Laser Products; Proposed Amendment to Performance Standard, 37723-37741 [2013-14846]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Proposed Rules]
[Pages 37723-37741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14846]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1002, 1010, and 1040

[Docket No. FDA-2011-N-0070]
RIN 0910-AF87


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 or Agency) is proposing 
to amend the performance standard for laser products to achieve closer 
harmonization between the current standard and the International 
Electrotechnical Commission (IEC) standards for laser products and 
medical laser products, to reduce the economic burden on affected 
manufacturers, to improve the effectiveness of FDA's regulation of 
laser products, and to better protect and promote the public health.

DATES: Submit either electronic or written comments on the proposed 
rule by September 23, 2013. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by July 24, 2013 (see 
section VIII, the ``Paperwork Reduction Act of 1995'' section of this 
document). See section IV of this document for the proposed effective 
date of a final rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0070 and/or Regulatory Information Number (RIN) 0910-AF87, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Information and Regulatory Affairs (OIRA), Office of 
Management and Budget (OMB) (see section VIII ``Paperwork Reduction Act 
of 1995'' of this document):

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-2011-N-0070, and RIN 0910-AF87 for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Information Collection Provisions

    The information collection provisions of this proposed rule have 
been submitted to OMB for review. Interested persons are requested to 
fax or email comments regarding the information collection provisions 
to the Office of Information and Regulatory Affairs, OMB (see DATES). 
To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-5806, 
or emailed to oira_submission@omb.eop.gov">oira_submission@omb.eop.gov. All comments should be 
identified with the OMB control number 0910-0025. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Robert J. Doyle, Office of 
Communication, Education, and Radiation Programs, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993, 301-796-
5863.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Laser Standards and the Laser Industry
    B. Harmonization Efforts
II. Contents of the Proposed Regulation
III. Legal Authority
IV. Proposed Effective Date
V. Environmental Impact
VI. Analysis of Impacts
    A. Need for Regulation
    B. Background
    C. Affected Entities
    D. Costs of the Proposed Regulation
    E. Benefits of the Proposed Regulation
    F. Summary of Costs and Benefits
    G. Impact on Small Entities
VII. Federalism
VIII. Paperwork Reduction Act of 1995
IX. Comments
X. References

I. Background

A. Laser Standards and the Laser Industry

    The Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629) 
transferred the provisions of the Radiation Control for Health and 
Safety Act of 1968 (Pub. L. 90-602) from title III of the Public Health 
Service Act (42 U.S.C. 201 et seq.) to Chapter V of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351 et seq.). Under 
the FD&C Act, FDA administers an electronic product radiation control 
program to protect the public health and safety. FDA also develops and 
administers radiation safety performance standards for electronic 
products, including lasers.
    The Agency is proposing to amend its regulations applicable to 
laser products under Chapter 1, Subchapter J of Title 21 of the Code of 
Federal Regulations (21 CFR) because the current performance standard 
for laser products, last updated in 1985, is based on an outdated 
understanding of photobiological science and no longer reflects the 
current state of a technologically-evolving industry. Lasers now 
commonly used in the semiconductor and communications industries, for 
example, had not yet been invented at the time of the last update. FDA 
is proposing this amendment in order to make its standard consistent 
with current science and achieve closer harmonization with 
international standards already in use by the global laser industry. 
Moreover, this amendment to the performance standard addresses laser 
technology advancements and concomitant risks and benefits in order to 
more effectively protect and promote the public health.
    The term ``laser industry'' covers manufacturers in numerous 
industries. Examples of products that incorporate lasers are compact 
disc and DVD players, fax machines, fiber optic and free-air 
communication peripherals, bar code scanners, cutting and welding 
tools, and laser speed detectors.
    Through this action, the Agency intends to better harmonize its 
standard applicable to the laser industry with the current IEC 
standards (IEC 60825-1, Safety of laser products--Part 1: Equipment 
classification and requirements, 2d edition, 2007-03 as corrected by 
IEC 60825-1 (2d edition--2007), Corrigendum 1:2008-08

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(identified as ``IEC 60825-1:2007'') and (IEC 60601-2-22, Medical 
electrical equipment--Part 2-22: Particular requirements for basic 
safety and essential performance of surgical, cosmetic, therapeutic and 
diagnostic laser equipment, Edition 3.0, 2007-05 (identified as ``IEC 
60601-2-22:2007'')) by adopting various aspects of the IEC standards. 
By doing so, we would bring FDA's standard up to date with current 
science and better align FDA's standard for emission limits and hazard 
classes with those in international use. Currently, firms producing 
laser products for sale within the United States and abroad have to 
follow both IEC and FDA standards. Aligning such standards would mean 
that firms currently complying with two different sets of standards 
would generally need to comply with only one, except where the 
standards differ (e.g., collateral radiation limit). In addition, this 
rule results in better protection of public health because adherence to 
the rule will mitigate identified risks associated with laser 
technology.

B. Harmonization Efforts

    In the Federal Register of March 24, 1999 (64 FR 14180), FDA 
published a proposed rule to amend the performance standard for laser 
products to achieve harmonization between the current standard and the 
IEC standards in place at that time for laser products and medical 
laser products (the March 1999 proposal). Since the time of that 
proposal, the IEC has amended its standards, and continued work on the 
March 1999 proposal would no longer have achieved FDA's goal of 
increased harmonization of requirements. In the Federal Register of 
November 26, 2004 (69 FR 68831), the Agency withdrew its March 1999 
proposal.
    In September 1999, FDA consulted with its advisory committee, the 
Technical Electronic Product Radiation Safety Standards Committee 
(TEPRSSC), and discussed the options for responding to the developing 
changes in the IEC standards. At that time, amendments to the 1993 
version of IEC 60825-1 had been distributed as a Committee Draft for 
Vote (CDV) by the members of IEC Technical Committee 76 (TC76). The 
advice from TEPRSSC was for FDA to wait upon the results of that 
voting. The TEPRSSC recommended that if the CDV was approved by the IEC 
and it appeared that the amendments to the 1993 version of IEC 60825-1 
would continue to progress toward adoption, FDA should modify its March 
1999 proposal accordingly. The CDV was approved in October 1999. At its 
plenary meeting in November 1999, TC76 approved circulation for vote of 
the amendments as a Final Draft International Standard (FDIS). FDA then 
began drafting this reproposal of its amendments based on the FDIS.
    In June 2000, FDA presented a status report to TEPRSSC. TEPRSSC 
recommended that FDA continue on this course towards increased 
harmonization with IEC standards regardless of the outcome of the vote 
on the IEC FDIS. The IEC approved the FDIS in October 2000, resulting 
in an amended version of the standard which, at that time, was IEC 
60825-1, Ed. 1.2: 2001-08. IEC subsequently made additional amendments 
to IEC 60825-1, resulting in the current version, IEC 60825-1, Ed. 
2:2007-03 (as corrected by Corrigendum 1: 2008-08), major portions of 
which are incorporated by reference in these proposed amendments. FDA 
kept TEPRSSC apprised of its efforts to amend the Agency's performance 
standard for laser products through the presentation of status reports 
in May 2001, May 2002, and October 2003.
    In response to concerns some manufacturers expressed about having 
to comply with two different standards (i.e., the IEC and FDA 
standards), in the Federal Register of July 26, 2001 (66 FR 39049), FDA 
published a notice of availability of a guidance entitled, ``Laser 
Products--Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; Final 
Guidance for Industry and FDA (Laser Notice 50) (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm).'' This notice announced the Agency's intent to amend 
its standard for laser products and stated that, while that process is 
underway, FDA would not object to industry's compliance with certain 
aspects of the IEC standards instead of meeting the corresponding FDA 
requirements. These corresponding requirements include hazard 
classification, measurements, performance requirements, and labeling. 
Laser Notice 50 was revised on June 24, 2007, to reference the revised 
IEC standards, IEC 60825-1, Ed. 2:2007-03 and IEC 60601-2-22, Ed. 3: 
2007-05.
    At this time, we are proposing specific amendments aimed at 
achieving closer alignment with the amended IEC standards, IEC 60825-
1:2007 and IEC 60601-2-22:2007, by incorporating by reference many of 
the provisions found in these standards. However, FDA believes that 
some differences remain appropriate where FDA's standard is more 
precise than the IEC's. For example, FDA's current standard with 
respect to collateral radiation, human access, modification of laser 
products, and key control capability protect against other hazards not 
reflected in the IEC standards. These differences relate specifically 
to the criteria in the IEC standards for determining human access to 
low levels of laser radiation that are recognized to be ocular hazards 
only, and concern the emission limits for surveying and visual display 
laser products.
    Because the organization and structure of the IEC standards have 
been considerably different from the FDA standard for the past quarter 
century, the proposed amendments have adopted the concepts of the IEC 
standards while retaining the traditional organizational structure of 
the FDA standard. We believe this approach is appropriate because the 
manufacturers who have been producing laser products for the U.S. 
market are accustomed to the organization and structure of the FDA 
standard. We seek comments on this approach, specifically whether 
manufacturers would prefer that the Agency organize and structure its 
rules to match the IEC standards.

II. Contents of the Proposed Regulation

    Proposed Sec.  1002.1 (21 CFR 1002.1) revises the entries in table 
1, for laser products, to reflect the hazard classification 
designations used in the IEC standards.
    Proposed Sec.  1010.1 (21 CFR 1010.1), Scope, is amended to update 
the reference to the legal authority for these regulations and 
amendments.
    Proposed Sec. Sec.  1010.2(d) and 1010.3(b) (21 CFR 1010.2(d) and 
1010.3(b)) would authorize the Director, Center for Devices and 
Radiological Health (CDRH), or as delegated, on the Director's own 
initiative or upon written application by the manufacturer, to approve 
alternate means of providing certification and identification 
information.
    Proposed Sec.  1040.5 (21 CFR 1040.5) incorporates by reference 
into Sec. Sec.  1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11) many 
of the provisions found in two amended IEC standards relating to laser 
products (i.e., IEC 60825-1:2007 and IEC 60601-2-22:2007) in order to 
bring the FDA standard up to date and achieve closer alignment with the 
IEC standards.
    Proposed Sec.  1040.10(a) retains the existing applicability 
stipulations and contains a note emphasizing that the standard is not 
being expanded to apply to light emitting diodes (LEDs) unless such 
products are also laser products as defined in Sec.  1040.10(b)(4). 
LEDs do not typically meet the definition of laser

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product because they do not exhibit light amplification by controlled 
stimulated emission (capable of producing a high-intensity, long-
distance hazard) and FDA does not want to apply unnecessarily-stringent 
requirements to LED manufacturers.
    FDA is proposing to amend Sec.  1040.10(a)(3) by adding a new 
paragraph (iii) as a means of addressing uncertified, unreported 
complete laser systems that are sold as components. FDA has observed 
that some manufacturers and distributors are marketing what are 
actually complete laser systems as components or original equipment 
manufacturer (OEM) parts. New Sec.  1040.10(a)(3)(iii) would require 
that the seller document that the purchaser meets the definition of 
manufacturer in Sec.  1000.3(n) (21 CFR 1000.3(n)) or that the 
purchaser is excluded from applicability of the standard in accordance 
with Sec.  1040.10(a)(1) or Sec.  1040.10(a)(2). The provision also 
would require the seller to maintain such documentation as specified in 
Sec.  1002.31 (21 CFR 1002.31). FDA is seeking comments on our proposed 
approach to addressing this issue.
    Proposed Sec.  1040.10(b) incorporates by reference many of the 
numbered definitions in clause 3 of IEC 60825-1:2007 that apply to 
laser products, but excludes those aspects of the definition in clause 
3 that are not applicable in the context of FDA's regulation because 
they pertain to the purchaser's use of the laser product, an aspect 
generally not regulated by FDA.
    Proposed Sec.  1040.10(b)(2) provides a definition for children's 
toy laser products to distinguish between laser products provided for 
use as tools in professional or academic settings and those promoted 
for novelty use by children (Refs. 1, 2, and 3). In general, FDA's 
criterion for a children's toy laser product is a laser product when 
the expected use is by children under 14 years of age and the laser 
emission has a novelty or visual entertainment purpose. FDA's proposed 
standard focuses on radiation safety while the corresponding IEC 
standards are much broader in terms of product safety.
    Proposed Sec.  1040.10(b)(8) seeks to avoid confusion and clarifies 
that the terms must as used in Sec. Sec.  1040.10 and 1040.11 and shall 
as used in Sec. Sec.  1040.10 and 1040.11 and the IEC standards are 
equivalent in meaning and signify a requirement.
    Proposed Sec.  1040.10(b)(9) would add two sentences to the 
definition at subclause 3.24 of IEC 60825-1:2007, which would be 
incorporated by reference by proposed Sec.  1040.10(b)(1). This 
language would clarify the definition of the term ``collateral 
radiation'' consistent with current and proposed requirements as well 
as longstanding FDA policy. The proposal specifies that x-radiation 
would also be included in the definition of ``collateral radiation,'' 
which is consistent with the current definition at Sec.  1040.10(b)(12) 
and the requirements of both current and proposed Sec.  1040.10(d), but 
is not included in subclause 3.24 of IEC 60825-1:2007. FDA remains 
concerned about the potential for unintentional exposure to x-radiation 
from laser products and this potential hazard is not addressed in the 
IEC subclause. For this reason, FDA wants to retain its x-ray 
collateral radiation accessible emission limit in 1040.10(d). In the 
1992 HHS Publication FDA 86-8260--Compliance Guide for Laser Products 
(https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095304.pdf), FDA 
specified that collateral radiation includes ``x-radiation produced by 
a high voltage power supply, plasma glow in a discharge tube, 
excitation lamp light, or reradiation from a workpiece.'' Proposed 
Sec.  1040.10(b)(9) includes similar language to make clear that the 
definition of ``collateral radiation'' includes, but is not limited to, 
these types of radiation. FDA believes this will inform the public and 
clarify the breadth of objects that can, unbeknownst to the user, 
absorb and then re-emit radiation.
    Proposed Sec.  1040.10(c) incorporates by reference the hazard 
classifications of the IEC standard IEC 60825-1:2007.
    Proposed Sec.  1040.10(d) incorporates by reference tables of 
accessible emission limits (AELs) for the classes of laser products 
identified in IEC 60825-1:2007. FDA acknowledges that the AELs of the 
IEC are more up to date and better represent current understanding of 
the biological hazards of laser radiation. However, FDA is not 
proposing to eliminate its more-precise emission limits for collateral 
radiation. FDA believes that its experience demonstrates that the 
collateral radiation limits provide objective criteria for safety. 
Proposed Sec.  1040.10(d) retains the AELs for collateral radiation but 
reduces the time base for which collateral radiation is to be 
evaluated. FDA is adopting the IEC collateral radiation standard in 
whole but retaining its own additional, more precise limits for 
collateral x-ray radiation because this aspect is not addressed in the 
IEC collateral radiation standard.
    Proposed Sec.  1040.10(e) incorporates by reference the measurement 
conditions set forth in IEC 60825-1:2007 for use in determining the 
hazard classification of the laser product. However, FDA retains its 
requirement that tests under this section be part of the basis of the 
required certification of the product. FDA considers the IEC 
stipulation that conformance be evaluated under each and every 
reasonably foreseeable single failure condition to be impractical and 
is not proposing to adopt this stipulation. The stipulation is also 
unnecessary because FDA's notification and correction requirements in 
parts 1003 and 1004 (21 CFR parts 1003 and 1004) already provide an 
effective procedure for dealing with failures to comply or product 
radiation safety defects.
    Proposed Sec.  1040.10(f) incorporates by reference the engineering 
specifications provisions of clause 4 of IEC 60825-1:2007 with certain 
exceptions. The exceptions include retention of the existing authority 
in current Sec.  1040.10(f)(6) for CDRH to approve alternate means of 
safety in lieu of a beam attenuator. Proposed Sec.  1040.10(f)(4) is 
intended to allow more flexibility to manufacturers in providing means 
to preclude unintended or unauthorized use of Class 3B or 4 laser 
systems. The existing FDA requirement in current Sec.  1040.10(f)(4) is 
for a ``key control'' that prevents ``operation of the laser'' when the 
key is removed. The wording of the existing FDA requirement precludes 
the use of momentary key switches to start the laser or, if taken very 
literally, the use of computer passwords. FDA believes that the 
critical aspects of access control are the necessity for the use of the 
key to permit activation of the laser and the ability to turn off the 
laser without a key. Because FDA had concerns that the flexibility to 
use a key that is not captured by the key switch mechanism or to use a 
computer password only addressed the starting of the laser, the 
proposed change also includes a requirement that there be a means for 
terminating operation of the laser. The title of this section has also 
been changed to ``security master control'' to reflect the broadening 
of the section.
    Proposed Sec.  1040.10(f)(12) relating to collateral radiation 
would not incorporate subclause 4.14.2 of IEC 60825-1:2007, but instead 
require that the protective housing of laser products must prevent 
human access to collateral radiation that exceeds the limits for 
collateral radiation as specified in proposed Sec.  1040.10(d)(2). This 
requirement is necessary to assure the safety of laser product users 
because the

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IEC standard allows the use of protective housing to be at the 
discretion of the manufacturer, rather than a safety requirement.
    Proposed Sec.  1040.10(g) incorporates by reference the labeling 
provisions of IEC 60825-1:2007 but allows labeling in the format 
specified in the American National Standards Institute (ANSI) 535 
series for labels. Under this provision, either type of labeling could 
comply with the regulations.
    Proposed Sec.  1040.10(h)(1) includes minor conforming changes. 
Proposed Sec.  1040.10(h)(2)(ii) reorganizes and clarifies what service 
information must be made available by manufacturers. In particular, the 
service information addresses procedures or adjustments which may 
affect any aspect of the products performance. The preambles of the 
proposed FDA standard published in 1974 (39 FR 32097) and the final 
rule published in 1975 (40 FR 32256) indicate that the Agency's main 
intent in issuing the service information requirement was to safeguard 
the persons performing service on the laser equipment from possible 
exposure to unsafe levels of radiation. Subsequent to the standard's 
issuance, some stakeholders have interpreted this provision to apply to 
all service instructions, often leading to inappropriate access to non-
safety related service information by dealers, distributors, and other 
unqualified personnel. Proposed Sec.  1040.10(h)(2)(ii) clarifies that 
this part of the standard is intended to address laser radiation safety 
during service procedures and that the decision to provide additional 
information is at the discretion of the manufacturer.
    Proposed Sec.  1040.11(a), which applies to medical laser products, 
would incorporate by reference certain pertinent clauses and subclauses 
from the IEC standard IEC 60601-2-22:2007 including instructions for 
use (subclause 201.7.9.2) and laser radiation (clause 201.10). These 
clauses and subclauses are more current than the existing FDA standard 
in addressing current technology and use conditions. FDA is not 
proposing to adopt other clauses and subclauses of the IEC standards 
with respect to medical laser products because they do not pertain to 
radiation safety, but rather relate to other product safety concerns.
    FDA is proposing to amend Sec.  1040.11(b) and (c) to change the 
highest allowed class designation from Class IIIa to Class 3R. This 
change is necessitated by the incorporation of the IEC classifications 
and measurements for classification by reference into Sec.  1040.10(d) 
and (e).
    FDA is also proposing to amend Sec.  1040.11 by adding a new 
paragraph (d). Proposed Sec.  1040.11(d) would restrict to Class 1 
under any conditions of operation, maintenance, service, or failure, 
any laser products that are made or promoted as children's toys. We are 
proposing this amendment to ensure children will not be harmed by laser 
radiation under any conditions including disassembly or breakage. 
Because the class of the laser within the toy could be higher than the 
class of the toy product itself, the amendment protects children from 
unanticipated harmful exposure. The Consumer Product Safety Commission 
has requirements that address other safety concerns pertaining to 
children's toys (see 16 CFR part 1500).
    FDA, in response to a specific request from the U.S. Department of 
Defense (DOD), is proposing a new Sec.  1040.11(e) that codifies an 
exemption from the standard granted for the DOD in 1976 for laser 
products that are intended for use in combat, combat training, or that 
are classified in the interest of national security. This proposed 
amendment states that these laser products must have specific 
authorization from the procuring DOD authority in order for the 
exemption to apply. Detailed information about the implementation of 
this exemption is contained in the CDRH guidance document, which is 
available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094416.htm.

III. Legal Authority

    FDA is taking this action under the FD&C Act, as amended by the 
SMDA. Section 532 of the FD&C Act (21 U.S.C. 360ii) authorizes FDA to 
establish and administer an electronic product radiation control 
program to protect the public health and safety. Section 534 of the 
FD&C Act (21 U.S.C. 360kk) authorizes FDA by regulation to prescribe, 
amend, and revoke performance standards for electronic products. 
Section 1003(b)(2)(E) of the FD&C Act (21 U.S.C. 393(b)(2)(E)) requires 
FDA to ensure that public health and safety are protected from 
electronic product radiation. In addition, section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for 
the efficient enforcement of the FD&C Act.

IV. Proposed Effective Date

    FDA proposes that any final rule that issues based on this proposed 
rule become effective 2 years after the date of publication of the 
final rule in the Federal Register. A product is certified compliant 
with a particular standard as that standard exists on the Date of 
Manufacture, that is, the date it passed final testing including the 
compliance tests. Therefore, products which were completed and dated 
before the effective date of the amendments would not have to be 
recertified even if they are sold after that effective date.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.34(c) that this proposed 
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 environment impact statement is 
required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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). This proposed rule is a significant regulatory action as 
defined by Executive Order 12866, and as such, it has been reviewed by 
OMB.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The Agency prepared an initial regulatory 
flexibility analysis (see section VI.G ``Impact on Small Entities'' of 
this document).
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

[[Page 37727]]

A. Need for Regulation

    As discussed previously in this document, the Agency is proposing 
to amend its regulations relating to laser products. The current FDA 
standard for laser products is based on an outdated understanding of 
photobiological science and no longer reflects the current state of a 
technologically evolving industry. For example, lasers now commonly 
used in the semiconductor and communications industries had not yet 
been invented at the time the standard was last updated by FDA.
    Through this rulemaking, the Agency intends to better harmonize its 
standard with the current IEC standards (IEC 60825-1:2007 and IEC 
60601-2-22:2007). By doing so, we would bring the FDA's standard up to 
date with current science and better align the FDA's standard for 
emission limits and hazard classes with those used by most countries of 
the world. Currently, firms producing laser products for sale within 
the United States and abroad have had to follow both IEC and FDA 
standards. Aligning such standards would mean that firms currently 
complying with two different sets of standards would generally need to 
comply with only one, except where the standards differ.
    Despite the advantages of using an updated internationally-
recognized safety standard, private incentives alone would be 
inadequate to move the laser industry to this new standard. Current 
regulations, based on a different standard, would prevent such a move. 
Some entities might choose not to adopt the new standard. Under section 
534(a)(4) of the FD&C Act, a new regulation is necessary to amend FDA's 
existing standard. For these reasons, FDA concludes this rule is 
necessary.

B. Background

    Lasers are given hazard classifications according to the radiation 
hazard they present. Class I lasers, such as DVD players, are 
considered to be safe under intended conditions of operation. Under the 
harmonized standard, these lasers would be in Class 1 (not known to be 
hazardous) and Class 1M (not known to be hazardous to the unaided 
eye).\1\ Class II lasers are more hazardous, but should be safe as long 
as humans blink and aversion responses operate. These lasers would be 
either Class 2 or Class 2M (safe as long as one did not use optical 
instruments for viewing and one's blink and aversion responses did 
operate). Class IIIa lasers are more powerful, but are still considered 
as low risk. These lasers would be classified in class 3R under the 
harmonized standard. Class IIIb lasers are potentially dangerous and 
most would be classified as Class 3B under the harmonized standard. 
Some lower power lasers that are currently in Class IIIb may be able to 
move to lower classes under the harmonized standard. Class IV lasers, 
such as those used for cutting, are particularly dangerous. These would 
be in Class 4 under the harmonized standard.
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    \1\ A laser could be in Class I(1) because it emits very little 
radiation or because the radiation is fully contained, as in a laser 
printer.
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    While some firms in the laser industry would incur a burden 
associated with adopting a new standard, our impression from discussion 
with industry experts is that greater harmonization should lower the 
overall economic burden on the U.S. laser industry. The Agency believes 
increased harmonization to be consistent with the goal of adopting 
voluntary consensus standards, as has been articulated in OMB Circular 
A-119 (Ref. 4). Moreover, to the extent that the current FDA standard 
differs from those used by other trading partners, harmonization would 
reduce costs associated with trade and would indirectly benefit U.S. 
consumers of laser products.
    In addition to bringing FDA's laser standard in line with current 
science and partially harmonizing with the rest of the laser industry, 
this action would also clarify the scope of existing laser regulations. 
Children's toy laser products, not currently included among ``specific 
purpose laser products,'' would now be covered. These could include, 
for example, lasers mounted on toy guns for ``aiming,'' spinning tops 
which project laser beams while they spin, dancing laser beams 
projected from a stationary column, or lasers intended for creating 
entertaining optical effects. We do not know the number of firms 
manufacturing these products but believe nearly all are located outside 
the United States. Laser products claiming exemption as a product 
intended for use in combat, combat training, or classified in the 
interest of national security would continue to be required to have 
specific authorization from the DOD. This proposed rule clarifies when 
the exemption applies.
    The Agency believes rulemaking to be the preferred approach to 
moving this large, heterogeneous industry to a partially harmonized 
standard. As previously mentioned in this document, some laser 
manufacturers would incur one-time additional costs from increased 
harmonization, approximately $6.7 million at 7 percent and $5.9 million 
at 3 percent, but expected recurring benefits to laser manufacturers of 
$13.4 million would exceed these costs. In 2001, the Agency addressed 
the need for an updated standard by issuing Laser Notice 50 (Ref. 5). 
Laser Notice 50 declared that FDA would not object to compliance with 
IEC standards to satisfy certain FDA requirements while the Agency was 
in the process of amending its own standard. Firms following the 
approach described in Laser Notice 50 have been allowed to benefit from 
harmonization during this period of transition to a new harmonized 
standard. We seek comments from firms using the Laser Notice 50 
approach to help us examine the costs and benefits of this regulatory 
action. Laser Notice 50, however, was intended only as a stopgap 
measure. Through this action, laser product manufacturers will benefit 
from increased regulatory certainty. Also, safety inspectors examining 
these products will be able to work from far more similar standards.
    By moving to a safety standard more attuned to current science, the 
Agency expects this action to benefit public health. There is a risk of 
serious injury associated with the use of lasers. High-powered lasers 
have the potential to burn human tissue, but nearly all of the reported 
injuries from the use of lasers have been retinal (Ref. 6, p. 466). A 
study published in 2000 found over 100 reports of laser eye injuries 
over the course of 35 years (1965-2000) in the medical literature, but 
noted many more injuries went unreported because of confidentiality 
requirements associated with the legal proceedings and the sensitivity 
of military operations (Ref. 6, p. 465). Another study estimated that 
there are fewer than 15 retinal injuries each year worldwide from 
industrial and military lasers (Ref. 7, p. 1211). Accidents involving 
higher-powered lasers have resulted in permanent loss of visual acuity 
and even blindness. Injuries from lower powered lasers have been 
associated with temporary disturbances in vision. While these eye 
injuries are not permanent, the temporary loss of vision can result in 
serious accidents (Refs. 14, 15). Our understanding of potential 
sources of laser injuries has evolved significantly over time because 
of developments in the science. FDA believes its standard should be 
aligned with the most recent valid science in order to minimize risk of 
injury. Scientific studies have identified radiation safety issues 
associated with lasers that were previously unknown such as repetitive 
pulse output and additional spectral regions where photochemical 
hazards must be considered. This regulation

[[Page 37728]]

accounts for variables that were not addressed by the previous 
regulation.

C. Affected Entities

    The proposed rule would directly affect establishments that 
manufacture laser products. In general, all products incorporating a 
laser or laser system are subject to the current performance standard. 
Laser products that are also medical devices are also subject to the 
Agency's regulations pertaining to medical devices. Manufacturers that 
market products internationally must also comply with internationally-
recognized standards, such as IEC 60825-1:2007 and 60601-2-22:2007.
    Because a wide variety of products contain lasers, the term ``laser 
industry'' actually refers to manufacturers in numerous industries. 
Examples of products that incorporate lasers are compact disc and DVD 
players, fax machines, fiber optic and free-air communication 
peripherals, bar code scanners, cutting and welding tools, and laser 
speed detectors. For the year 2006, worldwide revenues for the laser 
industry were approximately $5.6 billion (Ref. 8). In 1997, U.S. sales 
accounted for approximately 60 percent of industry revenues according 
to the January 1998 edition of the trade publication Laser Focus World, 
the last edition to report that statistic. Assuming that share still 
holds, the domestic laser industry has annual sales of approximately 
$3.4 billion. Global revenues increased slightly between 2005 and 2006.
    The Agency contracted with the Eastern Research Group (ERG), Inc. 
to estimate the economic impact of partial FDA harmonization with these 
two IEC standards. ERG's report, ``Technical Quality and Economic 
Implications of International Harmonization of Laser Performance 
Standards--An Update'' (ERG Report) (Ref. 9) is summarized here and on 
file with the Division of Dockets Management as well as https://www.regulations.gov (see ADDRESSES).
    ERG estimates that there are 1,283 U.S. manufacturers of laser 
products spanning 18 North American Industrial Classification System 
(NAICS) classifications. All of these firms would be affected by this 
proposed rule because all are assumed to produce for U.S. consumers 
and, therefore, required to meet the FDA standard. Those firms 
producing only for U.S. consumers (875 of the 1,283 firms according to 
ERG) would bear costs because they would need to adopt a new set of 
standards. Firms producing for both U.S. consumers and for export (408 
of the 1,283 firms) would benefit from this proposed rule because they 
would generally need to comply with only one standard instead of two 
sets, except where the standards differ. Based on our experience 
regulating and inspecting these exporting firms and our understanding 
that the current IEC standards and this proposal that would incorporate 
the IEC standards by reference are similar, we assume for this analysis 
that exporting firms are already in compliance with the IEC standards. 
We recognize, however, that this is a critical assumption and welcome 
comments from the public. The Agency does not know of any U.S. firms 
producing solely for export.

D. Costs of the Proposed Regulation

    The costs of complying with this proposed rule would be the costs 
associated with elements of the harmonized standard that are not in the 
existing standard. Because exporting firms are presumed to already be 
in compliance with the IEC standards, only firms not currently 
producing for export would be expected to incur these costs. The ERG 
Report identifies four cost-generating elements: Protective housing 
labeling, repetitive pulse correction factor, testing with 50 
millimeters (mm) aperture, and compliance testing for de minimis 
changes. We also recognize that there may be some costs associated with 
IEC standards documentation, documentation requirements for 
manufacturers of some laser products that are intended as components, 
and DOD exemption documentation. We do not rule out potential 
additional training costs associated with learning the new standard, 
but believe estimated costs would be so minor that they would be 
difficult to reliably quantify.
1. Protective Housing Labeling
    Section 1040.10(d)(2) of the proposed rule changes the wording on 
the label that must appear on all housings that prevent access to laser 
light. The cost of making this change would depend on the labor 
associated with the change, any IT system changes required, and on the 
cost of creating and printing new labels. The ERG Report noted that 
manufacturers of consumer products have shorter product cycles than 
manufacturers of industrial products and that many consumer product 
manufacturers would be able to make the label change in the ordinary 
cycle of production. This analysis assumes similarity between the 
manufacturers of consumer products and manufacturers of laser products. 
Nevertheless, because of the difficulty in identifying consumer 
products among the various NAICS classifications, ERG applied the 
protective housing label costs to all NAICS industries affected (Ref. 
9, p. 42). Because firms in classification 334119 (other computer 
peripheral equipment manufacturing) are believed to export, they are 
assumed to be unaffected. According to the ERG Report, a label change 
would cost an estimated $4,966, or approximately $5,000, per product. 
The costs roughly break down as approximately $4,300 for an engineering 
change order, including $400 in label design and tooling expenses, plus 
$600 in label inventory losses.
    The total cost of this provision would be a function of the number 
of affected products. Firms with a single product would face a cost of 
about $5,000. ERG estimates that the 875 non-exporting firms affected 
by this provision of the proposed rule produce approximately 3,100 
products, resulting in a cost of $15.4 million. Because the ERG 
analysis was completed in 2005, we adjust for inflation using the most 
current (2009) Implicit Price Deflator for the Gross Domestic Product. 
Adjusting for inflation of 9.77 percent, the estimated cost is $16.9 
million. The annualized cost of this provision, at a 7 percent discount 
rate over a 10-year horizon is $2.2 million. At 3 percent, the 
annualized cost is $1.8 million (Ref. 9, Table 3-5, p. 53). Adjusting 
for inflation, these amounts are $2.4 million and $2.0 million.
    This estimate may substantially overstate the cost of compliance 
because it does not consider product labeling that could be updated 
during the 2-year implementation period. If the labeling for some 
products would normally be updated every 6 years, a sizable fraction of 
these products would be able to revise the labeling as part of the 
normal product cycle during the 2-year implementation period. Because 
the Agency does not know the lifespan of these labels and the ERG 
Report does not cover this issue, we have not attempted to calculate 
the fraction that would be updated in a 2-year period.
2. Repetitive Pulse Correction Factor
    The harmonized standard for laser products includes a new technical 
specification for calculating the power of scanning or repetitively 
pulsed laser products. Pulse repetition potentially increases the risk 
of injury and was not a standard feature of laser products when the 
current standard was issued (Ref. 16). Because of this new technical 
specification, certain products might be reclassified as presenting a 
greater threat to safety and may require more safety-related features. 
Due to the increased granularity of the classifications in the IEC 
standards as compared to FDA's existing standard, some Class I

[[Page 37729]]

products, such as certain laser range finders or laser pointers, might 
be reclassified as Class 1M or 3R. Some Class II or IIIa products might 
be reclassified as Class 3B. The impact of this provision would be felt 
among firms in NAICS classification 334519 (other measuring and 
controlling device manufacturing), where, according to Table 2-5 of the 
ERG Report, there are 71 affected firms.
    Under this proposal, Class 3B laser products require more safety-
related features than products in Class I, II, or IIIa. Such safety 
features would include an indicator light at each aperture to show when 
the laser is operating, a key or password lock, a connector to 
facilitate remote interlocking, and a beam attenuator. The increase in 
safety requirements may also lead to other changes, such as the 
revision of safety manuals or the use of more elaborate installation 
procedures. Manufacturer costs associated with this provision would 
include both one-time engineering costs relating to changes to design 
and documentation, plus recurring production costs for the inclusion of 
these safety-related features in the manufacture of each unit.
    To comply with this provision, manufacturers faced with 
reclassification to a more stringent class would face the costs of 
redesigning the product. In some cases, however, a manufacturer might 
be able to make adjustments to the product, itself, to stay in a lower 
class. For example, if power output is a factor in moving a product to 
a more stringent class, the manufacturer might avoid the move if it can 
lower the power of the unit without harming the functionality of the 
product.
    The one-time cost for product design to incorporate the additional 
safety features would be between $25,000 and $100,000 per product (Ref. 
9, p. 43). These costs would include labor and materials for redesign, 
purchasing, establishing manufacturing and quality control procedures, 
and product documentation changes. The range for these costs reflects 
that the required safety changes can vary from being fairly 
straightforward to being substantially more complex. The average 
expected one-time cost of compliance is $55,400 per affected product, 
as derived in Table 3-1 of the ERG report.\2\ Over all affected 
products in NAICS classification 334519, the estimated one-time cost of 
this provision is $6.3 million. Adjusting for inflation of 9.77 
percent, the estimated cost is $6.9 million. The 10-year annualized 
cost at a 7 percent discount rate is $892,000. At 3 percent, the 
annualized cost is $734,000 (Ref. 9, Table 3-5, p. 54). Adjusting for 
inflation, these amounts are $979,000 and $806,000.
---------------------------------------------------------------------------

    \2\ The estimate assumes 160 hours of managerial time at a rate 
of $53.28 per hour, 1,200 hours of professional staff time at $38.47 
per hour, and 40 hours of clerical time at $18.08 per hour.
---------------------------------------------------------------------------

    In addition to the one-time costs associated with making these 
changes, there would also be recurring costs for the increased material 
and labor used in manufacturing. Based on information in the ERG Report 
from discussions with industry experts, the Agency estimates that these 
additional components would cost approximately $5 per unit and would 
require an additional 0.1 hours to install for each unit. Assuming a 
1,000 unit production run for a typical product affected by this rule, 
ERG has estimated that the total recurring costs per product for this 
aspect of the proposed rule to be $7,004 per product (Ref. 9, p. 43). 
Many laser product manufacturers have significantly higher production 
volumes, but an ERG analysis of U.S. International Trade Commission 
export statistics for the affected NAICS codes supports this lower 
estimate. Moreover, companies with higher production volumes are likely 
to be exporters already familiar with IEC standards and manufacturers 
of Class I devices which would not be affected by this proposal. 
Nevertheless, estimated recurring costs for a hypothetical affected 
company with a production volume of 100,000 units would be 100 times as 
great, or $700,000 per product. We therefore request comment on this 
assumption.
    Over the estimated 113 affected products in NAICS classification 
334519, the cost would be $792,000. Adjusting for 9.77 percent 
inflation, the cost is $870,000. Adding this to the annualized one-time 
cost, the annualized total cost of this provision at a 7 percent 
discount rate over 10 years is $1.7 million. At a 3 percent discount 
rate, the annualized cost is $1.5 million. Adjusting for inflation, 
these amounts are $1.8 million and $1.7 million.
3. Testing With 50 mm Aperture
    Under the proposed rule, the power of many visible and near 
infrared lasers would be tested using an aperture of 50 mm. Previous 
test methods used a smaller aperture and did not capture some power 
from lasers with a wide beam width. According to the ERG Report, most 
laser products have a beam width smaller than 50 mm and would not be 
affected by this provision. But a few products with diverging or 
expanded beam diameters may be affected. Examples of potentially 
affected products with wide beam widths are laser speed guns and 
distance-measuring products used in construction.
    With the larger test aperture leading to more measured power, some 
products may move into more stringent class designations. As with the 
previously discussed repetitive pulse correction factor, a manufacturer 
with a product that has moved to a more stringent class could either 
redesign the product to meet the stricter requirements or lower the 
product's power. For the purposes of this analysis, we assume the 
manufacturer redesigns the product. The Agency assumes the cost of the 
provision to be the same as that in the repetitive pulse correction 
factor: $55,400 for one-time product design and a little over $7,000 
for increases in the cost of production.
    In its report, ERG assumed this provision would affect products 
manufactured by firms in NAICS classifications 334511 (search, 
detection, navigation, guidance, aeronautical, and nautical system and 
instrument manufacturing) and 334519 (other measuring and controlling 
device manufacturing). ERG estimated there to be 11 affected firms with 
33 affected products in classification 334511 and 71 affected firms 
with 113 affected products in classification 3345193.\3\
---------------------------------------------------------------------------

    \3\ See ERG report, Tables 3-3 and 3-5. Table 3-5 does not 
explicitly list the number of affected products, but this can be 
deducted from the total costs in the table on p. 55 and the per-
device cost as calculated in table 3-1.
---------------------------------------------------------------------------

    The estimated one-time cost for classification 334511 for this 
provision is approximately $1.8 million ($55,400 per product x 33 
affected products). The estimated recurring costs are approximately 
$229,000 ($7,000 per product x 33 products). The estimated one-time 
cost for classification 334519 is $6.3 million ($55,400 per product x 
113 products) and the recurring costs are $792,000 ($7,000 per product 
x 113 products).
    For both classifications combined, the one-time cost for this 
provision is approximately $8.1 million ($1.8 million + $6.3 million), 
which is $1.1 million when annualized at 7 percent and $946,000 when 
annualized at 3 percent. The recurring cost is approximately $1.0 
million ($229,000 + $792,000). The estimated total cost of this 
provision, annualized over 10 years at 7 percent is $2.2 million, and 
at 3 percent, the cost is $2.0 million. Adjusting for inflation of 9.77 
percent, the one-time cost is $8.9 million, and the recurring cost is 
$1.1 million. Annualized over 10 years at 7 percent,

[[Page 37730]]

the inflation-adjusted cost is $2.4 million, and at 3 percent the cost 
is $2.2 million.
4. Compliance Reporting for de Minimis Changes
    Changes in laser products must be reported to FDA under both the 
current regulation and the proposed regulation. As noted earlier, some 
firms would be required to change their protective housing labeling. 
When a firm changes the labeling of a product, it must submit to FDA a 
report of the change and a copy of the new label.
    In addition to the costs associated with the actual label change, a 
firm would also incur the costs to compile and submit the information 
for the change notice to FDA. ERG estimates this cost to be about $100 
per product (Ref. 9, p. 45). This estimate potentially overstates the 
impact, as many firms would be able to notify FDA of product changes 
through the annual report process and would not need to submit an 
additional notice.
    As noted previously in this document, the 875 non-exporting firms 
affected by the label change provision (and, therefore, this provision) 
are responsible for approximately 3,100 laser products. ERG estimates 
the one-time cost of these notifications to be $334,000, which is 
$47,000 when annualized at 7 percent and $39,000 when annualized at 3 
percent (Ref. 9, Table 3-5, p. 56). Adjusted for inflation, the one-
time cost is $366,000, which is $52,000 annualized at 7 percent and 
$43,000 annualized at 3 percent.
5. IEC Standards Documentation
    In addition to the issues addressed in the ERG Report, the Agency 
recognizes that some laser manufacturers may need to purchase an 
official set of IEC Standards.\4\ Document IEC 60825-1, Edition 2, 
March 2007, costs CHF 255 (Ref. 10).\5\ Document IEC 60601-2-22, 
Edition 3.0, May 2007, costs CHF 135. Thus, these IEC standards can be 
purchased for CHF 390, which is about $350. Assuming all 875 laser 
manufacturing firms not currently producing for export would purchase 
these documents, the total one-time cost would be $289,500. When 
annualized at 7 percent over 10 years this cost is $41,200, and when 
annualized at 3 percent, it is $33,900.
---------------------------------------------------------------------------

    \4\ The standards are sold through the IEC Web site (https://www.iec.ch).
    \5\ Swiss Francs are represented by the symbol CHF. 1 Swiss 
Franc = 0.9342 U.S. Dollars. Per midrates 21:20 UTC, April 21, 2010.
---------------------------------------------------------------------------

6. Manufacturer Status Documentation
    Regulatory requirements for those selling components or OEM parts 
to manufacturers are less burdensome than are the requirements for 
those selling complete laser systems to consumers. Under current 
regulations, components and OEM parts may only be sold to 
manufacturers. New Sec.  1040.10(a)(3)(iii) would reinforce these 
provisions by requiring those selling components or OEM parts to 
document that the purchaser meets the definition of manufacturer in 
Sec.  1000.3(n) or that the purchaser is excluded from the standard in 
accordance with Sec.  1040.10(a)(1) or Sec.  1040.10(a)(2). The 
provision would also require the seller to maintain documentation as 
specified in Sec.  1002.31.
    ERG did not analyze this provision in their report. The regulation 
would require those selling components to maintain records showing that 
their customers are manufacturers. The Agency believes sellers could 
generally comply with this provision by accumulating information 
gathered in the course of doing business. Additional information 
required to verify that a particular purchaser was a manufacturer could 
be obtained through email or fax. The Agency assumes that it would 
take, on average, approximately 10 minutes, or 0.17 hours for a 
component seller to obtain and file information on each customer. The 
ERG Report assumes an average wage rate for clerical and administrative 
staff of $18.08 per hour, so the cost per record would be $3 (Ref. 9, 
p. 13).
    FDA does not know how many manufacturers or suppliers are 
purchasers from each manufacturer with a registered component product. 
According to the FDA product registration database, there were 574 
component product registrations from 155 component manufacturers filed 
during the 11-year period from 1997 to 2007, an annual average of 52 
product registrations (574 / 11) from 14 manufacturers (155 / 11). 
Assuming each accession number in the registration database represents 
a unique purchaser who is a manufacturer or supplier, there would be 52 
new records each year. At $3 per record and adjusting for 9.77 percent 
inflation, the annual cost of this provision would be $172. We invite 
comment on these estimates and the extent to which this provision would 
prevent manufacturers from improperly shifting the responsibility for 
certifying, reporting, or registering products to end users.
7. Department of Defense Exemption
    The FDA laser safety standard may not be appropriate for laser 
products used in combat, combat training, or other national security 
situations. Visible or audible emission indicators and highly visible 
warning labels, for example, may be inappropriate when concealment is 
vital. For this reason, laser products procured for combat, combat 
training, or classified for reasons of national security are exempted 
by FDA from the laser safety standard (Ref. 11).
    Nevertheless, FDA is concerned that the lack of clear regulatory 
language hampers the effectiveness of this exemption. FDA has become 
aware of manufacturers claiming to possess a DOD exemption when they 
have not followed the proper procedures and obtained the required 
exemption letter. FDA is also concerned that the manufacturer may 
attempt to import laser products without an exemption letter, resulting 
in the products being detained because there is no proof that the 
products have been exempted by the laser performance standard. FDA 
believes incorporating this exemption into this Agency's regulations 
would make it more effective.
    FDA estimates 25 manufacturers per year would obtain exemption 
letters from the DOD. An unknown number of manufacturers are currently 
obtaining exemption letters from the DOD, as required in current 
guidance. Assuming it takes 5 minutes to request the exemption letter 
and then 10 minutes to file it, each exemption letter would require 15 
minutes of time from a clerical worker. The ERG Report uses an average 
wage rate for clerical and administrative staff of $18.08 per hour, so 
the cost per exemption letter would be $4.50. With an upper bound of 25 
letters each year and adjusting for 9.77 percent inflation, the annual 
cost of this provision would be $123. If each of these manufacturers 
are already obtaining exemption letters as required in current 
guidance, there would be no additional cost incurred by these 
manufacturers.
8. Total Costs of the Regulation
    Table 1 of this document summarizes and totals the costs of the 
regulation. The total one-time costs of this proposed regulation are 
estimated to be $33.4 million. Annualized over 10 years at 7 percent, 
this cost is $4.7 million; at 3 percent the annualized cost is $3.9 
million (Ref. 9, Table 3-5, p. 57).\6\ The

[[Page 37731]]

estimated total recurring costs of the regulation are $2.0 million. The 
estimated total cost of this regulation annualized over 10 years at 7 
percent is $6.7 million. When annualized at 3 percent, the cost is $5.9 
million.
---------------------------------------------------------------------------

    \6\ These figures differ slightly from those in the ERG Report 
(Ref. 6) because of the inclusion of the cost of purchasing copies 
of the IEC standards.

                  Table 1--Total Cost of the Regulation
------------------------------------------------------------------------
                                             One-time        Recurring
                  Issue                     (millions)      (millions)
------------------------------------------------------------------------
Protective Housing Labeling.............           $16.9  ..............
Repetitive Pulse Correction Factor......             6.9            $0.9
Testing with 50 mm Aperture.............             8.9             1.1
Reporting for de Minimis Changes........             0.4  ..............
IEC Standards Documentation.............             0.3  ..............
Validation of Manufacturer Status.......  ..............             0.0
Department of Defense Exemption.........  ..............             0.0
Sum All Provisions......................            33.4             2.0
Annualized Costs at 7 percent...........             4.7             2.0
Annualized Costs at 3 percent...........             3.9             2.0
                                         -------------------------------
Total Annualized Costs at 7 percent.....  ..............             6.7
Total Annualized Costs at 3 percent.....  ..............             5.9
------------------------------------------------------------------------

    This cost estimate is based on available data, but may overstate 
certain items, especially those associated with changing the wording of 
the label appearing on protective housings. This is estimated to be the 
most expensive provision, but, as previously stated, some firms would 
already be revising their labels during the 2-year compliance period 
and would bear a lesser burden. We seek comments on our estimates, 
including whether this proposed rule triggers costs for the 408 firms 
which produce for both U.S. consumers and for export.

E. Benefits of the Proposed Regulation

    This proposed rule would be beneficial in a number of ways. The 
proposed rule would align safety standards to the current scientific 
knowledge and thinking on laser safety and update rules that were 
established before many current laser products existed. In doing so, we 
expect there to be benefits to public health. The benefits associated 
with improved laser safety, such as the reduced risk of retinal injury, 
have been described qualitatively earlier in this document. Such 
benefits, however, are difficult to quantify and, therefore, are not 
included here.
    Taking steps towards the harmonization of laser safety standards 
potentially benefits consumers through lower prices. Requiring foreign 
laser manufacturers to maintain completely separate safety standards 
for the U.S. market increases the cost of doing business. Reducing such 
divergences encourages trade, increases social welfare, and benefits 
U.S. consumers. These benefits are difficult to quantify and are not 
included in this analysis. Nevertheless, we have estimated the U.S. 
market for laser products to be $3.4 billion. As summarized above, the 
estimated total annualized costs of this proposed rule are $6.7 
million. Gains to consumers of at least 0.2 percent of sales would be 
enough to outweigh the estimated costs of the proposed rule.
    In this analysis, we limit the quantified benefits to the savings 
that would be expected to be realized by laser manufacturers currently 
exporting and in compliance with IEC standards. Under this proposed 
rule, manufacturers currently complying with two standards would 
generally only need to comply with a single harmonized standard, except 
where the standards differ. Under harmonization, these firms would be 
partially relieved of a burden. The Agency believes these benefits 
could be substantial.
    In its report, ERG noted that most industry representatives 
believed harmonization would be beneficial to the U.S. laser product 
industry (Ref. 9, p. 12). Yet, ERG found it difficult to accurately 
quantify the expected savings from this proposed rule and did not do so 
in their report. In response to a prior proposed rulemaking, the Agency 
received several comments from industry encouraging harmonization of 
laser safety requirements, citing potential administrative savings from 
the elimination of multiple regulatory requirements (Ref. 12). We 
attempt to quantify these administrative benefits from harmonization of 
laser safety standards, but due to the uncertainty in our methodology, 
we request comment on our approach.
    This proposed rule would reduce the expenditures needed to comply 
with two sets of safety standards. This burden would include costs 
associated with physically testing products to satisfy existing FDA and 
IEC standards. Firms currently producing multiple variations of 
products to comply with both sets of standards would save on 
manufacturing costs. In addition, under the proposed rule, if 
finalized, all class IIa products and certain class II products will 
move to less stringent class 1 or class 1M laser classifications, 
thereby reducing the costs of meeting safety requirements. There also 
would be cost savings associated with the reduction of administrative 
elements of compliance, such as the creation of duplicate labeling and 
documentation.
    According to the ERG report, 408 of the 1,283 U.S. firms 
manufacturing laser products are exporters that currently comply with 
multiple standards. The 875 non-exporters manufacture 3,100 products, 
or about 3.5 products per firm. We do not have information on the 
numbers of products for exporting firms, but we assume that firms 
serving a larger customer base would in general have larger product 
assortments. ERG assumed that small firms have, on average, a single 
product, but larger firms have potentially dozens (Ref. 9, Table 2-
6).\7\ As exporters serve a larger potential market, we assume they are 
more likely to be larger, and, for the purposes of this analysis, to 
have an average of 5 products. As we lack hard data to support this 
assumption, we request comment on this estimate. Assuming that the 408 
exporting manufacturers have on average 5 products each results in an 
estimated 2,000 affected products.
---------------------------------------------------------------------------

    \7\ Includes estimates for the average number of products per 
firm for each affected NAICS.
---------------------------------------------------------------------------

    As we previously stated in this document, a manufacturer producing 
for both U.S. and foreign consumers currently must comply with dual 
standards. Compliance with multiple standards might involve the 
production

[[Page 37732]]

of multiple versions of the same product. Such costs would be incurred 
on an annual basis.
    According to ERG's work on compliance costs, the burden of 
modifying a product to comply with safety regulations is estimated to 
be approximately $7,000 (Ref. 9, Table 3-1 and p. 43). This estimate 
assumes small production runs typically faced by non-exporting 
manufacturers. Exporting manufacturers, according to the ERG report, 
would generally have larger production runs and the estimate would be 
higher (Ref. 9, p. 43). So while we use a recurring $7,000 per product 
as an acceptable proxy for the additional cost of production to comply 
with multiple standards, we believe this may be an underestimate.
    Because of uncertainty, we also consider a scenario in which we 
assume the administrative burden of complying with an extra set of 
standards to be equivalent to designing a new label each year. As 
discussed previously in this analysis (see section VI.D.1 of this 
document), ERG has estimated that a labeling change would cost the 
manufacturer approximately $5,000. Thus, reducing the expenditures 
needed to comply with two sets of safety standards would save 
manufacturers $5,000 per product per year. Of course, we realize some 
firms may be producing drastically different product versions to comply 
with both IEC and current FDA standards. In those instances, firms 
would see substantially higher benefits from harmonization.
    Assuming 2,000 products are manufactured by exporters, the 
estimated annual benefit would be $14.3 million ($7,004 per product x 
2,040 products). These are annual benefits with no one-time impacts. 
Using our lower estimate of $5,000 per product per year, our annual 
benefits would be $10.1 million ($4,966 x 2,040). The total quantified 
annual benefits of this proposed rule fall within a range from $10.1 
million to $14.3 million. For the purposes of our analysis, we use the 
midpoint of this range, which is $12.2 million. Adjusting for 9.77 
percent inflation, the annual benefits would be $13.4 million.
    As previously noted in this document, we do not attempt to quantify 
the public health benefits of this proposed rule. Harmonization would 
also be expected to benefit consumers by reducing the cost of products 
sold domestically, thus facilitating trade.
    We also believe there would be difficult-to-quantify benefits to 
having a globally recognized scientific standard and to ensuring that 
manufacturers selling finished laser products to end users were 
properly certifying and/or registering their products.

F. Summary of Costs and Benefits

    The total costs and benefits are summarized in Table 2 of this 
document. The estimated total cost of this proposed rule, annualized at 
7 percent, is approximately $6.7 million. The annualized cost at 3 
percent is $5.9 million. The estimated total annualized benefit of this 
proposed rule is approximately $13.4 million.
    The annualized benefits exceed the annualized costs by 
approximately $6.7 million at a 7 percent discount rate and $7.5 
million at a 3 percent discount rate. Moreover, as stated earlier in 
the report, we may have overestimated costs and underestimated 
benefits. Thus, net benefits, annualized at 7 percent, may be larger 
than $5.9 million (and larger than $6.7 million annualized at 3 
percent).

                 Table 2--Summary of Costs and Benefits
------------------------------------------------------------------------
                                                               Total
                         Impact                             (millions)
------------------------------------------------------------------------
Total Annualized Costs at 7 percent.....................            $6.7
Total Annualized Costs at 3 percent.....................             5.9
Total Annualized Benefits...............................            13.4
Net Benefits (Costs) at 7 percent.......................             6.7
Net Benefits (Costs) at 3 percent.......................             7.5
------------------------------------------------------------------------

G. Impact on Small Entities

    FDA recognizes that many of the manufacturers that would be 
required to modify their products to comply with the harmonized 
standard may be small entities with limited resources. As a result, the 
Agency has prepared this initial Regulatory Flexibility Analysis and 
requests public comment regarding the economic impact of the proposed 
rule on small entities.
    ERG estimates 875 firms may incur increased costs as a result of 
one or more of the provisions in this proposed rule. Of these affected 
firms, 811, or 93 percent are small entities as defined by the criteria 
established by the Small Business Administration (SBA) and listed in 
Table 4-1 of the ERG Report (Ref. 9, p. 57). Under these criteria, 
firms are small entities if they have fewer than a certain critical 
number of employees. Depending on the relevant NAICS classification, 
this critical number of employees could be 500, 750, or 1,000 
employees. ERG has extended this to estimate impacts on very small 
firms with fewer than 20 employees.
    Table 4-2 of the ERG Report provides a breakdown of the estimated 
compliance costs as a percentage of firm revenues for each of the 
affected NAICS classes, by firm size.\8\ ERG finds no NAICS category 
for which this percentage exceeds the threshold of three to five 
percent typically used for unequivocally establishing the existence of 
a significant impact (Ref. 13). ERG does identify two NAICS 
classifications with subclasses of small firms facing burdens of 
greater than 1 percent of sales. ERG small firms (defined by ERG as 
having fewer than 20 employees) in NAICS classification 334511 (Search, 
Detection, Navigation, Guidance, and Nautical System & Instrument 
Manufacturing) face an estimated burden of 1.7 percent of sales 
(annualizing at a 7 percent discount rate). ERG small firms (fewer than 
20 employees) in classification 334519 (Other Measuring and Controlling 
Device Manufacturing) face an estimated burden of 1.4 percent of sales. 
The burden on firms in that class with fewer than 500 employees (SBA 
small) is 1 percent. No other NAICS class has a subclass of firms 
facing a burden greater than 0.15 percent of sales. Thus, no small 
entities face significant impacts in any of the other NAICS 
classifications.
---------------------------------------------------------------------------

    \8\ The ERG analysis does not include the cost of obtaining a 
copy of the IEC standards. As the estimated $350 cost would be a 
fraction of a percent of revenues, the impact would be negligible.
---------------------------------------------------------------------------

    The two classifications mentioned previously in this document, 
334511 and 334519, are affected by the provisions associated with the 
repetitive pulse correction factor and testing with the 50 mm aperture. 
ERG estimates there to be 6 affected firms with fewer than 20 employees 
in NAICS 334511 and 44 affected firms with fewer than 20 employees in 
class 334519 (Ref. 9, Table 4-2). Firms in classification 334511 with 
fewer than 750 employees and firms in classification 334519 with fewer 
than 500 employees are defined by the SBA to be small. Thus, all 50 
firms would meet the SBA criteria for small.
    The Agency finds it highly unlikely that all 50 firms necessarily 
face a significant burden from this proposed rule, but we cannot rule 
out the possibility that some small subset of the 50 might face a 
significant impact. The Agency expects the impact among these firms to 
be uneven and that the harmonized standard may have a significant 
impact on a few of them.
    Some of these affected firms, for example, may need to make 
engineering changes to comply with the harmonized

[[Page 37733]]

standard. These changes may be minor or, as stated in the cost section 
of this document, may be more substantial and cost up to $100,000 if 
the difference between the standards is large. Based on our 
understanding of the requirements imposed by this proposed rule and the 
state of the industry in the relevant NAICS classes, we conclude that 
few, if any, firms would be faced with such a burden. The Agency does 
not believe a substantial number of firms would be faced with a 
significant impact.
    We identified and assessed regulatory options to mitigate impacts 
on small entities. We considered allowing manufacturers to continue to 
comply with the current FDA standard indefinitely, thus avoiding 
burdens altogether. We also considered leaving the harmonized standard 
as optional, essentially extending the provisions of Laser Notice 50 
indefinitely. These alternatives would both be inconsistent with the 
goal of establishing a more uniform recognized safety standard for 
laser products. Multiple existing standards or indefinite compliance 
periods could increase confusion as to proper safety standards. 
Indefinite compliance periods with multiple standards may dissuade 
risk-averse firms from abandoning the current FDA standard. In an 
attempt to strike a balance between the need for a recognized safety 
standard while minimizing the burdens on affected entities, the Agency 
would allow for a 2-year effective date to minimize the burden on 
affected entities.
    The Agency also analyzed modifying the harmonized standard for 
certain laser classes to bring such firms into compliance. That is, the 
Agency considered adopting certain modifications to the IEC standards 
so as not to move firms out of compliance due to the repetitive pulse 
correction factor or the 50 mm testing aperture. Such a move would have 
eliminated the costs associated with these specific provisions. This 
alternative would have been inconsistent with the objective of 
establishing a safety standard that is harmonized with current science 
and internationally-recognized standards. Moreover, the benefits 
associated with this alternative would have likely been minimal, 
because few, if any, firms would face large costs in the shift to a 
harmonized standard.
    The Agency believes that the provisions of the proposed rule, 
combined with a 2 year effective date that will give industry ample 
time to make any necessary changes without undue burden, are the best 
approach to establishing a harmonized standard.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision at section 542 of the FD&C Act (21 U.S.C. 360ss) that 
preempts the States from establishing, or continuing in effect, any 
standard with respect to an electronic product which is applicable to 
the same aspect of product performance as a Federal standard prescribed 
pursuant to section 534 of the FD&C Act (21 U.S.C. 360kk) and which is 
not identical to the Federal standard. See Medtronic v. Lohr, 518 U.S. 
470 (1996); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). If this 
proposed rule is made final, the final rule would prescribe a Federal 
standard pursuant to section 534 of the FD&C Act. However, section 542 
of the FD&C Act does not ``prevent the Federal Government or the 
government of any State or political subdivision thereof from 
establishing a requirement with respect to emission of radiation from 
electronic products procured for its own use if such requirement 
imposes a more restrictive standard than that required to comply with 
the otherwise applicable Federal standard.'' 21 U.S.C. 360ss.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). A description of these provisions is given in 
the Description section of this document with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Proposed Amendment to Laser Product Performance Standard.
    Description: Sections 532 through 542 of the FD&C Act (21 U.S.C. 
360ii through 360ss) direct the Secretary of the Department of Health 
and Human Services (the Secretary) to establish and carry out an 
electronic product radiation control program to protect the public from 
unnecessary radiation from electronic products.
    The Agency is proposing to amend its regulation of laser products 
in Sec.  1040.11 by adding a new paragraph (e) which requires that 
manufacturers of laser products intended for DOD use who wish to have 
the exemption from the performance standard that was granted to DOD 
apply to their specific products must obtain a letter from the DOD 
procuring Agency that applies the exemption to the products. The 
exemption letter must be obtained prior to sale and must be retained 
for subsequent sales to any DOD Agency.
    The Agency is proposing to amend its regulation of laser products 
in Sec.  1040.10 by adding new paragraph (a)(3)(iii) that requires 
manufacturers of laser product components or replacement parts to 
maintain a record that identifies the purchaser as the party that will 
certify or register a host product that contains the manufacturer's 
component or replacement part, or identifies the purchaser as a 
supplier who sells the manufacturer's registered laser component or 
replacement part. Records do not need to identify purchasers who 
acquire the product as a replacement part for a certified product for 
purposes other than resale.
    Description of Respondents: Manufacturers and importers of laser 
products.
    FDA estimates the burden of this information collection as follows:

[[Page 37734]]



                                                     Table 3--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                               Number of       Number of     Total annual                                                 operating  and
              21 CFR Section                  respondents    responses per     responses     Average burden per response    Total hours     maintenance
                                                              respondent                                                                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
1040.11(e)................................              25               1              25  0.08 (5 minutes)............               2           $2.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                               Number of       Number of     Total annual        Average burden per                       operating  and
              21 CFR Section                 recordkeepers    records per       records             recordkeeping           Total hours     maintenance
                                                             recordkeeper                                                                      costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(iii)........................              14               4              56  0.17 (10 minutes)...........              10           $2.00
1040.11(e)................................              25               1              25  0.17 (10 minutes)...........               4           $2.00
                                           -------------------------------------------------------------------------------------------------------------
    Total Hours...........................  ..............  ..............  ..............  ............................  ..............              14
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Reporting Burden: For Sec.  1040.11(e) we estimate 25 respondents 
would need to collect information once per year for a total of 25 
correspondences. Manufacturers would request information from DOD and 
this process is estimated to take 5 minutes (.08 hours) per letter, for 
a total of 2 hours.
    Recordkeeping Burden: For Sec.  1040.10(a)(3)(iii) we estimate 14 
respondents would generate 4 records per year for a total of 56 
records. Under the existing regulation at Sec.  1002.31, we require 
records to be kept for 5 years. Since many companies correspond 
regularly with customers as a matter of business practice, the 
recordkeeping burden for maintaining a file of documentation obtained 
from customers (correspondence, cancelled check, purchase agreement) 
over the course of 5 years are considered usual and customary, although 
FDA requests comment on whether this recordkeeping requirement, 
including its duration, continues to be appropriate. Documentation 
obtained actively (electronic copy of company Web site or brochure, 
proof of business license, signed agreement, etc.) could be obtained 
via fax or email attachment. This task is expected to be performed by 
clerical staff, who prepare a letter, email or fax requesting the 
information from the manufacturer or supplier, and respondent 
manufacturer or supplier clerical staff, who prepare a response that 
verifies the purchaser is a bona fide business that will certify or 
register the component or replacement part as a manufacturer or sell 
the part as a supplier. This process is estimated to take 10 minutes 
(0.17 hours) per record to scan and email or photocopy and mail 
documentation, for a total of 10 hours annually.
    For Sec.  1040.11(e) we estimate 25 respondents would need to 
collect information once per year for a total of 25 records. 
Manufacturers would file the information received from DOD and this 
process is estimated to take 10 minutes (0.17 hours) per record, for a 
total of 4 hours.
    The operating and maintenance costs associated with this 
information collection are based upon correspondence costs (postage) 
for non-email communications for 20 percent of respondents (8), 
estimated at $0.50 per correspondence for a total of $4.00.
    Time estimates are based on experience performing similar 
activities in FDA's Division of Mammography Quality and Radiation 
Programs, CDRH.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the title ``Proposed Amendment to Laser Product 
Performance Standard.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.
    This proposed rule also refers to currently approved collections of 
information found in FDA regulations. The collections of information in 
Sec.  1040.10(a)(3)(i), (h)(1)(i) through (h)(1)(vi), (h)(2)(i) and 
(h)(2)(ii) have been approved under OMB control number 0910-0025.
    The labeling requirements in Sec.  1040.10(g) are not subject to 
review under the PRA because they are a public disclosure of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public (5 CFR 
1320.3(c)(2)).

IX. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at https://www.regulations.gov. (FDA 
has verified the Web site addresses in this reference section, but FDA 
is not responsible for any subsequent changes to the Web sites

[[Page 37735]]

after this document publishes in the Federal Register.)

1. Israeli, D., Y. Hod, and O. Geyer, ``Laser Pointers: Not to be 
Taken Lightly,'' British Journal of Ophthalmology, 84 (5), 554d 
(2000).
2. Seeley, D., ``Laser Pointer Causes Eye Injuries,'' ILSC 
Proceedings of the International Laser Conference, pp. 560-563 
(1997).
3. Sell, C. H. and J. S. Bryan, ``Maculopathy From Handheld Diode 
Laser Pointer,'' Archives of Ophthalmology, 117: 1557-1558 (1999).
4. ``Circular No. A-119--Federal Register (Federal Participation in 
the Development and Use of Voluntary Consensus Standards and in 
Conformity Assessment Activities),'' https://www.whitehouse.gov/omb/circulars/a119/a119.html, accessed May 2008.
5. ``Laser Products--Conformance with IEC 60825--1, Am. 2 and IEC 
60601-2-22 (Laser Notice 50)'' (66 FR 39049, July 26, 2001) (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm).
6. Barkana, Yaniv and Michael Belkin, ``Laser Eye Injuries,'' Survey 
of Opthalmology, 44: 459-478, 2000.
7. Mainster, Martin A., Bruce E. Stuck, and Jeremiah Brown, 
``Assessment of Alleged Retinal Laser Injuries,'' Archives of 
Ophthalmology,'' 122: 1210-1217, 2004.
8. Kincade, Kathy and Stephen G. Anderson, ``Laser Marketplace 2007: 
Laser Industry Navigates its Way Back to Profitability.'' LaserFocus 
World, January 2007, https://www.laserfocusworld.com/articles/print/volume-43/issue-1/features/laser-marketplace-2007-laser-industry-navigates-its-way-back-to-profitability.html.
9. Eastern Research Group ``Technical Quality and Economic 
Implications of International Harmonization of Laser Performance 
Standards--An Update,'' Eastern Research Group, September 2005.
10. Universal Currency Converter, https://www.xe.com/ucc/, accessed 
April 21, 2010.
11. ``Guidance on the Department of Defense Exemption from the FDA 
Performance Standard for Laser Products (Laser Notice No. 52),'' 
issued July 12, 2002.
12. ``Laser Products; Proposed Amendment to Performance Standard'' 
(64 FR 14180, March 24, 1999).
13. U.S. Department of Health & Human Services, ``Guidance on Proper 
Consideration of Small Entities in Rulemakings of the U.S. 
Department of Health and Human Services,'' May 2003.
14. Wyrsch, Stefan, M.D., Philipp B. Baenninger, M.D., and Martin K. 
Schmid, M.D., ``Retinal Injuries from a Handheld Laser Pointer'' New 
England Journal of Medicine 2010; 363:1089-1091 AND.
15. ``Party Laser `Blinds' Russian Ravers,'' New Scientist, 14 July 
2008, https://www.newscientist.com/article/dn14310?DCMP=ILC-tabView&nsref=dn14310.
16. Sliney, David H., John Mellerio, Veit-Peter Gabel, and Karl 
Shulmeister, ``What is the Meaning of Threshold in Laser Injury 
Experiments? Implications for Human Exposure Limits.'' Health 
Physics, 82(3):335-347; 2002.

List of Subjects

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

21 CFR Part 1010

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

21 CFR Part 1040

    Electronic products, Incorporation by reference, 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 1002, 1010, and 1040 be amended as follows:

PART 1002--RECORDS AND REPORTS

0
1. The authority citation for 21 CFR part 1002 is revised to read as 
follows:

    Authority:  21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374, 393.


0
2. Section 1002.1 is amended by revising Table 1 to read as follows:


Sec.  1002.1  Applicability.

* * * * *

                                                  Table 1--Record and Reporting Requirements by Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Manufacturer                                                                   Dealer &
-------------------------------------------------------------------------------------------------------------------------------------------  Distributor
                                                                                                                                           -------------
                                                            Product                    Abbreviated     Annual        Test     Distribution  Distribution
                                                            reports     Supplemental      reports     reports      records    records Sec.  records Sec.
                        Products                              Sec.      reports Sec.       Sec.         Sec.         Sec.       1002.30(b)       Sec.
                                                            1002.10        1002.11       1002.12      1002.13     1002.30(a)       \2\       1002.40 and
                                                                                                                     \1\                       1002.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY \3\ (1020.30, 1020.31, 1020.32,
 1020.33):
    Computed tomography.................................            X               X  ...........            X            X             X             X
    X-ray system \4\....................................            X               X  ...........            X            X             X             X
    Tube housing assembly...............................            X               X  ...........            X            X             X  ............
    X-ray control.......................................            X               X  ...........            X            X             X             X
    X-ray high voltage generator........................            X               X  ...........            X            X             X             X
    X-ray table or cradle...............................  ...........  ..............            X  ...........            X             X             X
    X-ray film changer..................................  ...........  ..............            X  ...........            X             X  ............
    Vertical cassette holders mounted in a fixed          ...........  ..............            X  ...........            X             X             X
     location and cassette holders with front panels....
    Beam-limiting devices...............................            X               X  ...........            X            X             X             X
    Spot-film devices and image intensifiers                        X               X  ...........            X            X             X             X
     manufactured after April 26, 1977..................
    Cephalometric devices manufactured after February     ...........  ..............            X  ...........            X             X  ............
     25, 1978...........................................
    Image receptor support devices for mammographic X-    ...........  ..............            X  ...........            X             X             X
     ray systems manufactured after September 5, 1978...
CABINET X RAY (1020.40):
    Baggage inspection..................................            X               X  ...........            X            X             X             X
    Other...............................................            X               X  ...........            X            X             X  ............
PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-
 RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY:
    Medical.............................................  ...........  ..............            X            X            X             X  ............
    Analytical..........................................  ...........  ..............            X            X            X             X  ............
    Industrial..........................................  ...........  ..............            X            X            X             X  ............
TELEVISION PRODUCTS (1020.10):

[[Page 37736]]

 
    <25 kilovolt (kV) and <0.1 milliroentgen per hour     ...........  ..............            X        X \6\  ...........  ............  ............
     (mR/hr IRLC5 6.....................................
    >=25kV and <0.1mR/hr IRLC 5.........................            X               X  ...........            X  ...........  ............  ............
    >=0.1mR/hr IRLC 5...................................            X               X  ...........            X            X             X  ............
MICROWAVE/RF:
    MW ovens (1030.10)..................................            X               X  ...........            X            X             X  ............
    MW diathermy........................................  ...........  ..............            X  ...........  ...........  ............  ............
    MW heating, drying, security systems................  ...........  ..............            X  ...........  ...........  ............  ............
    RF sealers, electromagnetic induction and heating     ...........  ..............            X  ...........  ...........  ............  ............
     equipment, dielectric heaters (2-500 megahertz)....
OPTICAL:
    Phototherapy products...............................            X               X  ...........  ...........  ...........  ............  ............
    Laser products (1040.10, 1040.11)
        Class 1 lasers and products containing such                 X  ..............  ...........            X            X  ............  ............
         lasers \7\.....................................
        Class 1 laser products containing class 1M, 2,              X  ..............  ...........            X            X             X  ............
         2M, 3R lasers \7\..............................
        Class 1M, 2, 2M, 3R lasers and products other               X               X  ...........            X            X             X             X
         than class 1 products containing such lasers
         \7\............................................
        Class 3B and 4 lasers and products containing               X               X  ...........            X            X             X             X
         such lasers \7\................................
    Sunlamp products (1040.20)
        Lamps only......................................            X  ..............  ...........  ...........  ...........  ............  ............
        Sunlamp products................................            X               X  ...........            X            X             X             X
    Mercury vapor lamps (1040.30)
        T lamps.........................................            X               X  ...........            X  ...........  ............  ............
        R lamps.........................................  ...........  ..............            X  ...........  ...........  ............  ............
ACOUSTIC:
    Ultrasonic therapy (1050.10)........................            X               X  ...........            X            X             X             X
    Diagnostic ultrasound...............................  ...........  ..............            X  ...........  ...........  ............  ............
    Medical ultrasound other than therapy or diagnostic.            X               X  ...........  ...........  ...........  ............  ............
    Nonmedical ultrasound...............................  ...........  ..............            X  ...........  ...........  ............  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\ The requirement includes Sec.  Sec.   1002.31 and 1002.42, if applicable.
\3\ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).
\4\ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).
\5\ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (Sec.   1020.10(c)(3)(iii)).
\6\ Annual report is for production status information only.
\7\ Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
3. 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, 393.

0
4. Section 1010.1 is revised to read as follows:


Sec.  1010.1  Scope.

    The standards listed in this subchapter are prescribed pursuant to 
section 534 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360kk) and are applicable to electronic products as specified herein to 
control electronic product radiation from such products. Standards so 
prescribed are subject to amendment or revocation and additional 
standards may be prescribed as are determined necessary for the 
protection of the public health and safety.
0
5. 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, the Director, Center 
for Devices and Radiological Health (or delegate) may approve an 
alternate means by which such certification may be provided. Approval 
may be granted either upon written application by the manufacturer or 
on the Director's own initiative.
0
6. Section 1010.3 is amended by revising paragraph (b) 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, the Director, Center for Devices and Radiological Health (or 
delegate) may approve an alternate means by which such identification 
may be provided. Approval may be granted either upon written 
application by the manufacturer or on the Director's own initiative.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
7. The authority citation for 21 CFR part 1040 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381, 393.

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8. Section 1040.5 is added to read as follows:


Sec.  1040.5  Standards incorporated by reference.

    (a) Certain material from the standards identified in paragraph (b) 
of this section relating to lasers is incorporated by reference into 
this part with the approval of the Director of the Federal Register 
under 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect copies of the 
standards identified in this section at FDA's Electronic Products 
Branch, Office of Communication, Education, and Radiation Programs,

[[Page 37737]]

Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver 
Spring, MD 20993, 301-796-5710; or FDA's Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; or the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to 
https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In addition, you may obtain copies of 
these standards from the sources listed in paragraph (b) of this 
section.
    (b) International Electrotechnical Commission (IEC), 3, rue de 
Varemb[eacute], P.O. Box 131, CH-1211 GENEVA 20, Switzerland (Phone: 
+41 22 919 02 11, Fax: +41 22 919 03 00, email: inmail@iec.ch), or the 
American National Standards Institute, Attn: Customer Service 
Department, 25 West 43d St., 4th Floor, New York, NY 10036, USA (Phone: 
+1 212 642 4980, Fax: +1 212 302 1286, email: info@ansi.org).
    (1) IEC 60601-2-22 (IEC 60601-2-22:2007), Medical electrical 
equipment--Part 2-22: Particular requirements for basic safety and 
essential performance of surgical, cosmetic, therapeutic and diagnostic 
laser equipment, Edition 3.0, May 2007, incorporated by reference in 
Sec. Sec.  1040.10 and 1040.11 except as otherwise noted in those 
sections.
    (2) IEC 60825-1 (IEC 60825-1:2007), Safety of laser products--Part 
1: Equipment classification and requirements, Edition 2.0, March 2007, 
including Corrigendum 1, dated August 2008, incorporated by reference 
in Sec. Sec.  1040.10 and 1040.11 except as otherwise noted in those 
sections.
0
9. 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 [A DATE WILL BE ADDED 2 YEARS AFTER 
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], except 
when:
    (1) Such a laser product is sold to a manufacturer of an electronic 
product for use as a component (or replacement for such component) in 
an electronic product subject to this standard, or
    (2) Such a laser product is sold by or for a manufacturer of an 
electronic product for use as a component (or replacement for such 
component) in an electronic product subject to this standard, provided 
that the component (or replacement for such component) laser product:
    (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,
    (ii) Is labeled with a statement that it is designated for use 
solely as a component or replacement for such component in an 
electronic product subject to this standard 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
    (3) The manufacturer of the component (or replacement) laser 
product, if manufactured after August 20, 1986,
    (i) Registers and provides a listing by type of component (or 
replacement) laser products manufactured that includes the product 
name, model number, and laser medium or emitted wavelength(s). The 
registration and listing must include the name and address of the 
manufacturer and must be submitted to the Director, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993-0002;
    (ii) Maintains and allows access to any sales, shipping, or 
distribution records that identify the purchaser of the component (or 
replacement) laser product by name and address, the product type, the 
number of units sold, and the date of sale (shipment). These records 
must be maintained and made available as specified in Sec.  1002.31 of 
this subchapter; and
    (iii) Documents that the purchaser of such laser product is a 
manufacturer as defined in Sec.  1000.3(n) of this subchapter who will 
incorporate the component (or replacement for such component) into a 
certified laser product, or that the purchaser is another component (or 
replacement) supplier excluded from applicability of the standard as 
described in paragraphs (a)(1) or (a)(2) of this section. These records 
must be maintained and made available as specified in Sec.  1002.31 of 
this subchapter.
    Note to paragraph (a): Sections 1040.10 and 1040.11 are not 
applicable to light emitting diodes (LEDs) or products containing LEDs 
unless such products are also laser products as defined in Sec.  
1040.10(b)(4).
    (b) Definitions. (1) The numbered definitions in clause 3 of IEC 
60825-1:2007 that apply to laser products are incorporated by reference 
(see Sec.  1040.5), except as otherwise noted in this section.
    (2) ``Children's toy laser product'' means a product that is 
manufactured, designed, intended or promoted for use by children under 
14 years of age.
    (3) ``Invisible radiation'' means laser or collateral radiation 
having wavelengths equal to or greater than 180 nanometers (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).
    Note to paragraph (b)(3): Although vision scientists consider the 
wavelength ranges from about 380 to 400 nm and from 700 to about 780 nm 
to be visible, these ranges are treated as invisible in this standard 
because of the reduced visual sensation.
    (4) ``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 is also a 
laser product.
    (5) ``Protective housing'' means those portions of a laser product 
that prevent human access to laser radiation as required by subclause 
4.2.1 of IEC 60825-1:2007 (incorporated by reference, see Sec.  
1040.5).
    (6) The definitions from the following subclauses of IEC 60825-
1:2007 are not applicable under this section:
    (i) 3.4 administrative control;
    (ii) 3.15 beam expander;
    (iii) 3.42 laser controlled area;
    (iv) 3.44 laser hazard area;
    (v) 3.47 laser safety officer;
    (vi) 3.61 nominal ocular hazard area;
    (vii) 3.62 nominal ocular hazard distance.
    (7) The reference to IEC 60050-845 in the first paragraph of Clause 
3 of IEC 60825-1:2007 does not apply.
    (8) ``Must'' as used in Sec. Sec.  1040.10 and 1040.11 and 
``shall'' as used in Sec. Sec.  1040.10, 1040.11, IEC 60825-1:2007, and 
IEC 60601-2-22:2007 (incorporated by reference, see Sec.  1040.5) are 
equivalent in meaning and signify a requirement.
    (9) In addition to the wavelengths specified in the definition at 
subclause 3.24 of IEC 60825-1:2007 (incorporated by reference, see 
Sec.  1040.5), collateral radiation includes x-radiation. Collateral 
radiation includes but is not limited to electronic product radiation 
that may arise from a high voltage laser

[[Page 37738]]

power supply, laser medium flashlamp excitation, laser tube plasma 
glow, or secondary radiation from a work piece.
    (c) Classification of laser products--(1) All laser products. Laser 
products shall be classified in accordance with subclauses 8.1, 8.2, 
and 8.3 of IEC 60825-1:2007 (incorporated by reference, see Sec.  
1040.5).
    (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 accessible emission of laser 
radiation when so removed.
    (d) Accessible emission limits--(1) Accessible emission limits for 
laser radiation. The requirements of the accessible emission limits in 
Tables 4, 5, 6, 7, 8, 9, and 10 of IEC 60825-1:2007 (incorporated by 
reference, see Sec.  1040.5).
    (2) Accessible emission limits for collateral radiation from laser 
products. (i) Accessible emission limits for collateral radiation 
having wavelengths greater than 180 nm but less than or equal to 1.0 X 
10\6\ nm are identical to the accessible emission limits for Class 1 
laser radiation for emission durations less than or equal to 100 
seconds.
    (ii) Accessible emission limits for collateral radiation within the 
x-ray range of wavelengths is 0.5 milliroentgen in an hour, averaged 
over a cross-section parallel to the external surface of the product, 
having an area of 10 square centimeters with no dimension greater than 
5 centimeters (cm).
    (e) Tests for determination of compliance--(1) Tests for 
certification. Tests on which certification under Sec.  1010.2 of this 
subchapter is based must account for all errors and statistical 
uncertainties in the measurement process.
    (2) Rules and tests for classification. Clause 9 of IEC 60825-
1:2007 (incorporated by reference, see Sec.  1040.5) applies, except 
that the portion of subclause 9.1 which prescribes that tests must be 
made under each and every reasonably foreseeable single fault condition 
is not applicable.
    (f) Performance requirements. Each laser product must comply with 
the applicable performance requirements as specified in the subclauses 
cited in paragraphs (f)(1) through (f)(5) and (f)(7) through (f)(11) of 
this section from IEC 60825-1:2007, Clause 4 (incorporated by 
reference, see Sec.  1040.5) except as otherwise noted.
    (1) Protective housing. The requirements for protective housings 
are found in subclauses 4.2.1, 4.2.2, and 4.12 of IEC 60825-1:2007.
    (2) Safety interlocks. The requirements for safety interlocks are 
found in subclause 4.3 of IEC 60825-1:2007.
    (3) Remote interlock connector. Follow the requirements of 
subclause 4.4 of IEC 60825-1:2007. The following requirement is added 
to the requirements of subclause 4.4: The electrical potential 
difference between the terminals must not be greater than 130 root-
mean-square volts.
    (4) Security master control. Follow the requirements of subclause 
4.6 of IEC 60825-1:2007, except for the second sentence. The following 
requirement is added to the requirements of subclause 4.6: The key may 
be removable and in the absence of the key, there shall be a means to 
terminate production of laser radiation.
    (5) Laser radiation emission indicator. Follow the requirements 
found in subclause 4.7 of IEC 60825-1:2007. The following requirement 
is added to those in subclause 4.7: The warning shall occur 
sufficiently prior to emission of such radiation to allow appropriate 
action to avoid exposure to the laser radiation.
    (6) Beam stop or attenuator. Subclause 4.8 of IEC 60825-1:2007 is 
not applicable. The following is instead applicable:
    (i) Each laser system classified as a Class 3B or 4 laser product, 
must be provided with one or more permanently attached means, other 
than laser energy source switch(es), electrical supply main connectors, 
or the security 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, 1M, 2, or 2M as 
applicable.
    (ii) Upon written application by the manufacturer or on the 
initiative of the Director, Center for Devices and Radiological Health, 
the Director may, upon determination that the configuration, design, or 
function of the laser product would make compliance with this 
requirement unnecessary, approve alternate means to accomplish the 
radiation protection provided by the beam stop or attenuator.
    (7) Location of controls. Follow the requirements of subclause 4.9 
of IEC 60825-1:2007.
    (8) Viewing optics. Follow the requirements of subclause 4.10 of 
IEC 60825-1:2007.
    (9) Scanning safeguard. Follow the requirements of subclause 4.11 
of IEC 60825-1:2007.
    (10) Manual reset mechanism. Follow the requirements of subclause 
4.5 of IEC 60825-1:2007.
    (11) Environmental conditions. Subclause 4.13 of IEC 60825-1:2007 
applies except the references to IEC 61010-1, Safety requirements for 
electrical equipment for measurement, control, and laboratory use--Part 
1--General requirements, 2d edition, 2001-02, in subclause 4.13 are not 
applicable.
    (12) Collateral radiation. The protective housing of laser products 
must prevent human access to collateral radiation that exceeds the 
limits for collateral radiation as specified in Sec.  1040.10(d)(2). 
Subclause 4.14.2 of IEC 60825-1:2007, Collateral radiation, is not 
applicable.
    (13) Non-optical hazards. Subclause 4.14.1 of IEC 60825-1:2007, 
Non-optical hazards, is not applicable.
    (g) Labeling requirements. In addition to the requirements of 
Sec. Sec.  1010.2 and 1010.3 of this subchapter, each laser product 
must comply with the applicable labeling requirements of this 
paragraph. Clause 5 of IEC 60825-1:2007 (incorporated by reference, see 
Sec.  1040.5) applies, except as otherwise noted in this paragraph.
    (1) Applicability. The second and third paragraphs of subclause 5.1 
are not applicable.
    (2) Alternate labeling. If the labeling prescribed in subclauses 
5.1 through 5.8 of IEC 60825-1:2007 are not used, the following 
alternative labeling shall be used:
    (i) Class 1M designation and warning. Each Class 1M laser product 
must have a label bearing the following wording:
    ``LASER RADIATION DO NOT VIEW DIRECTLY WITH OPTICAL INSTRUMENTS 
CLASS 1M LASER PRODUCT''
    Instead of affixing this label to the Class 1M laser product, the 
manufacturer may include the specified warning in the user 
instructions.
    (ii) Class 2 and 2M designations and warnings. (A) Each Class 2 
laser product must have affixed a label bearing the warning logotype A 
(Figure 1 in this paragraph) and include 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.''

[[Page 37739]]

[GRAPHIC] [TIFF OMITTED] TP24JN13.000

    (B) Each Class 2M laser product must have affixed a label bearing 
the warning logotype A (Figure 1 of this paragraph) and include 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 2M LASER PRODUCT.''

    (iii) Class 3R and 3B designations and warnings. (A) Each Class 3R 
laser product with accessible radiation in the wavelength range from 
400 nm to 1400 nm must have affixed a label bearing the warning 
logotype A (Figure 1 of this paragraph) and include the following 
wording:


[Position 1 on the logotype]

    ``LASER RADIATION--AVOID DIRECT EYE EXPOSURE''; and,


[Position 3 on the logotype]

    ``CLASS 3R LASER PRODUCT.''

    (B) Each Class 3R laser product with accessible radiation outside 
the wavelength range from 400 nm to 1400 nm must have affixed a label 
bearing the warning logotype A (Figure 1 of this paragraph) and include 
the following wording:


[Position 1 on the logotype]

    ``LASER RADIATION--AVOID DIRECT EXPOSURE TO BEAM''; and,


[Position 3 on the logotype]

    ``CLASS 3R LASER PRODUCT.''

    (C) Each Class 3B laser product must have affixed a label bearing 
the warning logotype B (Figure 2 of this paragraph) and include the 
following wording:


[Position 1 on the logotype]

    ``LASER RADIATION--AVOID EXPOSURE TO BEAM''; and,


[Position 3 on the logotype]

    ``CLASS 3B LASER PRODUCT''.

[[Page 37740]]

[GRAPHIC] [TIFF OMITTED] TP24JN13.001

    (iv) Class 4 designation and warning. Each Class 4 laser product 
must have affixed a label bearing the warning logotype B (Figure 2 of 
this paragraph) and include 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.''

    (v) Radiation output information on warning logotype. Each Class 
1M, 2, 2M, 3R, 3B, and 4 laser product must 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 emitted 
wavelength(s).
    (3) Additional wording. In addition to the wording for labels for 
access panels as specified in subclause 5.9 of IEC 60825-1:2007 
(incorporated by reference, see Sec.  1040.5), the following wording is 
required.
    (i) ``CAUTION--Hazardous electromagnetic radiation when open'' for 
collateral radiation in excess of the accessible emission limit in 
paragraph (d)(2)(i) of this section.
    (ii) ``CAUTION--Hazardous x-rays when open'' for collateral 
radiation in excess of the accessible emission limit in paragraph 
(d)(2)(ii) of this section.
    (4) 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 specified in 
paragraph (d)(2) of this section.
    (5) Visible and/or invisible laser radiation. Subclauses 5.10 and 
5.11 of IEC 60825-1:2007 (incorporated by reference, see Sec.  1040.5) 
are applicable.
    (6) 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, or 
service, as appropriate. If 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, the Director, 
Center for Devices and Radiological Health, on the Director's own 
initiative or upon written application by the manufacturer, may 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 must provide or cause to be provided with any user 
instruction or operation manual that is regularly supplied with the 
product or, if a manual is not so supplied, must provide 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 of paragraph (d) of this section determined using the 
tests prescribed under paragraph (e) of this section, and a schedule of 
maintenance necessary to keep the product in compliance with this 
section and, if applicable, with 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 radiation 
detectable in each direction in excess of the accessible emission 
limits of Class 1.
    (iii) Legible reproductions (color optional) of all labels and 
hazard warnings required by paragraph (g) of this section and, if 
applicable, by Sec.  1040.11, are to be affixed to the laser product or 
provided with the laser product, including all required information and 
warnings. The corresponding position of each label affixed to the 
product must 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 must 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 as 
specified

[[Page 37741]]

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, with Sec.  1040.11.
    (vi) For Class 1M and 2M laser products, an additional warning is 
required. This warning must state that viewing the laser output with 
optical instruments may result in an eye hazard for Class 1M or an 
increased eye hazard for Class 2M.
    (2) Purchasing and servicing information. Manufacturers of laser 
products must provide or cause to be provided:
    (i) In all catalogs, specification sheets, and descriptive 
brochures pertaining to each laser product, a statement of the class 
designation of the laser product.
    (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 radiation safety procedures 
during service. The radiation safety procedures must include:
    (A) Precautions to be taken to avoid possible exposure of service 
and other personnel to hazardous levels of laser and collateral 
radiation,
    (B) A listing of controls and procedures that could be utilized by 
persons other than the manufacturer or the manufacturer's agents to 
increase the hazard by increasing accessible levels of radiation,
    (C) A description of the displaceable portions of protective 
housings that could allow human access to hazardous levels of laser or 
collateral radiation, and
    (D) Legible reproductions (color optional) of required labels and 
hazard warnings required by paragraph (g) of this section and, if 
applicable, by Sec.  1040.11, to be affixed to the laser product or 
provided with the laser product.
    (i) Modification of certified laser products. The modification of a 
laser product previously certified under Sec.  1010.2 of this 
subchapter 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 must recertify and re-identify 
the product in accordance with the provisions of Sec. Sec.  1010.2 and 
1010.3 of this subchapter.

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10. Section 1040.11 is revised to read as follows:


Sec.  1040.11  Specific purpose laser products.

    (a) Medical laser products. Each medical laser product must comply 
with all of the applicable requirements of Sec.  1040.10 for laser 
products of its class. In addition, such products must comply with the 
following specified clauses and subclauses of IEC 60601-2-22:2007 and 
IEC 60825-1:2007 (incorporated by reference; see Sec.  1040.5).
    (1) Instructions for use, subclause 201.7.9.2 of IEC 60601-2-
22:2007;
    (2) Protection against unwanted and excessive radiation hazards, 
clause 201.10 of IEC 60601-2-22:2007, except for:
    (i) Applicability to medical LED products, and
    (ii) Emission indicator, subclause 201.10.4(e) of IEC 60601-2-
22:2007, for which subclause 4.7 of IEC 60825-1:2007 is applicable;
    (3) Indication of laser output, subclause 201.12.1.101 of IEC 
60601-2-22:2007;
    (4) Indication of parameters relevant to safety, subclause 
201.12.4.2 of IEC 60601-2-22:2007;
    (5) Calibration procedures, subclause 201.7.9.2.101, 4th dash of 
IEC 60601-2-22:2007;
    (6) Incorrect output, subclause 201.12.4.4 of IEC 60601-2-22:2007; 
and
    (7) Emergency laser stop, subclause 201.12.4.4.101 of IEC 60601-2-
22:2007.
    (b) Surveying, leveling, and alignment laser products. Each 
surveying, leveling, or alignment laser product must comply with all of 
the applicable requirements of Sec.  1040.10 for a Class 1, 2, or 3R 
laser product and must not permit human access to laser radiation in 
excess of the accessible emission limits of Class 3R.
    (c) Demonstration laser products. Each demonstration laser product 
must comply with all of the applicable requirements of Sec.  1040.10 
for a Class 1, 2, or 3R laser product and must not permit human access 
to laser radiation in excess of the accessible emission limits of Class 
3R.
    (d) Children's toy laser products. Each children's toy laser 
product must comply with all of the applicable requirements of Sec.  
1040.10 for a Class 1 laser product and must not permit human access to 
laser radiation in excess of the accessible emission limits of Class 1 
under any conditions of operation, maintenance, service, or failure. If 
a children's toy laser product also meets the definition of a 
demonstration laser product or surveying, leveling, and alignment laser 
product, then the classification limit for children's toy laser product 
applies.
    (e) Laser products procured by the U.S. Department of Defense 
(DOD). Laser products procured by the DOD for use in combat, combat 
training, or that are classified in the interest of national security 
are exempt from the other provisions of this section, and from 
Sec. Sec.  1002.10, 1002.11, 1002.13 of this subchapter, and those 
provisions of Sec.  1040.10 that are determined not to be appropriate 
for the intended military application. In order for this exemption to 
apply to a specific laser product, the manufacturer of such product 
shall obtain a letter from an authorized DOD procuring Agency that 
applies the exemption to the products. The exemption letter must be 
obtained prior to sale and must be retained for subsequent sales of the 
exempted products under the specific contract to any DOD Agency.

    Dated: June 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14846 Filed 6-21-13; 8:45 am]
BILLING CODE 4160-01-P