Laser Products; Proposed Amendment to Performance Standard

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.

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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

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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

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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:

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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:

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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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(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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(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]

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