions" should be defined.

Response: The department changed the words "emergency precautions" to "laser emergency situations."

Comment: Concerning §289.301(p)(3), the commenter noted that under LSO qualifications, the LSO requires "knowledge of potential laser radiation hazards "or" emergency precautions." The term "emergency precautions" is not consistent with safety or risk management language and has no clear meaning. The commenter suggested the term needs be defined or eliminated. A definition should include how a knowledge of "emergency precautions" can replace a knowledge of laser hazards.

Response: The department changed the words "emergency precautions" to "laser emergency situations."

Comment: Concerning §289.301(q)(6), the commenter noted that the responsibility for compliance is a registrant obligation and the LSO is the instrument through which compliance is understood, evaluated, and communicated. The LSO will specify engineering or operational controls with these recommendations being supported by the registrant. The LSO is charged by the registrant to assist the operation with understanding the compliance issues and periodically evaluating operational compliance.

Response: The department agrees with the commenter. No change was made as a result of the comment.

Comment: Concerning §289.301(r), the commenter noted that the LSO shall specify alternate requirements that should have at least a base limit of safety or clear definition of equivalence and asked how equivalence is to be determined. 

Response: The department allows alternate equivalent engineering controls for protection against laser radiation to obtain laser safety protection. The requirements are performance-based, therefore equivalence to the stated requirements may be achieved through multiple methods. If the performance goal of the rule is met, the requirements are satisfied. No change was made as a result of the comment. 

Comment: Concerning §289.301(r), the commenter stated that engineering controls are generally regarded as the best type of control, but the LSO should be able to make substitution in areas besides medical applications. Research laboratories often have multiple lasers in a single large laser laboratory without the benefit of walled areas and interlocks to prevent operation if someone enters the NHZ. While administrative alternates are available (procedures, training, and signs), it is clear these do not offer "equivalent laser safety protection." The consequence of this rule would result in the possible elimination or curtailment of research or drive up the cost of research where lasers are an integral part. 

Response: The department allows that latitude and the section clearly states that alternate equivalent engineering controls to obtain laser safety protection are permitted, including research and development. The term "medical procedures or surgery" is stated as an example. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(1), the commenter suggested that there needs to be reiteration of the medical release for this statement. If the theory is that MPE can exist within the NHZ, then personnel within 3 feet of the active laser appliance will qualify in a surgical application.

Response: The allowance for specifying alternate controls is stated in subsection (r). The statements in subsection (r) apply to paragraphs (1) and (2) of the subsection. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2), the commenter suggested that a paragraph that overviews the performance standards could suffice for the next several paragraphs. All of the engineering controls other than "controlled area" are specified in the federal performance standards that are required prior to entering commerce. A simple pointer to these requirements should suffice for those persons engaging in the manufacture of lasers or laser products.

The commenter noted that the purpose and scope of this document do not include manufacture of lasers or laser products. Therefore, the requirements of the United States Food and Drug Administration (FDA) for performance standards and labeling are inappropriate in this document. In cases where there are additional requirements specified by Texas, the FDA requirements take precedence and the Texas requirements fall mute. The commenter suggested requiring conformance to the federal requirements and accepting the FDA’s rulings on international products.

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(A), the commenter noted that collateral radiation is defined in (d)(19) as any electromagnetic (EM) radiation. Use of this term in subsections (r)(2)(A) and (w)(5) of this section implies a requirement for measuring EM radiation throughout the spectrum. This would involve an array of specialized equipment and expertise, or use of consultants which would be a significant expenditure of resources. If this is not really intended, the statements or definition should be clarified.

Response: The term "survey" as used in this section is consistent with the definition in §289.201 of this chapter and the rule does not require measurement of beam output or other radiation. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(A)(ii), the commenter suggested that the rule reference 21 CFR 10.40.10(f).

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(B)(iii) and (iv), the commenter stated that these subsections distinguish between pulsed and continuous wave (CW) lasers with regard to control requirements. This is confusing in that the control measure example given for CW lasers, the use of shutters, is applicable and in current use for many pulsed laser systems. The wording of the regulations seems to prevent the use of shutters for pulsed lasers.

Response: The examples given are not controlling and do not prevent the use of shutters for pulsed lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(B)(iv), the commenter suggested deleting "class IIIb and IV" and adding "continuous wave (CW)" instead.

Response: The department deleted the words "class IIIb and IV" because it was redundant.

Comment: Concerning §289.301(r)(2)(B)(v), the commenter suggested adding between parenthesis another sentence such as "(A manual reset or operator instruction must accomplish the re-establishment of the interlock circuit and restore the function of the laser.)"

Response: As this section is a performance-based rule, the department does not specify how an interlock must prohibit automatic accessibility. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(B)(vi), the commenter questioned what is meant by "failure."

Response: The department replaced the word "such" with "interlock" to clarify that upon interlock failure, either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing shall be provided.

Comment: Concerning §289.301(r)(2)(B)(vi)(II), the commenter suggested that the rule reference 21 CFR 1040.10(f).

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(C)(ii), the commenter suggested that the rule reference 21 CFR 1040.10(f).

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(D), the commenter suggested deleting "except those that allow access only to less than 5 milliwatt (mW) peak visible laser radiation," since it is in the definition of IIIa.

Response: The department believes the wording is necessary because, depending upon the wavelength of the laser, the exception may be applicable. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(E), the commenter stated that in specifying requirements for the laser controlled area, the department should restrict the text to stating the requirements and not extend the text into the methods of compliance. This becomes prescriptive and loses the flexibility the department has achieved in other parts of the document. These recommendations and methods for accomplishing the control of laser hazards may be better served in a regulatory guide. The information is applicable and reasonable, but may limit the ability of an LSO to achieve the objectives of laser safety in an operational environment. The commenter also suggested deleting the words, "except those that allow access only to less than 5 mW visible peak power."

Response: The statements in subsection (r) of this section apply to paragraphs (1) and (2), including paragraph (2)(E). Therefore, the LSO has the latitude to specify alternate controls that achieve equivalent laser radiation safety. The rule is not strictly prescriptive in that it states options for signage and ways to prevent unauthorized entry. The department believes the wording, "except those that allow access only to less than 5 mW visible peak power," is necessary because, depending upon the wavelength, the exception may be applicable to other lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(E)(ii), the commenter questioned through what means shall there be restriction.

Response: As this is a performance-based rule, the department does not specify how to restrict access to controlled areas. If the performance goal of the rule is met, the requirements are satisfied. No change was made as a result of the comment.

Comment: Concerning §289.301(r)(2)(E)(iii)(II)(-b-), the commenter noted that laser radiation is not ionizing radiation and that the current requirements for protection from non-ionizing do not include such a barrier nor are any available by organizations like Rockwell Laser Institute, who have been key to national laser safety regulation for over 20 years.

Response: The department replaced the word "and" with "or" to allow the registrant to choose what is best suitable to attenuate laser radiation at the entryway. 

Comment: Concerning §289.301(r)(2)(E)(iii)(II)(-c-), the commenter noted that illuminated or audible signs have not been considered necessary to date. A correctly worded signage is accepted as a national standard in medical arenas. 

Response: The rule allows "other appropriate signage." The department changed the word "or" to ", and" for grammatical correctness. 

Comment: Concerning §289.301(r)(2)(E)(iii)(II)(-c-), the commenter suggested changing the wording "are some" for "is one" in the second sentence. 

Response: The department changed the word "or" to "and" for grammatical correctness. 

Comment: Concerning §289.301(r)(2)(E)(v), the commenter noted that controlled air space has a specific definition in the arena of air traffic control. Outdoor laser operations can be performed safely outside of controlled air space with appropriate safe guards. The commenter stated that the rule needs to be reworded to allow ongoing national and international, as well as state, research activities to continue to be performed in Texas. The commenter suggested that the wording "adequate protection to be provided for any visible or class IIIb and class IV laser projecting into navigable air space to assure protection of air traffic," should be considered in place of "controlled air space." This protection shall include consideration of hazards resulting from non-damaging light levels entering the cockpits or aircraft during critical flight operations, such as landing approach and departure. 

Response: The department deleted the words "the beam path is limited to controlled air space" and replaced them with the words "air traffic is protected from any laser projecting into navigable air space" to clarify the intentions of the rule. 

Comment: Concerning §289.301(s)(1), the commenter noted that this is a point of good information, but it doesn’t belong in the regulation. A regulatory guide would be a beneficial use of this and most of the controlled area information. 

Response: The department deleted the last sentence. 

Comment: Concerning §289.301(t)(1)(C), the commenter noted that the table appears to describe to the user that for a particular laser power that a specific optical density (OD) is required and will provide protection. This logic is not acceptable given the orders of magnitude difference in MPE that is the level to which the OD should be reducing the radiant energy or irradiance. The MPE is the objective and the output power or energy is the information that determines the acceptable OD, not this table. The MPE and thereby, the OD are subject to the laser wavelength and the biological effects that drive the MPE levels. 

The commenter suggested deleting the OD table and refer the user to the equation for OD and MPE tables or direct the user to ANSI standard for guidance. 

Response: The department believes the first sentence in the subparagraph is sufficient and deleted the last two sentences, including the table. 

Comment: Concerning §289.301(t)(1)(E), the commenter asked how the eyewear is to be tested and whether by the user, outside company, or the manufacturer. If there is no commercially or user accessible test, then the user has no alternative but to discard. There is currently no definition for "suspicious condition." The commenter suggested defining the term or removing the last sentence. 

Response: The department changed the wording in the last sentence to ensure that unreliable eyewear be discarded. 

Comment: Concerning §289.301(v)(3), the commenter noted that the purpose and scope of this document do not address the manufacture of lasers and laser products that are covered by the FDA requirements. It is inappropriate to repeat those requirements in this document. If the information is for the benefit of the user, then the information can be provided in a regulatory guide or just direct the LSO to the FDA regulations (21 CFR 1040.10). 

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment. 

Comment: Concerning §289.301(v)(3)(A), the commenter suggested deleting the words "shall have a label...." 

Response: The department believes that this wording is needed to clearly specify the intentions of the rule. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(C), the commenter noted that aperture labels are covered by 10 CFR 1040.10(g) and do not need to be restated here. The user should maintain the labeling on the laser, but not determine what labeling is appropriate. That is a manufacturer requirement for meeting the performance standards.

The commenter also noted that if there is an exemption for medical lasers in the state of Texas that relieves the manufacturer from labeling the aperture, then the commenter is unaware of its purpose or benefit.

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. In order to maintain appropriate labeling on the laser, the department believes it is prudent for the user to know what the labels must state. The fiber optics of some medical lasers are considered to be the aperture and labeling of such is infeasible. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(C), the commenter suggested deleting the words "..laser or collateral radiation in excess of the limits specified in subsection (cc)(5) and (cc)(8) of this section with the following wording as applicable."

Response: In order to maintain appropriate labeling on the laser, the department believes it is prudent for the user to know what the labels must state. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(C)(ii) and (iii), the commenter suggested deleting this wording.

Response: The proposed rules are not a recapitulation of the FDA requirements, but are items that department inspectors may verify during the course of inspection. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(D), the commenter suggested replacing the word "the" before "output" with "and the" and noted that these are FDA requirements.

Response: The suggested change would not be grammatically correct. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(E), the commenter suggested deleting the words "or collateral radiation" after "human access to laser."

Response: The department believes it is prudent to include collateral radiation for safety purposes. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(E)(ii), the commenter suggested deleting this clause, including the subclauses. 

Response: There can be electromagnetic or x-ray radiation associated with laser production, so such labels are necessary for safety awareness. No change was made as a result of the comment.

Comment: Concerning §289.301(v)(3)(F), the commenter suggested deleting the word "labels" and adding "information" instead. 

Response: The department replaced the word "labels" with "information" to clarify that the required information includes labels and signs.

Comment: Concerning §289.301(v)(3)(F)(i), the commenter suggested deleting the words "labels and." 

Response: In order to maintain appropriate labeling on the laser, the department believes it is prudent for the user to know what the labels must state. No change was made as a result of the comment. 

Comment: Concerning §289.301(v)(3)(F)(ii), the commenter suggested deleting the words "labels and." 

Response: In order to maintain appropriate labeling on the laser, the department believes it is prudent for the user to know what the labels must state. No change was made as a result of the comment. 

Comment: Concerning §289.301(v)(3)(G), the commenter suggested deleting the words "labels placed on lasers or" and the words "and the limits listed in subsection (cc)(8) of this section." 

Response: The department deleted subparagraphs (G) and (H) and added new subparagraph (G) to clarify how and where labels and signs shall be attached. 

Comment: Concerning §289.301(v)(3)(H), the commenter suggested deleting the words "Labels and," replacing the word "permanently" with "firmly" and deleting the word "or" before facility. 

Response: In order to maintain appropriate labeling on the laser, the department believes it is prudent for the user to know what the labels must state. The label should be permanently attached to the laser. Deleting the word "or" does not reflect the intent of the rule. No change was made as a result of the comment. However, subparagraph (H) was deleted and the wording was incorporated in new subparagraph (G) to consolidate requirements for signs and labels. 

Comment: Concerning §289.301(w), the commenter suggested adding the word "(Inspections)" after "Surveys". The commenter stated that these issues should be initially dealt with upon installation and reviewed only when changes have been made that would impact the laser control measures. 

Response: The word "survey" as used in this section is consistent with the definition in §289.201 of this chapter. Also, the department believes that 12 months is the appropriate interval to conduct surveys. No change was made as a result of the comment. 

Comment: Concerning §289.301(w), the commenter stated that this could be all encompassing and practically impossible for registrants to fully address. The commenter suggested that this should be required only if problems are suspected or have occurred in the recent past (at least for academia). In the university environment, a laser will not provide any useful results if it is not operating correctly in terms of output radiation. The commenter stated that making periodic measurements of the beam output will not provide any useful safety information in the academic situation. Measurement of other types of radiation can prove to be very expensive. The definition of "collateral radiation" implies that the registrant must check for all electromagnetic radiations. The commenter noted that it would be useful to have examples of situations that have actually happened that have lead to accidents because of the lack of such surveys.

Response: The term "survey" as used in this section is consistent with the definition in §289.201 of this title and the rule does not require measurement of beam output or other radiation. The phrase "that may be" was added to subsection (w)(5) of this section for clarification.

Comment: Concerning §289.301(w)(1), the commenter suggested that the wording be changed to read "a review that laser protective devices are correctly labeled and appear to work properly and are properly chosen for lasers in use".

Response: The department believes that the rule wording is appropriate and states the intent of the rule. However, changes were made for grammatical correctness.

Comment: Concerning §289.301(w)(2), the commenter suggested that the wording be changed to read "a review that all warning devices are functioning properly within their design specifications".

Response: The department believes that rule wording is appropriate and states the intent of the rule. No change was made as a result of the comment.

Comment: Concerning §289.301(w)(3), the commenter suggested that the wording be changed to read "a review that the laser hazards are properly controlled and posted with accurate warning signs in accordance with subsection (v) of this section". 

Response: The department believes that the rule wording is appropriate and states the intent of the rule. No change was made as a result of the comment. 

Comment: Concerning §289.301(w)(4), the commenter suggested adding the words "changes to" after "re-evaluation of." 

Response: The department believes that a re-evaluation is necessary whether changes have been made or not. No change was made as a result of the comment. 

Comment: Concerning §289.301(w)(5), the commenter suggested deleting this paragraph and noted that lasers are not "surveyed" like x-ray producing machines. The open beam applications are the areas needing the control. Once controls are in place, the hazards are contained until the applications are changed. 

Response: The term survey as used in this section is consistent with the definition in §289.201 of this title and the rule does not require measurement of beam output or other radiation. The phrase "that may be" was added to subsection (w)(5) of this section for clarification. 

Comment: Concerning §289.301(w)(5), two commenters asked for clarification of this paragraph. 

Response: The term survey as used in this section is consistent with the definition in §289.201 of this title and the rule does not require measurement of beam output or other radiation. The phrase "that may be" was added to subsection (w)(5) of this section for clarification. 

Comment: Concerning §289.301(w)(5), a commenter stated that collateral radiation is defined in (d)(19) as any EM radiation which, given the vastness the spectrum, must include ionizing, microwave, infrared, ultraviolet, radiowaves and extremely low frequency. Regarding laser radiation, the point of classification by the manufacturer renders unnecessary any regulatory or safety survey of laser output. Measurement of EM radiation is vague and is of dubious value unless some problem is suspected. Equipment and design (§289.301(y)) depends on what part of the EM band you survey. The commenter stated that routine ionizing surveys to demonstrate areas are less than 100 mR/year are not needed. Only high voltage sources even have the capacity to create x-ray fields and historical data do not support the contention that an individual will exceed any limit in 25 TAC §289.202. Compiling annual surveys of the entire EM spectrum will necessarily require the purchase, maintenance and calibration of highly specialized instrumentation and/or use of consultants, all of which require resources which will compete with the safety dollar of any institution. 

Response: The term survey as used in this section is consistent with the definition in §289.201 of this title and the rule does not require measurement of beam output or other radiation. The phrase "that may be" was added to subsection (w)(5) of this section for clarification. 

Comment: Concerning §289.301(w)(5), a commenter noted that the term "survey" in this section should be carefully defined to avoid confusion as to what is required. Routine surveys should not include beam output measurements or measurements of collateral radiation. Such measurements require expensive devices wavelength specific to the laser output from the specific unit. Accurate measurement of general collateral radiation is very difficult if not impossible in practice. Such measurements usually give negative data which provide a false sense of security for the user. Specific collateral radiation such as ionizing radiation can be more easily measured, but only certain very high voltage sources have the capacity to create x-ray fields and historical data does not show that any individual has received such radiation in excess of any applicable limit when operating such lasers. The commenter noted that operational procedures, built-in interlocks/engineering controls, and labeling are much more important to a good laser safety program. 

Response: The term survey as used in this section is consistent with the definition in §289.201 of this title and the rule does not require measurement of beam output or other radiation. The department agrees with the last sentence of the comment. The phrase, "that may be" was added to subsection (w)(5) of this section for clarification. 

Comment: Concerning §289.301(z)(1)(B), a commenter suggested adding the word "(bleeding)" after "skin." 

Response: Bleeding is not often associated with laser injury. No change was made as a result of the comment. 

Comment: Concerning §289.301(bb)(2)(B), a commenter suggested using "attending" or "operating," rather than "referring." 

Response: This information is not necessary for the 30-day written report and the department deleted the subparagraph from the paragraph. The department renumbered subsequent subparagraphs as reflected in §289.301(bb)(2)(B)-(E). 

Comment: Concerning §289.301(cc), a commenter noted that classification tables for accessible emission limit (AEL) are duplicated from the Center for Devices and Radiological Health (CDRH) and are available through the FDA and on the world-wide web. The commenter suggested keeping MPE tables for laser hazards analyses and OD calculations.

Response: The department is aware of the availability of the AEL tables through the FDA and on the world-wide web, but not every registrant has access to the world-wide web. No change was made as a result of the comment.

Comment: Concerning §289.301(cc)(8), a commenter suggested deleting the last part of the sentence, "as determined from subsection (cc)(1) of this section for the appropriate wave-length( s) and emission duration" and clauses (i) and (ii).

Response: Because the laser classifications are definitions in subsection (d) of this section and the definitions reference subsection (cc)(8), subsection (cc)(8) is needed in the rule. No change was made as a result of the comment.

Comment: Concerning §289.301(cc)(8)(B), the commenter suggested deleting the words "and MPE."

Response: The department deleted the words "and MPE" to clarify the intent of the rule.

Comment: Concerning §289.301(cc)(8)(C), a commenter suggested deleting the subparagraph.

Response: The department deleted the subparagraph because it is not necessary.

Comment: Concerning §289.301(cc)(9)-(11), a commenter suggested deleting paragraphs (9)-(11).

Response: The department believes it is prudent to include these paragraphs for accessibility by all registered laser users. No changes were made as a result of the comment.

Comment: Concerning §289.301(cc)(11)(A), a commenter suggested changing the wording to "The MPE information is excerpted from American National Standard for the Safe Use of Lasers, ANSI Z136.1."

Response: The department does not believe that the additional wording is necessary for the registration and radiation safety requirements for lasers. No change was made as a result of the comment.

Comment: Concerning §289.301(cc)(11)(B), a commenter suggested deleting the subparagraph.

Response: The commenter gives no reason for deletion and the department believes that it is necessary for this wording to be in rule. No change was made as a result of the comment. 

Comment: Concerning §289.301(dd), a commenter noted that there should also be an allowance for the use of the IEC 60825 laser symbol. The CDRH has made allowances for this symbol provided the laser classification conforms to the CDRH requirements.

Response: The department will review and make changes to the rule when federal changes mandate. No change was made as a result of the comment.

Comment: Concerning §289.301(dd)(3)-(10), a commenter noted graphical representations of the MPE are nice, but the numerical tables are more accurate and the values can be calculated instead of estimated. The commenter suggested deleting the graphs and pointing the user to the ANSI standard if they want to use the graphs.

Response: The department believes it is prudent to include these paragraphs for accessibility by all registered laser users. No change was made as a result of the comment.

Commenters included representatives from The University of Texas Southwestern Medical Center, Seton Hospital, Texas A & M University, M. D. Anderson Cancer Center, NASA’s Goddard Space Flight Center, and Texas Instruments. In addition, numerous individuals commented. The commenters were generally favorable of the rule as proposed; however, the commenters had questions or specific concerns, and offered suggestions for changes to the proposal as discussed in the summary of comments.

Subchapter A. Control of Radiation

25 TAC §289.2

The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health (board) with authority to adopt rules and guidelines relating to the control of radiation; and §12.001, which provides the board the authority to adopt rules for its procedures and the performance of each duty imposed by law on the board, the department, and the commissioner of health. The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature is implemented by the proposal.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency’s legal authority.

Filed with the Office of the Secretary of State on January 25, 1999.

TRD-9900488

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 14, 1999

Proposal publication date: October 2, 1998

For further information, please call: (512) 458–7236

Subchapter E. Registration Regulations

25 TAC §289.301

The new section is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health (board) with authority to adopt rules and guidelines relating to the control of radiation; and §12.001, which provides the board the authority to adopt rules for its procedures and the performance of each duty imposed by law on the board, the department, and the commissioner of health. The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature is implemented by the proposal.

§289.301. Registration and Radiation Safety Requirements for Lasers.

(a) Purpose.

(1) This section establishes requirements for the registration of persons who receive, possess, acquire, transfer, or use class IIIb and class IV 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 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.

(2) This section also establishes requirements for protection against laser radiation hazards resulting from activities conducted with class IIIb or class IV lasers. This section includes responsibilities of the registrant and the laser safety officer (LSO), laser hazard control methods, training requirements and notification of injuries.

(b) Scope.

(1) Except as otherwise specifically provided, this section applies to all persons who receive, possess, acquire, transfer, or use lasers that emit or may emit laser radiation. Nothing in this section shall be interpreted as limiting the intentional exposure of patients to laser radiation for the purpose of diagnosis, therapy, or treatment by a licensed practitioner of the healing arts. Individuals shall not use lasers on humans for medical or cosmetic purposes unless under the supervision of a licensed practitioner of the healing arts. This chapter does not apply to the manufacture of lasers.

(2) Lasers, including lasers used on humans for research demonstration, shall meet the requirements of any applicable federal standards in 21 Code of Federal Regulations (CFR) 1040. All lasers shall meet the requirements of these and any other applicable state requirements.

(3) If any conflict arises between the requirements of this section and the laser performance standards in 21 CFR 1040, the requirements of the federal standard shall apply.

(4) This section applies to lasers that operate at wave-lengths between 180 nanometers (nm) and 1 millimeter (mm).

(5) In addition to the requirements of this section, all registrants are subject to the applicable requirements of §289.112 of this title (relating to Hearing and Enforcement Procedures); §289.201 of this title (relating to General Provisions); §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections); and §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services).

(c) Prohibitions.

(1) The agency may prohibit uses of lasers that pose significant threat or endanger public health and safety, in accordance with §289.112 of this title and §289.201 of this title.

(2) Individuals shall not be intentionally exposed to laser radiation unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

(A) exposure of an individual for training, demonstration, or other non- healing arts purposes;

(B) exposure of an individual for the purpose of healing arts screening, except as specifically authorized by the agency; and

(C) exposure of an individual for the purpose of research. Any research using radiation producing devices on humans must be approved by an institutional review board (IRB) as required by 45 Code of Federal Regulations (CFR) 46 and 21 CFR 56. The IRB must include at least one practitioner of the healing arts to direct use of laser radiation in accordance with subsection (b)(1) of this section.

(d) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Accessible emission limit (AEL) - The maximum accessible emission level permitted within a particular class.

(2) max - The angular limit beyond which extended source maximum permissible exposures (MPE) for a given exposure duration are expressed as a constant radiance or integrated radiance. This value is defined as 100 milliradians.

(3) min - (See definition for limiting angular subtense.)

(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) Attenuation - The decrease in the radiant ux of any optical beam as it passes through an absorbing or scattering medium.

(7) Beam - A collection of rays that may be parallel, divergent, or convergent.

(8) C A - Correction factor that increases the MPE values in the near infrared (IR-A) spectral band (700-1400 nm) based upon reduced absorption properties of melanin pigment granules found in the skin and in the retinal pigment epithelium.

(9) C B - Correction factor that increases the MPE values in the red end of the visible spectrum (550-700 nm) because of greatly reduced photochemical hazards.

(10) C C - Correction factor that increases the MPE values for ocular exposure because of pre-retinal absorption of radiant energy in the spectral region between 1150 and 1400 nm.

(11) C E - Correction factor used for calculating the ex-tended source MPE for the eye from the intrabeam MPE, when the laser source subtends a visual angle exceeding min .

(12) C F - Correction factor that reduces the MPE for repetitively pulsed exposure of the eye.

(13) Class I laser - Any laser that does not permit access during the operation to levels of laser radiation in excess of the accessible emission limits contained in subsection (cc)(1) of this section.

(14) Class II laser - Any laser that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in subsection (cc)(1) of this section, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in subsection (cc)(2) of this section.

(15) Class IIIa laser - Any laser that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in subsection (cc)(2)of this section, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in subsection (cc)(3) of this section.

(16) Class IIIb laser - Any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits of subsection (cc)(3) of this section, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in subsection (cc)(4) of this section.

(17) Class IV laser - Any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits contained in subsection (cc)(4) of this section.

(18) 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.

(19) Collateral radiation - Any electromagnetic radiation, except laser radiation, emitted by a laser that is physically necessary for its operation.

(20) Collimated beam - Effectively, a "parallel" beam of light with very low divergence or convergence. (See definition for intrabeam viewing.)

(21) Continuous wave (CW) - 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 a period ³0.25 seconds is regarded as a CW laser.

(22) Controlled area - An area where the occupancy and activity of those within is subject to control and supervision by the registrant for the purpose of protection from radiation hazards.

(23) Cosmetic - Radiation intended to be applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance.

(24) Diopter - A measure of the power of a lens, defined as 1/¦ 0 , where ¦0 is the focal length of the lens in meters.

(25) Divergence - For purposes of this section, divergence is taken as the full angle, expressed in radian, of the beam spread measured between those points that include laser energy or irradiance equal to 1/e (where e means base natural logarithm) of the maximum value (the angular extent of a beam that contains all the radius vectors of the polar curve of radiant intensity that have length rated at 36.8% of the maximum). This is also referred to as beam spread.

(26) Electromagnetic radiation - 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 occupy various portions of the electromagnetic spectrum and differ only in frequency, wavelength, or photon energy.

(27) 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.

(28) 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).

(29) Entertainment laser - Any laser manufactured, de-signed, intended, or promoted for purposes of entertainment, advertising display, or artistic composition.

(30) Focal point - The point toward which radiation converges or from which radiation diverges or appears to diverge. 

(31) Hertz (Hz) - The unit that expresses the frequency of a periodic oscillation in cycles per second.

(32) Infrared radiation - Electromagnetic radiation with wavelengths that lie within the range 700 nm to 1 mm.

(33) Institutional Review Board (IRB) - Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.

(34) Intrabeam viewing - The viewing condition where the source subtends an angle at the eye that is equal to or less than min , the limiting angular subtense. This category includes most collimated beams and so called point sources.

(35) Irradiance (at a point of a surface) - The quotient of the radiant ux incident on an element of the surface containing the point at which irradiance is measured, by the area of that element. Unit: watt per square centimeter (W/cm 2 ).

(36) Joule - A unit of energy. One joule is equal to one watt • second.

(37) Laser - A device that produces an intense, coherent, directional beam of light by stimulating electronic or molecular transitions to lower energy levels. "Laser" is an acronym for light amplification by stimulated emission of radiation. The term "laser" also includes the assembly of electrical, mechanical, and optical components associated with the laser.

(38) Laser product - Any manufactured product or assemblage of components that constitutes, incorporates, or is intended to incorporate a laser and is classified as a class I, II, IIIa, IIIb or IV laser product according to the performance standards set by the United States Food and Drug Administration (FDA). A laser that is intended for use as a component of an electronic product shall itself be considered a laser product. A laser product contains an enclosed laser with an assigned class number higher than the inherent capability of the laser in which it is incorporated and where the product’s lower classification is appropriate due to the engineering features limiting accessible emission.

(39) Laser safety officer - An individual who has a knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and who must be specifically authorized on a certificate of laser registration.

(40) Limiting angular subtense ( min ) - The apparent visual angle that divides intrabeam viewing from extended-source viewing.

(41) Limiting aperture (D r ) - The maximum diameter of a circle over which irradiance and radiant exposure can be averaged.

(42) Limiting exposure duration (T max ) - An exposure duration that is specifically limited by the design or intended use(s).

(43) Maximum permissible exposure (MPE) - The level of laser radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin.

(44) Medical event - Any adverse patient health effect that is a result of failure or misuse of a laser safety equipment.

(45) Nominal hazard zone (NHZ) - The space 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.

(46) Optical density (D ) - The logarithm to the base ten of the reciprocal of the transmittance. D = -log 10 ˝ , where ˝ is transmittance.

(47) Point source - A source of radiation whose dimensions are small enough to result in a subtended angle that is less than min . For the purpose of this section, a point source leads to intrabeam viewing condition.

(48) Practitioner of the healing arts (practitioner) - A person licensed to practice the healing arts by either the Texas State Board of Medical Examiners as a physician; the Texas State Board of Dental Examiners; the Texas Board of Chiropractic Examiners; or the Texas State Board of Podiatry Examiners.

(49) Protective housing - An enclosure surrounding the laser 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 work station and shall limit access to other associated radiant energy emissions and to electrical hazards associated with components and terminals.

(50) Provider of lasers - A person who furnishes a laser(s) on a routine basis for a limited time period to a facility(ies) that operates the laser(s) during that limited time period.

(51) 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. 

(52) Pulsed laser - A laser 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 <0.25 seconds in a pulsed laser. 

(53) Reflection - The deviation of radiation following incidence on a surface. 

(54) Service - The performance of those procedures or adjustments described in the manufacturer’s service instructions that may affect any aspect of the performance of the laser. 

(55) Source - A laser or a laser-illuminated reflecting surface. 

(56) T 1 - The exposure duration (time) at which MPEs based upon thermal injury are replaced by MPEs based upon photochemical injury to the retina. 

(57) T max - (See definition for limiting exposure duration.) 

(58) Transmission - Passage of radiation through a medium. 

(59) Ultraviolet radiation - Electromagnetic radiation with wavelengths smaller than those of visible radiation; for the purpose of this section 180 to 400 nm. 

(60) Visible radiation (light) - Electromagnetic radiation that can be detected by the human eye. This term is commonly used to describe wavelengths that lie in the range of 400 to 700 nm. 

(61) Watt - The unit of power or radiant flux. 1 watt equals 1 joule per second. 

(62) Wavelength (  ) - The distance between two successive points on a periodic wave that have the same phase. 

(e) Exemptions. 

(1) Lasers in 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 I, class II, and class IIIa lasers or products are exempt from the requirements of this section. 

(4) Class III mobile lasers are exempt from registration only if they are continuous wave (CW) in the wavelength range of 400 <  £ 700 nm and have a peak radiant power of less than or equal to5 x 10 -3 watts. 

(f) Registration of laser uses and services. 

(1) For purposes of this section, laser uses and services shall include, but may not be limited to: 

(A) possession and use of lasers in the healing arts, veterinary medicine, industry, academic, and research and development institutions; 

(B) demonstration and sales of lasers that require the individual to operate or cause a laser to be operated in order to demonstrate or sell; 

(C) provision of lasers on a periodic basis to a facility for limited time periods by a provider of lasers; 

(D) alignment, calibration, and/or repair; or 

(E) laser light shows. 

(2) A person who has made application for registration in accordance with this section and is using a laser 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 shall be completed on forms prescribed by the agency and shall contain all the information required by the form and accompanying instructions. 

(B) A laser safety officer (LSO) shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The LSO shall meet the applicable requirements of subsection (p) of this section and carry out the responsibilities of subsection (q) of this section. 

(C) If the applicant is a corporation under the Texas Business Corporation Act, BRC Form 226-1 shall be submitted with the application to confirm that no tax owed the state under Tax Code, Chapter 171, is delinquent. 

(D) Each application for a certificate of laser registration shall be accompanied by the appropriate fee prescribed in §289.204 of this title. 

(E) An application for a certificate of laser registration may include a request for a certificate of laser registration authorizing one or more activities. 

(F) The agency may, at any time after filing of the original application and before issuance of the certificate of registration, require further statements in order to enable the agency to determine whether the application should be granted or denied. 

(G) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with §289.201(n) of this title. 

(2) Application for use of laser on humans or animals. 

(A) In addition to the requirements of subsection (g)(1) of this section, each person having a laser for use in the healing arts, or for use on animals shall submit an application to the agency within 30 days following the commencement of operation of that laser. 

(B) An application for healing arts shall be signed by a licensed practitioner of the healing arts. An application for veterinary medicine shall be signed by a veterinarian. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner’s signature if the facility is a licensed hospital or a medical facility. A signature by the administrator, president, or chief executive officer does not relieve the practitioner user or veterinarian user from complying with the requirements of this section. 

(C) If a person is furnished a laser by a provider of lasers, that person is responsible for ensuring that a licensed practitioner of the healing arts authorizes intentional exposure of laser radiation to humans. 

(3) Application for use of lasers in industrial, academic, and research and development institutions. In addition to the requirements of subsection (g)(1) of this section, each applicant having a laser(s) for use in industrial, academic, and research and development institutions shall submit an application to the agency within 30 days following the commencement of operation. 

(4) Application for demonstration for the purpose of sales of lasers. 

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

(B) In addition to the requirements of subsection (g)(1) of this section, the applicant shall submit a statement confirming that no demonstration will be performed on humans unless directed by a licensed practitioner of the healing arts. 

(5) Application for providers of lasers. 

(A) Each applicant shall apply for and receive a certificate of laser registration before providing lasers. 

(B) In addition to the requirements of subsection (g)(1) of this section, the applicant shall submit the following: 

(i) 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; and 

(ii) a list of facilities where the laser will be provided. 

(6) Application for alignment, calibration, and/or repair. 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 lasers. 

(7) Application for laser light show. 

(A) Each applicant shall apply for and receive a certificate of laser registration for laser light show before beginning any show. 

(B) In accordance with subparagraph (A) of this paragraph and in addition to the requirements of subsection (g)(1) of this section, each applicant shall submit the following: 

(i) a valid variance issued from the FDA for the laser intended to be used. The registrant shall comply with the conditions of the FDA variance. 

(ii) a written notice of the laser light show to be performed in Texas. The information contained in BRC Form 301-1 shall be provided seven days prior to each show. If, in a specific case the seven working-day period would impose an undue hardship on the applicant, the applicant may, upon written request to the agency, obtain permission to proceed sooner. 

(8) Application for mobile services used in the healing arts and veterinary arts. 

(A) Each applicant shall apply for and receive a certificate of laser registration for mobile services before beginning to provide mobile services. 

(B) In addition to the requirements of subsection (g)(1) of this section, each applicant shall submit the address of the established main location where the laser, records, etc. will be maintained for inspection. This shall be a physical street address, not a post office box number. 

(C) An application for mobile services for healing arts shall be signed by a licensed practitioner of the healing arts and an application for mobile services for veterinary medicine shall be signed by a veterinarian. 

(h) Issuance of certificate of laser registration. 

(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 it deems appropriate or necessary. 

(2) The agency may incorporate in the certificate of laser registration at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the registrant’s receipt, possession, use, and transfer of lasers subject to this section as it deems appropriate or necessary in order to: 

(A) minimize danger to public health and safety; 

(B) require such reports and the keeping of such records for inspection by the agency; and 

(C) prevent loss or theft of lasers subject to this section. 

(i) Specific terms and conditions of certificates of laser registration. 

(1) Each certificate of laser registration issued in accordance with this section 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 agency. 

(2) Each person registered by the agency for laser use in accordance with this section shall confine use and possession of the laser registered to the locations and purposes authorized in the certificate. 

(3) No certificate of laser registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the agency authorizes the transfer in writing. 

(j) Responsibilities of registrant. 

(1) The registrant shall notify the agency in writing within 30 days of a change in any of the following: 

(A) name and mailing address; 

(B) laser safety officer (LSO); or 

(C) name of facility contracted for "provider of services", if applicable. 

(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. 

(3) When requested by the agency, the registrant shall submit an inventory of lasers possessed and used, including disposition. 

(4) The mobile service company providing mobile services shall provide evidence of registration with the agency to each facility receiving the services. 

(5) The registrant is responsible for complying with this section and the conditions of the certificate of laser registration. 

(k) Expiration of certificates of laser registration. 

(1) Except as provided by subsection (m) of this section, each certificate of laser registration that specifies an expiration date expires at the end of the day on that date. Expiration of the certificate of laser registration does not relieve the registrant of the requirements of this chapter. 

(2) If a registrant does not submit an application for renewal of the certificate of laser registration under subsection (m) of this section, as applicable, the registrant shall on or before the expiration date specified in the certificate of laser registration terminate use and/or services of laser(s) and request termination as outlined in subsection (l) of this section. 

(l) Termination of certificates of laser registration. 

(1) Each registrant shall notify the agency immediately, in writing, and request termination of the certificate of laser registration when the registrant decides to terminate all activities involving lasers authorized under the certificate of laser registration. 

(2) Concurrent with the notification and request for termination of the certificate of laser registration, the registrant shall do the following: 

(A) submit a record of disposal of lasers; and 

(B) pay any outstanding fees in accordance with §289.204 of this title. 

(m) Renewal of certificate of registration. 

(1) Application for renewal of laser registration shall be filed in accordance with subsection (g) of this section. 

(2) If a registrant files an application in proper form before the existing certificate of laser registration expires, such existing certificate of laser registration shall not expire until the application status has been determined by the agency. 

(n) Modification and revocation of certificates of laser registration. 

Modification, suspension, and revocation of certificates of laser registration shall be in accordance with §289.205 of this title. 

(o) Notifications. 

(1) Each registrant shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by or against: 

(A) a registrant; 

(B) an entity controlling a registrant or listing the certificate of laser registration of the registrant as property of the estate; or 

(C) an affiliate of the registrant. 

(2) This notification shall include: 

(A) the bankruptcy court in which the petition for bankruptcy was filed; 

(B) the name of the entity in bankruptcy; and 

(C) the date of the filing of the petition. 

(3) A copy of the "petition for bankruptcy" shall be submitted to the agency along with the written notification. 

(p) LSO qualifications. LSO qualifications shall be submitted to the agency and shall include the following: 

(1) 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. 

(q) LSO duties. Specific duties of the LSO shall include, but not be limited to the following: 

(1) ensuring that users of lasers are trained in laser safety, as applicable for the class and type of lasers the individual uses; 

(2) assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions; and 

(3) specifying whether any changes in control measures are required following: 

(A) any service and maintenance of lasers that may affect the output power or operating characteristics; or 

(B) whenever deliberate modifications are made that could change the laser class and affect the output power or operating characteristics. 

(4) ensuring maintenance and other practices required for safe operation of the laser(s) are performed; 

(5) ensuring the proper use of protective eyewear and other safety measures; and 

(6) ensuring compliance with the requirements in this section and with any engineering or operational controls specified by the registrant. 

(r) Requirements for protection against laser radiation. These requirements are for lasers in their intended mode of operation and include special requirements for service, testing, maintenance, and modification. During some laser operations, certain engineering controls may be inappropriate. In situations where an engineering control may be inappropriate, for example, during medical procedures or surgery, the LSO shall specify alternate controls to obtain equivalent laser safety protection. 

(1) MPE. Each registrant or user of any laser shall not permit any individual to be exposed to levels of laser or collateral radiation higher than are specified in subsection (cc)(5)-(8) of this section. 

(2) Engineering controls. 

(A) Protective housing. 

(i) Each laser shall have a protective housing that prevents human access during the operation of the laser and collateral radiation that exceeds the limits of class I and subsection (cc)(8)(A) and (B) of this section, wherever and whenever such human access is not necessary in order for the laser to perform its intended function. 

(ii) Wherever and whenever human access to laser radiation levels that exceed the limits of class I and subsection (cc)(8)(A) and (B) of this section is necessary, these levels shall not exceed the limits of the lowest laser class necessary to perform the intended function(s). 

(B) Safety interlocks. 

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

(ii) Adjustment during operation, service, testing, or maintenance of a laser containing interlocks 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 shall be designed so as to prevent firing of the laser; for example, by dumping the stored energy into a dummy load. 

(iv) For CW lasers, the interlocks shall turn off the power supply or interrupt the beam; for example, by means of shutters. 

(v) An interlock 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 shall be provided, if failure of a single interlock would allow the following: 

(I) human access to levels of laser radiation in excess of the radiant power accessible emission limit of class IIIa laser radiation; or 

(II) laser radiation in excess of the accessible emission limits of class II to be emitted directly through the opening created by 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 shall incorporate suitable means to attenuate the laser and collateral radiation transmitted through the port to less than the MPE and the limits listed in subsection (cc)(8) of this section under any conditions of operation of the laser. 

(ii) Since optical systems such as lenses, telescopes, and microscopes may increase the hazard to the eye or the skin, the potential hazard and specific administrative procedures and the use of controls such as interlocks or filters shall be determined. 

(D) Warning systems. 

Each class IIIb or IV laser or laser product shall provide visual or audible indication during the emission of accessible laser radiation. In the case of class IIIb lasers, except those that allow access only to less than 5 milliwatt (mW) peak visible laser radiation, and class IV lasers, this indication shall be sufficient prior to emission of such radiation to allow appropriate action to avoid exposure. Any visual indicator shall be clearly visible through protective eyewear designed specifically for the 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 shall incorporate visual or audible indicators. The visual indicators shall be positioned so that viewing does not require human access to laser radiation in excess of the MPE. 

(E) Controlled area. With a class IIIb laser, except those that allow access only to less than 5 mW visible peak power, or class IV laser, a controlled area shall be established when exposure to the laser radiation in excess of the MPE or the limits listed in subsection (cc)(8) of this section is possible. The controlled area shall meet the following requirements, as applicable. 

(i) The area shall be posted as required by subsection (v) of this section. 

(ii) Access to the controlled area shall be restricted. 

(iii) For class IV indoor controlled areas, latches, interlocks, or other appropriate means shall be used to prevent unauthorized entry into controlled areas. 

(I) Such measures shall be designed to allow rapid egress by the laser personnel at all times and admittance to the controlled area in an emergency condition. For such emergency conditions, a control-disconnect switch or equivalent device (panic button) 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 shall apply. 

(-a-) All authorized personnel shall be trained in laser safety and appropriate personal protective equipment shall be provided upon entry. 

(-b-) A door, blocking barrier, screen, or curtains shall be used to block, screen, or attenuate the laser radiation at the entryway. The level at the exterior of these devices shall not exceed the applicable MPE, nor shall personnel experience any exposure above the MPE immediately upon entry. 

(-c-) At the entryway there shall be a visible or audible signal indicating that the laser is energized and operating at class IV 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 IV indoor controlled areas, during tests requiring continuous operation, the individual in charge of the controlled area shall be permitted to momentarily override the safety interlocks to allow access 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 IV indoor controlled areas, optical paths (for example, windows) from an indoor facility 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 and the limits listed in subsection (cc)(8) of this section. (When the laser beam must exit the indoor controlled area (as in the case of exterior atmospheric beam paths), the operator 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 and the limits listed in subsection (cc)(8) of this section). 

(vi) When the removal of panels or protective covers and/or overriding of interlocks becomes necessary, such as for servicing, testing, or maintenance, and accessible laser radiation exceeds the MPE and the limits listed in subsection (cc)(8) of this section, a temporary controlled area shall be established and posted. 

(s) Additional requirements for special lasers and applications. 

(1) Infrared laser. The beam from a laser 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 shall be specified in the operating and safety procedures. 

(2) Laser optical fiber transmission system. 

(A) Laser transmission systems that employ optical cables shall be considered enclosed systems with the optical cable forming part of the protective housing. 

(B) Disconnection of a connector resulting in access to radiation in excess of the applicable MPE or the limits listed in subsection (cc)(8) of this section shall take place in a controlled area. Except for medical lasers whose manufacture has been approved by the FDA, the use of a tool shall be required for the disconnection of a connector for service and maintenance purposes when the connector is not within a secured enclosure. All connectors shall bear the appropriate label or tag specified in subsection (v)(3) of this section. 

(t) Additional requirements for safe operation. 

(1) Eye Protection. Protective eyewear shall be worn by all individuals with access to class IIIb and/or class IV levels of laser radiation. Protective eyewear devices 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(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(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 shall be discarded. 

(2) Skin protection. When there is a possibility of exposure to laser radiation that exceeds the MPE limits for skin as specified in subsection (cc)(7) of this section, the registrant shall require the appropriate use of protective gloves, clothing, or shields. 

(u) NHZ. 

Where applicable, in the presence of unenclosed class IIIb and class IV beam paths, an NHZ shall be established. If the beam of an unenclosed class IIIb or class IV laser is contained within a region by adequate control measures to protect personnel from exposure to levels of radiation above the appropriate MPE, that region may be considered to contain 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. 

(v) Caution signs, labels, and posting. 

(1) General requirements. Except as otherwise authorized by the agency, signs, symbols, and labels prescribed by this section shall use the design and colors specified in subsection (dd)(1) and (2) of this section. 

(2) Posting and instructions. 

(A) The laser controlled area shall be conspicuously posted with an appropriate sign or signs as specified in paragraph (3) of this subsection and subsection (dd)(1) and (2) of this section. 

(B) Operating personnel of each laser shall be provided with written instructions for safe use, including clear warnings and precautions to avoid possible exposure to laser and collateral radiation in excess of the MPE and the limits listed in subsection (cc)(8) of this section. 

(3) Labeling lasers and posting laser facilities. 

(A) Class IIIb lasers shall have a label and facilities shall be posted with a sign(s) with the warning specified in subsection (dd)(2) of this section that includes the following wording: "LASER RADIATION - AVOID DIRECT EXPOSURE TO BEAM. CLASS IIIb LASER (OR LASER PRODUCT)." 

(B) Class IV lasers and facilities shall have a label affixed and be posted with a sign(s) with the warning specified in subsection (dd)(2) of this section that includes the following wording: "LASER RADIATION - AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION. CLASS IV LASER (OR LASER PRODUCT)." 

(C) Lasers, except lasers used in the practice of medicine, shall have a label(s) in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the limits specified in subsection (cc)(5) and (8) of this section with the following wording as applicable. 

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

(ii) "AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted from this aperture," if the radiation emitted through such aperture is collateral radiation. 

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

(D) Each laser shall state, on the required warning logotype, the maximum output of laser radiation, the pulse duration when appropriate, and the laser medium or emitted wavelength(s). 

(E) Each 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 would permit human access to laser or collateral radiation, shall have labels as follows. 

(i) For laser radiation in excess of the accessible emission limits of class IIIb, the wording: "DANGER - LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION." 

(ii) For collateral radiation in excess of the emission limits of subsection (cc)(8) of this section: 

(I) if the limits in subsection (cc)(8)(A) of this section are exceeded, the wording: "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN"; and 

(II) if the limits in subsection (cc)(8)(B) of this section are exceeded, the wording: "CAUTION - HAZARDOUS X-RAY RADIATION." 

(iii) For protective housing or enclosures that provide a defeatable interlock, the words "and interlock defeated" shall be included in the labels specified in clauses (i) and (ii) of this subparagraph. 

(F) Other required information. 

(i) The word "invisible" 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" 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. 

(G) Labels required by this subparagraph 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. 

(w) Surveys. Each registrant shall make or cause to be made such surveys as may be necessary to comply with this section. Surveys shall be performed at intervals not to exceed 12 months, to include but not be limited to the following: 

(1) a determination that all laser protective devices are labeled correctly, functioning within the design specifications, and properly chosen for lasers in use; 

(2) a determination that all warning devices are functioning within their design specifications; 

(3) a determination that the laser controlled area is properly controlled and posted with accurate warning signs in accordance with subsection (v) of this section; 

(4) a re-evaluation of potential hazards from surfaces that may be associated with laser beam paths; and 

(5) additional surveys that may be required to evaluate the laser and collateral radiation hazard incident to the use of lasers. 

(x) Records. Each registrant shall maintain current records in accordance with subsection (ee) of this section. 

(y) Measurements and instrumentation. Each determination requiring a measurement for compliance with this section shall use instrumentation that is calibrated and designed for use with the laser that is to be tested. 

(z) Notification of injury other than a medical event. 

(1) Each registrant shall immediately seek appropriate medical attention for the individual and notify the agency by telephone of any injury involving a laser possessed by the registrant, other than intentional exposure of patients for medical purposes, that has or may have caused: 

(A) an injury to an individual that involves the partial or total loss of sight in either eye; or 

(B) an injury to an individual that involves perforation of the skin or other serious injury exclusive of eye injury. 

(2) Each registrant shall, within 24 hours of discovery of an injury, report to the agency each injury involving any laser possessed by the registrant, other than intentional exposure of patients for medical purposes, that 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. 

(aa) Reports of injuries. 

(1) Each registrant shall make a report in writing, or by electronic transmittal, within 30 days to the agency of any injury required to be reported in accordance with subsection (z) of this section. 

(2) Each report shall describe the following: 

(A) the extent of injury to individuals to laser radiation; 

(B) power output of laser involved; 

(C) the cause of the injury; and 

(D) corrective steps taken or planned to be taken to prevent a recurrence. 

(3) Any report filed with the agency in accordance with this subsection shall include the full name of each individual injured and a description of the injury. The report shall be prepared so that this information is stated in a separate part of the report. 

(4) When a registrant is required in accordance with paragraphs (1)-(3) of this subsection to report to the agency any injury of an individual to laser radiation, the registrant shall also notify the individual. Such notice shall be transmitted to the individual at a time not later than the transmittal to the agency. 

(bb) Medical event. 

(1) The registrant shall notify the agency, by telephone or electronic transmittal, within 24 hours of any injury to or death of a patient. Within 30 days after a 24 hour notification is made, the registrant shall submit a written report to the agency of the event. 

(2) The written report shall include the following: 

(A) the registrant’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 informed the patient or the patient’s responsible relative or guardian. 

(3) When a medical event occurs, the registrant shall promptly investigate its cause, make a record for agency review, and retain the records as stated in subsection (ee) of this section. 

(cc) Appendices. 

(1) Class I accessible emission limits for laser radiation. The following table contains class I accessible emission limits for laser radiation. 

Figure: 25 TAC §289.301(cc)(1) 

(2) Class II accessible emission limits for laser radiation. The following table contains class II accessible emission limits that are identical to class I accessible emission limits except: 

Figure: 25 TAC §289.301(cc)(2) 

(3) Class IIIa accessible emission limits for laser radiation. The following table contains class IIIa accessible emission limits that are identical to class I accessible emission limits except: 

Figure: 25 TAC §289.301(cc)(3) 

(4) Class IIIb accessible emission limits for laser radiation. The following table contains class IIIb accessible emission limits for laser radiation. 

Figure: 25 TAC §289.301(cc)(4) 

(5) MPE for direct ocular exposure (intrabeam viewing) to a laser beam. The following table contains the MPEs for direct ocular exposure. 

Figure: 25 TAC §289.301(cc)(5) 

(6) MPE for viewing a diffuse reflection of a laser beam or an extended-source laser. The following table contains the MPEs for viewing a diffuse reflection of a laser beam or an extended source laser. 

Figure: 25 TAC §289.301(cc)(6) 

(7) MPE for skin exposure to a laser beam. The following table contains the MPEs for skin exposure to a laser beam. 

Figure: 25 TAC §289.301(cc)(7) 

(8) Accessible emission limits for collateral radiation from lasers or facilities and MPE. The following table contains accessible emission limits for collateral radiation from lasers or facilities and MPE. 

(A) Accessible emission limits for collateral radiation having wavelengths greater than or equal to 180 nm but less than or equal to 1 mm are identical to the accessible emission limits of class I laser radiation as determined from subsection (cc)(1) of this section for the appropriate wavelength(s) and emission duration. 

(i) In the wavelength range of £ 400 nm, for all emission durations. 

(ii) In the wavelength range > 400 nm, for all emission durations less than or equal to 1 x 10 3 seconds and, when applicable for all emission durations. 

(B) Accessible emission limit for collateral radiation within the x-ray range of wavelengths is 0.5 milliroentgen in an hour, averaged over an area of 10 square centimeters with no dimension greater than 5 centimeters. 

9) Values of wavelength dependent correction factors. 

Figure: 25 TAC §289.301(cc)(9) 

(10) Selected numerical solutions. 

Figure: 25 TAC §289.301(cc)(10) 

(11) Maximum aperture diameters (limiting aperture) for measurement averaging. The following table contains maximum aperture diameters (limiting aperture) for measurement averaging. 

Figure: 25 TAC §289.301(cc)(11) 

(A) This material is from American National Standard for the Safe Use of Lasers, ANSI Z136.1. 

(B) For the specific case of optical viewing (beam collecting) instruments, the apertures listed for eye MPE and skin MPE apply to the exit beam of such devices. 

(dd) Signs and graphs. 

(1) Caution sign. The following sign contains an appropriate sign in accordance with subsection (v)(2)(A) of this section. 

Figure: 25 TAC §289.301(dd)(1) 

(2) Danger sign. The following sign contains an appropriate sign in accordance with subsection (v)(2)(A) of this section. 

Figure: 25 TAC §289.301(dd)(2) 

(3) Graph A. The following graph contains graphic representation in accordance with subsection (cc)(5) of this section. 

Figure: 25 TAC §289.301(dd)(3) 

(4) Graph B. The following graph contains graphic representation in accordance with subsection (cc)(5)-(7) of this section. 

Figure: 25 TAC §289.301(dd)(4) 

(5) Graph C. The following graph contains graphic representation in accordance with subsection (cc)(5)-(7) of this section. 

Figure: 25 TAC §289.301(dd)(5) 

(6) Graph D. The following graph contains graphic representation in accordance with subsection (cc)(6) of this section. 

Figure: 25 TAC §289.301(dd)(6) 

(7) Graph E. The following graph contains graphic representation in accordance with subsection (cc)(5)-(7) of this section. 

Figure: 25 TAC §289.301(dd)(7) 

(8) Graph F. The following graph contains graphic representation in accordance with subsection (cc)(5) and (6). 

Figure: 25 TAC §289.301(dd)(8) 

(9) Graph G. The following graph contains graphic representation in accordance with subsection (cc)(5) and (6) of this section. 

Figure: 25 TAC §289.301(dd)(9) 

(10) Graph H. The following graph contains graphic representation in accordance with subsection (cc)(5) and (6) of this section. 

Figure: 25 TAC §289.301(dd)(10)

(ee) Record keeping. The following are time requirements for record keeping:

Figure: 25 TAC §289.301(ee)

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency’s legal authority.

Filed with the Office of the Secretary of State on January 25, 1999.

TRD-9900489

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 14, 1999

Proposal publication date: October 2, 1998

For further information, please call: (512) 458–7236