[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Proposed Rules]
[Pages 14180-14200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1010 and 1040

[Docket No. 93N-0044]


Laser Products; Proposed Amendment to Performance Standard

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the performance standard for laser products to achieve harmonization 
between the current standard and the International Electrotechnical 
Commission (IEC) standard for laser products and medical laser 
products. FDA is proposing additional changes that reflect FDA's 
understanding of how photobiological and behavioral factors, such as 
involuntary eye and body motion, affect the risk of injury from 
exposure. In addition, FDA is clarifying the requirement that 
manufacturers provide certain information to servicers. Generally, the 
proposed amendments will reduce the regulatory burden on affected 
manufacturers and improve the effectiveness of FDA's regulation of 
laser products. This action is being taken under the Federal Food, 
Drug, and Cosmetic Act as amended by Radiation Control for Health and 
Safety Act of 1968.

DATES: Written comments on the proposed rule should be submitted by 
June 22, 1999. See section IV of this document for the proposed 
effective date of a final rule based on this document.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.


[[Page 14181]]


FOR FURTHER INFORMATION CONTACT: Jerome E. Dennis, Center for Devices 
and Radiological Health (HFZ-342), Food and Drug Administration, 2094 
Oak Grove Rd., Rockville, MD 20850, 301-594-4654, ext. 135.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 23, 1992, FDA's Center for Devices and Radiological 
Health (CDRH) mailed to all listed manufacturers and importers of laser 
products and interested persons a notice that FDA was considering 
amendments to the Federal performance standard for laser products 
(Secs. 1040.10 and 1040.11) (21 CFR 1040.10 and 1040.11). Accordingly, 
in the Federal Register of May 10, 1993 (58 FR 27495), FDA published a 
notice of intent (NOI) that informed interested persons that FDA was 
considering amending the performance standard for laser products to: 
(1) Achieve greater consistency between the performance standard and 
the IEC standards for laser products and medical laser products (IEC 
825-1 and IEC 601-2-22); (2) improve compliance; and (3) develop a more 
efficient enforcement program. The NOI explained that the impetus for 
many of the changes under consideration stemmed largely from extensive 
FDA involvement in international standardization efforts for laser 
products with IEC, an international standards development organization 
with participants from many countries. The NOI also informed interested 
persons that additional changes to the current standard that are 
unrelated to harmonization were being considered as a result of FDA's 
continuing effort to evaluate new information and experience enforcing 
the present laser standard and processing variance applications.
    At this time, the agency is proposing specific amendments discussed 
in the NOI and is also proposing additional items responding to 
amendments to the IEC 825-1 standard. A significant amendment to the 
IEC standard, which was approved in 1993, expanded the scope of the IEC 
825-1 standard to include light emitting diodes (LED's) and products 
incorporating LED's. This amendment was approved because LED's are: (1) 
Very similar to semiconductor laser diodes, (2) often electrically and 
mechanically interchangeable with laser diodes, and (3) considered to 
represent similar hazards to the eyes. After the publication of IEC 
825-1, considerable controversy developed because manufacturers of 
LED's became aware that the conditions for measuring radiant power and 
energy to enable product hazard classification resulted in an 
exaggeration of the hazard of many LED's. Unlike lasers, LED's are 
often extended sources (i.e., have relatively large physical 
dimensions) and therefore are not capable of being focussed to as small 
and intense a retinal image as comparable lasers. At this time, it 
appears that the IEC will be publishing an amendment that will 
partially address this concern. However, FDA is not aware of any 
injuries that have occurred from LED radiation. In consideration of the 
economic impact of including LED's in the applicability of its 
standard, the FDA has reconsidered its former notifications and is 
eliminating LED products from this proposed rulemaking. The agency 
believes that other remedies exist that can be used if needed and can, 
in the future, propose additional amendments if warranted.
    FDA recognizes its responsibility not only to participate in the 
development of radiation safety standards for electronic products, but 
also to use its role in the development of the standard to demonstrate 
leadership and to exert influence. Although harmonization with the IEC 
standard is in itself a worthwhile goal, FDA disagrees with certain 
parts of the IEC standard. Specifically, under the IEC standard, the 
conditions for the measurement of radiant energy and power for the 
purpose of product classification contain a requirement that assumes 
that the output of diverging laser sources will be collected by large 
aperture optical instruments at a short distance from the source, and 
that optical components to collimate the diverging sources are 
currently commercially offered as accessories. FDA believes that the 
present IEC approach fails to allow for realistic factors of risk 
likely in the use of the products. FDA also believes that when 
collimators are offered as accessories, the classification measurements 
are to be made using the collimators; this situation is equivalent to 
offering the collimated laser product in a kit form. The entire laser 
product industry, however, should not be burdened with excessive 
classification and requirements for controls, indicators, and warnings. 
Therefore, FDA is proposing that measurements of radiant energy and 
power be made in accordance with the scheme developed by Working Group 
1 of the IEC Technical Committee 76 (IEC TC76/WG1) at its meeting in 
Washington, DC, in February, 1995, which does not require the use of 
large aperture optical instruments in all cases. The IEC TC76/WG1:1995 
scheme is described in section II of this document.
    Another departure from the requirements of IEC 825-1 relates to the 
criterion for human access that applies to levels of laser radiation 
that are less than the accessible emission limit (AEL) of Class 2 
(Class II under FDA's current standard). Such levels of radiation are 
considered to be ocular hazards only for exposures longer than 0.25 
seconds. However, the criterion for human access is based on skin 
exposure, i.e., interception by any part of the human body. FDA has 
recently identified laser products that are classified as Class 2 but 
have configurations that prevent direct eye exposure. The present 
classification is based upon the ability to insert a part of a hand or 
finger into a laser field that is not recognized to be a skin hazard. 
FDA recognizes that the classification of an eye hazard based on the 
possibility of skin exposure is unnecessarily burdensome on such 
products and is therefore proposing to amend this criterion. Although 
it is acknowledged that the possibility exists for a person to insert a 
mirror and extract the beam, this is not considered to be a realistic 
risk upon which all such products need be evaluated.

II. Contents of the Proposed Regulation

    Proposed Secs. 1010.2(d) and 1010.3(b) (21 CFR 1010.2(d) and 
1010.3(b)) authorize the Director, Office of Compliance, CDRH, to 
approve alternate means of providing certification and identification 
information. The 1985 amendments to the standard authorized the 
Director, Office of Compliance, to give similar approvals for labeling 
required by part 1040 (21 CFR part 1040). FDA is now proposing to give 
the Director, Office of Compliance, similar authority under 
Secs. 1010.2 and 1010.3.
    In proposed Sec. 1040.10(d)(4), FDA is introducing the concept of 
reduced emission duration for classification of products for which 
viewing of the radiation is not intended within the range of their 
applications. This is to harmonize with IEC 825-1 and to reduce the 
burden on manufacturers of products that have been in higher classes 
because of the use of emission durations for classification that are 
unrealistically long given the use of the products. Therefore, the 
current Class IIa would no longer be needed, and its definition, table 
of AEL, and warning label requirements would be eliminated.
    Under proposed Sec. 1040.10(b), FDA would change to the use of 
Arabic numerals for class designations because Arabic numerals are less 
ambiguous. Also, changing to Arabic numerals will

[[Page 14182]]

harmonize with IEC 825-1 and the American National Standard Institute 
(ANSI) Z136.1 standards. However, FDA would not object to continued use 
of Roman numerals providing that the classification is correct as of 
the date of manufacture of the product as shown on the identification 
label required by Sec. 1010.3.
    Proposed Sec. 1040.10(b)(7) redefines Class 3A (IIIa). The proposed 
new definition would expand the range of wavelengths included in the 
class and have an AEL for radiant power and energy that is five times 
that of Class 1 in addition to an AEL for radiant exposure and 
irradiance to account for increased hazard as a result of the use of 
collecting optics. Although the new Class 3A would exclude visible 
radiation if the irradiance exceeds 2.5 milliwatts per square 
centimeter (mW/cm2), the performance and labeling 
requirement currently applicable to Class IIIa would apply to the new 
class.
    Under proposed Sec. 1040.10(d) and Table 1, FDA is deleting the 
Class 1 AEL for integrated radiance and replacing these limits with 
correction factors to the AEL for radiant energy and power based on the 
angular subtense of the radiation source. This concept is in accord 
with the current bioeffects science and will harmonize with IEC 825-1. 
Current bioeffects science indicates that repetitive pulse exposures 
have an increased hazard compared either to a simple summation of the 
individual pulses or to a continuous exposure to the same average power 
for the same duration. For this reason, the AEL for Class 1 should be 
reduced by a factor of the number of pulses raised to the negative one 
fourth power (N-1/4).
    The measurement parameters for radiant energy and power are those 
proposed by IEC TC76/WG1:1995 and endorsed by the U.S. Technical 
Advisory Group for that standards committee. This proposal would 
require two measurements for visible or near-infrared wavelengths, a 50 
millimeters (mm) aperture at 2 meters (m) from the apparent source, and 
a 7 mm aperture at 100 mm. The measurement yielding the greater result 
is to be used for classification. For sources that have a high degree 
of divergence, the 7 mm aperture at a close distance is believed to 
accurately represent a worst practical viewing condition without the 
use of optical aides. This proposal by WG1 received a majority of the 
votes within IEC TC-76, but not a high enough number for acceptance. 
The TC-76 has, since approved, a more conservative proposal for the 
purpose of providing relief for LED's that can be considered to be 
extended sources. This more conservative approach, however, uses a 50 
mm aperture at 100 mm from the apparent source and reflects the 
assumption that the classification will be based upon the hazard 
associated with viewing highly divergent sources through collecting 
optics, which increase the hazard. In addition, the use of the 7 mm 
aperture with sources that subtend greater than 
 permits the aperture to 
be placed at a distance greater than 100 mm from the apparent source. 
In order to be in further agreement with IEC 825-1, the aperture 
diameter over which the power or energy is averaged to determine the 
radiant exposure or irradiance is determined from a table (Table 6) and 
is determined by the wavelength and emission duration.
    Under proposed Sec. 1040.10(f)(5) and (f)(6), FDA would eliminate 
the requirements for an emission indicator and beam attenuator for 
systems in Class 2, 3A, and for systems in Class 3B having a visible 
output power of 5 mW or less. Because such systems present minimal 
hazard or, by virtue of the visibility of their output, give adequate 
warning of its presence, this relaxation is considered to be 
appropriate.
    FDA is proposing to eliminate the requirement in 
Sec. 1040.10(f)(9)(ii) that requires a scanning safeguard to determine 
if a change in scan parameters results from a failure or is 
intentional, and to react only to those changes resulting from failure. 
This requirement has not been invoked by the agency and has been found 
very difficult for the industry to understand.
    Proposed Sec. 1040.10(g) allows the use of warning logotype labels 
and protective housing labels that comply with IEC 825-1. The logotype 
labels in current Sec. 1040.10(g) are of a design specified by ANSI. It 
is noted that the ANSI standard for laser safety allows use of the IEC 
style labels. The IEC labels for protective housings use the word 
``CAUTION'' in all cases. In permitting use of the IEC labels, for 
consistency purposes, FDA will also permit this wording change.
    The agency is not proposing significant changes to 
Sec. 1040.10(h)(2)(ii); however, FDA is using this preamble to clarify 
the agency's interpretation of that provision in response to the 
evident confusion among manufacturers and servicers.
    Finally, FDA is proposing to eliminate the quoted caution statement 
in Sec. 1040.10(h)(1)(iv), while retaining the requirement in general 
terms. This proposed change will avoid otherwise unnecessary approvals 
or notifications and allow manufacturers to fulfill the requirement by 
using their own wordings for this warning.

III. Summary and Analysis of Comments and FDA's Response

    The NOI set out the proposed changes to Secs. 1040.10 and 1040.11 
and invited comments and recommendations on such changes. Interested 
persons were given until August 9, 1993, to comment on the NOI. FDA 
received a total of 13 comments from laser product manufacturers, 
government organizations, a consultant, an industry association, and a 
professional medical association. These comments generally supported 
the proposed changes and the concept of harmonization with 
international requirements, except for the comments that follow.
    1. Several comments suggested clarifying the proposed amendments to 
Sec. 1040.10(d), which proposed reducing the emission durations to be 
used for the classification of Class 1 laser products that emit visible 
or infrared (IR) laser radiation not intended to be viewed, as 
determined from the design of the product or its intended function. 
These comments included the following:

A. Long-Term Viewing or Exposure

    Four comments requested that FDA clarify the amendment as being 
applicable to products for which ``long-term'' viewing or exposure is 
intended or inherent in the design of the product, to differentiate 
between products in which viewing or exposure would only occur for 
short periods.

B. Products Emitting in the Near-IR Range

    Four comments assumed that products which emit in the near-IR range 
that are classified on the basis of 100 seconds of emission would 
continue to be so classified, even if they are general purpose 
products. The comments noted that it would help to clarify the proposal 
by adding ``general construction'' to the applications listed for use 
with the 100 seconds classification time.

C. Surveying Lasers

    Six comments stated that surveying lasers should not be included in 
the category with laboratory laser systems for a 10,000 seconds 
classification because they are not intended to be viewed for long 
durations. One comment noted that the purpose of the design of 
surveying lasers is to permit the beam to be viewed by electronic or 
mechanical devices. Two comments cited the existence of the 
Occupational Safety and Health Administration

[[Page 14183]]

regulations promoting safe use of surveying lasers. One manufacturer 
submitted an analysis stipulating that the current standard provides an 
adequate safety margin for its laser surveying products and noted that 
the proposed amendment would mandate a large reduction of output power 
for such products, which would render the technology useless.
    FDA agrees with comments 1.A and 1.B of section III of this 
document. The proposed amendments have been drafted to incorporate the 
concepts and language of IEC 825-1, 1993. Although FDA agrees with the 
point in comment 1.C of section III of this document that invisible 
radiation intended for detection only by electronic means is not 
considered to be intended to be viewed, FDA notes that visible 
radiation emitted by surveying lasers that is used for leveling must be 
assumed to be intended to be viewed by the eyes. Further, viewing for 
more than 100 seconds cannot be considered to be unlikely. Therefore, 
the proposed 30,000 second maximum sampling interval is retained.
    2. Four comments noted that the amendments to reduce the AEL for 
repetitively pulsed lasers should only be made if the change to reduce 
the time period for classification discussed in comment 1 of section 
III of this document is also made. If the proposed reduction in the AEL 
were made without reducing the time period for classification, the 
result would be a lowering of the allowable power for some products and 
an inconsistency with the IEC 825 standard. The comments also suggested 
that ``repetitively pulsed lasers'' be changed to ``products with 
scanning or repetitively pulsed outputs,'' to clarify that the 
requirement would also apply to scanning products.
    FDA agrees with these comments and believes that the wording of the 
proposed amendments addresses the concern relating to the time period 
for classification. The clarification that the requirement applies both 
to repetitive pulses and scanned radiation has been made.
    3. One comment suggested use of the revised ANSI AEL in the 1,150 
to 2,800 nanometers (nm) spectral band rather than merely revising the 
AEL in the 1,535 to 1,540 nm spectral band. The comment noted that the 
revisions, which relate to both fiber optic exposure and so-called 
``eye-safe'' laser exposure, are important to consider because of the 
greatly expanding technology in that spectral region.
    FDA agrees that a revision of the AEL is appropriate to incorporate 
up-to-date understanding of the biological effects of exposure to 
certain spectral bands. The method used in the ANSI standard to 
determine the AEL is to calculate using the maximum permissible 
exposure. Although this is appropriate in the ANSI standard, which is 
primarily concerned with the safe use of lasers, FDA believes that it 
is appropriate to employ tables of AEL in a product standard. In 
addition, in the interests of global harmonization, the AEL in the 
proposed amendments to the standard are identical to those of IEC 825-
1, which is accepted in most other countries.
    4. One comment disagreed with FDA's approach in its proposal to 
amend the tables in Sec. 1040.10(d) for the purpose of making the 
resulting classifications agree more nearly with the IEC and ANSI 
classifications. The comment disagreed with FDA's contention that the 
present structure of these tables should be retained because the 
existing structure is simpler than the corresponding ANSI and IEC 
tables. The comment stated that although the ANSI calculations are more 
complex, if more simplified tables (such as those in the FDA standard) 
result in some systems being considered more hazardous than they would 
be under the ANSI or IEC methods, then the more complex method should 
be used.
    FDA partially agrees with this comment. Upon further consideration, 
it became clear that reformatting the IEC tables of AEL to conform to 
those in the present standard was practically unworkable. Therefore, 
the proposal contains tables of AEL that are identical to those of IEC 
825-1. Further, FDA agrees that the standard should not result in an 
exaggeration of the hazard; therefore, the specified conditions for 
measurement of radiant energy and power for classification are more 
relaxed than those of IEC 825-1. FDA recognizes that this is a 
potential obstacle to harmonization and hopes that the IEC TC-76 will 
follow the agency's lead in this area.
    5. Four comments stated that it would be helpful to clarify the 
amendment regarding relaxation of the laser radiation levels for which 
the requirements of Sec. 1040.10(f)(2) for safety interlocks are 
applicable. These comments requested that FDA clarify that the 
relaxation discussed with regard to ``radiation emitted directly 
through the opening created by removal or displacement of the 
interlocked portion of the protective housing'' refers only to Class 3A 
radiation that is ``emitted out, not just any radiation level.''
    FDA agrees with this comment and has inserted an explanatory note 
in the performance requirement for protective housing.
    6. Five comments noted that the proposed interlock requirement 
(Sec. 1040.10(f)(2)) exceeds the requirements in Amendment 2 to IEC 
825. One comment noted that safety interlocks are not now required by 
IEC 825 on Class 4 lasers and suggested a requirement that the lids of 
laser boxes be interlocked so that the laser turns off when the lid is 
lifted, or a requirement that the laser beam be fully enclosed within 
the box, inside a cover which is either interlocked itself or that 
requires a tool for removal.
    FDA disagrees with this comment and notes that this performance 
requirement was made identical to that in the current CDRH standard in 
the amendments of the IEC standard that were approved in 1993. FDA has 
always maintained that interlock protection during operation or 
maintenance that entails human access to hazardous levels of laser 
radiation is equally appropriate for all classes of laser products.
    7. Four comments noted that the proposed amendment of 
Sec. 1040.10(f)(5) to require ``visible indications of actual emission 
from remote laser apertures of Class 3B and 4 laser systems'' exceeds 
the requirements of the IEC amendments, which only require such 
indications when the aperture could be emitting energy. The comments 
expressed concern that the proposed amendment, as worded, would be 
difficult to implement and may not provide additional safety for the 
user. FDA has considered these comments and decided that the proposed 
amendment would provide additional safety for the user and that any 
difficulty in implementation would be outweighed by the increase in 
safety. The proposed change addresses concern about some industrial 
workstations where the laser aperture is located at a considerable 
distance from either the laser or the control station. The concern is 
even greater for those situations in which the output of a single high 
power laser is shared by a number of workstations. The proposed 
requirements are in agreement with those under consideration by the IEC 
TC-76.
    8. Several comments addressed the proposed amendments to warning 
labels, signal words, and labels for noninterlocked and defeatably 
interlocked protective housings. These comments are as follows:

[[Page 14184]]

A. Acceptance of IEC Labels

    Five comments believed that the acceptance of IEC labels will ease 
the burden on manufacturers. Several of these comments expressed 
concern, however, that the differences in measurement criteria for 
classification between the IEC and FDA standards may cause problems and 
confusion. The comments noted that these problems might be addressed in 
the third set of amendments to the IEC standard.

B. Signal Words

    One comment disagreed with eliminating the signal words ``CAUTION'' 
and ``DANGER'' because U.S. consumers are accustomed to the type of 
markings that include a signal word. The use of signal words resulted 
from consensus agreements between consumer and legal interests in the 
United States a number of years ago, and the standard 3-part marking 
specified in most U.S. product safety standards, which are ANSI 
approved, requires the use of a signal word.

C. Permission of the Word ``CAUTION'' in Place of the Word ``DANGER''

    Three comments that agreed with the proposed amendment to 
Sec. 1040.10(g)(6) permitting the word ``CAUTION'' in place of the word 
``DANGER'' believed that this amendment should also apply to 
Sec. 1040.10(g)(7).

D. Proposed Simplification

    Four comments agreed with the proposed simplification of the 
requirements in Sec. 1040.10(g)(6) and (g)(7) applicable to labels for 
noninterlocked and defeatably interlocked protective housings.
    FDA is in general agreement with comment 8.A of section III of this 
document. Although it is true that differences in measurement criteria 
will cause problems and confusion for a small number of products, FDA 
believes that the disadvantages of adopting the present measurement 
criteria of IEC 825-1 outweigh the disadvantages of having different 
FDA and IEC criteria.
    In response to comment 8.B of section III of this document, FDA 
believes that the benefit resulting from the use of ``CAUTION'' or 
``DANGER'' is outweighed, in this case, by that of averting 
noncompliance through harmonized requirements.
    FDA agrees with comment 8.C of section III of this document as it 
applies to Class 2 and certain Class 3A accessible laser radiation and 
collateral radiation. Proposed Sec. 1040.10(g)(6) and (g)(7) permit use 
of the word ``CAUTION'' on labels for the protective housing on 
products emitting these levels of radiation.
    Proposed Sec. 1040.10(g)(6) and (g)(7) are simplified in accordance 
with the NOI and with comment 8.D of section III of this document.
    9. One comment requested clarification of the proposed amendment to 
Sec. 1040.11(a) requiring optical or electrical monitoring of the 
operation of lasers in Class 3B and 4 medical laser products. The 
proposed amendment states that ``an electrical or optical quantity that 
is directly related to the laser or LED level generated shall be 
continually monitored during operation.'' The comment noted that for 
very low repetition rate pulsed laser systems, the energy is usually 
measured before a procedure begins or between patient exposures. 
According to this comment, if an additional means of monitoring is 
required beyond the level of normal compliance, the ``additional 
means'' would be a ``significant engineering feat.'' This is because 
``real-time'' monitoring of the pulsed energy during an actual 
treatment pulse requires an instantaneous shuttering or shutoff of the 
laser pulse while the specified energy level is reached. FDA believes 
that monitoring the voltage of a charged capacitor could satisfy this 
requirement for a pulsed laser system. The comment concluded that the 
cost of new pulsed laser systems would be increased substantially if 
this engineering change were required for new or existing laser 
systems.
    FDA agrees with this comment and has clarified its intent in 
proposed Sec. 1040.11(a). The item was intended to harmonize with the 
requirements of IEC 601-2-22 for medical laser and LED products. The 
present standard requires that Class 3B and 4 medical laser products 
incorporate a means of optical measurement of the level of laser 
radiation intended to be incident upon the target tissue. FDA has 
determined that this requirement can be met by a measurement at a 
location within the product or prior to emission from the distal 
aperture. IEC 601-2-22 addresses the same intent by imposing an 
accuracy specification relative to the preset or selected level. IEC 
601-2-22 further requires that the operation of the laser be monitored 
electrically or optically, that there be an alarm if the actual 
monitored value differs by more than 20 percent from the 
preset value, and that the user instructions specify how and when to 
actually measure the delivered output. Proposed Sec. 1040.11(a) adopts 
these requirements.
    10. One comment requested that a section be included in the 
amendment that certain low-power laser products be exempt from 
reporting. This section would condense and clarify provisions set forth 
in exemptions granted by Laser Notices 36, 41, and 42 and other notices 
as applicable. The author of the comment believes that inclusion of 
such a section would make this information available to the broad 
audience, and reduce misunderstandings associated with the 
administration of the regulation.
    FDA agrees with this comment and believes the question has already 
been addressed in the amendments to part 1002 (21 CFR part 1002) 
published in the Federal Register of September 19, 1995 (60 FR 48374).
    11. One comment believed that the lasers in compact disk (CD) 
players should be exempt from FDA regulation and should only be subject 
to general safety certification (UL, CSA, etc.)
    FDA believes that the amendments to part 1002 have addressed this 
concern, but notes that the lasers themselves that are in CD players 
are generally Class 3B. However, when the laser is incorporated into a 
cell with a focusing lens, this assembly becomes the smallest component 
that is replaceable in service and is Class 1. Because of the low cost 
of such components, it is unlikely that any individual or firm would be 
motivated to disassemble the components and then to attempt to cause 
them to emit. FDA has determined that the level of laser radiation that 
could be accessible during service may be considered to be the maximum 
level accessible from the smallest replaceable component.
    12. In addition, FDA has recently received inquiries, suggestions, 
and one trade complaint concerning the interpretation of 
Sec. 1040.10(h)(2)(ii), which requires manufacturers of laser products 
to provide adequate instructional information to servicers and others 
upon request. Although the correspondence does not directly relate to 
the advanced notice of proposed rulemaking, the agency believes this 
proposal is an appropriate forum for presenting its construction of the 
current regulation and inviting comment from interested persons.
    The correspondence FDA has received has reflected disagreement 
between manufacturers and independent servicers of laser products about 
whether the regulation authorizes manufacturers to interpret 
``adequate'' to include training provided by the manufacturer. The 
agency believes that it is appropriate for the manufacturer to decide, 
in the first instance, what constitutes ``adequate'' servicing 
instructions. If the agency learns, however, through the inspection of 
laser

[[Page 14185]]

manufacturing facilities or otherwise, that manufacturers are using the 
requirement of ``adequate'' as a pretext for making the provision of 
servicing instructions contingent upon costly or burdensome training, 
FDA will deem the manufacturer's product to be noncompliant with the 
laser performance standard and will take appropriate regulatory action.

IV. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 1 year after the date of publication of the 
final rule in the Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impact of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Regulatory Fairness Act of 1966 
(Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4). Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
The agency believes that this proposed rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, the proposed rule is not a significant regulatory action 
as defined by the Executive Order and so is not subject to review under 
the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule in many instances decreases the 
regulatory burden from that imposed by the current regulations and 
increases the level of consistency between Federal law and 
international law to which small entities may be subject, the agency 
certifies that the proposed rule will not have a significant economic 
impact on a substantial number of small entities. In addition, this 
proposed rule will not impose costs of $100 million or more in either 
the private sector or State, local, and tribal governments in the 
aggregate, and therefore a summary statement of analysis under section 
202(a) of the Unfunded Mandates Reform Act is not required.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
burden hours required for Sec. 1040.10(a)(4)(i), (h)(1)(i) through 
(h)(1)(vi), (h)(2)(i) and (h)(2)(ii), (i), and Sec. 1040.11(a)(2)(iv) 
are reported and approved under OMB control number 0910-0213.

VIII. Comments

    Interested persons may, on or before June 22, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in the brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Part 1010

    Administrative practice and procedures, Electronic products, 
Exports, Radiation protection.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 1010 and 1040 be amended as follows:

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

    1. The authority citation for 21 CFR part 1010 is revised to read 
as follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

    2. Section 1010.2 is amended by revising paragraph (d) to read as 
follows:

Sec. 1010.2  Certification.

* * * * *
    (d) In the case of products for which it is not feasible to certify 
in accordance with paragraph (b) of this section, upon application by 
the manufacturer or upon his or her initiative, the Director, Office of 
Compliance, Center for Devices and Radiological Health, may approve an 
alternate means by which such certification may be provided.
    3. Section 1010.3 is amended by revising paragraph (b) to read as 
follows:

Sec. 1010.3  Identification.

* * * * *
    (b) In the case of products for which it is not feasible to affix 
identification labeling in accordance with paragraph (a) of this 
section, upon application by the manufacturer or upon his or her 
initiative, the Director, Office of Compliance, Center for Devices and 
Radiological Health, may approve an alternate means by which such 
identification may be provided.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

    4. The authority citation for 21 CFR part 1040 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 
U.S.C. 263b-263n.

    5. Section 1040.10 is revised to read as follows:

Sec. 1040.10  Laser products.

    (a) Applicability. The provisions of this section and Sec. 1040.11, 
as amended, are applicable as specified to all laser products 
manufactured or assembled after (date 1 year after date of publication 
in the Federal Register of any final rule that issues based on this 
proposed rule), except when:
    (1) Such a laser cannot under any conditions of operation, 
maintenance, service, or single failure emit radiation in excess of the 
accessible emission limits of a Class 1 laser product, or
    (2) Such a laser is sold to a manufacturer of an electronic product 
for use as a component (or replacement) in such electronic product, or
    (3) Such a laser is sold by or for a manufacturer of an electronic 
product for use as a component (or replacement) in such electronic 
product, provided that such laser:
    (i) Is accompanied by a general warning notice that adequate 
instructions for the safe installation of the product are provided in 
servicing information available from the complete product manufacturer 
under paragraph (h)(2)(ii) of this section, and should be followed,

[[Page 14186]]

    (ii) Is labeled with a statement that it is designated for use 
solely as a component of such electronic product and therefore is not 
required to comply with the appropriate requirements of this section 
and Sec. 1040.11 for complete laser products, and
    (iii) Is not a removable laser system as described in paragraph 
(c)(2) of this section; and
    (4) The manufacturer of such a laser product, if manufactured after 
August 20, 1986,
    (i) Registers and provides a listing by type of such laser products 
manufactured that includes the product name, model number, and laser 
medium or emitted wavelength(s). The registration and listing shall 
include the name and address of the manufacturer and shall be submitted 
to the Director, Office of Compliance (HFZ-342), Center for Devices and 
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850; and
    (ii) Maintains and allows access to any sales, shipping, or 
distribution records that identify the purchaser of such a laser 
product by name and address, the product by type, the number of units 
sold, and the date of sale (shipment). These records shall be 
maintained and made available as specified in Sec. 1002.31 of this 
chapter.
    (b) Definitions. As used in this section and Sec. 1040.11, the 
following definitions apply:
    (1) Accessible emission level means the magnitude of accessible 
laser or collateral radiation of a specific wavelength and emission 
duration at a particular point as measured according to paragraph (e) 
of this section. Accessible laser or collateral radiation is radiation 
to which human access is possible.
    (2) Accessible emission limit means the maximum accessible emission 
level permitted within a particular class as set forth in paragraphs 
(c) and (d) of this section when measured according to paragraph (e) of 
this section.
    (3) Aperture means any opening in the protective housing or other 
enclosure of a laser product through which laser or collateral 
radiation is emitted, thereby allowing human access to such radiation.
    (4) Aperture stop means an opening serving to limit the size and to 
define the shape of the area over which radiation is measured.
    (5) Class 1 laser means any laser that does not permit access 
during the operation to levels of laser radiation in excess of the 
accessible emission limits contained in Table 1 of paragraph (d) of 
this section.\1\
---------------------------------------------------------------------------

    \1\ Class 1 levels of laser or radiation are not considered to 
be hazardous.
---------------------------------------------------------------------------

    (6) Class 2 laser means any laser that permits human access during 
operation to levels of visible laser radiation in excess of the 
accessible emission limits contained in Table 1 in paragraph (d) 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 Table 2 of paragraph (d) of this section.\2\
---------------------------------------------------------------------------

    \2\ Class 2 levels of laser radiation are considered to be a 
chronic viewing hazard.
---------------------------------------------------------------------------

    (7) Class 3A laser means any laser that permits human access during 
operation to levels of visible laser radiation in excess of the 
accessible emission limits contained in Table 2 of paragraph (d) 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 Table 3 of paragraph (d) of this section.\3\
---------------------------------------------------------------------------

    \3\ Class 3A levels of laser radiation are considered to be 
either an acute viewing hazard at visible or near-infrared (700 to 
1,400 nanometers (nm)) wavelengths if viewed directly with optical 
instruments, or a nominal hazard at wavelengths outside these 
ranges.
---------------------------------------------------------------------------

    (8) Class 3B laser product means any laser product that permits 
human access during operation to levels of laser radiation in excess of 
the accessible emission limits of Table 3 of paragraph (d) 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 Table 4 of paragraph (d) of this section.\4\
---------------------------------------------------------------------------

    \4\ Class 3B levels of laser radiation are considered to be an 
acute hazard to the skin and eyes from direct radiation.
---------------------------------------------------------------------------

    (9) Class 3 laser product means any Class 3A or Class 3B laser 
product.
    (10) Class 4 laser product means any laser product that permits 
human access during operation to levels of laser radiation in excess of 
the accessible emission limits contained in Table 4 of paragraph (d) of 
this section.\5\
---------------------------------------------------------------------------

    \5\ Class 4 levels of laser radiation are considered to be an 
acute hazard to the skin and eyes from direct and scattered 
radiation.
---------------------------------------------------------------------------

    (11) Collateral radiation means any electronic product radiation, 
except laser radiation, emitted by a laser product as a result of the 
operation of the laser(s) or any component of the laser product that is 
physically necessary for the operation of the laser(s).
    (12) Demonstration laser product means any laser product 
manufactured, designed, intended, or promoted for purposes of 
demonstration, entertainment, advertising display, or artistic 
composition. The term ``demonstration laser product'' does not apply to 
laser products which are not manufactured, designed, intended, or 
promoted for such purposes, even though they may be used for those 
purposes or are intended to demonstrate other applications.
    (13) Emission duration means the temporal duration of a pulse, a 
series of pulses, or continuous operation, expressed in seconds, during 
which human access to laser or collateral radiation could be possible 
as a result of operation, maintenance, or service of a laser product.
    (14) Human access means the capacity to intercept laser or 
collateral radiation by any part of the human body. For laser products 
that contain Class 3B or 4 levels of laser radiation, ``human access'' 
also means access to laser radiation that can be reflected directly 
onto any part of the human body by any single introduced flat surface 
from the interior of the product through any opening in the protective 
housing of the product.
    (15) Invisible radiation means laser or collateral radiation having 
wavelengths of equal to or greater than 180 nm but less than or equal 
to 400 nm or greater than 700 nm but less than or equal to 1,000,000 nm 
(1 millimeter).
    (16) Irradiance means the time-averaged radiant power incident on 
an element of a surface divided by the area of that element, expressed 
in watts per square centimeter.
    (17) Laser means any device that can be made to produce or amplify 
electromagnetic radiation at wavelengths greater than 180 nm but less 
than or equal to 1,000,000 nm (1 millimeter) primarily by the process 
of controlled stimulated emission.
    (18) Laser energy source means any device intended for use in 
conjunction with a laser to supply energy for the operation of the 
laser. General energy sources such as electrical supply mains or 
batteries shall not be considered to constitute laser energy sources.
    (19) Laser product means any manufactured product or assemblage of 
components which constitutes, incorporates, or is intended to 
incorporate a laser or laser system. A laser or laser system that is 
intended for use as a component of an electronic product shall itself 
be considered a laser product.
    (20) Laser radiation means all electromagnetic radiation emitted by 
a laser product within the spectral range specified in paragraph 
(b)(17) of this section that is produced as a result of controlled 
stimulated emission or that is detectable with radiation so produced 
through the appropriate aperture stop as

[[Page 14187]]

specified in paragraph (e) of this section.
    (21) Laser system means a laser in combination with an appropriate 
laser energy source with or without additional incorporated components. 
See paragraph (c)(2) of this section for an explanation of the term 
``removable laser system.''
    (22) Maintenance means performance of those adjustments or 
procedures specified in user information provided by the manufacturer 
with the laser product which are to be performed by the user for the 
purpose of assuring the intended performance of the product. It does 
not include operation or service as defined in paragraphs (b)(27) and 
(b)(37) of this section.
    (23) Maximum output means the maximum radiant power and, where 
applicable, the maximum radiant energy per pulse of accessible laser 
radiation emitted by a laser product during operation, as determined 
under paragraph (e) of this section.
    (24) Maximum angular subtense means the value of angular subtense 
of the apparent source above which the AEL's are independent of the 
source size ( = 0.1 rad 
(100 mrad)).
    (25) Medical laser means any laser product which is a medical 
device as defined in 21 U.S.C. 321(h) and is manufactured, designed, 
intended, or promoted for in vivo laser irradiation of any part of the 
human body for the purpose of:
    (i) Diagnosis, surgery, or therapy; or
    (ii) Relative positioning of the human body.
    (26) Minimum angular subtense means the value of angular subtense 
of the apparent source above which the source is considered to be an 
extended source. Maximum permissible exposures (MPE's) and AEL's are 
independent of source size for angles less than the minimum angular 
subtense ().
     = 0.0015 rad t 
 0.7s
    0.002t3/4 rad 0.7s  t  10s
    0.01rad t  10s
    (27) Operation means the performance of the laser product over the 
full range of its functions. It does not include maintenance or service 
as defined in paragraphs (b)(22) and (b)(37) of this section.
    (28) Protective housing means those portions of a laser product 
which are designed to prevent human access to laser or collateral 
radiation in excess of the prescribed accessible emission limits under 
conditions specified in this section and in Sec. 1040.11.
    (29) Pulse duration means the time increment measured between the 
half-peak-power points at the leading and trailing edges of a pulse.
    (30) Radiant energy means energy emitted, transferred or received 
in the form of radiation, expressed in joules (J).
    (31) Radiant exposure means the radiant energy incident on an 
element of a surface divided by the area of the element, expressed in 
joules per square centimeter (Jcm-2).
    (32) Radiant power means time-averaged power emitted, transferred 
or received in the form of radiation, expressed in watts (W).
    (33) Remote interlock connector means an electrical connector which 
permits the connection of external remote interlocks.
    (34) Safety interlock means a device associated with the protective 
housing of a laser product to prevent human access to excessive 
radiation in accordance with paragraph (f)(2) of this section.
    (35) Sampling interval means the time interval during which the 
level of accessible laser or collateral radiation is sampled by a 
measurement process. The magnitude of the sampling interval in units of 
seconds is represented by the symbol (t).
    (36) Scanned laser radiation means laser radiation having a time-
varying direction, origin or pattern of propagation with respect to a 
stationary frame of reference.
    (37) Service means the performance of those procedures or 
adjustments described in the manufacturer's service instructions which 
may affect any aspect of the product's performance for which this 
section and Sec. 1040.11 have applicable requirements. It does not 
include maintenance or operation as defined in paragraphs (b)(22) and 
(b)(27) of this section.
    (38) Surveying, leveling, or alignment laser product means a laser 
product manufactured, designed, intended, or promoted for one or more 
of the following uses:
    (i) Determining and delineating the form, extent, or position of a 
point, body, or area by taking angular measurement;
    (ii) Positioning or adjusting parts in proper relation to one 
another; and
    (iii) Defining a plane, level, elevation, or straight line.
    (39) Visible radiation means laser or collateral radiation having 
wavelengths of greater than 400 nm but less than or equal to 700 nm.
    (40) Warning logotype means a logotype as illustrated in either 
Figure 1 or Figure 2 of paragraph (g) of this section.
    (41) Wavelength means the propagation wavelength in air of 
electromagnetic radiation.
    (c) Classification of laser--(1) All laser products. Each laser 
shall be classified in Class 1, 2, 3A, 3B, or 4 in accordance with 
definitions set forth in paragraphs (b)(5) through (b)(10) of this 
section. The product classification shall be based on the highest 
accessible emission level(s) of laser radiation to which human access 
is possible during operation in accordance with paragraphs (d), (e), 
and (f)(1) of this section.
    (2) Removable laser systems. Any laser system that is incorporated 
into a laser product subject to the requirements of this section and 
that is capable, without modification, of producing laser radiation 
when removed from such laser product, shall itself be considered a 
laser product and shall be separately subject to the applicable 
requirements in this subchapter for laser products of its class. It 
shall be classified on the basis of the accessible emission level of 
laser radiation the system is capable of producing when so removed.
    (d) Accessible emission limits. Accessible emission limits for 
laser radiation in each class are specified in Tables 1, 2, 3, and 4 of 
this paragraph. Accessible emission limits for collateral radiation are 
specified in Table 7 of this paragraph.
NOTE APPLICABLE TO TABLES 1, 2, 3, 4, AND 6
    The variable t in the expressions of emission limits is the 
magnitude of the sampling interval in units of seconds.
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BILLING CODE 4160-01-C

    (1) Beam of a single wavelength. Laser or collateral radiation 
single wavelength exceeds the accessible emission limits of a class if 
its accessible emission level is greater than the accessible emission 
limit of that class within any of the ranges of emission duration 
specified in Tables 1, 2, 3, and 4 of this paragraph.
    (2) Beam of multiple wavelengths in same range. Laser or collateral 
radiation having two or more wavelengths within any one of the 
wavelength ranges specified in Tables 1, 2, 3, and 4 of this paragraph 
exceeds the accessible emission limits of a class if the sum of the 
ratios of the accessible emission level to the corresponding accessible 
emission limit at each such wavelength is greater than unity for that 
combination of emission duration and wavelength distribution which 
results in the maximum sum.
    (3) Beam with multiple wavelengths in different ranges. Laser or 
collateral radiation having wavelengths within two or more of the 
wavelength ranges specified in Tables 1, 2, 3, and 4 of this paragraph 
exceeds the accessible emission limits of a class if it exceeds the 
applicable limits within any one of those wavelength ranges. This 
determination is made for each wavelength range in accordance with 
paragraph (d)(1) or (d)(2) of this section.
    (4) Maximum sampling interval. Three maximum sampling intervals are 
used for the classification of laser. Which interval applies depends 
upon the accessible emission level of the product and whether viewing 
the radiation is an inherent feature of the product. The accessible 
emission limits of a class are exceeded, if exceeded within any 
emission duration less than or equal to the following maximum sampling 
intervals:
    (i) 30,000 seconds for wavelengths less than or equal to 400 nm and 
for wavelengths greater than 400 nm if intentional viewing of the 
radiation is inherent in the design or function of the product, or
    (ii) 100 seconds for wavelengths greater than 400 nm unless 
intentional viewing of the radiation is inherent in the design or 
function of the product.
    (iii) 0.25 seconds for Class 2 and for Class 3A laser radiation 
within the wavelength range from 400 to 700 nm.
    (5) Repetitively pulsed or scanned laser radiation. For 
repetitively pulsed or scanned laser radiation in the wavelength range 
from 400 nm to 1,000,000 nm (1 millimeter) the AEL is determined by 
using the most restrictive of requirements in paragraphs (d)(4)(i), 
(d)(4)(ii), and (d)(4)(iii) of this section as appropriate. For 
wavelengths less than 400 nm, the AEL is determined by using the most 
restrictive of requirements in paragraphs (d)(4)(i) and (d)(4)(ii) of 
this section.
    (i) The emission level of any single pulse within a pulse train 
shall not exceed the AEL for a single pulse.
    (ii) The average power of a pulse train of duration t shall not 
exceed the power corresponding to the AEL given in Tables 1, 2, 3, and 
4 of this paragraph, respectively, for a single pulse of duration t.
    (iii) The emission level of any single pulse within a pulse train 
shall not exceed the AEL for a single pulse multiplied by the 
correction factor C5:
    AELtrain = AELsingle x C5
    NOTE: C5 is only applicable to pulse durations shorter 
than 0.25 sec. where:
    AELtrain = AEL for any single pulse in the pulse train
    AELsingle = AEL for a single pulse
    C5 = N-1/4
    N = number of pulses in the pulse train during the sampling 
interval.
NOTE: In some cases, AELtrain this value may fall below the 
AEL that would apply for continuous operation at the same peak power 
using the same time base. Under these circumstances, the AEL for 
continuous operation may be used.
    (e) Tests for determination of compliance--(1) Tests for 
certification. Tests on which certification under

[[Page 14195]]

Sec. 1010.2 of this chapter is based shall account for all errors and 
statistical uncertainties in the measurement process. Because 
compliance with the standard is required for the useful life of a 
product, such tests shall also account for increases in emission and 
degradation in radiation safety with age.
    (2) Test conditions. Except as provided in Sec. 1010.13 of this 
chapter, tests for compliance with each of the applicable requirements 
of this section and Sec. 1040.11 shall be made as appropriate during 
operation, maintenance, service, or single failure as follows:
    (i) Under those conditions and procedures that maximize the 
accessible emission levels, including start-up, stabilized emission, 
and shut-down of the laser product; and
    (ii) With all controls and adjustments listed in the operation, 
maintenance, and service instructions adjusted in combination to result 
in the maximum accessible emission level of radiation; and
    (iii) At locations where human access to laser radiation is 
possible, e.g., if operation may require removal of portions of the 
protective housing and defeat of safety interlocks, measurements shall 
be made at points accessible in that product configuration; and
    (iv) With the measuring instrument detector so positioned and so 
oriented with respect to the laser product as to result in the maximum 
detection of radiation by the instrument; and
    (v) For a laser product other than a laser system, with the laser 
connected to that type of laser energy source that is specified as 
compatible by the laser product manufacturer and that produces the 
maximum emission level of accessible radiation from that product.
    (3) Measurement parameters. Accessible emission levels of laser and 
collateral radiation shall be based upon the measurements in paragraph 
(e)(3)(i) of this section as appropriate, or their equivalent. For the 
purposes of the measurements in paragraphs (e)(3)(i)(A) through 
(e)(3)(i)(D), and paragraph (e)(3)(ii) of this section, the 50-
millimeter aperture will be the limiting case with collimated beams, 
and the measurement distances referring to the apparent source are 
measured from the apparent source irrespective of any optical element 
placed between the source and the measurement aperture.
    (i) Radiant power (W) or radiant energy (J) measurable under the 
following conditions:
    (A) Within a circular aperture stop of 50-millimeter diameter 
placed at a distance of 2 meters from the closest point of human 
access. In general, the 50-millimeter aperture will be the limiting 
case with collimated beams, or
    (B) In the wavelength range from 400 nm to 1,400 nm within a 
circular aperture stop of 7-millimeter diameter placed at a distance of 
100 millimeters from the apparent source.
    (C) For apparent sources subtending an angle () (measured 
at a minimum distance of 100 millimeters) less than 
 and within the 
wavelength range from 400 nm to 1,400 nm, within a circular aperture 
stop of 7-millimeter diameter positioned at a distance (r) from the 
source depending upon the angular subtense  (between a minimum 
of 1.5 mrad and a maximum of 
) of the source. The 
distance (r) of the 7-millimeter measurement aperture from the source 
is determined by:
BILLING CODE 4160-01-F

[GRAPHIC] [TIFF OMITTED] TP24MR99.007

BILLING CODE 4160-01-C

NOTE: In cases where the apparent source is recessed within the product 
at a distance greater than that specified in paragraph (e)(3)(i)(B) or 
(e)(3)(i)(C) of this section, the minimum measurement distance should 
be at the closest point of human access, such as the exit window or 
lens. This measurement is needed to determine the user information 
required for Class 1 laser products (see paragraph (h)(1)(vi) of this 
section).
    (D) For wavelengths less than 400 nm and greater than 1,400 nm, 
within a circular aperture stop of 7-millimeter diameter (or as 
otherwise specified) placed at a distance of 14 millimeters from the 
closest point of human access.
    (E) For the calculation of the AEL expressed in terms of radiant 
power, radiant energy, irradiance, or radiant exposure, the value of 
the angular subtense of a rectangular or linear source is determined by 
the arithmetic mean of the two angular dimensions of the source. Any 
angular dimension that is greater than 
 or less than 
 shall be limited to 
 or 
, respectively, prior to 
calculating the mean.
    (F) For scanned laser radiation, the direction of the solid angle 
of acceptance shall change as needed to maximize detectable radiation, 
with an angular speed of up to 5 radians/second.
    (ii) The irradiance (Wcm-2) or radiant exposure 
(Jcm-2) equivalent to the radiant power (W) or radiant 
energy (J) measurable through a circular aperture stop having a 
diameter as specified in Table 6 of paragraph (d) of this section shall 
be divided by the area of the aperture stop.
    (f) Performance requirements--(1) Protective housing. Each laser 
product shall have a protective housing that prevents human access 
during operation to laser and collateral radiation that exceed the 
limits of Tables 1 or 7 of paragraph (d) of this section wherever and 
whenever such human access is not necessary for the product to perform 
its intended function. Wherever and whenever human access to laser 
radiation levels that exceed the limits of Class 1 is necessary, these 
levels shall not exceed the limits of the lowest class necessary to 
perform the intended function(s) of the product.
NOTE: If there is an opening or openings, such as for cooling, in a 
protective housing that encloses Class 3B or 4 levels of laser 
radiation, the adequacy of the protective housing shall be determined 
by whether the level of radiation that can be reflected out through the 
opening(s) by a single flat reflector exceeds the accessible emission 
limits of Class 1.
    (2) Safety interlocks--(i) Each laser, regardless of its class, 
shall be provided with at least one safety interlock for each portion 
of the protective housing which is designed to be removed or

[[Page 14196]]

displaced during operation or maintenance, if removal or displacement 
of the protective housing could permit, in the absence of such 
interlock(s), human access to:
    (A) Laser radiation in excess of the accessible emission limits of 
Class 3A; or
    (B) Laser radiation in excess of the accessible emission limits of 
Class 2 to be emitted directly through the opening created by removal 
or displacement of the interlocked portion of the protective housing.
    (ii) Each required safety interlock, unless defeated, shall prevent 
human access to laser radiation as described in paragraphs (f)(2)(i)(A) 
through (f)(2)(i)(B) of this section upon removal or displacement of 
such portion of the protective housing.
    (iii) Either multiple safety interlocks or a means to preclude 
removal or displacement of the interlocked portion of the protective 
housing shall be provided, if failure of a single interlock would 
allow:
    (A) Human access to a level of laser radiation in excess of the 
accessible emission limits of Class 3A; or
    (B) Laser radiation in excess of the accessible emission limits of 
Class 2 to be emitted directly through the opening created by removal 
or displacement of the interlocked portion of the protective housing.
    (iv) Laser products that incorporate safety interlocks designed to 
allow safety interlock defeat shall incorporate a means of visual or 
aural indication of interlock defeat. During interlock defeat, such 
indication shall be visible or audible whenever the laser product is 
energized, with and without the associated portion of the protective 
housing removed or displaced.
    (v) Replacement of a removed or displaced portion of the protective 
housing shall not be possible while required safety interlocks are 
defeated.
    (3) Remote interlock connector. Each laser system classified as a 
Class 3B or 4 laser product, except for Class 3B with not more than 
five times the AEL of Class 2 in the wavelength range of 400 to 700 nm, 
shall incorporate a readily available remote interlock connector having 
an electrical potential difference of no greater than 130 root-mean-
square volts between terminals. When the terminals of the connector are 
not electrically joined, human access to all laser and collateral 
radiation from the laser product in excess of the accessible emission 
limits of Class 1 and Table 7 of paragraph (d) of this section shall be 
prevented.
    (4) Key control. Each laser system classified as a Class 3B or 4 
laser product, except for Class 3B with not more than five times the 
AEL of Class 2 in the wavelength range of 400 to 700 nm, shall 
incorporate a key-actuated master control. The key shall be removable 
and the laser shall not be operable when the key is removed.
    (5) Laser radiation emission indicator--(i) Each laser system 
classified as a Class 3B or 4 laser product, except for Class 3B with 
not more than five times the AEL of Class 2 in the wavelength range of 
400 to 700 nm, shall incorporate an emission indicator which provides a 
visible or audible signal during emission of accessible laser radiation 
in excess of the accessible emission limits of Class 1, and 
sufficiently prior to emission of such radiation to allow appropriate 
action to avoid exposure to the laser radiation.
    (ii) For laser systems manufactured on or before August 20, 1986, 
if the laser and laser energy source are housed separately and can be 
operated at a separation distance of greater than 2 meters, both laser 
and laser energy source shall incorporate an emission indicator as 
required in accordance with paragraph (f)(5)(i) of this section.
    (iii) Any visible signal required by paragraph (f)(5)(i) or 
(f)(5)(ii) of this section shall be clearly visible through protective 
eyewear designed specifically for the wavelength(s) of the emitted 
laser radiation.
    (iv) Emission indicators required by paragraph (f)(5)(i) or 
(f)(5)(ii) of this section shall be located so that viewing does not 
require human exposure to laser or collateral radiation in excess of 
the accessible emission limits of Class 1 and Table 7 of paragraph (d) 
of this section.
    (6) Beam attenuator--(i) Each laser system classified as a Class 3B 
or 4 laser product, except for Class 3B with not more than five times 
the AEL of Class 2 in the wavelength range of 400 to 700 nm, shall be 
provided with one or more permanently attached means, other than laser 
energy source switch(es), electrical supply main connectors, or the 
key-actuated master control, capable of preventing access by any part 
of the human body to all laser and collateral radiation in excess of 
the accessible emission limits of Class 1 and Table 7 of paragraph (d) 
of this section.
    (ii) Upon written application by the manufacturer or on the 
initiative of the Director, Office of Compliance, Center for Devices 
and Radiological Health, the Director may, upon determination that the 
configuration, design, or function of the laser product would make 
unnecessary compliance with the requirement in paragraph (f)(6)(i) of 
this section, approve alternate means to accomplish the radiation 
protection provided by the beam attenuator.
    (7) Location of controls. Each Class 2, 3, or 4 laser product shall 
have operational and adjustment controls located so that human exposure 
to laser or collateral radiation in excess of the accessible emission 
limits of Class 1 and Table 7 of paragraph (d) of this section is 
unnecessary for operation or adjustment of such controls.
    (8) Viewing optics. All viewing optics, viewports, and display 
screens incorporated into a laser product, regardless of its class, 
shall limit the levels of laser and collateral radiation accessible to 
the human eye by means of such viewing optics, viewports, or display 
screens during operation or maintenance to less than the accessible 
emission limits of Class 1 and Table 7 of paragraph (d) of this 
section. For any shutter or variable attenuator incorporated into such 
viewing optics, viewports, or display screens, a means shall be 
provided:
    (i) To prevent access by the human eye to laser and collateral 
radiation in excess of the accessible emission limits of Class 1 and 
Table 7 of paragraph (d) of this section whenever the shutter is opened 
or the attenuator varied.
    (ii) To preclude, upon failure of such means as required in 
paragraph (f)(8)(i) of this section, opening the shutter or varying the 
attenuator when access by the human eye is possible to laser or 
collateral radiation in excess of the accessible emission limits of 
Class 1 and Table 7 of paragraph (d) of this section.
    (9) Scanning safeguard. Laser products that emit accessible scanned 
laser radiation shall not, as a result of any failure causing a change 
in either scan velocity or amplitude, permit human access to laser 
radiation in excess of the accessible emission limits of the class of 
the product.
    (10) Manual reset mechanism. Each laser system manufactured after 
August 20, 1986, classified as a Class 4 laser shall be provided with a 
manual reset to enable resumption of laser radiation emission after 
interruption of emission caused by the use of a remote interlock or 
after an interruption of emission in excess of 5 seconds duration due 
to the unexpected loss of main electrical power.
    (g) Labeling requirements. In addition to the requirements of 
Secs. 1010.2 and 1010.3 of this chapter, each laser product shall be 
subject to the applicable labeling requirements of this paragraph. 
Labeling in accordance with the International Electrotechnical 
Commission (IEC) Document 825-1 will

[[Page 14197]]

satisfy the requirements of paragraphs (g)(1) through (g)(10) of this 
section.
    (1) Class 2 designation and warnings. Each Class 2 laser product 
shall have affixed a label bearing the warning logotype A (Figure 1 in 
this paragraph) that includes the following wording:
[Position 1 on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM''; and
[Position 3 on the logotype]
``CLASS 2 LASER PRODUCT''.
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BILLING CODE 4160-01-C

    (2) Class 3A and 3B designations and warnings. (i) Each Class 3 
laser product that does not exceed the accessible emission limits of 
Table 3A shall have affixed a label bearing the warning logotype A 
(Figure 1 of paragraph (g)(1) of this section) that includes the 
following wording:
[Position 1 on the logotype]
``LASER RADIATION DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL 
INSTRUMENTS''; and,
[Position 3 on the logotype]
``CLASS 3A LASER PRODUCT''.
    (ii) Each Class 3 laser product that exceeds the accessible 
emission limits of Table 3A in the wavelength range of 400 to 700 nm 
and less than the AEL of Class 3A at other wavelengths shall have 
affixed a label bearing the warning logotype B (Figure 2 in this 
paragraph) and including the following wording:
[Position 1 on the logotype]
``LASER RADIATION AVOID DIRECT EYE EXPOSURE''; and,
[Position 3 on the logotype]
``CLASS 3B LASER PRODUCT''.
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[[Page 14198]]

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BILLING CODE 4160-01-C

    (iii) Each Class 3B laser product except as specified in (g)(2)(ii) 
shall have affixed a label bearing the warning logotype B (Figure 2 of 
paragraph (g)(2)(ii) of this section) and including the following 
wording:
[Position 1 on the logotype]
``LASER RADIATION AVOID DIRECT EXPOSURE TO BEAM''; and,
[Position 3 on the logotype]
``CLASS 3B LASER PRODUCT''.
    (3) Class 4 designation and warning. Each Class 4 laser product 
shall have affixed a label bearing the warning logotype B (Figure 2 of 
paragraph (g)(2)(ii) of this section), and including the following 
wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED 
RADIATION''; and,
[Position 3 on the logotype]
``CLASS 4 LASER PRODUCT''.
    (4) Radiation output information on warning logotype. Each Class 2, 
3, and 4 laser product shall state in appropriate units, at position 2 
on the required warning logotype, the maximum output of laser 
radiation, the pulse duration when appropriate, and the laser medium or 
emitted wavelength(s).
    (5) Aperture label. Each laser, except medical lasers, shall have 
affixed, in close proximity to each aperture through which is emitted 
accessible laser or collateral radiation in excess of the accessible 
emission limits of Class 1 and Table 7 of paragraph (d) of this 
section, a label or labels bearing 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 described in Table 7, item 1 of 
paragraph (d) of this section.
    (iii) ``AVOID EXPOSURE--Hazardous x-rays are emitted from this 
aperture,'' if the radiation emitted through such aperture is 
collateral radiation described in Table 7, item 2 of paragraph (d) of 
this section.
    (6) Labels for noninterlocked protective housings. For each laser 
product, labels shall be provided for each portion of the protective 
housing which has no safety interlock and which is designed to be 
displaced or removed during operation, maintenance, or service, and 
thereby could permit human access to laser or collateral radiation in 
excess of the limits of Class 1 and Table 7 of paragraph (d) of this 
section. Such labels shall be visible on the protective housing prior 
to displacement or removal of such portion of the protective housing 
and visible on the product in close proximity to the opening created by 
removal or displacement of such portion of the protective housing, and 
shall include the wording:
    (i) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM.'' 
for Class 2 accessible laser radiation.
    (ii) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM 
OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class 3A accessible 
laser radiation.
    (iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE 
EXPOSURE.'' for Class 3B accessible

[[Page 14199]]

laser radiation with an irradiance greater than 0.0025 W/
cm-2 and with not more than five times the AEL of Class 2 in 
the wavelength range of 400 to 700 nm.
    (iv) ``DANGER Laser radiation when open. AVOID DIRECT EXPOSURE TO 
BEAM.'' for Class 3B accessible laser radiation other than that 
described in paragraph (g)(6)(iii) of this section.
    (v) ``DANGER Laser radiation when open. AVOID EYE OR SKIN EXPOSURE 
TO DIRECT OR SCATTERED RADIATION.'' for Class 4 accessible laser 
radiation.
    (vi) ``CAUTION Hazardous electromagnetic radiation when open.'' for 
collateral radiation in excess of the accessible emission limits in 
Table 7, item 1 of paragraph (d) of this section.
    (vii) ``CAUTION Hazardous x-rays when open.'' for collateral 
radiation in excess of the accessible emission limits in Table 7, item 
2 of paragraph (d) of this section.
    (7) Labels for defeatably interlocked protective housings. For each 
laser product, labels shall be provided for each defeatably interlocked 
(as described in paragraph (f)(2)(iv) of this section) portion of the 
protective housing which is designed to be displaced or removed during 
operation, maintenance, or service, and which upon interlock defeat 
could permit human access to laser or collateral radiation in excess of 
the limits of Class 1 or Table 7 of paragraph (d) of this section. Such 
labels shall be visible on the product prior to and during interlock 
defeat and shall be in close proximity to the opening created by the 
removal or displacement of such portion of the protective housing, and 
shall include the wording:
    (i) ``CAUTION--Laser radiation when open and interlock defeated. DO 
NOT STARE INTO BEAM.'' for Class 2 accessible laser radiation.
    (ii) ``CAUTION--Laser radiation when open and interlock defeated. 
DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for 
Class 3A accessible laser radiation with an irradiance less than or 
equal to 0.0025 W/cm-2.
    (iii) ``DANGER Laser radiation when open and interlock defeated. 
AVOID DIRECT EYE EXPOSURE.'' for Class 3B accessible laser radiation 
with an irradiance greater than 0.0025 W/cm-2 and with not 
more than five times the AEL of Class 2 in the wavelength range of 400 
to 700 nm.
    (iv) ``DANGER Laser radiation when open and interlock defeated. 
AVOID DIRECT EXPOSURE TO BEAM.'' for Class 3B accessible laser 
radiation other than that described in paragraph (g)(7)(iii) of this 
section.
    (v) ``DANGER Laser radiation when open and interlock defeated. 
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for 
Class 4 accessible laser radiation.
    (vi) ``CAUTION Hazardous electromagnetic radiation when open and 
interlock defeated.'' for collateral radiation in excess of the 
accessible emission limits in Table 7 item 1 of paragraph (d) of this 
section.
    (vii) ``CAUTION Hazardous x-rays when open and interlock 
defeated.'' for collateral radiation in excess of the accessible 
emission limits in Table 7, item 2 of paragraph (d) of this section.
    (8) Warning for visible and/or invisible radiation. On the labels 
specified in this paragraph, if the laser or collateral radiation 
referred to is:
    (i) Invisible radiation, the word ``invisible'' shall appropriately 
precede the word ``radiation''; or
    (ii) Visible and invisible radiation, the words ``visible and 
invisible'' or ``visible and/or invisible'' shall appropriately precede 
the word ``radiation.''
    (iii) Visible laser radiation only, the phrase ``laser light'' may 
replace the phrase ``laser radiation.''
    (9) Positioning of labels. All labels affixed to a laser product 
shall be positioned so as to make unnecessary, during reading, human 
exposure to laser radiation in excess of the accessible emission limits 
of Class 1 radiation or the limits of collateral radiation established 
to Table 7 of paragraph (d) of this section.
    (10) Label specifications. Labels required by this section and 
Sec. 1040.11 shall be permanently affixed to, or inscribed on, the 
laser product, legible, and clearly visible during operation, 
maintenance, and service, as appropriate. Upon written application by 
the manufacturer, or on the initiative of the Director, Office of 
Compliance, Center for Devices and Radiological Health, the Director 
may, upon determination that the size, configuration, design, or 
function of the laser product would preclude compliance with the 
requirements for any required label or would render the required 
wording of such label inappropriate or ineffective, approve alternate 
means of providing such label(s) or alternate wording for such label(s) 
as applicable.
    (h) Informational requirements--(1) User information. Manufacturers 
of laser products shall provide as an integral part of any user 
instruction or operation manual which is regularly supplied with the 
product, or, if not so supplied, shall cause to be provided with each 
laser:
    (i) Adequate instructions for assembly, operation, and maintenance, 
including clear warnings concerning precautions to avoid possible 
exposure to laser and collateral radiation in excess of the accessible 
emission limits in Tables 1, 2, 3, 4, and 7 of paragraph (d) of this 
section determined under paragraph (e) of this section, and a schedule 
of maintenance necessary to keep the product in compliance with this 
section and, if applicable, Sec. 1040.11.
    (ii) A statement of the magnitude, in appropriate units, of the 
pulse duration(s), maximum radiant power and, where applicable, the 
maximum radiant energy per pulse of the accessible laser detectable in 
each direction in excess of the accessible emission limits in Table 1 
of paragraph (d) of this section.
    (iii) Legible reproductions (color optional) of all labels and 
hazard warnings required by paragraph (g) of this section and, if 
applicable, Sec. 1040.11, to be affixed to the laser product or 
provided with the laser product, including the information and warnings 
required for positions 1, 2, and 3 of the applicable logotype (Figure 1 
of paragraph (g)(1) or Figure 2 of paragraph (g)(2)(ii) of this 
section). The corresponding position of each label affixed to the 
product shall be indicated or, if provided with the product, a 
statement that such labels could not be affixed to the product but were 
supplied with the product and a statement of the form and manner in 
which they were supplied shall be provided.
    (iv) A listing of all controls, adjustments, and procedures for 
operation and maintenance, including a cautionary warning that the use 
of controls or adjustments or performance of procedures other than 
specified may result in hazardous radiation exposure.
    (v) In the case of laser products other than laser systems, a 
statement of the compatibility requirements for a laser energy source 
that will assure compliance of the laser product with this section and, 
if applicable, Sec. 1040.11.
    (vi) For Class 1 laser products, if the output power (or energy) 
measured according to paragraph (e)(3)(i)(D) of this section is greater 
than that measured in accordance with paragraph (e)(3)(i)(A) or 
(e)(3)(i)(B) of this section and that level exceeds the Class 1 limit, 
an additional warning is required. This warning shall state that 
viewing the laser output with optical instruments having a magnifying 
power greater than

[[Page 14200]]

2.5 (e.g., eye loupes) may pose an eye hazard.
    (2) Purchasing and servicing information. Manufacturers of laser 
products shall provide or cause to be provided:
    (i) In all catalogs, specification sheets, and descriptive 
brochures pertaining to each laser product, a legible reproduction 
(color optional) of the class designation and warning required by 
paragraph (g) of this section to be affixed to that product, including 
the information required for positions 1, 2, and 3 of the applicable 
logotype (Figure 1 of paragraph (g)(1) or Figure 2 of paragraph 
(g)(2)(ii) of this section).
    (ii) To servicing dealers and distributors and to others upon 
request, at a cost not to exceed the cost of preparation and 
distribution, adequate instructions for service adjustments and service 
procedures for each laser product model, including clear warnings and 
precautions to be taken to avoid possible exposure to laser and 
collateral radiation in excess of the accessible emission limits in 
Tables 1, 2, 3, 4, and 7 of paragraph (d) of this section, and a 
schedule of maintenance necessary to keep the product in compliance 
with this section and, if applicable, Sec. 1040.11. All such service 
instructions shall include a listing of those controls and procedures 
that could be used by persons other than the manufacturers or their 
agents to increase accessible emission levels of radiation and a clear 
description of the location of displaceable portions of the protective 
housing that could allow human access to laser or collateral radiation 
in excess of the accessible emission limits in Tables 1, 2, 3, 4, and 7 
of paragraph (d) of this section. The instructions shall include 
protective procedures for service personnel to avoid exposure to levels 
of laser and collateral radiation known to be hazardous for each 
procedure or sequence of procedures to be accomplished, and legible 
reproductions (color optional) of required labels and hazard warnings.
    (i) Modification of a certified product. The modification of a 
laser product, previously certified under Sec. 1010.2 of this chapter, 
by any person engaged in the business of manufacturing, assembling, or 
modifying laser products constitutes manufacturing under the Federal 
Food, Drug, and Cosmetic Act if the modification affects any aspect of 
the product's performance or intended function(s) for which this 
section or Sec. 1040.11 have an applicable requirement. The person who 
performs such modification shall recertify and reidentify the product 
in accordance with the provisions of Secs. 1010.2 and 1010.3 of this 
chapter.
    5. Section 1040.11 is revised to read as follows:


Sec. 1040.11  Specific purpose laser products.

    (a) Medical laser products. Each medical laser product shall comply 
with all of the applicable requirements of Sec. 1040.10 for laser 
products of its class. In addition:
    (1) A label bearing the wording: ``Laser aperture.'' shall be 
affixed in close proximity to each aperture through which is emitted 
accessible laser radiation in excess of the accessible emission limits 
of Class 1, and
    (2) For each Class 3B or 4 medical laser system, except those of 
Class 3B not exceeding 5 milliwatts at visible wavelengths and not 
intended for ocular exposure:
    (i) The accessible emission level, shall not deviate from the 
preset or selected level by more than 20 percent,
    (ii) An electrical or optical quantity that is directly related to 
the laser level generated shall be continually monitored during 
operation,
    (iii) A visible or audible indication shall be given whenever the 
monitored quantity denotes deviation from the preset or selected level 
by more than 20 percent,
    (iv) The user instructions shall specify an instrument, procedure, 
and schedule for calibration of the accessible emission level,
    (v) If the system emits either continuously or a series of pulses 
for longer than 0.25 seconds, the system shall incorporate a visual or 
audible indication of actual emission in addition to the emission 
indicator required by Sec. 1040.10(f)(5),
    (vi) The system shall include a hand or foot operated control to 
stop the emission of laser radiation. The switch shall be colored red 
and be located so that it is clearly visible and quickly accessible to 
the operator from the operating position. If it is a push-button type, 
it shall be of the ``mushroom-head'' type.
    (b) Surveying, leveling, and alignment laser products. Each 
surveying, leveling, or alignment laser product shall comply with all 
of the applicable requirements of Sec. 1040.10 for a Class 1, 2 or 3A 
laser product and shall not permit human access to laser radiation in 
excess of the accessible emission limits of Class 3A.
    (c) Demonstration laser products. Each demonstration laser product 
shall comply with all of the applicable requirements of Sec. 1040.10 
for a Class 1, 2, 3A or Class 3B laser, except for Class 3B with not 
more than five times the AEL of Class 2 in the wavelength range of 400 
to 700 nanometers, and shall not permit human access to laser radiation 
in excess of the accessible emission limits of such classes.

    Dated: March 17, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-7158 Filed 3-23-99; 8:45 am]
BILLING CODE 4160-01-F